Key Points: – FOXO Technologies has signed a non-binding agreement to acquire Vector Biosource, a biospecimen sourcing provider. – Vector is expected to generate $800,000 in revenue in 2025 without additional capital. – The acquisition involves Series D Preferred Stock and milestone-based earnout payments.
FOXO Technologies Inc. (NYSE American: FOXO) has announced the execution of a non-binding agreement to acquire Vector Biosource Inc., a provider of information and biospecimen sourcing services for the biotechnology, clinical research, and pharmaceutical industries. The acquisition aligns with FOXO’s strategy of expanding its footprint in healthcare and biotechnology sectors.
The proposed transaction includes an initial payment of $750,000 in Series D Cumulative Redeemable Preferred Stock, with an additional $750,000 in Series D Preferred Stock contingent on Vector meeting specific revenue and cash collection milestones in 2025. Further earnout payments in Series D Preferred Stock are structured based on Vector’s performance in 2026 and 2027. The deal remains subject to definitive agreements, due diligence, and the provision of $1 million in working capital.
Seamus Lagan, CEO of FOXO Technologies, emphasized the strategic benefits of the deal, stating, “We are excited to have reached agreement with Vector to move forward with this strategic acquisition. We were attracted to Vector’s unique position in this healthcare sector and its growth profile, and we are focused on working closely with Vector senior leadership to aggressively expand the Vector platform.”
Vector’s CEO, Frank Dias, Jr., highlighted the advantages of the partnership, noting, “We believe the partnership with FOXO will allow Vector to achieve its near and long-term growth plans by providing growth capital, corporate infrastructure, and potential synergies with other FOXO subsidiaries. We anticipate a significant increase in expected revenues with the provision of growth capital and corporate infrastructure by FOXO.”
FOXO Technologies operates through three subsidiaries:
Rennova Community Health, Inc.: Owner and operator of Scott County Community Hospital (Big South Fork Medical), a critical access hospital in East Tennessee.
Myrtle Recovery Centers, Inc.: A 30-bed behavioral health facility offering inpatient detox, residential treatment, and outpatient services.
Foxo Labs, Inc.: A biotechnology company dedicated to advancing health and lifespan through innovative technology and product solutions.
The acquisition of Vector Biosource marks another step in FOXO’s broader growth strategy as it continues to integrate specialized healthcare and biotechnology services under its corporate umbrella. The deal is expected to close within the next 45 days, subject to regulatory approvals and standard closing conditions.
Key Points: – AstraZeneca is acquiring Belgium-based EsoBiotec for $425 million upfront, with an additional $575 million contingent on milestones. – The deal enhances AstraZeneca’s cell therapy capabilities through EsoBiotec’s ENaBL platform, which enables in vivo immune cell engineering. – The acquisition aligns with AstraZeneca’s broader strategy of leveraging cell therapies, gene editing, and radioconjugates for oncology and immune disorders.
AstraZeneca has announced a significant expansion of its cell therapy pipeline with the planned acquisition of EsoBiotec, a Belgium-based biotech firm specializing in immune cell engineering. The deal, valued at up to $1 billion, consists of a $425 million upfront payment with the potential for an additional $575 million based on development and regulatory milestones. The acquisition is expected to close in the second quarter of 2025.
EsoBiotec’s ENaBL platform represents a transformative approach to cell therapy. Unlike conventional ex vivo cell therapies that require the extraction, modification, and reinfusion of patient cells, ENaBL allows for direct genetic programming of immune cells within the body. This eliminates the need for invasive lymphodepletion procedures and could significantly lower costs while improving accessibility for patients.
AstraZeneca has not yet disclosed specific target indications for EsoBiotec’s platform but has emphasized its potential applications in oncology and immune-mediated diseases. The ENaBL technology could help develop novel cancer treatments or autoreactive cell therapies for conditions such as autoimmune disorders.
This acquisition marks another step in AstraZeneca’s aggressive expansion into the cell therapy space. The pharmaceutical giant has been actively pursuing high-value deals to strengthen its pipeline in this emerging field. In 2022, AstraZeneca acquired TeneoTwo for up to $1.27 billion, securing its T cell engager TNB-486, now renamed AZD0486, which is in Phase III trials for follicular lymphoma and Phase II trials for B cell non-Hodgkin lymphoma.
Further reinforcing its position, AstraZeneca made another major investment in December 2023 with the $1 billion purchase of Gracell Biotechnologies. This deal added GC012F, now known as AZD0120, an investigational CAR T therapy targeting CD19 and BCMA for multiple myeloma and systemic lupus erythematosus.
Beyond acquisitions, AstraZeneca has formed strategic collaborations in cell therapy, including a $245 million agreement with Cellectis in November 2023 and a potential $2 billion partnership with Quell Therapeutics in June 2023. These investments highlight the company’s commitment to leveraging cutting-edge biotechnologies to expand its capabilities in immune modulation and oncology.
As a relative latecomer to the cell therapy market, AstraZeneca is rapidly scaling its presence through acquisitions and partnerships. By integrating EsoBiotec’s ENaBL platform into its pipeline, AstraZeneca positions itself to compete with industry leaders in the race to develop next-generation cell therapies that offer improved efficacy, lower costs, and enhanced patient accessibility.
With this latest acquisition, AstraZeneca continues to build a robust portfolio of cell therapies that could redefine treatment approaches for cancer and immune-related diseases. Investors and industry analysts will be closely monitoring how effectively AstraZeneca integrates these new technologies and translates them into viable commercial therapies.
LOS ALTOS, Calif., March 13, 2025 (GLOBE NEWSWIRE) — Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced that it will present patient reported outcomes data from its pivotal UNI-OLC-201 clinical study characterizing the potential impact of oxylanthanum carbonate (OLC) on the treatment of hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis. These data will be presented at three medical meetings, including the 2025 Annual Dialysis Conference (ADC), March 13-16, 2025, National Kidney Foundation (NKF) Spring Clinical Meetings, April 10-13, 2025, and the 2025 American Nephrology Nurses Association (ANNA) National Symposium, being held on May 1-4, 2025.
Unicycive’s investigational drug OLC leverages proprietary nanoparticle technology to reduce the number and size of pills that patients must take. If approved, OLC may provide patients and their physicians with a welcome new option to control hyperphosphatemia. The New Drug Application (NDA) for OLC was accepted by the U.S. Food and Drug Administration (FDA) for the treatment of hyperphosphatemia in patients with chronic kidney disease on dialysis. The FDA set a Prescription Drug User Fee Act (PDUFA) Target Action Date of June 28, 2025.
“Despite the availability of several approved phosphate binders, hyperphosphatemia remains uncontrolled in 75% of people in the U.S. on dialysis due to challenges of insufficient potency, pill burden and unpalatable formulations. There is a critical need for more effective solutions,” said Shalabh Gupta, M.D., Chief Executive Officer of Unicycive. “Innovative solutions such as OLC that improve phosphate control and minimize pill size and count have the potential to significantly improve adherence, empowering those on dialysis to manage their treatment more effectively.”
Unicycive abstracts to be presented at the upcoming medical meetings include:
ADC
Title: Patient-Reported Outcomes in a Pivotal Clinical Study of Hyperphosphatemia: Oxylanthanum Carbonate Reduces Pill Burden by Half and Improves Adherence – Poster #: A-6870
Presentation Details: Friday, March 14, 5:30-7:30 p.m. PT
Presenting Author: Doug Jermasek
NKF Spring Clinical Meetings
Title: Patient-Reported Outcomes in a Pivotal Clinical Study of Hyperphosphatemia: Oxylanthanum Carbonate Reduces Pill Burden by Half and Improves Adherence – Poster #: G-018
Presentation Details: Thursday, April 10, from 5:15-7:30 p.m. ET
Presenting Author: Guru Reddy, PhD
Title: Pill Burden and Large Tablet Size Are Key Barriers to Phosphate Binder Adherence in Dialysis Patients – Poster #: G-297
Presentation Details: Thursday, April 10, from 5:15-7:30 p.m. ET
Presenting Author: Dr. Hill Gallant, PhD, RD, Associate Professor of Nutrition in the Department of Food Science and Nutrition at the University of Minnesota-Twin Cities
ANNA
Title: Pill Burden and Large Tablet Size Are Key Barriers to Phosphate Binder Adherence in Dialysis Patients
Presentation Details: Friday, May 2, starting at 8:45 a.m. PT
About Oxylanthanum Carbonate (OLC)
Oxylanthanum carbonate is a next-generation lanthanum-based phosphate binding agent utilizing proprietary nanoparticle technology being developed for the treatment of hyperphosphatemia in patients with chronic kidney disease (CKD). OLC has over forty issued and granted patents globally. Its potential best-in-class profile may have meaningful patient adherence benefits over currently available treatment options as it requires a lower pill burden for patients in terms of number and size of pills per dose that are swallowed instead of chewed. Based on a survey conducted in 2022, Nephrologists stated that the greatest unmet need in the treatment of hyperphosphatemia with phosphate binders is a lower pill burden and better patient compliance.1 The global market opportunity for treating hyperphosphatemia is projected to be in excess of $2.28 billion, with the North America accounting for more than $1 billion of that total.2 Despite the availability of several FDA-cleared medications, 75 percent of U.S. dialysis patients fail to achieve the target phosphorus levels recommended by published medical guidelines.3
Unicycive is seeking FDA approval of OLC via the 505(b)(2) regulatory pathway. The NDA submission package is based on data from three clinical studies (a Phase 1 study in healthy volunteers, a bioequivalence study in healthy volunteers, and a tolerability study of OLC in CKD patients on dialysis), multiple preclinical studies, and the chemistry, manufacturing and controls (CMC) data. OLC is protected by a strong global patent portfolio including issued patents on composition of matter with exclusivity until 2031, and with the potential for patent term extension until 2035.
About Hyperphosphatemia
Hyperphosphatemia is a serious medical condition that occurs in nearly all patients with End Stage Renal Disease (ESRD). If left untreated, hyperphosphatemia leads to secondary hyperparathyroidism (SHPT), which then results in renal osteodystrophy (a condition similar to osteoporosis and associated with significant bone disease, fractures and bone pain); cardiovascular disease with associated hardening of arteries and atherosclerosis (due to deposition of excess calcium-phosphorus complexes in soft tissue). Importantly, hyperphosphatemia is independently associated with increased mortality for patients with chronic kidney disease on dialysis. Based on available clinical data to date, over 80% of patients show signs of cardiovascular calcification by the time they become dependent on dialysis.4
Dialysis patients are already at an increased risk for cardiovascular disease (because of underlying diseases such as diabetes and hypertension), and hyperphosphatemia further exacerbates this. Treatment of hyperphosphatemia is aimed at lowering serum phosphate levels via two means: (1) restricting dietary phosphorus intake; and (2) using, on a daily basis, and with each meal, oral phosphate binding drugs that facilitate fecal elimination of dietary phosphate rather than its absorption from the gastrointestinal tract into the bloodstream.
About Unicycive Therapeutics
Unicycive Therapeutics is a biotechnology company developing novel treatments for kidney diseases. Unicycive’s lead drug candidate, oxylanthanum carbonate (OLC), is a novel investigational phosphate binding agent being developed for the treatment of hyperphosphatemia in chronic kidney disease patients on dialysis. Positive pivotal trial results were reported in June 2024 for OLC, and a New Drug Application (NDA) is under review by the U.S. Food and Drug Administration (FDA) with a Prescription Drug User Fee Act (PDUFA) Target Action Date of June 28, 2025. OLC is protected by a strong global patent portfolio including an issued patent on composition of matter with exclusivity until 2031, and with the potential patent term extension until 2035 after OLC approval. Unicycive’s second asset, UNI-494, is a patent-protected new chemical entity in clinical development for the treatment of conditions related to acute kidney injury. UNI-494 has successfully completed a Phase 1 trial. For more information, please visit Unicycive.com and follow us on LinkedIn, X, and YouTube.
Forward-looking statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified using words such as “anticipate,” “believe,” “forecast,” “estimated” and “intend” or other similar terms or expressions that concern Unicycive’s expectations, strategy, plans or intentions. These forward-looking statements are based on Unicycive’s current expectations and actual results could differ materially. There are several factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results; our clinical trials may be suspended or discontinued due to unexpected side effects or other safety risks that could preclude approval of our product candidates; risks related to business interruptions, which could seriously harm our financial condition and increase our costs and expenses; dependence on key personnel; substantial competition; uncertainties of patent protection and litigation; dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties related to market conditions and other factors described more fully in the section entitled ‘Risk Factors’ in Unicycive’s Annual Report on Form 10-K for the year ended December 31, 2023, and other periodic reports filed with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Unicycive specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.
1Reason Research, LLC 2022 survey. Results here. 2 Fortune Business Insights™, Hyperphosphatemia Treatment Market, 2023-2030 3 US-DOPPS Practice Monitor, May 2021; http://www.dopps.org/DPM 4 Block GA, Klassen PS, Lazarus JM, Ofsthun N, Lowrie EG, Chertow GM. Mineral metabolism, mortality, and morbidity in maintenance hemodialysis. J Am Soc Nephrol. 2004 Aug;15(8):2208-18. doi: 10.1097/01.ASN.0000133041.27682.A2. PMID: 15284307.
Key Points: – Eli Lilly (LLY) is acquiring Organovo’s (ONVO) FXR program, including lead drug candidate FXR314, for further development. – Organovo will receive an upfront payment along with milestone-based regulatory and commercial payouts. – ONVO stock surged over 200% following the announcement.
In a significant move for the biotechnology sector, Organovo Holdings, Inc. (Nasdaq: ONVO) announced the sale of its FXR program, including its lead candidate FXR314, to pharmaceutical giant Eli Lilly and Company (NYSE: LLY). The acquisition, disclosed on Tuesday, marks a pivotal moment for Organovo as it aligns its proprietary 3D human tissue technology with a global leader in drug development.
The FXR program, focused on inflammatory bowel disease (IBD), is a major step toward advancing novel treatment approaches. Organovo’s Executive Chairman, Keith Murphy, expressed confidence in Lilly’s ability to further develop FXR314, highlighting the company’s world-class expertise and commitment to patient care.
Under the agreement, Organovo will receive an upfront cash payment, with additional milestone payments contingent on regulatory approvals and commercial success. While the specific financial terms remain undisclosed, the market’s response has been overwhelmingly positive.
Following the announcement, ONVO shares skyrocketed by over 200%, reflecting investor optimism about the deal’s potential impact. Lilly’s stock also saw a modest gain of 2.32% as the acquisition strengthens its pipeline in the IBD treatment space.
For Organovo, this transaction reinforces its ability to leverage its cutting-edge 3D tissue technology for drug development partnerships. The company, known for pioneering bioprinting innovations, has been positioning itself as a key player in personalized medicine and regenerative therapies.
For Eli Lilly, the acquisition aligns with its broader strategy of expanding its immunology portfolio. FXR314’s development complements Lilly’s existing research efforts in inflammatory diseases, further cementing its position as a leader in next-generation therapeutics.
With FXR314 now under Lilly’s stewardship, the biotech industry will closely monitor its progression into Phase 2 trials. If successful, the drug could represent a breakthrough in IBD treatment, addressing a significant unmet medical need.
As Organovo pivots towards future innovation, and Lilly integrates this promising asset into its pipeline, investors and analysts alike will be watching closely to gauge the long-term benefits of this high-profile acquisition.
Key Points: – AbbVie and Xilio Therapeutics announce a partnership to develop innovative tumor-activated immunotherapies, including masked T-cell engagers. – Xilio will receive $52 million upfront and is eligible for up to $2.1 billion in milestone payments and royalties. – The collaboration aims to enhance the effectiveness of immunotherapy while minimizing systemic side effects.
AbbVie and Xilio Therapeutics have entered a strategic collaboration to advance next-generation tumor-activated immunotherapies, a move that could significantly impact the oncology space. The partnership will focus on developing masked T-cell engagers (TCEs), a cutting-edge approach designed to precisely target tumors while reducing the systemic toxicity often associated with immunotherapies.
Under the terms of the agreement, Xilio will receive an upfront payment of $52 million, with the potential to earn up to $2.1 billion in milestone payments and royalties if the collaboration yields successful drug candidates. This deal highlights the growing interest in tumor-selective therapies as biopharmaceutical companies seek to refine cancer treatments for better efficacy and safety.
Immunotherapy has revolutionized cancer treatment over the past decade, with checkpoint inhibitors and CAR-T therapies offering promising results. However, many of these treatments come with serious side effects, such as cytokine release syndrome and immune-related toxicities, which can limit their widespread use. Tumor-activated therapies, like those being developed through the AbbVie-Xilio collaboration, aim to overcome these challenges by ensuring immune system activation occurs predominantly at the tumor site rather than throughout the body.
This strategy aligns with a broader industry trend where major pharmaceutical companies are investing heavily in precision oncology. Companies such as Bristol Myers Squibb, Merck, and Roche are also exploring targeted immune therapies, with some already advancing their own masked TCE platforms.
AbbVie’s decision to partner with Xilio follows similar collaborations between biotech startups and large pharmaceutical firms. Smaller biotech companies often bring innovative drug discovery capabilities, while established players like AbbVie provide the resources and expertise needed to navigate clinical development and regulatory approval.
The move also positions AbbVie competitively in the immuno-oncology space, where it faces increasing competition from global drugmakers. The company has been expanding its oncology pipeline following the success of Imbruvica and Venclexta, and this partnership could strengthen its position in the next generation of cancer therapeutics.
Meanwhile, Xilio Therapeutics, a biotech firm specializing in tumor-selective treatments, stands to gain significant financial backing and research support through this agreement. Its proprietary technology platform, which develops highly potent, tumor-activated biologics, has the potential to redefine immunotherapy approaches for solid tumors.
With oncology continuing to be one of the most lucrative and rapidly evolving fields in biotech, tumor-activated immunotherapies are poised to become a major focus of drug development. The potential to minimize toxicity while enhancing efficacy makes these therapies particularly appealing for both patients and healthcare providers.
If successful, the AbbVie-Xilio collaboration could lead to groundbreaking advancements in cancer treatment, opening doors for future partnerships and expanding the role of tumor-targeted biologics in oncology.
Key Points: – Novo Nordisk’s amycretin led to 22% average weight loss in a 36-week trial. – Shares rose 7.13%, marking the best single-day gain since March 2024. – Amycretin targets dual hormones to tackle hunger and appetite, showcasing groundbreaking innovation.
Novo Nordisk shares surged Friday after the pharmaceutical giant announced promising early-stage trial results for amycretin, a groundbreaking weight-loss drug administered through a once-weekly injection. The Danish company revealed that the treatment led to an average weight reduction of 22% in overweight and obese patients over a 36-week trial, marking a significant advancement in the fight against obesity. This compares to a 2% weight gain observed in patients receiving a placebo, showcasing the drug’s potential to reshape the treatment landscape for weight management.
The trial involved 125 participants and highlighted amycretin’s innovative mechanism of action. The drug targets GLP-1, a gut hormone that regulates appetite, and amylin, a hormone produced by the pancreas that influences hunger. This dual-action approach is a step forward from Novo Nordisk’s flagship products, Wegovy, which mimics GLP-1, and Ozempic, its well-known diabetes treatment. Amycretin’s ability to address weight loss through multiple pathways underscores its potential to provide life-changing results for patients struggling with obesity.
Novo Nordisk’s stock rose by 7.13% on Friday, reaching its best single-day performance since March 2024. The initial gains peaked at nearly 14% before settling, reflecting strong investor confidence in the company’s ability to expand its market dominance in obesity therapeutics. Fellow Danish drugmaker Zealand Pharma also benefited from the announcement, with shares climbing 4.7%, while rival Eli Lilly, the maker of obesity drug Zepbound, saw a slight dip in premarket trading.
The pharmaceutical industry has been increasingly focused on developing more effective weight-loss solutions, with obesity affecting millions worldwide and posing significant health risks. Novo Nordisk’s continued innovation in this space has made it a frontrunner, and the results from the amycretin trial further solidify its position. The company is already exploring oral formulations of the drug, which, in a separate early-stage trial announced last September, demonstrated a 13.1% weight reduction over 12 weeks.
Safety and tolerability are key considerations for any obesity treatment, and amycretin appears to meet these benchmarks. The most common side effects observed during the trial were gastrointestinal issues, but most were mild to moderate in severity. These findings align with patient tolerability seen in previous trials for similar drugs, making amycretin a promising addition to Novo Nordisk’s portfolio.
Martin Lange, executive vice president for development at Novo Nordisk, expressed optimism about the trial results. “We are very encouraged by the subcutaneous phase 1b/2a results for amycretin in people living with overweight or obesity,” Lange said in a statement. “The results seen in the trial support the weight-lowering potential of this novel unimolecular GLP-1 and amylin receptor agonist.”
As Novo Nordisk invests further in amycretin, the drug has the potential to transform the obesity treatment market, which is projected to grow substantially in the coming years. The company’s strategic focus on innovative, science-driven solutions positions it to maintain a competitive edge while addressing a critical global health challenge.
Key Points: – Combined company to focus on ML/AI-powered drug development platform – Decoy shareholders to own 86% of merged entity – Pipeline includes treatments for respiratory viruses and GI cancers
In a strategic move to accelerate the development of next-generation therapeutics, Salarius Pharmaceuticals (NASDAQ: SLRX) announced today its merger with privately-held Decoy Therapeutics in an all-stock transaction. The combined company, which will operate under the Decoy Therapeutics name, aims to leverage artificial intelligence and machine learning to revolutionize peptide conjugate drug development.
The merger brings together Decoy’s proprietary IMP3ACT™ platform, which has already attracted approximately $7 million in non-dilutive funding from prestigious organizations including The Bill & Melinda Gates Foundation, with Salarius’ clinical-stage pipeline and public market presence. Under the terms of the agreement, Decoy shareholders will own approximately 86% of the combined company, with Salarius stockholders retaining the remaining 14%.
“Peptide conjugates have become one of the most important drug classes as measured by prescription rates and revenue growth,” said Rick Pierce, Decoy’s Co-founder and CEO, who will lead the combined company. “Our highly experienced team is excited to be able to unlock significant shareholder value from our IMP3ACT platform, which can rapidly design new peptide conjugate drugs by applying ML and AI tools.”
The merged entity’s immediate focus includes advancing a pan-coronavirus antiviral toward an FDA Investigational New Drug (IND) application within the next 12 months. Additionally, the company plans to develop a broad-acting antiviral targeting flu, COVID-19, and respiratory syncytial virus (RSV), as well as a peptide drug conjugate for gastrointestinal cancers.
David Arthur, Salarius’ CEO, emphasized the strategic rationale: “The compelling science supporting Decoy’s peptide conjugate technology and the company’s management team are truly impressive. Based on our diligence, we believe Decoy is poised to advance multiple drug candidates that address significant unmet needs in numerous therapeutic areas.”
The combined company will maintain Salarius’ ongoing Phase 1/2 clinical trial at MD Anderson Cancer Center while exploring strategic alternatives for its seclidemstat program. The merger has received unanimous approval from both companies’ boards of directors and is expected to close following customary closing conditions.
Key Points: – All-stock merger creates first integrated blood and tissue biomarker detection platform – Combined company projects $40M in annual cost savings by 2026 – Post-merger entity to maintain $175M cash position with zero debt
In a groundbreaking move that promises to revolutionize disease detection and monitoring, Quanterix Corporation announced today its acquisition of Akoya Biosciences in an all-stock transaction. The merger unites Quanterix’s ultra-sensitive biomarker detection capabilities with Akoya’s spatial biology expertise, creating the first integrated platform for comprehensive blood- and tissue-based protein biomarker analysis.
The strategic combination positions the merged entity at the forefront of liquid biopsy innovation, a market that Quanterix CEO Masoud Toloue believes will eventually eclipse all other diagnostic testing segments combined. “This transaction accelerates our progress by creating the first platform that lets researchers and clinicians track disease progression from tissue to blood,” said Toloue, who will continue as CEO of the combined company.
The deal structure gives Akoya shareholders 0.318 shares of Quanterix common stock for each Akoya share, representing a 19% premium to Akoya’s unaffected stock price from November 14, 2024. Post-merger, current Quanterix shareholders will hold approximately 70% of the combined company, with Akoya shareholders owning the remaining 30%.
Looking ahead, the merged company projects annual cost synergies of $40 million by the end of 2026, with half that amount expected within the first year post-closing. These savings will come from streamlined operations, improved commercial infrastructure, and optimized facilities. The combined entity will maintain a strong financial position with approximately $175 million in cash and no debt at closing.
Akoya CEO Brian McKelligon emphasized the strategic importance of the merger: “We are thrilled to be part of an established leader in the life science tools and diagnostics market that not only strengthens our presence in critical markets but also accelerates our ability to scale, innovate and ultimately bring to market products that impact human health.”
The transaction, expected to close in the second quarter of 2025, will create a powerhouse in biomarker detection with a combined installed base of 2,300 instruments and trailing 12-month revenue of approximately $220 million. The merger has already secured support from shareholders owning more than 50% of Akoya’s common stock.
OCU410 has a very favorable safety and tolerability profile
No serious adverse events related to the study drug have been reported, such as exudation, infectious endophthalmitis, intraocular Inflammation, anterior ischemic optic neuropathy, or vasculitis
MALVERN, Pa., Dec. 19, 2024 (GLOBE NEWSWIRE) — Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologics, and vaccines, today announced that the Data and Safety Monitoring Board (DSMB) for the OCU410 ArMaDa clinical trial recently convened and approved continuation of the second phase of the Phase 1/2 study. OCU410 (AAV5-hRORA) is a novel modifier gene therapy candidate being developed for geographic atrophy (GA) secondary to dry age-related macular degeneration (dAMD).
“The DSMB assessed data on 15 subjects from Phase 2. Initial data indicates that OCU410 appears to be safe and well-tolerated,” said Peter Chang, MD, FACS, Co-President and Partner of the Massachusetts Eye Research and Surgery Institution (MERSI). “No serious adverse events (SAEs) related to OCU410 have been reported to date.”
The ArMaDa clinical trial will assess the safety and efficacy of unilateral subretinal administration of OCU410 in subjects with GA. Phase 2 is an ongoing, randomized, outcome assessor-blinded, dose-expansion study in which 45 subjects are randomized in a 1:1:1 ratio to either one of two OCU410 treatment groups (5×1010 vg/mL or 1.5 ×1011 vg/mL) or an untreated control group.
“Currently approved treatments for GA require 6-12 intravitreal injections annually and frequent injections are a burden on patients and caregivers,” said Huma Qamar, MD, MPH, CMI, Chief Medical Officer of Ocugen. “We are very enthusiastic about the potential of OCU410 to serve as a game-changing, one-time treatment for life for patients with GA.”
Positive preliminary efficacy and safety data from the Phase 1 dose-escalation portion of the ArMaDa clinical trial demonstrated: no drug-related serious adverse events, reduced lesion growth, preservation of retinal tissue, and—most importantly—there was a positive effect on the functional visual measure of low luminance visual acuity (LLVA).
dAMD is a multifactorial disease involving genetic and environmental factors that is one of the world’s leading causes of blindness in people aged 50 years and older. Four cellular pathways drive the pathology of dry AMD: lipid metabolism, inflammation, oxidative stress, and complement. Currently approved therapies target only the latter, while OCU410 addresses all four and thereby helps reestablish retinal homeostasis.
The ArMaDa clinical trial is currently being performed at 13 leading retinal surgery centers across the U.S. Dosing in the OCU410 ArMaDa clinical trial will be completed in early 2025 and the Company will continue to provide 9- and 12-month efficacy updates from Phase 1.
About dAMD and GA dAMD affects approximately 10 million Americans and more than 266 million people worldwide. It is characterized by the thinning of the macula. The macula is the part of the retina responsible for clear vision in one’s direct line of sight. dAMD involves the slow deterioration of the retina with submacular drusen (small white or yellow dots on the retina), atrophy, loss of macular function and central vision impairment. dAMD accounts for 85-90% of the total AMD population.
About OCU410 OCU410 utilizes an AAV delivery platform for the retinal delivery of the RORA (RAR Related Orphan Receptor A) gene. The RORA protein plays an important role in lipid metabolism, reducing lipofuscin deposits and oxidative stress, and demonstrates an anti-inflammatory role in vitro and in vivo (animal model) studies. These results demonstrate the ability of OCU410 to target multiple pathways linked with dAMD pathophysiology. Ocugen is developing AAV5–hRORA as a one-time gene therapy for the treatment of GA.
About Ocugen, Inc. Ocugen, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines that improve health and offer hope for patients across the globe. We are making an impact on patient’s lives through courageous innovation—forging new scientific paths that harness our unique intellectual and human capital. Our breakthrough modifier gene therapy platform has the potential to treat multiple retinal diseases with a single product, and we are advancing research in infectious diseases to support public health and orthopedic diseases to address unmet medical needs. Discover more at www.ocugen.com and follow us on X and LinkedIn.
Cautionary Note on Forward-Looking Statements This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, including, but not limited to, strategy, business plans and objectives for Ocugen’s clinical programs, plans and timelines for the preclinical and clinical development of Ocugen’s product candidates, including the therapeutic potential, clinical benefits and safety thereof, expectations regarding timing, success and data announcements of current ongoing preclinical and clinical trials, the ability to initiate new clinical programs; statements regarding qualitative assessments of available data, potential benefits, expectations for ongoing clinical trials, anticipated regulatory filings and anticipated development timelines, which are subject to risks and uncertainties. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks, and uncertainties that may cause actual events or results to differ materially from our current expectations, including, but not limited to, the risks that preliminary, interim and top-line clinical trial results may not be indicative of, and may differ from, final clinical data; that unfavorable new clinical trial data may emerge in ongoing clinical trials or through further analyses of existing clinical trial data; that earlier non-clinical and clinical data and testing of may not be predictive of the results or success of later clinical trials; and that that clinical trial data are subject to differing interpretations and assessments, including by regulatory authorities. These and other risks and uncertainties are more fully described in our annual and periodic filings with the Securities and Exchange Commission (SEC), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events, or otherwise, after the date of this press release.
Key Points: – Cara Therapeutics and Tvardi Therapeutics announce an all-stock merger, set to create a Nasdaq-listed biopharmaceutical company. – Tvardi’s recent $28 million financing strengthens the combined company’s financial outlook, funding operations into 2026. – The new entity will focus on developing STAT3 inhibitors for fibrosis-driven diseases, with Phase 2 data expected in 2025.
Cara Therapeutics (Nasdaq: CARA) and Tvardi Therapeutics have announced a definitive merger agreement, marking a significant step in the development of innovative treatments for fibrosis-driven diseases. The all-stock transaction will combine Cara’s resources with Tvardi’s promising pipeline, including its lead candidate, TTI-101, a small-molecule STAT3 inhibitor. The combined entity will be Nasdaq-listed under the name Tvardi Therapeutics, Inc. and is expected to trade under the ticker symbol “TVRD” once the deal closes in the first half of 2025, subject to regulatory and shareholder approvals.
The merger will give pre-merger Cara stockholders an estimated 17% stake in the new company, while Tvardi investors will own around 83%, assuming Cara’s cash balance at closing falls within the expected range. This transaction comes after Tvardi completed a $28 million private financing round, which, alongside the combined company’s cash, will provide funding into 2026, supporting clinical development through critical data readouts expected in 2025.
Tvardi’s pipeline, which is focused on fibrosis-driven diseases, will be the cornerstone of the merged company’s future. The lead candidate, TTI-101, is currently in Phase 2 trials for idiopathic pulmonary fibrosis (IPF) and Phase 1b/2 trials for hepatocellular carcinoma (HCC). The drug is designed to inhibit STAT3, a central transcription factor involved in the progression of these diseases. Early-stage data from the clinical trials is expected to be reported in the second half of 2025, potentially marking significant inflection points for the company.
In addition to TTI-101, Tvardi is developing TTI-109, another STAT3 inhibitor that is set to enter clinical trials in 2025. Tvardi’s innovative approach to targeting STAT3 positions the combined company as a key player in addressing serious, chronic diseases with significant unmet medical need.
The new company will be headquartered in Houston, Texas, and led by Tvardi CEO Imran Alibhai, Ph.D. The board will consist of members from both Cara and Tvardi, with six directors from Tvardi and one from Cara. This leadership structure is expected to ensure a seamless transition as the combined company moves forward with its mission to develop novel, oral therapies for fibrosis-driven diseases.
This merger comes at a time when the biopharmaceutical sector is increasingly focused on addressing complex diseases with limited treatment options. With a strong financial foundation, a promising pipeline, and a leadership team well-versed in the challenges of drug development, the combined company is poised to make significant strides in the field.
As the merger progresses, investors and industry watchers will be closely monitoring upcoming clinical trial results and further developments in the company’s pipeline, which could position Tvardi Therapeutics as a leader in the treatment of fibrosis-driven diseases.
Key Points – Quanterix acquires EMISSION for $10M, expanding its technological capabilities and entering the OEM market. – EMISSION’s bead technology enhances Quanterix’s Simoa platform for high-multiplex and multi-omic assays. – The acquisition is expected to drive revenue growth and improve margins by 2026.
Quanterix Corporation (NASDAQ: QTRX), a company advancing scientific discovery through ultrasensitive biomarker detection, has announced the acquisition of EMISSION iNC., a Georgetown, TX-based manufacturer of proprietary magnetic beads and mid-plex assay platforms. The transaction, expected to close in January 2025, aims to vertically integrate EMISSION’s bead technology into Quanterix’s next-generation platform and drive a new multi-plex segment targeting OEM customers.
Masoud Toloue, Quanterix’s CEO, emphasized the importance of controlling core components to expand their technology stack and capabilities. “EMISSION’s proprietary bead technology has already been validated on our upcoming new Simoa platform and will enable us to provide OEM beads to other non-Quanterix platforms. We look forward to welcoming EMISSION’s innovations and colleagues to the Quanterix team,” he stated.
EMISSION’s magnetic beads are designed for low and mid-plex assays, offering high uniformity and scalability. Their integration into Quanterix’s platform will enhance multi-plex and multi-omic capabilities, ensuring greater control over critical components. EMISSION CEO Van Chandler expressed enthusiasm about the partnership, noting that their high-quality bead technology aligns with Quanterix’s vision to make advanced multi-plex assays accessible to all labs.
The acquisition involves an upfront cash payment of $10 million, with an additional $10 million contingent on the completion of technical milestones. EMISSION may also earn up to $50 million in performance-based payouts, expected to be funded through cash generated from meeting those milestones. Quanterix anticipates the deal will positively impact revenue and gross margins by 2026.
This strategic move reinforces Quanterix’s commitment to innovation in biomarker detection and diagnostics. By integrating EMISSION’s technology, the company strengthens its position in the multi-plex assay market while opening new revenue streams through OEM partnerships. With Simoa technology already setting industry standards for ultrasensitive biomarker detection, the acquisition marks a significant step toward broadening the reach of Quanterix’s tools and solutions.
Quanterix’s focus on neurology, oncology, immunology, and infectious disease research continues to fuel breakthroughs in disease understanding and management. With nearly two decades of experience, the company remains a trusted partner for researchers, boasting over 2,900 peer-reviewed publications featuring its technology. The integration of EMISSION’s beads is expected to enhance Quanterix’s ability to deliver precise, flexible solutions to researchers and clinicians worldwide, further cementing its leadership in the field.
Furthermore, the acquisition aligns with Quanterix’s strategy of vertical integration, which is increasingly critical in the competitive field of diagnostics. By bringing key components in-house, Quanterix not only enhances its technological control but also reduces dependence on external suppliers, paving the way for faster innovation cycles and cost efficiencies. This approach is expected to drive long-term growth and maintain the company’s edge in a rapidly evolving industry.
The addition of EMISSION’s proprietary bead technology also has implications for the broader scientific community. By targeting third-party OEM customers, Quanterix is fostering collaboration and expanding access to advanced diagnostic tools. This could accelerate the adoption of multi-plex assays across various laboratories and research institutions, driving progress in disease diagnostics and personalized medicine.
As the demand for high-sensitivity biomarker detection continues to grow, Quanterix’s ability to deliver scalable, high-quality solutions becomes increasingly vital. The integration of EMISSION’s technology not only reinforces Quanterix’s position as a market leader but also underscores its commitment to empowering scientists with cutting-edge tools to address complex healthcare challenges. With this acquisition, Quanterix is poised to play a pivotal role in shaping the future of diagnostics and research.
CHICAGO–(BUSINESS WIRE)– MAIA Biotechnology, Inc., (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, today announced that the FDA has designated THIO for the treatment of pediatric-type diffuse high-grade gliomas (PDHGG) as a drug for a “rare pediatric disease.”
“THIO is a versatile anti-cancer agent that has demonstrated positive results in multiple difficult to treat cancer types, including pediatric high-grade glioma, which is among the most treatment-resistant cancers in children. THIO is shown to activate the immune system while evading tumor immunosuppression, a novel therapeutic approach for this devastating childhood disease,” said MAIA Chairman and Chief Executive Officer Vlad Vitoc, M.D. “We are proud to receive the FDA’s Rare Pediatric Disease designation for THIO, which significantly bolsters our plans for continuing research in the PDHGG indication.”
MAIA’s Vice President and Head of Regulatory and Quality K. Robinson Lewis added, “Rare pediatric disease designation also offers a highly valuable incentive for MAIA. Upon FDA approval of a future new drug application in PDHGG, MAIA would be eligible to receive a priority review voucher that can be redeemed or sold as an asset at a very high valuation.”
Rare pediatric disease priority review vouchers (PRVs) can be redeemed by drug developers for FDA priority review of a different product or transferred or sold to another sponsor. Since 2015, FDA priority review vouchers have sold as assets at an average amount of $100 million.1
Previous research showcased THIO’s potency as a treatment for a PDHGG subtype known as diffuse intrinsic pontine glioma (DIPG). A research collaboration between MAIA and Nationwide Children’s Hospital found that THIO combined with ionizing radiation (IR) resulted in significantly decreased cell proliferation and produced potent anticancer effects in highly aggressive DIPG. The data was presented in April 2024 at the American Association for Cancer Research (AACR) Annual Meeting.
MAIA collaborated with Only Orphans Cote for THIO’s designation request. Only Orphans Cote is a foremost provider of regulatory services and strategies for FDA orphan drug designations and marketing authorization.
In addition to its rare pediatric disease designation in PDHGG, THIO holds orphan drug designations (ODD) in three cancer types: hepatocellular carcinoma (HCC), small cell lung cancer (SCLC) and glioblastoma. MAIA believes that THIO is the only direct telomere-targeting agent currently in clinical development.
About THIO
THIO (6-thio-dG or 6-thio-2’-deoxyguanosine) is a first-in-class investigational telomere-targeting agent currently in clinical development to evaluate its activity in Non-Small Cell Lung Cancer (NSCLC). Telomeres, along with the enzyme telomerase, play a fundamental role in the survival of cancer cells and their resistance to current therapies. The modified nucleotide 6-thio-2’-deoxyguanosine (THIO) induces telomerase-dependent telomeric DNA modification, DNA damage responses, and selective cancer cell death. THIO-damaged telomeric fragments accumulate in cytosolic micronuclei and activates both innate (cGAS/STING) and adaptive (T-cell) immune responses. The sequential treatment with THIO followed by PD-(L)1 inhibitors resulted in profound and persistent tumor regression in advanced, in vivo cancer models by induction of cancer type–specific immune memory. THIO is presently developed as a second or later line of treatment for NSCLC for patients that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.
About MAIA Biotechnology, Inc.
MAIA is a targeted therapy, immuno-oncology company focused on the development and commercialization of potential first-in-class drugs with novel mechanisms of action that are intended to meaningfully improve and extend the lives of people with cancer. Our lead program is THIO, a potential first-in-class cancer telomere targeting agent in clinical development for the treatment of NSCLC patients with telomerase-positive cancer cells. For more information, please visit www.maiabiotech.com.
Forward Looking Statements
MAIA cautions that all statements, other than statements of historical facts contained in this press release, are forward-looking statements. Forward-looking statements are subject to known and unknown risks, uncertainties, and other factors that may cause our or our industry’s actual results, levels or activity, performance or achievements to be materially different from those anticipated by such statements. The use of words such as “may,” “might,” “will,” “should,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “project,” “intend,” “future,” “potential,” or “continue,” and other similar expressions are intended to identify forward looking statements. However, the absence of these words does not mean that statements are not forward-looking. For example, all statements we make regarding (i) the initiation, timing, cost, progress and results of our preclinical and clinical studies and our research and development programs, (ii) our ability to advance product candidates into, and successfully complete, clinical studies, (iii) the timing or likelihood of regulatory filings and approvals, (iv) our ability to develop, manufacture and commercialize our product candidates and to improve the manufacturing process, (v) the rate and degree of market acceptance of our product candidates, (vi) the size and growth potential of the markets for our product candidates and our ability to serve those markets, and (vii) our expectations regarding our ability to obtain and maintain intellectual property protection for our product candidates, are forward looking. All forward-looking statements are based on current estimates, assumptions and expectations by our management that, although we believe to be reasonable, are inherently uncertain. Any forward-looking statement expressing an expectation or belief as to future events is expressed in good faith and believed to be reasonable at the time such forward-looking statement is made. However, these statements are not guarantees of future events and are subject to risks and uncertainties and other factors beyond our control that may cause actual results to differ materially from those expressed in any forward-looking statement. Any forward-looking statement speaks only as of the date on which it was made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. In this release, unless the context requires otherwise, “MAIA,” “Company,” “we,” “our,” and “us” refers to MAIA Biotechnology, Inc. and its subsidiaries.
Key Points: – Candel Therapeutics’ stock surged 172% after its Phase III trial of CAN-2409 for localized prostate cancer met its primary endpoint. – The trial showed a 14.5% relative improvement in disease-free survival compared to placebo, with promising long-term results. – The company plans to use Phase III data to seek regulatory approval from the FDA for CAN-2409.
Candel Therapeutics (CADL) has seen its stock price surge by 172% following the announcement of positive results from its Phase III clinical trial of CAN-2409, a viral immunotherapy designed for localized prostate cancer. This breakthrough was announced on December 11, 2024, signaling the potential of CAN-2409 as a new treatment option for patients battling prostate cancer.
The Phase III trial, conducted under a Special Protocol Assessment (SPA) with the U.S. Food and Drug Administration (FDA), tested CAN-2409 in combination with radiation therapy and the antiviral drug valacyclovir. The trial showed a statistically significant improvement in disease-free survival, with patients experiencing a 14.5% relative increase in survival compared to the placebo group after 54 months of observation. These results demonstrate the treatment’s ability to improve long-term outcomes for prostate cancer patients.
In addition to the survival benefit, the study also found an increased proportion of patients achieving a prostate-specific antigen (PSA) level associated with remission, further supporting CAN-2409’s potential as a promising treatment. The therapy works by stimulating the immune system to attack prostate cancer cells, offering a novel approach compared to traditional treatments, which often rely on chemotherapy or radiation alone. Importantly, the treatment demonstrated no new safety concerns, with a safety profile similar to that of existing therapies.
The company’s CEO, Paul Peter Tak, expressed confidence in the results, emphasizing that the Phase III trial validated earlier observations of CAN-2409’s effectiveness in hard-to-treat tumors. Tak noted that the study’s design, agreed upon by the FDA, could allow Candel to seek regulatory approval for CAN-2409 as a treatment for localized prostate cancer.
Dr. Glen Gejerman, the principal investigator of the study, highlighted the clinical significance of the results, noting that the improvement in disease-free survival could mark a major advancement in prostate cancer care. Gejerman also pointed out that CAN-2409 offers a treatment option without introducing substantial toxicity, which is a key concern for many prostate cancer therapies.
Candel Therapeutics now plans to use the data from this Phase III trial to advance its marketing application to the FDA. If approved, CAN-2409 could provide a much-needed treatment alternative for patients with localized prostate cancer, transforming the current treatment paradigm.
This success positions Candel as a leader in the prostate cancer space, with investors reacting positively to the trial’s results. The company’s stock price has risen significantly, reflecting growing confidence in its future prospects.
Candel’s success comes at a time when other companies in the prostate cancer field, such as Arvinas and Pfizer, are also advancing their own treatments. However, the dramatic stock increase following the Phase III results highlights the excitement surrounding CAN-2409 and its potential to change the landscape of prostate cancer treatment.
As the company moves toward FDA approval, the oncology community will be watching closely. If successful, CAN-2409 could become a game-changing option for prostate cancer patients, offering new hope and a more effective treatment strategy.
