US Market News
1週前
Lunai Bioworks and BrainStorm Therapeutics Launch Foundation-Funded Parkinson's and Rare Epilepsy AI Discovery CollaborationMay 28, 2026 9:15 AM
PR Newswire (US) Collaboration integrates AI discovery, human brain organoid modeling, and in vivo validation to generate differentiated neurology assets for pharmaceutical partnering and developmentSACRAMENTO, Calif. and SAN DIEGO, May 28, 2026 /PRNewswire/ -- Lunai Bioworks' (NASDAQ: LNAI) wholly owned subsidiary BioSymetrics and BrainStorm Therapeutics today announced a strategic collaboration and Letter of Intent (LOI) to jointly discover, validate, and advance novel therapeutic targets for neurological diseases. The collaboration is supported by a newly awarded grant from the LouLou Foundation. The collaboration combines BioSymetrics' AI-driven target discovery and in vivo zebrafish validation platform with BrainStorm Therapeutics' proprietary human-derived organoid systems to create an integrated translational engine for neurology drug discovery. The companies intend to generate high-confidence therapeutic programs designed for pharmaceutical partnering, licensing, and downstream development.The collaboration is aligned with emerging FDA guidance encouraging adoption of innovative new approach methodologies (NAMs) that improve human translational relevance and reduce dependence on traditional mammalian animal models in drug development. Initial efforts will focus on rare genetic epilepsies and neurodegenerative diseases, including Parkinson's disease.As part of the collaboration, the companies are integrating BrainStorm's Parkinson's disease midbrain organoid foundation model with BioSymetrics' proprietary analysis of the Parkinson's Progression Markers Initiative (PPMI) dataset, to identify progression-associated biomarkers and high-confidence therapeutically actionable targets. The program is intended to support precision medicine strategies and accelerate the development of differentiated CNS therapeutics.In a flagship program under the collaboration, BioSymetrics and Brainstorm Therapeutics, together with Dr. Calum MacRae at Brigham and Women's Hospital and Harvard Medical School, have received funding from the LouLou Foundation to identify and advance novel therapeutic approaches for a rare genetic epilepsy. The initiative is expected to generate mechanistic insights, biological validation data, and development-stage assets while establishing a scalable framework for future neurology programs.Concurrently, the companies have entered into a Letter of Intent to expand the collaboration across additional neurological indications. The LOI outlines a structured framework to:?Identify and prioritize therapeutic targets using integrated computational, organoid, and in vivo discovery approaches?Rapidly validate targets across complementary biological systemsAdvance differentiated programs supported by mechanistic rationale and translational validation data?Engage pharmaceutical partners, strategic collaborators, and investors around selected development opportunitiesThe collaboration is designed to efficiently progress programs from discovery through translational validation and external partnering, with the goal of creating multiple value-generating opportunities across the neurology pipeline."Neurological diseases remain one of the largest areas of unmet medical need, yet CNS drug development continues to suffer from high rates of clinical trial failure due to poor target selection and limited translational predictability" said Dr. Robert Fremeau, Founder & CEO of BrainStorm Therapeutics. "By combining human-relevant organoid biology with AI-driven discovery and rapid in vivo validation, we believe this collaboration can generate higher-confidence therapeutic programs with stronger development and partnering potential.""We believe the combination of AI, organoids, and in vivo validation creates a scalable framework for generating high-value neurology programs," said David Weinstein, Lunai's CEO. "Our focus is not simply discovery but efficiently advancing targets toward pharmaceutical partnering and downstream clinical development."Neurological diseases represent one of the fastest-growing areas of global healthcare burden, yet drug development success rates remain among the lowest in the industry. The companies believe that integrating computational discovery with human-relevant biology and rapid functional validation may improve translational success while creating multiple pathways for value creation, including strategic partnerships, joint ventures, licensing transactions, and asset-centric financings.The collaboration is intended to generate a portfolio of discrete, development-ready neurology programs that may be advanced through a range of structures, including licensing agreements, co-development partnerships, special purpose vehicles, and new company formation. By focusing on biologically validated targets with defined translational pathways, the companies aim to accelerate timelines to partnering and unlock additional opportunities for non-dilutive funding.About Lunai Bioworks
Lunai Bioworks (NASDAQ: LNAI) is an AI-driven biotechnology company focused on accelerating drug discovery and development across the central nervous system (CNS) and other high-unmet-need areas. Lunai integrates data analytics and experimental biology to improve development efficiency, reduce cost, and increase the probability of success. For more visit https://lunaibioworks.com.About BrainStorm Therapeutics
BrainStorm Therapeutics is a precision neuroscience company focused on developing innovative therapies for neurological disorders using advanced human-relevant model systems, translational biology, and artificial intelligence–driven discovery approaches. The company leverages proprietary organoid platforms, computational biology, and disease biology insights to support therapeutic discovery, target validation, and therapeutic development. For more visit https://brainstormtherapeutics.org.Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the expected scope, objectives, and potential benefits of the collaboration, the ability to generate and validate therapeutic targets, and the potential for future partnerships, financings, or development programs. These statements are based on current expectations and involve risks and uncertainties that may cause actual results to differ materially.Factors that could affect outcomes include the parties' ability to generate and validate data, advance programs, enter into definitive agreements, secure partnerships or funding, and achieve regulatory milestones. The companies undertake no obligation to update forward-looking statements except as required by law. View original content to download multimedia:https://www.prnewswire.com/news-releases/lunai-bioworks-and-brainstorm-therapeutics-launch-foundation-funded-parkinsons-and-rare-epilepsy-ai-discovery-collaboration-302784369.htmlSOURCE Lunai Bioworks Inc. Original: Lunai Bioworks and BrainStorm Therapeutics Launch Foundation-Funded Parkinson's and Rare Epilepsy AI Discovery Collaboration
US Market News
2週前
Federal Judge Orders Expedited Discovery to Identify 'John Doe' Defendants 'Naked' Short-Sellers of Lunai Common StockMay 22, 2026 9:15 AM
PR Newswire (US) WASHINGTON, May 22, 2026 /PRNewswire/ -- On Wednesday, May 20, 2026, a United States District Court Magistrate Judge in Delaware granted the Motion of Lunai Bioworks, Inc. (Nasdaq: LNAI) (Lunai) to conduct expedited discovery to identify the "John Doe" "naked" short sellers of Lunai common stock on the Nasdaq Stock Market in late 2025 and throughout the first half of 2026. Co-lead counsel, Jacob Frenkel, Securities Enforcement Practice Chair at Dickinson Wright, stated: "This is the first step to amending the Complaint and holding accountable and pursuing substantial damages from the 'naked' short sellers who have caused real market harm to Lunai and its shareholders." The Court's Order granted Lunai's Emergency Ex Parte Motion for Leave to Engage in Expedited Limited Third-Party Discovery filed on Monday, May 18, 2026, after carefully reviewing the governing legal precedent and establishing that Lunai, through counsel, established "good cause" to permit discovery before the more typical timing under the Federal Rules of Civil Procedure. In finding "good cause," the Court made the threshold determination that Lunai "established a prima facie case for each essential element of the claim(s) in question." The Court recognized that Lunai demonstrated "[a] that it has no other way to identify the alleged wrongdoers, aside from obtaining the discovery at issue[,] or that expedited discovery is necessary because evidence identifying the defendants may be otherwise destroyed[.]" The Court concluded that Lunai "made a prima facie showing for each element of at least Counts I and/or II of the three counts … via the detailed allegations it made regarding an alleged scheme involving 'naked short selling and manipulative trading intended to depress [Plaintiff's] stock price[.]'" Additionally, in recognizing the need to take discovery beginning with broker-dealers and custodians, the Court acknowledged that "this type of information is 'uniquely held by market infrastructure entities and market participants.'" Moreover, the Court pointed out that the "timing" of the trading anomalies and urgency and the "context" also were factors supporting granting the Motion.Co-lead counsel, Sidney Liebesman, Senior Litigation Partner in Fox Rothschild's Delaware office, added: "The Court appreciated both the gravity and time sensitivity of the need to commence discovery. Our courts in Delaware understand the harms that can be perpetrated against quality corporations, and we look forward to pressing this case aggressively on behalf of Lunai."Lunai, through its two law firm counsel, will be issuing discovery to the broker-dealers and custodians identifiable as having traded Lunai stock as the first layer of discovery. According to the Motion and the 18-page, 21-items discovery request attached as an exhibit to the Motion, Lunai will be seeking, among many things, the identity of all investors who took naked short positions, confirmation that the naked short sellers had violated the law by not borrowing the stock, information regarding the number of shares sold short and the specific naked short sale transactions, and trading blotters.On Monday, May 11, 2026, national law firms Dickinson Wright and Fox Rothschild joined forces to file the lawsuit on behalf of their firms' client, Lunai, alleging securities fraud (stock manipulation) and intentional tort against "John Doe" "naked" short sellers of Lunai common stock on the Nasdaq Stock Market. The Complaint seeks compensatory damages, which could multiply if Lunai amends the Complaint to assert civil RICO claims. Frenkel, a former federal prosecutor and SEC Enforcement lawyer, added that "such egregious conduct cries out for amending the Complaint to allege civil RICO. A civil RICO judgment against naked short sellers should reverberate across the market, and the Court permitting us to push discovery only advances that goal."Lunai, as set forth in the lawsuit, is an AI-driven platform for precision medicine that identifies targets for new therapeutics and biodefense countermeasures. The company also has developed a cancer immunotherapy for solid tumors. The Complaint tells the company's story for 2025 to the present -- referencing an April 2025 strategic merger, a May 2025 launch of an AI-powered precision neurology platform, a November 2025 announcement of the company's next-generation dendritic cell immunotherapy having achieved complete regression of both primary and metastatic pancreatic tumors in preclinical humanized mouse models to mark a potential treatment, a March 2026 national initiative that uses artificial intelligence and cross-sector collaboration to accelerate the discovery and development of chemical countermeasures for emerging threats, an April 2026 deployment of an AI-powered platform for chemical threat assessment, and May 2026 intellectual property acquisitions that expanded Lunai's central nervous system platform.The Complaint asserts three counts: (1) securities fraud under Section 10(b) of the Securities Exchange Act of 1934 and Rule 10b-5 thereunder; (2) market manipulation under Section 9(a) of the Securities Exchange Act of 1934; and (3) the intentional tort of wire fraud under 18 U.S.C. § 1343. Lunai seeks compensatory and special damages, injunctive relief, prejudgment and post-judgment interest, and recovery of costs and reasonable attorneys' fees. The defendants are identified in the complaint as Does 1-50, Roe Corporations 1-50, and XYZ LLCs 1-50, pending discovery that will reveal their true identities. Dickinson Wright and Fox Rothschild intend to pursue expedited discovery to identify the defendants and seek emergency injunctive relief to halt the ongoing manipulative trading.The Complaint in Lunai Bioworks, Inc. v. Does 1-50, Roe Corporations 1-50, and XYZ LLCs 1-50, 1:26-cv-00549-CFC (filed Monday, May 11, 2026) is on file in the United States District Court for the District of Delaware. Jacob Frenkel (Dickinson Wright, Washington, D.C.), and Sidney Liebesman (Fox Rothschild, Wilmington, Delaware) are co-lead counsel to Lunai, and Brian Yu (Dickinson Wright, Washington, D.C.) also is litigation counsel to Lunai.About Lunai Bioworks, Inc.
Lunai Bioworks, Inc. is a Delaware corporation headquartered in Sacramento, California. Lunai is an AI-driven platform for precision medicine that identifies targets for new therapeutics and biodefense countermeasures. The company has developed a cancer immunotherapy for solid tumors and proprietary, patented technologies that transform complex biomedical data into predictive insights. Lunai's platforms include Augusta, an AI-powered precision neurology platform, and a portfolio focused on central nervous system disorders. The company also pursues federal government contracts in support of national security and biodefense applications through its AI platform.About Fox Rothschild LLP
Fox Rothschild LLP is a law firm with approximately 1000 attorneys in 30 offices across major markets in the United States. Fox represents public and private companies, financial institutions, and individual clients in complex commercial litigation, securities law, intellectual property, corporate transactional matters, and related practice areas. Fox's Securities Litigation group has extensive experience representing issuers in federal court and before the SEC, as well as pursuing securities fraud claims against market manipulators and wrongdoers.About Dickinson Wright PLLC
Dickinson Wright is a general practice business law firm with more than 500 attorneys among more than 40 practice areas and 16 industry groups. The firm has 23 offices in the U.S. and Canada, including Arizona, California, Colorado, Florida, Illinois, Kentucky, Michigan, Nevada, Ohio, Tennessee, Texas, Washington, and Washington, D.C. The firm's Canadian offices are located in Toronto and Windsor. Dickinson Wright has a strong securities and capital markets practice, with particular expertise in securities fraud litigation, enforcement matters, and complex commercial disputes. The firm's attorneys regularly represent public companies, underwriters, and investors in high-stakes securities litigation. The firm's Government Investigations and Securities Enforcement Practice regularly assists clients across all industries in formal and informal government investigations, enforcement proceedings, administrative actions and litigation by the SEC, PCAOB, FINRA, OTC Markets, DOJ (and US Attorney's Offices), securities exchanges, state regulators, and Congressional committees. View original content to download multimedia:https://www.prnewswire.com/news-releases/federal-judge-orders-expedited-discovery-to-identify-john-doe-defendants-naked-short-sellers-of-lunai-common-stock-302779803.htmlSOURCE Lunai Bioworks Inc. Original: Federal Judge Orders Expedited Discovery to Identify 'John Doe' Defendants 'Naked' Short-Sellers of Lunai Common Stock
US Market News
2週前
LUNAI BIOWORKS, INC. ANNOUNCES REVERSE STOCK SPLITMay 20, 2026 9:15 AM
PR Newswire (US) SACRAMENTO, Calif., May 20, 2026 /PRNewswire/ -- Lunai Bioworks, Inc. (Nasdaq: LNAI) (the "Company") today announced that it will effect a reverse stock split of its issued and outstanding common stock, par value $0.0001 per share (the "Common Stock"), at a ratio of 1-for-8 (the "Reverse Stock Split"). The Reverse Stock Split is expected to become effective at 12:01 a.m. Eastern Time on May 22, 2026, and the Company's Common Stock is expected to begin trading on a split-adjusted basis on The Nasdaq Capital Market at the opening of trading on May 22, 2026, under the existing trading symbol "LNAI." The Company's Common Stock will trade under a new CUSIP number, 29350E302 following the effectiveness of the Reverse Stock Split.At the Company's Special Meeting of Stockholders held on May 8, 2026, the Company's stockholders approved a proposal authorizing the Company's Board of Directors to amend the Company's Certificate of Incorporation to effect a reverse stock split of the Common Stock at a ratio in the range of 1-for-3 to 1-for-30, inclusive, with the exact ratio to be determined by the Board in its sole discretion and publicly announced prior to the effective time of the Reverse Stock Split. The Board of Directors subsequently approved the final 1-for-8 Reverse Stock Split ratio.The Reverse Stock Split is intended primarily to increase the market price per share of the Company's Common Stock to assist the Company in regaining compliance with Nasdaq Listing Rule 5550(a)(2), which requires a minimum bid price of at least $1.00 per share for continued listing on The Nasdaq Capital Market. The Company previously effected a 1-for-10 reverse stock split on September 30, 2025.As a result of the Reverse Stock Split, every 8 shares of issued and outstanding Common Stock will automatically be combined into one issued and outstanding share of Common Stock. The Reverse Stock Split will not change the par value of the Common Stock or the number of authorized shares of Common Stock. The Reverse Stock Split will reduce the number of issued and outstanding shares of Common Stock from approximately 36,271,119 shares to approximately 4,533,890 shares, subject to adjustment for the treatment of fractional shares.No fractional shares will be issued in connection with the Reverse Stock Split. Any fractional share that would otherwise result from the Reverse Stock Split will be automatically rounded up to the next whole share at the registered stockholder or DTC participant level, as applicable. Registered stockholders holding shares in book-entry form will receive information from the Company's transfer agent regarding their post-split holdings. Beneficial owners holding shares through a bank, broker or other nominee will have their positions adjusted in accordance with the procedures of their bank, broker or nominee.The Company's transfer agent, Securities Transfer Corporation, will act as exchange agent for the Reverse Stock Split. Stockholders holding shares electronically in book-entry form are not required to take any action to receive post-split shares.Proportionate adjustments will be made, as appropriate and in accordance with the terms of the applicable instruments, to the number of shares of Common Stock issuable upon the exercise, vesting, conversion or exchange of our outstanding options, warrants, restricted stock units and other convertible or exercisable securities, as well as to the exercise or conversion prices thereof and to share reserves under our equity compensation plans.Lunai Bioworks (Nasdaq: LNAI) is an AI-driven life sciences company advancing drug discovery and chemical defense through its integrated platform. Lunai combines clinical data, machine learning, and in vivo validation to identify disease biology and develop precision therapeutics. The Company is focused on central nervous system diseases and oncology, with a mission to reduce development timelines and improve clinical success rates.Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of applicable federal securities laws. Forward-looking statements include, without limitation, statements regarding the expected timing and effectiveness of the Reverse Stock Split, the expected commencement of split-adjusted trading, the Company's ability to regain or maintain compliance with Nasdaq continued listing requirements, and the expected effects of the Reverse Stock Split on the Company's capitalization, trading price, liquidity and stockholders. These forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied, including risks that the Reverse Stock Split may not result in a sustained increase in the market price of the Common Stock; may result in reduced liquidity, wider bid-ask spreads or increased volatility; may not enable the Company to regain or maintain compliance with Nasdaq Listing Rule 5550(a)(2) or other Nasdaq continued listing requirements; may be subject to Nasdaq, FINRA, DTC or other processing delays; and may be affected by general market conditions, trading prices, investor acceptance and the determinations of the Nasdaq Hearings Panel. Additional risks and uncertainties are described in the Company's filings with the U.S. Securities and Exchange Commission, including the risk factors in the Company's most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q. The Company undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. View original content to download multimedia:https://www.prnewswire.com/news-releases/lunai-bioworks-inc-announces-reverse-stock-split-302777713.htmlSOURCE Lunai Bioworks Inc. Original: LUNAI BIOWORKS, INC. ANNOUNCES REVERSE STOCK SPLIT
US Market News
3週前
CNS Drug Delivery Technologies Are Reshaping Alzheimer's and Biodefense ResearchMay 13, 2026 9:00 AM
InvestorsHub NewsWireCNS Drug Delivery Technologies Are Reshaping Alzheimer's and Biodefense ResearchBioMedWire Editorial Coverage: Among the most guarded structures in human biology, the brain is also one of the hardest to treat. The blood-brain barrier ("BBB"), a specialized biological membrane, shields neural tissue from foreign substances, including most therapeutic agents. As cases of Alzheimer's disease climb worldwide and governments sharpen their focus on biodefense, the absence of efficient pathways for delivering drugs to the brain is fast becoming one of medicine's most pressing unresolved problems. Companies such as Oncotelic Therapeutics Inc. (OTCQB: OTLC) (Profile) are responding to this challenge with next-generation delivery platforms engineered to circumvent biological barriers and ensure direct, targeted access to the central nervous system ("CNS"). Oncotelic has developed a proprietary intranasal nose-to-brain ("N2B") system capable of rapidly shuttling therapeutics to the brain, a signal of growing industry consensus that delivery innovation, not merely drug discovery, will drive the next wave of breakthroughs in CNS medicine. Oncotelic joins a group of leading biopharma companies working in the biopharmaceutical and advanced therapeutics space, including Amgen Inc. (NASDAQ: AMGN), Johnson & Johnson (NYSE: JNJ), AbbVie Inc. (NYSE: ABBV) and Lunai Bioworks Inc. (NASDAQ: LNAI).While the blood-brain barrier is vital for maintaining neurological health, it simultaneously creates a major obstacle for drug developers.Oncotelic Therapeutics is pursuing a position in a segment of the market focused on enabling faster, more reliable access to the brain.CNS drug delivery is not only a concern for chronic disease, it is also a strategic priority in the area of national security and biodefense.Designed as a device-enabled approach to direct CNS delivery, Oncotelic's N2B delivery system offers a potential alternative to traditional systemic or intramuscular routes.Oncotelic Therapeutics is building along these lines. Its focus on scalable, adaptable delivery infrastructure positions the company to pursue multiple CNS indications from a shared platform base.Click here to view the custom infographic of the Oncotelic Therapeutics editorial.Why the Blood-Brain Barrier Is So Difficult to OvercomeThe blood-brain barrier functions as a tightly regulated biological filter, shielding brain tissue from harmful substances traveling through the bloodstream. While this defense mechanism is vital for maintaining neurological health, it simultaneously creates a major obstacle for drug developers. Research shows that the BBB blocks the passage of most chemical compounds, permitting entry only to certain molecules that meet narrow size and chemistry criteria. The result is that even promising therapeutic candidates often fail to produce meaningful effects simply because they cannot reach the brain in sufficient concentrations.The scale of this problem is striking. Scientific consensus suggests that close to 98% of small-molecule drugs and virtually all biologic therapies are unable to cross the BBB effectively, making this a defining limitation in CNS pharmaceutical development. It also contributes disproportionately to clinical trial failures in neurology, compounds that show real therapeutic promise may nonetheless stumble in trials not because the drug is ineffective, but because it cannot reach its target.The downstream consequences reach across some of the most prevalent and devastating conditions in neurology, from Alzheimer's and Parkinson's disease to primary brain tumors. After decades of intensive research and massive capital investment, effective treatment options for many CNS disorders remain frustratingly scarce. The persistent failure to achieve adequate drug concentrations in the brain has slowed progress across the field, making the search for workable delivery solutions an urgent scientific and commercial priority.Within this context, Oncotelic Therapeutics is developing technologies specifically aimed at getting around these BBB limitations. A concrete marker of progress is the company's recent announcement that it has finalized a strategic monetization agreement with Lunai Bioworks, in which Oncotelic transferred rights to its N2B delivery system for defined applications in biodefense and Alzheimer's disease."Under the terms of the agreement, Oncotelic has granted Lunai Bioworks worldwide rights to the N2B delivery system IP portfolio within defined fields, specifically biodefense medical countermeasures and Alzheimer's disease only," the announcement stated. "The company continues to evaluate additional partnerships to further monetize its portfolio while maintaining strategic control over core assets."By treating delivery infrastructure as a core asset rather than a secondary consideration, Oncotelic is positioning itself within a broader industry move toward integrated solutions that attack the CNS delivery problem head-on.The Growing Weight of Alzheimer's, Neurological DiseaseThe worldwide toll of Alzheimer's disease and other similar forms of dementia is expanding at an alarming pace. According to the World Health Organization, some 57 million people are currently living with dementia globally, a figure projected to grow sharply in the decades ahead as aging populations increase. The human and economic costs of this expansion are substantial, placing mounting pressure on healthcare systems, families, and public finances.Despite this, therapeutic progress has moved slowly. The Alzheimer's Association notes that while researchers have made meaningful strides in understanding the disease at a molecular level, clinical translation has lagged. Drug candidates that look compelling in preclinical settings frequently falter in human trials, often because adequate therapeutic concentrations cannot be sustained within brain tissue, a problem that loops directly back to delivery.New developments across the biopharma landscape highlight both the promise and the stubborn limitations of current approaches. Therapies with demonstrated clinical signals still face ongoing scrutiny over whether effects are consistent and durable, and debates frequently return to the challenge of achieving reliable drug exposure in the brain. These dynamics support the view that delivery remains one of the defining bottlenecks in CNS medicine.Against this backdrop, Oncotelic Therapeutics is pursuing a position in a segment of the market focused on enabling faster, more reliable access to the brain. By orienting its platform toward targeted and precision delivery, the company is placing itself within a space where solving the delivery problem could substantially improve results across a spectrum of neurodegenerative conditions.Biodefense and the Imperative for Fast CNS InterventionCNS drug delivery is not only a concern for chronic disease, it is also a strategic priority in the area of national security and biodefense. Certain chemical and biological threats act directly on the nervous system, and when they do, the window for effective intervention can be extremely narrow. In these high-stakes scenarios, how fast and how effectively a treatment reaches the brain can mean the difference between survival and catastrophic neurological damage.Federal agencies have taken notice. The Biomedical Advanced Research and Development Authority ("BARDA") plays a leading role in funding medical countermeasure development for chemical, biological, radiological, and nuclear threats. Meanwhile, the U.S. Department of Defense has identified CNS injury treatment and neuroprotection as core research areas, a reflection of the operational importance of maintaining neurological function in personnel exposed to hazardous environments.These policy priorities converge on a shared need: Delivery systems that work fast, bypass conventional physiological obstacles, and ensure therapeutics arrive in the brain at concentrations sufficient to produce meaningful effects. When minutes matter, inefficient delivery translates directly into worsened outcomes.Oncotelic Therapeutics is navigating this landscape by exploring applications of its delivery technology that span both commercial medicine and government-funded biodefense programs. This dual-use potential, which is capable of addressing both civilian neurological diseases and emergency response needs, reflects a broader movement toward versatile platforms that can generate value across multiple high-impact markets.Nose-to-Brain Delivery Emerges as a Leading AlternativeWith conventional drug delivery approaches repeatedly running into BBB-related constraints, alternative methods that circumvent the barrier entirely are attracting growing scientific and commercial interest. Among them, intranasal, or "nose-to-brain," delivery has established itself as a particularly compelling option. This pathway leverages anatomical connections between the nasal passages and the brain to transport therapeutic agents directly into CNS tissue, bypassing the bloodstream altogether.Research highlights the capacity of intranasal delivery systems to meaningfully improve drug transport to the brain while keeping systemic exposure low. Evidence from multiple studies indicates that this approach can raise bioavailability and reduce adverse effects—a combination that makes it attractive for long-term use in neurological conditions where patients require sustained treatment.Industry analysis from Deloitte reinforces this trend, noting that CNS therapeutic innovation is shifting its center of gravity from new molecular entities toward delivery technologies. As pharmaceutical and biotech companies seek more consistent clinical outcomes, the ability to get drugs to the right place in the right amounts is increasingly the variable that separates success from failure.Oncotelic's N2B delivery system embodies this philosophy. Designed as a device-enabled approach to direct CNS delivery, it offers a potential alternative to traditional systemic or intramuscular routes. By bypassing the blood-brain barrier, the platform is engineered to accelerate therapeutic onset and improve targeting of the neurological pathways implicated in both acute biodefense emergencies and chronic conditions like Alzheimer's disease.Platform Strategies Are Reshaping CNS InnovationThe trajectory of CNS drug development is moving away from single-asset bets and toward platform-based architectures that can support multiple therapies, indications and commercial pathways. Unlike conventional drug development models, platform approaches offer scalability and adaptability, both qualities particularly suited to an area such as CNS medicine, where diverse conditions often share the same core delivery challenges.Platform-based models allow companies to spread risk across multiple programs while building on a shared technological foundation. By engineering systems that can be configured for different drugs or conditions, developers create multiple routes to revenue while reducing overexposure to any single program's outcome. This structure also aligns naturally with the principles of precision medicine, in which targeted delivery is integral to achieving outcomes that are both effective and patient-specific.For investors, platform strategies carry a distinct appeal. They offer exposure across a range of markets, including neurodegenerative diseases and biodefense, while creating natural opportunities for partnerships, out-licensing, and monetization. This blend of near-term revenue potential with long-term pipeline value is especially compelling in a sector where timelines are long and the risk of any individual asset failing is high.Oncotelic Therapeutics is building along these lines. Its focus on scalable, adaptable delivery infrastructure positions the company to pursue multiple CNS indications from a shared platform base. By combining short-term monetization strategies, such as the Lunai Bioworks agreement, with longer-term development opportunities, the company reflects an industry-wide shift toward approaches that address both the scientific complexity and the commercial realities of the CNS space.The challenge of delivering drugs to the brain persists as one of the most consequential barriers in contemporary medicine. With Alzheimer's disease caseloads climbing and national attention focusing on biodefense, the demand for faster and more reliable CNS delivery solutions is intensifying. Meeting that demand will require progress not just in discovering new compounds but in reimagining how those compounds are transported to their targets.Companies working to overcome the blood-brain barrier and enable targeted, efficient brain delivery are staking out positions at the leading edge of a significant shift. Oncotelic Therapeutics is one participant in this broader movement, advancing platform-based approaches designed to expand what is therapeutically possible in CNS medicine. As the field continues to evolve, the capacity to deliver drugs reliably and precisely to the brain may well emerge as the central determinant of future medical progress.Biopharma Innovation Continues Advancing TherapeuticsThe biopharma and advanced therapeutics sector continues to see strong momentum as companies expand research pipelines, pursue strategic partnerships and accelerate development of next-generation treatments targeting complex diseases. Recent announcements across oncology, immunology and precision medicine highlight growing investment in innovative biologics, AI-driven drug discovery, targeted therapies and advanced platform technologies designed to improve outcomes for patients with difficult-to-treat conditions.Amgen Inc. (NASDAQ: AMGN) has acquired Dark Blue Therapeutics, a move that will bolster the company's oncology pipeline and expand its capabilities in targeted protein degradation and leukemia therapeutics. The company noted that acute myeloid leukemia remains one of the most difficult cancers to treat and that the acquisition complements and extends its research in targeted protein degradation and leukemia therapeutics, as well as advances its strategy to invest in novel therapeutic targets and next-generation oncology medicines designed to address difficult-to-treat cancers.Johnson & Johnson (NYSE: JNJ) continues advancing its position in the biopharma and advanced therapeutics space through its Innovative Medicine division, which the company describes as "leading where medicine is going." According to JNJ, patients inform and inspire the company's science-based innovations, which continue to change and save lives with rigorous science and compassion by addressing the most complex diseases and focusing on unlock the medicines of tomorrow. The company's areas of healthcare focus include oncology, immunology, neuroscience and cardiopulmonary.AbbVie Inc. (NYSE: ABBV) has entered an exclusive licensing agreement with RemeGen for the development, manufacturing and commercialization of RC148, a novel investigational Programmed Cell Death-1 ("PD-1")/Vascular Endothelial Growth Factor ("VEGF")-targeted bispecific antibody. RC148 is being developed both as a monotherapy and in combination regimens across multiple advanced solid tumors, reinforcing the company's continued expansion in next-generation oncology therapeutics. The agreement reflects AbbVie's strategy to strengthen its oncology pipeline through innovative biologics and advanced immunotherapy approaches targeting difficult cancers.Lunai Bioworks Inc. (NASDAQ: LNAI) announced the launch of an AI oncology pilot with a clinical-stage partner to analyze randomized phase 2 metastatic colorectal cancer survival trial data. The objective of the partnership is to define biologically meaningful patient subgroups that may benefit most from the investigational therapy. Under the pilot agreement, Lunai will deploy its proprietary Augusta AI platform to evaluate de-identified patient-level clinical, imaging, and longitudinal outcomes data, with a focus on overall survival and disease progression endpoints. By integrating traditional clinical variables with AI-derived imaging features and temporal response patterns, Lunai aims to generate data-driven enrichment strategies designed aid in the FDA trial design, including optimized inclusion criteria, endpoint strategy, and its statistical powering.These developments reflect the increasing importance of scientific innovation, data-driven discovery and advanced therapeutic modalities in shaping the future of medicine. As the industry continues evolving toward more personalized, targeted and technology-enabled approaches, companies operating in the space are positioning themselves to play a major role in advancing treatment options across a broad range of serious diseases.For further information about Oncotelic Therapeutics Inc., visit the Oncotelic Therapeutics profile.About BioMedWireBioMedWire ("BMW") is a specialized communications platform with a focus on the latest developments in the Biotechnology (BioTech), Biomedical Sciences (BioMed) and Life Sciences sectors. 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Editor@BioMedWire.comBioMedWire is powered by IBN Original: CNS Drug Delivery Technologies Are Reshaping Alzheimer's and Biodefense Research
US Market News
1月前
Lunai Bioworks Completes $20 Million Preferred Issuance to Acquire CNS Delivery and Neurotherapeutic IPMay 4, 2026 9:35 AM
PR Newswire (US)
Transaction Adds Dual BBB Delivery Strategies, Supports Alzheimer's Programs, Combination Therapies, 505(b)(2) Pathways, and CNS Countermeasure ApplicationsSACRAMENTO, Calif., May 4, 2026 /PRNewswire/ -- Lunai Bioworks, Inc. (NASDAQ: LNAI) today announced the completion of a $20 million preferred equity issuance to acquire intellectual property assets from two counterparties, expanding the Company's central nervous system (CNS) platform with complementary neurotherapeutic compounds and delivery technologies. The acquired portfolio is designed to address a key limitation in neurological disease treatment, including Alzheimer's disease, where the blood-brain barrier (BBB) can restrict therapeutic access to the brain. The expanded intellectual property portfolio introduces complementary CNS delivery technologies and multi-agent, combinatorial therapeutic approaches, which will be integrated into Lunai Bioworks IP, Inc., a wholly owned subsidiary, broadening the Company's growing platform of neurological disease and biodefense applications.
The transaction integrates two distinct CNS delivery approaches into Lunai's platform: a BBB-crossing prodrug system and a nose-to-brain (N2B) delivery pathway that bypasses the BBB via olfactory and trigeminal routes. Together, these approaches are intended to support both individual and combination therapies, align with Lunai's AI-driven patient stratification strategy, expand potential applications across neurological disease, 505(b)(2) development pathways, and CNS-targeted biodefense and countermeasure programs, and position Lunai for potential partnership, licensing, and non-dilutive funding opportunities.The acquired intellectual property expands Lunai's ability to connect therapeutic discovery with delivery, supporting a more integrated approach to CNS drug development. By pairing compound design with delivery optimization, the Company is advancing a framework aimed at increasing drug concentration in the brain while reducing systemic exposure. This approach addresses both challenges by combining novel neurotherapeutic compounds with complementary delivery technologies, improving CNS access and enabling multi-agent, combinatorial strategies. Together, the portfolio strengthens Lunai's ability not only to deliver therapeutics to the brain, but to develop and deploy both single-agent and combination therapies that target distinct aspects of disease biology. This approach may be applicable across multiple neurological indications as well as in settings requiring rapid CNS access.Lunai's Augusta platform is designed to stratify patient populations based on underlying biological drivers rather than traditional disease classifications. The integration of these assets is expected to support the development of targeted therapeutic combinations matched to specific patient subgroups, including in the context of neurological disease and acute toxic or environmental exposures. This combined approach is intended to improve the efficiency of candidate selection and advancement.The combined platform is also expected to support multiple regulatory pathways, including potential 505(b)(2) opportunities for reformulated or repurposed therapeutics. These pathways may enable more efficient development timelines and reduced clinical risk relative to traditional de novo drug development programs.In addition, the expanded intellectual property portfolio is expected to strengthen Lunai's role in biodefense-related initiatives, including its Pathfinder program, by increasing its capacity to evaluate and deploy CNS-targeted countermeasures. This includes the potential use of established pharmacological agents in combination with alternative delivery approaches designed for rapid administration and central nervous system access following chemical or environmental exposures."This transaction brings together complementary CNS delivery approaches that address one of the most persistent challenges in neurological drug development," said David Weinstein, Chief Executive Officer of Lunai Bioworks. "By integrating these technologies with our existing platform, we are expanding our ability to develop and deliver targeted therapies, while also opening additional pathways for partnership, licensing, and non-dilutive funding."On May 1, 2026, the Company completed the Merger and issued the Series B Preferred Stock having an aggregate Stated Value of $20,000,000 to the Holders. The Merger and the related issuance of the Series B Preferred Stock is the principal transaction undertaken by the Company to achieve compliance with the Nasdaq Stockholders' Equity Rule and the Company will determine and disclose the equity treatment of the Series B Preferred Stock in accordance with applicable accounting standards. After giving effect to the Merger, the issuance of the Series B Preferred Stock, and based on the Company's preliminary accounting and fair-value analysis, the Company believes its stockholders' equity exceeds the $2.5 million minimum required by Nasdaq Listing Rule 5550(b)(1). The Company is awaiting the Panel's formal determination of compliance with the Stockholder's Equity Rule. There can be no assurance that the Panel will determine that the Company has satisfied the Stockholders' Equity Rule, and any such determination by the Panel is subject to the Panel's continuing review of the Company's disclosures, financial condition and progress toward compliance with the Bid Price Rule. If the Panel determines that the Company has not satisfied the conditions set forth in the Panel's decision (as so extended), Nasdaq may take further action to delist the Company's common stock from The Nasdaq Capital Market.About Lunai Bioworks, Inc.
Lunai Bioworks (NASDAQ: LNAI) is an AI-driven life sciences company advancing drug discovery and chemical defense through its integrated platform. Lunai combines clinical data, machine learning, and in vivo validation to identify disease biology and develop precision therapeutics. Lunai is focused on central nervous system diseases and oncology, with a mission to reduce development timelines and improve clinical success rates.Forward-Looking Statements
This press release contains forward-looking statements within the meaning of applicable securities laws. These statements include, but are not limited to, statements regarding the expected benefits of the transaction, potential applications of the acquired intellectual property, development timelines, regulatory pathways, and potential partnership, licensing, or funding opportunities. These statements are based on current expectations and assumptions and are subject to risks and uncertainties that could cause actual results to differ materially. Lunai undertakes no obligation to update these statements except as required by law.
View original content to download multimedia:https://www.prnewswire.com/news-releases/lunai-bioworks-completes-20-million-preferred-issuance-to-acquire-cns-delivery-and-neurotherapeutic-ip-302761369.htmlSOURCE Lunai Bioworks Inc.
Original: Lunai Bioworks Completes $20 Million Preferred Issuance to Acquire CNS Delivery and Neurotherapeutic IP
US Market News
2月前
Lunai Bioworks (NASDAQ: LNAI) and Geneial Sign LOI to Build Rare Disease Patient Cohorts for Pharma PartnershipsApril 15, 2026 9:10 AM
PR Newswire (US)
Collaboration converts patient-led data into trial-ready cohorts to support drug development, commercial partnerships, and revenue-generating opportunities.Initial programs underway to integrate rare disease datasets and advance commercial partnership opportunities with pharmaceutical companies.SACRAMENTO, Calif., and HOUSTON, April 15, 2026 /PRNewswire/ -- Lunai Bioworks, Inc. (NASDAQ: LNAI) ("Lunai"), an AI-driven drug discovery company, and Geneial, Inc., a precision medicine data infrastructure and patient engagement company, today announced that BioSymetrics, a wholly owned Lunai subsidiary, has signed a Letter of Intent (LOI) with Geneial to pursue a strategic collaboration in rare neurological disorders.
The collaboration is designed to support rare disease research and advocacy groups in converting fragmented, patient-generated data into actionable drug development programs, including the creation and activation of trial-ready patient cohorts that can support pharmaceutical partnerships.Rare diseases affect approximately 300 million people globally, yet drug development remains constrained by limited access to structured, usable patient data. The targeted rare neurological segment represents a multi-billion-dollar and growing market opportunity.Initial programs are expected to integrate datasets across multiple patient registries, incorporating longitudinal clinical data to support cohort development and translational research across indications.Under the proposed collaboration, BioSymetrics and Geneial plan to:Integrate and standardize patient-led rare disease datasetsIdentify defined patient subgroups for clinical developmentGenerate actionable insights to support therapeutic programsEnable the activation of trial-ready cohorts for pharma and biotech engagementThis approach is intended to reduce development risk, improve the probability of trial success, and accelerate timelines by addressing a key bottleneck in rare disease drug development: connecting longitudinal patient data and engaged cohorts with translational research and clinical development opportunities.The companies expect to pursue commercial partnerships enabled by these efforts, supporting potential revenue-generating collaborations and downstream partnering opportunities with pharmaceutical and biotechnology partners."Geneial's mission is to accelerate precision medicine by connecting patient communities, researchers, and industry partners," said Adam Hansen, CEO of Geneial. "This collaboration connects our AI-enabled patient engagement and data platform with BioSymetrics' capabilities to translate real-world data into targeted therapies and accelerate development timelines.""Rare neurological disorders represent a large unmet need, but the underlying data have historically been difficult to use," said Gabe Musso, Chief Scientific Officer of BioSymetrics. "This collaboration is focused on making that data actionable for developmental programs and enabling a more efficient path toward the clinic."Geneial and BioSymetrics will combine patient engagement infrastructure with data integration and analysis capabilities to support therapeutic development and clinical pathway design.The initial focus will include select rare neurodevelopmental disorders, with the goal of building scalable programs that can expand over time.The LOI is non-binding. Specific projects and commercial terms are expected to be defined in future definitive agreements.About Lunai Bioworks
Lunai Bioworks (NASDAQ: LNAI) is an AI-driven biotechnology company focused on accelerating drug discovery and development across central nervous system (CNS) and other high unmet need areas. Lunai integrates data analytics and experimental biology to improve development efficiency, reduce cost, and increase probability of success. For more visit https://lunaibioworks.com.About Geneial
Geneial is an AI-powered precision medicine data infrastructure company focused on rare and genetic diseases. Its platform integrates patient engagement, longitudinal data, and semantic interoperability, connecting patients, researchers, and industry partners to accelerate therapeutic development and care navigation. For more visit https://geneial.com.Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the expected scope, objectives, and potential benefits of the proposed collaboration, the potential development of datasets and patient cohorts, and the possibility of future commercial partnerships. These statements are based on current expectations and involve risks and uncertainties that may cause actual results to differ materially.Factors that could affect outcomes include the parties' ability to enter into definitive agreements, advance proposed projects, generate and validate data, secure partnerships, obtain necessary funding or regulatory support, and realize the anticipated benefits of the collaboration. Lunai undertakes no obligation to update forward-looking statements except as required by law.
View original content to download multimedia:https://www.prnewswire.com/news-releases/lunai-bioworks-nasdaq-lnai-and-geneial-sign-loi-to-build-rare-disease-patient-cohorts-for-pharma-partnerships-302743186.htmlSOURCE Lunai Bioworks Inc.
Original: Lunai Bioworks (NASDAQ: LNAI) and Geneial Sign LOI to Build Rare Disease Patient Cohorts for Pharma Partnerships
US Market News
2月前
Lunai Bioworks (NASDAQ: LNAI) Secures First Revenue-Generating Defense Collaboration Through BioSymetrics, Deploying AI Platform for Chemical Threat Assessment; Additional Engagements Under DiscussionApril 7, 2026 9:05 AM
PR Newswire (US)
Advancing AI-enabled chemical threat detection and dual-use biodefense technologies through initial commercial deploymentSACRAMENTO, Calif., April 7, 2026 /PRNewswire/ -- Lunai Bioworks, Inc. (NASDAQ: LNAI), an AI-driven drug discovery and biodefense company, today announced that its subsidiary, BioSymetrics, has entered into a revenue-generating, commercial defense-focused collaboration with a specialized biotechnology partner to support the development of an advanced AI-enabled platform for chemical threat assessment, with initial engagement underway and additional engagements currently under discussion.
Under the agreement, BioSymetrics will deploy its proprietary phenotypic screening and artificial intelligence capabilities to enhance the identification, classification, and mechanistic understanding of neuroactive and neurotoxic compounds. The collaboration, structured as a multi-year commercial engagement, represents a key step in expanding Lunai Bioworks' presence in defense and national security applications.BioSymetrics will implement an integrated approach combining in vivo zebrafish-based phenotypic screening with AI-driven mechanism-of-action (MOA) prediction, enabling rapid hypothesis generation and validation for compounds of interest. This dual capability is designed to accelerate the detection and characterization of chemical threats while improving translational relevance and operational applicability, with screening systems capable of evaluating hundreds to thousands of compounds per week.Key Components of the Collaboration:Experimental screening of chemical compounds with a focus on central nervous system-active agentsAI-based computational modeling to predict mechanisms of action and identify novel or unknown threatsIntegration of biological and computational datasets to improve identification of neuroactive and toxic compounds and enhance readinessSupport for defense-oriented partnership pathways and interoperability across allied research frameworks"This collaboration reflects Lunai Bioworks' commitment to applying cutting-edge AI and phenotypic science to real-world challenges in global security," said David Weinstein, Chief Executive Officer of Lunai Bioworks. "BioSymetrics' platform is uniquely positioned to bridge experimental biology and machine learning, enabling faster and more reliable insights into complex chemical threats."The project also reinforces Lunai Bioworks' broader strategy to advance dual-use technologies spanning defense and pharmaceutical applications, including toxicity prediction, drug safety, and neurobiology.About Lunai Bioworks
Lunai Bioworks (NASDAQ: LNAI) is an AI-driven life sciences company advancing drug discovery and chemical defence through its integrated platform. Lunai combines clinical data, machine learning, and in vivo validation to identify disease biology and develop precision therapeutics. Lunai is focused on central nervous system diseases and oncology, with a mission to reduce development timelines and improve clinical success rates.Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, among others, statements regarding the anticipated benefits, impact, and future expansion of the collaboration described herein, the development and performance of Lunai Bioworks' and BioSymetrics' platforms and technologies, and Lunai's broader strategy and future plans. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including risks related to the Company's ability to successfully execute and expand its collaborations, advance its platforms and product candidates through research and development, obtain and maintain regulatory approvals, secure additional funding, and maintain compliance with Nasdaq listing requirements, as well as other risks described from time to time in the Company's filings with the Securities and Exchange Commission. Lunai undertakes no obligation to update any forward-looking statements except as required by law.
View original content to download multimedia:https://www.prnewswire.com/news-releases/lunai-bioworks-nasdaq-lnai-secures-first-revenue-generating-defense-collaboration-through-biosymetrics-deploying-ai-platform-for-chemical-threat-assessment-additional-engagements-under-discussion-302735530.htmlSOURCE Lunai Bioworks Inc.
Original: Lunai Bioworks (NASDAQ: LNAI) Secures First Revenue-Generating Defense Collaboration Through BioSymetrics, Deploying AI Platform for Chemical Threat Assessment; Additional Engagements Under Discussion
INV4
2月前
Microcap March Madness: LNAI, FAGI, VSA, LNKS Sweet 16 Underdogs to Watch
March 26, 2026
A new wave of activity across biotech innovation, artificial intelligence, digital infrastructure, and global manufacturing is drawing increased investor attention as several emerging growth companies report significant developments that could shape their next phase of expansion.
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Lunai Bioworks, Inc. (NASDAQ: LNAI) Targets Alzheimer’s Breakthrough with $20M Strategic Transaction.
Lunai Bioworks, Inc. (NASDAQ: LNAI) announced it has executed a $20 million strategic transaction to acquire blood-brain barrier (BBB) delivery technology and central nervous system (CNS) Alzheimer’s drug assets.
The acquisition is focused on enabling more effective delivery of therapies across the BBB—one of the most significant challenges in treating neurological diseases. The platform has potential applications beyond Alzheimer’s, including broader CNS disorders, positioning Lunai within a high-growth segment of the biotech, neuroscience, and drug delivery markets.
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Full Alliance Group, Inc. (OTCQB: FAGI) Expands Multi-Vertical Ecosystem with Clinics and Digital Infrastructure
Full Alliance Group (OTCQB: FAGI) continues building its multi-vertical ecosystem strategy through the expansion of MAXX Health Clinics across the Southeastern United States. The clinics provide advanced therapeutic services while supporting the company’s broader vision of integrating service-based businesses, product development, and digital engagement platforms.
The company is also advancing initiatives around blockchain infrastructure, tokenized engagement systems, and Web3-enabled digital ecosystems, positioning FAGI at the intersection of real-world operations and digital asset innovation. This hybrid approach reflects a growing trend where companies combine traditional revenue models with tokenization and decentralized technology frameworks.
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VisionSys AI Inc. (NASDAQ: VSA) Advances AI-Powered Brain-Machine Interaction Technology
VisionSys AI Inc. (NASDAQ: VSA) is gaining visibility as it develops AI-powered brain-machine interaction systems designed to transform healthcare and biotechnology applications.
The company focuses on combining advanced algorithms with hardware and software platforms to enable intelligent systems capable of enhancing human-machine communication. As AI in healthcare, neural interfaces, and smart systems continue to evolve, VisionSys is positioning itself within a rapidly expanding segment of the AI and biotech convergence market.
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Linkers Ltd. (NASDAQ: LNKS) Expands Manufacturing Footprint with Thailand Acquisition Strategy
Linkers Ltd (NASDAQ: LNKS) is moving to expand its global manufacturing capabilities after entering into a memorandum of understanding to acquire equity interests in LPW Electronics Co. Ltd. in Thailand.
The proposed transaction could enhance Linkers’ production capacity and support expansion across electronics manufacturing, wire harness systems, and supply chain infrastructure. As demand increases for automotive electronics, industrial systems, and connectivity solutions, the company’s regional expansion strategy may strengthen its position within the global manufacturing sector.
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Emerging Themes Driving Investor Attention
Across these companies, several high-growth themes are emerging:
• Biotech innovation and Alzheimer’s research (LNAI)
• Blockchain infrastructure and tokenized ecosystems (FAGI)
• Artificial intelligence and brain-machine interfaces (VSA)
• Global manufacturing expansion and supply chain growth (LNKS)
As capital continues rotating into AI, biotech, digital assets, and infrastructure-driven microcaps, investors are increasingly monitoring companies that combine innovation, scalability, and strategic expansion initiatives.
Link article
$LANI 🗞️
INV4
2月前
Recent news:
What's Behind The Jump In Lunai Bioworks Stock?
March 26, 2026
Shares of Lunai Bioworks Inc. LNAI are soaring Thursday after the company announced that it will acquire blood-brain barrier delivery technology and central nervous system Alzheimer’s drug assets from the Clemann Group for $20 million.
Lunai To Acquire Alzheimer Drug Assets
Lunai Bioworks executed a binding $20 million strategic transaction to acquire blood-brain barrier delivery technology and central nervous system (CNS) Alzheimer’s drug assets from the Clemann Group. The transaction is structured as Series B Convertible Preferred at a fixed conversion price of $1.50 per share, subject to a 19.9% beneficial ownership limitation.
Notably, this platform has broad CNS delivery applications, indicating that Lunai Bioworks is making strides in its endeavors within the CNS and Alzheimer’s therapy sector. The acquisition brings a delivery platform to Lunai that addresses effectively transporting therapeutics into the brain.
“This is a step-change in our capabilities,” said David Weinstein, CEO of Lunai Bioworks. “We are now combining the ability to identify the right biology with a validated mechanism to deliver therapies directly into the brain. This has profound implications for how we treat Alzheimer’s and other complex CNS diseases that have historically been unreachable.”
LNAI Shares Soar In Regular Trading
LNAI Stock Price Activity: Lunai Bioworks shares were up 57.29% at roughly 63 cents at the time of publication on Thursday, according to Benzinga Pro data.
Link article
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AI Life Sciences Stock Lunai Bioworks (NASDAQ: LNAI) Makes Nasdaq Top Gainer List on News
March 26, 2026
(Investorideas.com Newswire) a go-to platform for big investing ideas, including AI, biotech stock issues, news, and trading alerts for Lunai Bioworks (NASDAQ: LNAI), an AI-driven life sciences company.
The stock makes the Nasdaq top percentage gainer list following news, currently trading at $0.6080, up 0.2065, gaining 51.69% on a volume of over 200 million shares.
Lunai Bioworks (NASDAQ: LNAI) is an AI-driven life sciences company advancing drug discovery through its integrated platform. The Company combines clinical data, machine learning, and in vivo validation to identify disease biology and develop precision therapeutics. Lunai is focused on central nervous system diseases and oncology, with a mission to reduce development timelines and improve clinical success rates.
Lunai Bioworks just announced it has executed a binding $20 million strategic transaction to acquire blood-brain barrier (BBB) delivery technology and central nervous system (CNS) Alzheimer's drug assets from the Clemann Group, SAS, or its assignee.
The transaction is structured as Series B Convertible Preferred at a fixed conversion price of $1.50 per share, subject to a 19.9% beneficial ownership limitation. The structure contains no variable pricing or reset provisions, strengthening the company's equity position while remaining NASDAQ compliant.
This acquisition brings a delivery platform to Lunai that addresses one of the most significant bottlenecks in CNS drug development: effectively transporting therapeutics into the brain. The underlying chemistry allows compounds to cross the blood-brain barrier, remain inactive in the body, and then activate specifically inside the brain. The platform's mechanism of action targets pathways central to acetylcholinesterase modulation in the brain, which are broadly implicated in neurological disease.
What makes this important is that it directly strengthens Lunai's CNS Alzheimer's pipeline by pairing precise biological target identification with a proven delivery method. At the same time, it expands the company's ability to develop next-generation treatments across a broad range of CNS disorders where traditional drugs struggle to penetrate the brain effectively, offering the potential for improved safety and efficacy.
"This is a step-change in our capabilities," said David Weinstein, CEO of Lunai Bioworks. "We are now combining the ability to identify the right biology with a validated mechanism to deliver therapies directly into the brain. This has profound implications for how we treat Alzheimer's and other complex CNS diseases that have historically been unreachable."
Link article
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Lunai Bioworks (NASDAQ: LNAI) Launches National Chemical Defense Consortium Targeting $400M-$1.2B U.S. Countermeasure Programs; 3-Year AI Antidote Development Model
March 19, 2026
AI platform integrates academic and defense research to accelerate rapid antidote discovery and federal stockpiling for emerging chemical threats.
SACRAMENTO, Calif., March 19, 2026 /PRNewswire/ -- Lunai Bioworks (NASDAQ: LNAI), through its wholly owned subsidiary BioSymetrics, today announced the formation of a national consortium designed to accelerate the discovery and development of chemical countermeasures for emerging battlefield and terrorism threats. The Pathfinder Consortium, a national academic–industry alliance designed to consolidate historically siloed U.S. chemical warfare preparedness resources into a unified, execution-ready infrastructure capable of accelerating medical countermeasure development to approximately three years.
For decades, America's chemical defense capabilities have existed in fragmented silos: academic toxicology labs, military research units, federal agencies, and biotech innovators operating independently. Pathfinder integrates these capabilities into a coordinated framework engineered for speed, capital efficiency, and national readiness.
A 3-year regulatory pathway, not a 10-year drug timeline
Unlike traditional pharmaceutical development cycles, chemical countermeasures can follow accelerated regulatory pathways.
The Pathfinder model is structured to:
• Demonstrate efficacy in yeast and cell-based systems
• Validate therapeutic effects in FDA-recognized zebrafish models
• Complete two confirmatory animal studies
• Conduct a 50-person Phase I safety study
The full process can be completed in approximately 36 months.
In many cases, existing FDA-approved drugs may be repurposed, potentially reducing timelines even further.
"Chemical defense cannot operate on a decade-long pharmaceutical clock," said David Weinstein, CEO of Lunai Bioworks. "The regulatory framework allos for speed, and Pathfinder is designed to execute within that accelerated pathway."
Responding to the new invisible battlefield
With rising geopolitical tensions in Iran and across the Middle East, and the rapid integration of AI, autonomous drones, and chemical payload delivery systems, Lunai believes the threat landscape has shifted materially.
The modern battlefield is no longer confined to visible front lines. It is algorithmic. It is airborne. It is chemical.
Pathfinder represents a strategic response, a scalable national platform positioned for what the Company envisions as a potential "Warp Speed 2" era of chemical preparedness.
Strategic and financial significance
Validated countermeasures are typically procured by the U.S. government for national stockpiling programs ranging between $400 million and $1.2 billion per program.
By mobilizing and organizing national capabilities, Pathfinder positions BioSymetrics to:
• Access non-dilutive funding sources Compete for BARDA, DoD, and Homeland Security programs
• Pursue large-scale federal procurement contracts
• Monetize repurposed compounds through rapid deployment pathways
• Diversify revenue beyond traditional biotech development cycles
The Consortium leverages BioSymetrics' proprietary AI-enabled phenotypic platform, integrating machine learning analytics with high-throughput vertebrate screening to rapidly identify toxicologic signatures and therapeutic leads.
National Leadership and Execution Framework
Pathfinder includes collaboration with nationally recognized experts, including:
• Dr. Calum MacRae (Brigham and Women's Hospital and Harvard Medical School)
• Dr. Vik Bebarta (Colonel, U.S. Air Force Reserve; University of Colorado)
• Dr. Randall Peterson (University of Utah)
• Dr. Vincent Jo Davidson (Purdue University)
By aligning academic, military, and AI-driven biotech capabilities under a single operational structure, Pathfinder transitions chemical defense from a fragmented research model into an execution-oriented national preparedness platform.
About Lunai Bioworks
Lunai Bioworks (NASDAQ: LNAI) is an AI-enabled biotechnology company advancing rapid in vivo phenotypic drug discovery across CNS and biodefense applications. By integrating high-throughput vertebrate screening with machine learning analytics, Lunai seeks to accelerate therapeutic discovery while reducing cost, time, and capital intensity.
For more information, visit www.lunaibioworks.com.
Link article
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Lunai Bioworks (NASDAQ: LNAI) Locks Down Core AI Architecture with U.S. Patent Enabling Precision Disease Subtyping
Feb 19, 2026
Foundational Patent Strengthens AI Moat Across Multimodal Data Standardization, Disease Stratification and Gene Mapping
SACRAMENTO, Calif., Feb. 19, 2026 /PRNewswire/ -- Lunai Bioworks, Inc. (NASDAQ: LNAI), an AI-driven biotechnology company advancing precision therapeutics in central nervous system (CNS) disorders and oncology, as well as solutions for biodefense, today announced the issuance of U.S. Patent No. 12,369,861, titled "Methods, Systems, and Frameworks for Debiasing Data in Drug Discovery Predictions."
As outlined in their recent shareholder update (https://www.prnewswire.com/news-releases/lunai-bioworks-inc-issues-letter-to-shareholders-302682738.html), Lunai Bioworks is focused on strengthening its core technology platform, expanding its defensible intellectual property moat, and building scalable AI infrastructure capable of supporting long-term pharmaceutical collaborations. The issuance of this patent and the advancement of additional applications represent tangible execution against that strategy.
"Precision disease subtyping begins with clean, standardized multimodal data," said David Weinstein, Chief Executive Officer of Lunai Bioworks. "This patent protects the critical first step in our closed-loop AI architecture, increasing confidence in biomarker discovery, disease stratification, and gene network mapping across our CNS and biodefense programs. Strengthening our AI infrastructure moat is central to our long-term value creation strategy."
The newly issued patent protects the foundational first step of Lunai's proprietary closed-loop disease reverse engineering platform, multimodal data standardization and structural bias removal prior to predictive modeling.
AI-driven drug discovery models are only as reliable as the data they ingest. Hidden dataset bias and fragmentation across genomic, clinical, imaging, and phenotypic sources can distort biomarker discovery and reduce translational reliability. Lunai's patented architecture systematically detects, standardizes, and removes structural bias across multimodal inputs before downstream artificial intelligence modeling begins.
By protecting this core data layer, Lunai strengthens its ability to accurately identify biologically coherent patient subtypes and trace those subtypes to the gene networks most strongly associated with each disease type.
About Lunai Bioworks, Inc.
Lunai Bioworks (NASDAQ: LNAI) is an AI-driven biotechnology company focused on transforming drug discovery and precision medicine through advanced machine learning, federated learning, and secure data analytics technologies. The Company's proprietary platform integrates diverse biomedical datasets to generate actionable insights for therapeutic development and clinical advancement.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements are based on current expectations and involve risks and uncertainties that could cause actual results to differ materially from those expressed or implied. Readers are encouraged to review Lunai's filings with the U.S. Securities and Exchange Commission for a discussion of these risks and uncertainties.
Link article
$LNAI 🗞️
US Market News
2月前
Lunai Bioworks Executes $20M Strategic Transaction at Fixed $1.50 Conversion, Acquiring BBB Delivery Platform for CNS Alzheimer's Therapies with Broad CNS Delivery ApplicationsMarch 26, 2026 8:50 AM
PR Newswire (US)
SACRAMENTO, Calif., March 26, 2026 /PRNewswire/ -- Lunai Bioworks, Inc. (NASDAQ: LNAI) today announced it has executed a binding $20 million strategic transaction to acquire blood-brain barrier (BBB) delivery technology and central nervous system (CNS) Alzheimer's drug assets from the Clemann Group, SAS or its assignee.
The transaction is structured as Series B Convertible Preferred at a fixed conversion price of $1.50 per share, subject to a 19.9% beneficial ownership limitation. The structure contains no variable pricing or reset provisions, strengthening the Company's equity position while remaining NASDAQ compliant.This acquisition brings a delivery platform to Lunai that addresses one of the most significant bottlenecks in CNS drug development: effectively transporting therapeutics into the brain. The underlying chemistry allows compounds to cross the blood-brain barrier, remain inactive in the body, and then activate specifically inside the brain. The platform's mechanism of action targets pathways central to acetylcholinesterase modulation in the brain, which are broadly implicated in neurological disease.What makes this important is that it directly strengthens Lunai's CNS Alzheimer's pipeline by pairing precise biological target identification with a proven delivery method. At the same time, it expands the Company's ability to develop next-generation treatments across a broad range of CNS disorders where traditional drugs struggle to penetrate the brain effectively, offering the potential for improved safety and efficacy."This is a step-change in our capabilities," said David Weinstein, CEO of Lunai Bioworks. "We are now combining the ability to identify the right biology with a validated mechanism to deliver therapies directly into the brain. This has profound implications for how we treat Alzheimer's and other complex CNS diseases that have historically been unreachable."About Lunai Bioworks
Lunai Bioworks (NASDAQ: LNAI) is an AI-driven life sciences company advancing drug discovery through its integrated platform. The Company combines clinical data, machine learning, and in vivo validation to identify disease biology and develop precision therapeutics. Lunai is focused on central nervous system diseases and oncology, with a mission to reduce development timelines and improve clinical success rates.Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements are based on current expectations and assumptions and involve known and unknown risks, uncertainties, and other factors that may cause actual results to differ materially. These risks include, but are not limited to, the ability to complete the transaction on anticipated terms, the successful integration of acquired technologies, the advancement of product candidates through development, regulatory approvals, and the Company's ability to maintain compliance with Nasdaq listing requirements. Lunai undertakes no obligation to update any forward-looking statements except as required by law.
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Original: Lunai Bioworks Executes $20M Strategic Transaction at Fixed $1.50 Conversion, Acquiring BBB Delivery Platform for CNS Alzheimer's Therapies with Broad CNS Delivery Applications
Trooperstocks
2月前
$LNAI News: Lunai Bioworks Executes $20M Strategic Transaction at Fixed $1.50 Conversion, Acquiring BBB Delivery Platform for CNS Alzheimer's Therapies with Broad CNS Delivery Applications
PR Newswire
Thu, March 26, 2026 at 8:50 AM EDT
SACRAMENTO, Calif., March 26, 2026 /PRNewswire/ -- Lunai Bioworks, Inc. (NASDAQ: LNAI) today announced it has executed a binding $20 million strategic transaction to acquire blood-brain barrier (BBB) delivery technology and central nervous system (CNS) Alzheimer's drug assets from the Clemann Group, SAS or its assignee.
The transaction is structured as Series B Convertible Preferred at a fixed conversion price of $1.50 per share, subject to a 19.9% beneficial ownership limitation. The structure contains no variable pricing or reset provisions, strengthening the Company's equity position while remaining NASDAQ compliant.
This acquisition brings a delivery platform to Lunai that addresses one of the most significant bottlenecks in CNS drug development: effectively transporting therapeutics into the brain. The underlying chemistry allows compounds to cross the blood-brain barrier, remain inactive in the body, and then activate specifically inside the brain. The platform's mechanism of action targets pathways central to acetylcholinesterase modulation in the brain, which are broadly implicated in neurological disease.
What makes this important is that it directly strengthens Lunai's CNS Alzheimer's pipeline by pairing precise biological target identification with a proven delivery method. At the same time, it expands the Company's ability to develop next-generation treatments across a broad range of CNS disorders where traditional drugs struggle to penetrate the brain effectively, offering the potential for improved safety and efficacy.
"This is a step-change in our capabilities," said David Weinstein, CEO of Lunai Bioworks. "We are now combining the ability to identify the right biology with a validated mechanism to deliver therapies directly into the brain. This has profound implications for how we treat Alzheimer's and other complex CNS diseases that have historically been unreachable."
About Lunai Bioworks
Lunai Bioworks (NASDAQ: LNAI) is an AI-driven life sciences company advancing drug discovery through its integrated platform. The Company combines clinical data, machine learning, and in vivo validation to identify disease biology and develop precision therapeutics. Lunai is focused on central nervous system diseases and oncology, with a mission to reduce development timelines and improve clinical success rates.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements are based on current expectations and assumptions and involve known and unknown risks, uncertainties, and other factors that may cause actual results to differ materially. These risks include, but are not limited to, the ability to complete the transaction on anticipated terms, the successful integration of acquired technologies, the advancement of product candidates through development, regulatory approvals, and the Company's ability to maintain compliance with Nasdaq listing requirements. Lunai undertakes no obligation to update any forward-looking statements except as required by law.
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US Market News
3月前
Lunai Bioworks (NASDAQ: LNAI) Launches National Chemical Defense Consortium Targeting $400M-$1.2B U.S. Countermeasure Programs; 3-Year AI Antidote Development ModelMarch 19, 2026 9:57 AM
PR Newswire (US)
AI platform integrates academic and defense research to accelerate rapid antidote discovery and federal stockpiling for emerging chemical threats.SACRAMENTO, Calif., March 19, 2026 /PRNewswire/ -- Lunai Bioworks (NASDAQ: LNAI), through its wholly owned subsidiary BioSymetrics, today announced the formation of a national consortium designed to accelerate the discovery and development of chemical countermeasures for emerging battlefield and terrorism threats. The Pathfinder Consortium, a national academic–industry alliance designed to consolidate historically siloed U.S. chemical warfare preparedness resources into a unified, execution-ready infrastructure capable of accelerating medical countermeasure development to approximately three years.
For decades, America's chemical defense capabilities have existed in fragmented silos: academic toxicology labs, military research units, federal agencies, and biotech innovators operating independently. Pathfinder integrates these capabilities into a coordinated framework engineered for speed, capital efficiency, and national readiness.A 3-year regulatory pathway, not a 10-year drug timelineUnlike traditional pharmaceutical development cycles, chemical countermeasures can follow accelerated regulatory pathways.The Pathfinder model is structured to:Demonstrate efficacy in yeast and cell-based systemsValidate therapeutic effects in FDA-recognized zebrafish modelsComplete two confirmatory animal studiesConduct a 50-person Phase I safety studyThe full process can be completed in approximately 36 months.In many cases, existing FDA-approved drugs may be repurposed, potentially reducing timelines even further."Chemical defense cannot operate on a decade-long pharmaceutical clock," said David Weinstein, CEO of Lunai Bioworks. "The regulatory framework allos for speed, and Pathfinder is designed to execute within that accelerated pathway."Responding to the new invisible battlefieldWith rising geopolitical tensions in Iran and across the Middle East, and the rapid integration of AI, autonomous drones, and chemical payload delivery systems, Lunai believes the threat landscape has shifted materially.The modern battlefield is no longer confined to visible front lines. It is algorithmic. It is airborne. It is chemical.Pathfinder represents a strategic response, a scalable national platform positioned for what the Company envisions as a potential "Warp Speed 2" era of chemical preparedness.Strategic and financial significanceValidated countermeasures are typically procured by the U.S. government for national stockpiling programs ranging between $400 million and $1.2 billion per program.By mobilizing and organizing national capabilities, Pathfinder positions BioSymetrics to:Access non-dilutive funding sources Compete for BARDA, DoD, and Homeland Security programsPursue large-scale federal procurement contractsMonetize repurposed compounds through rapid deployment pathwaysDiversify revenue beyond traditional biotech development cyclesThe Consortium leverages BioSymetrics' proprietary AI-enabled phenotypic platform, integrating machine learning analytics with high-throughput vertebrate screening to rapidly identify toxicologic signatures and therapeutic leads.National Leadership and Execution FrameworkPathfinder includes collaboration with nationally recognized experts, including:Dr. Calum MacRae (Brigham and Women's Hospital and Harvard Medical School)Dr. Vik Bebarta (Colonel, U.S. Air Force Reserve; University of Colorado)Dr. Randall Peterson (University of Utah)Dr. Vincent Jo Davidson (Purdue University)By aligning academic, military, and AI-driven biotech capabilities under a single operational structure, Pathfinder transitions chemical defense from a fragmented research model into an execution-oriented national preparedness platform.About Lunai BioworksLunai Bioworks (NASDAQ: LNAI) is an AI-enabled biotechnology company advancing rapid in vivo phenotypic drug discovery across CNS and biodefense applications. By integrating high-throughput vertebrate screening with machine learning analytics, Lunai seeks to accelerate therapeutic discovery while reducing cost, time, and capital intensity.For more information, visit www.lunaibioworks.com.
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Original: Lunai Bioworks (NASDAQ: LNAI) Launches National Chemical Defense Consortium Targeting $400M-$1.2B U.S. Countermeasure Programs; 3-Year AI Antidote Development Model
US Market News
4月前
Lunai Bioworks (NASDAQ: LNAI) Locks Down Core AI Architecture with U.S. Patent Enabling Precision Disease SubtypingFebruary 19, 2026 8:30 AM
PR Newswire (US)
Foundational Patent Strengthens AI Moat Across Multimodal Data Standardization, Disease Stratification and Gene MappingSACRAMENTO, Calif., Feb. 19, 2026 /PRNewswire/ -- Lunai Bioworks, Inc. (NASDAQ: LNAI), an AI-driven biotechnology company advancing precision therapeutics in central nervous system (CNS) disorders and oncology, as well as solutions for biodefense, today announced the issuance of U.S. Patent No. 12,369,861, titled "Methods, Systems, and Frameworks for Debiasing Data in Drug Discovery Predictions."
As outlined in their recent shareholder update (https://www.prnewswire.com/news-releases/lunai-bioworks-inc-issues-letter-to-shareholders-302682738.html), Lunai Bioworks is focused on strengthening its core technology platform, expanding its defensible intellectual property moat, and building scalable AI infrastructure capable of supporting long-term pharmaceutical collaborations. The issuance of this patent and the advancement of additional applications represent tangible execution against that strategy."Precision disease subtyping begins with clean, standardized multimodal data," said David Weinstein, Chief Executive Officer of Lunai Bioworks. "This patent protects the critical first step in our closed-loop AI architecture, increasing confidence in biomarker discovery, disease stratification, and gene network mapping across our CNS and biodefense programs. Strengthening our AI infrastructure moat is central to our long-term value creation strategy."The newly issued patent protects the foundational first step of Lunai's proprietary closed-loop disease reverse engineering platform, multimodal data standardization and structural bias removal prior to predictive modeling.AI-driven drug discovery models are only as reliable as the data they ingest. Hidden dataset bias and fragmentation across genomic, clinical, imaging, and phenotypic sources can distort biomarker discovery and reduce translational reliability. Lunai's patented architecture systematically detects, standardizes, and removes structural bias across multimodal inputs before downstream artificial intelligence modeling begins.By protecting this core data layer, Lunai strengthens its ability to accurately identify biologically coherent patient subtypes and trace those subtypes to the gene networks most strongly associated with each disease type.About Lunai Bioworks, Inc.
Lunai Bioworks (NASDAQ: LNAI) is an AI-driven biotechnology company focused on transforming drug discovery and precision medicine through advanced machine learning, federated learning, and secure data analytics technologies. The Company's proprietary platform integrates diverse biomedical datasets to generate actionable insights for therapeutic development and clinical advancement.Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements are based on current expectations and involve risks and uncertainties that could cause actual results to differ materially from those expressed or implied. Readers are encouraged to review Lunai's filings with the U.S. Securities and Exchange Commission for a discussion of these risks and uncertainties.
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Original: Lunai Bioworks (NASDAQ: LNAI) Locks Down Core AI Architecture with U.S. Patent Enabling Precision Disease Subtyping
US Market News
4月前
Lunai Bioworks, Inc. Issues Letter to ShareholdersFebruary 9, 2026 11:14 AM
PR Newswire (US)
SACRAMENTO, Calif. , Feb. 9, 2026 /PRNewswire/ --
Dear Shareholders,We have completed our AI platform in the last 12 months and now it is commercial. Negotiations are moving forward with several pharmaceutical and drug discovery companies. Partnerships and collaborations are imminent. Why? -because Lunai Bioworks operates a closed loop AI system that is truly disruptive (and complementary) to current discovery platforms and that turns complex biology into real-world action in several ways with less cash burn and new revenue streams. Our Augusta platform starts with real biological signals from patients — genetic, molecular, and clinical data — and uses artificial intelligence to reverse-engineer diseases into biologically defined subgroups. Instead of asking, "What drug hits this target?" Lunai asks, "What biology is actually driving this subgroup of patients?"Then comes the part most AI companies can't do.Lunai rapidly tests its predictions in living systems using high-throughput in vivo models. That means its drug ideas aren't just computer outputs — they're biologically validated early, before hundreds of millions of dollars are spent. Our approach is designed to shorten pharmaceutical companies' current drug discovery programs from over 2 years to under a year, same them substantial money, and increase the probability of success.In short:Better data ? smarter targets ? earlier proof ? lower risk.Lunia has established three revenue driven enginesA) AI Drug Discovery: enabling pharmaceutical companies to understand disease biology and design better clinical trials, so promising therapies reach patients faster. We have established new fully owned company technologies for royalty-based partnerships. While we have been focused on CNS diseases today, we launched a new AI oncology pilot with a clinical-stage partner using our Augusta platform to re-analyze data from a randomized Phase 2 metastatic colorectal cancer survival trial—work that can expand into a broader commercial relationship. We validated the foundation for this project in our work for Northwell Health and J&J (Janssen) using real-world hospital data from severe COVID-19 patients to show that different patient subgroups experience very different outcomes. This program demonstrated that analyzing large clinical datasets can reveal which patients are most likely to benefit from specific treatments, reinforcing the value of Lunai's precision-medicine approach.B) AI Bio-Defense discoveries: using AI to detect emerging chemical/biological threats, understand their effects quickly, and help identify effective antidotes and countermeasures. This initiative applied our same technology stack in reverse. We already understand chemical toxicity which we use to screen out potential new drugs. For biodefense we can use our data in combination with other large data sets to identify new chemical weapons, test antidotes in our closed loop in vivo system, and can then identify countermeasures. Our goal is to monetize this program through government contracts.C) Immunotherapy: we reported that its next-generation allogeneic dendritic cell (DC) immunotherapy achieved complete regression of both primary and metastatic pancreatic tumors in preclinical humanized mouse models, and that these results were published in a peer-reviewed Brief Report in the journal Vaccines (Nov. 2025). We have recieved an LOI to license the therapy and are currently in discussion with several other companies for licensing other parts of our oncology platform.Path A: AI Drug Discovery — making clinical trials smarter and more likely to succeedDespite billions spent every year, drug development still fails more than it succeeds — especially in brain diseases like Alzheimer's, Parkinson's, alcohol use disorder, and epilepsy. The traditional model is slow, expensive, and based largely on educated guesswork. Companies pick a target, design a drug, and hope it works in humans years later. Most don't. The reason that no drugs have worked for what call Alzheimer's and Parkinsons is that the "one-size-fits-all" drugs were doomed from the start because the assumption was wrong. Each category of these CNS diseases is defined by a collection of different biological subtypes. By standardizing human data, and then using AI to reverse engineer the disease, Lunai traces the biology of each subtype to the related genes and then discovers potential drugs of interest and test them in living systems. We did this for Supernus Pharmaceuticals (NASDAQ: SUPN) by identifying the right epilepsy subgroup for their lead candidate (SPN_817) phase 2 clinical trial. We have recently announced three distinct types of Parkinsons and are working towards commercial deals in Parkinsons and Alzheimer's.We announced today that we are also applying our drug discovery platform to cancer through the launch of a new oncology collaboration with a clinical-stage partner to analyze data from a randomized Phase 2 metastatic colorectal cancer trial. Cancer trials are expensive and difficult, and many fail late because the right patients weren't identified early enough. What we're doing in the program announced today is straightforward to explain:We're using Augusta to learn more from existing clinical trial data—combining patient clinical data, AI-derived imaging signals, and long-term outcomes—to identify which patients benefit most from a new colon cancer drug and why. Our technology platform identifies biologically meaningful subgroups that are designed to enable our partner to:enroll the right patients,choose the right endpoints,size trials more accurately,and reduce costly and time consuming late-stage risk in programs targeting FDA submissions. This engagement begins as a defined pilot, with a clear path to expand into a multi-study commercial relationship based on results. For Lunai, this is the kind of near-term work that can translate into repeatable revenue while proving out our approach in real-world datasets. Path B: AI Bio Defense discoveries, - prevention, response, and countermeasures when time mattersIn parallel, Lunai has built a biodefense platform aimed at a hard problem: modern threats can spread quickly, and decision-makers often need answers when information is incomplete.Our biodefense stack is designed to support the full lifecycle: Sentinel (Prevention): AI systems designed to help detect and prevent the misuse of chemical and biological knowledge before harm occurs. Pathfinder (Response): rapid assessment of emerging threats—predicting potential toxicity, affected organ systems, and mechanisms of action. CounterAct (Countermeasures): identifying and validating antidotes, including rapid repurposing of approved drugs and development of novel countermeasures where none exist. Our objective is to help the U.S. and allied stakeholders prepare for elevated geopolitical risk, including the possibility of chemical weapons deployment, and to support evaluation, regulatory pathways, and potential stockpiling of effective countermeasures. We are actively in negotiation's with Government programs and with private-sector partners given the urgency and national security alignment of this work, and we intend to share more details in the near term. How these two paths fit togetherBoth efforts rely on the same core idea: AI should not just generate hypotheses, - we have put AI to work owning serious patents and IP today, so it delivers usable answers:In healthcare: answers and tools that improve trial design and reduce development risk.In biodefense: answers and tools that improve prevention, readiness, response, and treatment options under pressure.What we're focused on next (near-term milestones)Over the coming period, our focus is to:Advance late-stage commercial discussions across clinical data analytics, precision trial design, and biology-driven discoveries. Finalizing biodefense funding conversations and defining the roadmap for Sentinel, Pathfinder, and CounterAct. Complete a big new pharma Royalty partnership program on in-house immunotherapy technologies. We know many of you have read several Lunai announcements recently. The message we want to leave you with is simple: Lunai has established three immediately scalable revenue generating engines; AI powered drug discovery for CNS diseases and cancer and AI Bio Defense discoveries and tools, each designed for real-world impact, and each capable of creating long-term value and partnerships when implemented and executed with discipline; - our high level focus is driven by one thing only - creating value for our Shareholders. We are trying to fix one of the most expensive problems in medicine using a model that aligns perfectly with how drug development is evolving. When it executes, the gap between what it is today and what it could become is exactly how shareholder value is created.Thank you for your continued support and confidence in Lunai's mission for a safer and better future for all. Sincerely,David WeinsteinChief Executive OfficerLunai Bioworks, Inc. Forward-Looking StatementsThis press release contains forward-looking statements, including statements regarding potential clinical impact, therapeutic benefit, development timelines, partnering strategy, and commercial value. These statements are subject to risks and uncertainties that may cause actual results to differ materially. Lunai Bioworks undertakes no obligation to update forward-looking statements, except as required by law.
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Original: Lunai Bioworks, Inc. Issues Letter to Shareholders
US Market News
4月前
Lunai Bioworks (NASDAQ: LNAI) Launches AI Oncology Pilot with Clinical-Stage Partner to Analyze Randomized Phase 2 Metastatic Colorectal Cancer Survival Trial DataFebruary 9, 2026 9:15 AM
PR Newswire (US)
AI-driven analysis of Phase 2 survival and progression data aims to identify high-benefit patient subgroups and optimize future registrational trial strategySACRAMENTO, Calif., Feb. 9, 2026 /PRNewswire/ -- Lunai Bioworks (NASDAQ: LNAI), an AI-powered drug discovery and biodefense company, today announced the launch of a new oncology collaboration with a clinical-stage partner to analyze data from a randomized Phase 2 metastatic colorectal cancer trial.
The objective is to define biologically meaningful patient subgroups that may benefit most from the investigational therapy. Under the pilot agreement, Lunai will deploy its proprietary Augusta AI platform to evaluate de-identified patient-level clinical, imaging, and longitudinal outcomes data, with a focus on overall survival and disease progression endpoints.By integrating traditional clinical variables with AI-derived imaging features and temporal response patterns, Lunai aims to generate data-driven enrichment strategies designed aid in the FDA trial design, including optimized inclusion criteria, endpoint strategy, and its statistical powering."This collaboration reflects how AI can unlock hidden value in existing oncology datasets," said David Weinstein, Chief Executive Officer of Lunai Bioworks. "Our platform is built to identify which patients derive the greatest survival benefit from a drug candidate, enabling smarter development decisions and potentially accelerating the path toward approval."The collaboration begins as a defined pilot project, with the potential to expand into a broader commercial multi-study program as supported by the data. If successful, the parties anticipate exploring additional applications across multiple tumor types, earlier-line treatment settings, and adaptive trial designs such as basket or umbrella studies.As pharmaceutical companies increasingly seek AI-enabled patient stratification to reduce late-stage development risk, Lunai's approach positions the company at the intersection of machine learning, precision oncology, and clinical trial optimization.Patient stratification divides trial participants into subgroups based on key characteristics like biomarkers, genetics, or disease severity. This improves trial power by reducing variability within groups, minimizing bias, and enabling detection of treatment effects in specific patient subsets who benefit most. There will be more details about this press release in the shareholder letter being sent out today.About Lunai BioworksLunai Bioworks (NASDAQ: LNAI) is an AI-powered drug discovery and biodefense company pioneering safe and responsible generative biotechnology. Leveraging advanced machine learning and proprietary phenotypic and neurotoxicity datasets, Lunai is redefining how artificial intelligence can accelerate therapeutic innovation while safeguarding society from emerging threats. For more information, visit https://lunaibioworks.com.Forward-Looking StatementsThis press release contains forward-looking statements, including statements regarding potential clinical impact, therapeutic benefit, development timelines, partnering strategy, and commercial value. These statements are subject to risks and uncertainties that may cause actual results to differ materially. Lunai Bioworks undertakes no obligation to update forward-looking statements, except as required by law.
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Original: Lunai Bioworks (NASDAQ: LNAI) Launches AI Oncology Pilot with Clinical-Stage Partner to Analyze Randomized Phase 2 Metastatic Colorectal Cancer Survival Trial Data
US Market News
4月前
Lunai Bioworks (NASDAQ: LNAI) Launches Sentinel, an AI Safeguard to Block Large Language Models from Generating Novel Chemical WeaponsJanuary 27, 2026 3:36 PM
PR Newswire (US)
Transformer-based biosecurity layer embeds directly into foundation models, using Lunai's proprietary toxicology and in-vivo datasets to detect and prevent creation of previously unknown threat agents in real time.SACRAMENTO, Calif., Jan. 27, 2026 /PRNewswire/ -- As global attention intensifies around the dual-use risks of advanced artificial intelligence in chemistry and biology, Lunai Bioworks (NASDAQ: LNAI) today announced the deployment of Sentinel™, a transformer-based AI safeguard designed to be embedded directly within large language and scientific foundation models to prevent the generation of novel chemical agents. Built on Lunai's expansive molecular AI platform and strengthened by proprietary toxicology and in-vivo phenotypic datasets, Sentinel operates as a real-time biosecurity layer, screening molecular outputs before they are produced and stopping potentially hazardous designs at the source. The launch positions Lunai at the forefront of AI safety infrastructure as governments, regulators, and technology developers move to address emerging biosecurity risks associated with increasingly capable generative models.
"We built Sentinel to function as the immune system for scientific AI," said David Weinstein, CEO of Lunai Bioworks. "As AI models become more powerful, safety has to move closer to the core. Sentinel operates inside AI systems — not outside them — stopping dangerous chemical designs before they are ever produced."Modern chemical weapons are increasingly designed to be short-acting, localized, and infrastructure-preserving, enabling tactical use without large-scale destruction. Recent battlefield reports from Ukraine indicate the repeated use of banned chemical agents to force defenders from fortified positions, underscoring the re-emergence of chemical weapons in modern conflict. As artificial intelligence accelerates the speed at which new compounds can be designed, the risk of rapidly developed, previously unseen chemical threats continues to grow.Lunai Bioworks has structured its biodefense strategy to address this evolving threat landscape through three integrated programs: Sentinel (AI-based prevention of dangerous molecular design), Pathfinder (rapid identification of novel chemical agents and selection of potential countermeasures from existing stockpiles), and Counteract (development of new medical countermeasures for emerging threats).Executives at major AI research organizations have publicly emphasized that as foundation models grow more capable in scientific reasoning, biosecurity safeguards must evolve from policy discussions into embedded technical controls. Anthropic CEO Dario Amodei has highlighted the importance of preparing for biological misuse risks as AI systems advance, while Aleksander Madry, Head of Preparedness at OpenAI, has stressed the need for proactive defenses against emerging AI-enabled threat vectors. Sentinel answers that call by providing a purpose-built molecular security layer that integrates directly into AI workflows, helping ensure powerful generative systems are used for innovation, not misuse.Embedding Safety at the Core of Scientific AISentinel uses transformer-based molecular encoders trained to recognize structural and mechanistic signatures associated with toxicological and chemical-weapons-relevant activity. When an AI system attempts to design, analyze, or suggest a molecule, Sentinel can evaluate the request in molecular embedding space and can flag or block outputs linked to neurotoxic, cytotoxic, or other hazardous mechanisms, including patterns consistent with known chemical threat pathways.Unlike conventional keyword filters or rule-based screening, Sentinel identifies latent risk in novel molecular structures, even when no public toxicity annotation exists. This allows it to prevent unsafe outputs that traditional AI safety systems would not recognize.Scientific Validation Powered by Massive Proprietary DataSentinel is built on Lunai's transformer-based chemical foundation model trained on:~550 million public chemical structures, and fine-tuned with,Lunai's proprietary in-house biological, toxicological, and phenotypic datasets generated through its AI-driven in vivo screening and molecular intelligence platformsThis proprietary data layer significantly enhances Sentinel's ability to detect previously uncharacterized toxic signatures, recognize hidden similarity to known threat mechanisms, and deliver higher-confidence predictions on entirely novel molecular structures.Because Sentinel's detection operates in deep molecular embedding space, it can identify subtle structural and functional relationships that would be invisible to surface-level AI safety tools.AI Safety Meets National Security InfrastructureSentinel's release comes as policymakers and industry leaders focus on the growing intersection of AI capability and biosecurity risk. Advanced AI models are increasingly capable of assisting in scientific design tasks, raising the need for embedded safeguards that operate at the molecular reasoning level rather than relying solely on external moderation layers.Sentinel is designed to support:AI developers seeking integrated biosecurity protectionGovernment agencies concerned with AI-enabled chemical and biological threatsLife sciences platforms requiring safe molecular design environmentsUnlike generative chemistry tools that could be misused to create harmful agents, Sentinel is built exclusively for prediction, screening, and prevention.About Lunai BioworksLunai Bioworks (NASDAQ: LNAI) is an AI-powered drug discovery and biodefense company pioneering safe and responsible generative biology. With proprietary neurotoxicity datasets, advanced machine learning, and a focus on dual-use risk management, Lunai is redefining how artificial intelligence can accelerate therapeutic innovation while safeguarding society from emerging threats. For more, visit https://lunaibioworks.com.Forward-Looking StatementsThis press release contains forward-looking statements, including statements regarding research progress, therapeutic development, market opportunity, and partnership potential. Actual results may differ materially due to risks and uncertainties, including scientific, regulatory, and financial factors.
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Original: Lunai Bioworks (NASDAQ: LNAI) Launches Sentinel, an AI Safeguard to Block Large Language Models from Generating Novel Chemical Weapons
US Market News
4月前
Lunai Bioworks (NASDAQ: LNAI) Expands NIH-Funded AI Program into Commercial Alcohol Use Disorder Drug DiscoveryJanuary 26, 2026 2:30 PM
PR Newswire (US)
AI Platform Achieves Key Milestones, Triggering Launch of Alcohol Use Disorder ProgramSACRAMENTO, Calif. , Jan. 26, 2026 /PRNewswire/ -- Lunai Bioworks (NASDAQ: LNAI), an AI-powered drug discovery and biodefense company, today announced it has completed a key commercial milestone under its NIH STTR-supported initiative, generating high-resolution, multidimensional behavioral signatures of ethanol exposure and alcohol withdrawal. Using high-throughput vertebrate screening, the company identified distinct, reproducible neurobehavioral phenotypes that are only partially addressed by currently approved therapies, highlighting previously underexplored biological mechanisms with strong translational potential. Based on these results, the company has initiated a new commercial drug discovery program targeting Alcohol Use Disorder (AUD), a condition affecting approximately 30 million individuals in the U.S. alone, with over 95% receiving no effective pharmacologic treatment.
Lunai's AUD program is designed to advance differentiated, mechanism-informed therapeutic candidates toward clinical translation, while remaining strategically positioned for partnerships, licensing, and non-dilutive funding opportunities. With scalable screening infrastructure now operational, the company believes the program can rapidly progress toward candidate nomination and downstream development."These results underscore both the magnitude of unmet need in Alcohol Use Disorder and the commercial opportunity for biologically grounded, precision therapies," said David Weinstein, CEO of Lunai Bioworks. "Our strategy is to build high-value, partner-ready programs that leverage our platform to address large, underpenetrated CNS markets."The program is supported by a Small Business Technology Transfer (STTR) grant from the National Institutes of Health (NIH) and is being conducted in collaboration with Dr. Calum MacRae, Vice Chair, Scientific Innovation at Brigham and Women's Hospital and Professor of Medicine at Harvard Medical School. Alcohol Use Disorder represents one of the largest and most underserved markets in neuropsychiatry. Excessive alcohol use is estimated to cost the U.S. economy approximately $250 billion annually, contributes to over 200 disease states, and is the leading global risk factor for mortality among adults aged 15–49. Despite this burden, fewer than 5% of individuals with AUD are treated by a healthcare professional, reflecting both therapeutic limitations and biological heterogeneity."Alcohol Use Disorder is not a single disease but a spectrum of biologically distinct states," said Dr. Calum MacRae. "This work demonstrates that high-resolution behavioral phenotyping can reveal mechanistic signals that conventional approaches miss, creating a rational foundation for precision therapeutic development."About Lunai BioworksLunai Bioworks (NASDAQ: LNAI) is an AI-powered drug discovery and biodefense company pioneering safe and responsible generative biology. With proprietary neurotoxicity datasets, advanced machine learning, and a focus on dual-use risk management, Lunai is redefining how artificial intelligence can accelerate therapeutic innovation while safeguarding society from emerging threats.For more, visit https://lunaibioworks.com.Forward-Looking StatementsThis press release contains forward-looking statements, including statements regarding research progress, therapeutic development, market opportunity, and partnership potential. Actual results may differ materially due to risks and uncertainties, including scientific, regulatory, and financial factors.
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Original: Lunai Bioworks (NASDAQ: LNAI) Expands NIH-Funded AI Program into Commercial Alcohol Use Disorder Drug Discovery