On February 26, 2026 Synthekine Inc., an engineered cytokine therapeutics company, reported that it has entered into a clinical trial collaboration and supply agreement with Merck (known as MSD outside of the United States and Canada). STK-012, a first-in-class α/β-IL-2 receptor biased partial agonist, will be evaluated in combination with standard of care chemotherapy and Keytruda (pembrolizumab), Merck’s anti-PD-1 (programmed cell death receptor-1) therapy, in the ongoing SYNERGY-101 randomized Phase 2 study in first-line, PD-L1 negative nonsquamous (NSQ) non-small cell lung cancer (NSCLC).

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"In our Phase 1b study, STK-012 in combination with pembrolizumab and chemotherapy has shown promising efficacy in first-line PD-L1 negative NSQ NSCLC patients, with a 50% response rate in this population presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting 2025," said Debanjan Ray, Chief Executive Officer of Synthekine. "We are excited to collaborate with Merck on our randomized Phase 2 study to further demonstrate the potential of this combination to deliver improved clinical outcomes for these patients, who receive limited benefit from current standard of care therapies."

STK-012 is a first-in-class α/β-IL-2 receptor biased partial agonist engineered to selectively stimulate antigen-activated T cells, which are associated with potent anti-tumor activity, and avoid broad stimulation of other lymphocytes, such as natural killer (NK) cells, which are associated with IL-2 toxicity.

Under the terms of the agreement, Merck will provide its anti-PD-1 therapy, Keytruda, to be used in combination with STK-012 and standard of care chemotherapy in the SYNERGY-101 trial. SYNERGY-101 is a global, randomized Phase 2 study that has already begun enrollment, with the first patient dosed in November 2025. This study will investigate the safety and efficacy of STK-012 in combination with standard dose pembrolizumab and chemotherapy vs. the safety and efficacy of standard dose pembrolizumab and chemotherapy in patients with first-line, PD-L1 negative NSQ NSCLC. Synthekine and Merck will each retain all commercial rights to their respective compounds for use as monotherapies or in combination regimens.

For additional information about the trial, please visit www.clinicaltrials.gov using the identifier NCT05098132.

(Press release, Synthekine, FEB 26, 2026, View Source [SID1234663099])

On February 26, 2026 Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX), a global pharmaceutical company focused on the discovery, development and commercialization of novel therapeutics for endocrine diseases and endocrine-related tumors, reported financial results for the fourth quarter and full year ended December 31, 2025.

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"2025 was a breakout year for Crinetics, as the approval and launch of Palsonify demonstrated our ability to bring an innovative therapy from concept to the patients who need it most," said Scott Struthers, Ph.D., founder and chief executive officer of Crinetics. "With strong launch dynamics, we are now focused on building a business capable of scaling that success. We have the commercial infrastructure, the pipeline depth and the capital to build a premier, multi-product company that will define the future of endocrinology."

Full Year 2025 and Recent Highlights:

Secured FDA approval on September 25, 2025 for PALSONIFY as the first and only once-daily oral somatostatin receptor ligand for the treatment of acromegaly. The subsequent U.S. commercial launch in Q4 2025 demonstrated strong early execution, generating $5.4 million in net product revenue and over 200 enrollment forms at the end of December 2025. In addition, over 125 unique HCPs prescribed PALSONIFY in Q4 2025.
Today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending the marketing authorization of PALSONIFY (paltusotine) for the medical treatment of adult patients with acromegaly. The positive opinion is now referred to the European Commission (EC) for an approval decision. PALSONIFY was previously granted Orphan Designation by the EMA in February of 2025.

Reported positive data from the Phase 2 open-label study of atumelnant in patients with congenital adrenal hyperplasia (CAH), with 88% of participants in Cohort 4 reducing glucocorticoid doses to physiologic replacement levels by week 12, while maintaining androstenedione (A4) reductions similar to those observed in earlier cohorts. Across all cohorts of the Phase 2 open-label study, atumelnant administration has resulted in rapid, substantial and sustained statistically significant reduction in A4 levels. Atumelnant has been well-tolerated and treatment with atumelnant has been associated with significant clinical improvements. These results reinforce the strong clinical rationale for the ongoing pivotal Phase 3 development program and highlight atumelnant’s potential as a best-in-class oral ACTH antagonist.

Initiated three pivotal trials including the CAREFNDR Phase 3 trial evaluating paltusotine for carcinoid syndrome, the CALM-CAH Phase 3 trial evaluating atumelnant in adults with congenital adrenal hyperplasia (CAH), and the BALANCE-CAH Phase 2/3 trial addressing the critical unmet need in pediatric CAH patients.
Finalized protocol for the pivotal seamless Phase 2/3 EQUILIBRIUM study of atumelnant in patients with ACTH-dependent Cushing’s Syndrome with the first patient expected to enroll in the first half of 2026.
Brought the first candidate from our proprietary nonpeptide drug conjugate (NDC) platform, CRN09682, into clinical development with the initiation of the BRAVESST2 Phase 1/2 trial. The study is evaluating CRN09682 in patients with SST2-expressing neuroendocrine tumors (NETs) and other solid tumors, validating the company’s intent to extend its endocrine expertise into GPCR-targeted oncology indications.

Fourth Quarter and Full Year 2025 Financial Results:

Revenue was $6.2 million and $7.7 million for the quarter and year ended December 31, 2025, compared to $0.0 million and $1.0 million for the same periods in 2024. Revenue for the quarter and year ended December 31, 2025 includes $5.4 million in net product revenue from the U.S. commercial launch of PALSONIFY.
Cost of product revenue was $1.1 million for the quarter and year ended December 31, 2025, primarily related to costs in expanding our commercial manufacturing capacity.

Research and development expenses were $85.1 million and $332.1 million for the quarter and year ended December 31, 2025, compared to $66.6 million and $240.2 million for the same periods in 2024, and compared to $90.5 million in the quarter ended September 30, 2025. The increase compared to the prior year period reflects our continued commitment and investments in paltusotine, atumelnant, and other research and development programs. The sequential decline compared to the prior quarter was primarily due to pre-approval and launch costs, as well as startup costs associated with our ongoing Phase 3 trials, which were recognized in the third quarter but not the fourth quarter.

Selling, general and administrative expenses were $53.7 million and $191.3 million for the quarter and year ended December 31, 2025, compared to $28.2 million and $99.7 million for the same periods in 2024, and compared to $52.3 million in the quarter ended September 30, 2025. The increase compared to the prior year period is related to our commercial organization build-out and investment in our overall infrastructure as a commercialized company. The stability compared to the prior quarter reflects the company’s strategic decision to put in place key investments for commercialization, including field force, commercial team and corporate functions, prior to approval of PALSONIFY.
Net loss was $122.8 million and $465.3 million for the quarter and year ended December 31, 2025, compared to net loss of $80.6 million and $298.4 million for the same periods in 2024.

Crinetics used $326.2 million of net total cash, cash equivalents, and investment securities in 2025, which was below our guidance range of $340 million to $370 million.

Cash, cash equivalents, and investment securities totaled $1.0 billion as of December 31, 2025, compared to $1.4 billion as of December 31, 2024. On January 8, 2026, Crinetics completed an underwritten public offering of 8,763,000 shares of its common stock at a price to the public of $45.95 per share, which included 1,143,000 shares of common stock issued pursuant to the underwriters’ option to purchase additional shares. Net proceeds from the offering were approximately $380.0 million, after underwriting discounts and commissions and other offering costs. Immediately after the completion of this public offering, Crinetics had approximately $1.4 billion in cash, cash equivalents, and investment securities.

Guidance and Outlook:

Crinetics expects 2026 operating expenses presented in accordance with U.S. generally accepted accounting principles ("GAAP") to be between $600 million to $650 million and non-GAAP operating expenses – which exclude cost of product revenue, stock-based compensation, depreciation and amortization – to be between $480 million to $520 million.

Crinetics is unable to reconcile forward-looking non-GAAP operating expenses to the most directly comparable GAAP measure without unreasonable effort because the items that are being excluded are difficult to predict or a range of results could lead to disclosure that would be imprecise or potentially misleading. Material changes to any one of the exclusions could have a significant effect on our forward-looking estimates and GAAP results. Such items include cost of product revenue, stock-based compensation, depreciation and amortization. See "Use of Non-GAAP Financial Measures".

Conference Call and Webcast Details
Management will hold a live conference call and webcast today, Thursday, February 26 at 4:30 p.m. ET. To participate, please dial 1-833-470-1428 (domestic) or 1-646-844-6383 (international) and refer to Access Code 027322. To access the webcast, the direct link (here) or visit the Events page of the Crinetics website. Following the live event, the webcast will be archived on the Investor Relations section of www.crinetics.com.

(Press release, Crinetics Pharmaceuticals, FEB 26, 2026, View Source [SID1234663065])

On February 26, 2026 OPKO Health, Inc. (NASDAQ: OPK) (OPKO) reported business highlights and financial results for the three and 12 months ended December 31, 2025, and introduces financial guidance for the first quarter and full year 2026.

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Highlights from the fourth quarter of 2025 and recent weeks include the following:

Entered into a research collaboration with Regeneron Pharmaceuticals to develop multispecific antibodies. This new partnership leverages ModeX’s MSTAR technology platform with Regeneron’s proprietary binders to develop single molecule candidates that target multiple distinct biological pathways in several clinical indications. ModeX received an upfront payment and is entitled to potential milestone payments exceeding $200 million for each program. The overall potential value of the collaboration exceeds $1 billion if multiple products from the collaboration are successful. In addition, ModeX is eligible to receive tiered royalties on global net sales, reaching low double digits at the highest tier. Regeneron is responsible for funding all preclinical and clinical development, as well as all commercialization activities.

Merck completed the Phase 1 Epstein-Barr virus vaccine trial (NCT06655324). This investigational vaccine candidate is being developed in collaboration with Merck. The Phase 1 trial evaluating safety and tolerability in over 200 healthy adults was completed in the fourth quarter of 2025. Additional studies are in progress to inform dose and adjuvant selection for potential Phase 2 studies.

MDX2003, a first-in-class trispecific T-cell engager-expander for the treatment of leukemia and lymphoma, was approved for Phase 1 studies in Australia, which are expected to begin in the first half of 2026. Also, an abstract was presented at 2025 ASH (Free ASH Whitepaper) Annual Meeting. In November, an abstract titled "MDX2003, a novel tetraspecific T cell engager-expander targeting CD19xCD20xCD3xCD28, demonstrates potent preclinical activity against B cell malignancies" was presented at the American Society of Hematology (ASH) (Free ASH Whitepaper)’s 67th ASH (Free ASH Whitepaper) Annual Meeting and Exposition. In an animal model, MDX2003 prevented further tumor growth at low doses and was well-tolerated with low levels of cytokines in the blood and no observable toxicity.

Abstract for MDX2004, a first-in-class trispecific antibody-fusion protein immune rejuvenator, was presented at SITC (Free SITC Whitepaper) 2025. In November, an abstract titled "MDX2004, a novel immune rejuvenator targeting CD3, CD28, and 4–1BB, augments tumor immunity in preclinical animal models" was presented at SITC (Free SITC Whitepaper) 2025, the annual meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper). The ongoing Phase 1/2a study (NCT07110584) is designed to evaluate the safety, tolerability and biologic activity of MDX2004 as an immunotherapy for advanced cancers.

Abstract for MDX2001 cMet-Trop2/CD3-CD28, a first-in-class tetraspecific T-cell engager, was presented at ESMO (Free ESMO Whitepaper) 2025. In October, an abstract titled "A phase I/IIa, multicenter, first-in-human, open-label clinical trial evaluating MDX2001, a tetraspecific T cell engager-expander in patients with advanced solid tumors" was presented at ESMO (Free ESMO Whitepaper) Congress 2025, the annual meeting of the European Society for Medical Oncology. The MDX2001 cMet-Trop2/CD3-CD28 tetraspecific antibody has advanced to the fifth dose level in its Phase 1 clinical trial, with Phase 1b studies in select solid tumors expected to begin in the first half of 2026.

FDA permission to proceed to Phase 1 granted to MDX2301, a tetravalent bispecific antibody that neutralizes all known strains of SARS-CoV2, for the prevention and treatment of COVID-19 infection. Supported by non-dilutive funding from BARDA, the clinical trial in healthy volunteers is scheduled to begin in the second quarter of 2026, with pharmacokinetic and immunogenicity data expected later this year.

Expanded partnership with Entera Bio to advance first-in-class oral long-acting PTH tablet for patients with hypoparathyroidism. This third program under the collaboration combines OPKO’s proprietary long-acting PTH variants with Entera’s proprietary N-Tab technology. Following favorable pharmacodynamic and pharmacokinetic data reported in December 2025, the companies have jointly decided to accelerate development and expect to file an investigational new drug (IND) application with the U.S. Food and Drug Administration (FDA) in late 2026. OPKO and Entera Bio each hold a 50% pro-rata ownership interest in the long-acting PTH hypoparathyroidism program and each is responsible for 50% of the program’s development costs.

Fourth Quarter Financial Results

Consolidated: Consolidated total revenues for the fourth quarter of 2025 were $148.5 million compared with $183.6 million for the 2024 period, with the decrease principally resulting from the sale of certain BioReference assets in 2025. Operating loss for the fourth quarter of 2025 was $38.3 million compared with operating loss of $33.1 million for the 2024 quarter. Net loss for the fourth quarter of 2025 was $31.3 million, or $0.04 per share, compared with net income of $14.0 million, or $0.01 per diluted share, for the 2024 quarter. Net income for the fourth quarter of 2024 included a realized gain of $54.1 million from the sale of shares of GeneDx, as well as non-cash other income of $21.4 million.
Pharmaceuticals: Revenue from products in the fourth quarter of 2025 was $43.7 million compared with $37.4 million in the fourth quarter of 2024, driven by a positive net foreign exchange impact of $4.0 million and by higher sales volumes in our international operations. Revenue from Rayaldee was $8.8 million compared with $9.1 million in the comparable prior-year quarter. Revenue from the transfer of intellectual property and other was $33.7 million in the fourth quarter of 2025 compared with $43.1 million in the 2024 period. Gross profit share payments for NGENLA, which totaled $12.5 million in the 2025 period compared with $9.6 million in the 2024 period, reflect the global commercial progress by Pfizer. In addition, the fourth quarter of 2025 included $4.3 million in royalty revenue from Eli Lilly following the commercial launch of mazdutide in China by their partner Innovent Biologics and a $7.0 million upfront payment from Regeneron. The comparable period of 2024 included a $12.5 million milestone payment from Merck, as well as a $7.0 million decrease in commercial milestones at our Eirgen business and a $4.1 million decrease in revenue from our contract with BARDA. Total costs and expenses increased to $88.0 million in the fourth quarter of 2025 from $82.6 million in the prior-year period, primarily due to higher cost of revenue related to higher sales volume, higher research and development expenses driven by advancements in early-stage programs and employee-related expenses reflecting an increase in headcount to support ongoing clinical activities. Operating loss was $10.7 million in the fourth quarter of 2025, which included $18.3 million in depreciation and amortization expense, compared with operating loss of $2.1 million in the fourth quarter of 2024, which included $18.1 million of depreciation and amortization expense.

Diagnostics: Revenue from services in the fourth quarter of 2025 was $71.1 million compared with $103.1 million in the prior-year period. The decrease was principally a result of the sale of certain BioReference assets in 2025 and the resulting decline in clinical test volume, and lower clinical test reimbursement rates, partially offset by increased demand and higher average reimbursement for the 4Kscore test, resulting in a 16% increase in revenue to $7.0 million in the 2025 quarter compared with $6.0 million in revenue in the 2024 quarter. Total costs and expenses were $89.4 million in the fourth quarter of 2025 compared with $124.8 million in the fourth quarter of 2024. The decrease was primarily attributable to the assets sold and to continued cost-reduction initiatives at BioReference. Operating loss was $18.3 million in the fourth quarter of 2025, which included $4.1 million of depreciation and amortization expense, compared with operating loss of $21.7 million in the 2024 period, which included $6.0 million of depreciation and amortization expense. The fourth quarter of 2025 was impacted by non-recurring transition-related adjustments of $5.8 million, primarily from severance, asset write-offs, third-party revenue adjustments, and capital tax expense. The fourth quarter of 2024 included revenue of $26.3 million and costs and expenses of $32.9 million from the oncology assets that were sold to Labcorp on September 15, 2025.

Cash, cash equivalents, marketable securities and restricted cash: Cash, cash equivalents and restricted cash were $369.1 million as of December 31, 2025. As of December 31, 2025, approximately $87.3 million of OPKO’s common stock had been repurchased, including $13.5 million in the fourth quarter of 2025, under the program since its authorization in July 2024. Approximately $112.7 million remained authorized and available for future repurchases.

2026 Financial Guidance: The table below reflects financial guidance for the first quarter and full year 2026 (in millions):

For the three months ended March 31, 2026 For the year ended December 31, 2026
Low High Low High
Revenue
Services revenue $ 71 $ 75 $ 300 $ 312
Product revenue 38 45 160 170
IP and other revenue 15 20 70 80
Total revenues 125 140 530 560

Included in revenue
Pfizer profit share 5 6 34 37
BARDA contract 7 9 18 22

Total costs and expenses 170 180 725 750

R&D included in costs and expenses 30 32 125 135

Conference Call and Webcast Information

OPKO’s senior management will provide a business update, discuss fourth quarter financial results, provide financial guidance and answer questions during a conference call and live audio webcast today beginning at 4:30 p.m. Eastern time. Participants are encouraged to pre-register for the conference call here. Callers who pre-register will receive a unique PIN to gain immediate access to the call and bypass the live operator. Participants may register at any time, including up to and after the call start time. Those unable to pre-register may participate by dialing 833-630-0584 (U.S.) or 412-317-1815 (International). A webcast of the call can also be accessed at OPKO’s Investor Relations page and here.

A telephone replay will be available until March 5, 2026, by dialing 855-669-9658 (U.S.) or 412-317-0088 (International) and providing the passcode 2367034. A webcast replay will be available beginning approximately one hour after the completion of the live conference call here.

(Press release, Opko Health, FEB 26, 2026, View Source [SID1234663084])

On February 26, 2026 A2 Biotherapeutics, Inc. (A2 Bio), a clinical-stage immunotherapy company developing first-in-class logic-gated therapies for solid tumors, reported the first patient dosed with A2B543, initiating the second arm of the Phase 1/2 EVEREST-2 study (NCT06051695).

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A2B543 is an autologous CAR T cell therapy that builds upon A2 Bio’s proprietary Tmod platform. A2B543 adds an inducible, membrane-tethered IL-12 booster, augmenting the platform’s core ability to selectively kill tumor cells while protecting normal tissue. Designed to activate only when the Tmod cell engages a tumor antigen, the booster aims to enhance the potency and persistence of Tmod cells within the immunosuppressive solid tumor microenvironment while avoiding systemic toxicity.

"Dosing the first patient with A2B543 is a significant step forward in the evolution of the Tmod platform," said John Welch, M.D., Ph.D., chief medical officer of A2 Bio. "While systemic IL-12 induces a potent antitumor immune response, its use has been limited by severe toxicity. With A2B543, we are arming our Tmod cells with a membrane-tethered, inducible IL-12 component. This design allows us to localize the impact of IL-12 to the tumor microenvironment, boosting the persistence and potency of Tmod without the systemic side effects."

Enabling Efficient Patient Identification for A2 Bio Precision Medicine Studies

The A2 Bio clinical programs include A2B543, A2B694, A2B395, and the BASECAMP-1 prescreening study, as well as several preclinical programs exploring additional pipeline expansion opportunities using the proprietary Tmod technology platform. The Tmod platform comprises a suite of technologies that can be used in isolation or in combination, and in both autologous and allogeneic settings, to create novel therapies for cancers and other grievous diseases.

The BASECAMP-1 (NCT04981119) master prescreening study enables efficient identification of patients for all A2 Bio precision medicine studies. Patients are enrolled in EVEREST-2 through BASECAMP-1, which identifies patients with HLA loss of heterozygosity (LOH) at any time in the course of their disease via next-generation sequencing. Upon disease progression, the patients may screen for enrollment in EVEREST-2. There is no time requirement between the studies, and patients may go directly from BASECAMP-1 to EVEREST-2 based on their own disease course. BASECAMP-1 utilizes artificial intelligence (AI)-enabled precision diagnostics as a cost-effective, high-yield approach to identify eligible patients for all A2 Bio clinical studies.1,2

For more information about A2 Bio clinical studies and how to enroll, visit www.a2bioclinicaltrials.com.

About A2B543

A2B543 is designed for the treatment of germline heterozygous HLA-A*02 adults with recurrent unresectable, locally advanced, or metastatic solid tumors that express MSLN and have lost HLA-A*02 expression. A2B543 is comprised of autologous Tmod cells transduced with two lentiviral vectors: one expressing both the HLA-A*02-targeted blocker and the MSLN-targeted CAR activator; and a second expressing an inducible, membrane-tethered IL-12 (mem-IL-12) booster. The inducible mem-IL-12 booster, which activates only upon engagement with tumor antigens, is designed to reduce toxicity associated with systemic IL-12 while enhancing the long-term potency and persistence of Tmod.

About EVEREST-2

The EVEREST-2 master protocol (NCT06051695) is a seamless Phase 1/2 study evaluating the safety and efficacy of A2B694 (Arm 1) and A2B543 (Arm 2), autologous logic-gated investigational cell therapies developed from the A2 Bio proprietary Tmod platform. The Tmod platform provides selective killing of tumor cells and protection of normal cells via a dual-receptor design consisting of an activator that targets tumor cells and a blocker that protects normal cells. A2B694 consists of an activator that targets MSLN and a blocker that targets HLA-A*02. HLA-A*02 is lost in tumor cells and present in normal cells in the eligible patient population. A2B543 contains the same Tmod construct as A2B694 with an added mem-IL-12 booster. The EVEREST-2 study is recruiting patients with colorectal cancer, pancreatic cancer, non-small cell lung cancer, ovarian cancer, mesothelioma, and other solid tumors that express MSLN and have lost HLA-A*02 expression.

About the Tmod Platform

Invented at A2 Bio, the TmodTM platform is a precision-targeting cellular system, designed with logic-gate technology to enable immune cells to unequivocally differentiate tumors from normal tissues. The system consists of activator and blocker receptors. The activator recognizes antigens on tumor cells and triggers their destruction, while the blocker recognizes antigens on normal cells and protects them. This novel blocker technology enables precise, personalized, and effective T-cell targeting specifically against tumors.

(Press release, A2 Biotherapeutics, FEB 26, 2026, View Source [SID1234663100])

On February 26, 2026 CEOCFO Magazine, an independent business and investor publication that highlights important technologies and companies, reported an interview with David J. Arthur, CEO, of Fort Worth, Texas based NanOlogy, LLC advancing their PURCISION technology platform aimed at improving the treatment of cancer without increasing toxicity.

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David J. Arthur, during the interview with CEOCFO’s Senior Editor Lynn Fosse, addressing the concept behind NanOlogy said, "NanOlogy is a clinical-stage oncology company advancing a technology platform aimed at improving the treatment of cancer without increasing toxicity. The technology, called PURCISION, forms particles of pure cancer drugs optimized for intratumoral (IT) delivery. These particles are delivered directly to the site of the tumor, where they continuously deliver high local concentration of drug to the tumor over time, with minimal systemic toxicity. NanOlogy has established feasibility of the PURCISION technology in many small molecules and has studied three intratumorally delivered investigational drugs preclinically or clinically in several solid tumors. The technology, supporting data, and team all attracted me to take on the role of CEO as I believe my background and experience can help position the company to benefit cancer patients and create long term value to shareholders. I think NanOlogy has got to be one of the more attractive companies out there right now."

On the need to improve the treatment of solid tumors, David J. Arthur told Lynn, "A significant unmet need in oncology is to improve the treatment of solid tumors. Solid tumors are very hard to treat and rational combinations including chemotherapies, and newer agents like targeted therapies and immunotherapies, will remain standard of care (SOC) for the foreseeable future. Research has shown that chemo and targeted therapies help kill the tumor and elicit an immune response, called "immune priming", to help improve solid tumor response to immunotherapy.

Over the years, researchers have been working on many methods to target the delivery of cancer drugs to help improve solid tumor response. Targeted therapies given systemically are an example but have not lived up to their promise because of off-target toxicities and other limitations."

As for how their technology approach is different, David J. Arthur shared, "Instead of systemic administration, the PURCISION technology is designed to be given locally to directly kill the primary tumor or tumors and prime the immune system to increase solid tumor response to newer SOC therapies. Our proprietary technology uniquely uses supercritical fluid carbon dioxide as an antisolvent to form what we have come to characterize as large surface area microparticles, or "LSAMs", of pure drug optimized for intratumoral delivery. The microparticles retain a particle size that is sufficient for tumor retention but with a huge increase in surface area that allows for high local drug release over time. LSAMs are covered by a composition of matter patent forming the foundation of more than 100 issued patents filed globally protecting composition, use, formulation, and technology."

Asked where they are in the development process, David J. Arthur replied, "There are many different types of solid tumors, and most are now accessible because of advancements in imaging and advancements in interventional procedures over the last decade. One of the things that excited me about NanOlogy when I came onboard was the breadth of clinical experience that they have already achieved with their LSAM investigational drugs. On two LSAM assets, NanOlogy has run seven clinical trials across six different solid tumors including bladder, lung, pancreas, prostate, ovarian, and peritoneal cancers. We are now talking with Strategic Pharma and other groups to advance those assets further in clinical development in prioritized indications."

Pointing to another asset they have in development, David J. Arthur offered, "Another asset we are excited about is the development of cisplatin into LSAM-Cisplatin. Cisplatin is a chemotherapy that has been around for a while with many uses but has terrible side effects when given systemically. We have developed a clinical formulation of LSAM-Cisplatin and are nearing completion of preclinical studies with our lead indication for a rare devastating pediatric brainstem tumor called diffuse intrinsic pontine glioma (DIPG). This is a devastating, highly lethal cancer in children, with typical onset between the ages of two and ten. There is no treatment other than radiation. Unfortunately, the median survival for these children after diagnosis is only 10 months."

As for their approach to DIPG, David J. Arthur continued, "A key problem is that DIPG is deep in the brain. It is very difficult to get systemically administered drugs through the blood brain barrier to the tumor, and these tumors are inoperable because of their location. But recent advances have allowed us to use a highly precise MRI guided targeting system, to inject LSAM-Cisplatin directly into the tumor. We are hopeful that delivery LSAM-Cisplatin directly to the tumor will offer hope for children and families facing this horrible disease and that LSAM-Cisplatin could become one of the first approved medicines with significant benefit for the treatment of DIPG."

Addressing emerging interest in Intratumoral Therapy, David J. Arthur told CEOCFO, "Intratumoral therapy is rapidly gaining momentum as a potential important part of the treatment of solid tumors – in early disease to prevent or delay progression and in late disease, combined with newer systemic agents, to improve response without the severe stacked toxicities associated with systemic combinations. We are beginning to see the proverbial hockey stick in interest emerge – whereas only a few clinical trials involving IT modalities were underway a few years ago, almost 200 clinical trials are currently underway. Large pharma is beginning to take note, too, with companies like J&J already significantly investing in the space. NanOlogy is a leader in IT therapy aimed at improving solid tumor response without increasing toxicity with growing evidence in support of this aim."

(Press release, NanOlogy, FEB 26, 2026, View Source;utm_medium=rss&utm_campaign=nanology-llc-ceo-david-j-arthur-discusses-their-purcision-technology-advancing-intratumoral-therapy-to-treat-cancer [SID1234663127])