Speratum Biopharma was founded in 2014 with a mission to advance groundbreaking research in microRNA-based therapies. Our goal is to revolutionize cancer treatment by leveraging the power of precision medicine to address unmet needs in oncology.

Speratum Biopharma combines cutting-edge technologies, such as Nano-In™ and NoPass™, with a focus on miRNA-198 to create targeted therapies for solid tumors. Our innovative platforms ensure precision delivery while minimizing side effects, setting us apart from traditional cancer treatments.

Our lead candidate, miRNA-198, targets solid tumors, including pancreatic cancer, ovarian cancer, and other treatment-resistant cancers. By addressing the molecular drivers of these cancers, we aim to create therapies that improve patient outcomes.

Our mission is to combat cancer by developing innovative, safe, and effective therapies that leverage the natural regulatory power of microRNAs. We strive to make precision oncology accessible to patients worldwide.

Speratum Biopharma is headquartered in San José, Costa Rica, where our research and development efforts are centered. We also have a corporate office in Dover, Delaware and soon to have another location within the Johnson & Johnson family of companies named JLABS in Houston, Texas.

We are guided by innovation, integrity, and a commitment to improving patients’ lives. Our collaborative approach emphasizes scientific excellence, patient focus, and global impact.

We focus on developing therapies for solid tumors, including aggressive and treatment-resistant cancers. Our research targets the molecular drivers of cancer to create precise and effective treatments.

Yes, Speratum Biopharma actively collaborates with research institutions, industry partners, and academic centers to advance microRNA-based therapies. For more details, please contact us at [email protected].

Our funding comes from a combination of private investors, venture capital, and grants. We are actively seeking partnerships and additional funding to accelerate the development of our pipeline.

We are in the preclinical development phase for NM-198, with plans to initiate Phase 1b clinical trials for solid tumours in Q1 2026.

We adhere to international regulatory standards and are preparing for submission of an Investigational New Drug (IND) application with the FDA as part of our clinical trial planning.

MicroRNA (miRNA) is a small, non-coding RNA molecule that regulates gene expression. In cancer, miRNAs can play critical roles by either suppressing or promoting tumor growth. Speratum leverages the therapeutic potential of miRNA to create targeted cancer treatments.

NM-198 is our lead candidate, a microRNA-198 therapeutic designed to target and disrupt cancer at its molecular roots. Its precision approach minimizes off-target effects, offering a promising new avenue for cancer care.

A: Nano-In™ is Speratum Biopharma’s proprietary delivery system that ensures miRNA-based therapies are delivered precisely to their targets within the body, maximizing efficacy while minimizing side effects.

No-Pass™ is another innovative platform developed by Speratum. It enhances the safety and efficiency of therapeutic delivery, ensuring that our treatments reach the intended site of action with optimal results.

Oligonucleotides are short sequences of nucleic acids (RNA or DNA) that interact with specific genetic material in the body to regulate gene expression or modify disease-related pathways. At Speratum Biopharma, we focus on microRNA-based oligonucleotides, particularly miRNA-198, which plays a critical role in suppressing tumor growth and progression in solid tumors.

Our key upcoming milestones include:

Filing an IND application for NM-198 in 2025.
Launching Phase 1b clinical trials in early 2026.
Expanding our research partnerships and advancing additional candidates in our pipeline.

Therapeutic oligonucleotides include:

Antisense Oligonucleotides (ASOs): Bind to RNA to prevent protein translation or degrade RNA molecules.
Small Interfering RNAs (siRNAs): Trigger RNA interference to silence specific genes.
MicroRNA (miRNA) Mimics/Inhibitors: Regulate gene expression by mimicking or inhibiting natural miRNAs.
Aptamers: Bind to proteins and inhibit their function.
Splice-Switching Oligonucleotides (SSOs): Modify RNA splicing to produce functional proteins.

At Speratum, we specialize in microRNA mimics, focusing on miRNA-198 to restore natural regulatory mechanisms disrupted in cancer. By mimicking miRNA-198, we aim to suppress oncogenic pathways and halt tumor progression.

While NM-198 is specifically designed to target solid tumors, its underlying technology could have broader applications. Our current research focuses on cancers where microRNA-based approaches are most effective.

While our treatments are not yet available to the public, we are preparing to launch clinical trials. Patients interested in participating can reach out to [email protected] for updates and more information.

Eligibility for our clinical trials will depend on specific criteria, including the type and stage of cancer. Once trials begin, we will provide detailed qualification requirements to potential participants.

Our initial clinical trials will take place in the US, but we hope to expand globally in the future. Patients outside the US can contact us to learn more about future opportunities.

Research institutions interested in collaborating with us can contact [email protected]. We offer opportunities to explore innovative therapeutic approaches and advance the understanding of microRNA-based therapies.

A qualified investigator is a clinical research professional responsible for conducting clinical trials. They ensure that all aspects of the trial are performed in compliance with regulatory standards and patient safety guidelines.

Speratum Biopharma is committed to ensuring our treatments are accessible. By partnering with investors, institutions, and researchers, we aim to offset the costs of development and focus on delivering life-saving therapies to those who need them.

Patient safety is our top priority. Our therapies undergo rigorous preclinical testing, and our platforms are designed to maximize efficacy while minimizing side effects and immune responses.

There are many ways to support Speratum Biopharma’s mission:

Investors can fund our cutting-edge research.
Researchers can collaborate on advancing microRNA-based therapies.
Advocates can raise awareness about our work.
For more details, reach out to [email protected].

Investors interested in supporting Speratum Biopharma can reach out to us at [email protected]. We welcome opportunities to collaborate with those who share our vision of transforming cancer treatment.

Cancer is a group of diseases characterized by the uncontrolled growth and spread of abnormal cells. If not treated, it can invade surrounding tissues and spread to other parts of the body.

Key challenges include:

Stability: Oligonucleotides are susceptible to degradation by nucleases in the body.
Delivery: Reaching target tissues efficiently while avoiding off-target effects.
Immune Response: Minimizing potential immunogenicity.
At Speratum, we address these challenges using our proprietary Nano-In™ and No-Pass™ platforms. These delivery systems protect our miRNA-based therapies from degradation, enhance tissue targeting, and minimize immune activation, ensuring safe and effective delivery of miRNA-198 to tumor sites.

Therapeutic oligonucleotides are designed through advanced computational models and molecular biology techniques to target specific genetic sequences. At Speratum, our miRNA-198 therapy is carefully designed to mimic natural miRNA function, ensuring high specificity and minimal off-target effects. Chemical modifications are added to improve stability, binding affinity, and resistance to enzymatic degradation.

Oligonucleotides are distributed through the bloodstream and internalized by cells via endocytosis. Once inside the cells, they interact with their specific genetic targets to regulate disease pathways. At Speratum, our miRNA-198 mimic is designed to bind to oncogenic targets, restoring tumor-suppressive functions disrupted in solid tumors.

Oligonucleotide drugs are typically formulated as injectable solutions or lyophilized powders. Common routes of administration include:

Intravenous (IV): For systemic delivery to multiple tissues.
Intratumoral (IT): Direct injection into the tumor for localized effects.

At Speratum, we are initially focusing on intravenous administration of miRNA-198 to ensure systemic reach to solid tumors while leveraging our delivery platforms for precision targeting.

Innovation is at the heart of everything we do. From pioneering miRNA-based therapies to developing advanced delivery platforms like Nano-In™ and NoPass™, we are dedicated to pushing the boundaries of oncology research.

Oligonucleotides offer a unique therapeutic approach by targeting disease mechanisms at the genetic level. Their specificity reduces side effects and provides opportunities for addressing diseases that are otherwise difficult to treat. At Speratum, the clinical potential of miRNA-198 lies in its ability to suppress multiple oncogenic pathways, making it a promising option for solid tumor therapy.

Synthesis: Oligonucleotides are chemically synthesized using solid-phase synthesis, where each nucleotide is added step by step.
Purification: Techniques such as high-performance liquid chromatography (HPLC) and ion-exchange chromatography are used to ensure high purity.
Analytical Control: Quality is verified through mass spectrometry, capillary electrophoresis, and other rigorous testing methods.
At Speratum, we maintain strict quality standards to ensure that our miRNA-198 therapies meet the highest levels of purity, stability, and safety before advancing into clinical development.

We aim to bridge the gap between cutting-edge research and real-world cancer treatment. By collaborating with international institutions and focusing on scalable innovations, we strive to make precision oncology a global reality.