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Random freezes, missing sound and display glitches usually trace back to one bad driver. Find and replace yours safely.Free scan · under a minuteTune Therapeutics announced on January 13, 2025, that it had completed more than $175 million in Series B financing to advance TUNE-401, its investigational therapy for chronic hepatitis B, and expand its TEMPO epigenome-editing platform. The Seattle- and Durham-based biotechnology company was already preparing Phase 1b studies in New Zealand and Hong Kong.
The financing is significant because it gives Tune capital to move from platform development deeper into clinical testing. It is not evidence that TUNE-401 has been proven effective, approved, or shown to deliver a hepatitis B cure.
What Tune Therapeutics raised
The Series B was led by New Enterprise Associates, Yosemite, Regeneron Ventures and Hevolution Foundation. Tune did not disclose additional financing terms in the announcement, so the public information does not establish whether the round included debt or other components beyond the stated financing.
The company said it would use the money to advance TUNE-401, continue developing its TEMPO “genetic tuning” platform and expand its broader pipeline. GeekWire reported that Tune had raised more than $200 million in total after the Series B and employed roughly 80 people in January 2025, split approximately evenly between Seattle and Durham. Those figures were reported by GeekWire and are not presented here as independently verified company totals.
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The round provides resources for activities such as international clinical studies, regulatory work, manufacturing clinical material and additional platform research. Investor participation is a measure of financing support and confidence in the opportunity—not clinical validation.
TUNE-401 is Tune’s first clinical focus
TUNE-401 is an investigational epigenetic-silencing therapy for chronic hepatitis B, or HBV. Tune announced authorization to begin a Phase 1b study in New Zealand on November 14, 2024, followed by authorization in Hong Kong on January 7, 2025. The early study was designed to evaluate safety, tolerability, pharmacokinetics and pharmacodynamics.
Authorization to start a clinical trial is not marketing approval. At this stage, researchers are still determining how the treatment behaves in people, what biological effects it produces, and whether those effects can translate into meaningful and durable disease control.
How the epigenome-editing approach works
Conventional gene editing generally changes the DNA sequence, often by cutting, removing or rewriting genetic material. Epigenome editing instead aims to change whether genetic material is active or inactive without changing its underlying sequence.
Tune calls its platform TEMPO. The company describes TEMPO as a system for activating, silencing or fine-tuning gene activity. In TUNE-401, the objective is to silence HBV genetic material inside infected liver cells rather than cut the DNA.
That distinction matters. “Epigenetic editing” does not automatically mean that a treatment is safer than DNA editing. Clinical risk still depends on delivery, targeting, durability, immune reactions, liver effects and unintended changes in gene activity.
RNA and lipid nanoparticles
TUNE-401 uses lipid nanoparticles, or LNPs, to carry RNA instructions to liver cells. The RNA is intended to be translated into an HBV-targeting epigenetic-silencing protein. Tune identifies Acuitas Therapeutics as the provider or licensor of the LNP technology.
This does not mean Tune invented LNP delivery, nor does LNP use guarantee perfectly liver-specific delivery. The treatment must reach enough infected hepatocytes while avoiding unacceptable effects elsewhere in the body.
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Existing HBV medicines can suppress viral replication and reduce disease activity, but treatment often does not remove the virus’s persistent genetic reservoirs. One important reservoir is covalently closed circular DNA, or cccDNA, which remains in the nuclei of infected liver cells and can provide a template for making new viral material.
HBV DNA can also become integrated into the chromosomes of host cells. According to Tune’s description of the program, TUNE-401 is designed to silence both cccDNA and integrated HBV DNA through epigenetic regulation.
The company’s goal is a potential functional cure. In this context, that generally means durable control of HBV after treatment ends, not necessarily the physical removal of every trace of viral genetic material. A finite treatment that achieves sustained viral control would be clinically meaningful, but it would still need to be demonstrated in appropriately designed trials.
What evidence was available when the financing was announced?
At the time of the January 2025 financing announcement, the public case for TUNE-401 relied substantially on preclinical research and early clinical development.
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Tune reported near-complete HBV repression in human cells and in a humanized mouse model. Earlier company data also reported repression lasting beyond 550 days in certain laboratory models. In separate platform research, Tune reported PCSK9 repression in non-human primates and reduced LDL cholesterol for almost two years after a single transient delivery.
Those findings are encouraging as laboratory and animal evidence, but they do not establish equivalent durability, safety or efficacy in humans. In particular, the PCSK9 work is platform evidence rather than a clinical result for TUNE-401 or hepatitis B.
The company has described TUNE-401 as “first-in-class,” but that is a company characterization. The relevant tests for patients and investors are human safety data, reproducible antiviral activity, durability after treatment and evidence that the treatment improves outcomes compared with existing care.
What changed by 2026?
On May 30, 2026, Tune reported initial Phase 1b/2a proof-of-concept data and said the study showed deep and durable antiviral activity, including direct silencing of cccDNA. The company said it planned to advance TUNE-401 into a larger Phase 2 study, potentially beginning as early as late 2026.
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As of August 18, 2026, that Phase 2 program should be described as planned or expected unless a separate verified update confirms that it has begun. The 2026 announcement remains company-reported early clinical evidence and forward-looking development guidance, not regulatory approval or proof of a functional cure.
Readers evaluating the results should distinguish the company’s summary from the underlying EASL 2026 presentation and clinical-trial information. Patient numbers, safety findings, response definitions and durability measurements matter more than promotional descriptions alone.
Independent reader supportYour contribution helps us test, update, and keep practical guides available for everyone.Why the financing matters—and what could still go wrong
A financing of this size can help Tune run international studies, manufacture an RNA/LNP medicine, prepare regulatory submissions and continue research beyond HBV. It also supports a platform thesis: if TEMPO can regulate disease-relevant genetic activity in a controlled way, the same approach could potentially be applied to additional targets.
But several risks remain:
- Clinical-stage risk: Phase 1b/2a studies are primarily intended to establish safety, pharmacology and preliminary biological activity. They are not definitive efficacy trials.
- Delivery risk: The medicine must reach sufficient numbers of infected liver cells without causing unacceptable liver, immune or off-target effects.
- Durability risk: Epigenetic silencing may last a long time in models but could be reversible in human cells.
- Viral-biology risk: HBV persists in different molecular forms, and patients may have different viral genotypes and disease histories.
- Combination-treatment risk: If participants remain on nucleos(t)ide analog therapy, researchers must carefully separate TUNE-401’s effects from the effects of background treatment.
- Safety risk: Unintended epigenetic changes could alter expression of non-target genes.
- Manufacturing risk: Producing a consistent RNA/LNP medicine at larger commercial scale can be difficult.
- Commercial and financing risk: Even a successful treatment would need to show a meaningful advantage over established suppressive medicines, and Tune may require additional capital before pivotal trials or commercialization.
What to watch next
The most important milestones are detailed human clinical results, continued regulatory progress, the design and start of any Phase 2 study, and evidence that viral suppression persists after treatment stops. Investors should also watch whether safety findings support repeated or finite dosing and whether the company can manufacture the therapy consistently.
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For patients and advocates, TUNE-401 remains an investigational therapy—not an available treatment. Existing HBV care should not be stopped or changed based on company announcements or early-stage research.
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