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Healthcare companies set for deals spree as drug patents expire

A gathering of pharmaceutical executives comes as the sector has rebounded from uncertainty over Trump’s policies

Healthcare executives gather for their big annual conference in San Francisco on Monday as the sector is flush with cash and set for a deals spree as patents on drugs worth almost 12 per cent of the industry’s revenues expire in the years ahead.

The JPMorgan healthcare conference takes place as uncertainty recedes over President Donald Trump’s trade wars, drug pricing policy and the leadership of key regulators such as the US Food and Drug Administration. In response, the S&P biotech index, known as the XBI, has surged to a four-year high, outperforming the wider index.

In addition, drugs that contribute about $180bn of revenue a year are set to go off patent in 2027 and 2028, representing almost 12 per cent of the global market, according to research firm Evaluate Pharma. More than $40bn of sales are expected to lose patent protection this year, Evaluate has estimated.

“The need to take big swings becomes more pressing,” said Jeremy Meilman, head of healthcare investment banking at JPMorgan. “Several of the large-cap pharmaceutical companies are shopping around for strong assets and a number have taken action but still have more firepower. This contributes to our optimism for 2026.”

hTtps://www.ft.com/content/7b07a9d5-7254-490b-8ce9-ec2633094d8e

Another brilliant interview by Eric, "2026 will be catalyst year, they've done their work and now it's time for harvesting and are going to JP Morgan next week with a full appointments book, and now ready for potential harvesting of their results to bring in non-dilutive funding cash into the company. Excitement building, in Eric we trust!!! Gla ;-)

Genflow Biosciences Ltd (LSE:GENF, OTCQB:GENFF) CEO Dr Eric Leire talked with Proactive's Stephen Gunnion about the company’s key programs and upcoming catalysts as it enters what management expects to be a pivotal year.

Leire discussed why 2026 is shaping up as “a year of catalysts” for the company, with particular focus on the dog ageing trial, progress in MASH, and the group’s approach to partnerships and licensing.

Leire explained that the dog longevity study is the nearest catalyst, with the trial expected to be unblinded shortly and early efficacy readouts anticipated in the near term. While safety has already been confirmed, the study remains blinded, meaning efficacy results are still unknown. The first data will focus on biological age, measured using a methylation clock, with a more detailed analysis of muscle biopsies and mitochondrial function to follow. According to Leire, “this trial could be very important for our shareholders, because it will trigger a deal with an animal health company bringing non-dilutive money in the company.”

The interview also explored Genflow’s repositioning in MASH toward advanced fibrosis and the prevention of hepatocellular carcinoma. Leire highlighted the significant unmet need in late-stage disease, noting that recent therapies target earlier stages and leave patients with advanced fibrosis facing limited options. He said the company’s preclinical data have been encouraging and form a key part of the IND package, helping differentiate Genflow from existing and emerging treatments.

In addition, Leire discussed the company’s licensing strategy, including plans to out-license the dog program to an animal health specialist and pursue early-stage partnerships for glaucoma, while retaining focus on age-related conditions such as sarcopenia. With meetings planned during JPMorgan week, Leire said the company is seeking non-dilutive capital and strategic validation as it moves forward.

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Gene therapy biotech Genflow eyes busy year ahead as dog ageing trial nears results

Published: 02:40 08 Jan 2026

Genflow Biosciences Ltd (LSE:GENF, OTCQB:GENFF) has wrapped up 2025 with steady progress across a range of gene therapy programmes, including a closely watched trial into dog ageing that could lay the groundwork for future human applications.

The London-listed company, which is working on ways to extend healthy lifespan using gene therapy, said it had completed dosing in its lead canine study with no reported side effects.

The dogs will now be monitored over six months for signs of improved muscle strength and health-related biomarkers, with initial results expected in the first quarter of this year.

The trial, which began in March and uses a therapy based on the SIRT6 gene, a known regulator of ageing and DNA repair, is being conducted in a blinded format. A follow-up analysis is due around mid-year to assess the durability of the effects.

Alongside the dog ageing study, Genflow said it had made progress in a programme targeting advanced stages of MASH, or metabolic dysfunction-associated steatohepatitis, a type of fatty liver disease.

Existing GLP-1 drugs such as Ozempic and Wegovy have shown benefits in early MASH, but Genflow is aiming at patients with more severe fibrosis, where options remain limited.

It is now finalising regulatory paperwork to support a human trial and is exploring the use of mRNA technology, similar to that used in Covid-19 vaccines, as a more flexible and cost-effective delivery method than traditional viral vectors.

In a new push into eye disease, the company is also investigating the use of its gene therapy platform in glaucoma.

Early lab results suggest that increasing SIRT6 levels may help protect the optic nerve from damage, potentially offering a way to slow or prevent vision loss rather than simply reducing eye pressure, which is the current standard treatment.

Genflow said it was in talks with a lipid nanoparticle delivery partner to support this programme and was hiring a specialist contract research firm to help move the candidate towards preclinical testing.

Elsewhere in its pipeline, work is ongoing in sarcopenia, the loss of muscle mass that often accompanies ageing, and in a broader initiative called ExoFastTrack, which supports several of its research efforts.

Looking to the year ahead, Genflow said it would focus its efforts on the most promising areas of its portfolio and seek early licensing or partnership deals to bring in fresh funds without issuing new shares.

“With multiple upcoming data readouts, an expanding partner network, and a maturing intellectual property position, we believe Genflow is well positioned to enter its next phase of growth,” the company said.

The first set of clinical results, particularly from the dog study, will be key in setting the tone for 2026.

Outstanding non-dilutive grant funding could land at anytime, although a lucrative JV licensing deal could also land at anytime and so let's see what transpires at next weeks the prestigious JP Healthcare Conference next week, where Genflow have planned meetings, presumably with potential suitors and every chance Eric will have initial efficacy data from the Dog Trial and maybe and maybe positive Data with their Ophthalmology partner for Glaucoma to present and so confirmation of a commercial deal or two would be transformational for all invested and any funding concerns would be assigned to history. Gla holders....Excitement building!!! :-)

Ps if Genflow need to raise cash because of the delay in receipt of the €4m outstanding non-dilutive grant funding, then raising cash from 16th January is going to become easier, cheaper and less dilutive. :-)

The new Financial Conduct Authority (FCA) regulations are designed to facilitate less discounted fundraising for small caps by reducing the regulatory burden and increasing the threshold for requiring a full prospectus, thus making secondary capital raising faster and cheaper. Key changes, effective from January 19, 2026 (with some listing rule changes effective from July 29, 2024), aim to attract more companies to list and grow in the UK.

Key Regulatory Changes and Their Impact on Small Cap Fundraising

The FCA's reforms introduce several key changes that support more efficient and potentially less discounted fundraising for smaller listed companies:

Increased Prospectus Threshold The most significant change for secondary fundraising is that a full prospectus is now only required if a company issues shares amounting to 75% or more of its existing share capital, a substantial increase from the previous 20% threshold. This allows companies, particularly smaller ones, to raise further capital more quickly and at a lower cost without the time and expense associated with a full prospectus, which should reduce the need for heavily discounted placings.

08 January 2026

A Review of an Exciting 2025

2025 has been a year of focused scientific progress and continued advancement of Genflow Bioscience's mission to extend healthy lifespan through our novel longevity gene therapy platform. Across our portfolio, we have maintained momentum in both animal health where progress in our canine study may provide translational insights relevant to future human applications as well as therapeutic development for dogs.

These advancements have been supported by a strengthened network of leading academic collaborators and laboratories. Together, with continued backing from international institutional investors and previously awarded government grants, this ecosystem helped accelerate Genflow's scientific and clinical development throughout 2025.

Program Highlights

We've made a number of notable strides across our programs this year, including:

· Dog Aging (GF-1004)

We made significant strides in our clinical trial for aging dogs with full administration of our investigational SIRT6-based gene therapy now completed. No adverse events were reported during the dosing phase of the study, with no serious, moderate, or minor side effects observed. The study which began in March 2025, is being conducted as a blinded clinical trial; an initial efficacy readout is expected in Q1 2026, including blood analyses and muscle biopsies to evaluate potential benefits related to sarcopenia, healthspan, and lifespan-associated biomarkers.

Dogs enrolled in the trial will be monitored for 180 days, with a second efficacy assessment planned at the six-month timepoint and results expected in June-July 2026 to evaluate durability and longer-term effects.

· MASH (GF-1002)

Our MASH program saw good progress in 2025. While GLP-1 therapies have addressed early-stage MASH, patients with advanced fibrosis - roughly one-third of the population - still face limited treatment options. In response, we repositioned GF-1002 to target this high-need group, leveraging its antifibrotic properties and potential to prevent progression to cirrhosis and liver cancer. Additionally, we have generated new pre-clinical POC data on the prevention of HCC.

We are now finalizing our IND package and evaluating mRNA/LNP delivery as an alternative to AAV, an approach that could enable repeat dosing and lower manufacturing costs. Encouraging data continue to support this next phase of research and development.

· Glaucoma

In 2025, we expanded into ophthalmology, where SIRT6-based gene therapy shows promise in glaucoma, a leading cause of irreversible blindness. Current treatments primarily manage intraocular pressure but do little to prevent optic nerve degeneration. Our preclinical data suggest SIRT6 overexpression may protect retinal ganglion cells and preserve optic nerve function, shifting the focus from symptom control to true neuroprotection.

The Gap

No approved neuroprotective therapies

The mRNA Opportunity - Wide Open

LNP targeted delivery to retina – now possible

NO APPROVED OR CLINICAL-STAGE MRNA THERAPIES FOR GLAUCOMA

PARTNERING WITH LNP PROVIDER

Paradigm shift to retinal protection

• Pre-clinical evidence links SIRT6 activity with RGC protection in glaucoma/optic neuropathy models

• Demonstrating RGC rescue and preserved function would be a strong disease-modifying signal Delivery is now tractable

• Targeted LNP (tLNP) platforms are removing a major historical barrier for in vivo RNA therapeutics to reach retina/RGCs Clear decision point

A single well-designed rodent POC that shows

• focal RGC expression of SIRT6 cent

• preserved RGC counts and

• preserved RGC function with acceptable ocular safety, gives a clean go/no-go for IND enabling work

AGED DOGS COMPARATIVE TRIAL

Proof-of-Concept comparative clinical trial of in-vivo naked DNA gene therapy in aged dogs

Conducted at Syngene's strategic partner site in Morocco, AAALAC and GLP certified

26 (24+2) aged Beagles dogs (age>10 years)

Group 1 (n=6): untreated

Group 2 (n=6): treated with gene therapy IV bolus of SIRT6 AAV

Group 3 (n=6): treated with gene therapy IV infusion of naked DNA (low dose)

Group 4 (n=6): treated with gene therapy IV infusion of naked DNA (high dose)

Blinded: first read-out in January 2026

• Treatment period: 180 days with follow-up period: 90 days

• Gene therapy has been administered to all dogs with demonstrated excellent

safety profile Endpoints

• Pan-mammalian methylation clock (Steve Horvath),

• sarcopenia (including muscle biopsies) and other markers of aging

MASH PROGRAM

Affects est. 35 million people globally

• Increasing prevalence

• Leading cause of chronic liver disease and liver transplant

Significant unmet medical need

Clear regulatory accelerated development pathway.

EMA and FDA guidelines accept:

✓ Key surrogate outcomes for therapeutic trials: regression of fibrosis or resolution of NASH

✓ Histological changes are achievable within a 12-18-month time-frame

✓ Placebo control

✓ Conditional fast-track approval

2025 KEY HIGHLIGHTS

LARGE AND EXPANDING MARKET OPPORTUNITY MASH: 35 Million globally. Increasing prevalence. Door opener to even broader anti-aging indication

Awarded to new grants in 2024 expanding research pipeline

Ophthalmology: retina preservation

GROWING IP PORTFOLIO WITH LONG LIFE

2 proprietary patent families SIRT6 centenarian (cent SIRT6) and gene delivery (entering National Phase); Additional upcoming patent applications (entering PCT)

MRNA/LNP GENE DELIVERY SYSTEMS

Innovative gene delivery systems: targeted LNPs delivering cent SIRT6 mRNA GF-1002

Multiple key clinical and regulatory milestones expected in next 18 months;

Undervalued stock opportunity; Potential acquisition by pharmaceutical partner

GF-1004: Pet

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