Validation is a word that pops up naturally in conversation with Sharon Cunningham and Orlaith Ryan, co-founders of Shorla Oncology and reigning EY Entrepreneurs of the Year.
The much-prized award – “we were so shocked,” says Cunningham – delivered a great big dose of validation in November when they were named the emerging entrepreneur category winners and also claimed the overall title. “It’s just a huge honour,” says Ryan.
Shorla has a “small and mighty” team of “35 and growing” spread across its headquarters in Clonmel, Co Tipperary, a London office and its base in Cambridge, Massachusetts. After years of painstaking work and $45 million (€43.7 million) in funds raised, it is now poised to ramp up its commercial operations and find new ways to meet otherwise unmet needs.
But back at the start of their eight-year journey with Shorla, when the two Eirgen Pharma colleagues were dreaming of becoming healthcare entrepreneurs in their own right, they needed to validate their own ideas first. Nobody has a business plan quite like theirs.
“There are companies doing variations of what we do, and I would say there are companies looking to diversify into what we do. But it is unique and very focused. There aren’t any companies we’ve come across that are doing exactly what we do,” Cunningham says.
Shorla Oncology, which has a portfolio of four drugs approved by the US Federal Drug Administration (FDA), specialises in “formulation re-innovation”. This means it develops and also commercialises reformulated versions of certain cancer treatments. Its priority is to launch products, often for paediatric and orphan cancers (rare and neglected ones), that are more convenient in some way than the existing treatments or provide an alternative where there is a shortage.
Cunningham, Shorla’s chief executive and a chartered accountant by background, and scientist Ryan, Shorla’s chief technical officer (CTO), met when they both joined Co Waterford chemotherapy drug producer Eirgen in its early-stage start-up days. They stayed with it through various transactions and due diligence processes as well as its ultimate sale in 2015 to US company Opko Health.
Inspired by the achievements of Eirgen co-founders Tom Brennan and Patsy Carney, they started laying the groundwork for what would later become Shorla, spending the next two years honing their vision for the company “by night and at weekends”, says Cunningham.
“We really felt compelled to do something meaningful, stay within oncology because that’s the area that we knew, but do something different or novel with existing treatments to make them better in some way.”
Some rare cancers are overlooked by larger pharmaceutical companies, while certain patient populations can be underserved. “That’s where we come in,” she says.
The planning phase included trips to the US, Shorla’s initial target market, “speaking to key opinion leaders and anybody who would give us time, basically, to validate our ideas and ensure that the market was there and the need was there”.
They formally established Shorla – the name is a contraction of Sharon and Orlaith – in January 2018 and hit the ground running.
“We’re not going into the novel molecule discovery. We would consider our products novel, but they’re not new chemical entities that have to go into phase one clinical trial, 20 years, billions of dollars,” says Ryan.
“We are very targeted, very focused on looking at the current treatments, identifying the problems – the pain points – for patients, caregivers, hospital pharmacists, clinicians, and then looking to see where we can bring a solution through our R&D and formulation expertise.”
Often the target patients for their products are young children or elderly people who have difficulty swallowing tablets or capsules, which might then have to be dissolved in water or juice. But as cancer drugs can be highly cytotoxic (toxic to living cells), breaking open capsules can have adverse effects for caregivers.
A stable oral liquid reformulation of the treatment, if it can be developed, will not only be easier to administer, it will also facilitate dosing accuracy, says Ryan, giving caregivers “that flexibility within the one bottle that they get sent home with”.
“We know how hard it is to get a simple medicine into a small child, let alone a cancer drug,” says Cunningham.
We are speaking in The Irish Times office the day after Cunningham, who relocated to Boston with her husband and three children in 2021, flew back to Ireland for Christmas.
She briefly checks with Ryan – who is based in Clonmel, where Shorla’s R&D takes place – that she has her dates right when she says it was 3½ years ago that she made the move to set up Shorla’s US base.
“Time flies when you’re having fun!” says Ryan.
Are they in contact with each other a lot?
“By the minute,” says Ryan instantly.
“Emails, WhatsApp, texting daily,” says Cunningham.
“There are so many forms of communication,” Ryan says. “We are very like-minded in terms of ambition. We are so equally motivated to succeed. If we need to communicate, we communicate. There’s always something to talk about, always a new idea to brainstorm. Sometimes they’re crazy, sometimes we implement the next day, the next month.”
Cunningham agrees: “We go from hands-on, day-to-day [matters] to strategy, like, in a split-second.”
But while they have a similar sense of purpose and commitment, they’re also “very different individuals”, she adds.
“I’m probably quieter, you know,” says Ryan. “Regulatory is my background, which is probably atypical for an entrepreneur, but I’m strategic also.”
“You’re very structured,” says Cunningham. “You love process.”
“Which is beneficial for us,” says Ryan. “The entrepreneurial side is extremely thrilling as a result to me, because it is different to the structured side.”
Cunningham, by contrast, has that adrenalin-seeking tendency that many entrepreneurs are proud to share.
“Some things I come out with are probably bizarre, and it’s great that Orlaith is there as the voice of reason,” says Cunningham. “Now sometimes my ideas are good,” she clarifies. “They’re not all bad.”
“No, totally,” says Ryan, laughing. “If you reach for the moon ...”
“I’m not into routine,” says Cunningham. “I’m into spontaneity. I like having flexibility within a plan.”
Ryan continues: “Which is good for the stage of our business. If you couldn’t cope with change, if you couldn’t react, then we wouldn’t be here.”
Their complementary professional backgrounds have helped shape Shorla into a company that both develops and commercialises products, a key difference between it and Eirgen being that its products are branded.
“It’s great that Orlaith can look at things from a scientific point of view. Is this going to work? Can we actually do it? And I’m on the other end going, well, is it going to be viable commercially? Does it make sense for the business to do? We constructively challenge each other on those points constantly,” says Cunningham.
The big breakthrough for Shorla came in 2023, when it received its first product approval from the FDA in the US.
“We had many hurdles to overcome, it was not all easy for sure. So when we did get that first approval, it was a huge celebration, a huge milestone for the company, and, you know, the result of serious graft,” says Ryan.
The product, Nelarabine Injection, is a critical treatment for patients with T-cell acute lymphoblastic leukaemia – most common among children – and T-cell lymphoblastic lymphoma. It provides patients with an alternative to an existing nelarabine product that had historically suffered shortages and has been “performing extremely well” since launch, says Cunningham.
It has since added three further FDA-approved drugs to its portfolio, one of which it acquired for the US market from UK-based pharma company Therakind. This deal led to Shorla’s second commercial launch, oncology and autoimmune drug Jylamvo, an orange-flavoured oral methotrexate solution that eliminates the need for crushing or splitting pills or compounding them.
In a reflection of the brand recognition the company has gained, it recently signed a contract with the pharmacy chain Walgreens to stock the product. A second contract with another leading chain is in the works.
Jylamvo, which also has the advantage of remaining stable at room temperature, was initially approved only for the treatment of adults, but Shorla recently received expanded FDA approval for its use with children and this product – Jylamvo for paediatric indications – will be launched soon.
Another product launch in its near future is Tepylute, a ready-to-dilute formulation developed by Shorla that treats breast and ovarian cancer in an easier to prepare, injectable product. It has FDA approval for a 15mg vial size and is waiting on approval for a second, larger vial size before launching the product.
Meanwhile, the company has just dispatched its first orders for Imkeldi, the first oral liquid form of a drug called imatinib that treats certain forms of leukaemia and other cancers.
With all of this going on, 2025 looks set to be “equally as exciting and busy” as 2024, says Cunningham.
Not every formulation will result in a product with a commercial shelf-life, but it is the technical complexity of the R&D process that creates the opportunity for a company like Shorla, says Ryan.
They are starting to look at expanding beyond the US market, too.
“We focused to begin with on the US market to get established and because it would allow us to scale, but we absolutely have ambition to make these products available globally,” Cunningham says.
“We have monetisable assets that we can take elsewhere and that’s exactly what we’re going to do now.”
Shorla could do this by out-licensing its products – selling the rights to another company. This is one possible approach, for instance, to the “quite laborious and fragmented” European market.
“It is a complex landscape to navigate, and hence why it may be more beneficial to partner, and ultimately get there more efficiently and effectively,” explains Ryan. “We know how to execute on that.”
Shorla is not profitable yet, but they expect it will be in the short to medium term.
“It’s different to a traditional business model. Very different. It’s very capital intensive to begin with but the opportunity is large to justify it,” says Cunningham.
The two co-founders intend to retain stakes in the well-backed company, which closed a series A funding round led by Dublin-headquartered venture capital (VC) company Seroba Life Sciences in 2022, with Paris-based VC firm Kurma Partners leading its $35 million series B round a year later.
It will be seeking series C funding this year to fuel its ever-expanding pipeline, says Cunningham. “We’re open for business.”
If the intricacies of their industry can sometimes be hard to grasp for people not working in it, their motivation won’t be.
When loved ones undergo treatment for cancer, it lends extra validation for why they do what they do, says Ryan. Someone close to her has lately been enduring a significant pill burden to treat their condition, at times while having difficulty swallowing.
Growing up, Cunningham saw how family members were affected by cancer.
“It did have a huge impact on me. That’s the reason why I chose to go into a company that focused on oncology. And most of the people I interview for roles are there because they have also been affected by it,” she says.
“They choose to go into oncology for very distinct reasons, and you can tell. It’s that passion and that drive to make a difference and to ensure that another person doesn’t have to suffer like your family did.”
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CVs
Names: Sharon Cunningham (39) and Orlaith Ryan (38).
Roles: Cunningham is CEO and Ryan is CTO of Shorla Oncology, which they cofounded.
Education: Cunningham’s qualifications include an MBA from the UCD Smurfit School and a BSc in finance from UCC. Ryan’s qualifications include an MSc in regulatory affairs from the University of Wales and a BSc in applied biology with quality management from Waterford Institute of Technology.
Background and family: Cunningham is from Stradbally, Co Waterford, and now lives in Boston, Massachusetts, with her husband Stephen Cunningham and their three boys, Rónan, Oisín and Tadhg. Ryan lives in Clonmel, where she is from. She and her husband Patrick Ryan have two boys, Lorcan and Oscar.
Interests: Running and skiing are two of Cunningham’s interests outside work, while Ryan enjoys cardio Pilates, fashion and reading.
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