You don’t need a PhD to run a biotech, but sometimes it helps, as these companies deal in one of the most complicated mysteries still to be solved today: the human body.

Biotech CEOs and chairs tend to be the cross-over scientists. However, they’re the ones who understand the fiddly details of the science behind the tech yet can also communicate it to laymen and convince people to part with large sums of money to support it.

Stockhead is profiling nine biotech bosses who are either at the top of their game, leading fascinating little companies, or are steering damaged ships to port — a valuable skill when the rate of failure for new drug development is above 90 per cent.

These are the first five.


Allegra Orthopaedics (ASX:AMT) CEO Jenny Swain

Jenny Swain is not a scientist, but a nurse with 15 years of experience.

She has led Allegra, a medical devices company selling off-the-shelf implants and researching synthetic bone for spinal cages and kangaroo tendons as replacements for dodgy human ones, for almost four years.

It was her background as a theatre nurse with strong relationships with surgeons, as well as her later career in orthopedic sales, that endeared Swain to the Allegra board in 2016.

Allegra received a licence from the University of Sydney for a composite biocompatible ceramic material known as Sr-HT-Gahnite in 2014.

But until Swain appeared on the scene, the company was in flux: there were several CEO changes and research on synthetic bone scaffold using the above material was not moving ahead quickly.

Under Swain’s leadership the company bought into research on making products from kangaroo tendon for ligament and tendon replacements in humans, and has finally started an FDA-approved preclinical animal trial in sheep for its biodegradable cervical fusion device, made out of the Sr-HT-Gahnite material.

Allegra is facing some challenges though, with sales dipping for one of its replacement products and overall sales in Australia suffering from the government’s ‘benefits reduction’ of 10.5 per cent on prosthesis rebates from private health insurers, which began in 2017.


Cellmid (ASX:CDY) CEO and managing director Maria Halasz

Maria Halasz has been at the top of hair loss company Cellmid since 2007 when it was Medical Therapies.

She came from the world of corporate finance, jumping into the then $10m company from a biotech fund called Direct Capital, but her accession wasn’t assured in that first year.

A stoush with major shareholder the University of Sydney coincided with the 2007 AGM where proxies for Halasz’s re-election to the board and the granting of $135,000 went strongly against her. The motions were withdrawn and Halasz quit the board (but remained as CEO), only for her peers to reappoint her in the aftermath to managing director.

Since then Halasz led Cellmid not only through a name change in 2009 but more importantly a shift from pharmaceutical products to treat various cancers and inflammatory diseases to hair loss products in 2010.

She began losing her hair when she turned 40 but a trip to Japan for Cellmid found a cure: at Kumamoto University she found scientists who’d isolated a protein called FGF5, which controls the hair’s natural cycle of growth-transition-rest.

She bought the rights to it and set the new Cellmid onto developing it for commercialisation.
The company has retained its IP around midkine, a protein associated with various disease states including chronic inflammatory diseases and cancer but these are still in preclinical studies.

But it’s the hair growth and hair care products that are where the money is at. While the company is yet to come close to making a profit, revenue from the hair business grew 30 per cent in FY19 to $7.3m and has been rising significantly for the last two years, after the company broke into the Chinese market.

Dimerix (ASX:DXB) CEO and managing director Dr Nina Webster

Dr Nina Webster is a PhD biotech chief, her research being in drug delivery of pharmaceuticals at Cardiff University.

She’s been the boss of Dimerix, a company with two phase 2 clinical trials underway, since 2018, and has a strong small cap pedigree having worked at Acrux (ASX:ACR) and Immuron (ASX:IMC), as well as a UK company that is now part of Pfizer.

Webster took over from Kathy Harrison, who’d been tasked with bringing the company’s key drugs to human clinical trials, a job she handled with aplomb. Webster was brought in to commercialise the drugs.

Dimerix’s drug DMX-200 is coming to the end of phase 2 trials for diabetic kidney disease and for focal segmental glomerulosclerosis (FSGS), or scarring of the kidney, with results due in mid-2020.

Webster told Stockhead earlier this year that communicating biotechs to non-PhDs could be tricky.

“Getting the message out there is important. Every biotech is going to tell you they’re undervalued, but the challenge for us we have two phase 2 trials running with a market cap of only $16m,” Webster said.

“There’s a serious disconnect and I think a lot of that is because people just didn’t genuinely understand what we have.”

Dimerix is focusing potential commercialisation on the US. The FSGS has orphan drug designation in the US, meaning it can be fast tracked and receives tax and other concessions to get it to market.

Dimerix just raised $2.5m from investors to take another drug, named DMX-700, towards proof of concept studies for Chronic Obstructive Pulmonary Disease.


Factor Therapeutics (ASX:FTT) chair Cherrel Hirst

Factor chair Dr Cherrel Hirst is trying to lead this lamb away from the slaughter, after the company was pronounced dead by then CEO Dr Rosalind Wilson.

Factor’s trial testing its wound-dressing drug VF001 to treat venous leg ulcers failed in November 2018 and the stock was nearly entirely wiped out, with more than $59m slashed from the value of the stock the second the market opened.

With the rate of drug-in-development failures at above 90 per cent, this kind of collapse is not rare among biotechs.

Since then Hirst has been soothing upset shareholders and looking for something to buy.

If anyone is qualified to do so, she is.

Hirst gained her reputation in the field of breast cancer screening and diagnosis as director of the Wesley Breast Clinic, earning her an Officer of the Order of Australia (AO) in 1998, Queenslander of the Year in 1995, and the Australian Government Centenary Medal in 2003.

But more recently her background is just as much in the corporate world.

Hirst was CEO of government investor QIC BioVentures, chairs ImpediMed (ASX:IPD) and sits on the boards of Medibank Private, Gold Coast Health and Hospital Service, and RSL Care RDNS.

Hirst and the board are looking for a life sciences deal at the clinical stage and must “consider a large number of opportunities.”

“We have progressed a small number of opportunities through deep due diligence but have declined to proceed to a transaction,” she said in October.

She recognised shareholder frustration but argued due diligence was vital.


Imugene (ASX:IMU) CEO and managing director Leslie Chong

Over the last year Leslie Chong has presided over a levelling up for Imugene.

Its gastric cancer vaccine HER-Vaxx handsomely passed a phase 1b clinical trial and began a phase 2 trial, and the company started talks with the US Federal Drug Administration (FDA) for a Pre-Investigational New Drug (IND) application for its Key-Vaxx immunotherapy cancer treatment.

Chong learned the oncology trade at global major GlaxoSmithKline, then at Exelixis and Genentech, and has been at the helm of Imugene since 2016.

Her inspiration for becoming involved in oncology came after her father was diagnosed with stomach cancer and her mother with lung cancer.

Imugene’s latest deal however was to buy an immuno-oncology drug developer from Vaxinia, a private company linked to Imugene executive chairman Paul Hopper — the same Paul Hopper who early last year sold ASX-listed Viralytics to Merck for $502m.

Imugene acquired the global licence for CF33, a chimeric vaccinia (pox) virus developed by Professor Yuman Fong, the chair of surgery at California’s City of Hope Comprehensive Cancer Centre.

CF33 shows early promise in inciting a “local and systemic’’ tumor response in mice, in standard xenograft models of breast, pancreatic and colorectal cancers.

The company also acquired the rights to a line of B-cell peptide vaccines from Ohio State University and Mayo Clinic, in August last year.