Type of investment
The product development segment consists of biotech and pharma companies advancing products or technologies to proof-of-concept, clinical or otherwise, and towards marketing approval. These companies have a massive valuation uplift potential and a clear pathway to success. Flerie encourages partnering, licensing and expansion of the investor base to provide resources or opportunities. Flerie remains engaged to the appropriate endpoint, which could include the company entering commercial growth.
Alder Therapeutics, founded in 2021 by Kristian Tryggvason, is a newly formed Swedish pre-clinical stage biotech, based on discoveries and IP generated by and licensed from DUKE-NUS Medical School in Singapore and Biolamina (which Kristian co-founded). Alder focuses on building a novel cell therapy platform with the best functional cells based on the most simple and robust processes. Alder is a virtual company working with leading cell therapy experts around the world, and have established a strategic partnership with sister company NorthX Biologics. Their unique platform, initially focusing on retinal and cardiac cell therapeutic products, will allow for better pluripotent cell therapy treatment for the wider masses.
Amarna Therapeutics is a Dutch preclinical stage gene therapy company that has developed a novel platform to address a fundamental problem and a known limiting factor of existing platforms. Specifically, their platform aims to address pre-existing immunity, which disqualifies a large patient group from current therapies, by developing a non-immunogenic viral vector for gene therapies. This innovation also enables multiple dosing without the development of neutralizing antibodies, which is not possible with AAV, and can "rescue" low responders. The team is currently conducting IND-enabling animal studies and designing an adaptive clinical trial in patients with haemophilia B, which could have the potential to become a registrational study.
AnaCardio is a Swedish clinical stage biopharmaceutical company developing novel drugs to treat heart failure, increasing contractility with a unique and proprietary mechanism of action. It is based on Professor Lars Lund’s research at Karolinska Institutet on the ghrelin peptide, demonstrating a normalisation of heart function in a proof-of-concept trial in patients without increasing oxygen consumption, arrhythmia, ischaemia, or hypotension. The lead program AC01 is an in-licensed oral peptidomimetic small-molecule being investigated in a phase Ib/IIa clinical study in 2023 in patients with heart failure and reduced ejection fraction. If proven successful, AC01 can be recognised as having block-buster potential in an area with a high unmet need.
Atrogi is a company in clinical phase developing a first-in-class drug for the oral treatment of type 2 diabetes, based on Professor Tore Bengtsson’s research at Stockholm University. The lead compound, ATR-258, is a new small molecular compound, targeting the β2-adrenoreceptor (β2-AR) in a novel way, leading to stimulation of glucose uptake in skeletal muscle, independently of the insulin signaling pathway. This leads to improvement in glycaemic control with several additional advantageous non-glyceamic effects. A phase 1 trial is ongoing with the lead candidate ATR-258 in healthy volunteers and patients for patients with type 2 diabetes. There is large interest from big pharma for a drug with such an effective and competitive profile, with blockbuster potential.
Alexandra Ekman Ryding
Beactica Therapeutics is a privately held Swedish precision oncology company committed to the fight against cancer. The company is advancing a pipeline of novel small molecule therapeutics to treat genetically defined cancers with significant unmet medical need. Beactica’s approach is centered around targeting synthetically lethal disease proteins with allosteric modulators and targeted protein degraders (PROTACs). Beactica’s lead asset BEA-17, a first-in-class targeted degrader of LSD1 and its cofactor CoREST, has been granted Orphan Drug Designation by the FDA for the treatment of glioblastoma. BEA-17 is also being evaluated for other cancers. Beactica aims to advance its programmes to clinical proof of concept.
Buzzard Pharma is a Swedish clinical stage oncology company developing a potent Interleukin-1 inhibitor, Isunakinra, for the treatment of solid tumors in combination with a PD-1 inhibitor (checkpoint inhibitor). Isunakinra is a chimeric protein binding to IL1R1, inhibiting signaling with high potency. The rights to the drug were acquired from Eleven Biotherapeutics in 2017, repositioning the drug from the ophthalmology area to oncology. Isunakinra is currently in phase I/II in solid tumour patients at the Baylor Research Institute in Dallas, Texas. The company was founded by serial biotech entrepreneur Maarten de Château, founder of Cormorant Pharmaceuticals, sold to Bristol Myers Squibb in 2016 for up to $520 million.
Maarten de Château
Egetis Therapeutics is a publicly listed Swedish company, formed by the merger of PledPharma and Rare Thyroid Therapeutics in 2020. It is a dedicated orphan drug development company with two late-stage orphan drug assets: Emcitate® for treatment of MCT8 deficiency and and Aladote® for prevention of acute liver injury caused by paracetamol poisoning. Egetis intends to submit a marketing authorisation application (MAA) for Emcitate to the European Medicines Agency (EMA) in the first half of 2023 based on existing clinical data and a new drug application (NDA) in the US in mid-2023. For Aladote, a proof of principle study has been successfully completed and a pivotal phase IIb/III study is planned to start in 2023, after which they will apply for market approval in the US and Europe.
Empros is a late phase clinical stage company developing EMP16, an oral anti-obesity drug product. The product is a re-purposing of established weight-loss and diabetes drugs (orlistat and acarbose). The new controlled-release formulation has an impressive therapeutic effect, while avoiding the troublesome side effects of the two compounds on their own, improving compliance and quality of life. The aim is to develop a safe oral first-line treatment for this growing patient group, with additional opportunities for paediatric, OTC and maintenance use. A phase 2a study has demonstrated a 6% weight loss compared to placebo, with a second phase 2a study to start in 2023, comparing EMP16 with MR-orlistat and Xenical.
EpiEndo is a clinical-stage biopharmaceutical company with a unique approach to inflammatory disorders that focuses on the enhancement of epithelial barrier integrity to reduce disease-causing inflammation. Epithelial cells are a key part of the barrier that makes up human lung tissue and other organs such as the gut and skin. A breakdown of this barrier is implicated in several chronic inflammatory diseases. EpiEndo’s new class of orally available macrolide, with reduced AMR effect, known as a ‘Barriolide’, shows promise as a first-in-class therapeutic for chronic respiratory diseases as well as other inflammatory indications. EpiEndo’s lead asset, EP395, is the first Barriolide to enter into Phase II clinical trials, for chronic obstructive pulmonary disease (COPD). EP395, aims to be the first on-market oral, barrier strengthening and anti-inflammatory macrolide with reduced AMR effect, for the treatment of COPD, which has a significant unmet need. According to the WHO, COPD is the third leading cause of death globally, and the global economic burden of COPD projected to cost $4.8 trillion by 2030.
Eurocine Vaccines is a pharmaceutical development company. The business strategy is to develop vaccine candidates into clinical phase with the aim of demonstrating proof-of-concept in humans, i.e. support for clinical relevance. At an appropriate time in the development of each vaccine candidate, the company aims to enter into commercial agreements with one or more pharmaceutical companies, i.e. license the vaccine candidates to partners for further development and commercialization. The company has the exclusive global rights to two vaccine candidates – a therapeutic vaccine candidate against Herpes simplex virus type 2 (HSV-2) and a prophylactic vaccine candidate against Chlamydia trachomatis (Chlamydia). Near to mid-term goals include to show preclinical proof-of-principle in the relevant animal models of each project by end 2023, conduct a regulatory advice meeting and develop industrial manufacturing processes during 2024, followed by toxicological and clinical studies.
Geneos Therapeutics, a US-based clinical stage biotherapeutics company believes that the company’s personalized therapeutic cancer vaccines (PTCVs) may serve an important role in new immunotherapeutic paradigms for cancer. The company’s approach, using its proprietary GT-EPIC™ platform, is to target neoantigens (abnormal mutations produced by cancer cells) from individual patient tumors to develop novel and uniquely personalized treatments for cancer. They are targeting solid tumours, initially liver cancer (hepatocellular carcinoma, HCC). There is an ongoing phase Ib/IIa trial in second-line HCC patients, with initial encouraging results, including a number of complete responses pointing towards a potential cure in a patient group known for its poor prognosis. The company is planning a potentially registrational clinical trial and has established manufacturing supply partnerships, notably an in-depth collaboration with sister company NorthX Biologics. As manufacturing turnaround time is of utmost importance for these cancer patients, NorthX has geared up to support Geneos by optimising for a fast turnaround of these GMP plasmid DNA vaccines to significantly less than the industry standard of 12 weeks.
KAHR is an Israeli clinical stage cancer immunotherapy company developing novel bi-functional fusion proteins. Their customizable immuno-recruitment cancer drug candidates utilise various methods to synergistically disable cancer defenses and activate a targeted response involving both innate and adaptive immunity. Their Multifunctional Immune Recruitment Protein (MIRP) platform is used to develop next generation solid and haematological tumour treatments with a number of ongoing clinical and preclinical programmes. KAHR’s lead product, DSP107, is a first-in-class CD47x41BB targeting agent currently in clinical development for patients with solid tumors.
Lipum is a publicly listed Swedish clinical stage drug development company. Its biological anti-inflammatory drug candidate SOL-116 has a novel mechanism of action targeting the BSSL protein (originally found in breast milk). Their initial focus is on the treatment of rheumatoid arthritis, but they are in parallel exploring additional inflammatory diseases with a high unmet medical need such as juvenile idiopathic arthritis and inflammatory bowel disease.
Microbiotica is a UK based microbiome company, spun-out from the Sanger Institute in Cambridge, UK in 2016. They are a leading player in the field of microbiome-based therapeutics and biomarkers. The company can identify gut bacteria linked to phenotype with unprecedented precision in order to discover and develop live bacterial therapeutics (LBPs) and biomarkers from clinical datasets, initially focussing on immune-oncology (IO) and ulcerative colitis (UC). Their aim is to develop LBPs that can increase the response rate of cancer patients to immune checkpoint inhibitors and induce remission in patients with inflammatory bowel disease. Microbiotica's two lead products, both orally-delivered capsules containing fully manufactured bacterial consortia, MB097 (immuno-oncology candidate) and MB310 (ulcerative colitis candidate) will be evaluated in Phase 1b clinical studies. In addition to its lead programs, Microbiotica is developing a pipeline of follow-on candidates and biomarkers. Microbiotica has partnered with leading organisations, such as Cancer Research UK, Cambridge University Hospitals, University of Adelaide and Genentech.
Prokarium is a UK-based clinical stage biopharmaceutical company, pioneering the field of microbial immunotherapy. Their pipeline is designed to unlock the next level of immuno-oncology by building on the most recent advances in cancer immunology. Prokarium’s lead program is focused on transforming the treatment paradigm in bladder cancer by orchestrating immune-driven, long-lasting antitumor effects. It builds on the natural ability of their bacterial strains to seek out and colonise solid tumours. They have developed attenuated strains capable of targeting tumours without causing pathology in normal tissues. These strains are also capable of delivering specific immunostimulatory cargo aimed at activating the patient’s immune system to destroy tumours. In parallel, the company is developing an oral RNA platform.
Sixera Pharma is a Swedish clinical stage company developing a new treatment for Netherton syndrome, an ultra-orphan (very rare) and serious skin condition. The lead candidate SXR1096 is a small molecule formulated in a cream that is applied topically on the skin, comprising of a specific inhibitor of certain proteases (Kallikreins 5, 7, and 14). SXR1096 has the potential of becoming the first available treatment for this patient group, and it has received orphan drug designation (ODD) both by the EMA and the FDA for the treatment of Netherton syndrome. A phase I/II proof of concept study is being carried out to evaluate the safety and efficacy of the drug in patients at five European sites. The company’s CEO is serial biotech entrepreneur Maarten de Château, founder of Cormorant Pharmaceuticals, sold to Bristol Myers Squibb in 2016 for up to $520 million.
Maarten de Château
Strike Pharma is a Swedish company founded by KOL and serial entrepreneur Sara Mangsbo in 2021, developing a novel next generation Antibody-Drug Conjugate (ADC) technology within the immuno-oncology precision medicine space, the ADAC technology. ADACs are short for Adaptable Drug Affinity Conjugates and are built to improve the delivery of tailor-made synthetic molecules to specific cell types for improved immune modulation. Their aim is to take precision medicine to a new level, enabling development of individualized immunotherapeutic treatments based on the genetic profile of each patient’s tumor. Such highly targeted treatments offer the potential to increase therapeutic efficacy and reduce dosage levels thereby minimizing the risk of side effects. Their lead molecule STRIKE2001-KRAS, covering multiple KRAS mutations, is currently in preparation for phase I trials.
Synerkine Pharma is a Dutch biopharmaceutical company developing a novel class of biologics, called Synerkines, that connect two different anti-inflammatory cytokines and enhance their activity via a unique mode of action. Their initial focus is on chronic pain. The company’s lead programme SK-01 is a fusion of interleukins IL-4 and IL-10 for complex regional pain syndrome, a severe form of chronic pain, and osteoarthritis. The SK-02 programme is a fusion of IL-4 and IL-13 and is being developed for in chemotherapy-induced peripheral neuropathy (CIPN). Synerkine Pharma has proof of concept data in relevant animal models for the first in human indication and is working on the next development steps towards a first clinical trial. The ability to treat chronic pain with drugs that mimic endogenous immune molecules and are based on a different mechanism of action than the traditional analgesic drugs holds tremendous therapeutic and commercial potential.
Toleranzia is a publicly listed Swedish drug development company aiming to restore the immune system’s normal ability to tolerate the endogenous substances that are mistakenly targeted in patients suffering from severe autoimmune diseases. The Company’s tolerogens have the potential to be the first long-acting or curative therapies that act specifically on the underlying cause of the autoimmune disease for which they are developed. Toleranzia's primary drug candidate, TOL2, is being developed as a treatment for the autoimmune orphan disease myasthenia gravis, which is a chronic and progressive disease that causes gradually increasing muscle weakness. The second drug candidate, TOL3, is being developed as a treatment for the autoimmune orphan disease ANCA vasculitis, which is a chronic and progressive disease that causes blood vessel inflammation and damage to blood vessel walls. The company is currently in the process of scaling up the production of TOL2 in collaboration with their manufacturing partner in preparation for their upcoming phase I/IIa clinical trial in myasthenia gravis patients.
Vitara Biomedical is a US-based MedTech company in the preclinical phase of development. Inspired by nature, Vitara is developing a fluid-filled incubator for premature infants to reduce mortality and improve quality of life compared to the current standard of care. By reducing lifelong complications such as bronchial pulmonary dysplasia, chronic lung disease, sepsis, loss of vision, and necrotizing enterocolitis the quality of life of the baby could be dramatically improved.
Xintela is a publicly listed Swedish biopharma company developing allogeneic stem cell-based treatments focusing on osteoarthritis and difficult-to-heal leg ulcers and, through its wholly owned subsidiary Targinta, targeted antibody-based treatments for aggressive cancer. Xintela's programmes are based on a unique cell marker technology platform, utilising the cell surface molecule integrin α10β1. The lead programme, investigating the stem cell product XSTEM in knee osteoarthritis, started a clinical phase I/IIa study in Australia in April 2022. The second programme, in difficult-to-heal venous leg ulcers was initiated in September 2022, with a clinical phase I/IIa study in Sweden. XSTEM is manufactured in Xintela’s own GMP facility. Targinta is in preclinical stage with two antibody leads candidates; the antibody-drug conjugate (ADC) TARG9 and the function/blocking antibody TARG10, targeting integrin α10β1 in triple-negative breast cancer and the brain cancer glioblastoma. The next step is to validate the target and treatment concept in an innovative 'Clinical phase 0 study' in cancer patients.
XNK Therapeutics is a Swedish clinical stage immunotherapy company focusing its efforts on preventing and treating cancer by developing unique and individualised NK cell-based therapies. Their autologous lead drug candidate, evencaleucel, is being investigated in a phase II study in combination with Sanofi’s anti CD 38 monoclonal antibody Sarclisa (isatuximab) as consolidation therapy following stem cell transplantation in newly diagnosed multiple myeloma patients. There is also ongoing research and development targeting both haematologic malignancies and solid tumours (initially bladder cancer) in mono- and combination therapy. The company has collaborations with Sanofi and MD Andersson Cancer Center. XNK has developed a proprietary technology platform of broad utility and benefits from its tailormade GMP facility, in addition to its attractive co-location with the Karolinska Institutet and the Karolinska University Hospital.
Xspray Pharma is a Swedish publicly listed pharmaceutical company developing improved protein kinase inhibitors (PKIs) for the treatment of cancer using an innovative technology platform. PKIs are the second largest group of drugs in oncology, whereby drug prices are high. Xspray use their innovative, patented RightSize™ technology to develop improved stable amorphous versions of marketed drugs. This allows them to gain entry as the first competitor to today’s original drugs before the secondary patents expire. The current pipeline includes improved versions of three blockbuster cancer drugs Sprycel®, Tasigna® and Inlyta® plus an undisclosed pipeline. Their lead candidate Dasynoc (XS004) has achieved bioequivalence with a 30 percent lower dose compared to the original drug, Sprycel®, and is unaffected by the pH value of the stomach. Therefore this improved version can thus be used together with omeprazole without affecting the absorption of dasatinib, which facilitates treatment of peptic ulcers while the patient is being treated for cancer. There is an ongoing litigation process with Bristol Myers Squibb relating to the IND submission of Dasynoc with the FDA, which was completely expected by the company.