Lundbeckfonden Ventures

Ventures is the Foundation’s evergreen venture fund, investing in international life science with a focus on the development of innovative new medicines in areas of high unmet medical need.

2021 was, in many ways, an exciting and remarkable year for Ventures, with two exits and two initial public offerings (IPOs). While COVID-19 impacted some companies, the portfolio continued to perform well, as demonstrated by the very tangible results that also included the filing of New Drug Applications (NDA), the initiation of new clinical studies, and the closing of significant financing rounds.

During the year, Spero Therapeutics completed the filing of a NDA in the USA for its lead programme, tebipenem HBr for the treatment of complicated urinary tract infections (cUTIs). If approved, tebipenem HBr would be the only oral carbapenem antibiotic available for use in cUTIs, which are considered a significant, unmet medical need. The NDA followed the successful completion of the Phase III ADAPTPO trial in 2020. During an eventful year, Spero also partnered with Pfizer on SPR206 - a clinical-stage, intravenously-administered, next generation polymyxin - in a combined equity investment and licensing agreement.

Significant progress was also made elsewhere in the portfolio, as several companies managed to keep their clinical trials on track despite the challenges of COVID-19, including late-stage trials at Sanifit, Enterome, Reneo Pharmaceuticals, Lexeo Therapeutics and Imara. In addition, VarmX moved into the clinic and dosed its first patients.

Ventures supported several portfolio companies participating in their follow-on financing, including Aura Biosciences, Lexeo Therapeutics and Reneo Pharmaceuticals.

Lexeo Therapeutics followed its 2020 series A round, with a successful series B round in 2021, raising USD 100m with participation from existing and new investors. Lexeo is focused on developing novel gene therapies for rare and nonrare monogenic diseases and has a comprehensive pipeline, including three clinical-stage, gene therapy programmes. During 2021, Lexeo expanded its cardiology pipeline through the acquisition of Stelios Therapeutics, which added three investigational adeno-associated virus (AAV) mediated gene therapy programmes to the Lexeo pipeline.

Aura Biosciences and Reneo Pharmaceuticals both completed IPOs on Nasdaq, raising USD 76m and USD 94m, respectively. Aura’s IPO followed the closing of an oversubscribed USD 80m private financing round earlier in the year, and the company will use the combined proceeds to fund the clinical development of its laser-activated, virus-like drug conjugate (VDC) platform, including the pivotal Phase III programme for the company’s lead candidate, AU-011, for use in first-line choroidal melanoma - a malignant intraocular tumour. Reneo’s IPO will allow the company to complete the clinical development of its lead molecule in primary mitochondrial myopathies, a group of related mitochondrial diseases predominantly, but not exclusively, affecting skeletal muscle.

Last but not least, Ventures made two successful exits during 2021. In April, Amplyx accepted an offer to be acquired by Pfizer. The company’s lead compound, fosmanogepix, is a first-in-class, anti-fungal compound, under development for the treatment of invasive fungal infections, which is an indication with a large unmet need and mortality rates as high as 30-80%. If approved, fosmanogepix would be the first novel therapeutic class of antifungal therapies to be approved by the US Food and Drug Administration (FDA) in nearly 20 years. In November, Sanifit was acquired by Vifor Pharma for a EUR 205m upfront payment, plus substantial precommercial and commercial milestones. Vifor Pharma will continue its development of SNF472, a novel, first-in-class inhibitor of vascular calcification, for the treatment of calcific uremic arteriolopathy (CUA) and peripheral artery disease (PAD) in patients with end-stage kidney disease.

FINANCIAL RESULTS Ventures’ investments in new and existing companies, amounted to DKK 281m. The net return for the year was DKK 34m versus DKK -7m in 2020. The negative result reflected the substantial negative share price development during the year in the US public biotech market.

The fair market value of the portfolio was DKK 1,876m at 31 December 2021, compared to DKK 1,733m at the end of 2020.

At year-end, the Ventures portfolio comprised 14 companies, of which seven were listed. The complete portfolio is listed on the following page.

PUBLIC PORTFOLIO COMPANIES

Marketing two drugs on the US market: Barhemsys, for post-operative nausea and vomiting, and Byfavo, for procedural sedation.

Aura’s first product candidate, the laseractivated AU-011, is currently being investigated in a Phase III study for the treatment of patients with small-tomedium primary ocular melanoma.

Developing IMR-687 as a potentially disease-modifying, oral, chronic treatment for patients with sickle cell disease and beta-thalassaemia. Currently conducting Phase IIb clinical trials in both indications.

In clinical trials in genetic mitochondrial diseases with a drug that enhances mitochondrial function and potentially increases the number of mitochondria.

Developing a proprietary subcutaneous furosemide for heart failure diuresis, and medicines for bacterial infections, that are delivered via an easy-to-operate, onbody infuser. Expected to file an NDA with the FDA at the end of Q1 2022 for subcutaneous administration of furosemide.

A multi-asset, clinical-stage biopharmaceutical company, focused on identifying, developing and commercialising novel treatments for multi-drug resistant (MDR) bacterial infections. The lead programme has completed Phase III with positive results and an NDA has been submitted to the FDA.

The company is running a Phase IIb/III clinical trial with Haduvio™ (nalbuphine ER) for the treatment of pruritus in prurigo nodularis, plus a Phase IIb trial in chronic cough in patients with idiopathic pulmonary fibrosis. Develops novel immunomodulators. An NDA has been filed for the lead candidate, reltecimod, aimed at patients with necrotising soft tissue infections (NSTIs). Reltecimod has also been granted Fast Track and Orphan Drug designations by the FDA and the European Medicines Agency (EMA).

Markets high-resolution, digital colposcopes with an adjunctive map overlaid on a live image of the cervix, to help with the identification of the most relevant biopsy sites when cancerous and pre-cancerous cervical cancer lesions are suspected.

Enterome is pioneering the development of novel microbiome based drugs. In Phase II studies in Crohn’s disease patients and Phase I/II studies in immuno-oncology.

Progressing a pipeline of gene therapy programmes based on the company’s AAV10 platform. The lead programme targets treatment of the cardiomyopathy that occurs in patients suffering from the genetic disorder Friedreich’s ataxia (FA).

PsiOxus is developing gene-based, immuno-oncology treatments for solid tumours, using its proprietary, intravenously-administered T-SIGn virus platform. The portfolio of differentiated gene therapy products are all delivered systemically but act locally within the tumour. The company has several programmes in clinical trials.

Develops treatments for calcification disorders such as end-stage renal disease (ESRD) and calciphylaxis. The lead product, SNF472, is currently in Phase III for calciphylaxis.

PRIVATE PORTFOLIO COMPANIES

Clinical candidate VMX-C001 is intended to safely and effectively restore haemostasis in case of bleeding or emergency surgery in patients taking oral factor Xa inhibitors.

“Despite challenging circumstances, our companies have made advances in developing drug candidates and launching new products with the potential to improve the lives of patients around the world. The year also saw significant transactional activity, with successful exits and financing events”

METTE KIRSTINE AGGER Managing Partner, Ventures