Crowdfunding for Biotechs
Market uncertainty – which comes in high doses these days – is forcing companies to think differently. Market Data Forecast tells us that SEC regulated Regulation A+ funding, which begins with a crowdfunding round, can reach $55 billion by 2029 and may not only be the best chance for biotech start-ups to thrive, but it may also be a viable way to survive difficult market conditions.
Reg CF/A+ is an alternative to VC funding that can offer biotech start-ups a lifeline when part of a thoughtful growth strategy. Reg CF allows US start-ups to raise up to $5 million per year to facilitate access to capital while protecting investors through transparency and regulatory oversight. Reg A+ allows companies to raise up to $75 million in 12 months from any investor through public offerings. The European Crowdfunding Service Providers Regulation (ECSPR) allows businesses to raise up to €5 million within a 12-month period.
Global private markets have been navigating treacherous waters since venture capital funding reached its peak in 2021 surpassing $330 billion. Investor anxiety has grown as more funding rounds were flat or simply down. Consequently, VC money is still tight. Fundraising remained bifurcated in 2025 – with larger funds and later-stage deals showing resilience while early-stage biotech felt the squeeze, according to McKinsey's 2025 analysis of private markets. This trend is expected to continue this year. For European companies the EU has largely maintained or increased investment in the healthcare sector.
Reg CF/A+ can play a critical role in helping determine the future of medicine. It can open the doors for companies to gain the funds to develop their drugs. Reg CF/A+ allows accredited and non-accredited investors to invest in biotech companies developing drugs for diseases that are affecting their lives. Reg CF/A+ can enable a company to gain access to sufficient funds to run clinical trials and may be able to bridge the early-stage gap – known as the valley of death – now being overlooked by traditional investors.
Biotech start-ups should consider crowdfunding as a viable alternative to VC funding to get more programmes through development and clinical trials. Importantly, it doesn't close the door on using other traditional biotech funding sources or participating in strategic alternatives. A new paradigm is emerging where funding new treatments will come from a broader range of parties. The drugs people want and need most can get a financial boost to jumpstart the process.
Protego Raises Finance
Forbion of the Netherlands has co-led, along with Novartis Venture Fund, a $130 million Series B funding for a US company developing small molecule chaperones to correct the misfolding of proteins in cells – a cause of Alzheimer's and other diseases. The developer, Protego Biopharma Inc of San Diego, US, is a clinical stage company whose lead product is poised to enter a trial in patients with primary amyloidosis, a disease affecting the heart and kidneys. Announced on 1 December, the financing syndicate included the new investors Omega Funds, YK Bioventures and Digitalis Ventures from the US, and Droia Ventures from Belgium.
Protego joins a growing cohort of large pharma and small biotech companies developing chaperone therapies for misfolded proteins. The chaperones bind to the molecules, stabilise them and help them fold correctly. Besides Alzheimer's disease, other disorders, such as Parkinson's disease and amyotrophic lateral sclerosis are causally linked to misfolded proteins. Protego's lead product, PROT-001 is completing a Phase 1 study in 122 healthy adult participants to confirm the drug's safety and tolerability.
Protego said that its molecule differs from others in that it specifically targets misfolded immunoglobulin light chains of the target molecules, preparing them for clearance from the body.
Deal for BC Platforms
BC Platforms AG of Switzerland is to collaborate with a US data company to significantly increase its access to patient information for real world evidence studies. The agreement with GeneVault Lifesciences of Cambridge, US, was announced on 18 December and is expected to give the Swiss company new data sources across Asia, the Middle East, Africa and Latin America. These regions represent some of the world's most genetically diverse yet historically under-studied populations. Currently, BC Platforms draws data from the US and Europe and to a lesser extent from the Asia Pacific and Middle East regions.
Founded in 1997 from a project at the Massachusetts Institute of Technology, US, BC Platforms collects and analyses data on patient health coming from sources other than clinical settings. The data sources can be patient registries and health insurance claims. Once analysed, this real world data becomes real world evidence that can be used to evaluate the safety and effectiveness of new medicines. Increasingly, it is also being used for drug discovery and development. With GeneVault as a new partner, BC Platforms will have access to an additional 115-plus medical facilities and more than 120 hospitals and medical centres. Financial terms of the agreement were not disclosed.
Separately, the US Food and Drug Administration announced on 15 December that it will update guidance on the use of real world evidence in regulatory submissions by relaxing a requirement that this data include confidential personal patient information. By relaxing this requirement, the agency expects to have access to information from large datasets with valuable macro-level data.
This article was written by Michael Wyand, chief executive of Oxeia Biopharmaceuticals Inc, a clinical-stage biotech company developing therapeutics for mild traumatic brain injury.
