APRINOIA Therapeutics Inc. (“APRINOIA”), a clinical-stage biotechnology company focused on neurodegenerative diseases such as Alzheimer’s Disease (“AD”) and Progressive Supranuclear Palsy (“PSP”), and Ross Acquisition Corp II, a special purpose acquisition company founded by former Commerce Secretary Wilbur Ross, today announced that they have entered into a definitive agreement (the “Business Combination Agreement”) for a business combination (the “Business Combination”).
ROSS and APRINOIA are combining at an implied fully diluted transaction equity value of US$280 million for APRINOIA. As part of the Business Combination, Mr. Ross has personally invested US$7.5 million through a convertible note and has committed to provide up to US$12.5 million of capital infusion at the closing of the Business Combination (the “Closing”). This funding is intended to meet the capital requirements needed to bring the company’s lead product, 18F-APN-1607 (“APN-1607”), through to commercialization in China.
APRINOIA, incorporated in 2015, is a Cambridge, MA based global clinical-stage biotech company developing novel therapeutics and precision diagnostics for the treatments of neurodegenerative diseases in collaboration with leading global biotech companies such as Biogen and Celgene (acquired by Bristol Myers Squibb), which includes certain non-exclusive license agreements on its lead tau PET tracer, APN-1607. Concurrently with this announcement, APRINOIA is also announcing the out license of the China rights of APN-1607 to a large pharmaceutical company, whereby such company licensee has executed a binding term sheet agreeing to lead the product through its current Phase 3 trial in AD and target 2024 for commercialization of APN-1607 in China, subject to regulatory review and approval. The licensee has committed approximately US$8 million and RMB 14 million as an upfront payment and has committed to milestone payments and royalties of up to 15% of sales in China, where it is estimated that around 10 million people suffer from AD. APRINOIA will continue to lead the development of APN-1607 in other jurisdictions. APN-1607 is in a Phase 2 trial for AD, with sites in the United States, Japan, and Taiwan, and is preparing for a Phase 3 trial in PSP in the United States, subject to regulatory approval of the FDA.
APRINOIA has established four platforms with different modalities: unique PET diagnostic tracers, small molecule modulators, antibodies, and degraders. Each of the modalities targets pathological aggregated proteins such as tau, alpha-Synuclein, and TDP43 that contribute to the pathogenesis of rare dementia or movement disorders, including PSP, multiple system atrophy (“MSA”) and frontotemporal dementia (“FTD”), as well as common diseases such as AD and Parkinson’s diseases (“PD”).
APN-1607 is a new generation tau PET tracer with a higher specificity than older generations to the pathological tau aggregates and an improved off-target profile. APN-1607 has been validated in 2,600+ human subjects, demonstrating wide clinical utilities for AD and non-AD tauopathies, including PSP, corticobasal degeneration (“CBD”) and traumatic brain injuries to differentially quantify the amount and spatial distribution of tau protein abnormality in those patients. Its features potentially enable more accurate clinical diagnosis in earlier stages, distinguish different stages of these diseases, may help monitor disease progression over time, and potentially allow clinicians to differentiate among different types of neurodegenerative diseases. APRINOIA leverages the advantage of image-validated binders to form the core of its protein degraders, with the benefit of knowing that these binders have shown statistically significant correlation to disease worsening in diseases such as AD and PSP (based on physician scoring). It is APRINOIA’s goal, whether independently or with a pharma partner, to be the first company to advance a CNS protein degradation molecule into human clinical studies.
APRINOIA is also currently running a Phase 1 study in the United States for its tau antibody, APN-005. This antibody targets a conformational-dependent epitope in the mid-domain region of tau, which epitope is thought to be exclusively present on aggregated forms of tau.
“After 7 years of dedicated R&D on neurodegeneration to realize precision neuroscience, we are excited to take our company to the next level of finance and corporate development. Our R&D and collaboration successes are a demonstration of the quality of our products, our team, and the support of our research and commercial partners. We will continue to grow our company and our pipeline to develop innovative products for our physicians and patients with critical medical needs,” said Ming-Kuei Jang, CEO of APRINOIA.
“We are excited to partner with APRINOIA and support its quest in addressing one of the most important disease areas. With more than 6.5 million Alzheimer’s patients in the US currently, and an economic burden expected to reach over US$350 billion by 2040, it became clear that this was a problem worth our attention. APRINOIA’s tau approach is potentially complementary to beta-Amyloid based products like Lecanemab. We’re encouraged by the progress made in this field over the last two years, and believe we’re partnering with APRINOIA at the right time to continue advancing this field,” added Wilbur Ross, CEO of ROSS.
“APRINOIA is an advanced biotechnology company focused on tauopathies and alpha-synucleinopathies, which are neurodegenerative diseases that continue to alarmingly increase in numbers globally,” added Nadim Qureshi, Head of M&A for ROSS.