InhaleRx’s $12.6M Funding Raises Stakes in Treatment-Resistant Depression Race
InhaleRx has boosted its funding facility by $12.6 million to accelerate clinical trials of SRX-25, a novel oral treatment for Treatment-Resistant Depression. This brings total available capital to $52.3 million, positioning the company for pivotal Phase III studies.
- Linlithgow Family Office commits additional $12.6M for SRX-25 development
- Total funding facility now approximately $52.3M covering three drug programs
- SRX-25 combines Esketamine with CYP450 inhibitor to improve oral bioavailability
- Funding structured with options issuance tied to Phase 2 trial milestones
- Company aims for Phase 3 readiness within three years of Phase 1 start
Funding Boost for SRX-25 Development
InhaleRx Limited has secured an additional $12.6 million in funding from the Linlithgow Family Office, significantly enhancing its financial runway for the development of SRX-25. This oral fixed-dose combination therapy targets Treatment-Resistant Depression (TRD), a condition affecting roughly 30% of patients with major depressive disorders who do not respond to standard treatments.
The new funds will specifically support manufacturing, non-clinical studies, and Phase 1 and 2 clinical trials. This injection of capital raises the total committed facility to approximately $52.3 million, consolidating the financing for SRX-25 alongside the company’s other two drug candidates, IRX-211 and IRX-616a.
Innovative Approach to Oral Esketamine
SRX-25 combines Esketamine, a known rapid-acting antidepressant, with a CYP450 inhibitor designed to reduce first-pass metabolism and improve systemic exposure. This oral formulation aims to replicate the pharmacokinetic benefits of intranasal Esketamine but with a more scalable and patient-friendly administration route. The development pathway follows the 505(b)(2) regulatory framework, which allows for an expedited approval process by leveraging existing clinical data.
InhaleRx plans to initiate a Phase 1 pharmacokinetic study followed by a Phase 2 proof-of-concept trial, targeting Phase 3 readiness within three years. The company’s CEO, Darryl Davies, highlighted the potential for SRX-25 to transform TRD treatment by offering a more accessible and scalable option for patients and clinicians.
Structured Funding and Strategic Incentives
The funding arrangement includes a structured loan facility with no repayment required until the completion of clinical trials, providing financial predictability. Additionally, the Linlithgow Family Office will receive options representing approximately 20% of the company’s shares post-placement, subject to shareholder approval. These options vest in alignment with the completion of Phase 2 trials for each drug candidate, incentivizing value creation and aligning investor interests with clinical milestones.
InhaleRx also plans to leverage the Australian Research & Development Tax Incentive program to reduce the loan balance and interest costs, demonstrating a strategic approach to capital management.
Positioning for Market and Regulatory Success
With this funding secured, InhaleRx is well-positioned to advance SRX-25 alongside IRX-211 and IRX-616a into Phase III trials. The company emphasizes clear communication with the investment community to ensure its share price reflects the value of its clinical assets as they mature. The focus on rapid and cost-effective regulatory pathways underscores the company’s ambition to bring innovative therapies to market efficiently.
Overall, this funding milestone marks a significant step in InhaleRx’s journey to address unmet needs in psychiatric medicine and pain management through novel inhaled and oral therapies.
Bottom Line?
With $52.3 million secured, InhaleRx is poised to push SRX-25 and its pipeline toward pivotal clinical milestones that could reshape depression treatment.
Questions in the middle?
- How will SRX-25’s oral formulation compare in efficacy and safety to existing Esketamine treatments?
- What are the timelines and key endpoints for the upcoming Phase 1 and Phase 2 trials?
- How might the option issuance impact shareholder dilution and company valuation?
