Two Healthcare stocks from ASX listed companies got a boost after reporting achievement of significant mile stone. These potential growth companies are
Immutep Limited (IMM)
Immutep Limited (IMM) has reported promising data from its TACTI-003 Phase IIb trial presented at ESMO Immuno-Oncology 2024, showcasing the potential of eftilagimod alfa (efti) in combination with pembrolizumab for first-line head and neck squamous cell carcinoma (1L HNSCC) patients with low PD-L1 expression (CPS <1). Key highlights include a median overall survival (OS) that has not yet been reached, a 12-month OS rate of 67%, and a median progression-free survival (PFS) of 5.8 months. The interim duration of response (DOR) stands at 9.3 months, with a notable 35.5% objective response rate (ORR) and a disease control rate (DCR) of 58.1%. The treatment was well-tolerated, with no new safety concerns. These results are favorable compared to historical benchmarks for anti-PD-1 monotherapy in this patient population, which typically faces limited treatment options.
Efti’s strong performance in HNSCC complements regulatory advancements for its broader clinical pipeline. The Australian Therapeutic Goods Administration recently approved the pivotal TACTI-004 Phase III trial in metastatic non-small cell lung cancer (NSCLC), a key milestone marking Immutep’s transition to a Phase III-stage company. This global trial will evaluate efti in combination with pembrolizumab and chemotherapy in ~750 patients, aiming to establish a new standard of care for 1L NSCLC irrespective of PD-L1 expression. Dual primary endpoints of progression-free survival and overall survival will drive its success, with enrolment set to begin in Q1 CY2025.
Financially, Immutep remains well-capitalized with A$172.3M in cash and equivalents as of 30 September 2024, providing runway through CY2026. Operating cash outflows were A$8.6M in Q1 FY25, reflecting increased R&D activity tied to expanded clinical trials. The company also received A$3.6M from French and Australian R&D tax rebates. Net R&D expenditure rose to A$9.5M, supporting advancing clinical programs, while general and administrative costs decreased to A$961k.
The company’s addition to the S&P ASX 300 Index underscores its growth trajectory, further enhancing visibility among investors. Positive FDA feedback for TACTI-004 Phase III and dosing of the first participant in the IMP761 Phase I autoimmune program highlight significant progress across its pipeline. Immutep is one of the best growth stocks to buy now, positioned to deliver value through transformative immunotherapy innovations, targeting underserved patient populations globally.
Orthocell Limited (ASX: OCC)
Orthocell Limited (ASX: OCC) announced a significant milestone today, December 12, 2024, with the first sales of its leading peripheral nerve repair device, Remplir™, in Singapore. This achievement accelerates the company's commercialisation efforts, surpassing the expected market launch date of Q1 CY25. The early sales are a clear testament to the product's quality and the strength of Orthocell's distribution partner, Device Technologies Asia (DVT Asia). DVT Asia has quickly established relationships with key surgeons in Singapore, marking a crucial step in expanding Remplir's reach in the Southeast Asian market. This also positions Singapore as a strategic entry point into other ASEAN markets, as the global nerve repair market is expected to exceed US$3.5 billion.
Orthocell is among high growth stocks as it continues to make remarkable strides in its global expansion. The company is well-positioned to enter the U.S. market, with U.S. FDA clearance for Remplir expected in Q1 2025. The device has already received regulatory approval in Australia, New Zealand, and Singapore, with strong sales growth and increasing adoption by surgeons in these regions. Orthocell's financial position is strong, with approximately $33 million in cash, enabling further market launches and regulatory advancements in key markets like the U.S., Canada, the UK, Europe, and other ASEAN nations. The company is on track to submit its U.S. 510(k) application in December 2024, with commercial distribution in the U.S. anticipated shortly after FDA approval.
Orthocell's financial performance has shown consistent growth, with FY24 revenue reaching $6.76 million, a 30.8% increase from FY23. The company’s product sales saw a 55.3% rise, primarily driven by the successful performance of Striate+ and Remplir in clinical practice. The compounded quarterly growth rate of 9.1% over the last eight quarters further demonstrates the traction Orthocell is gaining among new and existing surgeons. With solid financial backing and a strong product portfolio, Orthocell is poised for continued growth and success in the global regenerative medicine market.
Source: Company’s Report
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