Pharma & biotech stocks on the move in October
We take a look at 4 Pharma & Biotech companies whose share prices rallied in October on the back of positive announcements.
The Pharma & Biotech market had a relatively muted month. There were a number of companies that experienced strong share price movements but this was on limited newsflow and limited liquidity. Below we take a look at 4 Pharma & Biotech companies whose share prices rallied in October on the back of positive announcements.
Nyrada Inc. (ASX: NYR)
Nyrada’s share price rose 84.6% in October on the back of the announcement that the preclinical study for the Company’s lead drug candidate NYR-BI03 had shown strong efficacy limiting cardiovascular damage associated with coronary heart disease. NYR-BI03 demonstrated superior efficacy compared to Captopril, an FDA-approved therapy, although we note that this is a preclinical study. The results potentially expand the use of NYR-BI03 with myocardial infarction a leading cause of morbidity and mortality worldwide.
The Company remains on track to commence a Phase 1 clinical trial for its lead drug candidate in 4Q’2024. The clinical trial follows the positive preclinical trial results announced earlier in the year with regards to the stroke study, which showed NYR-BI03 achieved a statistically significant neuroprotective effect, rescuing 42% of brain tissue in the penumbra region of treated animals.
The Phase 1 clinical trial will assess the safety, tolerability, and pharmacokinetics of NYR-BI03 in healthy volunteers. Pharmacokinetic testing includes evaluating how the drug is absorbed, distributed, metabolised, and excreted in the body. The trial will be a randomised, double-blind placebo-controlled, dose escalation design, which will assess the drug across 5 cohorts comprising 8 participants each on a 6:2 active and placebo treatment ratio.
The Company had $3 million in cash as at 30 September 2024, raising $3.36 million in late October to boost the cash position. New shares were issued at $0.12 per share, a 14% discount to the share price prior to the announcement of the raising.
The potential size of the market for the drug candidate is significant with positive results from the Phase 1 trial and progression to Phase II trials to be significant events for the Company.
Orthocell Limited (ASX: OCC)
Orthocell’s share price was up 45.9% in October, following on from the positive momentum in September. During the month, the Company reported revenue of $2.03 million for the September quarter, the second consecutive quarter of record revenue reported by the Company.
The Company’s product suite includes Striate+ and Remplir. Striate+ is a unique collagen barrier membrane used in dental guided bone and tissue regeneration procedures and Remplir is a collagen nerve wrap used in the repair of peripheral nerve injuries.
Straite+ is currently sold in US, Canada, Europe, UK, Australia and New Zealand with Remplir sold in Australia, New Zealand and recently receiving approval for sale in Singapore. The Company is seeking to add new markets with the Company continuing to accelerate its program of regulatory approvals into new jurisdictions. The Company has submitted the final data for the approval process with the FDA for Remplir with the Company anticipating submission and approval in 1Q’2025.
Striate+ is distributed globally by BioHorizons Implant Systems Inc (BioHorizons), one of the largest global dental implant companies. Remplir is distributed by Device Technologies (DVT), a respected name in the provision of medical devices and healthcare solutions across Australia, New Zealand and Asia. Orthocell has been working with its distributor partners to drive uptake of Striate+ and Remplir in key regulatory markets.
During the month, Orthocell raised $17 million through the issuance of new shares at $0.60 per share to institutional investors. The capital will be used to fund the launch of Remplir in the US as well as other global markets including funding the scale up of manufacturing infrastructure, automation projects to enhance manufacturing cost efficiency, sales force and marketing resources to oversee distribution and working capital. The capital raising means the Company is well to placed to advance its growth ambitions with over $35 million in cash.
The addressable markets for the Company’s products are sizable with the expansion of approvals for sale of Remplir expected to contribute to the continued revenue growth of the Company. The successful launch into additional jurisdictions, in particular the US, is expected to result in continued support for the share price.
Respiri Limited (ASX: RSH)
Respiri’s share price advanced 116.7% in October. Respiri is an eHealth SaaS Company supporting respiratory healthcare management and remote patient monitoring in the USA.
In late September, Respiri entered into two individual remote patient monitoring (RPM) agreements with Liliha Healthcare Center and The Care Center of Honolulu, which are Skilled Nursing Facilities (SNFs) based in Hawaii.
SNFs are important facilities in the US playing a vital role in ensuring the safe and successful transition of patients from acute hospitalisation discharge back to the home. SNFs act as a transition facility for those patients discharged from hospital but still too ill to return home, requiring further supervised nursing care. The Respiri program supports patients through safe discharge to their home by assisting with patient SNF discharge, appointment scheduling and coordination of physician follow-up, medication management, Social Determinants of Health (SDoH) needs, disease management/monitoring and more.
The agreements are worth US$1 million p.a. at an annual patient recruitment rate of 33%. This could increase to as much as US$2.4 million with 100% recruitment from the two facilities, which have ~1,000 patient discharges every year.
The Company’s Clinic in Cloud (CiC) business solution will enable Respiri to further streamline service delivery generating between US$130-US$220 pppm, well above the target range of US$70-US$100. This pppm range is determined by the number of Remote Patient Monitoring and Chronic Care Management reimbursed services delivered to each of the patients by Respiri clinical staff in a 30-day period. There are up to 6 reimbursement codes for which these patients could qualify.
The initial contract term is three years with automatic annual renewal and contract termination is without cause, with 90 days’ notice by either party.
There are 42 Skilled Nursing Facilities in Hawaii, discharging approximately 5,000 patients every year, all with similar patient management requirements. Respiri is in discussions to expand this model to a larger proportion of these facilities.
In early October, the Company announced the patient programs have shown what is considered to be a significant reduction in hospitalisations and emergency room visits. This has resulted in accelerated discussion with new and existing clients, particularly those with risk share/value-based payor/insurer contracts.
The Company’s progress saw the Company secure a $1.6 million investment by Merchant Biotech Fund and other investors. The capital will be used to accelerate revenue growth with the Company expecting to reach profitability by the end of 2024. The Placement was done at 4.5 cents per share. The share price has doubled since the announcement of the capital raise.
Tryptamine Therapeutics Limited (ASX: TYP)
Tryptamine Therapeutics share price was up 77.8% in October, with the share price jumping sharply on the announcement that the Company had secured $6 million to accelerate the Company’s clinical trial strategy for TRP-8803, the Company’s lead drug candidate.
The capital raising was strongly supported by cornerstone investors, Merchant Biotech Fund and Dr. Daniel Tillett, who will be appointed as a Director on the Board as part of the Placement. 300 million new shares were issued at 2 cents per share. The Placement will be completed in two tranches. The first tranche comprised 137.5 million shares and undertaken utilising the Company’s available placement capacity under ASX listing rules. The second tranche will comprise 162.5 million shares and 162 million options and will be subject to shareholder approval.
The Company is developing proprietary, novel formulations for the administration of psilocin in combination with psychotherapy to treat diseases with unmet medical needs. TRP-8803 is a proprietary formulation of IV-infused psilocin (the active metabolite of psilocybin) with potential to alleviate numerous shortcomings of oral psilocybin including reducing the time to onset of the psychedelic state, controlling the depth and duration of the psychedelic experience, and reducing the overall duration of the intervention to a commercially feasible timeframe.
The Company has completed a Phase 2a clinical trial for the treatment of binge eating disorder, which demonstrated an average reduction in binge eating episodes of more than 80%.
The Company has also completed a Phase 2a clinical trial for the treatment of fibromyalgia and initiated a Phase 2a clinical trial for the treatment of abdominal pain and visceral tenderness in patients suffering from irritable bowel syndrome. Each of the studies is utilising TRP-8802 (synthetic, oral psilocybin) to demonstrate clinical benefit in these indications. Where a positive clinical response is demonstrated, subsequent studies are expected to utilise TRP-8803 (IV-infused psilocin), that has the potential to further improve efficacy, safety, and patient experience.
The use of psychedelic’s as a treatment option is being explored with the potential benefits being unlocked. The field has been boosted by regulatory changes, however it still remains early days for the market with the use of these treatments not yet mainstream. Results from the early stage trials of the Company suggest there may be some benefit to the target indications, however we would need to see this across a much larger population group.
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The views here are not recommendations and should not be considered as investment advice.
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