Finest-performing Small-cap Biotech Shares on the ASX in 2024

12 months-to-date acquire: 284.06 p.c; market cap: AU$193.79 million; share value: AU$1.325

First up on this listing of best-performing ASX small cap biotech shares is clinical-stage LTR Pharma, which is working to commercialise a brand new PDE5 inhibitor intranasal spray know-how designed to deal with erectile dysfunction in 10 minutes or much less. Generally known as SPONTAN, the intranasal spray has efficiently accomplished a Part I human proof of idea examine by which its supply know-how was proven to achieve most focus 5 occasions sooner than oral PDE5 inhibitors.

Shares in LTR Pharma began the 12 months off at AU$0.33. The inventory’s worth reached AU$0.93 on June 11, shortly after the outcomes of the Part 1 SPONTAN have been launched on June 7.

LTR Pharma’s share value spiked once more in mid-August to a year-to-date excessive of AU$1.38 following a spate of constructive newsflow. On August 5, the firm introduced that SPONTAN had been prescribed to first sufferers underneath Australia’s Therapeutic Items Administration (TGA) Particular Entry Scheme. Just a few days later got here the information {that a} second males’s well being clinic had begun prescribing SPONTAN underneath the scheme.

The most important hike got here after the August 13 announcement that LTR signed a co-development settlement with Aptar Pharma, a subsidiary of Aptar Group (NYSE:ATR), to commercialise SPONTAN within the US and different international markets. One other main milestone got here on August 16 with first sufferers prescribed underneath the TGA Authorised Prescriber scheme, permitting for “broader affected person entry for sufferers with a selected medical situation moderately than on a case-by-case foundation,” acknowledged the press launch.

12 months-to-date acquire: 80.72 p.c; market cap: AU$35.65 million; share value: AU$0.135

The biotech firm Amplia is advancing a pipeline of focal adhesion kinase inhibitors for most cancers and fibrosis. Amplia’s lead candidate is narmafotinib (AMP945), which is at present in Part 1b/2a research focusing on pancreatic most cancers, and within the planning phases for a Part 2 examine focusing on ovarian most cancers.

Shares in Amplia Pharma have spent many of the 12 months in a buying and selling vary of AU$0.06 to AU$0.08. On July 25, the corporate launched constructive information pertaining to sustained discount in tumour measurement in three out of 26 sufferers throughout its Part 2a medical trial for Narmafotinib together with standard-of-care chemotherapy in superior pancreatic most cancers sufferers. In response, shares spiked from AU$0.06 to AU$0.10 the identical day.

Just a few weeks later, a further affected person on this medical examine offered with related outcomes, bumping Amplia’s inventory worth as much as AU$0.14 on August 6. If the trials can obtain a discount in tumour measurement in a complete of 6 sufferers, a further 24 sufferers could also be enrolled within the examine.

Since then, Amplia’s shares have managed to maintain that value degree on a collection of additional constructive developments. On August 7, the corporate was granted a key patent for narmafotinibin Japan and Europe, extending patent safety in these markets till at the least 2040. The next week, the firm obtained an R&D tax incentive refund of AU$3.18 million for the 2023/2024 monetary 12 months.

Most lately, on August 21, a fifth affected person recorded a discount in tumour measurement throughout the Part 2a medical trial. “The continued constructive knowledge from the trial is extraordinarily gratifying and at this charge we stay assured we are going to reopen recruitment in early October,” Amplia CEO Dr. Chris Burns acknowledged.

12 months-to-date acquire: 62 p.c; market cap: AU$104.89 million; share value: AU$0.81

Argenica Therapeutics is growing novel neuroprotective therapeutics. The corporate’s lead product candidate is ARG-007, a neuroprotective peptide candidate supposed to guard mind cells and cut back cell dying throughout a stroke and different kinds of neural accidents.

Shares in Argenica have skilled a level of volatility for the primary half of the 12 months, buying and selling in a spread of AU$0.47 to AU$0.67 earlier than leaping to AU$0.88 on June 19 and on to a year-to-date excessive of AU$0.93 on July 8.

On March 25, the corporate reported that the US Meals and Drug Administration had granted ARG-007 a uncommon pediatric illness designation for the remedy of hypoxic ischaemic encephalopathy in new child time period infants.

A lot of the highest information popping out for Argenica this 12 months has associated to its Part 2 medical trial for its neuroprotective drug ARG-007 in acute ischaemic stroke sufferers, for which the primary affected person was efficiently dosed in late March.

The next month, the corporate reported that after reviewing the security knowledge of the primary 5 sufferers dosed within the trial, the Information Security Monitoring Board (DSMB) really useful the examine proceed with out requiring modifications to the examine. Quickly after, shares in Argenica started their regular climb. In mid-Might, Argenica shared {that a} pre-clinical ferret animal trial of ARG-007 in treating traumatic mind accidents confirmed a important discount in injury to mind cells.

On July 23, the firm reported that eight of the ten hospitals collaborating within the Part 2 medical trial had been activated with the rest set to start out up by the top of the month. At the moment, a complete of 20 sufferers had been enrolled out of a deliberate 92 by the shut of the enrollment interval on the finish of 2025.

Argenica’s shares have managed to remain above the AU$0.80 degree for a lot of the third quarter to this point.

12 months-to-date acquire: 61.54 p.c; market cap: AU$36.11 million; share value: AU$0.21

Biotech penny inventory Cynata Therapeutics is a clinical-stage stem cell and regenerative drugs firm growing cell therapies primarily based on its proprietary therapeutic stem cell platform know-how, Cymerus. Its medical pipeline contains a wide range of indications corresponding to graft-versus-host illness (GvHD), osteoarthritis, diabetic wounds and acute respiratory misery syndrome.

Cynata shares kicked off the 12 months at a worth of AU$0.12, and had their first massive leap on Feb 26 to AU$0.23 per share. This got here the identical day because the firm introduced encouraging preliminary knowledge from its Part 1 medical trial of CYP-006TK in diabetic foot ulcers exhibiting a larger proportion of discount in wound floor space within the energetic CYP-006TK group in comparison with the management group.

The next month, Cynata obtained regulatory and ethics approval within the European Union for its Part 2 medical trial of CYP-001 in high-risk acute GvHD. On Might 22, the firm introduced the publication of two-year follow-up knowledge from its CYP-001 in sufferers with steroid-resistant acute GvHD within the peer-reviewed journal Nature Medication.

“Two-year total survival charge in sufferers with steroid-resistant acute GvHD was 60 (p.c),” acknowledged the press launch. Shares in Cynata went on to hit its year-to-date peak of AU$0.34 on Might 31.

12 months-to-date acquire: 8.48 p.c; market cap: AU$442.1 million; share value: AU$0.36

The final ASX small cap biotech firm on this listing is Immutep, which is concentrated on growing autoimmune and most cancers immunotherapy remedies. Its drug pipeline is constructed round eftilagimod alpha, its proprietary lymphocyte activation gene-3 (LAG-3) protein, an immune checkpoint molecule concerned within the regulation of the immune system. LAG-3 was found by Immutep Chief Scientific Officer Frédéric Triebel.

The primary affected person was enrolled and safely dosed within the firm’s INSIGHT-005 Part I trial in early January. It is a collectively funded examine with Merck (NYSE:MRK) to judge eftilagimod alpha together with Merck’s BAVENCIO (avelumab) in as much as 30 sufferers with metastatic urothelial carcinoma.

On March 5, Immutep shared that knowledge from the security lead-in of its AIPAC-003 trial reveals 90 milligrams of eftilagimod alpha together with paclitaxel for remedy of HR-positive, HER2-negative, low metastatic breast most cancers is secure and properly tolerated. The corporate’s share value reacted with a bump up from AU$0.38 to AU$0.41 on March 8.

One other share value leap got here from the April 24 launch of constructive preliminary topline outcomes from its TACTI-003 Part 2b trial evaluating eftilagimod alpha together with Merck’s anti-PD-1 remedy KEYTRUDA as first-line remedy of recurrent, metastatic head and neck squamous cell carcinoma sufferers with adverse PD-L1 expression. The inventory value jumped from AU$0.35 to AU$0.45 that day.

Shares in Immutep reached a year-to-date excessive on Might 7 to shut at AU$0.48 a couple of days after the launch of preliminary medical knowledge from its EFTISARC-NEO Part 2 trial evaluating eftilagimod alpha together with radiotherapy and KEYTRUDA for sufferers with mushy tissue sarcoma.

Nonetheless, outcomes from its TACTI-003 Part 2b trial, whereas comparatively constructive, have been not as anticipated and the market reacted. This led the worth of its inventory to say no from AU$0.44 on June 26 to a low of AU$0.28 on July 3.