Board Change • Jun 01
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 3 experienced directors. No highly experienced directors. CEO, MD & Director James Garner was the last director to join the board, commencing their role in 2023. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model. New Risk • Apr 28
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 40% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (22% average weekly change). Earnings are forecast to decline by an average of 90% per year for the foreseeable future. Shareholders have been substantially diluted in the past year (40% increase in shares outstanding). Market cap is less than US$10m (AU$7.61m market cap, or US$5.47m). Minor Risks Currently unprofitable and not forecast to become profitable next year (AU$19m net loss next year). Revenue is less than US$5m (AU$1.7m revenue, or US$1.2m). New Risk • Apr 17
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 16% This is considered a minor risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (20% average weekly change). Earnings are forecast to decline by an average of 90% per year for the foreseeable future. Market cap is less than US$10m (AU$6.30m market cap, or US$4.51m). Minor Risks Currently unprofitable and not forecast to become profitable next year (AU$19m net loss next year). Shareholders have been diluted in the past year (16% increase in shares outstanding). Revenue is less than US$5m (AU$1.7m revenue, or US$1.2m). Announcement • Mar 16
Percheron Therapeutics Limited has filed a Follow-on Equity Offering in the amount of AUD 2.174875 million. Percheron Therapeutics Limited has filed a Follow-on Equity Offering in the amount of AUD 2.174875 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 434,975,053
Price\Range: AUD 0.005
Security Features: Attached Options
Transaction Features: Rights Offering New Risk • Aug 31
New major risk - Revenue size The company makes less than US$1m in revenue. Total revenue: AU$1.4m (US$936k) This is considered a major risk. Companies with a small amount of revenue are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-AU$16m free cash flow). Earnings have declined by 22% per year over the past 5 years. Revenue is less than US$1m (AU$1.4m revenue, or US$936k). Market cap is less than US$10m (AU$12.0m market cap, or US$7.83m). Minor Risks Share price has been volatile over the past 3 months (15% average weekly change). Shareholders have been diluted in the past year (21% increase in shares outstanding). New Risk • Aug 29
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -AU$16m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-AU$16m free cash flow). Earnings have declined by 22% per year over the past 5 years. Market cap is less than US$10m (AU$12.0m market cap, or US$7.82m). Minor Risks Share price has been volatile over the past 3 months (15% average weekly change). Shareholders have been diluted in the past year (21% increase in shares outstanding). Revenue is less than US$5m (AU$1.8m revenue, or US$1.2m). Announcement • Aug 28
Percheron Therapeutics Limited, Annual General Meeting, Oct 22, 2025 Percheron Therapeutics Limited, Annual General Meeting, Oct 22, 2025. Recent Insider Transactions • Apr 07
Independent Non-Executive Director recently bought AU$58k worth of stock On the 31st of March, Ben Price bought around 5m shares on-market at roughly AU$0.012 per share. This transaction increased Ben's direct individual holding by 5x at the time of the trade. In the last 3 months, there was an even bigger purchase from another insider worth AU$475k. Insiders have collectively bought AU$1.2m more in shares than they have sold in the last 12 months. Recent Insider Transactions • Feb 27
CEO, MD & Director recently bought AU$476k worth of stock On the 26th of February, James Garner bought around 40m shares on-market at roughly AU$0.012 per share. This transaction increased James' direct individual holding by 13x at the time of the trade. This was the largest purchase by an insider in the last 3 months. James has been a buyer over the last 12 months, purchasing a net total of AU$495k worth in shares. Reported Earnings • Feb 20
First half 2025 earnings released: AU$0.009 loss per share (vs AU$0.007 loss in 1H 2024) First half 2025 results: AU$0.009 loss per share (further deteriorated from AU$0.007 loss in 1H 2024). Revenue: AU$151.8k (down 87% from 1H 2024). Net loss: AU$8.54m (loss widened 80% from 1H 2024). Over the last 3 years on average, earnings per share has fallen by 9% per year but the company’s share price has fallen by 52% per year, which means it is performing significantly worse than earnings. New Risk • Feb 05
New minor risk - Profitability The company is currently unprofitable and not forecast to become profitable over the next 3 years. Trailing 12-month net loss: AU$12m Forecast net loss in 3 years: AU$1.6m This is considered a minor risk. Companies that are not profitable are more likely to be burning through cash and less likely to be well established. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. Without profits, the company is under pressure to grow significantly while potentially having to reduce costs and possibly needing to take on debt or raise capital to remain afloat. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (30% average weekly change). Market cap is less than US$10m (AU$8.70m market cap, or US$5.45m). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (AU$1.6m net loss in 3 years). Shareholders have been diluted in the past year (21% increase in shares outstanding). Revenue is less than US$5m (AU$3.0m revenue, or US$1.9m). Breakeven Date Change • Feb 05
No longer forecast to breakeven The 2 analysts covering Percheron Therapeutics no longer expect the company to break even during the foreseeable future. The company was expected to make a profit of AU$6.18m in 2027. New consensus forecast suggests the company will make a loss of AU$2.33m in 2027. Major Estimate Revision • Dec 18
Consensus revenue estimates decrease by 34% The consensus outlook for fiscal year 2025 has been updated. 2025 revenue forecast fell from AU$1.47m to AU$970.0k. EPS estimate unchanged from -AU$0.021 per share at last update. Pharmaceuticals industry in Australia expected to see average net income decline 14% next year. Consensus price target down from AU$0.21 to AU$0.09. Share price fell 90% to AU$0.007 over the past week. Price Target Changed • Dec 18
Price target decreased by 7.1% to AU$0.20 Down from AU$0.21, the current price target is provided by 1 analyst. New target price is 2,686% above last closing price of AU$0.007. Stock is down 87% over the past year. The company is forecast to post a net loss per share of AU$0.026 next year compared to a net loss per share of AU$0.014 last year. Announcement • Nov 26
Percheron Therapeutics Limited has completed a Follow-on Equity Offering in the amount of AUD 13.01854 million. Percheron Therapeutics Limited has completed a Follow-on Equity Offering in the amount of AUD 13.01854 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 135,231,746
Price\Range: AUD 0.08
Discount Per Security: AUD 0.0048
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 27,500,000
Price\Range: AUD 0.08
Discount Per Security: AUD 0.0048
Transaction Features: Subsequent Direct Listing Announcement • Nov 15
Percheron Therapeutics Limited has completed a Follow-on Equity Offering in the amount of AUD 0.185287 million. Percheron Therapeutics Limited has completed a Follow-on Equity Offering in the amount of AUD 0.185287 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 23,160,916
Price\Range: AUD 0.008 New Risk • Nov 12
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 15% This is considered a minor risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Minor Risks Share price has been volatile over the past 3 months (13% average weekly change). Shareholders have been diluted in the past year (15% increase in shares outstanding). Revenue is less than US$5m (AU$3.0m revenue, or US$2.0m). Market cap is less than US$100m (AU$89.2m market cap, or US$58.6m). Major Estimate Revision • Nov 08
Consensus EPS estimates upgraded to AU$0.031 loss The consensus outlook for fiscal year 2025 has been updated. 2025 losses forecast to reduce from -AU$0.054 to -AU$0.031 per share. Revenue forecast unchanged from AU$1.47m at last update. Pharmaceuticals industry in Australia expected to see average net income growth of 2.7% next year. Consensus price target down from AU$0.22 to AU$0.21. Share price was steady at AU$0.08 over the past week. Announcement • Oct 23
Percheron Therapeutics Limited has filed a Follow-on Equity Offering in the amount of AUD 2 million. Percheron Therapeutics Limited has filed a Follow-on Equity Offering in the amount of AUD 2 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 25,000,000
Price\Range: AUD 0.08 Announcement • Oct 18
Percheron Therapeutics Limited has filed a Follow-on Equity Offering in the amount of AUD 13.01854 million. Percheron Therapeutics Limited has filed a Follow-on Equity Offering in the amount of AUD 13.01854 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 135,231,746
Price\Range: AUD 0.08
Discount Per Security: AUD 0.0048
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 27,500,000
Price\Range: AUD 0.08
Discount Per Security: AUD 0.0048
Transaction Features: Subsequent Direct Listing New Risk • Oct 18
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -AU$10m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risk Less than 1 year of cash runway based on free cash flow trend (-AU$10m free cash flow). Minor Risks Share price has been volatile over the past 3 months (14% average weekly change). Revenue is less than US$5m (AU$3.0m revenue, or US$2.0m). Market cap is less than US$100m (AU$80.2m market cap, or US$53.9m). Major Estimate Revision • Oct 10
Consensus EPS estimates upgraded to AU$0.034 loss The consensus outlook for fiscal year 2025 has been updated. 2025 losses forecast to reduce from -AU$0.04 to -AU$0.034 per share. Revenue forecast unchanged from AU$2.90m at last update. Pharmaceuticals industry in Australia expected to see average net income growth of 2.7% next year. Consensus price target of AU$0.22 unchanged from last update. Share price rose 9.5% to AU$0.12 over the past week. Breakeven Date Change • Oct 10
Forecast to breakeven in 2027 The 3 analysts covering Percheron Therapeutics expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of AU$6.18m in 2027. Average annual earnings growth of 10% is required to achieve expected profit on schedule. Major Estimate Revision • Sep 05
Consensus revenue estimates decrease by 40% The consensus outlook for fiscal year 2025 has been updated. 2025 revenue forecast fell from AU$4.90m to AU$2.94m. EPS estimate unchanged from -AU$0.066 per share at last update. Pharmaceuticals industry in Australia expected to see average net income growth of 2.7% next year. Consensus price target broadly unchanged at AU$0.22. Share price fell 4.8% to AU$0.08 over the past week. Major Estimate Revision • Feb 02
Consensus EPS estimates upgraded to AU$0.022 loss The consensus outlook for fiscal year 2024 has been updated. 2024 losses forecast to reduce from -AU$0.027 to -AU$0.022 per share. Revenue forecast unchanged from AU$3.60m at last update. Pharmaceuticals industry in Australia expected to see average net income growth of 22% next year. Consensus price target down from AU$0.27 to AU$0.25. Share price was steady at AU$0.058 over the past week. Price Target Changed • Jan 17
Price target increased by 7.1% to AU$0.30 Up from AU$0.28, the current price target is an average from 2 analysts. New target price is 426% above last closing price of AU$0.057. Stock is down 40% over the past year. The company is forecast to post a net loss per share of AU$0.032 next year compared to a net loss per share of AU$0.017 last year. Announcement • Oct 17
Antisense Therapeutics Limited, Annual General Meeting, Nov 15, 2023 Antisense Therapeutics Limited, Annual General Meeting, Nov 15, 2023, at 14:00 AUS Eastern Standard Time. Location: Minter Ellison, Collins Arch Level 20 447 Collins Street Melbourne VIC 3000 Melbourne Australia Agenda: To receive and consider the Annual Financial Report of the Company for the year ended 30 June 2023 (2023 Annual Report), comprising the Financial Report, the Directors' Report, and the Auditor's Report; to consider Non-Binding Resolution to Adopt the 2023 Remuneration Report; to consider Re-Election of Director Dr. Charmaine Gittleson; to consider Ratification of Prior Issue of Shares to Institutional Investors; to consider Approval for issue of Options to Dr. James Garner; to consider Approval of Employee Share Option Plan; to consider Approval for issue of Options to Dr. Charmaine Gittleson; to consider Approval of change of Company name and modification of Constitution; and to consider Approval of 10% Placement Facility. Major Estimate Revision • Sep 01
Consensus revenue estimates increase by 71% The consensus outlook for revenues in fiscal year 2024 has improved. 2024 revenue forecast increased from AU$2.10m to AU$3.60m. Forecast losses expected to reduce from -AU$0.028 to -AU$0.019 per share. Pharmaceuticals industry in Australia expected to see average net income growth of 23% next year. Consensus price target of AU$0.27 unchanged from last update. Share price rose 11% to AU$0.059 over the past week. New Risk • Aug 25
New minor risk - Financial data availability The company's latest financial reports are more than 6 months old. Last reported fiscal period ended December 2022. This is considered a minor risk. If the company has not reported its earnings on time, it may have been delayed due to audit problems or it may be finding it difficult to reconcile its accounts. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-AU$6.8m free cash flow). Earnings are forecast to decline by an average of 37% per year for the foreseeable future. Minor Risks Latest financial reports are more than 6 months old (reported December 2022 fiscal period end). Currently unprofitable and not forecast to become profitable over next 2 years (AU$21m net loss in 2 years). Shareholders have been diluted in the past year (35% increase in shares outstanding). Revenue is less than US$5m (AU$2.0m revenue, or US$1.3m). Market cap is less than US$100m (AU$47.8m market cap, or US$30.6m). New Risk • Aug 15
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -AU$6.8m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-AU$6.8m free cash flow). Earnings are forecast to decline by an average of 37% per year for the foreseeable future. Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (AU$21m net loss in 2 years). Shareholders have been diluted in the past year (25% increase in shares outstanding). Revenue is less than US$5m (AU$2.0m revenue, or US$1.3m). Market cap is less than US$100m (AU$42.7m market cap, or US$27.7m). New Risk • Jul 24
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 25% This is considered a minor risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risk Earnings are forecast to decline by an average of 40% per year for the foreseeable future. Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (AU$25m net loss in 2 years). Shareholders have been diluted in the past year (25% increase in shares outstanding). Revenue is less than US$5m (AU$2.0m revenue, or US$1.4m). Market cap is less than US$100m (AU$46.0m market cap, or US$31.0m). Announcement • Jun 29
Antisense Therapeutics Limited Receives MHRA Approval for ATL1102 Phase IIb DMD Clinical Trial in UK Antisense Therapeutics Limited announced that it has received both regulatory authority and ethics committee approval to conduct its double-blind, placebo controlled Phase IIb trial of ATL1102 in non-ambulant boys with Duchenne muscular dystrophy (DMD) in the United Kingdom (UK). Following these approvals, requisite contracts are anticipated to be finalised for initiation of trial sites, expected during third quarter current year 2023. Announcement • Feb 15
Antisense Therapeutics Limited Receives Regulatory Authority Approval from the Turkish Medicines and Medical Device Agency Antisense Therapeutics Limited announced that it has received regulatory authority approval from the Turkish Medicines and Medical Device Agency (TMMDA) to conduct its double-blind, placebo controlled Phase IIb trial of ATL1102 in non-ambulant boys with Duchenne muscular dystrophy (DMD). As previously advised, the Company had submitted a Clinical Trial Application (CTA) for approval to conduct the Phase IIb trial in UK, Bulgaria and Turkey. This first trial approval by a regulatory authority is an important milestone for the Company in affirming the quality and acceptability of the Phase IIb trial design and critically, in providing the `green light' for trial initiation at expected high patient enrolling sites. The Phase IIb study aims to enrol and randomize 45 non-ambulant boys with DMD from multiple clinical trial sites in Europe and Australia. Following the initial six-month regimen of either placebo, 25 mg or 50 mg ATL1102 once weekly (blinded phase), participants will continue into a further six-month open label treatment period. Trial approvals in Bulgaria, the UK and Australia are expected to come through in a staggered manner depending on the respective regulatory agencies' evaluation process and timelines. The Company will make further announcements as and when material progress updates emerge. As per previous guidance, reporting of the results from the blinded phase of the trial is anticipated in First half of 2024. Announcement • Feb 13
Antisense Therapeutics Limited Commences the Second Phase (Chronic Setting) of Its Program to Study the Effects of an Antisense Oligonucleotide (ASO) to CD49d (Mouse Equivalent of ATL1102) in a LGMDR2 Animal Model of Dysferlin Deficiency Antisense Therapeutics Limited announced the commencement of the second phase (chronic setting) of its program to study the effects of an antisense oligonucleotide (ASO) to CD49d (mouse equivalent of ATL1102) in a LGMDR2 animal model of dysferlin deficiency. Having previously successfully demonstrated drug activity (reducing target and immune cell RNA in muscle) in the first study in the dysferlin deficient animals, this follow-on chronic study will assess longer duration treatment effects on key disease progression endpoints including reduction in muscle adipose (fat) levels. The study is being undertaken in collaboration with experts in genetic muscle disease at the Murdoch Children's Research Institute (MCRI) in Melbourne and the Jain Foundation in the USA. Suitably aged mice with the dysferlin mutation and related disease progression characteristics have been sourced via the Jain Foundation for use in the study. In this blinded and controlled study, mice will be treated for four months with results to follow mid-2023. LGMDR2 (also known as dysferlinopathy) is a rare genetic muscle disease that is caused by mutations in the dysferlin gene that leads to significant reduction or absence of dysferlin protein levels in muscle fibers. LGMDR2 is characterized by muscle inflammation, fibrosis, adiposity (fat) and progressive weakness in the hip and shoulder area (the limb girdle) proximal muscles (those closest to the center of the body) with loss of ambulation and upper limb function in adulthood. LGMDR2 affects ~ 1 in 125,000 people. To date, no treatments have proven to be beneficial in slowing LGMDR2 disease progression. The use of ATL1102 as a treatment for dysferlinopathy is covered in ANP's patent application PCTAU2020/050445 directed at modifying muscle performance by reducing muscle adiposity and provisional application 2021903024 that claims the use of ATL1102 to reduce thrombospondin-1 reported to be beneficial in treating the disease. As LGMDR2 is a rare disease, the Company expects to be eligible to apply for additional market exclusivity protection via Orphan Drug Designation in the US and Europe. Such applications would be sought in the event of positive outcomes from this chronic study in the dysferlin deficient animal model. Announcement • Feb 03
Antisense Therapeutics Limited Reports Initial Positive Muscle Functional Data from A DMD Antisense Therapeutics Limited reported initial positive muscle functional data from a DMD mdx animal study assessing the use of the combination of antisense (ASO) to CD49d with a dystrophin exon skipping restoration drug. The use of the combination improved the specific maximum force of the extensor digitorum longus (EDL) muscle, a lower leg muscle, and the eccentric muscle force remaining following induced damage to the EDL. This functional data supports the potential use of ATL1102 in combination with dystrophin restoration drugs to improve therapeutic outcomes in patients with DMD. Under the collaborative research agreement with the Murdoch Children's Research Institute's (MCRI), six groups of DMD mdx mice (n=8 per group) were treated for 6 weeks with antisense oligonucleotide to CD49d (mouse equivalent of ATL1102), or control oligonucleotide mismatch or saline treatments, or the morpholino exon skipping dystrophin restoration drug alone and in combination. The muscle physiology of the EDL was assessed for force parameters including specific maximum force and the force drop following 1 to 10 eccentric (lengthening) contraction each involving induced muscle damage by the stretching of the muscle by 10%. The EDL is 1 of 4 muscles in the front of the lower leg whose function is to invert the foot at the ankle. Another of these muscles is the tibialis anterior (TA) on which the ASO to CD49d has previously reported a benefit in reducing eccentric muscle damage in mdx mice. The ASO to CD49d and morpholino exon skipping combination improved the specific maximum force (the maximum force corrected for size/mass and cross-sectional area of the EDL muscle) and both the eccentric muscle force remaining after a single and 10 repeated lengthening contractions with statistically significant effects compared to saline control. This combination after the 10 repeated lengthening contractions, also showed a significant effect (P<0.001) compared to the exon skipping drug used alone and the exon skipping drug used together with the control oligo. In addition, the ASO to CD49d showed a significant effect vs the saline and its control oligo. The morpholino exon skipping drug showed a significant effect compared to the saline control. A provisional patent application titled "Combination Compositions and Methods for Treatment of Muscular Dystrophy" is to be filed to cover the use of the ASO to CD49d and the morpholino exon skipping drug combination to seek protection of the combination of ATL1102 with the dystrophin restoration/exon skipping drugs to 2044, well beyond the patent life of the registered dystrophin restoration drugs. Notably the dystrophin restoration drugs have yet to demonstrate in controlled clinical studies a slowing of the loss of ambulation beyond use of corticosteroids, highlighting the clinical need for a more efficacious therapeutic approach.Further investigations are ongoing in the mdx mouse combination study to determine the possible mechanisms by which the combination approach is providing the observed functional benefits. Muscle RNA and protein samples have been isolated from the mdx mice quadricep muscle for analysis of the dystrophin levels in the muscle to determine if higher levels are seen with the use of the combination than with the dystrophin restoration agent alone. Cellular markers of inflammation and fibrosis including those observed in the ATL1102 DMD Phase II study, will also be assessed to elucidate the potential mechanisms that may be involved. Results from this analysis are anticipated before the end of the first quarter of current year 2023. Announcement • Dec 20
Antisense Therapeutics Limited Announces Clinical Trial Application Submit for ATL1102 Phase IIb DMD trial conduct in Europe Antisense Therapeutics Limited announced that it has now submitted a Clinical Trial Application (CTA) in three European countries (UK, Bulgaria and Turkey) for approval to conduct its double-blind, placebo controlled Phase IIb trial of ATL1102 in non-ambulant boys with Duchenne muscular dystrophy (DMD). The CTA submission for Ethics Committee (EC) approval to initiate trial sites in Australia is scheduled for submission following the holiday period to the EC for review early in the new year. The Phase IIb study aims to enrol and randomize 45 non-ambulant boys with DMD from multiple clinical trial sites in Europe and Australia. Following the initial six-month regimen of either placebo, 25 mg or 50 mg once weekly (blinded phase), participants will continue into a further six-month open label treatment period. The CTA submissions are a critical step in the clinical trial set-up process and represent the company's resolve to develop ATL1102 for DMD. CTA approvals are expected to come through in a staggered manner in early 2023 depending on the respective regulatory agencies' evaluation process and timelines. As per previous guidance, reporting of the results from the blinded phase of the trial is anticipated in first half of 2024. Board Change • Nov 22
Less than half of directors are independent Following the recent departure of a director, there is only 1 independent director on the board. The company's board is composed of: 1 independent director. 2 non-independent directors. Independent Non-Executive Chair Charmaine Gittleson was the last independent director to join the board, commencing their role in 2021. The company's minority of independent directors is a risk according to the Simply Wall St Risk Model. Price Target Changed • Nov 16
Price target increased to AU$0.31 Up from AU$0.27, the current price target is an average from 2 analysts. New target price is 210% above last closing price of AU$0.10. Stock is down 55% over the past year. The company is forecast to post a net loss per share of AU$0.022 next year compared to a net loss per share of AU$0.0092 last year. Announcement • Nov 15
Antisense Therapeutics Limited Announces Retirement of Mark Diamond as Chief Executive Officer Antisense Therapeutics Limited advised that following his significant tenure as the Company's Chief Executive Officer and Managing Director, Mark Diamond has advised that he is retiring as CEO. Mark will continue his responsibilities as CEO until a successor is appointed. Announcement • Nov 14
Antisense Therapeutics Limited Initiates the Process with Contract Research Organisation Pharmaron Antisense Therapeutics Limited initiates the process with Contract Research Organisation (CRO) Pharmaron to conduct a nine-month chronic monkey toxicology study to support the advancement of the ATL1102 program in the US for Duchenne muscular dystrophy (DMD) or any other clinical application of ATL1102. Successful completion of the toxicology study is expected to be the final requisite step for the lifting of the partial clinical hold in the US that presently limits the dosing of ATL1102 to 25mg per week for 6 months. Lifting of the partial clinical hold would also allow ANP to apply for expedited program status with the US Food and Drug Administration (FDA) including Fast Track or potential Breakthrough Therapy designation. There has been a well-documented long-term shortage of monkeys of the appropriate type and age available to the CROs for the conduct of such studies, leading to significant uncertainty on the possible future timing for an ANP study start. An opportunity recently presented to the Company whereby Pharmaron is able to run a study much earlier than anticipated following the cancellation of a similar study by one of Pharmaron's customers. To take advantage of this opportunity, ANP has taken on the husbandry and housing costs of the pre-allocated animals while completing the necessary arrangements with the CRO*. This enables Pharmaron to initiate the Company's chronic toxicology study with dosing of all animals to commence before the end of this calendar year with the reporting of key study findings expected in 1H'24, around the same time as six-month dosing results from the ATL1102 in DMD Phase IIb clinical study. Announcement • Oct 06
Antisense Therapeutics Limited Announces Appointment of Anthony Filippis as Chief Commercial Officer Antisense Therapeutics Limited announced the appointment of Dr. Anthony Filippis as the Company's Chief Commercial Officer (CCO). Anthony is an internationally experienced senior leader with deep understanding and knowledge of the biotechnology, pharmaceutical, healthcare and investment industries. He is currently the CEO & Managing Director of Neurosciences Victoria Limited (NSV), a role he has held since 2017. Anthony is an accomplished executive with over 25 years' experience in business development, corporate strategy, operations, and senior management in ASX-listed and private companies. He has a strong track record in negotiating transactions, partnering (in- and out-licensing), M&A and raising capital for drug development, medical device and diagnostics companies in various fields including neuroscience, oncology, endocrinology and rare diseases. At Antisense Therapeutics, Anthony will have responsibility for the negotiation and execution of partnering transactions as approved by the Board. Anthony will also provide commercial advice and leadership on the Company's development programs and commercialisation plans. Anthony will look to establish/expand on the Company's business development and partnering activities across its various programs and to detail the features of these programs with potential partners through direct contact and attendance at relevant international conferences. Anthony will assist in the process for accessing additional development capital and will also have an important role in supporting the Company's investor relations activities with a strategic focus on the US to increase the Company's profile in that key market. Anthony has been a consultant to many international companies, including Takeda Pharmaceuticals (USA), Mundipharma (UK), and Solasia K.K. (Japan) and an experienced Non-Executive Director on Boards, including NSV, Impel Neuropharma Australia Pty Ltd, Cerebral Therapeutics Pty Ltd, AnaptysBio Pty Ltd, MingSight Pharmaceuticals Pty Ltd, Qponics Ltd. and Connectivity Ltd. Currently, Anthony is Chair of the Commercialisation Committee of the Australian Stroke Alliance Ltd. and is a member of its Risk & WHS Committee. Anthony is also a Founder of Senz Oncology Pty Ltd. Anthony received his PhD in biochemistry from the University of Melbourne and holds an MBA, specialising in entrepreneurship and innovation and new venture creation from La Trobe University. Anthony will commence at Antisense Therapeutics in mid-November. Price Target Changed • Sep 13
Price target increased to AU$0.31 Up from AU$0.27, the current price target is an average from 2 analysts. New target price is 230% above last closing price of AU$0.094. Stock is down 48% over the past year. The company is forecast to post a net loss per share of AU$0.024 next year compared to a net loss per share of AU$0.0092 last year. Announcement • Sep 12
Antisense Therapeutics Limited Announces Dosing Commenced in DMD Combination Therapy Study Antisense Therapeutics Limited announced that dosing has commenced in a muscular dystrophy (mdx) mouse model of DMD to assess the potential clinical utility of ATL1102 in combination with dystrophin restoration drugs (approved in the US for the treatment of DMD) to improve on therapeutic outcomes for patients with DMD. Under the collaborative research agreement with the Murdoch Children's Research Institute's (MCRI), mice will be dosed with an antisense oligonucleotide designed to target CD49d (mouse equivalent of ATL1102) or control oligonucleotide or saline treatments in combination with a dystrophin restoration drug (morpholino oligonucleotide exon skipping drug of the same drug chemistry as the exon skipping treatments marketed in the US). Antisense inhibition of CD49d has previously demonstrated activity in an mdx mouse model as a monotherapy, reducing CD49d+ immune cells and both the CD49d target in the muscle and muscle damage. The combination study will assess the effects of antisense inhibition of CD49d in combination with a dystrophin restoration drug on markers of drug activity in the DMD mdx model including the potential of the combination to improve dystrophin expression levels beyond that achieved by the dystrophin restoration agent used alone, and thereby point to the potential utility of the combination treatmentin the clinic. This study is on track to be completed with results due fourth quarter of calendar year 2022. Major Estimate Revision • Sep 08
Consensus forecasts updated The consensus outlook for 2023 has been updated. 2023 revenue forecast fell from AU$2.14m to AU$1.30m. EPS estimate unchanged from -AU$0.018 per share at last update. Pharmaceuticals industry in Australia expected to see average net income growth of 22% next year. Consensus price target down from AU$0.27 to AU$0.26. Share price fell 11% to AU$0.093 over the past week. Announcement • Sep 07
Antisense Therapeutics Limited Intends to Conduct Double-Blind, Placebo Controlled Six Month Dosing Trial of Atl1102 Followed by Six Month Open Label Phase Antisense Therapeutics Limited announced that it intends to conduct a double-blind, placebo controlled six month dosing trial of ATL1102 followed by a six month open label phase (collectively the `Phase IIb' trial) in non-ambulantboys with Duchenne's Muscular Dystrophy (DMD). The primary endpoint of PUL2.0 will be assessed after six months of treatment (versus 12 months in the Phase IIb/III study). This follows the Company's previous announcement on 13th July 2022 advising the re-evaluation of its clinical plans for ATL1102 in DMD to focus on the most effective deployment of existing cash reserves and to reduce upfront capital requirements. The Phase IIb study aims to enrol and randomize 45 non-ambulant boys with DMD. Following the initial six-month regimen of either placebo, 25 mg or 50 mg once weekly, participants will be invited into a further six-month open label follow-up treatment period in which all boys will be on active treatment (25 or 50mg). This additional time period will be used to demonstrate longevity of response as well as collect additional safety data and facilitate streamlining and de-risking of a Phase III study, the most expensive phase of the drug's development (i.e., may reduce the number of dosing arms). It is the Company's view that if results from the Phase IIb proved to be highly successful, it would then engage with Regulatory Agencies in relation to obtaining an accelerated approval for the unmet medical need of non-ambulant DMD patients. The Phase IIb trial design is modelled on the Phase IIb/III study outlined in Company's Paediatric Investigation Plan (PIP) (refer to following presentation for details on the Phase IIb trial design) and agreed by the European Medicines Agency (EMA) and The Medicines and Healthcare products Regulatory Agency (MHRA) in the UK. The Phase IIb/III clinical trial application submitted in Germany (BfArM) is undergoing evaluation. With the regulatory focus now directed to submission of the Phase IIb trial applications, no additional Phase IIb/III trial submissions are planned at this time. The Company had previously announced that the next clinical milestone following Phase IIb/III trial initiation would have been a planned futility analysis after the first approximately 48 patients had completed their 6 months of dosing. This was to be a blinded analysis of the data by the Data Safety Monitoring Board and the outcome communicated as either a go or no-go decision to continue dosing as per protocol. No statistically analysed efficacy data would have been available at that time for reporting to the market. The revised trial design now to be conducted brings forward the definitive reporting of unblinded and statistically analysed trial data following the completion of the initial randomized blinded six-month dosing period. The Company believes that if successful, positive data from a controlled trial of ATL1102 in DMD patients could add substantial value to the program and, based on previous external feedback, garner serious partnering interest at an earlier point in the development program than previously anticipated. The revised trial design has allowed for the opportunity to incorporate Australian sites alongside key trial centres in Europe. This provides the important benefit of continuity of working with Australian investigators who were involved in the conduct of the previous successful Phase II clinical trial of ATL1102 in DMD. The addition of Australian trial sites is expected to facilitate a significantly greater proportion of the trial costs as being eligible for the R&D tax incentive cash rebate, which should have a material impact on reducing the cash requirements for the conduct of the study. The Company is able to leverage preparatory work undertaken for the Phase IIb/III trial including trial site and clinical investigator identification, selection and relationship development, clinical trial protocols and applications. The new strategy allows the Company to confirm drug efficacy through the rigor of the placebo-controlled trial design so as to allow for discussion with regulators for potential fast tracking into registration phase or potential accelerated approval, pending trial outcomes. The Company anticipates the first of the trial sites for the Phase IIb trial to be initiated in this calendar year. Based on current enrolment expectations, the last patient is projected to enter the trial in early 3Q'23 with the blinded phase of the trial to complete once the last patient has finished their six months of dosing. Reporting of the trial results would follow shortly thereafter. These revised clinical plans have substantially reduced the Company's budgeted trial costs, and with the expected additional R&D tax incentive rebates, the Company now estimates that it can fund both the Company and the trial into 4Q'23. The Company will move forward with the study initiation as outlined above. There is an approximately mid-single digit A$m additional future cash requirement to get to the time point of the reporting of trial results and the Company will update the market upon confirmation of the amount of such additional future funding and how it will be sourced. Reported Earnings • Sep 01
Full year 2022 earnings released: AU$0.009 loss per share (vs AU$0.015 loss in FY 2021) Full year 2022 results: AU$0.009 loss per share (up from AU$0.015 loss in FY 2021). Net loss: AU$5.81m (loss narrowed 28% from FY 2021). Over the next year, revenue is forecast to grow 18%, compared to a 657% growth forecast for the Pharmaceuticals industry in Australia. Over the last 3 years on average, earnings per share has fallen by 6% per year but the company’s share price has increased by 26% per year, which means it is well ahead of earnings. Announcement • Aug 24
Antisense Therapeutics Limited Announces Long COVID-19 Study Identifies Novel Blood Markers as Potential Diagnostic and Therapeutic Targets Antisense Therapeutics Limited advised of outcomes from its collaboration to study the neurological aspects of Long COVID-19 (Long Neuro COVID-19) with US based researchers led by global leader in the field, Dr. Igor Koralnik, at the Northwestern Medicine Neuro-COVID clinic in Chicago, USA. The study has elucidated novel blood markers as potential diagnostic and therapeutic targets in the treatment of Long COVID-19 patients. Three (3) provisional patent applications have been filed in the US to seek protection for these new inventions. Under the collaboration, blood samples that had been collected from Long COVID-19 patients who had not been hospitalized (focused on those with neurological symptoms including brain fog, where blood immune cell changes were observed1), were used to generate data on up to 7,000 proteins in the blood utilising a large-scale protein analysis known as proteomics. Industry leading proteomics group Somalogic in Boulder Colorado USA undertook the analysis, successfully testing the samples using their SomaScan® assay and then the data was statistically analyzed using their Dataviz program. The analyzed data has identified a number of proteins that are significantly modulated in the blood of Long Neuro COVID-19 patients when compared to convalescent subjects who had recovered from Long COVID-19 infection with no persistent symptoms and to healthy subjects. This data has been included in recently filed patent applications as potential diagnostic and therapeutic targets for the treatment of Long COVID-19. Certain targets when combined (as few as 5) identified all 48 Neuro Covid-19 patients and the 42 of 44 subjects who were convalescent or healthy controls suggestive of these targets’ diagnostic potential. A number of targets (<15) have been identified as potentially amenable to treatment by currently available drugs or other therapeutic approaches on the market. The mechanisms of action of those drugs are known to modulate the discovered target proteins, therefore the marketers/developers of those drugs have been identified as initial prospects for partnering interest. A smaller number of diagnostic markers have been detected that could assist in the identification of Neuro Long Covid patients for better designed clinical trials and potentially for earlier treatment intervention. Accordingly, the Company also plans to review its newly generated intellectual property (IP) with targeted pharmaceutical and diagnostic companies for potential commercial discussions, noting that for these discussions to progress, the Company and potential partner companies would need to agree on licensing and/or joint development of this newly generated IP to advance as either diagnostic or therapeutic programs. Of the 94.7 million people in the US diagnosed as infected and surviving COVID-193, approximately 82 million (87%) people are non-hospitalized4, and 45% of non-hospitalized patients5 have developed some manifestation of Long COVID-19 syndrome which suggests more than 24 million people are afflicted by the condition to some extent. The main neurological symptom is brain fog (defined with the established memory tests conducted) and reported in 81% suggesting an impact on nearly 20 million people in the US. Announcement • Aug 19
Antisense Therapeutics Limited Announces Outcomes from Its Collaboration to Study the Neurological Aspects of Long COVID-19 Antisense Therapeutics Limited advised the outcomes from its collaboration to study the neurological aspects of Long COVID-19 (Long Neuro COVID-19) with US based researchers led by global leader in the field, Dr. Igor Koralnik, at the Northwestern Medicine Neuro-COVID clinic in Chicago, USA. The study has elucidated novel blood markers as potential diagnostic and therapeutic targets in the treatment of Long COVID-19 patients. Three (3) provisional patent applications have been filed in the US to seek protection for these new inventions. Under the collaboration, blood samples that had been collected from Long COVID-19 patients who had not been hospitalized (focused on those with neurological symptoms including brain fog, where blood immune cell changes were observed1), were used to generate data on up to 7,000 proteins in the blood utilising a large-scale protein analysis known as proteomics. Industry leading proteomics group Somalogic in Boulder Colorado USA undertook the analysis, successfully testing the samples using their SomaScan® assay and then the data was statistically analyzed using their Dataviz program. The analyzed data has identified a number of proteins that are significantly modulated in the blood of Long Neuro COVID-19 patients when compared to convalescent subjects who had recovered from Long COVID- 19 infection with no persistent symptoms and to healthy subjects. This data has been included in recently filed patent applications as potential diagnostic and therapeutic targets for the treatment of Long COVID-19. Certain targets when combined (as few as 5) identified all 48 Neuro Covid-19 patients and the 42 of 44 subjects who were convalescent or healthy controls suggestive of these targets' diagnostic potential. A number of targets (<15) have been identified as potentially amenable to treatment by currently available drugs or other therapeutic approaches on the market. The mechanisms of action of those drugs are known to modulate the discovered target proteins, therefore the marketers/developers of those drugs have been identified as initial prospects for partnering interest. A smaller number of diagnostic markers have been detected that could assist in the identification of Neuro Long Covid patients for better designed clinical trials and potentially for earlier treatment intervention. Accordingly, the Company also plans to review its newly generated intellectual property (IP) with targeted pharmaceutical and diagnostic companies for potential commercial discussions, noting that for these discussions to progress, the Company and potential partner companies would need to agree on licensing and/or joint development of this newly generated IP to advance as either diagnostic or therapeutic programs. Announcement • Jul 13
Antisense Therapeutics Limited Announces ATL1102 DMD Clinical Trial Application Submitted in Europe Antisense Therapeutics Limited announced that it has submitted its first clinical trial application (CTA) for the Phase IIb/III clinical trial of ATL1102 in non-ambulant patients with Duchenne muscular dystrophy (DMD) to the Federal Institute for Drugs and Medical Devices in Germany (BfArM) for their evaluation and subsequent approval of the application. This is a significant milestone for ANP encapsulating an extensive effort by the Company in establishing an agreed clinical and regulatory pathway with the European Medicines Agency and in preparing the comprehensive documentation package required by the regulators for trial approval. The Company is continuing to work with its Clinical Research Organisation partner, Parexel, in advancing the regulatory process for the program in Europe and will continue to provide updates on material progress. In parallel the Company has been extensively evaluating its clinical plans for ATL1102 in DMD with the focus on deploying its existing cash reserves in the most effective manner, to reduce upfront capital requirements and extend its cash runway. The Company believes this capital management focus, including the review of financing requirements and options for sourcing future funding (as and when required), to be prudent given the present challenging market conditions. The Company remains committed to its DMD program and to initiating the next clinical trial of ATL1102 in DMD as soon as possible to advance its clinical development for the benefit of the patients with DMD and the broader Duchenne community. The Company expects to provide a more detailed program update in the coming weeks once the planning in line with the expectations noted above is sufficiently affirmed. Announcement • Jun 23
Antisense Therapeutics Limited Announces Results from First Study of Antisense to CD49d in Limb Girdle Muscular Dystrophy R2 Mouse Model Antisense Therapeutics Limited announced the results from a first study of antisense to CD49d in a limb girdle muscular dystrophy R2 mouse model. LGMDR2 is a rare genetic muscle disease that is caused by mutations in the dysferlin gene that leads to significant reduction or absence of dysferlin protein levels in muscle fibers. Dysferlin loss occurs in both males and females with the condition called dysferlinopathy or LGMDR2. LGMDR2 is characterized by muscle inflammation, fibrosis,adiposity and progressive weakness in the hip and shoulder area proximal muscles with loss of ambulation and upper limb function in adulthood. LGMDR2 affects 1 in 125,000 people. There are no disease modifying agents in advanced development and no treatments have proven to be beneficial to slow the progression of the disease. This first study of antisense to CD49d in the LGMDR2 mouse model was undertaken in collaboration with experts in genetic muscle disease at the Murdoch Children's Research Institute in Melbourne and the Jain Foundation in the USA. In the study, Bla/J mice were treated with an antisense oligonucleotide to CD49d at three dose levels once weekly for six weeks, with a corresponding negative control oligonucleotide at the same dose levels. The study also included untreated Bla/J mice and healthy mice as controls. The results showed that at the low 5mg/kg/week ASO dose, the RNA levels of CD49d, and CD8 T cells and F4/80 macrophage cells in the quadricep muscle were significantly decreased by 42%, 86% and 70% respectively, compared to the levels observed in the mice dosed at the 5mg/kg/week doselevel of the control oligonucleotide. A significant reduction in CD8 RNA vs the untreated control Bla/J was also observed. Notably, in the quadricep muscle of the female untreated control mice, there was 2.5 times more F4/80 RNA than male mice. F4/80 is a marker of macrophages which are key immune cells involved in the disease and the increase in these cells is suggestive of a more active disease in the female mice. ASO treatment in female mice achieved significant reduction in F4/80 and CD8 cell mRNA in the quadricep muscle. In these same female mice, a trend towardsreduction of 38% in CD49d RNA was observed compared to untreated Bla/J in another proximal muscle called the Psoas. Given these observations the next study will be conducted in the female mice as agreed with the experts at the Jain Foundation. The results from this first investigation of the potential of an antisense to CD49d drug in the Bla/J dysferlin deficient mouse model have shown the use of a low dose of the drug reduces the target and key immune cell RNA in the muscle. The results support the Company's plans to move forward with the second phase of the program with a follow on study in the same mouse model to test the potential of the low dose to reduce adipose (fat) levels, muscle loss and damage. The second study is planned for 3Q/4QCY22 and designed to run for four months, with results to follow shortly thereafter. The use of ATL1102 as a treatment for dysferlinopathy is covered in ANP's patent application PCTAU2020/050445 directed at modifying muscle performance by reducing muscle adiposity. The recently filed provisional application 2021903024 also claims the use of ATL1102 to reduce thrombospondin-1 reported to be beneficial in treating the disease. The data from Bla/J mice studies can be used to support the prosecution of these claims and the filing of a new patent application. Announcement • Jun 20
Antisense Therapeutics Limited Announces the Results from A First Study of Antisense to CD49d in A Limb Girdle Muscular Dystrophy R2 (LGMDR2) Mouse Model Antisense Therapeutics Limited announced the results from a first study of antisense to CD49d in a limb girdle muscular dystrophy R2 (LGMDR2) mouse model. LGMDR2 is a rare genetic muscle disease that is caused by mutations in the dysferlin gene that leads to significant reduction or absence of dysferlin protein levels in muscle fibers. Dysferlin loss occurs in both males and females with the condition called dysferlinopathy or LGMDR2. LGMDR2 is characterized by muscle inflammation, fibrosis, adiposity (fat) and progressive weakness in the hip and shoulder area (i.e. the limb girdle) proximal muscles (those closest to the center of the body) with loss of ambulation and upper limb function in adulthood. LGMDR2 affects 1 in 125,000 people. There are no disease modifying agents in advanced development and no treatments have proven to be beneficial to slow the progression of the disease. This first study of antisense to CD49d in the LGMDR2 mouse model (Bla/J mice with dysferlin loss) was undertaken in collaboration with experts in genetic muscle disease at the Murdoch Children's Research Institute (MCRI) in Melbourne. The Jain Foundation is coordinating the worldwide efforts to find a treatment for dysferlinopathy and have substantial experience with LGMDR2. In the study, Bla/J mice were treated with an antisense oligonucleotide (ASO) to CD49d at three dose levels (5, 10 and 20mg/kg) once weekly for six weeks, with a corresponding negative control oligonucleotide at the same dose levels. The study also included untreated Bla/J mice and healthy mice as controls. The results showed that at the low 5mg/kg/week ASO dose, the RNA levels of CD49d, and CD8 T cells and F4/80 macrophage cells in the quadricep muscle were significantly decreased by 42%, 86% and 70% respectively, compared to the levels observed in the mice dosed at the 5mg/kg/week dose level of the control oligonucleotide (P<0.05 Fisher's Least Significant difference test). A significant reduction in CD8 RNA vs the untreated control Bla/J was also observed. Notably, in the quadricep muscle of the female untreated control mice, there was 2.5 times more F4/80 RNA than male mice (data on file). F4/80 is a marker of macrophages which are key immune cells involved in the disease and the increase in these cells is suggestive of a more active disease in the female mice. ASO treatment in female mice achieved significant reduction in F4/80 and CD8 cell mRNA in the quadricep muscle. In these same female mice, a trend towards reduction of 38% (P=0.0656) in CD49d RNA was observed compared to untreated Bla/J in another proximal muscle called the Psoas. Given these observations the next study will be conducted in the female mice as agreed with the experts at the Jain Foundation. The results from this first investigation of the potential of an antisense to CD49d drug in the Bla/J dysferlin deficient mouse model have shown the use of a low dose of the drug reduces the target (CD49d) and key immune cell (F4/80 macrophage and CD8+ T cells) RNA in the muscle. The results support the Company's plans to move forward with the second phase (chronic setting) of the program with a follow on study in the same mouse model to test the potential of the low dose to reduce adipose (fat) levels, muscle loss and damage. The second study is planned for 3Q/4QCY22 (pending the availability of suitably aged mice) and designed to run for four months, with results to follow shortly thereafter. The use of ATL1102 as a treatment for dysferlinopathy is covered in ANP's patent application PCTAU2020/050445 directed at modifying muscle performance by reducing muscle adiposity. The recently filed provisional application 2021903024 also claims the use of ATL1102 to reduce thrombospondin-1 reported to be beneficial in treating the disease. The data from Bla/J mice studies can be used to support the prosecution of these claims and the filing of a new patent application. Price Target Changed • Apr 27
Price target increased to AU$0.58 Up from AU$0.54, the current price target is provided by 1 analyst. New target price is 427% above last closing price of AU$0.11. Stock is down 48% over the past year. The company posted a net loss per share of AU$0.015 last year. Announcement • Feb 08
Antisense Therapeutics Limited Announces Dosing Commenced in MCRI Collaboration Animal Study Antisense Therapeutics Limited announced that dosing has commenced in an inflammatory muscle disease animal model under the previously advised collaborative research agreement with the Murdoch Children's Research Institute's (MCRI) to investigate the therapeutic potential of ATL1102 in a new muscle disease, where there are no effective treatments. All animals successfully received their first dose of the antisense CD49d drug or control (oligonucleotide mismatch or saline) treatment. ATL1102 has been shown to be clinically active in non-ambulant Duchenne muscular dystrophy (DMD) patients while antisense inhibition of CD49d has also demonstrated activity in a muscular dystrophy (mdx) mouse model of DMD, reducing both the CD49d target in the muscle and muscle damage. Having achieved positive results in the DMD mdx animal model, antisense inhibition of CD49d is now to be assessed in a mouse model of another inflammatory muscle disease, where there are similar immune mediated inflammatory features to the mdx model. While the Company has filed patents to seek protection for the use of ATL1102 in this new indication, the Company has not named the indication as further important intellectual property protection could be generated through the successful conduct of the study program at the MCRI. ANP can, however, advise that the new inflammatory muscle disease indication being studied is a rare muscle disease that effects both children and adults with no effective marketed therapy, no disease modifying agents in advanced development and where ATL1102's observed immunomodulatory activity would be suggestive of potential treatment benefits. Dosing has now commenced in the first phase (acute setting) of this development program where the antisense inhibition of CD49d target effects in the muscle will be assessed. Results from this first phase of the program are anticipated in 2Q'CY22. The second phase (chronic setting) of the program will study the drug effects over a longer dosing period in the animals where the antisense inhibition of CD49d target effects in reducing muscle damage, as determined by fat content in the muscle, will be assessed. Preventing increase in fat levels in the muscle is a key clinical goal for patients with this inflammatory muscle disease. Notably ANP has previously reported ATL1102's positive effect in stabilizing fat levels in the muscle of DMD patients. Data from the second chronic dosing phase is expected 2H'CY22. Expanding ATL1102's application into this new indication would allow ANP to leverage established core competencies (for example rare disease experience, scientific partnerships and scientific collaborations e.g. MCRI, KOL's etc.) and the extensive non-clinical and clinical data generated on ATL1102 to deepen the Company's product pipeline with the potential for ANP to move rapidly into the clinic based on positive animal data or out-license. Price Target Changed • Nov 13
Price target increased to AU$0.60 Up from AU$0.54, the current price target is an average from 2 analysts. New target price is 188% above last closing price of AU$0.21. Stock is up 110% over the past year. The company is forecast to post a net loss per share of AU$0.018 next year compared to a net loss per share of AU$0.015 last year. Announcement • Sep 24
Antisense Therapeutics Limited Announces New Data Supports ATL1102s Broader Clinical Potential Antisense Therapeutics Limited announced that the ATL1102 Phase II non-ambulant DMD patient plasma protein data was presented on September 24, 2021 at the 26th International Annual Congress of the World Muscle Society in the late breaking news poster titled "ATL1102 treatment in non-ambulant boys with DMD modulates Latent TGF-beta-binding protein 4, and thrombospondin-1, two disease genetic modifiers of ambulant DMD, and CXCL16". ATL1102 was assessed in an open label Phase II study in adolescent non-ambulant patients with DMD demonstrating highly promising trial results. Planned as part of the Phase II study, a large-scale protein analysis (known as a proteomics analysis) of retained blood plasma samples from the non-ambulant DMD patients treated with ATL1102 was undertaken to identify the proteins affected so as to provide further insight into the mode of action and biological activity of ATL1102. At the end of the 24 week dosing period, ATL1102 treated patients demonstrated a statistically significant mean reduction in Thrombospondin-1 (-49%), and increases in LTBP4 (20.7%), soluble CXCL16 (29.9%), and VCAM-1 (18.0%) compared to baseline levels (FDR p-value <0.0005). The ATL1102 induced positive LTBP4 increases and TSP-1 decreases in plasma indicates that ATL1102 modifies the levels of two proteins involved in modifying the rate of loss of ambulation (LoA) in DMD. LTBP4 sequesters TGF- to keep it latent and TSP-1 activates latent TGF- with LTBP4 and TSP-1 both involved in the fibrotic process in DMD. An inherited minor form of the TSP-1 gene with reduced expression of TSP-1 has been reported as being protective against loss of ambulation in DMD. A rare recessive inherited form of the LTBP4 gene in 12% of patients with greater levels is associated with milder DMD providing 1-2 years delayed loss of ambulation. ATL1102's effect in increasing blood levels of (i) soluble VCAM-1 (sVCAM-1), a CD49d ligand, is supportive of ATL1102's antisense mechanism of action in reducing CD49d to reduce sVCAM-1 bound to CD49d, and in reducing inflammation, and (ii) soluble CXCL16, a chemokine with a role in muscle regeneration, appears to align with the positive effects on muscle structure observed under MRI in the ATL1102 Phase II trial. These plasma proteins were increased such that they approached the median levels seen in an external control dataset of healthy adults, supporting the beneficial nature of the outcomes in ATL1102 treated DMD patients. The protein changes observed in the plasma of the ATL1102 treated non ambulant DMD patients in the Phase II study is also consistent with the drug's positive effects on muscle function and strength reported in the ATL1102 Phase II trial. Analysis of the plasma protein data is ongoing in order to further elucidate ATL1102's biological effects and to position the drug's development in disease settings. The Company will continue to report on any material developments from this ongoing data analysis and associated commercial opportunities. Based on the positive outcomes from the protein analysis reported above, Australian Provisional Patent Application No. 2021903024 was filed 20 September 2021 with claims covering applications of ATL1102 in new potential disease settings including diabetic, respiratory and age-related diseases to support the Company's future commercial and partnering plans for ATL1102. Breakeven Date Change • Aug 26
Forecast to breakeven in 2024 The 2 analysts covering Antisense Therapeutics expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of AU$21.1m in 2024. Average annual earnings growth of 54% is required to achieve expected profit on schedule. Price Target Changed • Jul 02
Price target increased to AU$0.54 Up from AU$0.47, the current price target is an average from 2 analysts. New target price is 155% above last closing price of AU$0.21. Stock is up 141% over the past year. Announcement • Jun 01
Antisense Therapeutics Limited Announces US FDA Feedback on Type C Meeting for ATL1102 in the US Antisense Therapeutics Limited announced that further to the Type C guidance meeting with the US Food and Drug Administration (FDA) held on 19 April 2021, the Company has received the official minutes of the meeting in relation to further development of ATL1102 in Duchenne muscular dystrophy (DMD) in the US. The feedback confirmed that the findings at 25mg/week in ANP's Phase II, open-label study conducted at Royal Children's Hospital in Melbourne, Australia are adequate to support larger studies. Provided appropriate safety-monitoring recommendations are adopted by ANP, FDA said it could consider the exploration of higher doses of ATL1102 beyond 25mg/week subject to adequate justification. Importantly, the FDA noted that the proposed design of the Phase IIb/III study (as a single, randomized double blind, placebo-controlled study) and the primary endpoint (PUL2.0) appears acceptable. Secondary endpoints of muscle strength as assessed by MyoGrip, MyoPinch, and predicted forced vital capacity (FVC), also appear reasonable as was the 52-week study duration, non-ambulant patient population and number of subjects relative to statistical power assumptions. The FDA has suggested that ANP submit a study protocol with the features outlined above for their review. With regard to the non-clinical requirements, the FDA expects the Company to conduct a nine-month monkey toxicology study to support the Phase IIb/III study. The agency stated, however, that because of the seriousness of the indication, ANP may initiate the 12-month Phase IIb/III human clinical study prior to submission of a nine-month toxicology study, provided that a draft study report is submitted before the duration of dosing in patients exceeds six months. ANP is consulting with its US based regulatory advisors on the appropriate next steps and to fine-tune the Phase IIb/III study design and development plans for the US and will evaluate the cost and feasibility of the nine-month monkey study, which would also support other clinical applications of ATL1102 beyond DMD. The Company also discussed potential expedited regulatory pathways with the FDA during the meeting, which the FDA thought reasonable. The Company continues to maintain its focus on the European Phase IIb study. ANP advises that a response from the European Medicines Agency's Paediatric Committee on its Paediatric Investigation Plan (PIP) is expected in the coming weeks and accordingly intends to provide a market update following its receipt. Announcement • May 26
Antisense Therapeutics Limited Announces Manufacture of ATL1102 clinical supplies for Phase IIb trial Antisense Therapeutics Limited provided the following progress update on the manufacture of clinical supplies for its planned Phase IIb clinical trial of ATL1102 in non-ambulant Duchenne (DMD) patients. The manufacture of ATL1102 active pharmaceutical ingredient (API) for the Phase IIb trial was undertaken in North America by Nitto Denko Avecia (Avecia) a contract manufacturing organization (CMO) with over 27 years of experience in oligonucleotide (antisense) development and production. Avecia has supported the commercial launch of oligonucleotide products since 2004 and offers complete continuity of supply up to multiple kilograms per batch with its large scale and commercial capabilities in support of advanced clinical trials and subsequent commercial supply. Upon completion of the manufacture of this batch of API by Avecia last month, the material was then shipped to Contract, Parenteral (injectable) Drug Product Manufacturer Pyramid Laboratories in Costa Messa, Southern California and formulated into injectable product for use in the Phase IIb trial. This formulated injectable product (Drug Product or DP) is currently undergoing finished product release testing for clinical use, with results anticipated later next month. Announcement • Feb 26
Antisense Therapeutics Limited Announces the Paediatric Investigation Plan for ATL1102 in DMD Submitted to European Medicines Agency Antisense Therapeutics Limited announced that the Paediatric Investigation Plan (PIP) for the development of ATL1102 for Duchenne muscular dystrophy (DMD) has been submitted to the European Medicines Agency (EMA) Paediatric Committee (PDCO). A paediatric investigation plan is a development plan aimed at ensuring that the necessary data are obtained through studies in children, to support the authorisation of a medicine for children. The PIP addresses the entire paediatric development program for ATL1102 in DMD. The ATL1102 DMD PIP submission incorporates the planned Phase IIb clinical trial of ATL1102 in non- ambulant DMD patients to be conducted in Europe. The Company is looking to confirm the Phase IIb trial design through the PIP and initial PDCO feedback ahead of submission of the Phase IIb trial application anticipated in second quarter of 2021. The Company is planning to conduct a multi-centre, randomised, double-blind placebo-controlled study of ATL1102 in non-ambulant patients dosed with ATL1102 for 12 months at two dose levels to be conducted as a potentially pivotal (approvable) trial with a follow-on open label extension phase. Further trial details will be outlined once the Company has received PIP feedback and has submitted its trial application. The Company has commenced the manufacture of ATL1102 active ingredient for the Phase IIb trial and is planning to have this material formulated into injectable product in second quarter of 2021. In parallel with above, the Company is in the process of selecting a suitably experienced Contract Research Organisation (CRO) for the running of the Phase IIb trial. The CRO will be responsible for the provision of clinical trial services such as clinical trial site selection and site set-up, patient recruitment, clinical trial monitoring services, data management, statistics, medical monitoring, pharmacovigilance and quality control processes. Given that clinical trial approval in the EU is under national sovereignty, submissions will be made to the respective national authorities of the European states where the Company expects to conduct the Phase IIb trial (locations to be confirmed following completion of the site feasibility assessments by the CRO). Announcement • Feb 24
Antisense Therapeutics Limited Announces Executive Changes Antisense Therapeutics Limited announced that Ms Alicia Mellors has been appointed as Joint Company Secretary, effective 24 February 2021. Mr. Phillip Hains, Managing Director of The CFO Solution will continue to act as Joint Company Secretary of the Company. Is New 90 Day High Low • Jan 15
New 90-day high: AU$0.21 The company is up 50% from its price of AU$0.14 on 16 October 2020. The Australian market is up 10.0% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Pharmaceuticals industry, which is up 12% over the same period. Announcement • Nov 17
Antisense Therapeutics Limited, Annual General Meeting, Dec 18, 2020 Antisense Therapeutics Limited, Annual General Meeting, Dec 18, 2020, at 10:00 AUS Eastern Standard Time. Agenda: To receive and consider the Annual Financial Report of the Company for the year ended 30 June 2020 (2020 Annual Report), comprising the Financial Report, the Directors Report, and the Auditor's Report; to consider the Non-binding resolution to adopt the 2020 Remuneration Report; to consider the re-election of Director Dr. Graham Mitchell; to consider the Ratification of past issue of Shares; to consider the Ratification of past issue of Shares; to consider the approval of 10% Placement Facility; and to consider others. Announcement • Oct 04
Antisense Therapeutics Limited Announces Statistically Significant Improvement in Pul2.0 with Atl1102 Treatment in Non-Ambulant Boys with DMD Compared to A Matched Natural History Control Antisense Therapeutics Limited reported results presented at the 25th International Annual Congress of the World Muscle Society. PUL2.0 (Performance of Upper Limb Function) mean data from the ATL1102 Phase II trial was compared to a natural history control of matched non-ambulant boys on standard of care (corticosteroids) and showed a statistically significant improvement in Total PUL2.0 with a greater frequency of patients achieving an improvement or maintenance of their Total PUL2.0 scores relative to the matched natural history control group over 24 weeks. ATL1102 was recently assessed in an open label Phase II study in adolescent non-ambulant patients with DMD. In the Phase II study, nine patients, 12 to 18 years old [mean 14.9 (SD 2.1) years] were dosed with ATL1102 for 24 weeks (8 of 9 on corticosteroids) and assessed using PUL2.0. In a post study analysis, the mean PUL2.0 data from the ATL1102 treated patients was then compared with the 24-week PUL2.0 data of 39 assessments in 20 non-ambulant patients [mean age 15.61 (SD 2.02) years; 19 on corticosteroid] from a natural history database of DMD patients in Rome, Italy - the Rome cohort (RC). The RC were identified using the same inclusion criteria used to enrol patients in the ATL1102 Phase II study. Announcement • Sep 26
An unknown buyer acquired a 49% stake in Antisense Therapeutics Limited (ASX:ANP) from Opthea Limited (ASX:OPT) for AUD 0.34 million. An unknown buyer acquired a 49% stake in Antisense Therapeutics Limited (ASX:ANP) from Opthea Limited (ASX:OPT) for AUD 0.34 million during the year ended June 30, 2019.
An unknown buyer completed the acquisition of a 49% stake in Antisense Therapeutics Limited (ASX:ANP) from Opthea Limited (ASX:OPT) during the year ended June 30, 2019. Announcement • Sep 07
Antisense Therapeutics Limited Auditor Raises 'Going Concern' Doubt Antisense Therapeutics Limited filed its Annual on Aug 26, 2020 for the period ending Jun 30, 2020. In this report its auditor, Ernst & Young LLP, gave an unqualified opinion expressing doubt that the company can continue as a going concern. 