Ankündigung • Jan 13
AdAlta Limited has completed a Follow-on Equity Offering in the amount of AUD 1.2 million. AdAlta Limited has completed a Follow-on Equity Offering in the amount of AUD 1.2 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 240,000,000
Price\Range: AUD 0.005
Discount Per Security: AUD 0.0003
Security Features: Attached Options
Transaction Features: Subsequent Direct Listing Ankündigung • Oct 20
AdAlta Limited has completed a Follow-on Equity Offering in the amount of AUD 1.1 million. AdAlta Limited has completed a Follow-on Equity Offering in the amount of AUD 1.1 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 366,666,667
Price\Range: AUD 0.003
Discount Per Security: AUD 0.00018
Security Features: Attached Options
Transaction Features: Subsequent Direct Listing Ankündigung • Sep 24
AdAlta Limited, Annual General Meeting, Nov 19, 2025 AdAlta Limited, Annual General Meeting, Nov 19, 2025. Location: piper alderman, level 23, 459 collins street, melbourne vic 3000, and, Australia New Risk • Aug 28
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$2.9m 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$2.9m free cash flow). Share price has been highly volatile over the past 3 months (28% average weekly change). Negative equity (-AU$598k). Shareholders have been substantially diluted in the past year (94% increase in shares outstanding). Revenue is less than US$1m (AU$696k revenue, or US$453k). Market cap is less than US$10m (AU$4.62m market cap, or US$3.01m). Ankündigung • Jun 30
Adalta Limited Announces Resignation of Iain Ross as Non-Executive Director, Effective Date Is June 30, 2025 AdAlta Limited announced that non-executive director, Iain Ross, has tendered his resignation effective from 30 June 2025 due to the potential for conflicts of interest to emerge between AdAlta and another company he serves. Ankündigung • May 01
AdAlta Limited has filed a Follow-on Equity Offering in the amount of AUD 1.286446 million. AdAlta Limited has filed a Follow-on Equity Offering in the amount of AUD 1.286446 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 317,148,667
Price\Range: AUD 0.003
Discount Per Security: AUD 0.00003
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 100,000,000
Price\Range: AUD 0.003
Discount Per Security: AUD 0.00018
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 11,666,667
Price\Range: AUD 0.003
Discount Per Security: AUD 0.00003
Transaction Features: Rights Offering New Risk • Apr 08
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of Australian stocks, typically moving 16% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. 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$3.9m free cash flow). Share price has been highly volatile over the past 3 months (16% average weekly change). Revenue is less than US$1m (AU$973k revenue, or US$588k). Market cap is less than US$10m (AU$4.50m market cap, or US$2.72m). Minor Risk Shareholders have been diluted in the past year (22% increase in shares outstanding). New Risk • Feb 21
New major risk - Revenue size The company makes less than US$1m in revenue. Total revenue: AU$973k (US$623k) 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$3.9m free cash flow). Revenue is less than US$1m (AU$973k revenue, or US$623k). Market cap is less than US$10m (AU$9.47m market cap, or US$6.07m). Minor Risks Share price has been volatile over the past 3 months (12% average weekly change). Shareholders have been diluted in the past year (20% increase in shares outstanding). New Risk • Feb 11
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of Australian stocks, typically moving 12% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. 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$5.3m free cash flow). Market cap is less than US$10m (AU$9.47m market cap, or US$5.95m). Minor Risks Share price has been volatile over the past 3 months (12% average weekly change). Shareholders have been diluted in the past year (20% increase in shares outstanding). Revenue is less than US$5m (AU$1.7m revenue, or US$1.1m). Ankündigung • Oct 23
AdAlta Limited Appoints Kevin Lynch as Consultant Chief Medical Officer of AdCella AdAlta Limited announced a significant addition to its AdCella leadership team. Kevin Lynch MB BS has been appointed as Consultant Chief Medical Officer. In this role he will help support the selection of in-licensed cellular immunotherapies and the design and execution of Phase I clinical trials by AdCella. Consultant CMO-AdCella, Kevin Lynch MB BS, based in Australia with leading industry and China haematology/oncology experience. Dr. Lynch has taken on the role of Consultant CMO-AdCella, as this AdAlta subsidiary continues to execute its East to West cellular immunotherapy strategy. Dr. Lynch is a highly experienced industry physician. His 30 years' experience span all stages of clinical development, regulatory and reimbursement approvals and post-registration medical activities. He has contributed to multiple transformational therapies in haematology/oncology at both early- to late-stage therapies, including imatinib, nilotinib, lenalidomide and pomalidomide. He has led high level regulatory interactions in Australia (including for cell therapies), China, South Korea, Singapore, Europe, and other markets. Importantly, he has also provided senior input into multiple interactions with the US Food & Drug Administration (FDA). Dr. Lynch is Co-Founder of PopulusBio srl. His previous leadership roles include CMO at Antengene and senior medical and clinical roles at Celgene and Novartis. Ankündigung • Oct 18
AdAlta Limited, Annual General Meeting, Nov 20, 2024 AdAlta Limited, Annual General Meeting, Nov 20, 2024. Location: at piper alderman, level 23, 459 collins stree, melbourne, 3000, Australia New Risk • Jun 04
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 62% 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 Risk Shareholders have been substantially diluted in the past year (62% increase in shares outstanding). Minor Risks Share price has been volatile over the past 3 months (15% average weekly change). Revenue is less than US$5m (AU$3.5m revenue, or US$2.3m). Market cap is less than US$100m (AU$16.1m market cap, or US$10.7m). New Risk • Feb 28
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$6.2m 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$6.2m free cash flow). Shareholders have been substantially diluted in the past year (67% increase in shares outstanding). Market cap is less than US$10m (AU$9.99m market cap, or US$6.54m). Minor Risk Revenue is less than US$5m (AU$3.5m revenue, or US$2.3m). Ankündigung • Dec 20
AdAlta Limited has completed a Follow-on Equity Offering in the amount of AUD 1.66 million. AdAlta Limited has completed a Follow-on Equity Offering in the amount of AUD 1.66 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 60,000,000
Price\Range: AUD 0.02
Discount Per Security: AUD 0
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 23,000,000
Price\Range: AUD 0.02
Discount Per Security: AUD 0.0012
Transaction Features: Subsequent Direct Listing Ankündigung • Dec 19
AdAlta Limited has completed a Follow-on Equity Offering in the amount of AUD 0.46 million. AdAlta Limited has completed a Follow-on Equity Offering in the amount of AUD 0.46 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 23,000,000
Price\Range: AUD 0.02
Discount Per Security: AUD 0.0012
Transaction Features: Subsequent Direct Listing New Risk • Nov 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$5.1m 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$5.1m free cash flow). Earnings have declined by 0.5% per year over the past 5 years. Market cap is less than US$10m (AU$8.41m market cap, or US$5.49m). Minor Risks Share price has been volatile over the past 3 months (15% average weekly change). Shareholders have been diluted in the past year (41% increase in shares outstanding). Revenue is less than US$5m (AU$3.5m revenue, or US$2.3m). Ankündigung • Nov 03
AdAlta Limited has filed a Follow-on Equity Offering in the amount of AUD 1.23 million. AdAlta Limited has filed a Follow-on Equity Offering in the amount of AUD 1.23 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 61,500,000
Price\Range: AUD 0.02
Discount Per Security: AUD 0
Transaction Features: Subsequent Direct Listing Ankündigung • Sep 22
AdAlta Limited, Annual General Meeting, Nov 22, 2023 AdAlta Limited, Annual General Meeting, Nov 22, 2023, at 11:01 AUS Eastern Standard Time. Location: Piper Alderman, Level 23, 459 Collins Street Melbourne Victoria Australia Agenda: To provide business update to Shareholders. New Risk • Aug 26
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$5.1m 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$5.1m free cash flow). Earnings have declined by 0.5% per year over the past 5 years. Market cap is less than US$10m (AU$10.2m market cap, or US$6.51m). Minor Risks Shareholders have been diluted in the past year (41% increase in shares outstanding). Revenue is less than US$5m (AU$3.5m revenue, or US$2.3m). Ankündigung • Jul 13
AdAlta Limited has completed a Follow-on Equity Offering in the amount of AUD 3.153759 million. AdAlta Limited has completed a Follow-on Equity Offering in the amount of AUD 3.153759 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 51,303,619
Price\Range: AUD 0.025
Discount Per Security: AUD 0.0015
Security Features: Attached Options
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 74,846,752
Price\Range: AUD 0.025
Discount Per Security: AUD 0.0015
Security Features: Attached Options
Transaction Features: Rights Offering Reported Earnings • Mar 03
First half 2023 earnings released: AU$0.009 loss per share (vs AU$0.015 loss in 1H 2022) First half 2023 results: AU$0.009 loss per share (improved from AU$0.015 loss in 1H 2022). Revenue: AU$1.11m (up 53% from 1H 2022). Net loss: AU$2.82m (loss narrowed 23% from 1H 2022). Over the last 3 years on average, earnings per share has increased by 38% per year but the company’s share price has fallen by 23% per year, which means it is significantly lagging earnings. Board Change • Nov 16
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. 4 non-independent directors. Independent Non-Executive Director Bob Peach was the last independent director to join the board, commencing their role in 2016. The company's minority of independent directors is a risk according to the Simply Wall St Risk Model. Ankündigung • Nov 03
AdAlta Limited Provides an Update on Its Lead Program, AD-214 AdAlta Limited provided an update on its lead program, AD-214, a first in class antifibrotic. AdAlta has made substantial progress expanding the potential disease areas (indications) and routes of delivery for AD-214. Considering available manufacturing and toxicology study slots and return on investment, AdAlta is now progressing four strategic priorities for AD-214. Prioritise clinical development of AD-214 for lung, kidney and eye fibrosis. Pre-clinical data and partnering discussions over the next six months to guide final choice of indication for next clinical trial. Progress injectable (intravenous/IV for lung, kidney fibrosis and intravitreal/IVT for eye fibrosis) routes of administration. Continue investment in manufacturing and formulation improvement strategies. Leverage progress in the development of an inhaled format of AD-214 for partnering for lung fibrosis. Several disease area opportunities - all with unmet need: To prioritise indications and routes of administration, AdAlta considered the unmet needs in each disease area and the competitive landscape. Also considered was the data, available or pending, supporting use of AD-214 in each indication, and the time and cost to progress each indication and route of administration to clinical proof of concept. AdAlta has compelling pre-clinical data using the IV version of AD-214 in lung and kidney fibrosis. Like lung fibrosis, kidney fibrosis is an area of high unmet need with a less competitive landscape. Progress to Phase II proof of concept studies using the IV version is underpinned by previously completed Phase I studies and encouraging progress made identifying opportunities to increase manufacturing yields and reduce liver clearance. Intravitreal (IVT) AD-214 could address an attractive, very underserved market in eye fibrosis with significant early stage partnering interest and a more favourable competitive landscape. Previous encouraging pre-clinical studies using the earlier version of the product, AD-114, are being replicated and extended using AD-214, with results due in the next six months. IVT AD-214 (intravitreal) could be progressed separately to IV AD-214 (intravenous) through engagement with partners, or by AdAlta directly. It has the potential to achieve clinical proof of concept via Phase I studies. Recent collaboration with GPCR Therapeutics for oncology Oncology is now the largest therapeutic market globally. The application of CXCR4 antagonists such as AD-214 to treat cancer is attracting significant interest. The recently announced collaboration with GPCR Therapeutics Inc. represents a cost-effective way for AdAlta to progress an oncology pipeline. Inhaled AD-214 - valuable data package for potential partners: AdAlta has now demonstrated the delivery of AD-214 via inhalation and the potential to reduce collagen deposition in cultured lung tissue. The additional time and cost to complete preclinical development and safety studies for IPF, coupled with the competitive clinical trial landscape has led the Company to focus resources on injectable formats and make the inhalation program available to lung fibrosis partners to progress. Next steps: AD-214 milestones in the next six months now include: Commencement of manufacturing of AD-214 for extended-dose toxicology studies; Additional pre-clinical results in eye and kidney fibrosis; Further details on clinical program indication and design; Continuation of partnering outreach for IV AD-214 in lung and kidney fibrosis. Ankündigung • Sep 29
AdAlta Limited, Annual General Meeting, Nov 22, 2022 AdAlta Limited, Annual General Meeting, Nov 22, 2022, at 11:01 AUS Eastern Standard Time. Location: K&L Gates, Level 25, Rialto South Tower Melbourne Victoria Australia Reported Earnings • Aug 30
Full year 2022 earnings released: AU$0.022 loss per share (vs AU$0.024 loss in FY 2021) Full year 2022 results: AU$0.022 loss per share. Revenue: AU$2.76m (down 31% from FY 2021). Net loss: AU$6.06m (loss widened 7.7% from FY 2021). Ankündigung • Jul 04
AdAlta Limited Modifies the Sequencing of AD-214 Manufacturing Campaigns and Toxicology Studies AdAlta Limited has modified the sequencing of AD-214 manufacturing campaigns and toxicology studies to better align these key programs with the emerging priorities of potential partners, and the results of pre-clinical studies due in the September quarter 2022. The Company has been able to secure a six-month deferral of pre-booked manufacturing campaigns and toxicology studies, which also ensures that AdAlta can delay financial commitments to these studies, extending its existing cash runway. The optimal volume of AD-214 to be manufactured for future toxicology and clinical studies, the final formulation step in manufacturing, and the optimal design of toxicology studies vary according to the indication to be studied in future clinical trials. The different disease area and geographic interests of different potential partners and the data that will become available through the September quarter 2022 will help shape AdAlta's formulation and partnering strategy. To ensure that its manufacturing campaigns and toxicology studies are designed to maximise the development options for, and hence value of, AD-214, the Company has negotiated a 6-month deferral of AD-214 production and toxicology campaigns to maximise decision- making flexibility and ensure that these significant cash commitments are made with the benefit of the maximum amount of pre-clinical data and confirmed partner indication priorities. Clinical timelines are expected be delayed by a lesser amount. AdAlta will now not need to commit cash to the next round of manufacturing and toxicology costs until the end of 2022. The changes to the program as outlined above have accordingly extended the company's cash runway. Price Target Changed • Apr 27
Price target increased to AU$0.27 Up from AU$0.18, the current price target is provided by 1 analyst. New target price is 297% above last closing price of AU$0.068. Stock is down 55% over the past year. The company posted a net loss per share of AU$0.024 last year. Board Change • Apr 27
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. 4 non-independent directors. Independent Non-Executive Director Bob Peach was the last independent director to join the board, commencing their role in 2016. The company's minority of independent directors is a risk according to the Simply Wall St Risk Model. Ankündigung • Apr 06
Adalta Limited Finalizes Reclinical Development Program to Develop Inhaled Version of AD-214 AdAlta Limited has finalised the preclinical development program to develop an inhaled version of AD-214, its lead asset. AD-214 is being developed as a first in class therapeutic for fibrotic diseases including Idiopathic Pulmonary Fibrosis (IPF) and other Interstitial Lung Diseases (ILDs). In July 2021, AdAlta announced the successful completion of a Phase I clinical trial assessing the safety and tolerability of AD-214 in healthy volunteers, the securing of production slots to deliver the next batch of clinical grade AD-214 in mid-2023 and that it would use the intervening period to develop a more patient convenient, lower cost inhaled formulation of AD-214. AdAlta has now finished mapping out the preclinical development plan for the inhaled formulation of AD-214. The development plan addresses three questions: 1. Delivery: can nebulised AD-214 reach the lower airways of the lungs intact? 2. Distribution and retention: can AD-214, once in the lower airways of the lungs, reach and be retained in fibrotic tissue? 3. Efficacy: can AD-214 moderate fibrotic disease progression when delivered directly to fibrotic lung tissue? The ongoing and planned experiments to address these questions are anticipated to produce a steady flow of data between now and completion in the September quarter. Delivery, distribution and retention will be studied using PET imaging and pathology studies in both animal and in vitro cultured tissue models. In vivo efficacy studies include the gold standard bleomycin mouse model of IPF. Data from this study has been delayed due to technical difficulties establishing a fibrosis baseline in the first attempt. This is not an uncommon issue for studies of this kind. This study will be repeated without affecting overall timelines. In vivo efficacy studies will be supported by in vitro studies in human lung airway cells and in cultured human lung tissue. They will be further complemented by results from studies of AD-214 in animal models of other fibrotic diseases (kidney and eye). Work to optimise a formulation of AD-214 for nebulisation and inhalation is expected to be completed in parallel with the preclinical studies, enabling large animal toxicology studies to be initiated in the March quarter of 2023. Assuming success, these will in turn enable the next clinical studies to commence in the second half of 2023 as previously announced. Next clinical studies are anticipated to comprise an initial healthy volunteer bridging safety study which will be combined with IPF patient imaging studies using the already developed radiolabelled (for PET imaging) version of AD-214 ahead of efficacy studies in IPF patients. In delivering this program, AdAlta is leveraging significant global expertise in inhaled drug delivery: Arrangements are being finalised to conduct imaging studies of AD-214 distribution and retention with Allergenix Pty Ltd. (Australia), a preclinical contract research organisation (CRO) specialising in sheep models of pulmonary drug delivery and pulmonary disease including asthma, COPD and fibrosis. Sheep lungs are structurally very similar to human lungs; Dr. Louise Organ, who developed the sheep IPF model and has extensive experience using cultured human lung tissue to model the activity of anti-fibrotic agents, has recently joined the AdAlta team and will lead these studies; Prof Antje Prasse, a world recognised IPF researcher at the Fraunhofer Institute (Germany), has previously shown that AD-114, the i-body incorporated into AD-214, can inhibit the growth of spheroids from cells collected from the lining of the airways in IPF patients, and is now repeating these studies using AD-214; Contracts are being finalised with a new contract research organisation to overcome the technical difficulties associated with establishing fibrosis in the bleomycin mouse model of IPF to further explore distribution, retention and anti-fibrotic effect of AD-214 directly delivered to the lungs; Specialist inhalation contract manufacturing firm, Vectura Ltd. (UK), has been contracted to optimise a formulation of AD-214 for nebulisation and inhalation; ITR Laboratories Canada Inc. (Canada) has been contracted for inhaled toxicology studies. Reported Earnings • Feb 28
First half 2022 earnings: Revenues exceed analysts expectations while EPS lags behind First half 2022 results: AU$0.015 loss per share (up from AU$0.021 loss in 1H 2021). Revenue: AU$727.3k (down 9.8% from 1H 2021). Net loss: AU$3.66m (loss narrowed 19% from 1H 2021). Revenue exceeded analyst estimates by 23%. Earnings per share (EPS) missed analyst estimates by 2.0%. Over the last 3 years on average, earnings per share has increased by 31% per year but the company’s share price has fallen by 32% per year, which means it is significantly lagging earnings. Ankündigung • Feb 05
AdAlta Limited has completed a Follow-on Equity Offering in the amount of AUD 1.253406 million. AdAlta Limited has completed a Follow-on Equity Offering in the amount of AUD 1.253406 million.
Security Name: Ordianry Share
Security Type: Common Stock
Securities Offered: 17,169,940
Price\Range: AUD 0.073
Discount Per Security: AUD 0.00438
Transaction Features: Rights Offering Reported Earnings • Aug 29
Full year 2021 earnings released: AU$0.024 loss per share (vs AU$0.037 loss in FY 2020) The company reported a solid full year result with reduced losses, improved revenues and improved control over expenses. Full year 2021 results: Revenue: AU$3.99m (up 4.2% from FY 2020). Net loss: AU$5.63m (loss narrowed 6.3% from FY 2020). Over the last 3 years on average, earnings per share has increased by 16% per year but the company’s share price has fallen by 33% per year, which means it is significantly lagging earnings. Reported Earnings • Mar 03
First half 2021 earnings released: AU$0.021 loss per share (vs AU$0.037 loss in 1H 2020) The company reported a solid first half result with reduced losses, improved revenues and improved control over expenses. First half 2021 results: Revenue: AU$806.5k (up 100% from 1H 2020). Net loss: AU$4.51m (loss narrowed 25% from 1H 2020). Over the last 3 years on average, earnings per share has increased by 4% per year but the company’s share price has fallen by 24% per year, which means it is significantly lagging earnings. Ankündigung • Feb 24
AdAlta Receives Orphan Drug Designation from the US Food and Drug Administration for Its Lead Product Candidate AD-214 for the Treatment of Idiopathic Pulmonary Fibrosis AdAlta Limited has received Orphan Drug Designation (ODD) from the US Food and Drug Administration (FDA) for its lead product candidate AD-214 for the treatment of Idiopathic Pulmonary Fibrosis (IPF). The Food and Drug Administration (FDA) created the Orphan Drug Act to encourage and provide special incentives to biopharmaceutical companies that undertake the development of promising potential treatments for rare or `orphan' diseases that affect fewer than 200,000 people in the United States. ODD entitles AD-214 to certain benefits during development for IPF including eligibility for seven years market exclusivity post approval, tax credits of 50% of qualified clinical drug testing costs awarded upon approval, additional protocol assistance, reduced review times and waiver of certain marketing authorisation application fees. In addition to bringing novel therapies to sufferers of rare diseases more rapidly, these benefits add additional economic value to AD-214 for AdAlta and its eventual commercialisation partners. The grant of ODD for AD-214 follows the previous grant of ODD for AD-114, the predecessor molecule to AD-214. Ankündigung • Dec 15
AdAlta Limited Announces Phase I HV Extension to Explore Encouraging Results AdAlta Limited, a clinical stage biopharmaceutical discovery and development company using i-body technology to address challenging drug targets will extend the healthy volunteer Part A of its Phase I clinical study of AD-214 to explore encouraging results from cohorts studied to date. AdAlta has now treated 34 healthy volunteers with lead product candidate AD-214 or placebo at doses ranging from 0.01 mg.kg to 10 mg/kg. The Safety Management Committee has found no adverse safety events of clinical concern and has now approved dose escalation to 20 mg/kg, the maximum planned dose in Part A of the Phase I clinical study. A key secondary endpoint of the Phase I study is the extent and duration of receptor occupancy, the percentage of target receptors on certain circulating white blood cells that are occupied by AD-214. High levels of receptor occupancy are generally required for therapeutic effect of any drug and the time over which receptor occupancy remains high is a key indicator of likely therapeutic dosing intervals (with longer intervals generally more convenient and lower cost). Throughout Part A of the Phase I study, AdAlta has observed a dose dependent increase in both the duration of white blood cell receptor saturation (100% receptor occupancy) and the time receptor occupancy remains above 50%. Blinded data from the most recent cohorts at 5 and 10 mg/kg shows that receptors remained saturated for three days after infusion of AD-214 and remained at 55% ± 14% and 86% ± 11% at seven days after infusion respectively. Ankündigung • Sep 23
AdAlta Limited Announces the Extension of its Collaboration with GE Healthcare AdAlta Limited announced the extension of its collaboration with global life sciences company GE Healthcare. AdAlta and GE Healthcare have confirmed that their collaboration to discover i-body candidates as diagnostic imaging agents for granzyme B will proceed to Stage 4 of a multistage collaboration. AdAlta has to date earned an initial milestone payment and research fees for the first three stages of the collaboration. These stages have yielded a panel of i-bodies with affinity, specificity and activity properties against granzyme B that warrant further development. GE Healthcare is a leading global medical technology and pharmaceutical company, providing a broad portfolio of products, solutions and services used in the diagnosis, treatment and monitoring of patients. Granzyme B is a key biomarker of response to cancer immunotherapy. GE Healthcare has exercised an option under the collaboration agreement to progress to Stage 4 during which the panel of i-bodies selected in Stage 3 and those closely related to them will be further characterised, prior to GE Healthcare progressing a lead i-body into pre-clinical development. The research fees for Stage 4 will be paid in instalments over the six months commencing in November 2020. Ankündigung • Sep 08
AdAlta Limited has completed a Follow-on Equity Offering in the amount of AUD 4 million. AdAlta Limited has completed a Follow-on Equity Offering in the amount of AUD 4 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 40,000,000
Price\Range: AUD 0.1
Discount Per Security: AUD 0.006
Transaction Features: Subsequent Direct Listing Ankündigung • Sep 07
AdAlta Limited has completed a Follow-on Equity Offering in the amount of AUD 4.09864 million. AdAlta Limited has completed a Follow-on Equity Offering in the amount of AUD 4.09864 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 40,986,403
Price\Range: AUD 0.1
Discount Per Security: AUD 0.003
Transaction Features: Regulation S; Rights Offering 