Cliantha Research Ltd.

STOCKHOLM, Sweden, 20 November 2024 – Lipidor AB (publ) (Nasdaq First North Growth Market: LIPI) today provides an update on the business from CEO Ola Holmlund, also announcing a company presentation to take place during Aktiespararna’s National Event in Stockholm next week. Statement from the CEO Due to the fact that Lipidor has switched to half-year reporting and the interim report for the third quarter has thus been discontinued, I would still like to provide the market with an update on the status of the company. Phase 3 Study Lipidor’s focus is on commercializing the drug candidate AKP02G2 and, with the implementation of a clinical Phase III study, the company is at a crucial stage of development. The main aim of the study is to compare the therapeutic effect of AKP02G2 against mild to moderate psoriasis with a market-leading product. The clinical study includes 294 patients and is being conducted in India by Cliantha Research, a reputable CRO (Clinical Research Organisation) with extensive experience in dermatological research. Development during the quarter and current status In August, it was announced that clinical trial material had been released according to plan, and in September we were able to confirm that the first patient had been included in the study. It is gratifying to see that over 90% of those screened for the study also meet the criteria for inclusion. After the first clinic started recruiting in September, several have gradually been added and there are now 11 clinics out of 15 that have started their recruitment. We would have liked to have seen a slightly faster recruitment rate, but Cliantha has prepared a detailed forecast for future recruitment, a forecast that shows continued confidence in a study result by the end of Q1 2025. Otherwise, work on the start-up has largely proceeded to plan. A potential challenge was identified around the possibility of including enough patients with lighter skin in the study, and this has since been addressed through an adjustment in the clinic selection. The winter season, which starts now, is the time when it is easiest to recruit patients because psoriasis increases significantly during this period. The next important milestone is to reach 50% of recruited patients. The third quarter started with the completion of the rights issue, through a directed share issue to the guarantors who have chosen to receive guarantee compensation in the form of shares in the company. It is the outcome of the financing process, together with the co-investment agreement with Cerbios Pharma, that has created the conditions for the work that is now being conducted. Lipidor's team continues to do its utmost to create substantial value from the efforts. The budget allocated for the implementation of the study is intact, and the implementation of the study is thus financed. We are convinced that the additional benefits for patients that AKP02G2 can be expected to provide will also mean sharp competitive advantages. Among other things, the new formulation, AKP02G2, dries even faster than its predecessor AKP02, and is therefore considered to make it even easier for patients. A PCT application that strengthens the protection of the updated formulation, AKP02G2, was submitted according to plan in October. Prospects In parallel with the study's implementation, we’re working with planning and activities linked to the next development steps, where the next focus will be the submission of a registration file. Even if Lipidor is not listed as the sender of this, it is up to us to ensure that documentation and activities on our part comply with regulations. Thus, next year will also involve focused work on AKP02G2 and associated key processes. According to the current business plan, capital injection from the warrant program TO2 and revenues, in the form of a milestone payment for approved study results, are included in the forecast for 2025. Together with RELIFE (pharmaceutical company), Aurena (manufacturing) and Cerbios (API) as strong business partners, there is an alliance that can take the company from development into the billion-dollar market for combination drugs for psoriasis. I hope that the update has given you as a reader a good picture of the company's status, operations and opportunities going forward. With confidence, Ola Holmlund CEO Company Presentation The CEO will present Lipidor at Aktiespararnas National Event in Stockholm, on 27th November at 10.30am. You are welcome to take part in person or digitally. Publication The information was provided for publication by Lipidor’s CEO on 20th November 2024 at 8.00am (CET). For more information, please contact: Ola Holmlund, CEO, Lipidor AB (publ) Telephone: +46 (0) 72 50 70 369 Email: ola.holmlund@lipidor.se The company’s Certified Adviser is Carnegie Investment Bank AB (publ). About Lipidor AB Lipidor AB (www.lipidor.se) is a pharmaceutical development company with a pipeline of pharmaceutical development projects in preclinical and clinical phases. The company can develop topical medical products for the treatment of diseases such as psoriasis, acne vulgaris, bacterial skin infections and atopic dermatitis by reformulation of proven pharmaceutical substances. Lipidor’s priority project is AKP02G2, which focusses on psoriasis. About AKVANO® AKVANO® is an innovative water-free and sprayable technology for formulating medicines and is particularly suitable for local application on, for example, the skin. AKVANO® is made up of carefully selected lipids which, together with a volatile solvent, form the carrier of selected active substances. By combining different lipids, AKVANO® can be optimized to achieve the desired function of active components in the formulation. When applied to the skin, the solvent evaporates and a thin lipid layer is formed on the skin surface for effective release of the active substance. Attachments Lipidor publishes CEO statement for the quarter: "Study results expected by the end of Q1 2025"

PK Study Successfully Demonstrates that Fingerprint Sweat Provides Reliable Sample for Drug Detection FDA 510(k) Clearance Would Enable the Introduction of INBS’ Technology to the US in 2025 NEW YORK, Nov. 13, 2024 (GLOBE NEWSWIRE) -- Intelligent Bio Solutions Inc. (Nasdaq: INBS) ("INBS" or the "Company"), a medical technology company delivering intelligent, rapid, non-invasive testing solutions, today announced strong initial results from its Pharmacokinetic (PK) study required for an FDA 510(k) submission. The data from the PK study shows that fingerprint sweat mimics the rate and extent of codeine in blood and saliva. The study successfully demonstrated that fingerprint sweat provides a reliable sample matrix for drug detection, showing quantitative PK data closely aligned to blood, based on statistical comparisons made at the 95% confidence level. "The close correlation of PK parameters in fingerprint sweat and blood highlights its robustness as a sampling approach. While independent data has consistently supported this, our clinical study further reinforces these findings,” said Harry Simeonidis, President and CEO of Intelligent Bio Solutions. “We are very pleased with the PK study results. This data highlights the potential for our technology to achieve widespread adoption in safety-critical industries and beyond, marking a significant achievement as we advance toward FDA clearance in the United States." FDA 510(k) clearance would enable INBS to introduce its innovative drug screening technology to the US market in 2025. The PK study results and other clinical data from the Company's clinical study plan will be submitted as part of the Company's 510(k) submission, expected in the fourth calendar quarter of this year. INBS is well-positioned to meet the increasing demand for drug testing in the United States, particularly in safety-critical industries like construction, mining, and transportation, as well as in law enforcement, drug rehabilitation, and forensic sectors. Results: Average Codeine Values in Whole Blood, Oral Fluid and Fingerprint Sweat1 The study results show that fingerprint sweat is a strong indicator of codeine ingestion. They further validate the ability of INBS' method to provide rapid and reliable drug screening through a simple fingerprint sweat sample without invasive procedures. The PK study, conducted in partnership with Cliantha Research, required a minimum of 36 subjects. The Company successfully recruited 39 healthy adult subjects from diverse backgrounds, including varying genders, ages, and ethnicities. The study compared the levels of opiates detected in fingerprint sweat with those found in blood, oral fluid, and urine samples following the medically supervised administration of codeine. All fingerprint sweat specimens collected using INBS' Intelligent Fingerprinting Drug Screening System, were analyzed by a validated, traceable liquid chromatography/tandem mass spectrometry (LC-MS/MS) method, widely accepted as the gold standard for such studies. About Intelligent Bio Solutions Intelligent Bio Solutions Inc. (NASDAQ: INBS) is a medical technology company delivering innovative, rapid, non-invasive testing solutions. The Company believes that its Intelligent Fingerprinting Drug Screening System will revolutionize portable testing through fingerprint sweat analysis, which has the potential for broader applications in additional fields. Designed as a hygienic and cost-effective system, the test screens for the recent use of drugs commonly found in the workplace, including opiates, cocaine, methamphetamine, and cannabis. With sample collection in seconds and results in under ten minutes, this technology would be a valuable tool for employers in safety-critical industries. The Company’s current customer segments outside the US include construction, manufacturing and engineering, transport and logistics firms, drug treatment organizations, and coroners. For more information, visit: http://www.ibs.inc/ Forward-Looking Statements Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, Intelligent Bio Solutions Inc.'s ability to successfully develop and commercialize its drug and diagnostic tests, realize commercial benefit from its partnerships and collaborations, and secure regulatory approvals, among others. Although Intelligent Bio Solutions Inc. believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. Intelligent Bio Solutions Inc. has attempted to identify forward-looking statements by terminology, including "believes," "estimates," "anticipates," "expects," "plans," "projects," "intends," "potential," "may," "could," "might," "will," "should," "approximately" or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, included in Intelligent Bio Solutions' public filings filed with the Securities and Exchange Commission. Any forward-looking statements contained in this release speak only as of its date. Intelligent Bio Solutions undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events. Company Contact: Intelligent Bio Solutions Inc.info@ibs.incLinkedIn | Twitter Investor & Media Contact: Valter Pinto, Managing DirectorKCSA Strategic CommunicationsPH: (212) 896-1254INBS@kcsa.com 1 Urine results are not included in this chart. Due to the nature of urine sample collection, which depends on an individual's need to urinate, samples cannot be collected at fixed intervals. Therefore, urine specimens were collected on an ad-lib basis as frequently as possible. A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/6806ebb4-b738-4c65-b0a0-e6a4c1dc9626

NEW YORK, Sept. 27, 2024 (GLOBE NEWSWIRE) -- Intelligent Bio Solutions Inc. (Nasdaq: INBS) (“INBS” or the “Company”), a medical technology company delivering intelligent, rapid, non-invasive testing solutions, today announced the successful completion of in-clinic testing proposed to the FDA earlier this year in the Company’s clinical study plan. The clinical studies are a key element of the Company's 510(k) submission, designed to demonstrate the accuracy and reliability of its sweat-based testing method. The studies included a pharmacokinetic (PK) study, which aimed to demonstrate that the measurement of drugs in fingerprint sweat delivers results comparable or superior to other specimen matrices, such as blood, saliva and urine. In addition to the PK study, a method comparison and usability study was conducted to validate the accuracy of the Company's fingerprint sweat drug screening method in the hands of intended users. The clinical phase of the PK study concluded in June 2024, with all laboratory analyses completed and data currently under review. The method comparison and usability studies, carried out across three sites, involved 135 subjects who were randomly dosed with codeine and then tested using the Company's drug screening system. The accuracy of the screening system results will be assessed relative to a traceable, laboratory-based reference method. “Executing these clinical studies required diligence and collaboration across multiple functions within Intelligent Bio Solutions and our CRO partners, CenExel and Cliantha,” said Daniel Brown, Head of Clinical Affairs at INBS. “Completion of these in-clinic studies marks a significant achievement for our team and brings us closer to our goal of obtaining FDA 510(k) Notification clearance,” said Harry Simeonidis, President and CEO at INBS. “The early feedback on results from these studies demonstrates the potential of our fingerprint-based testing method to provide a non-invasive, reliable alternative to traditional drug testing methods and address the needs of diverse sectors, including workplaces and government agencies.” With the in-clinic testing phase now complete, INBS is preparing for the next steps in its FDA submission process. Achieving FDA clearance will enable the Company to market its product as a clinically validated tool, paving the way for adoption in the US and potentially transforming the landscape of drug screening. The Company expects clinical data analysis to be completed in the fourth calendar quarter of 2024 and to submit the 510(k) package during the same quarter. About Intelligent Bio Solutions Inc. Intelligent Bio Solutions Inc. (NASDAQ: INBS) is a medical technology company delivering innovative, rapid, non-invasive testing solutions. The Company believes that its Intelligent Fingerprinting Drug Screening System will revolutionize portable testing through fingerprint sweat analysis, which has the potential for broader applications in additional fields. Designed as a hygienic and cost-effective system, the test screens for the recent use of drugs commonly found in the workplace, including opiates, cocaine, methamphetamine, and cannabis. With sample collection in seconds and results in under ten minutes, this technology would be a valuable tool for employers in safety-critical industries. The Company’s current customer segments outside the US include construction, manufacturing and engineering, transport and logistics firms, drug treatment organizations, and coroners. For more information, visit: http://www.ibs.inc/ Forward-Looking Statements: Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, Intelligent Bio Solutions Inc.’s ability to successfully develop and commercialize its drug and diagnostic tests, realize commercial benefit from its partnerships and collaborations, and secure regulatory approvals, among others. Although Intelligent Bio Solutions Inc. believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. Intelligent Bio Solutions Inc. has attempted to identify forward-looking statements by terminology, including “believes,” “estimates,” “anticipates,” “expects,” “plans,” “projects,” “intends,” “potential,” “may,” “could,” “might,” “will,” “should,” “approximately” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, included in Intelligent Bio Solutions’ public filings filed with the Securities and Exchange Commission. Any forward-looking statements contained in this release speak only as of its date. Intelligent Bio Solutions undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events. Company Contact: Intelligent Bio Solutions Inc.info@ibs.incLinkedIn | Twitter Investor & Media Contact: Valter Pinto, Managing DirectorKCSA Strategic CommunicationsPH: (212) 896-1254INBS@kcsa.com