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STOCKHOLM, Oct. 31, 2024 /PRNewswire/ -- BioArctic AB's (publ) (NASDAQ Stockholm: BIOA B) partner Eisai has presented the latest findings for lecanemab (Leqembi®) at the Clinical Trials on Alzheimer's Disease, CTAD, congress, held in Madrid, Spain, and virtually, October 29 to November 1. Three-year data show that lecanemab continues to give increased patient benefit for patients with early Alzheimer's disease, expanding approximately 1 point on CDR-SB compared to the ADNI[1]-population, with maintained safety profile. In addition, data show that 46% of patients who had low levels of brain amyloid at the start of treatment have improved or maintained cognition and function after three years of treatment. Highlights from the presentations at CTAD included: Benefits of continued treatment with lecanemab for people with early Alzheimer's disease Results from the open-label long-term extension study (OLE) following the core study of the lecanemab phase 3 Clarity AD study presented at AAIC in July, showed that the mean change from baseline in CDR-SB (global cognitive and functional scale) in the lecanemab treated group was -0.45 at 18 months compared to the placebo group. This had expanded to -0.95 compared to the ADNI-population at 36 months. The data also showed a 30% reduction in the risk of progressing to the next disease stage. Furthermore, the tau PET substudy of Clarity AD showed that with three years of continuous treatment with lecanemab, 59% of patients with no or low tau accumulation in the brain (no tau/low tau) at baseline showed improvement or no decline, and 51% showed improvement from baseline on the Clinical Dementia Rating-Sum of Boxes (CDR-SB) global cognitive and functional scale. Clarity AD data presented at CTAD expanded on these initial results to include additional measurements resulting from three years of continuous lecanemab treatment in patients with low levels of amyloid accumulation in the brain at baseline (less than 60 centiloids). These data show that 46% of patients improved or had no decline, and 33% showed improvement from baseline on the CDR-SB, with similar results for ADAS-Cog14 and on the ADCS MCI-ADL scales. These results – from no tau/low tau and low amyloid populations – suggest that earlier initiation of lecanemab treatment may have a positive impact on disease progression of early Alzheimer disease patients and may provide continued benefits to these patients over the long term. Safety matters No new safety findings were observed with continued lecanemab treatment over three years. Most Amyloid-related imaging abnormalities (ARIA) occurred in the first six months of treatment. After the first six months, ARIA rates were low and similar to ARIA rates on placebo. With regards to the incidence of ARIA by ApoE4 status during the continuous treatment, it was shown that the incidence was higher in ApoE4 homozygotes than in heterozygotes or non-carriers, but rates of new ARIA decreased after the completion of the 18 months core study as treatment continued, regardless of ApoE4 status. Alzheimer's disease continues to progress when treatment is stopped – continued treatment even after plaque clearance beneficial for patients Lecanemab continues to positively impact biomarkers over the course of treatment – Clinical data and biomarkers such as Aβ42/40 ratio, pTau181, pTau217 and GFAP suggests that AD does not stop progressing after plaque clearance. Data indicates that patients continue to benefit by remaining on treatment, potentially at a lower maintenance dose, which was shown to prevent reaccumulating of brain amyloid and worsening of plasma biomarkers. Population approved for treatment in Great Britain show greater effect and better safety data In a presentation of the Clarity AD data focused on the Alzheimer's disease population approved for treatment in Great Britain, ApoE4 heterozygotes or non-carriers, showed that the CDR-SB slowing of decline is greater at 33% compared to the 27% which was seen for the total study population. Simultaneously, the rate of the side effect ARIA-E was lower at 8.9% compared to 12.6% for the total population. Progress in the AHEAD 3-45 Study – patient enrollment completed AHEAD 3-45 is a four-year phase 3 clinical study for individuals with preclinical AD, meaning they are clinically unimpaired but have intermediate or elevated levels of amyloid in their brains. Based on the amount of amyloid accumulation in the brain as determined by amyloid PET, subjects were assigned to two (2) trials with different dose settings: the A3 trial (approximately 400 people), for those with intermediate levels of amyloid in the brain, and the A45 trial (approximately 1000 people), for those with increased amyloid levels in the brain. Screening with blood biomarker tests was important to improve eligibility for amyloid PET testing and reduced screening failure on amyloid PET from more than 70% to less than 30%. In particular, plasma p-tau217 was shown to correlate with amyloid PET, supporting its role as a useful blood biomarker to identify elevated amyloid in the brain. Enrollment for the AHEAD 3-45 study was completed in October 2024. "The long-term data for lecanemab which our partner Eisai has presented are impressive. It shows that the patient benefit of lecanemab continues to increase over time, which is exactly what is expected from a disease modifying treatment. In addition, the safety data reported from clinical practice in the US and Japan seems to be at least on par with phase 3 data," said Gunilla Osswald, CEO at BioArctic. "It is also encouraging to see the results of early Alzheimer disease patients from the low amyloid and no tau/low tau populations, with 46 to 59% showing improvement or no decline compared to baseline at 36 months. This suggest that earlier initiation of lecanemab treatment may have a positive impact on disease progression of early Alzheimer disease patients and could provide continued benefits to patients over the long term." Lecanemab is the result of a long-standing collaboration between BioArctic and Eisai, and the antibody was originally developed by BioArctic based on the work of Professor Lars Lannfelt and his discovery of the Arctic mutation in Alzheimer's disease. Eisai is responsible for the clinical development, applications for market approval and commercialization of lecanemab for Alzheimer's disease. BioArctic has the right to commercialize lecanemab in the Nordic region and pending European approval Eisai and BioArctic are preparing for a joint commercialization in the region. The information was released for public disclosure, through the agency of the contact person below, on October 31, 2024, at 08:30 a.m. CET. For further information, please contact: Oskar Bosson, VP Communications and IR E-mail: [email protected] Phone: +46 70 410 71 80 About lecanemab (Leqembi®) Lecanemab is the result of a strategic research alliance between BioArctic and Eisai. It is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble (protofibril) and insoluble forms of amyloid-beta (Aβ). Lecanemab is approved in the U.S., Japan, China, South Korea, Hong Kong, Israel, UAE and Great Britain for the treatment of MCI due to AD and mild AD dementia. Lecanemab's approvals in these countries were primarily based on Phase 3 data from Eisai's global Clarity AD clinical trial, in which it met its primary endpoint and all key secondary endpoints with statistically significant results. The most common adverse events (>10%) in the lecanemab group were infusion reactions, ARIA-H (combined cerebral microhemorrhages, cerebral macrohemorrhages, and superficial siderosis), ARIA-E (edema/effusion), headache, and fall. Lecanemab marketed in the U.S., Japan and China. Eisai has also submitted applications for approval of lecanemab in 10 countries and regions, including the European Union. Since July 2020 Eisai's Phase 3 clinical study (AHEAD 3-45) for individuals with preclinical AD, meaning they are clinically normal and have intermediate or elevated levels of amyloid in their brains, is ongoing. AHEAD 3-45 is conducted as a public-private partnership between the Alzheimer's Clinical Trial Consortium that provides the infrastructure for academic clinical trials in AD and related dementias in the U.S, funded by the National Institute on Aging, part of the National Institutes of Health and Eisai. Since January 2022, the Tau NexGen clinical study for Dominantly Inherited AD (DIAD), that is conducted by Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU), led by Washington University School of Medicine in St. Louis, is ongoing and includes lecanemab as the backbone anti-amyloid therapy. About the collaboration between BioArctic and Eisai Since 2005, BioArctic has a long-term collaboration with Eisai regarding the development and commercialization of drugs for the treatment of Alzheimer's disease. The most important agreements are the Development and Commercialization Agreement for the lecanemab antibody, which was signed 2007, and the Development and Commercialization agreement for the antibody Leqembi back-up for Alzheimer's disease, which was signed 2015. In 2014, Eisai and Biogen entered into a joint development and commercialization agreement for lecanemab. Eisai is responsible for the clinical development, application for market approval and commercialization of the products for Alzheimer's disease. BioArctic has the right to commercialize lecanemab in the Nordic region under certain conditions and is currently preparing for commercialization in the Nordics together with Eisai. BioArctic has no development costs for lecanemab in Alzheimer's disease and is entitled to payments in connection with regulatory approvals, and sales milestones as well as royalties on global sales. About BioArctic AB BioArctic AB (publ) is a Swedish research-based biopharma company focusing on innovative treatments that can delay or stop the progression of neurodegenerative diseases. The company invented Leqembi® (lecanemab) – the world's first drug proven to slow the progression of the disease and reduce cognitive impairment in early Alzheimer's disease. Leqembi has been developed together with BioArctic's partner Eisai, who are responsible for regulatory interactions and commercialization globally. In addition to Leqembi, BioArctic has a broad research portfolio with antibodies against Parkinson's disease and ALS as well as additional projects against Alzheimer's disease. Several of the projects utilize the company's proprietary BrainTransporter™ technology, which has the potential to actively transport antibodies across the blood-brain barrier to enhance the efficacy of the treatment. BioArctic's B share (BIOA B) is listed on Nasdaq Stockholm Large Cap. For further information, please visit . [1] ADNI is a clinical research project launched in 2005 to develop methods to predict the onset of AD and to confirm the effectiveness of treatments. The ADNI observational cohort represents the exact population of those in Clarity AD study; matched ADNI participants show similar degree of decline to placebo group out to 18 months This information was brought to you by Cision The following files are available for download: WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

WILMETTE, Ill., Oct. 30, 2024 (GLOBE NEWSWIRE) -- Monopar Therapeutics Inc. (Nasdaq: MNPR) (“Monopar Therapeutics” or the “Company”), a clinical-stage biotechnology company focused on developing innovative treatments for patients with unmet medical needs, today announced the closing of its previously announced best efforts public offering of shares of its common stock at a public offering price of $16.25 per share, for aggregate gross proceeds of approximately $19.2 million, before deducting the placement agent’s fees and other offering expenses payable by the Company. Janus Henderson Investors, RA Capital Management, L.P. and other notable growth and life science investors participated in the offering. Rodman & Renshaw LLC acted as the exclusive placement agent for the offering. Monopar Therapeutics intends to use the net proceeds from the offering for general corporate purposes, which may include research and development expenditures, clinical trial expenditures, manufacture and supply of product and working capital. The securities were offered and sold pursuant to a "shelf" registration statement on Form S-3 (File No. 333-268935), including a base prospectus, filed with the U.S. Securities and Exchange Commission (the “SEC”) on December 21, 2022, and declared effective on January 4, 2023. A final prospectus supplement and accompanying prospectus describing the terms of the offering has been filed with the SEC and is available on its website at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to this offering may also be obtained by contacting Rodman & Renshaw LLC at 600 Lexington Avenue, 32nd Floor, New York, NY 10022, by email at info@rodm.com, or by telephone at (212) 540-4414. This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. The offering was made only by means of the prospectus supplement and accompanying prospectus forming a part of the effective registration statement. About Monopar Therapeutics Monopar Therapeutics is a clinical-stage biotechnology company with late-stage ALXN-1840 for Wilson disease, and radiopharma programs including Phase 1-stage MNPR-101-Zr for imaging advanced cancers, and Phase 1a-stage MNPR-101-Lu and late preclinical-stage MNPR-101-Ac225 for the treatment of advanced cancers. For more information, visit: www.monopartx.com. Forward-Looking Statements Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Examples of these forward-looking statements include statements concerning: statements regarding the anticipated use of proceeds from the offering. The forward-looking statements involve risks and uncertainties including, but not limited to: our ability to raise sufficient funds in order for us to support continued clinical, regulatory and commercial development of our programs and to make contractual upfront and future milestone payments, as well as our ability to further raise additional funds in the future to support any existing or future product candidate programs through completion of clinical trials, the approval processes and, if applicable, commercialization; uncertainties related to the regulatory discussions we intend to initiate related to ALXN-1840 and the outcome thereof; the rate of market acceptance and competitiveness in terms of pricing, efficacy and safety, of any products for which we receive marketing approval, and our ability to competitively market any such products as compared to larger pharmaceutical firms; and the significant general risks and uncertainties surrounding the research, development, regulatory approval, and commercialization of imaging agents and therapeutics. Actual results may differ materially from those expressed or implied by such forward-looking statements. Risks are described more fully in Monopar's filings with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Monopar undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made. Any forward-looking statements contained in this press release represent Monopar’s views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. CONTACT: Monopar Therapeutics Inc.Investor Relations Karthik Radhakrishnan Chief Financial Officerkarthik@monopartx.com

SOMERVILLE, Mass., Oct. 30, 2024 /PRNewswire/ -- Aitia, a biotech company pioneering the use of causal AI and Digital Twins in drug discovery and development, is expanding its collaboration with Servier, a global and independent pharmaceutical company, to tackle gliomas, a broad group of brain cancers. This collaboration aims to use Aitia's breakthrough technology which is powered by millions of data points from patient cancer tissues to find new treatments for this deadly disease. Under the terms of the collaboration, Aitia and Servier will work together to discover and, validate novel drug targets and develop novel drug candidates for glioma using Aitia's Gemini Digital Twins and Servier's therapeutic discovery and clinical development expertise in oncology. This collaboration will include exploration of the heterogeneous biology of these brain cancers, mechanisms of resistance, and drug response at the individual patient level. In a recent breakthrough in another form of glioma, specifically Grade 2 astrocytoma or oligodendroglioma with a susceptible IDH1 or IDH2 mutation following surgery including biopsy, sub-total resection, or gross total resection in adult and pediatric patients 12 years and older, Servier recently announced approval of the brain cancer drug, VORANIGO, the first approved drug for this disease area in almost 25 years. Gliomas, tumors that originate in the brain or spinal cord from glial cells, affects more than 190,000 people worldwide annually. The most aggressive form of glioma, glioblastoma, has an average survival time after diagnosis of approximately 15 months, with less than 7% of patients surviving beyond five years, according to the National Brain Tumor Society. Despite standard treatments like surgery, radiation and chemotherapy, glioblastoma has a high rate of recurrence and there are currently no curative therapies. "We are excited to expand our collaboration with Aitia into gliomas as we continue to prioritize brain cancer after our recent positive results and approval of VORANIGO in the US and in growing number of territories," said Fabien Schmidlin, Global Head of Translational Medicine at Servier. "At Servier, we are committed to advancing therapies for cancer patients with high unmet medical needs, and we believe that integrating Aitia's Gemini Digital Twins with our expertise in oncology, particularly in targeting molecular mutations, could open new avenues for more effective treatments." "Glioma is the among the deadliest forms of cancer, and the lack of broadly effective treatments highlights the urgent need for new approaches that leverage the growth of genetic and multi-omic patient data and breakthroughs in AI," said Colin Hill, CEO and co-founder of Aitia. "We believe that our Gemini Digital Twins, along with Servier's drug discovery and clinical development expertise in hard-to-treat cancers can lead to new breakthrough therapies for this disease." This collaboration represents the fourth area of research Aitia and Servier are collaborating on. The companies began their partnership in 2022, to advance drug discovery, translational, and clinical development efforts in Multiple Myeloma, then expanding in 2023 to include drug discovery and development for pancreatic cancer, and again in January 2024 to discover patient responders for Servier's LRRK2 inhibitor in Parkinson's disease. Aitia's approach centers on two key innovations: causal AI and Gemini Digital Twins. Causal AI goes beyond correlative associations to identify which genetic or molecular changes drive diseases and patient response to therapies. Gemini Digital Twins are virtual models that are reverse-engineered from huge quantities of genetic, multi-omic, and clinical data from patients that reveal how genes, proteins, and other molecules interact within cells and tissues to drive clinical outcomes. These Gemini Digital Twins of a specific disease allow researchers to rapidly test billions of experiments such as gene and protein knockdowns or application of a drug candidate in a human patient context versus animal models or cells in petri dishes. These high-throughput "virtual experiments" in patient-derived Gemini Digital Twins leads to discovering and selecting drug candidates that are more likely to succeed in clinical trials in specific patient populations. About Aitia Aitia is an AI-enabled biotechnology company deploying causal AI and creating Gemini Digital Twins to discover the next generation of breakthrough drugs in neurodegenerative diseases and oncology, including a lead program in Huntington's disease. By leveraging the convergence of multi-omic patient data, high-performance computing, and causal AI, Aitia's Gemini Digital Twins reveal the hidden biological mechanisms of disease to transform the discovery and development of new therapeutics. To date, Gemini Digital Twins have been used to accelerate R&D in oncology, neurodegeneration, cardiometabolic, and immunology. Media Contact: Isabelle Caffry Senior Director, Strategy & Corporate Development [email protected] +1-617-374-2300 Ryan Flinn In Like Flinn Communications [email protected] +1 510-207-7616 SOURCE Aitia WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED