Announcement • Jun 30
Monopar Therapeutics Receives FDA Rare Pediatric Disease Designation For ALXN1840 For The Treatment Of Wilson Disease Monopar Therapeutics Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease (RPD) designation to ALXN1840 (tiomolibdate choline, TMC), the Company’s late-stage candidate for the treatment of Wilson disease. The FDA grants RPD designation to therapies intended to treat serious or life-threatening diseases that primarily affect children from birth to 18 years of age. The designation provides the Company with the potential at the time of NDA approval to receive a pediatric Priority Review Voucher (PRV), which can be used to obtain priority review of a subsequent marketing application or sold or transferred to another sponsor. Priority review can reduce the FDA’s target review time by several months. Wilson disease is a rare genetic disorder that affects approximately 1 in 30,000 people worldwide. It is caused by mutations in the ATP7B gene, which impairs the body’s ability to excrete copper. It is characterized by toxic accumulation of copper in the liver, brain, and other organs, leading to progressive and potentially fatal outcomes if untreated. ALXN1840 (tiomolibdate choline, TMC) is a novel first-in-class albumin tripartite complex (ATC) activator under investigation for the treatment of Wilson disease. ALXN1840 rapidly mobilizes and tightly sequesters excess copper in ATCs, suppressing its redox reactivity, limiting oxidative damage, and blocking transport across the blood–brain barrier. Clinical data demonstrate that ALXN1840 improves copper balance by increasing fecal copper excretion. In the Phase 3 pivotal trial, ALXN1840 met the primary endpoint by demonstrating rapid and sustained copper mobilization significantly greater than standard of care over 48 weeks in both previously treated and untreated patients. Durable clinical improvement and a favorable safety and tolerability profile were observed across 645 patient-years of follow-up in 266 patients. ALXN1840 is an oral tablet with a once-a-day dosing regimen. Announcement • Jun 29
Monopar Presents New Analyses of Phase 3 Focus Data At EAN 2026 Showing Greater Neurologic and Global Clinical Benefit with Alxn1840 Versus Standard of Care in Wilson Disease Monopar Therapeutics Inc. announced that new analyses from the Phase 3 FoCus randomized controlled clinical trial of ALXN1840 (tiomolibdate choline, TMC) will be presented at the 12th Congress of the European Academy of Neurology (EAN 2026), June 27–30, 2026, in Geneva, Switzerland. These analyses build upon the previously reported Phase 3 FoCus results demonstrating ALXN1840 met its primary endpoint of superior copper mobilization versus standard of care. In an encore poster presentation titled “Greater clinical benefit with tiomolibdate choline versus standard of care in neurologic Wilson disease patients in the Phase 3 FoCus Trial,” results showing that ALXN1840 produced significant neurologic improvement over time and greater global clinical improvement compared to standard-of-care (SoC) therapy in Wilson disease (WD) patients with neurologic symptoms at baseline. ALXN1840 also demonstrated similar or better outcomes compared to SoC across a range of psychiatric and hepatic measures during the 48-week study. In the subset of patients with neurologic symptoms at baseline from the 2:1 randomized Phase 3 FoCus clinical trial (NCT03403205; n=207), ALXN1840 demonstrated improved outcomes compared to SoC across multiple clinical measures: Neurologic improvement on the rater-blinded, physician-assessed Unified Wilson Disease Rating Scale (UWDRS) Part III was significant and continued over time with ALXN1840 (p=0.006) but not with SoC (p=0.435). Global clinical improvement as assessed by the Clinical Global Impressions – Improvement (CGI-I) scale at Week 48 was significantly greater with ALXN1840 than with SoC. Announcement • Jun 23
Monopar Therapeutics Inc. Elects Nicole Sweeny as Director Monopar Therapeutics Inc. announced that at the Annual Meeting held on June 22, 2026 approved the election of Nicole Sweeny as director. New Risk • Jun 03
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 German stocks, typically moving 8.8% 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 Risk Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$7.3m net loss in 3 years). Share price has been volatile over the past 3 months (8.8% average weekly change). Announcement • Jun 03
Monopar Therapeutics Presents Phase 2 Alxn1840 Data Demonstrating Liver Disease Stabilization and Neurologic Improvement in Treatment-Experienced Wilson Disease Patients At Easl 2026 Monopar Therapeutics Inc. announced the presentation of Phase 2 ALXN1840-WD-205 data at the European Association for the Study of the Liver Congress 2026. In a presentation titled “ALXN1840 (tiomolibdate choline) Stabilizes Liver Disease and Improves Neurological Symptoms as well as Quality of Life in Treatment-Experienced Wilson Disease Patients,” results from the open-label, multicenter Phase 2 trial evaluating the effects of ALXN1840 on liver pathology and clinical outcomes in heavily pre-treated patients with Wilson disease were presented. Wilson disease is a rare and progressive genetic condition caused by mutations in the ATP7B gene, in which the body’s pathway for removing excess copper is compromised, leading to damage from toxic copper build-up in organs such as the liver and brain. The open-label, multicenter, pathologist-blinded Phase 2 trial evaluated ALXN1840 monotherapy over 48 weeks in 29 treatment-experienced (at least one year on standard of care) Wilson disease patients, with an optional 48-week extension period. The study population had extensive prior treatment, with a median duration of 13.8 years. Liver biopsy was performed at baseline and Week 48 to assess hepatic copper concentration, stage of fibrosis, and grade of steatosis. Neurologic, clinical, and quality-of-life outcomes were also assessed at baseline and Week 48, with patients continuing in the extension period assessed again at Week 96. By Week 48, among the 24 patients with paired biopsies, the preponderance demonstrated stabilization or improvement across histologic measures assessed, including hepatocyte necrosis (96%), steatosis grade (88%), lobular inflammation (79%), portal inflammation (71%), NAFLD Activity Score total (71%), hepatocellular ballooning (75%), and fibrosis stage (67%). No statistically significant change in hepatic copper concentration after 48 weeks, consistent with published Wilson disease studies of standard of care therapies showing hepatic copper remains stable or increases even after years on treatment. Significant improvements in the Unified Wilson Disease Rating Scale (UWDRS) Part III score were observed at Week 48. Announcement • May 21
Monopar Therapeutics Inc Announces Publication of Phase 2 Study Demonstrating ALXN1840 Significantly Improves Copper Balance in Patients with Wilson Disease Monopar Therapeutics Inc. announced that Hepatology Communications has published a peer-reviewed manuscript entitled “Effect of Tiomolibdate Choline on Copper Balance in Patients with Wilson Disease: an Open-label Phase 2 Trial.” The publication reports results from the Phase 2 ALXN1840-WD-204 study (NCT04573309) and demonstrates that ALXN1840 (tiomolibdate choline) produces a rapid, statistically significant, and sustained improvement in daily copper balance in patients with Wilson disease, driven by increased fecal copper excretion. Wilson disease is a rare and progressive genetic condition in which the body’s pathway for removing excess copper is compromised, leading to damage from toxic copper build-up in organs such as the liver and brain. The open-label, single-arm Phase 2 trial evaluated daily dosing of ALXN1840 in nine patients with Wilson disease across two centers in the United Kingdom and New Zealand. Patients were admitted to a clinical research unit and initiated on a copper-controlled diet, with all copper intake and output collected during a pre-treatment baseline period and after initiation of daily ALXN1840 over multiple weeks. The publication builds on a recently published peer-reviewed Journal of Hepatology Letter to the Editor, which highlighted the importance of comparing outcomes to a pre-treatment baseline to accurately assess the effect of a potential Wilson disease treatment on copper balance. Statistically significant reduction in daily copper balance from baseline, due to increased fecal copper excretion. Cumulative mean decrease from baseline in copper balance of -6.08 mg over 21 days (95% CI: -10.18 mg to -1.98 mg). Mean daily copper balance change from baseline of -0.37 mg (p=0.005) during the 15 mg/day treatment period and -0.29 mg (p=0.023) through the overall study period. Approximately 50% increase in the daily fecal copper output-to-intake ratio compared to baseline (p=0.041). Immediate increases in plasma total copper and directly measured non-ceruloplasmin-bound copper (dNCC), consistent with copper mobilization and formation of stable albumin tripartite complexes (ATCs) consisting of copper, ALXN1840, and albumin. ALXN1840 was generally well tolerated; no serious adverse events were reported. The observed improvements in copper balance and copper mobilization occurred in a Wilson disease patient population with a mean prior current standard of care treatment duration of 16 years, suggesting that despite years of treatment with currently available therapies, patients present with a considerable amount of residual copper in the body that ALXN1840 is able to mobilize and eliminate. This finding is consistent with data from the completed 48-week Phase 3 trial, in which ALXN1840 demonstrated superior copper mobilization compared to standard of care even in patients with a mean prior standard of care treatment duration of 11 years. ALXN1840 (tiomolibdate choline, TMC) is a novel first-in-class Albumin Tripartite Complex (ATC) activator under investigation for the treatment of Wilson disease. ALXN1840 rapidly mobilizes and tightly sequesters excess copper in ATCs, suppressing its redox reactivity, limiting oxidative damage, and blocking transport across the blood–brain barrier. In the Phase 3 pivotal trial, ALXN1840 demonstrated rapid and sustained copper mobilization (primary endpoint) that was significantly greater than standard of care over 48 weeks in both previously treated and untreated patients. Durable clinical improvement and a favorable safety and tolerability profile were observed across 645 patient-years of follow-up in 266 patients. Announcement • May 04
Monopar Therapeutics Inc., Annual General Meeting, Jun 22, 2026 Monopar Therapeutics Inc., Annual General Meeting, Jun 22, 2026. Location: at 1000 skokie blvd., wilmette, il 60091, United States Announcement • Apr 20
Monopar Therapeutics Inc. Presents Phase 3 Data Showing Greater Neurologic Benefit With ALXN1840 Versus Standard of Care In Wilson Disease Patients With Neurologic Symptoms Monopar Therapeutics Inc. announced new analyses from the randomized controlled Phase 3 FoCus trial of ALXN1840 (tiomolibdate choline, TMC) showing greater neurologic benefit versus standard of care (SoC) in Wilson disease patients with neurologic symptoms at baseline. In a late-breaker oral and poster presentation titled “Greater clinical benefit with tiomolibdate choline versus standard-of-care in neurologic Wilson disease patients in the Phase 3 FoCus Trial,” Dr. Peter Hedera, MD, PhD, Department of Neurology, University of Louisville School of Medicine, will present results showing that ALXN1840 provided greater neurologic improvement and significantly less worsening than standard of care through Week 48, with durable neurologic benefit observed over multiple years of treatment. In the randomized FoCus trial, analysis of patients with neurologic symptoms at baseline (TMC: n=77; SoC: n=35) demonstrated that treatment with ALXN1840 resulted in both higher rates of improvement and lower rates of worsening, addressing a critical unmet need in the neurologic management of Wilson disease. Clinically meaningful neurologic worsening at Week 48 was observed in 25% of patients treated with standard of care vs 9% of ALXN1840-treated patients (p=0.038). Clinically meaningful neurologic improvement at Week 48 was observed in 45% of ALXN1840-treated patients vs 32% on standard of care. CGI-S improvement from baseline to Week 48 was greater with ALXN1840 vs standard of care (61% vs 17%; p=0.008). CGI-I improvement at Week 48 was greater with ALXN1840 vs standard of care (47% vs 19%; p=0.003). Durable neurologic benefit in the ALXN1840-treated group continued to increase during long-term follow-up on treatment and was sustained over approximately 3 years. Neurologic benefit was consistent across both treatment-naïve and treatment-experienced patients with neurologic symptoms at baseline, supporting ALXN1840’s potential as a novel treatment option for Wilson disease. ALXN1840 has demonstrated a well-characterized and favorable safety profile across Phase 2 and Phase 3 studies (266 patients; median 2.58 years on treatment; max >8 years), with drug-related serious adverse events (SAEs) limited to 4.9% of patients — including neurologic SAEs in < 1% — and no treatment-related deaths. These findings support the continued advancement of ALXN1840 toward the planned New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA) in mid-2026. Wilson disease is a rare genetic disorder that affects approximately 1 in 30,000 people worldwide. It is caused by mutations in the ATP7B gene, which impairs the body's ability to excrete copper. It is characterized by toxic accumulation of copper in the liver, brain, and other organs, leading to progressive and potentially fatal outcomes if untreated. ALXN1840 (tiomolibdate choline, TMC) is a novel first-in-class Albumin Tripartite Complex (ATC) activator under investigation for the treatment of Wilson disease. ALXN1840 rapidly mobilizes and tightly sequesters excess copper in ATCs, suppressing its redox reactivity, limiting oxidative damage, and blocking transport across the blood–brain barrier. Clinical data demonstrate that ALXN1840 improves copper balance by increasing fecal copper excretion. In the Phase 3 pivotal trial, ALXN1840 demonstrated rapid and sustained copper mobilization (primary endpoint) that was significantly greater than standard of care over 48 weeks in both previously treated and untreated patients. Durable clinical improvement and a favorable safety and tolerability profile were observed across 645 patient-years of follow-up in 266 patients. Announcement • Mar 03
Monopar Therapeutics Inc. Appoints Susan Rodriguez as Chief Commercial and Strategy Officer, Effective from March 2, 2026 Monopar Therapeutics Inc. announced the appointment of Susan Rodriguez as Chief Commercial and Strategy Officer, effective March 2, 2026. In this newly created executive role, Ms. Rodriguez will lead the Company’s commercial strategy and infrastructure build-out as Monopar prepares for the planned submission of a New Drug Application to the U.S. Food and Drug Administration in the first half of 2026 for ALXN1840, its late-stage investigational therapy for Wilson disease. Susan Rodriguez brings more than 30 years of biopharmaceutical leadership experience. She most recently served as Chief Operating Officer of Avadel Pharmaceuticals, where she led the company’s commercial strategy and execution, contributing to the recently completed acquisition of Avadel by Alkermes for over $2 billion. Prior to Avadel, Ms. Rodriguez was Chief Commercial Officer of Ardelyx, where she established the company’s first commercial organization and successfully transitioned Ardelyx from a development-stage company to a commercial biopharmaceutical enterprise. She led the launches of two key therapeutics, building market access, sales, marketing, and patient services capabilities and delivering strong early adoption in highly competitive areas. Before that, she served as Chief Executive Officer of Tolmar Pharmaceuticals, a specialty oncology company, where she established a new U.S. commercial entity, secured a market-leading position for its primary oncology therapy, advanced its pipeline, and successfully launched a new rare disease therapy. Earlier, she held various commercial leadership positions across multiple divisions at Abbott as well as the Abbott–Takeda joint venture, TAP Pharmaceuticals. She holds an M.S. and a B.S. in psychology, with a minor in chemistry, from the University of Pennsylvania. Announcement • Nov 10
Monopar Therapeutics Inc. Presents New Data and Analyses on Rapidly Improved Copper Balance in Wilson Disease Patients on Tiomolybdate Choline at AASLD - The Liver Meeting® 2025 Monopar Therapeutics Inc. announced that it is presenting new data and analyses from the Phase 2 ALXN1840-WD-204 copper balance study at the American Association for the Study of Liver Diseases (AASLD) - The Liver Meeting® 2025, taking place in Washington, D.C., from November 7-11, 2025. In an oral presentation titled "Rapidly Improved Cu Balance in Wilson Disease Patients on Tiomolybdate Choline," Professor Aftab Ala, MBBS, M.D., FRCP, Ph.D., Professor of Hepatology and Consultant Hepatologist at the Institute of Liver Studies at King's College Hospital in London, will be sharing results showing that treatment with ALXN1840 (tiomolybdate choline) led to a rapid and sustained improvement in daily copper balance in patients with Wilson disease, primarily through increased fecal copper excretion. The mean daily copper balance among patients treated with ALXN1840 in the study (n=8) was significantly lower - indicating improvement - compared with their pre-treatment baseline. Copper balance improved both during the initial 15 mg once-daily dosing period (days 1-28) and over the entire treatment duration (days 1-39), which included patients receiving either 15 mg every other day or 30 mg once daily. Additional new nonclinical and clinical data supporting these findings from the ALXN 1840-WD-204 study will also be presented. Announcement • Sep 24
Monopar Therapeutics Inc. has filed a Follow-on Equity Offering in the amount of $134.998998 million. Monopar Therapeutics Inc. has filed a Follow-on Equity Offering in the amount of $134.998998 million.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 1,034,433
Price\Range: $67.67
Discount Per Security: $4.0602
Security Name: Pre-Funded Warrants
Security Type: Equity Warrant
Securities Offered: 960,542
Price\Range: $67.669
Discount Per Security: $4.0602
Transaction Features: Registered Direct Offering Announcement • Sep 15
Monopar Therapeutics Inc. to Present New Long-Term Neurological Efficacy and Safety Data for ALXN1840 in Wilson Disease at the 150th American Neurological Association Annual Meeting Monopar Therapeutics Inc. announced that new data on the long-term neurological efficacy and safety of its investigational therapy ALXN1840 (tiomolybdate choline) for Wilson disease will be presented at the 150th American Neurological Association (ANA) Annual Meeting on September 14-15, 2025. The analysis pooled efficacy outcomes from three independent clinical trials (n=255), while safety data included a fourth independent clinical trial (n=266). Median treatment duration with ALXN1840 was approximately 2.6 years for both the efficacy and safety analyses. The new data presented at ANA highlight the long-term neurological benefit of ALXN1840, and follow the recent presentation of long-term hepatic and systemic efficacy and safety data at the European Association for the Study of the Liver (EASL) International Liver Congress 2025. Together, these findings underscore the potential of ALXN1840 for both the neurological and hepatic manifestations of Wilson disease. Key findings to be presented at ANA include: Sustained Neurological Improvement: Statistically significant neurologic improvement from baseline on the Unified Wilson Disease Rating Scale ("UWDRS") Part II (patient-reported symptoms) and Part III (clinician-reported symptoms) was sustained over 6 years. Crossover Benefit: Patients who crossed over from standard of care ("SoC") to ALXN1840 showed additional neurological improvement, including a majority of patients who had worsened on SoC demonstrating a reversal on ALXN1840. Psychiatric Outcomes: Statistically significant psychiatric improvement from baseline was sustained over multiple years, as measured by the Brief Psychiatric Rating Scale ("BPRS"). Consistency Across Trials: Neurological benefit was observed consistently across multiple independent studies. Favorable Safety Profile: Across more than 645 patient-years on ALXN1840, less than 1% of patients experienced a drug-related neurological serious adverse event (“SAE”). Announcement • Jun 11
Monopar Therapeutics Inc. and Excel Diagnostics and Nuclear Oncology Center Announce Expanded Access Program for Mnpr-101-Zr and Mnpr-101-Lu in Advanced Cancers Monopar Therapeutics Inc. in collaboration with Excel Diagnostics and Nuclear Oncology Center (EDNOC) announced that the physician-sponsored Expanded Access Program (EAP) for the investigational imaging agent MNPR-101-Zr and investigational therapeutic agent MNPR-101-Lu has received authorization to proceed from the U.S. Food and Drug Administration (FDA). The MNPR-101 EAP is now open for enrollment to patients with advanced solid tumors at EDNOC in Houston, Texas. EDNOC is among the first private outpatient facilities in the U.S. to be designated as a Radiopharmaceutical Therapy Center of Excellence by the Society of Nuclear Medicine and Molecular Imaging (“SNMMI”). Patients will be treated under the supervision of renowned investigator Ebrahim S. Delpassand, MD, founder and medical director of EDNOC. Announcement • May 07
Monopar Therapeutics Inc. Presents ALXN1840 Late-Breaker Data At EASL 2025 Monopar Therapeutics Inc. is presenting data on the long term efficacy and safety of its ALXN1840 (tiomolybdate choline) drug candidate for Wilson disease at the European Association for the Study of the Liver ("EASL") International Liver Congress 2025, one of the most prominent global conferences in liver disease. The poster supports the potential use of ALXN1840 as a therapeutic option for Wilson disease, a rare and progressive genetic condition in which the body's pathway for removing excess copper is compromised, leading to damage from toxic copper build-up in tissues and organs such as the liver and brain. Efficacy data were pooled and analyzed from three clinical trials: Phase 2 WTX101-201, Phase 2 ALXN1840-WD-205, and Phase 3 WTX101-301 (n=255). For safety analysis, data from the Phase 2 ALXN18 40-WD-204 trial were also included (n=266). The median treatment duration with ALXN1840 was 961 days (2.63 years) and 943.5 days (2.58 years) for the efficacy and safety datasets, respectively. The data presented highlight the following: Sustained improvements from baseline in the Unified Wilson Disease Rating Scale ("UWDRS") Part II (patient-reported symptoms) and Part III (clinician-assessed symptoms); Increased copper mobilization as evidenced by a sustained increase in dNCC (directly measured non-ceruloplasmin-bound copper); Improvements on the Clinical Global Impression - Improvement ("CGI-I") scale for ALXN1840 compared to standard of care; Improvement in the New Wilson Index (based on bilirubin, AST, INR, leukocytes, and albumin) for patients treated with ALXN1840; Higher patient-reported convenience and effectiveness of ALXN1840 compared To standard of care, including those who transitioned from standard of care to ALXN1840 in the extension portion of the Phase 3 clinical trial; and Fewer than 5% of patients experienced a drug-related serious adverse event ("SAE"), with no cases of a drug-related renal or urinary system SAE. Announcement • May 01
Monopar Therapeutics Inc., Annual General Meeting, Jun 17, 2025 Monopar Therapeutics Inc., Annual General Meeting, Jun 17, 2025. Location: 1000 skokie blvd, wilmette, il 60091, United States Announcement • Apr 01
Monopar Therapeutics Inc. Announces Recent Program Developments Monopar Therapeutics Inc. announced Recent Program Developments. ALXN1840 – Plan to Submit NDA with FDA for Wilson Disease in Early 2026. Wilson disease is a rare and progressive genetic condition in which the body’s pathway for removing excess copper is compromised, leading to damage from toxic copper build-up in tissues and organs such as the liver and brain. ALXN1840 is a potent binder and mobilizer of copper, as demonstrated in a Phase 3 clinical trial that met its primary endpoint. In October 2024, Monopar announced the execution of a worldwide exclusive license to ALXN1840 with Alexion, AstraZeneca Rare Disease (“AZ”). As part of this transaction, AZ received a total cash payment of $4.0 million, was issued 9.9% ownership of Monopar’s outstanding common stock, and is entitled to receive regulatory approval and sales milestones along with a tiered royalty based on net sales. MNPR-101 – Currently Enrolling Phase 1 Imaging and Therapeutic Oncology Trials Imaging agent MNPR-101-Zr (MNPR-101 conjugated to zirconium-89) and therapeutic agent MNPR-101-Lu (MNPR-101 conjugated to lutetium-177) target the urokinase plasminogen activator receptor (“uPAR”), which is expressed in numerous aggressive cancers such as triple-negative breast, colorectal, and pancreatic cancers. · Initiated Phase 1a clinical trial for novel therapeutic radiopharmaceutical MNPR-101-Lu in patients with advanced cancers · Dosed first patient with MNPR-101-Lu in December 2024 · Presented encouraging human clinical imaging and dosimetry data of MNPR-101-Zr at the European Association of Nuclear Medicine (“EANM”) 2024 Annual Congress · uPAR expression, as detected by MNPR-101-Zr, has been seen to date in breast, colorectal, pancreatic, adrenocortical carcinoma, and ovarian cancer patients · Filed a patent application covering new therapeutic radiopharmaceuticals based on a novel family of linkers used to connect radioisotopes with targeting agents, including Monopar’s uPAR targeting antibody MNPR-101. Announcement • Dec 21
Monopar Therapeutics Inc. has filed a Follow-on Equity Offering in the amount of $19.000002 million. Monopar Therapeutics Inc. has filed a Follow-on Equity Offering in the amount of $19.000002 million.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 798,655
Price\Range: $23.79
Transaction Features: Registered Direct Offering Announcement • Dec 06
Monopar Therapeutics Inc. Doses First Patient with its Novel Therapeutic Radiopharmaceutical MNPR-101-Lu Monopar Therapeutics Inc. announced the first patient ever dosed with MNPR-101-Lu. This novel therapeutic radiopharmaceutical combines MNPR-101, Monopar’s antibody that selectively targets the urokinase plasminogen activator receptor (uPAR), with the therapeutic radioisotope lutetium-177. uPAR is involved in tumor growth and metastasis, and is found in some of the most aggressive, deadly cancers, including pancreatic, ovarian, triple negative breast, and colorectal cancers. The MNPR-101-Lu intravenous infusion was well-tolerated with no serious adverse reactions reported. This patient, dosed under a compassionate use protocol in the US, has metastatic pancreatic cancer, and prior to dosing, the cancer was imaged using MNPR-101-Zr (a zirconium-89 imaging radioisotope conjugated to MNPR-101) with a PET/CT scanner and showed uPAR expression. Monopar is actively enrolling participants in two Phase 1 clinical studies in Australia, evaluating MNPR-101-Zr for imaging and MNPR-101-Lu for treatment of advanced solid tumors. Announcement • Oct 31
Monopar Therapeutics Inc. has completed a Follow-on Equity Offering in the amount of $19.200025 million. Monopar Therapeutics Inc. has completed a Follow-on Equity Offering in the amount of $19.200025 million.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 1,181,540
Price\Range: $16.25
Discount Per Security: $1.1375 Announcement • Oct 29
Monopar Therapeutics Inc. has filed a Follow-on Equity Offering. Monopar Therapeutics Inc. has filed a Follow-on Equity Offering.
Security Name: Common Stock
Security Type: Common Stock Announcement • Oct 16
Monopar Expands Radiopharma Intellectual Property Portfolio with Patent Filing on New Compounds and Linkers Monopar Therapeutics Inc. announced the filing of a provisional patent covering new therapeutic radiopharmaceuticals based on a family of linkers used to connect radioisotopes with targeting agents, including Monopar's uPAR targeting antibody MNPR-101. Highlights of the patent filing include: Composition of Matter: Claims cover a family of linkers, as well as Monopar's uPAR targeted agents linked with these along with therapeutic radioisotopes; Stability and Biodistribution: These proprietary new linkers have been created to enhance the stability and biodistribution of Monopar's array of therapeutic radiopharmaceuticals; and that this provisional patent could enable Monopar to use these linkers to create new proprietary radiopharmaceuticals going after well-established, high-value cancer targets of interest to Monopar or others in the industry opening the door to potential licensing and development collaborations. Announcement • Oct 07
Monopar Therapeutics Inc. Initiates Clinical Trial of Novel uPAR-Targeted Radiopharmaceutical Therapy in Advanced Cancers Monopar Therapeutics Inc. announced that the Phase 1a clinical trial for its novel therapeutic radiopharmaceutical MNPR-101-Lu (MNPR-101 conjugated to zirconium-177) is now active and recruiting patients with advanced cancers. The Phase 1a trial is an open-label dose-escalation study of MNPR-101-Lu in patients with solid tumors. The first clinical trial site activated for the study is the Melbourne Theranostic Innovation Centre (MTIC) in Australia. To help identify those patients most likely to benefit from MNPR-101-Lu, the trial will only be open to those participating in the ongoing MNPR-101-Zr Phase 1 imaging and dosimetry clinical trial. MNPR-101 is Monopar's proprietary antibody that targets the urokinase plasminogen activator receptor (uPAR), which is expressed in numerous tumor types including pancreatic, breast, colorectal, ovarian, and bladder. By selectively targeting uPAR, Monopar aims to deliver a radiopharma therapy that kills cancer cells while minimizing damage to healthy tissue. Both clinical (link) and preclinical (link) data to date have demonstrated highly specific and durable tumor uptake of MNPR-101- Zr (MNPR-101 conjUGated to zirconium -89). Announcement • Aug 28
Monopar Regains Compliance with Nasdaq Minimum Bid Price Rule Monopar Therapeutics Inc. announced that it received notice from The Nasdaq Stock Market LLC (Nasdaq) that it has regained compliance with the minimum bid price requirement under Nasdaq Listing Rule 5550(a)(2) as a result of the closing bid price of the Company’s common stock being $1.00 per share or greater for 10 consecutive trading sessions. The Company is now compliant with the minimum bid price listing standard for continued Nasdaq listing. Announcement • Aug 22
Monopar Receives Clearance to Proceed with Phase 1 Therapeutic Trial of Novel Radiopharmaceutical in Advanced Cancers Monopar Therapeutics Inc. announced it has received Human Research Ethics Committee (HREC) clearance in Australia to commence a Phase 1 therapeutic trial of its novel radiopharmaceutical MNPR-101-Lu. MNPR-101-Lu combines the therapeutic radioisotope lutetium-177 (Lu-177) with Monopar’s proprietary first-in-class humanized monoclonal antibody MNPR-101, which is highly selective against the urokinase plasminogen activator receptor (uPAR). The MNPR-101-Lu Phase 1 clinical trial will enroll patients with advanced solid cancers and will be a therapeutic follow-on study to the currently ongoing MNPR-101-Zr imaging and dosimetry clinical trial. The results from preclinical studies of MNPR-101-Lu are promising. In a 90-day efficacy study in a human pancreatic cancer xenograft mouse model as an example, MNPR-101-Lu demonstrated durable antitumor effects after a single injection, achieving complete elimination of tumors that lasted the duration of the study. The MNPR-101-Lu imaging data in a human pancreatic cancer xenograft mouse model presented in March provides additional insight into the strong therapeutic effect observed after a single injection of MNPR-101-Lu. The imaging data demonstrates the high specificity and durable uptake of MNPR-101-Lu in the tumor relative to normal tissue. Announcement • Aug 14
Monopar Therapeutics Inc. Announces Initial Data for First Patient Dosed in Radiopharma Phase 1 Clinical Trial of MNPR-101-Zr Monopar Therapeutics Inc. announced the successful dosing of the first patient in its open-label Phase 1 imaging and dosimetry clinical trial of its uPAR-targeted imaging radiopharmaceutical MNPR-101-Zr. MNPR-101-Zr was well-tolerated with no serious adverse reactions reported through the last imaging timepoint and the corresponding initial safety review. Preliminary analysis of MNPR-101-Zr’s pharmacokinetics and biodistribution suggests the low radiation dose to healthy tissue aligns with what was anticipated based on the previously presented MNPR-101-Zr preclinical biodistribution data. Dosimetry analysis showed absorbed organ doses were well below accepted safety limits; for example, the radiation dose to red bone marrow was about 14 mGy, which is around 150 times less than the generally accepted limit of 2-to-3 Gy. No unanticipated or excessive uptake of MNPR-101-Zr was observed in any critical organs through the end of the subject’s imaging period. The patient has metastatic disease from a cancer type not known for high uPAR expression. The study aims to include several patients with cancers known to express high levels of uPAR to gain insight into MNPR-101-Zr’s tumor uptake profile, in addition to patients with cancers of unknown uPAR expression. New Risk • Jul 25
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: -US$7.2m 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 (-US$7.2m free cash flow). Earnings are forecast to decline by an average of 17% per year for the foreseeable future. Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$15m net loss in 3 years). Share price has been volatile over the past 3 months (10% average weekly change). Shareholders have been diluted in the past year (33% increase in shares outstanding). Market cap is less than US$100m (€10.4m market cap, or US$11.3m). New Risk • Jul 17
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 18% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Earnings are forecast to decline by an average of 18% per year for the foreseeable future. Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$14m net loss in 3 years). Share price has been volatile over the past 3 months (11% average weekly change). Shareholders have been diluted in the past year (32% increase in shares outstanding). Market cap is less than US$100m (€11.8m market cap, or US$12.9m). Announcement • Jul 13
Monopar Therapeutics Inc., Annual General Meeting, Aug 05, 2024 Monopar Therapeutics Inc., Annual General Meeting, Aug 05, 2024. Location: 1000 skokie blvd., wilmette, il 60091, United States Announcement • Jul 09
Monopar Therapeutics Inc. Announces First Patient Enrolled in First-in-Human Phase 1 Trial for Its Novel Radiopharmaceutical MNPR-101-Zr Monopar Therapeutics Inc. announced the enrollment of the first patient in its first-in-human Phase 1 dosimetry and imaging clinical trial of MNPR-101-Zr. This novel radiopharmaceutical imaging agent combines MNPR-101, Monopar’s antibody that selectively targets the urokinase plasminogen activator receptor (uPAR), with the radioisotope zirconium-89. Monopar’s Phase 1 clinical trial, led by internationally recognized nuclear medicine physician Professor Rodney Hicks at the Melbourne Theranostic Innovation Centre, aims to assess the safety and dosimetry of MNPR-101-Zr in up to 12 patients with advanced cancers. This is the first human study to evaluate a radiolabeled monoclonal antibody targeting uPAR. Announcement • May 26
Monopar Therapeutics Inc. Announces CFO Changes Monopar Therapeutics Inc. announced that after a career spanning more than 35 years, Monopar’s Chief Financial Officer, Kim R. Tsuchimoto, will be retiring. Ms. Tsuchimoto will be transitioning over the next month, with her last day being on June 30, 2024. Ms. Tsuchimoto will remain as a member of Monopar’s Board of Directors. Monopar has been working over the past 6-plus months on a consulting basis with Karthik Radhakrishnan. Effective July 1, 2024, Mr. Radhakrishnan will be appointed Monopar’s Chief Financial Officer, Principal Accounting Officer, and Principal Financial Officer. Mr. Radhakrishnan brings over 20 years of financial strategy, investment and public company experience. Mr. Radhakrishnan has served as President and founder of Titania Partners LLC, a management consulting firm focused on the life science sector during which time he served as Chief Financial Officer of Santalis Pharmaceuticals Inc. and Chief Executive Officer of Asylia Therapeutics Inc. He has also previously served as Chief Financial Officer of Opexa Therapeutics Inc. and before that as Vice President at ING Investment Management in New York. Mr. Radhakrishnan is a Certified Financial Advisor charter holder and holds a B.S. in Chemical Engineering from Indian Institute of Technology, an M.S. in Civil and Environmental Engineering from State University of New York at Buffalo and an M.B.A. from University of Michigan Business School. Announcement • Apr 16
Monopar Therapeutics Inc. Announces Filing of Patent Protecting MNPR-101 Radiopharma Optimization Findings Monopar Therapeutics Inc. announced that it has filed a provisional patent application pertaining to the recent advancements and optimizations Monopar has achieved with its MNPR-101 radiopharmaceutical program. The provisional patent titled “Antibody Radioisotope Constructs” that was filed with the United States Patent and Trademark Office (USPTO) outlines the MNPR-101-Zr construct, including variations on the radioisotopes, linkers, and antibody which could enhance the clinical profile of the construct, including properties such as its stability and biodistribution. It also covers the formulations and uses of MNPR-101-Zr, a zirconium-89 imaging radioisotope labeled version of MNPR-101, Monopar’s proprietary first-in-class humanized monoclonal antibody that is highly-selective against the urokinase plasminogen activator receptor (uPAR). Monopar expects this provisional patent application to further strengthen its intellectual property around the MNPR-101 radiopharma program, under which the Company is aiming to develop therapies for numerous hard-to-treat advanced cancers that express uPAR. Monopar recently announced the initiation of its Phase 1 dosimetry clinical trial for MNPR-101-Zr in patients with advanced cancers. Announcement • Apr 10
Monopar Therapeutics Inc Initiates Radiopharma Phase 1 Clinical Trial for MNPR-101-Zr in Advanced Cancer Patients Monopar Therapeutics Inc. announced that its Phase 1 dosimetry clinical trial for its novel radiopharmaceutical imaging agent MNPR-101-Zr (MNPR-101 conjugated to zirconium-89) is now active and recruiting patients with advanced cancers. The antibody MNPR-101 targets the urokinase plasminogen activator receptor (uPAR), which is expressed on numerous tumor types including pancreatic, breast, colorectal, and bladder. The study is now open for enrollment at the Melbourne Theranostic Innovation Centre (MTIC) in Australia, and is being led by Professor Rodney Hicks, an internationally recognized physician and pioneer in the radiopharma space. MTIC will use one of the world's most sensitive, state-of-the-art, clinical total-body PET/CT (positron emission tomography–computed tomography) scanners, the Siemens Biograph Vision Quadra, to image the tumor targeting ability of MNPR-101-Zr in advanced cancer patients. The Phase 1 dosimetry trial is evaluating the safety and dosimetry of MNPR-101-Zr in up to 12 patients with advanced cancer. Preclinical data to date have shown highly specific and durable tumor uptake of MNPR-101-Zr in human cancer xenograft models. Moreover, Monopar recently shared positive preclinical efficacy data showing potent and durable anti-tumor activity of MNPR-101 bound to therapeutic radioisotopes. If the tumor uptake, biodistribution, and safety look encouraging in this Phase 1 clinical trial for MNPR-101-Zr, the Company plans to expand the study or initiate a new study to test the potential efficacy of MNPR-101 bound to a therapeutic radioisotope such as Ac-225 in patients with advanced cancers. New Risk • Mar 30
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: -US$7.9m 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 (-US$7.9m free cash flow). Share price has been highly volatile over the past 3 months (49% average weekly change). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$15m net loss in 3 years). Shareholders have been diluted in the past year (13% increase in shares outstanding). Market cap is less than US$100m (€9.38m market cap, or US$10.1m). Announcement • Mar 05
Monopar Therapeutics Inc. Announces Positive Preclinical Therapeutic Isotope Data for its MNPR-101 Radiopharma Program Monopar Therapeutics Inc. announced positive preclinical imaging data of a therapeutic radioisotope bound to its proprietary uPAR (urokinase plasminogen activator receptor) targeting agent MNPR-101. The data clearly demonstrate highly preferential uptake in the tumor. This is an extension of the tumor imaging and efficacy data Monopar released on February 22 (link), where Monopar disclosed biodistribution data with a diagnostic imaging radioisotope (Zirconium-89) as well as efficacy data with therapeutic radioisotopes (e.g., Actinium-225) bound to MNPR-101 in human tumor xenograft models. The new imaging data released provide additional support for the tumor-targeting ability of MNPR-101 and help explain the near complete elimination of tumors observed after a single injection of therapeutic radioisotopes bound to MNPR-101. Two of the most commercially successful radiopharmaceuticals, Pluvicto and Lutathera, use the therapeutic radioisotope Lutetium-177 (Lu-177). Beyond killing cancer cells, this radioisotope has the added advantage that its biodistribution can be visualized via SPECT (single-photon emission computed tomography) imaging. Monopar collected a sequential SPECT imaging time-series utilizing MNPR-101 conjugated to Lu-177 (MNPR-101-Lu) in a uPAR-expressing human pancreatic cancer xenograft model. High specificity and durable uptake of MNPR-101-Lu in the tumor relative to normal tissue is readily apparent, and these results are consistent with the previously released data for Monopar’s diagnostic imaging radiopharmaceutical MNPR-101-Zr. Monopar recently announced it received Human Research Ethics Committee (HREC) clearance in Australia to commence a Phase 1 dosimetry clinical trial for MNPR-101-Zr in advanced cancer patients. The data disclosed further support Monopar’s efforts to create a radiodiagnostic and radiotherapeutic pairing to image and treat uPAR-positive cancers. Announcement • Feb 29
Nasdaq Grants Extension to Monopar Therapeutics to Regain Compliance with the Minimum Bid Price Requirement As previously reported, on August 28, 2023, Monopar Therapeutics Inc. (the Company") received a letter from the Listing Qualifications Staff of The Nasdaq Stock Market LLC (Nasdaq") notifying the Company that, for the previous 30 consecutive business days, the bid price for the Company's common stock had closed below the minimum $1.00 per share requirement for continued listing on The Nasdaq Capital Market under Nasdaq Listing Rule 5550(a)(2) (the Minimum Bid Price Requirement"), and the Company was provided an initial period of 180 calendar days, or until February 26, 2024 (the Compliance Date"), to regain compliance with the Bid Price Requirement. On February 27, 2024, the Company received a letter from Nasdaq notifying that the Company had been granted an additional 180-day extension to August 26, 2024 (Extended Compliance Period") to regain compliance with the Minimum Bid Price Requirement, in accordance with Nasdaq Listing Rule 5810(c)(3)(A). If at any time during the Extended Compliance Period, the closing bid price of the Company's common stock is at least $1.00 per share for a minimum of 10 consecutive business days or up to 20 business days in certain circumstances in NASDAQ's discretion, the Staff will provide written confirmation that the Company has achieved compliance with the Minimum Bid Price Requirement. If the Company cannot demonstrate compliance during the Extended Compliance Period, the Staff will provide notice that the Company's common stock will be subject to delisting. At that time, the Company may appeal the Staff's determination to a hearings panel. The Company intends to continue to monitor the closing bid price of its common stock and will consider available options to regain compliance with the Minimum Bid Price Requirement, including potentially implementing a reverse stock split (if approved by the Company's shareholders). There can be no assurance that the Company will be able to regain compliance with the Minimum Bid Price Requirement during the Extended Compliance Period or will otherwise be in compliance with other Nasdaq listing requirements. Announcement • Feb 23
Monopar Therapeutics Inc. Announces Promising Preclinical Data for its MNPR-101 Radiopharma Program Targeting Advanced Cancers Monopar Therapeutics Inc. announced promising preclinical imaging and therapeutic efficacy data for its MNPR-101 radiopharmaceutical program. This novel first-in-class radiopharma program targets cancers expressing the urokinase plasminogen activator receptor (uPAR), which include a majority of all triple-negative breast, colorectal, and pancreatic cancers. MNPR-101 Conjugated to Imaging Radioisotope: Maximizing the dose delivered to the tumor relative to normal tissue is of paramount importance in radiopharmaceutical therapy. Monopar’s in-house radiopharmaceutical development team was able to significantly increase tumor uptake of MNPR-101-Zr while minimizing uptake in healthy tissue, as shown in this preclinical positron emission tomography (PET) sequential imaging time-series. The high specificity and durable tumor uptake are evident in the After Optimization panel below. MNPR-101 Conjugated to Therapeutic Radioisotopes: Preclinical data to date demonstrate compelling and durable anti-tumor benefits with MNPR-101 conjugated to therapeutic radioisotopes. Figure 2 below shows preclinical efficacy data in a triple negative breast cancer as well as a pancreatic cancer human tumor xenograft mouse model utilizing two different therapeutic radioisotopes conjugated to MNPR-101; one of these radioisotopes has already been disclosed as being actinium-225 (Ac-225). The results in both show near complete elimination of the tumor after a single injection of the radiopharmaceutical agent. These studies demonstrate the potential of a MNPR-101 based radiopharmaceutical to provide a very meaningful clinical benefit to patients. Announcement • Feb 20
Monopar Receives Clearance to Proceed with First-In-Human Phase 1 Trial of Novel Radiopharmaceutical MNPR-101-Zr in Advanced Cancers Monopar Therapeutics Inc. announced it has received Human Research Ethics Committee (HREC) clearance in Australia to commence a Phase 1 dosimetry trial of its novel radiopharmaceutical MNPR-101-Zr. The MNPR-101-Zr Phase 1 dosimetry clinical trial will enroll patients with advanced cancers and will utilize positron emission tomography (PET) imaging to assess tumor uptake, normal organ biodistribution, and safety. MNPR-101-Zr is a zirconium-89 (imaging radioisotope) labeled version of MNPR-101, Monopar’s proprietary first-in-class humanized monoclonal antibody that is highly selective against the urokinase plasminogen activator receptor (uPAR). PET imaging studies in preclinical xenograft models of triple-negative breast, colorectal, and pancreatic cancers displayed high and selective uptake of MNPR-101-Zr in these uPAR-expressing tumors. The imaging results, along with corresponding in vivo efficacy studies with actinium-225 (Ac-225, a powerful alpha-emitting therapeutic radioisotope) bound to MNPR-101 in preclinical xenograft tumor models, support the development MNPR-101 as a targeted radiopharmaceutical for multiple advanced cancer indications. If the tumor uptake, biodistribution, and safety look encouraging in this Phase 1 clinical trial, which is anticipated to enroll around 12 patients and to initiate in the near future, the plan is to evaluate the efficacy in humans of a therapeutically radio-labeled version of MNPR-101 bound to an isotope such as Ac-225. Announcement • Nov 02
Monopar Therapeutics Inc. Presents Data Showing Tumor Reduction Benefit of Camsirubicin from Ongoing Phase 1b at the 2023 Connective Tissue Oncology Society (CTOS) Annual Meeting Monopar Therapeutics Inc. will present data from its ongoing Phase 1b open-label, dose-escalating clinical trial of camsirubicin in patients with advanced soft tissue sarcoma (ASTS) later on November 1, 2023 Connective Tissue Oncology Society (CTOS) Annual Meeting, which is bringing together the world's leading sarcoma specialists. Clinical Trial Results To-Date: The Phase 1b clinical trial has enrolled 14 ASTS patients (9 female and 5 male) to-date ranging in age from 26 to 81 years (median = 52.5 years) across five dose cohorts. The trial is currently ongoing and is in the fifth dose level cohort (650 mg/m2). So far, 9 out of the 14 patients have had stable disease (SD, as defined by RECIST 1.1 criteria) after camsirubicin treatment. All patients in the fourth and fifth cohorts achieved stable disease, including the three most recently treated patients, each of whom also experienced an ~20% tumor size reduction at last study scan. One of these patients had unresectable cancer at study entry, but after the tumor size reduction, the patient became eligible for resection and underwent successful surgical removal of their cancer with clear margins. No dose-limiting toxicity, as defined in the protocol, has been observed to-date. A medically complex patient in the 650 mg/m2 dose cohort has an ongoing left ventricular ejection fraction (LVEF) decrease that is being monitored. This patient has a BMI of 42.5, one kidney, hypertension, a long standing heart murmur, and a maternal history of heart failure. No toxicities have occurred requiring expansion of a dose cohort, and the maximum tolerated dose (MTD) has not been reached. New Risk • Oct 13
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 German stocks, typically moving 8.9% 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 Share price has been highly volatile over the past 3 months (8.9% average weekly change). Earnings are forecast to decline by an average of 8.1% per year for the foreseeable future. Revenue is less than US$1m. Market cap is less than US$10m (€6.22m market cap, or US$6.53m). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$14m net loss in 3 years). Shareholders have been diluted in the past year (11% increase in shares outstanding). Announcement • Sep 01
Monopar Therapeutics Receives Letter from Nasdaq Regarding Bid Price Requirement On August 28, 2023, Monopar Therapeutics Inc. received a letter (the ‘Notice’) from the Listing Qualifications Department (the ‘Staff’) of The Nasdaq Stock Market LLC (‘Nasdaq’) notifying the Company that, for the previous 30 consecutive business days, the bid price for the Company’s common stock had closed below the minimum $1.00 per share requirement for continued listing on The Nasdaq Capital Market under Nasdaq Listing Rule 5550(a)(2) (the ‘Bid Price Requirement’). The Notice has no effect at this time on the Company’s common stock, which continues to trade on The Nasdaq Capital Market under the symbol ‘MNPR.’ In accordance with Nasdaq Listing Rule 5810(c)(3)(A), the Company has been provided an initial period of 180 calendar days, or until February 26, 2024 (the ‘Compliance Date’), to regain compliance with the Bid Price Requirement. If, at any time before the Compliance Date, the bid price for the Company’s common stock closes at $1.00 or more for a minimum of 10 consecutive business days, the Staff will provide written notification to the Company that it has regained compliance with the Bid Price Requirement, unless the Staff exercises its discretion to extend this 10-day period pursuant to Nasdaq Listing Rule 5810(c)(3)(H). If the Company is not in compliance with the Bid Price Requirement by the Compliance Date, the Company may qualify for a second 180 calendar day compliance period. To qualify, the Company would be required to meet the continued listing requirement for market value of publicly held shares and all other initial listing standards for The Nasdaq Capital Market, with the exception of the Bid Price Requirement, as of the Compliance Date and would need to provide written notice of its intention to cure the deficiency during the second compliance period. If the Company does not qualify for or fails to regain compliance during the second compliance period, then the Staff will provide written notification to the Company that its common stock will be subject to delisting. At that time, the Company may appeal the Staff’s delisting determination to the Nasdaq Hearings Panel. However, there can be no assurance that, if the Company receives a delisting notice and appeals the delisting determination, such an appeal would be successful. The Company will continue to monitor the closing bid price of its Common Stock and seek to regain compliance with all applicable Nasdaq requirements within the allotted compliance periods. There can be no assurance that the Company will regain compliance with the minimum bid price requirement during the 180-day compliance period, secure a second period of 180 days to regain compliance or maintain compliance with the other Nasdaq listing requirements. New Risk • Aug 15
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 8.1% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (9.4% average weekly change). Earnings are forecast to decline by an average of 8.1% per year for the foreseeable future. Revenue is less than US$1m. Market cap is less than US$10m (€8.91m market cap, or US$9.74m). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$14m net loss in 3 years). Shareholders have been diluted in the past year (11% increase in shares outstanding). New Risk • Aug 11
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 8.3% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Earnings are forecast to decline by an average of 8.3% per year for the foreseeable future. Revenue is less than US$1m. Market cap is less than US$10m (€9.04m market cap, or US$9.90m). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$14m net loss in 3 years). Share price has been volatile over the past 3 months (9.4% average weekly change). Shareholders have been diluted in the past year (3.9% increase in shares outstanding). Announcement • Aug 09
Monopar Therapeutics Inc. Provides Update on Camsirubicin Clinical Trial Monopar Therapeutics Inc. provided an update from its currently enrolling multi-center open-label Phase 1b clinical trial of camsirubicin in patients with advanced soft tissue sarcoma (ASTS). Both patients treated to date at the 650 mg/m2 dose level have experienced tumor size reductions – of 18% and 20% respectively – after the first two cycles of camsirubicin treatment. Both patients are set to receive additional cycles of camsirubicin treatment, as well, which may result in further tumor size reduction. The Phase 1b clinical trial data is continuing to support Monopar’s dose-response hypothesis with camsirubicin. The best response seen prior to the current 650 mg/m2 dose level was at the immediately prior dose level (520 mg/m2), which was a 21% reduction in tumor size in a patient after receiving six cycles of camsirubicin treatment. This patient’s cancer was unresectable at study entry, but after the tumor size reduction, became eligible and the patient underwent successful surgical removal of their cancer with clear margins. Furthermore, all three patients at the 520 mg/m2 dose level achieved stable disease and had either a net reduction or no overall change in tumor size per RECIST 1.1 while on study drug. Additionally, no drugrelated cardiotoxicity has been observed in the trial to date as evaluated by the industry standard left ventricular ejection fraction (LVEF), and no toxicities have been experienced by any patient that have required expanding the size of a dose cohort. Further, 71% of camsirubicin patients have experienced no hair loss, and only approximately 14% have experienced >50% hair loss, with the remainder having low grade hair loss. This compares favorably to the approximately 50% of doxorubicin treated patients in recent ASTS clinical trials reporting some amount of hair loss, with the majority of these patients experiencing >50% hair loss. Only 14% of camsirubicin patients in the Phase 1b trial have experienced mild-to-severe oral mucositis. This compares favorably to the roughly 35-40% of doxorubicin-treated patients in recent ASTS clinical trials that experienced mild-to-severe oral mucositis. ASTS is a deadly cancer with inadequate treatment options. Doxorubicin is currently the first-line standard of care treatment for most types of ASTS, and the average life expectancy from time of diagnosis for these patients is only about 12 to 15 months. Because of the risk of irreversible heart damage, patients discontinue doxorubicin treatment after just 6 to 8 cycles. Camsirubicin has been designed to retain the anti-cancer activity while avoiding the irreversible heart damage that is seen with doxorubicin. The value-driving hypothesis for camsirubicin is straightforward: modifying doxorubicin in order to reduce cardiac damage could enable higher and longer dosing, resulting in better efficacy and patient outcomes. The purpose of this dose escalation Phase 1b trial is to determine the maximum tolerated dose (MTD) of camsirubicin. Once the MTD is reached, Monopar has a clinical collaboration agreement in place with the Spanish Sarcoma Group (Grupo Español de Investigación en Sarcomas, or GEIS) to conduct a multi-country randomized Phase 2 clinical trial. The Phase 2 plan is to evaluate camsirubicin head-to-head against doxorubicin in patients with ASTS, with GEIS as the study sponsor with support from Monopar. New Risk • Jul 26
New major risk - Market cap size The company's market capitalization is less than US$10m. Market cap: €8.73m (US$9.67m) This is considered a major risk. Companies with a small market capitalization 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 Revenue is less than US$1m. Market cap is less than US$10m (€8.73m market cap, or US$9.67m). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$13m net loss in 3 years). Share price has been volatile over the past 3 months (9.7% average weekly change). Shareholders have been diluted in the past year (4.8% increase in shares outstanding). Announcement • Jun 02
Monopar Therapeutics Inc. Announces Encouraging Camsirubicin Phase 1b Trial Update Monopar Therapeutics Inc. announced an update from its currently enrolling multi-center open-label Phase 1b clinical trial of camsirubicin in patients with advanced soft tissue sarcoma (ASTS). Background on ASTS and Camsirubicin ASTS is a diverse type of cancer that typically develops in the connective tissue of the body and which has metastasized (spread) or is not amenable to surgery. Currently, doxorubicin is the first-line standard of care treatment for most types of ASTS. Doxorubicin is one of the most widely used cancer drugs worldwide with FDA approval in ASTS and 13 additional cancer indications. Unfortunately, although higher doses of doxorubicin are known to be more effective at treating cancer, the risk of irreversible heart damage increases with the cumulative dose and limits the lifetime amount that a patient can receive. The hypothesis for camsirubicin is straightforward: modifying doxorubicin in order to reduce cardiac damage could enable higher and longer dosing, resulting in better efficacy and patient outcomes. Updates from Currently Enrolling Phase 1b Clinical Trial: One patieient at the 520 mg/m2 dose level, unresectable at study entry, was deemed eligible for tumor resection after several cycles of camsirubic in treatment and a corresponding 21% reduction in tumor dimensions. This patient recently underwent surgical resection of the cancer. This is supportive of doseSHY-response hypothesis with camsirubicin. Two patients are currently enrolled in the fifth dose-SHYlevel cohort (650 mg/m2), which is nearly 2.5x the dose evaluated in any prior camsirubicin clinical trial (265mg/m2). No drugSHY-related cardiotoxicity has been observed in this trial to-date as evaluated by the industry standard left ventricular ejection fraction (LVEF). As previously reported, this trial continues to show less frequent and less severe hair loss and oral mucositis with camsirubic in patients with ASTS, with GEIS as the study sponsor with support from Monopar. Announcement • Feb 15
Monopar Therapeutics Inc. Announces Camsirubicin Clinical Program Update - Improved Side Effect Profile Seen to Date Compared to Doxorubicin Monopar Therapeutics Inc. announced the following update on its currently enrolling open-label Phase 1b camsirubicin Maximum Tolerated Dose (MTD) trial in patients with advanced soft tissue sarcoma (ASTS): Monopar has opened enrollment for the fifth dose level cohort, at an increased dose of 650 mg/m2, which is nearly 2.5x the highest dose evaluated in any prior camsirubicin clinical trial. To date, no drug-related cardiotoxicity has been observed with camsirubicin treatment as evaluated by the industry standard left-ventricular ejection fraction (LVEF). This compares favorably to the well-documented dose-restricting cardiotoxicity experienced with doxorubicin treatment, the current first-line treatment for ASTS. Only 17% of camsirubicin patients in the trial have experienced low grade hair loss; another 8% have experienced >50% hair loss. This compares favorably to the approximately 50% of doxorubicin treated patients in recent ASTS clinical trials reporting some amount of hair loss, with the majority of these patients experiencing >50% hair loss. Only 8% of camsirubicin patients in the trial have experienced low grade mild oral mucositis. This compares favorably to the roughly 35-40% of doxorubicin treated patients in recent ASTS clinical trials that experienced mild-to-severe oral mucositis. In addition to the initial Sarcoma Oncology Research Center clinical trial site in Santa Monica, CA, Monopar recently welcomed a second clinical trial site with Dr. Lee Cranmer and the Sarcoma Clinic at the Fred Hutchinson Cancer Center/University of Washington in Seattle, WA. Announcement • Jan 28
Monopar Therapeutics Inc. Announces Projected Timeline of Upcoming Quarter 1 2023 Data Events for Validive, Camsirubicin, and MNPR-101 RIT Monopar Therapeutics Inc. announced it is planning to report over the next two months: the interim go/no-go analysis for its Validive Phase 2b/3 VOICE trial, clinical data from its camsirubicin Phase 1b trial, and a preclinical progress update on its MNPR-101 RIT program. February 2023: Camsirubicin Phase 1b Clinical Trial Data Update: In addition to the previously reported improvement in median progression free survival over the prior camsirubicin Phase 2 study, Monopar plans to provide details of the Phase 1b trial’s improved toxicity and safety observed to date compared to doxorubicin. MNPR-101 Radioimmunotherapeutic (RIT) Preclinical Data Update: Monopar plans to report an update on recently generated preclinical data and anticipated next steps with partner NorthStar Medical Radioisotopes. March 2023: Interim Go/no-go Analysis for Validive Phase 2b/3 VOICE Trial: Monopar expects to have the interim analysis completed and to report out the go/no-go decision during March 2023; in the intervening time, patient enrollment and addition of new sites continue in preparation for a potentially positive interim. Announcement • Jan 19
Monopar Therapeutics Inc. Announces Successful Advancement of Camsirubicin Phase 1b Clinical Trial Past Fourth Cohort, Escalates Next to 650mg/m2 Monopar Therapeutics Inc. announced the positive recommendation from its safety review committee to advance to the fifth dose level (650 mg/m2) in its camsirubicin Phase 1b trial in patients with advanced soft tissue sarcoma (ASTS). This decision was made following a review of safety data from the patients in the first four dose cohorts. Camsirubicin is a novel, proprietary analog of the widely used cancer drug doxorubicin. It has been previously investigated in ASTS patients in a Phase 1 and a single-arm Phase 2 clinical trial. In these studies, no camsirubicin-treated patients developed the irreversible cardiotoxicity common to doxorubicin at higher cumulative doses. The most frequent adverse event observed in the Phase 1 study was neutropenia, which was mitigated in the Phase 2 study using prophylactic G-CSF. Based on encouraging clinical results from prior clinical trials, the current Phase 1b trial is designed to test camsirubicin at progressively higher doses than previously administered while using concomitant prophylactic G-CSF to prevent neutropenia. Soft tissue sarcomas (STS) are a diverse type of cancer that typically develop in the connective tissue of the body. Announcement • Dec 13
Monopar Therapeutics Inc. Announces Promising MNPR-202 Data from Ongoing National University of Singapore Collaboration Monopar Therapeutics Inc. released promising data with MNPR-202 from its ongoing collaboration with the Cancer Science Institute of Singapore (CSI Singapore) at the National University of Singapore (NUS). The data are displayed in the poster that NUS and Monopar will be presenting this Sunday at the 64thAmerican Society of Hematology (ASH) Annual Meeting & Exposition (ASH 2022). MNPR-202 is a promising DNA Damaging Response (DDR) drug candidate, and analog of doxorubicin. It has the same potentially non-cardiotoxic backbone as camsirubicin, Monopar’s clinical stage drug candidate that has shown a favorable heart toxicity profile to-date across three trials, but MNPR-202 is modified at additional sites with the intention of evading certain tumors’ resistance mechanisms to doxorubicin. Prior exploratory preclinical studies in solid tumors have shown MNPR-202 to have a similar cytotoxic potency to doxorubicin while retaining that potency even in doxorubicin-resistant cancers. Preclinical Results To-Date: Data from blood cancer preclinical studies to date show that MNPR-202: has a similar cytotoxic potency to doxorubicin. generates increased DNA damage compared to doxorubicin. has a unique immune activation profile versus doxorubicin. demonstrates increased apoptosis compared to doxorubicin. causes a distinct set of genes to be upregulated and downregulated versus doxorubicin; and may be superior to doxorubicin in certain combination treatment regimens. A combination drug screen with 183 compounds was performed, revealing distinct differences in the synergy profile between doxorubicin and MNPR-202 with other compounds. As example, MNPR-202 demonstrated a more favorable synergy profile with volasertib compared to doxorubicin. The results generated to date suggest doxorubicin and MNPR-202 have a similar cytotoxic potency, but likely work through distinct cellular pathways and cause a different ancillary innate immune activation. These intracellular differences also influence drug synergies observed with the two compounds, implying that in the context of certain combinatorial regimens, MNPR-202 may be superior to doxorubicin. MNPR-202 also shows the potential to work in cancers resistant to doxorubicin. Taken together, the company believe MNPR-202 has potential to disrupt the current chemotherapy landscape and impact a broad range of cancers. Board Change • Nov 18
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. 5 experienced directors. No highly experienced directors. Independent Director Arthur Klausner was the last director to join the board, commencing their role in 2017. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model. Announcement • Nov 17
Monopar Therapeutics Inc. Announces Encouraging Clinical Data from Ongoing Camsirubicin Phase 1B Trial Monopar Therapeutics Inc. released encouraging data from its ongoing Phase 1b open-label clinical trial of camsirubicin in advanced soft tissue sarcoma patients. The data is displayed in the poster Monopar will be presenting later at the 2022 Connective Tissue Oncology Society Annual Meeting, which is bringing together the world’s leading sarcoma specialists. Camsirubicin Background: Doxorubicin is one of the most widely used cancer drugs worldwide. Unfortunately, although higher doses of doxorubicin are known to be more effective at treating cancer, the risk of irreversible heart damage increases with the cumulative dose and limits the lifetime amount that a patient can receive. As a result, even if patients are responding, they discontinue doxorubicin treatment typically after only 6 to 8 cycles. The hypothesis behind camsirubicin is straightforward: molecularly modifying doxorubicin in order to reduce cardiac damage could enable higher and longer dosing, resulting in better patient outcomes. The prior exploratory clinical studies of camsirubicin in cancer patients showed the potential to treat patients with high doses for a year or longer. The preclinical and exploratory clinical studies also showed no irreversible heart toxicity with camsirubicin. The current Phase 1b study is designed to evaluate whether camsirubicin can be dosed even higher than previously achieved and continue for longer than doxorubicin. Camsirubicin Phase 1b Clinical Trial Design: The Phase 1b trial is an open label dose escalation design to determine the maximum tolerated dose of camsirubicin in advanced soft tissue sarcoma patients. The average life expectancy of ASTS patients at diagnosis is about 12 to 15 months, and doxorubicin is the current first-line standard of care treatment for most types of ASTS. The starting dose for the first three patients was set at 265 mg/m2, the highest dose previously tested in the exploratory clinical trials. With a positive recommendation from the trial safety review committee at the completion of each dose level,the trial is allowed to then treat at least three new patients at the next dose level, which is 25% higher. Clinical Trial Results To-Date: The Phase 1b clinical trial has enrolled 11 patients (8 female and 3 male) to-date ranging in age from 26 to 81 years 5 of 10 patients have exhibited stable disease at 12 weeks. 1 patient met the criteria for SD at the first CT scan but unfortunately died due to COVID-19 and was not evaluable at the 12-week CT scan. The ASTS subtype patients achieving stable disease on camsirubicin are in line with those also more likely to respond to doxorubicin. These encouraging results are in the face of all patients in the trial, at the time of enrollment, having had an Eastern Cooperative Oncology Group (ECOG) performance score of 1, or “strenuous physical activity restricted”. This suggests that the patients enrolled in this Phase 1b trial are more medically complex and challenging than those in other recent ASTS studies. The majority of patients enrolled in first-line ASTS trials of the past few years have had no physical activity impairments, with only a minority having an ECOG score of 1 or worse. Worse ECOG scores at the time of enrollment for advanced cancer patients are associated with reduced patient survival. The trial is presently at the fourth dose-level cohort (520mg/m2), almost twice the trial’s starting dose. No drug-related clinical cardiotoxicity has been observed in any patient, as tracked by left ventricular ejection fraction, an industry standard measure of cardiotoxicity. In line with the hypothesis of reaching a higher dose, the trial is continuing to enroll and dose-escalate, as there have been no signs of having yet hit the maximum tolerated dose. Announcement • Oct 06
Monopar Announces Completion of Phase 2b Enrollment and Commencement of Phase 3 Enrollment in Its Voice Trial for Severe Oral Mucositis Monopar Therapeutics Inc. announced an update on its actively enrolling Validive Phase 2b/3 VOICE clinical trial for the prevention of severe oral mucositis (SOM) in patients undergoing chemoradiotherapy (CRT) for oropharyngeal cancer. This is an indication for which there is currently no FDA-approved preventative or treatment. Monopar announced it has enrolled greater than 130 patients, has completed enrollment for the Phase 2b portion of the trial, has activated a total of 68 sites, has recently expanded the trial to include sites in Germany and Poland, and has commenced enrollment for the Phase 3 portion of the trial. The blinded interim analysis of clinical data from the Phase 2b patient cohort of the trial, to be performed by an independent data monitoring board, will be used to guide the Company as to whether or not to continue enrolling the Phase 3 portion of the trial. This analysis should be complete with interim results announced during First Quarter 2023. Announcement • May 02
Monopar Therapeutics Inc., Annual General Meeting, Jun 28, 2022 Monopar Therapeutics Inc., Annual General Meeting, Jun 28, 2022, at 11:00 Central Standard Time. Location: 1000 Skokie Blvd. Wilmette Illinois United States Agenda: To consider and vote upon the election of five directors named herein to its Board of Directors to serve until next annual meeting of stockholders or until their respective successors are duly elected and qualified; to consider ratification of the selection of BPM LLP as independent registered public accounting firm for the year ending December 31, 2022; and to approve an amendment to the 2016 Stock Incentive Plan. Board Change • Apr 29
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. 5 experienced directors. No highly experienced directors. Independent Director Arthur Klausner was the last director to join the board, commencing their role in 2017. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model. Announcement • Apr 03
Monopar Therapeutics Announces Resignation of Andrew P. Mazar as Member of the Board of Directors, Effective April 8, 2022 Monopar Therapeutics Inc. announced that Dr. Andrew P. Mazar, the Company’s Co-Founder, Executive Vice President of Research and Development, Chief Scientific Officer and Board Member, will be resigning from his position with the Company and as a member of the Company’s Board of Directors effective April 8, 2022. Announcement • Feb 16
Monopar Announces Clinical and Preclinical Program Updates Monopar Therapeutics Inc. announced program updates across its pipeline and anticipated 2022 highlights. Severe oral mucositis (SOM) is a painful and debilitating ulceration of the mucosal membranes of the mouth caused by the chemoradiotherapy used to treat patients with oropharyngeal cancer. SOM prevents these patients from being able to drink and/or eat, and can increase hospitalization rates, cause interruption or termination of chemoradiotherapy before completion of treatment, and cause aspiration induced lung injury. SOM results in significant short- and long-term negative impacts on clinical outcomes and quality of life. There is no FDA-approved preventative or treatment option for the estimated >40,000 newly diagnosed individuals with oropharyngeal cancer in the US who may receive chemoradiation each year and are at-risk of developing SOM. Recent trials show that the majority of oropharyngeal cancer patients receiving chemoradiotherapy will develop SOM. Validive is a once daily self-administered mucoadhesive tablet designed to prevent SOM in oropharyngeal cancer patients who receive hemoradiotherapy. Monopar is evaluating Validive in this patient population in the international Phase 2b/3 VOICE study. Updated highlights of this trial include: 43 clinical sites opened to date, active and enrolling patients in both the US and Europe. Interim analysis is currently anticipated to be reached in mid-2022. Further, based on timely findings extracted from public reporting of recently completed SOM trials, the Company is presently evaluating potential enhancements to and exact timing of the interim analysis. Advanced soft tissue sarcoma (ASTS) is a diverse type of cancer that typically develops in the connective tissue of the body and which has metastasized (spread) or is not amenable to surgery. The average life expectancy from time of diagnosis for patients with ASTS is about 12 to 15 months. Doxorubicin is the current 1st line standard of care treatment for most types of ASTS. Doxorubicin is FDA approved in 14 different types of cancers including soft tissue and bone sarcomas; metastatic stomach, ovarian, thyroid, lung, and breast cancer; acute myeloid and lymphoblastic leukemia; Hodgkin and non-Hodgkin lymphoma; and neuroblastoma, and is one of the most widely used cancer drugs around the world. It is a drug that becomes more effective at higher doses. Unfortunately, due to the potential development of irreversible heart damage, patients stop doxorubicin treatment once a certain cumulative lifetime dose limit threshold is reached. Dosing higher than this lifetime limit sharply increases the rate of irreversible heart damage. As a result, even if patients are responding to treatment, they discontinue doxorubicin treatment typically after only 6 to 8 cycles of doxorubicin. The Company is currently enrolling patients in an open-label Phase 1b dose escalation trial in ASTS patients to evaluate higher doses of camsirubicin than have been used in the previous Phase 1 and Phase 2 trials. Although this Phase 1b is designed to determine the maximum tolerated dose of camsirubicin, given the historical dose-dependent anti-tumor response repeatedly demonstrated with doxorubicin, efficacy measurements are being tracked in these patients as the dose is increased. Announcement • Dec 10
Monopar Therapeutics Inc. Advances Dosing of Camsirubicin to Higher Level Than Tested In Any Previous Clinical Trial Monopar Therapeutics Inc. announced the positive recommendation from its safety review committee to escalate to the second dose level in its camsirubicin Phase 1b trial in patients with advanced soft tissue sarcoma (ASTS). This decision was made following a review of safety data from the patients in the first dose cohort and will allow evaluation of a higher dose level of camsirubicin than has been administered in any prior clinical trial. Announcement • Sep 14
Monopar Therapeutics Inc. Expands Phase 2b/3 VOICE Clinical Trial to Europe Monopar Therapeutics Inc. announced it has received authorization to proceed with the Phase 2b/3 VOICE clinical trial in France. The trial, which began earlier this year in the US, is evaluating Validive® (clonidine HCl MBT) to prevent the onset of severe oral mucositis (SOM) in oropharyngeal cancer (OPC) patients treated with chemoradiotherapy. The trial’s rationale and design will be presented at the upcoming European Society for Medical Oncology (ESMO) Congress 2021. Monopar anticipates reaching the interim of the Phase 2b/3 VOICE trial in the first half of 2022. Announcement • Aug 05
Monopar Therapeutics Inc. Announces FDA Clearance to Proceed with Camsirubicin Clinical Trial Targeting Advanced Soft Tissue Sarcoma Monopar Therapeutics Inc. announced clearance from the US Food and Drug Administration (FDA) to proceed under its IND with an open-label Phase 1b dose-escalation trial evaluating camsirubicin plus growth factor support (pegfilgrastim) in patients with advanced soft tissue sarcoma (ASTS). The Company anticipates dosing the first patient in the trial in the fourth quarter of this year. Announcement • Jun 25
Monopar Therapeutics Inc. to Present Results from Analysis of Oropharyngeal Cancer Patients in Completed Phase 2 Validive® Trial At MASCC/ISOO Monopar Therapeutics Inc. announced that it will present its oropharyngeal cancer patient population analysis of the Phase 2 Validive® (clonidine HCl MBT) trial for the prevention of chemoradiotherapy-induced severe oral mucositis in head and neck cancer at the Multinational Association of Supportive Care in Cancer and International Society of Oral Oncology (MASCC/ISOO) 2021 annual meeting. This analysis provided the rationale for the design of Monopar’s Phase 2b/3 VOICE trial, which is open and accruing oropharyngeal cancer patients in the US. About Validive®: Validive (clonidine mucobuccal tablet; clonidine MBT) is a novel mucobuccal tablet (MBT) formulation. The mucobuccal tablet provides for prolonged and enhanced local delivery of clonidine to the regions of oral mucosal radiation damage in OPC patients. The tablet is self-administered once daily in the patient’s home setting with the patient placing it under the upper lip where it adheres to the gums and dissolves over several hours, continuously releasing clonidine into the saliva. Clonidine agonizes the alpha-2 adrenergic receptor on macrophages (white blood cells present in the immune tissues of the oropharynx), decreasing the macrophages’ expression of the destructive cytokines that are released in response to radiotherapy. A completed double-blind, randomized, placebo-controlled Phase 2 clinical trial of Validive showed reduced incidence compared to placebo (absolute decrease of 26%, relative decrease of 40%) in OPC patients treated with Validive 100 µg, a safety profile similar to placebo, and a high rate of treatment compliance (over 90%). Announcement • May 25
Monopar Therapeutics Inc. and Northstar Medical Radioisotopes Announce Patent Filing on Promising Radiopharmaceutical Discovery Monopar Therapeutics Inc. and NorthStar Medical Radioisotopes, LLC, announced the filing of a provisional patent with the U.S. Patent and Trademark Office (USPTO) titled “Bio-Targeted Radiopharmaceutical Compositions Containing Ac-225 and Methods of Preparation.” Radiopharmaceutical therapy is a promising approach to treat cancer and other diseases using radioactive metals bound with proteins/antibodies to target and kill cells. Actinium-225 (Ac-225) is emerging as a radioactive isotope of choice for radiopharmaceuticals due to favorable properties such as its long half-life, high potency, and induction of localized cell death. This provisional patent relates to the unexpected observation by Monopar and NorthStar that using the metal binding agent 3,6,9,15-tetraazabicyclo[9.3.1]pentadeca-1(15),11,13-triene-3,6,9-triacetic acid (PCTA) to attach Ac-225 to antibodies resulted in nearly 100% binding of Ac-225 to the PCTA-antibody conjugates. If validated through further evaluation, it could potentially improve efficacy and safety and enhance manufacturing efficiency of Actinium-based radiopharmaceuticals. Based on Monopar and NorthStar’s work to date, PCTA-antibody conjugates appear to bind Ac-225 and its daughter ions such as Bi-213 with high affinity. This could be important in the situation of transportation delays resulting in Ac-225 decaying during transport. Furthermore, when compared to DOTA (the standard binding agent for attaching Ac-225 to an antibody), PCTA-antibody conjugates displayed a significantly higher affinity to Ac-225. This high affinity binding may decrease the amount of Ac-225 and its daughter ions that detach from the antibody, which could potentially increase efficacy and reduce off-target toxicity and enable higher dosing. Monopar and NorthStar plan to explore both internal development and out-licensing opportunities of this promising approach in Actinium-based radiopharmaceuticals. Breakeven Date Change • May 17
Forecast to breakeven in 2025 The 3 analysts covering Monopar Therapeutics expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of US$2.14m in 2025. Average annual earnings growth of 7.1% is required to achieve expected profit on schedule. Announcement • Feb 19
Monopar Therapeutics Inc. Appoints Laura Kelly as Director of Clinical Operations Monopar Therapeutics Inc. announced the appointment of Laura Kelly as Director of Clinical Operations. Ms. Kelly will be responsible for managing Monopar’s clinical programs, including the recently launched Phase 2b/3 VOICE trial for the Company’s lead drug candidate Validive®. Ms. Kelly brings a wealth of clinical research experience, including oncology and the execution of Phase 1 through Phase 4 clinical trials, to the Monopar team. Prior to Monopar, Ms. Kelly served in strategic and clinical operation leadership roles at Merck/EMD Serono, AbbVie, Abbott Labs, and Amgen. Announcement • Feb 18
Monopar Announces First Patient Dosed in Its Phase 2b/3 VOICE Trial Evaluating Validive® for the Prevention of Chemoradiotherapy-Induced Severe Oral Mucositis (SOM) in Oropharyngeal Cancer (OPC) Monopar Therapeutics Inc. announced it has dosed the first patient in its Phase 2b/3 VOICE trial of Validive® for the prevention of chemoradiotherapy-induced severe oral mucositis in patients with oropharyngeal cancer (VOICE). Validive’s mucoadhesive buccal tablet formulation allows for prolonged and enhanced local delivery of drug to the regions of mucosal radiation damage, and its easy application under the upper lip allows for convenient once-daily self-administration in the patient’s home setting. The completed Validive Phase 2 trial showed that administering a single, once daily 100µg Validive tablet resulted in a 40% reduction in the incidence of SOM compared to placebo in OPC patients undergoing CRT treatment. Up to approximately 260 patients will be enrolled in the current multi-center, randomized, double-blind, placebo-controlled, adaptive design Phase 2b/3 VOICE trial. Announcement • Feb 13
Monopar Announces Publication Demonstrating Potential Utility of MNPR-101 as an Imaging Agent to Improve Surgical Outcomes in Bladder Cancer Monopar Therapeutics Inc. announced the publication of a peer-reviewed study in the European Journal of Cancer which shows the potential utility of MNPR-101 as a uPAR imaging agent to improve surgical outcomes in bladder cancer. Using Monopar’s proprietary humanized uPAR antibody, MNPR-101, a multimodal imaging probe was developed and tested in vivo in human bladder cancer models. The publication reports that high expression of uPAR in bladder cancer is localized at the tumor periphery, suggesting that using a fluorescent-conjugated MNPR-101 probe might allow surgeons to better visualize the borders of the tumor, potentially resulting in more complete tumor resection and thereby minimizing relapse. Similar approaches have been utilized successfully in the resection of other tumor types, such as breast cancer. Bladder cancer is often treated with transurethral resection to remove cancerous tissue; however, recurrence can occur in up to 78% of patients within 5 years. Up to 40% of recurrent cases develop muscle invasive disease, which has a poor prognosis and requires complete removal of the bladder. Many patients with muscle-invasive bladder cancer unfortunately go on to develop and succumb to metastatic disease. Is New 90 Day High Low • Jan 29
New 90-day high: €7.65 The company is up 88% from its price of €4.08 on 30 October 2020. The German market is up 20% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Biotechs industry, which is up 13% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is €3.15 per share. Is New 90 Day High Low • Dec 28
New 90-day high: €5.95 The company is up 44% from its price of €4.14 on 29 September 2020. The German market is up 7.0% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Biotechs industry, which is down 6.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is per share. Announcement • Dec 13
Monopar Therapeutics Inc. and NorthStar Medical Radioisotopes, LLC Announces Selection of uPRIT Candidate for Potential Treatment of Severe COVID-19 Monopar Therapeutics Inc. and NorthStar Medical Radioisotopes, LLC announced the selection of a uPRIT clinical candidate. Monopar and NorthStar partnered with IsoTherapeutics Group LLC to generate a panel of uPRIT leads, which were then screened by Aragen Bioscience Inc., resulting in the identification of a uPRIT clinical candidate plus several backup candidates. uPRITs are analogs of MNPR-101, Monopar’s proprietary humanized urokinase plasminogen activator receptor (uPAR) targeted antibody, that have been modified to enable attachment of a therapeutic radioisotope. uPRITs bind to uPAR with high affinity and are thought to selectively recognize the aberrantly activated, pro-inflammatory immune cells that express this target and also seem to be mediating the cytokine storm leading to respiratory failure and poor outcomes in severe COVID-19 patients. The cleaved, blood-circulating soluble form of uPAR, suPAR, has been gaining attention as a potentially important prognostic biomarker for severe COVID-19 in several recently published studies. Rovina et al. 2020 showed that patients with elevated levels of suPAR at the time of hospital admission are 17 times more likely to develop severe respiratory failure (p=0.0000000012); Arnold et al. 2020 showed suPAR to have the best performance in predicting outcome (such as intensive care unit admission and death) of all the biomarkers examined; and Eugen-Olsen et al. 2020 showed that low levels of suPAR are predictive of mild outcome in
COVID-19 patients. The aim with uPRITs is to bind to and rapidly eliminate the aberrantly activated immune cells, quickly shutting down the cytokine storm. If uPRITs are effective in this setting, they may also be effective in treating other diseases characterized by rapid and severe systemic inflammatory responses, including certain pneumonias and sepsis. Is New 90 Day High Low • Dec 11
New 90-day high: €5.00 The company is up 11% from its price of €4.52 on 11 September 2020. The German market is up 2.0% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Biotechs industry, which is down 8.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is per share. Is New 90 Day High Low • Oct 24
New 90-day low: €4.04 The company is down 36% from its price of €6.35 on 24 July 2020. The German market is down 1.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is down 12% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is per share. Is New 90 Day High Low • Oct 06
New 90-day low: €4.08 The company is down 39% from its price of €6.70 on 08 July 2020. The German market is up 2.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is down 7.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is per share. Announcement • Jul 02
Monopar Therapeutics Inc.(NasdaqCM:MNPR) dropped from Russell Microcap Value Index Monopar Therapeutics Inc.(NasdaqCM:MNPR) dropped from Russell Microcap Value Index 
