A Multicenter, Randomized, Controlled, Open-label, Rater-blinded Study to Evaluate Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of ALXN1840 Versus Standard of Care in Pediatric Participants With Wilson Disease

This study is being conducted to evaluate the efficacy, safety, pharmacokinetics (PK), and pharmacodynamics of ALXN1840 versus standard of care in pediatric participants with Wilson disease (WD).

Start Date13 Sep 2021

Sponsor / Collaborator

Alexion Pharmaceuticals, Inc.

EUCTR2020-005832-31-DK / Unknown statusPhase 2

Efficacy of ALXN1840 on human hepatic copper uptake quantified with 64CuCl2 PET/CT-scan. - ALXN1840-HV-Cu Absorption

Start Date13 Apr 2021

Sponsor / Collaborator

Alexion Pharmaceuticals, Inc.

EUCTR2021-000102-25-DK / Unknown statusPhase 2IIT

Efficacy of ALXN1840 on human biliary copper excretion quantified with 64CuCl2 PET/MR-scan - ALXN1840-WD-Cu Excretion

Start Date09 Apr 2021

Sponsor / Collaborator

Århus Universitetshospital

100 Clinical Results associated with Bis-choline tetrathiomolybdate

100 Translational Medicine associated with Bis-choline tetrathiomolybdate

100 Patents (Medical) associated with Bis-choline tetrathiomolybdate

137

Literatures (Medical) associated with Bis-choline tetrathiomolybdate

01 Oct 2024·JOURNAL OF ETHNOPHARMACOLOGY

Qiju Dihuang Pill protects the lens epithelial cells via alleviating cuproptosis in diabetic cataract

Article

Author: Kuang, Xinqi ; Gao, Yichen ; Tian, Fang ; Yang, Jun ; Mao, Han

ETHNOPHARMACOLOGICAL RELEVANCE:

Qiju Dihuang Pill (QDP) is a traditional Chinese medicine prescription for the treatment of eye diseases. Novel literature reports that copper-induced cell death, called as cuproptosis, is a copper-dependent and differs distinctly from other types of cell death.

AIM OF THE STUDY:

The present study aims to investigate whether QDP could protect lens epithelial cells via alleviating copper-induced death in diabetic cataract.

MATERIALS AND METHODS:

The different concentration of QDP medicated serum was administrated on high glucose (HG)-induced human lens epithelial cells (HLECs). The copper concentration was tested using Elabscience Copper Assay kit. The proliferation was detected using CCK-8 and EdU assays. The molecular binding was identified using RIP-PCR and luciferase reporter assay.

RESULTS:

Results indicated that HG culture condition triggered the copper concentration and repressed the proliferation of HLECs. Then, the elesclomol-Cu (Es-Cu) administration up-regulated the copper concentration and inhibited the proliferation, and cuproptosis inhibitor tetrathiomolybdate (TTM) could specifically reverse the consequence. QDP treatment reduced the copper concentration and cuproptosis-related genes (SLC31A1, FDX1). MeRIP-Seq and RIP-PCR confirmed that QDP reduced the stability of SLC31A1 mRNA through m⁶A modified site, and copper actually synergized the molecular binding efficiency. Rescue assay verified the role of QDP and SLC31A1 on HLECs' cuproptosis characteristic.

CONCLUSION:

This research identified the protective role of QDP on HG-induced HLECs in DC through decreasing m⁶A/SLC31A1-mediated cuproptosis in DC. This finding provides novel insights into mechanisms for QDP and sheds light on the multifaceted role of traditional prescription on DC.

01 Sep 2024·FREE RADICAL BIOLOGY AND MEDICINE

Superoxide signal orchestrates tetrathiomolybdate-induced longevity via ARGK-1 in Caenorhabditis elegans

Article

Author: Liu, Li ; Zhou, Yiming ; Wei, Fang ; Li, Guolin ; Zhang, Mengting ; Duan, Zhigui ; Lu, Siyu

PURPOSE:

While reactive oxygen species (ROS) have been identified as key redox signaling agents contributing to aging process, which and how specific oxidants trigger healthy longevity remain unclear. This paper aimed to explore the precise role and signaling mechanism of superoxide (O₂^•-) in health and longevity.

METHODS:

A tool for precise regulation of O₂^•- levels in vivo was developed based on the inhibition of superoxide dismutase 1 (SOD1) by tetrathiomolybdate (TM) in Caenorhabditis elegans (C. elegans). Then, we examined the effects of TM on lifespan, reproduction, lipofuscin accumulation, mobility, and stress resistance. Finally, the signaling mechanism for longevity induced by TM-O₂^•- was screened by transcriptome analysis and tested in sod-1 and argk-1 RNAi strains, sod-2, sod-3, and daf-16 mutants.

RESULTS:

TM promoted longevity in C. elegans with a concomitant extension of healthy lifespan as indicated by increasing fertility and mobility and reducing lipofuscin accumulation, as well as enhanced resistance to different abiotic stresses. Mechanically, TM could precisely regulate O₂^•- levels in nematodes via modulating SOD1 activity. An O₂^•- scavenger Mn(III)TBAP abolished TM-induced lifespan extension, while an O₂^•- generator paraquat at low concentration mimicked the life prolongation effects. The longevity in TM-treated worms was abolished by sod-1 RNAi but was not affected in sod-2 or sod-3 mutants. Further transcriptome analysis revealed arginine kinase ARGK-1 and its downstream insulin/insulin-like growth factor 1 signaling (IIS) as potential effectors for TM-O₂^•‾-induced longevity, and argk-1 RNAi or daf-16 mutant nullified the longevity.

CONCLUSIONS:

These findings indicate that it is feasible to precisely control specific oxidant in vivo and O₂^•- orchestrates TM-induced health and longevity in C. elegans via ARGK-1-IIS axis.

01 Apr 2024·Journal of hepatology

Effects of tetrathiomolybdate on copper metabolism in healthy volunteers and in patients with Wilson disease

Article

Author: Munk, Ditte Emilie ; Sandahl, Thomas Damgaard ; Kirk, Frederik Teicher ; Swenson, Eugene Scott ; Vendelbo, Mikkel Holm ; Quicquaro, Adam Michael ; Schilsky, Michael L ; Ott, Peter ; Larsen, Agnete

BACKGROUND & AIMS:

In Wilson disease (WD), copper accumulates in the liver and brain causing disease. Bis-choline tetrathiomolybdate (TTM) is a potent copper chelator that may be associated with a lower risk of inducing paradoxical neurological worsening than conventional therapy for neurologic WD. To better understand the mode of action of TTM, we investigated its effects on copper absorption and biliary excretion.

METHODS:

In a double-blind randomized setting, hepatic ⁶⁴Cu activity was examined after orally administered ⁶⁴Cu by PET/CT in 16 healthy volunteers before and after seven days of TTM treatment (15 mg/d) or placebo. Oral ⁶⁴Cu was administered one hour after the final TTM dose. Changes in hepatic ⁶⁴Cu activity reflected changes in intestinal ⁶⁴Cu uptake. Additionally, in four patients with WD, the distribution of ⁶⁴Cu in venous blood, liver, gallbladder, kidney, and brain was followed after i.v. ⁶⁴Cu dosing for up to 68 hours before and after seven days of TTM (15 mg/day), using PET/MRI. Increased gallbladder ⁶⁴Cu activity was taken as evidence of increased biliary ⁶⁴Cu excretion.

RESULTS:

In healthy volunteers, TTM reduced intestinal ⁶⁴Cu uptake by 82% 15 hours after the oral ⁶⁴Cu dose. In patients with WD, gallbladder ⁶⁴Cu activity was negligible before and after TTM, while TTM effectively retained ⁶⁴Cu in the blood, significantly reduced hepatic ⁶⁴Cu activity at all time-points and significantly reduced cerebral ⁶⁴Cu activity two hours after the intravenous ⁶⁴Cu dose.

CONCLUSIONS:

While we did not show an increase in biliary excretion of ⁶⁴Cu following TTM administration, we demonstrated that TTM effectively inhibited most intestinal ⁶⁴Cu uptake and retained ⁶⁴Cu in the blood stream, limiting the exposure of organs like the liver and brain to ⁶⁴Cu.

IMPACT AND IMPLICATIONS:

Bis-choline tetrathiomolybdate (TTM) is an investigational copper chelator being developed for the treatment of Wilson disease. In animal models of Wilson disease, TTM has been shown to facilitate biliary copper excretion. In the present human study, TTM surprisingly did not facilitate biliary copper excretion but instead reduced intestinal copper uptake to a clinically significant degree. Our study builds on our understanding of human copper metabolism and the mechanism of action of TTM.

News (Medical) associated with Bis-choline tetrathiomolybdate

08 Nov 2024

·www.globenewswire.com

Monopar Therapeutics Reports Third Quarter 2024 Financial Results and Recent Developments

In-licensed ALXN-1840 (a Late-Stage Wilson Disease Drug Candidate) from Alexion, AstraZeneca Rare DiseaseTwo Novel Radiopharma Clinical Trials now Active and Enrolling Patients with Advanced Solid Cancers WILMETTE, Ill., Nov. 08, 2024 (GLOBE NEWSWIRE) -- Monopar Therapeutics Inc. (“Monopar” or the “Company”) (Nasdaq: MNPR), a clinical-stage biotechnology company focused on developing innovative treatments for patients with unmet medical needs, today announced third quarter 2024 financial results and summarized recent developments. Recent Developments ALXN-1840 for Wilson disease – Late Stage On October 23, 2024, the Company entered into an exclusive license with Alexion, AstraZeneca Rare Disease whereby the Company gained worldwide rights to develop and commercialize ALXN-1840 (bis-choline tetrathiomolybdate). ALXN-1840 is a drug candidate for Wilson disease that is in late-stage development, having already completed a Phase 3 clinical trial. Monopar will be assembling a regulatory package and initiating discussions with the FDA, with an initial focus on Wilson disease patients with more severe symptoms. More details on this transaction can be found here (link). MNPR-101 for Radiopharmaceutical Use – Phase 1 In August 2024, the Company received regulatory clearance in Australia to commence a first-in-human Phase 1a therapeutic clinical trial of its novel urokinase plasminogen activator receptor (uPAR)-targeted radiopharmaceutical therapy MNPR-101-Lu (MNPR-101 conjugated to lutetium-177) in patients with advanced solid cancers. The Company activated its first clinical trial site and launched the study in October 2024; the trial is currently active and recruiting patients.In September 2024, the Company announced positive early clinical data from its ongoing open-label Phase 1 imaging and dosimetry clinical trial of MNPR-101-Zr that validate the tumor-targeting ability of MNPR-101-Zr. In October, the Company presented additional clinical data at the European Association of Nuclear Medicine Annual Congress 2024. The data demonstrate clear and durable tumor uptake of MNPR-101-Zr in a patient with advanced ovarian cancer and show favorable biodistribution with low off-target binding.The Company is also actively exploring opportunities to expand its radiopharmaceutical pipeline primarily through internal development efforts. In October 2024, the Company announced the filing of a provisional patent application for new radiopharmaceutical compounds and a family of linkers used to connect radioisotopes with targeting agents, including its uPAR-targeting antibody MNPR-101. This provisional patent could enable the Company to use these linkers to create new proprietary radiopharmaceuticals to pursue well-established, high-value cancer targets of interest. Capital Raise On October 30, 2024, the Company completed a registered public offering of 1,181,540 shares of the Company’s common stock at $16.25 per share, generating net proceeds of approximately $17.7 million, after deducting placement agent fees and other estimated offering expenses. Results for the Third Quarter Ended September 30, 2024 Compared to the Third Quarter Ended September 30, 2023 Cash and Net Loss Cash and cash equivalents as of September 30, 2024, were $6.0 million. As noted above, the Company completed a registered public offering on October 30, 2024 that yielded net proceeds to the Company of approximately $17.7 million, after deducting placement agent fees and other estimated offering expenses. Monopar projects that its current funds will be sufficient to continue operations at least into the first half of 2026, including to: (1) assemble a regulatory package and initiate discussions with the FDA on ALXN-1840 for Wilson disease; (2) continue to conduct and conclude its first-in-human imaging and dosimetry Phase 1 clinical trial with MNPR-101-Zr; (3) continue to conduct its first-in-human therapeutic radiopharma clinical trial with MNPR-101-Lu; (4) advance its preclinical MNPR-101-Ac program into the clinic, and (5) invest in internal R&D projects to expand its radiopharma pipeline. Net loss for the third quarter of 2024 was $1.3 million, or $0.37 per share, compared to net loss of $2.0 million, or $0.69 per share, for the third quarter of 2023. Research and Development (R&D) Expenses R&D expenses for the three months ended September 30, 2024 were $984,000, compared to $1,317,000 for the three months ended September 30, 2023. This represents a decrease of $333,000 attributed to (1) a decrease in camsirubicin manufacturing costs of $301,000 due to the Company’s decision to wind down that program, and (2) a decrease of $218,000 in Validive clinical trial related expenses due to the closure of the trial in March 2023. These decreases were partially offset by a net increase of $186,000 due to other R&D expenses attributable to MNPR-101 for radiopharmaceutical use. General and Administrative (G&A) Expenses G&A expenses for the three months ended September 30, 2024 were $591,000, compared to $749,000 for the three months ended September 30, 2023. This represents a decrease of $158,000 primarily attributed to (1) a reduction of stock based compensation expenses of $146,000 due to the full vesting of the 2020 grants in the fourth quarter of 2023, and (2) a decrease in stock-based compensation to the CEO and the board of directors of $64,000 as no equity awards have been issued to the CEO and the board of directors to date in 2024, partially offset by a net increase in consulting and other G&A expenses of $52,000. About Monopar Therapeutics Monopar Therapeutics Inc. is a clinical-stage biotechnology company with late-stage ALXN-1840 for Wilson disease, and radiopharma programs including Phase 1-stage MNPR-101-Zr for imaging advanced cancers, and Phase 1a-stage MNPR-101-Lu and late preclinical-stage MNPR-101-Ac225 for the treatment of advanced cancers. For more information, and links to SEC filings that contain detailed financial information, visit: https://ir.monopartx.com/quarterly-reports. Forward-Looking Statements Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Examples of these forward looking statements include statements concerning: that Monopar will be assembling a regulatory package and initiating discussions with the FDA, with an initial focus on Wilson disease patients with more severe symptoms; that Monopar is actively exploring opportunities to expand its radiopharmaceutical pipeline primarily through internal development efforts; that the provisional patent could enable the Company to use these linkers to create new proprietary radiopharmaceuticals to pursue well-established, high-value cancer targets of interest; and that Monopar projects that its current funds will be sufficient to continue operations at least into the first half of 2026. The forward-looking statements involve risks and uncertainties including, but not limited to: Monopar’s ability to raise sufficient funds in order for the Company to support continued clinical, regulatory and commercial development of its programs and to make contractual upfront and future milestone payments, as well as its ability to further raise additional funds in the future to support any existing or future product candidate programs through completion of clinical trials, the approval processes and, if applicable, commercialization; uncertainties related to the regulatory discussions that Monopar intends to initiate related to ALXN-1840 and the outcome thereof; the rate of market acceptance and competitiveness in terms of pricing, efficacy and safety, of any products for which Monopar receives marketing approval, and Monopar’s ability to competitively market any such products as compared to larger pharmaceutical firms; and the significant general risks and uncertainties surrounding the research, development, regulatory approval, and commercialization of imaging agents and therapeutics. Actual results may differ materially from those expressed or implied by such forward-looking statements. Risks are described more fully in Monopar's filings with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Monopar undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made. Any forward-looking statements contained in this press release represent Monopar’s views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. Contact Karthik Radhakrishnan Chief Financial Officer karthik@monopartx.com Follow Monopar on social media for updates:Twitter: @MonoparTx LinkedIn: Monopar Therapeutics

Phase 1License out/inFinancial StatementPhase 3

30 Oct 2024

·www.globenewswire.com

Monopar Therapeutics Inc. Announces Closing of $19.2 Million Public Offering of Common Stock

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

Phase 1

29 Oct 2024

·www.globenewswire.com

Monopar Therapeutics Inc. Announces Pricing of $19.2 Million Public Offering of Common Stock

WILMETTE, Ill., Oct. 28, 2024 (GLOBE NEWSWIRE) -- Monopar Therapeutics Inc. (Nasdaq: MNPR) (“Monopar Therapeutics” or the “Company”), a clinical-stage biotechnology company focused on developing innovative treatments for patients with unmet medical needs, today announced the pricing of its best efforts public offering of shares of its common stock at a public offering price of $16.25 per share, for aggregate gross proceeds of approximately $19.2 million, before deducting the placement agent’s fees and other offering expenses payable by the Company. The offering is expected to close on October 30, 2024, subject to satisfaction of customary closing conditions. Janus Henderson Investors, RA Capital Management, L.P. and other notable growth and life science investors participated in the offering. Rodman & Renshaw LLC is acting as the exclusive placement agent for the offering. Monopar Therapeutics intends to use the net proceeds from the offering for general corporate purposes, which may include research and development expenditures, clinical trial expenditures, manufacture and supply of product and working capital. The securities are being offered and sold pursuant to a "shelf" registration statement on Form S-3 (File No. 333-268935), including a base prospectus, filed with the U.S. Securities and Exchange Commission (the “SEC”) on December 21, 2022, and declared effective on January 4, 2023. A preliminary prospectus supplement and accompanying prospectus describing the terms of the offering has been filed with the SEC and is available on its website at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to this offering may also be obtained by contacting Rodman & Renshaw LLC at 600 Lexington Avenue, 32nd Floor, New York, NY 10022, by email at info@rodm.com, or by telephone at (212) 540-4414. The final terms of the offering will be disclosed in a final prospectus supplement to be filed with the SEC. This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. Any offer, if at all, will be made only by means of the prospectus supplement and accompanying prospectus forming a part of the effective registration statement. About Monopar Therapeutics Monopar Therapeutics is a clinical-stage biotechnology company with late-stage ALXN-1840 for Wilson disease, and radiopharma programs including Phase 1-stage MNPR-101-Zr for imaging advanced cancers, and Phase 1a-stage MNPR-101-Lu and late preclinical-stage MNPR-101-Ac225 for the treatment of advanced cancers. For more information, visit: www.monopartx.com. Forward-Looking Statements Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Examples of these forward-looking statements include statements concerning: statements regarding the completion of the offering, the satisfaction of customary closing conditions related to the offering and the anticipated use of proceeds therefrom. The forward-looking statements involve risks and uncertainties including, but not limited to: our near term ability to raise sufficient funds in order for us to support continued clinical, regulatory and commercial development of our programs and to make contractual upfront and future milestone payments, as well as our ability to further raise additional funds in the future to support any existing or future product candidate programs through completion of clinical trials, the approval processes and, if applicable, commercialization; uncertainties related to the regulatory discussions we intend to initiate related to ALXN-1840 and the outcome thereof; the rate of market acceptance and competitiveness in terms of pricing, efficacy and safety, of any products for which we receive marketing approval, and our ability to competitively market any such products as compared to larger pharmaceutical firms; and the significant general risks and uncertainties surrounding the research, development, regulatory approval, and commercialization of imaging agents and therapeutics. Actual results may differ materially from those expressed or implied by such forward-looking statements. Risks are described more fully in Monopar's filings with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Monopar undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made. Any forward-looking statements contained in this press release represent Monopar’s views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. CONTACT: Monopar Therapeutics Inc.Investor RelationsKarthik Radhakrishnan Chief Financial Officerkarthik@monopartx.com

Phase 1

100 Deals associated with Bis-choline tetrathiomolybdate

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Liver Cirrhosis, Biliary	NDA/BLA	US	AstraZeneca PLC	-
Hepatolenticular Degeneration	Phase 3	CN	Alexion Pharmaceuticals, Inc.	15 Feb 2018
Hepatolenticular Degeneration	Phase 3	BE	Alexion Pharmaceuticals, Inc.	15 Feb 2018
Hepatolenticular Degeneration	Phase 3	RU	Alexion Pharmaceuticals, Inc.	15 Feb 2018
Advanced breast cancer	Phase 2	GB	Cancer Research UK	01 Jun 2008
PR-positive breast cancer	Phase 2	GB	Cancer Research UK	01 Jun 2008
Non-metastatic prostate cancer	Phase 2	US	Attenuon, LLC	01 Nov 2006
Melanoma	Phase 2	US	Attenuon, LLC	01 Sep 2006
Multiple Myeloma	Phase 2	US	Attenuon, LLC	30 Jun 2006
Leukemia	Phase 1	US	Attenuon, LLC	30 Dec 2006

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04594252 (CTgov)	Phase 1	-	17	ALXN1840 (Group 1: ALXN1840)	rzduflbzzn(uodlfhyknq) = vhbpknipga gbzqrvxzib (ndragddcch, ekdhdbyyng - nxznhouexp) View more	-	19 Aug 2024
				ALXN1840 (Group 2: ALXN1840)	rzduflbzzn(uodlfhyknq) = sfiqdyboei gbzqrvxzib (ndragddcch, jsjytyeuhh - tbrrvupelu) View more
NCT04610580 (CTgov)	Phase 1	-	48	ALXN1840 (Crossover: ALXN1840 Test Formulation (Treatment A))	htxpaboxhd(wvplrnbwfs) = evliwmaphy esqwwxwqqd (eugtojogeg, vzdkrujwdr - nhnwyusxxw) View more	-	16 Jan 2024
				ALXN1840 (Crossover: ALXN1840 Reference Formulation (Treatment B))	htxpaboxhd(wvplrnbwfs) = qwsebxqxpf esqwwxwqqd (eugtojogeg, foairbczxe - qpalrmutaz) View more
NCT05641311 (CTgov)	Phase 1	Hepatolenticular Degeneration	24	ALXN1840 (Cohort 1: Japanese Participants)	hyxuffhekj(sspjcgezmc) = edyobehoch nwweubpjtc (ruungbnxoq, xdvdenchio - ppsombtjyp) View more	-	07 Nov 2023
				ALXN1840 (Cohort 2: Non-Japanese Participants)	hyxuffhekj(sspjcgezmc) = mgagxuoatt nwweubpjtc (ruungbnxoq, xbbfjcxmvw - mxnmyoogbi) View more
NCT04526210 (CTgov)	Phase 1	Hepatolenticular Degeneration	54	Bupropion HCl (Treatment A: Bupropion HCl)	blescameoc(oveqemmjon) = snavqrizgu cgxjyovzxt (wrmugpibud, nfotxbfzcr - uygeaupxet) View more	-	31 Aug 2023
				Bupropion HCl+ALXN1840 (Treatment B: Bupropion HCl + ALXN1840)	blescameoc(oveqemmjon) = ulmaqszajx cgxjyovzxt (wrmugpibud, zwanbkwdin - gzvsidbose) View more
NCT05303324 (CTgov)	Phase 1	-	48	ALXN1840 (ALXN1840 Treatment A)	usdoqfebdz(nwgupxtuhi) = kugxlhdtcj qxtgncpuqi (ydcwpzedgi, gnqlevjulv - ylfouirveh) View more	-	02 Aug 2023
				ALXN1840 (ALXN1840 Treatment B)	usdoqfebdz(nwgupxtuhi) = yfouayjahb qxtgncpuqi (ydcwpzedgi, cpfbgwqvsr - lkydzoopvy) View more
NCT05319912 (CTgov)	Phase 1	-	18	ALXN1840 (Treatment A: ALXN1840 (Fasted))	ycknmhjkry(xsfmcfjvzd) = cbmzkiqysu ynrjdsygam (lvedppotiz, jexbgroqux - rucfdmfqti) View more	-	02 Aug 2023
				ALXN1840 (Treatment B: ALXN1840 (Fed))	ycknmhjkry(xsfmcfjvzd) = foeorondkc ynrjdsygam (lvedppotiz, jjpcaqocjg - jfkxlegcaj) View more
NCT05319899 (CTgov)	Phase 1	-	18	ALXN1840 (Treatment A: ALXN1840 (Fasted))	naetwivppt(mqrppgxaeb) = jphylujcfq govtxwnjti (byzgxtfoil, ohgiuhedjj - psrpmqsday) View more	-	01 Aug 2023
				Omeprazole+ALXN1840 (Treatment B: Omeprazole + ALXN1840 (Fasted))	naetwivppt(mqrppgxaeb) = idezusdrxb govtxwnjti (byzgxtfoil, eooqhtmklw - ukcpnzmzlk) View more
EASL2022	Phase 3	Hepatolenticular Degeneration Cu sequestration	214	ALXN1840	fzxhtvfrwh(xfllpmdmpa) = yhjipgoqze hgutsfiwqm (kutpsjenxb )	-	23 Jun 2022
				ALXN1840	fzxhtvfrwh(xfllpmdmpa) = wsnrxaubse hgutsfiwqm (kutpsjenxb )
NCT02273596 (CTgov)	Phase 2	Hepatolenticular Degeneration	29	ALXN1840	qjtatjbyyf(xnfqetserf) = jeqjcizvjk ierwllhswe (tcswwwepjg, eljislihcf - ohzhtzmkbx) View more	-	29 Sep 2021

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