Monopar Therapeutics Inc Stock Price, News & Analysis

Monopar Therapeutics Inc. (Nasdaq: MNPR) is presenting encouraging data from its uPAR radiopharmaceutical program at the EANM 2024 Annual Congress. The presentation, recognized as a "Top-Rated Oral Presentation," showcases favorable human clinical dosimetry data for MNPR-101-Lu, derived from MNPR-101-Zr imaging studies.

Key highlights include:

• Favorable organ safety profile at high Lu-177 therapeutic dose levels
• Promising uPAR targeting in solid tumors
• Encouraging tumor uptake and low off-target binding
• Estimated favorable radiation dosimetry safety profile for off-target effects

The company's Phase 1a trial for MNPR-101-Lu (NCT06617169) and Phase 1 imaging and dosimetry trial for MNPR-101-Zr (NCT06337084) are ongoing.

Monopar Therapeutics Inc. (Nasdaq: MNPR) has filed a provisional patent for new therapeutic radiopharmaceuticals based on a family of linkers connecting radioisotopes with targeting agents, including Monopar's uPAR targeting antibody MNPR-101. The patent filing covers:

• Composition of Matter: Claims for a family of linkers and Monopar's uPAR targeting agents linked with these and therapeutic radioisotopes
• Stability and Biodistribution: Proprietary new linkers designed to enhance stability and biodistribution of Monopar's therapeutic radiopharmaceuticals
• Versatility: The new linker family works with various isotopes and targeting molecules, including small molecules/peptides and antibodies

The company believes these linkers could create new proprietary radiopharmaceuticals targeting high-value cancer targets and potentially lead to licensing and development collaborations in the industry.

Monopar Therapeutics Inc. (Nasdaq: MNPR) has initiated a Phase 1a clinical trial for its novel therapeutic radiopharmaceutical MNPR-101-Lu in patients with advanced cancers. The open-label dose-escalation study will recruit patients with solid tumors, focusing on those participating in the ongoing MNPR-101-Zr Phase 1 imaging and dosimetry trial. The first clinical site activated is the Melbourne Theranostic Innovation Centre (MTIC) in Australia.

MNPR-101 is Monopar's proprietary antibody targeting the urokinase plasminogen activator receptor (uPAR), expressed in various tumor types. The company aims to deliver targeted radiopharma therapy that kills cancer cells while minimizing damage to healthy tissue. Recent clinical and preclinical data have shown highly specific and durable tumor uptake of MNPR-101-Zr.

This trial may be the world's first uPAR-targeted therapeutic radiopharma clinical trial, with the goal of identifying tumors using MNPR-101-Zr and treating them with MNPR-101-Lu.

Monopar Therapeutics Inc. (Nasdaq: MNPR) announced positive early data from its ongoing MNPR-101-Zr Phase 1 imaging and dosimetry clinical trial, validating the tumor targeting ability of MNPR-101-Zr in humans. The trial focuses on MNPR-101, a proprietary first-in-class humanized monoclonal antibody targeting cancers expressing the urokinase plasminogen activator receptor (uPAR).

Key findings include:

• Highly preferential uptake of MNPR-101-Zr in metastatic tumors relative to normal tissue
• Specificity and durability of MNPR-101-Zr in tumor targeting
• Alignment of MNPR-101-Zr uptake with previously observed metastatic tumors on FDG PET imaging

Monopar also received clearance in Australia to initiate an MNPR-101-Lu Phase 1 therapeutic clinical trial, scheduled for Q4 2024. Additional data will be presented at the European Association of Nuclear Medicine 2024 Annual Congress in October.

Monopar Therapeutics (Nasdaq: MNPR), a clinical-stage biopharmaceutical company developing innovative cancer treatments, has announced its participation in the H.C. Wainwright 26th Annual Global Investment Conference. Chandler D. Robinson, MD, Monopar's CEO, will present at the conference. Key details include:

• Presentation will be webcast starting Monday, September 9, 2024 at 7:00 a.m. ET
• In-person one-on-one meetings will be held at the Lotte New York Palace, NY
• Conference dates: September 9 - 11, 2024

This event provides Monopar an opportunity to showcase its progress and connect with potential investors, potentially impacting its stock performance (MNPR).

Monopar Therapeutics (Nasdaq: MNPR), a clinical-stage radiopharma company, has regained compliance with Nasdaq's minimum bid price requirement. The company received notice from Nasdaq that it has met the listing rule 5550(a)(2), which requires a minimum bid price of $1.00 per share for at least 10 consecutive trading sessions. This development ensures Monopar's continued listing on the Nasdaq stock exchange, maintaining its visibility and access to capital markets. The compliance status is important for the company's ongoing efforts in developing innovative cancer treatments.

Monopar Therapeutics Inc. (Nasdaq: MNPR) has received Human Research Ethics Committee (HREC) clearance in Australia to begin a Phase 1 therapeutic trial of its novel radiopharmaceutical MNPR-101-Lu. This treatment combines lutetium-177 with Monopar's proprietary humanized monoclonal antibody MNPR-101, which targets the urokinase plasminogen activator receptor (uPAR). The trial will enroll patients with advanced solid cancers and follows the ongoing MNPR-101-Zr imaging and dosimetry clinical trial.

Preclinical studies have shown promising results, with MNPR-101-Lu demonstrating durable antitumor effects in a human pancreatic cancer xenograft mouse model. The treatment achieved complete tumor elimination after a single injection, lasting throughout the 90-day study. Imaging data also revealed high specificity and durable uptake of MNPR-101-Lu in tumors relative to normal tissue.

Monopar Therapeutics Inc. (Nasdaq: MNPR) has announced initial data from the first patient dosed in its Phase 1 clinical trial of MNPR-101-Zr, a uPAR-targeted imaging radiopharmaceutical. The drug was well-tolerated with no serious adverse reactions reported. Preliminary analysis suggests low radiation dose to healthy tissue, aligning with preclinical data. Dosimetry analysis showed absorbed organ doses well below accepted safety limits, with red bone marrow radiation dose about 150 times less than the generally accepted limit. No unanticipated or excessive uptake was observed in critical organs. The study aims to include patients with cancers known for high uPAR expression to gain insight into MNPR-101-Zr's tumor uptake profile.

Monopar Therapeutics Inc. (Nasdaq: MNPR) reported its Q2 2024 financial results and recent developments. Key highlights include:

1. Initiated and enrolling patients in MNPR-101-Zr First-in-Human Phase 1 Radiopharma Clinical Trial.

2. MNPR-101 radio-immuno-therapeutic (RIT) Clinical Trial on track to start in Q4 2024.

3. Cash position of $7.1 million as of June 30, 2024, sufficient to operate through August 31, 2025.

4. Net loss of $1.7 million ($0.10 per share) in Q2 2024, compared to $2.2 million ($0.16 per share) in Q2 2023.

5. R&D expenses decreased to $1,131,000 in Q2 2024 from $1,595,000 in Q2 2023.

6. G&A expenses decreased to $658,000 in Q2 2024 from $733,000 in Q2 2023.

7. Approved 1-for-5 reverse stock split, effective August 12, 2024, to regain Nasdaq compliance.