WILMETTE, Ill. - Monopar Therapeutics Inc . (NASDAQ: NASDAQ:MNPR), a clinical-stage biotech company, has obtained an exclusive worldwide license for ALXN-1840, a Phase 3 clinical trial drug candidate for Wilson disease, from Alexion (NASDAQ:ALXN), AstraZeneca (NASDAQ:AZN) Rare Disease. The agreement, announced today, transfers responsibility for all future development and commercialization of the drug to Monopar.
ALXN-1840, also known as bis-choline tetrathiomolybdate, has demonstrated efficacy in a pivotal Phase 3 trial, meeting its primary endpoint. This trial showed the drug's potential in mobilizing copper three times more effectively than the standard of care in patients with Wilson disease, a rare genetic disorder characterized by excessive copper accumulation in the body.
Monopar's CEO, Dr. Chandler D. Robinson, has a history with ALXN-1840, having researched it and contributed to its development from its early stages. His connection to the Wilson disease community, including a keynote address at the Wilson Disease Association's 2013 Annual Conference, has been a driving force behind the acquisition of the drug's rights.
The license agreement includes an upfront cash payment and equity in Monopar, with future payments structured around regulatory and sales milestones, as well as tiered royalties on net sales. Dr. Chris Starr, Co-Founder and Executive Chair of Monopar, highlighted the decision to pursue the opportunity, influenced by patient testimonials and the high level of unmet medical need.
Monopar plans to continue the development of ALXN-1840, which has been granted Orphan Drug Designation in the United States and the European Union. The company also maintains a focus on expanding its radiopharma program, as stated by Chief Operating Officer Andrew Cittadine.
Wilson disease affects approximately one in 30,000 live births in the US and can lead to severe liver, neurological, and psychiatric symptoms. ALXN-1840 is designed to selectively bind and remove excess copper from the body, offering a new treatment option for this condition.
This news is based on a press release statement from Monopar Therapeutics Inc. and reflects the company's current plans and expectations regarding ALXN-1840 and its pipeline of drug candidates.
In other recent news, Monopar Therapeutics has been the subject of significant developments. The company reported no generated revenues for the second quarter of 2024 and a net loss of $0.10 per share. Analyst firms H.C. Wainwright and Jones Trading maintained a Buy rating for Monopar, with H.C. Wainwright raising the price target to $6.00.
Monopar has shown promising results from its Phase I imaging trial involving the MNPR-101-Zr agent, which demonstrated high tumor uptake, indicating potential efficacy in cancer imaging. Moreover, the company has initiated a Phase I therapeutic trial for MNPR-101-Lu in Australia, targeting patients with advanced solid cancers.
The company also announced a 5-for-1 reverse stock split, reducing the total number of outstanding shares, and regained compliance with Nasdaq's minimum bid price requirement. Additionally, Monopar expanded its partnership with NorthStar Medical Radioisotopes, securing a long-term contract for the supply of actinium-225, a key radioisotope used in cancer treatment.
In terms of personnel changes, the company announced the retirement of CFO Kim R. Tsuchimoto, with Karthik Radhakrishnan set to assume her roles. These are the recent developments in Monopar Therapeutics' ongoing operations.
InvestingPro Insights
Monopar Therapeutics Inc. (NASDAQ: MNPR) has made a significant move with its acquisition of ALXN-1840, which could potentially reshape its financial outlook. According to InvestingPro data, the company currently has a market capitalization of $16.3 million, reflecting its status as a small-cap biotech firm. This acquisition aligns with the company's strategy to expand its drug pipeline and address unmet medical needs.
InvestingPro Tips highlight that Monopar "holds more cash than debt on its balance sheet" and "liquid assets exceed short term obligations." These factors could be crucial in supporting the development and potential commercialization of ALXN-1840, as clinical trials and regulatory processes often require substantial financial resources.
The company's stock has shown strong performance, with InvestingPro data indicating a remarkable 172.19% year-to-date price total return as of the latest available data. This suggests investor optimism about Monopar's prospects, possibly fueled by developments like the ALXN-1840 acquisition.
However, it's important to note that Monopar is not currently profitable, with an adjusted operating income of -$7.49 million over the last twelve months. This is consistent with the InvestingPro Tip stating that "analysts do not anticipate the company will be profitable this year." The success of ALXN-1840 could be pivotal in changing this financial trajectory.
For investors seeking a more comprehensive analysis, InvestingPro offers additional tips and insights that could provide a deeper understanding of Monopar's financial health and market position. There are 10 more InvestingPro Tips available for MNPR, which could offer valuable context for this recent development and its potential impact on the company's future.
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