Monopar Therapeutics: Radiopharmaceuticals And Rare Disease Potential In Focus

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Monopar Therapeutics is a clinical-stage biotech focused on radiopharmaceuticals for oncology and recently expanded into rare diseases with ALXN-1840.MNPR’s oncology pipeline includes MNPR-101-Zr for ...

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(NASDAQ:MNPR) develops radiopharmaceutical solutions to address the unmet medical needs of cancer patients and, more recently, rare diseases. MNPR integrates radiodiagnostics and radiotherapeutics to visualize and kill cancer cells. MNPR has MNPR-101-Zr, an imaging agent. Similarly, MNPR-101-Lu and MNPR-101-Ac are radiation-based treatments. More recently, in October 2024, the company expanded its pipeline by acquiring ALXN-1840, a late-stage drug candidate for Wilson disease. This marked MNPR’s entry into rare diseases and diversified its IP portfolio from a pure oncology play. Also, its recent equity raise seems to have provided MNPR with enough resources for the foreseeable future, further derisking the stock. Ultimately, I feel MNPR’s upside potential outweighs its risks, so I rate it a speculative “Buy” for investors who understand its inherent biotech risks. New Oncology Paradigm: Business Overview Monopar Therapeutics is a clinical-stage biopharmaceutical company founded in 2014. Its headquarters is located in Wilmette, Illinois, United States. The company develops therapies to address unmet medical needs for cancer patients, combining radiodiagnostics to visualize the malignancies and radiotherapeutics to target and precisely eliminate the disease cells using radioactive isotopes.   Source: Investor Presentation. September 2024. Under the hood, MNPR employs a mechanism of action [MoA] that uses a targeting agent, usually a monoclonal antibody or another molecule. This targeting agent then binds to a tumor maker, which is typically a receptor present in cancer cells but not in healthy ones. Additionally, the company uses radioactive isotopes linked to the monoclonal antibody by a chemical structure that allows for tumor visualization and mapping. For this, MNPR uses a positron emission tomography [PET] scan. In theory, MNPR could also emit other cancer isotopes to kill targeted cells with radiation for therapeutic purposes. This way, MNPR regards radiopharmaceutical solutions as the next substantial breakthrough in cancer therapies following several treatment generations. It’s worth mentioning that previous approaches relied on receptor-targeted medicines inhibiting cell growth or immuno-oncology techniques that harness the immune system to attack malignancies. This approach is commonly known as antibody-drug conjugates [ADCs] that bring cytotoxic drugs to the diseased cells via antibodies. Other approaches included cell therapies that modify immune cells to find and destroy cancer.   Source: MNPR’s website. Targeted radiopharmaceuticals. However, one of MNPR’s main differentiators is that its radiopharmaceutical therapies use radioactive isotopes instead, integrating diagnosis and treatment. On paper, this is a new paradigm for oncology treatments and could make MNPR highly valuable if its IP is successfully researched and commercialized. At this stage, MNPR mainly focuses on this next therapy wave, which includes MNPR-101-Zr for diagnostics and MNPR-101-Lu/Ac for therapeutic applications. This means that an MNPR’s therapy would combine these two isotopes, one for tumor visualization and the other for precise radiation delivery, potentially enhancing cancer care efficacy.   Source: Pipeline. Retrieved November 23, 2024, from the Monopar Therapeutics website. Therefore, MNPR’s pipeline includes products to fight solid cancers, such as MNPR-101-Zr. This candidate is a diagnostic tool to locate tumors expressing the urokinase plasminogen activator receptor [uPAR]. This is key because it’s what allows MNPR to potentially treat all triple-negative breast, colorectal, bladder, ovarian, gastric, and pancreatic cancers. Additionally, MNPR-101-Zr is a monoclonal antibody conjugated with a radioisotope of Zirconium-89 [Zr] for total-body PET scan imaging. The main drawback of MNPR is that its IP remains in the relatively early stages, as MNPR-101-Zr is still in Phase 1 clinical trials. Nevertheless, early data shows that a PET scan 7 days after intake of MNPR-101-Zr revealed the exact location of metastatic tumor ubications. MNPR-101-Zr also maintains its presence for longer periods, which is useful for monitoring prolonged therapeutic progress. Also, at this stage, Zn would be limited to only diagnostic purposes, not for therapeutic radiation, allowing the detection and monitoring of tumors.   Source: Pipeline. Retrieved November 23, 2024, from the Monopar Therapeutics website. Likewise, another investigational product is MNPR-101-Lu. This monoclonal antibody has a radiotherapeutic isotope, Lutetium-177 or Lu-177. As MNPR-101-Zr, it’s also in Phase 1 trials in Australia as a radiotherapy for solid cancers. Interestingly, early human results seem promising due to its radiopharmaceutical potential for eliminating malignant tumors. MNPR also works on MNPR-101-Ac, another monoclonal antibody conjugated with the isotope Actinium-255 [Ac]. This is also designed to supply radiation to tumors, acting as the cancer-killer arm of MNPR’s therapies. Yet, this latter IP is in the preclinical stages. Diagnostics and Rare Diseases In September 2024, MNPR’s stock rose by 60% after announcing positive clinical trial outcomes for MNPR-101-Zr. I believe this price action is justified as it provided enough clinical evidence in humans, illustrating its underlying science. Even if only its diagnostics agent were successful, it’d still be a substantial leap forward in oncology therapies. This way, healthcare providers can monitor how patients respond to treatment. This is particularly promising for diagnostics in aggressive cancers that express the uPAR biomarker. MNPR’s trial essentially confirmed that MNPR-101-Zr effectively binds to cancer cells. Then, on October 24, 2024, MNPR’s stock price spiked again by 20% after securing an exclusive worldwide license for ALXN-1840. It’s worth highlighting that ALXN-1840 is a copper-chelating agent indicated for Wilson disease and was developed by Alexion, the Rare Disease division of AstraZeneca (AZN). However, I don’t see a major complement between ALXN-1840 and the rest of MNPR’s oncology pipeline.   Source: Pipeline. Retrieved November 23, 2024, from the Monopar Therapeutics website. Nevertheless, under the agreement, MNPR will pay an upfront cash and equity stake to Alexion and tiered royalties on net sales and sales milestone achievement. In exchange, MNPR will receive all future proceeds from ALXN-1840. This also added a relatively late-stage IP to MNPR’s IP portfolio. ALXN-1840 is currently finishing Phase 3 trials for Wilson disease, which is characterized by copper accumulation in the brain, liver, and other organs. Unfortunately, such copper buildup eventually leads to severe symptoms and life-threatening outcomes. Thus, ALXN-1840 tries to attach to copper to eliminate it selectively. Additionally, ALXN-1840 has orphan drug designations in the US and the EU, so its pathway to regulatory approval also seems relatively favorable. High Optionality: Valuation Analysis From a valuation perspective, MNPR trades at a $106.1 million market cap, making it a microcap in its sector. As of Q3 2024, its balance sheet held $6.0 million in cash and equivalents against no financial debt. In fact, MNPR’s financials are mainly composed of cash and accounts payable, as reflected by its book value of just $4.9 million. However, this does indicate a high P/B of 21.6, which is much higher than its sector’s median P/B of 2.3. Moreover, the company is not yet projected to generate any revenues in the near term. So, we can’t rely on P/S multiples to gauge its fair value.   Source: Seeking Alpha. Still, I estimate MNPR’s latest quarterly cash burn reached $1.1 million by adding its CFOs and Net CAPEX. This suggests a cash runway of 1.4 years, which appears somewhat short. This is why MNPR recently announced an equity raise of $19.0 million on October 29, 2024. Initially, its stock price appeared to react negatively, dropping by 16%. However, its share price seems to have stabilized since then. It’s also interesting to note that MNPR priced its shares at $16.25 for that raise, and it’s currently trading well above that, indicating a favorable investor sentiment despite the dilution. Thus, MNPR’s cash balance post-raise should be roughly $25.0 million. Similarly, its book value probably increased to $23.9 million, making its actual P/B closer to 4.4. This raise also should extend MNPR’s cash runway to 5.7 years using my previous cash burn estimate. However, I think Phase 2 and 3 trials will be more cash-intensive, so its actual runway is likely much shorter than that.   Source: Investor Presentation. September 2024. Nonetheless, its valuation multiples now seem much more reasonable, especially considering that it acquired a Phase 3 candidate and has a potentially revolutionary oncology diagnosis monoclonal antibody radioisotope. With this in mind, its $106.1 million valuation seems reasonable, especially considering its high optionality if either research program reaches regulatory approval. Hence, I feel it’s worth rating MNPR as a speculative “Buy” for investors who understand its in-house IP remains years away from approval. Investment Caveats: Risk Analysis First, I must emphasize that MNPR is inherently a highly speculative bet as its in-house developed oncology pipeline is still in Phase 1 or earlier. Additionally, its Wilson IP was acquired, so it shouldn't be attributed to MNPR as a research achievement. Also, the acquisition itself stands out from the rest of its oncology pipeline, suggesting that MNPR might have some doubts about its ultimate viability. On the other hand, having a mostly unrelated IP does diversify its investment profile to some extent.   Source: TradingView. Also, I don’t think $25.0 million in cash is enough to carry MNPR’s oncology IP to regulatory approval. I do believe these resources should suffice until they potentially complete Phase 2 trials or start Phase 3. If there are no major setbacks, it could also be enough to push its acquired Wilson IP towards approval. Conversely, there’s always the possibility that neither IP succeeds, which could lead to substantial shareholder losses. A final consideration is that MNPR is a microcap with a relatively low trading volume. Seeking Alpha's dashboard shows that its volume is just 83,603 shares, which is approximately $1.6 million in USD terms at the current share price. This low trading volume means small buy or sell orders could substantially affect its stock price, so MNPR will likely remain highly volatile. There will also be significant slippage when trying to get in and out of the stock, which is an additional cost to consider when investing in MNPR. But overall, I think another dilutive event in the next few years is probable, so I can’t give it a “Strong Buy.” Instead, MNPR makes sense as a speculative bet for investors who can size their positions accordingly. Speculative “Buy”: Conclusion  Overall, MNPR is an intriguing biotech in oncology, with a new unrelated IP for Wilson’s disease as well. Taking a step back, this diversifies its investment profile to some extent. Also, MNPR post-raise does have enough resources for the foreseeable future, so I think it’s fair to give them the benefit of the doubt for now. In my view, its current market cap is also quite low, and any potential major breakthrough announcement could significantly appreciate its stock price. Thus, its upside seems greater than its downside risks, so I rate it a speculative “Buy” at this stage.","kind":"highlight","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"0","news_tag":"analysis","news_rank":0,"symbols":[],"gpt_button":1},"commentList":[],"isCommentEnd":true,"newsSizeData":{"likeSize":0,"commentSize":0,"repostSize":0,"favoriteSize":0,"likeStatus":false,"favoriteStatus":false},"APP":{"userAgent":"Mozilla/5.0 AppleWebKit/537.36 (KHTML, like Gecko; compatible; ClaudeBot/1.0; +claudebot@anthropic.com)","isDev":false,"isTTM":true,"deviceId":"web-server-community-laohu8-v3","version":"4.29.3","shortVersion":"4.29.3","platform":"web","vendor":"web","appName":"ttm","isIOS":false,"isAndroid":false,"isTiger":false,"isTHS":false,"isWeiXin":false,"isWeiXinMini":false,"isWeiBo":false,"isQQ":false,"isBaiduSwan":false,"isBaiduBox":false,"isDingTalk":false,"isToutiao":false,"isOnePlus":false,"isHuaWei":false,"isXiaomi":false,"isXiaomiWebView":false,"isOppo":false,"isVivo":false,"isSamsung":false,"isMobile":false},"href":"/m/news/2486852096"}