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Nov 12, 2026
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Monopar Therapeutics (MNPR) Reports Wider Q3 Loss While Advancing ALXN1840 NDA

Monopar Therapeutics (MNPR) Reports Wider Q3 Loss While Advancing ALXN1840 NDA

Key Takeaways

  • Monopar Therapeutics reported a third-quarter 2026 net loss of $6.2 million, or $0.72 per share, compared with a $3.4 million loss, or $0.48 per share, in the prior-year period.
  • Cash, cash equivalents, and investments totaled $129.4 million as of September 30, 2026, with the company expecting current funds to support operations through at least March 31, 2028.
  • Research and development (R&D) expenses rose to $4.44 million, while general and administrative (G&A) expenses increased to $3.03 million, reflecting heavier investment in the ALXN1840 program.
  • Monopar remains on track to complete the rolling New Drug Application (NDA) submission for ALXN1840, its Wilson disease candidate, within the next several weeks.
  • The company presented Phase 3 FoCus study data for ALXN1840 at the AASLD Liver Meeting 2026, reinforcing its late-stage regulatory push.

Earnings Context and Why It Matters

Monopar Therapeutics is a clinical-stage biopharmaceutical company with no recurring product revenue, so its quarterly results are measured less by sales growth than by cash burn, pipeline progress, and regulatory milestones. For a development-stage biotech, the earnings release functions as a progress report: investors are watching whether the company can advance ALXN1840 toward a potential approval without exhausting its capital. The third quarter matters because it arrives just as Monopar completes a rolling NDA submission to the U.S. Food and Drug Administration (FDA), a pivotal step that could transition the company from a pure research story toward a potential commercial launch. The widening loss is expected, but the durability of its cash runway is the central question.

Reported Results

For the third quarter ended September 30, 2026, MNPR reported a net loss of $6.2 million, or $0.72 per share, compared with a net loss of $3.4 million, or $0.48 per share, in the same period a year earlier. The result was roughly in line with analyst expectations, which had anticipated a loss near $0.72 per share.

R&D expenses totaled $4,436,543, up from $2,589,749 a year ago, driven primarily by higher contractor and consulting costs tied to the ALXN1840 program. G&A expenses climbed to $3,031,302 from $1,503,326, while interest income rose to $1,271,370 from $655,473, reflecting larger balances invested in Treasury securities and commercial paper. The company reported no product revenue, consistent with its clinical-stage status. For the nine months ended September 30, 2026, the net loss was $15.4 million, or $1.80 per share, versus $8.52 million, or $1.21 per share, in the prior-year period. I also checked this using Tickeron’s AI Screener to see how the stock compares to others in the industry.

Market Reaction and Investor Sentiment

Monopar shares have shown notable volatility over the past year, trading within a wide 52-week range as investors weigh the binary outcomes of a clinical-stage biotech awaiting an FDA filing. Heading into the report, sentiment was shaped less by the headline loss — which was widely expected — and more by the timing of the completed NDA submission and the company's cash runway guidance. The confirmation that current funds should support operations through at least March 31, 2028 provides reassurance against near-term dilution risk. For investors, the key interpretation hinges on whether the market views the upcoming NDA completion as a de-risking event or simply an incremental step in a process that still carries approval uncertainty.

Forward Outlook and Key Factors to Monitor

The most immediate catalyst is the completion of the rolling NDA submission for ALXN1840, expected within the next several weeks. Investors should watch for formal FDA acceptance of the filing and the assignment of a review timeline, as these steps will frame the regulatory path ahead.

Beyond the filing, attention will turn to how the company manages its expanding cost base. R&D spending has climbed as Monopar funds regulatory and pre-commercial activities, and continued increases in G&A expenses suggest the company is building infrastructure ahead of a possible launch. The $129.4 million cash position, with runway projected through at least March 31, 2028, provides flexibility, but the pace of burn will remain a closely watched metric.

Additional factors include further data presentations on ALXN1840 and progress across the radiopharmaceutical pipeline, including the MNPR-101 program candidates. While these earlier-stage assets are not yet central to the investment thesis, meaningful clinical updates could broaden the company's narrative beyond Wilson disease. Investors will be watching for regulatory milestones, spending discipline, and any signs of emerging commercial readiness. From what I see, this is important because it highlights the balance between execution and capital preservation.

Using AI Tools in Biotech Analysis

In my regular research process, I turn to Tickeron’s AI Screener to filter biotech names by fundamentals, technical patterns, and sector momentum. It helps surface comparable setups quickly and cross-checks how MNPR stacks up against peers without manual effort. This kind of tool adds efficiency when tracking development-stage companies like Monopar during key regulatory windows.

Disclaimer

The information on this webpage is provided for general informational and educational purposes only and is not intended as investment advice, a recommendation to purchase or sell any security, or an offer or solicitation related to investments. It does not consider your personal financial situation, goals, or risk profile, and all investing carries inherent risks, including the possibility of losing your entire investment. For more details, please review our full disclaimer.

Disclaimers and Limitations

Related Ticker: MNPR

Contributor

Sergey Savastiouk, Ph.D. has a degree in Applied Mathematics from Moscow University and has extensive experience as an entrepreneur, investor, manager, and mathematician. His professional expertise is in applied mathematics, mathematical modeling, system and pattern analysis, and software and hardware system integration. He has served as the CEO of several hi-tech start-up companies and nonprofit organizations, which has given him proven capabilities in business strategy for high-tech start-up companies, market assessment, company formation, team building, product development, marketing, and sales. He has published numerous articles in journals and magazines on related fields. As a retail investor, he spent 15 years developing his proprietary trading and quantitative algorithms (now Tickeron’s A.I.), which brought him significant returns in trading the stock market. His current work and goal in founding Tickeron is to bring professional, sophisticated stock market analysis capabilities to retail investors via an easy-to-use interface.


MNPR in +9.71% Uptrend, advancing for three consecutive days on November 09, 2026

Moving higher for three straight days is viewed as a bullish sign. Keep an eye on this stock for future growth. Considering data from situations where MNPR advanced for three days, in 223 of 266 cases, the price rose further within the following month. The odds of a continued upward trend are 84%.

Price Prediction Chart

Technical Analysis (Indicators)

Bullish Trend Analysis

The RSI Indicator points to a transition from a downward trend to an upward trend -- in cases where MNPR's RSI Oscillator exited the oversold zone, 24 of 31 resulted in an increase in price. Tickeron's analysis proposes that the odds of a continued upward trend are 77%.

The Moving Average Convergence Divergence (MACD) for MNPR just turned positive on October 20, 2026. Looking at past instances where MNPR's MACD turned positive, the stock continued to rise in 33 of 42 cases over the following month. The odds of a continued upward trend are 79%.

MNPR may jump back above the lower band and head toward the middle band. Traders may consider buying the stock or exploring call options.

Bearish Trend Analysis

The Stochastic Oscillator has been in the overbought zone for 1 day. Expect a price pull-back in the near future.

The Momentum Indicator moved below the 0 level on November 10, 2026. You may want to consider selling the stock, shorting the stock, or exploring put options on MNPR as a result. In 75 of 85 cases where the Momentum Indicator fell below 0, the stock fell further within the subsequent month. The odds of a continued downward trend are 88%.

Following a 3-day decline, the stock is projected to fall further. Considering past instances where MNPR declined for three days, the price rose further in 50 of 62 cases within the following month. The odds of a continued downward trend are 90%.

The Aroon Indicator for MNPR entered a downward trend on November 11, 2026. This could indicate a strong downward move is ahead for the stock. Traders may want to consider selling the stock or buying put options.

Fundamental Analysis (Ratings)

The Tickeron Valuation Rating of 6 (best 1 - 100 worst) indicates that the company is seriously undervalued in the industry. This rating compares market capitalization estimated by our proprietary formula with the current market capitalization. This rating is based on the following metrics, as compared to industry averages: P/B Ratio (3.663) is normal, around the industry mean (3.498). P/E Ratio (-32.464) is within average values for comparable stocks, (-1.193). Projected Growth (PEG Ratio) (0.000) is also within normal values, averaging (9.059). Dividend Yield (0.000) settles around the average of (130.981) among similar stocks. P/S Ratio (0.000) is also within normal values, averaging (440.869).

The Tickeron PE Growth Rating for this company is 14 (best 1 - 100 worst), pointing to outstanding earnings growth. The PE Growth rating is based on a comparative analysis of stock PE ratio increase over the last 12 months compared against S&P 500 index constituents.

The Tickeron Profit vs. Risk Rating rating for this company is 52 (best 1 - 100 worst), indicating well-balanced risk and returns. The average Profit vs. Risk Rating rating for the industry is 93, placing this stock slightly better than average.

The Tickeron Price Growth Rating for this company is 62 (best 1 - 100 worst), indicating steady price growth. MNPR’s price grows at a higher rate over the last 12 months as compared to S&P 500 index constituents.

The Tickeron SMR rating for this company is 95 (best 1 - 100 worst), indicating weak sales and an unprofitable business model. SMR (Sales, Margin, Return on Equity) rating is based on comparative analysis of weighted Sales, Income Margin and Return on Equity values compared against S&P 500 index constituents. The weighted SMR value is a proprietary formula developed by Tickeron and represents an overall profitability measure for a stock.

Notable companies

The most notable companies in this group are Moderna (NASDAQ:MRNA), Regeneron Pharmaceuticals (NASDAQ:REGN), Incyte Corp (NASDAQ:INCY), Exelixis (NASDAQ:EXEL), Arrowhead Pharmaceuticals (NASDAQ:ARWR), Sarepta Therapeutics (NASDAQ:SRPT), Novavax (NASDAQ:NVAX), Nektar Therapeutics (NASDAQ:NKTR), Inovio Pharmaceuticals (NASDAQ:INO), Cel-Sci Corp (ASE:CVM).

Industry description

Biotechnology involves genetic or protein engineering to produce medicines/therapies for treating and preventing ailments. The industry also provides crucial ingredients for diagnostics. This multi-billion-dollar industry is heavily focused on research and development, as companies attempt to continually come up with cutting-edge solutions for health. New discoveries for the treatment of diseases provide opportunities for growth for a company in this industry. Discoveries, however, must pass the regulatory approval from the U.S. Food and Drug Administration (FDA) before they can make it to markets. Amgen Inc., Gilead Sciences, Inc. and Celgene Corporation are examples of companies in this industry.

Market Cap

The average market capitalization across the Biotechnology Industry is 2.23B. The market cap for tickers in the group ranges from 58 to 138.67B. VRTX holds the highest valuation in this group at 138.67B. The lowest valued company is SEELQ at 58.

High and low price notable news

The average weekly price growth across all stocks in the Biotechnology Industry was 7%. For the same Industry, the average monthly price growth was -2%, and the average quarterly price growth was -16%. PEPG experienced the highest price growth at 115%, while KPTI experienced the biggest fall at -76%.

Volume

The average weekly volume growth across all stocks in the Biotechnology Industry was -22%. For the same stocks of the Industry, the average monthly volume growth was 23% and the average quarterly volume growth was -37%

Fundamental Analysis Ratings

The average fundamental analysis ratings, where 1 is best and 100 is worst, are as follows

Valuation Rating: 50
P/E Growth Rating: 43
Price Growth Rating: 66
SMR Rating: 93
Profit Risk Rating: 93
Seasonality Score: -4 (-100 ... +100)
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General Information

a clinical stage biopharmaceutical company, which engages in building a drug development pipeline of oncology therapeutics in late preclinical and clinical development stages

Industry Biotechnology

Industry
N/A
Address
1000 Skokie Boulevard
Phone
+1 847 388-0349
Employees
22
Web
https://www.monopartx.com
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