Monopar Therapeutics

Previous wording

Our cash, cash equivalents and investments as of March 31, 2024, were $8.8 million. As discussed further below and elsewhere in this Quarterly Report, we expect that our current funds will be sufficient at least through June 30, 2025 for us to: (1) continue to conduct and conclude our first-in-human clinical trial with our MNPR-101-Zr radiopharmaceutical program; and (2) advance our MNPR-101-RIT preclinical programs into the clinic. We are in the process of winding down the camsirubicin Phase 1b clinical trial and the preclinical development of MNPR-202 due to focusing our finite financial resources on our radiopharmaceutical programs. We will require additional funding to further advance our clinical and preclinical programs and we anticipate that we will seek to raise additional capital within the next 12 months to fund our future operations.

Current wording

Our cash, cash equivalents and investments as of June 30, 2024, were $7.1 million. As discussed further below and elsewhere in this Quarterly Report, we expect that our current funds will be sufficient at least through August 31, 2025 for us to: (1) continue to conduct and conclude our first-in-human clinical trial with our MNPR-101-Zr radiopharmaceutical program; and (2) advance our MNPR-101-RIT preclinical program into the clinic. We are in the process of winding down the camsirubicin Phase 1b clinical trial and the preclinical development of MNPR-202 due to focusing our finite financial resources on our radiopharmaceutical programs. We will require additional funding to further advance our clinical and preclinical programs and we anticipate that we will seek to raise additional capital within the next 12 months to fund our future operations.

Previous wording

Our primary funding source over the past three years was sales of shares of our common stock under at-the-market sales programs through Capital on Demand™ Sales Agreements with JonesTrading Institutional Services LLC (“Jones Trading”). For the three months ended March 31, 2024, we sold 2,545,305 shares of our common stock at an average gross price per share of $1.29 for net proceeds of $3,194,310, after fees and commissions of $81,932. There have been no additional sales of shares of our common stock after March 31, 2024 through the date of this filing.

Current wording

Our primary funding source over the past three years was sales of shares of our common stock under at-the-market sales programs through Capital on Demand™ Sales Agreements with JonesTrading Institutional Services LLC (“Jones Trading”). For the six months ended June 30, 2024, we sold 2,545,305 shares of our common stock at an average gross price per share of $1.29 for net proceeds of $3,194,310, after fees and commissions of $81,932. There have been no additional sales of shares of our common stock since March 31, 2024.

Previous wording

We have been generating promising preclinical data, and recently entered the clinic with our novel, proprietary MNPR-101 radiopharma program targeting the urokinase plasminogen activator receptor (uPAR). Based on these advances, we have made the strategic decision to focus our resources on the assets and capabilities we have been building up in the radiopharma space. As such, we are winding down our non-radiopharma programs, including camsirubicin (and our Phase 1b clinical trial) as well as MNPR-202. We are targeting launching our second radiopharma clinical trial as early as the end of this year or the first quarter of 2025.

Current wording

We have been generating promising preclinical data, and recently entered the clinic with our novel, proprietary MNPR-101 radiopharma program targeting the urokinase plasminogen activator receptor (uPAR). Based on these advances, we have made the strategic decision to focus our resources on the assets and capabilities we have been building up in the radiopharma space. As such, we are in the process of winding down our non-radiopharma programs, including camsirubicin (and our Phase 1b clinical trial) as well as MNPR-202. We are on track to initiate in the fourth quarter of 2024 our second radiopharma clinical trial.

Previous wording

Monopar has a proprietary first-in-class humanized monoclonal antibody, MNPR-101, that targets the urokinase plasminogen activator receptor ("uPAR"). uPAR is expressed on several of the more aggressive, deadly cancers including pancreatic, breast, colorectal, and bladder. Monopar has conjugated MNPR-101 to imaging and therapeutic radioisotopes for the purpose of creating highly precise radiopharmaceutical agents that have the potential to image and treat tumors expressing uPAR while sparing healthy tissues. In February 2024, we announced promising preclinical data and received regulatory clearance in Australia to commence a first-in-human Phase 1 imaging and dosimetry clinical trial with our novel MNPR-101-Zr (MNPR-101 conjugated to zirconium-89) in patients with advanced cancers. On April 10, 2024, we announced that our Phase 1 trial is active and recruiting patients. Our MNPR-101-RIT program, a therapeutic radioisotope conjugated to MNPR-101, is targeted to initiate a Phase 1 clinical trial by Q4 2024 / Q1 2025. We are also actively exploring opportunities to expand our radiopharmaceutical pipeline.

Current wording

Monopar has a proprietary first-in-class humanized monoclonal antibody, MNPR-101, that targets the urokinase plasminogen activator receptor ("uPAR"). uPAR is expressed on several of the more aggressive, deadly cancers including pancreatic, breast, colorectal, and bladder. Monopar has conjugated MNPR-101 to imaging and therapeutic radioisotopes for the purpose of creating highly precise radiopharmaceutical agents that have the potential to image and treat tumors expressing uPAR while sparing healthy tissues. In February 2024, we announced promising preclinical data and received regulatory clearance in Australia to commence a first-in-human Phase 1 imaging and dosimetry clinical trial with our novel MNPR-101-Zr (MNPR-101 conjugated to zirconium-89) in patients with advanced cancers. On July 9, 2024, we announced that our Phase 1 trial enrolled its first patient. Our MNPR-101-RIT program, a therapeutic radioisotope conjugated to MNPR-101, is on track to initiate a Phase 1 clinical trial in Q4 2024. We are also actively exploring opportunities to expand our radiopharmaceutical pipeline.

Previous wording

We have reprioritized our resources and funds toward the advancement of our radiopharmaceutical programs. As a result of this reprioritization, we intend to wind down in Q2 2024 our Phase 1b open-label camsirubicin clinical trial and the preclinical development of MNPR-202.

Current wording

We have reprioritized our resources and funds toward the advancement of our radiopharmaceutical programs. As a result of this reprioritization, we are in the process of winding down our Phase 1b open-label camsirubicin clinical trial and the preclinical development of MNPR-202.

Previous wording

During the three months ended March 31, 2024, there were two recently issued accounting pronouncements that are described in more detail in Note 2 of our condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q.

Current wording

During the three months ended June 30, 2024, there were three recently issued accounting pronouncements that are described in more detail in Note 2 of our condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q.

Previous wording

Stock-based compensation costs for stock awards granted to our employees, non-employee directors and consultants are based on the fair value of the underlying instruments calculated using the Black-Scholes option-pricing model on the date of grant for stock options and using the closing stock price on the date of grant for RSUs and recognized as expense on a straight-line basis over the requisite service period, which is the vesting period. Determining the appropriate fair value model and related assumptions requires judgment, including selecting methods for estimating our future stock price volatility and expected holding term. We granted 10,000 options to purchase shares of common stock to a consultant during the three months ended March 31, 2024. For awards granted during the three months ended March 31, 2024, the expected volatility rates are estimated based on our actual historical volatility over the four-year period from our initial public offering on December 18, 2019, through December 31, 2023. The expected term for stock options granted during the three months ended March 31, 2024, and 2023, was estimated using the simplified method. Forfeitures only include actual forfeitures to-date as we account for forfeitures as they occur due to a limited history of forfeitures. We have not paid dividends and do not anticipate paying a cash dividend in future vesting periods and, accordingly, use an expected dividend yield of zero. The risk-free interest rate is based on the rate of U.S. Treasury securities with maturities consistent with the estimated expected term of the awards.

Current wording

Stock-based compensation costs for stock awards granted to our employees, non-employee directors and consultants are based on the fair value of the underlying instruments calculated using the Black-Scholes option-pricing model on the date of grant for stock options and using the closing stock price on the date of grant for RSUs and recognized as expense on a straight-line basis over the requisite service period, which is the vesting period. Determining the appropriate fair value model and related assumptions requires judgment, including selecting methods for estimating our future stock price volatility and expected holding term. During the six months ended June 30, 2024, we granted 10,000 options to purchase shares of our common stock to a consultant, 25,000 options to purchase shares of our common stock to an officer and 43,592 options to purchase shares of our common stock to non-officer employees. For awards granted during the three and six months ended June 30, 2024, the expected volatility rates are estimated based on our actual historical volatility over the four-year period from our initial public offering on December 18, 2019, through December 31, 2023. For awards granted during the three and six months ended June 30, 2023, the expected volatility rates are estimated based on our actual historical volatility over the three-year period from our initial public offering on December 18, 2019, through December 31, 2022. The expected term for stock options granted during the three and six months ended June 30, 2024, and 2023, was estimated using the simplified method. Forfeitures only include actual forfeitures to-date as we account for forfeitures as they occur due to a limited history of forfeitures. We have not paid dividends and do not anticipate paying a cash dividend in future vesting periods and, accordingly, use an expected dividend yield of zero. The risk-free interest rate is based on the rate of U.S. Treasury securities with maturities consistent with the estimated expected term of the awards.

Previous wording

Comparison of the Three Months Ended March 31, 2024 and 2023

Current wording

Comparison of the Three and Six Months Ended June 30, 2024 and 2023

Previous wording

The following table summarizes the results of our operations for the three months ended March 31, 2024 and 2023:

Current wording

The following table summarizes the results of our operations for the three and six months ended June 30, 2024 and 2023:

Previous wording

R&D expenses for the three months ended March 31, 2024 were $966,000, compared to $1,653,000 for the three months ended March 31, 2023. This represents a decrease of $687,000 attributed to a decrease of $716,000 in Validive clinical trial-related expenses due to the closure of the trial in March 2023, partially offset by a net increase of $29,000 due to other R&D expenses.

Current wording

R&D expenses for the three months ended June 30, 2024 were $1,131,000, compared to $1,595,000 for the three months ended June 30, 2023. This represents a decrease of $464,000 attributed to (1) a decrease of $636,000 in Validive clinical trial-related expenses due to the closure of the trial in March 2023, and (2) decrease in camsirubicin manufacturing costs of $138,000. These decreases were partially offset by a net increaseof $310,000 due to other R&D expenses attributable to MNPR-101 for radiopharma use.

Previous wording

G&A expenses for the three months ended March 31, 2024 were $757,000, compared to $872,000 for the three months ended March 31, 2023. This represents a decrease of $115,000 primarily attributed to (1) a decrease in stock based compensation to the board of directors of $70,000 as no equity awards were issued in the first quarter of 2024, (2) a reduction of $62,000 in patent expenses related to the closure of the Validive trial, and (3) a reduction of stock based compensation expenses of $16,000 due to the full vesting of the 2020 grants in the fourth quarter of 2023, partially offset by an increase in consulting, tax services and other G&A expenses of $33,000.

Current wording

G&A expenses for thesix months ended June 30, 2024 were $1,415,000, compared to $1,605,000 for thesix months ended June 30, 2023. This represents a decrease of $190,000 primarily attributed to (1) a decrease in stock based compensation to the board of directors of $134,000 as no equity awards were issued to the board of directors in 2024, (2) a reduction of stock based compensation expenses of $51,000 due to the full vesting of the 2020 grants in the fourth quarter of 2023, and (3) a net decrease in consulting, tax services and other G&A expenses of $5,000.

Previous wording

Interest income for the three months ended March 31, 2024, decreased by $8,000 versus the three months ended March 31, 2023, due to less treasury bills which matured in the first quarter of 2024 versus the first quarter of 2023.

Current wording

Interest income for the three months ended June 30, 2024, decreased by $54,000 versus the three months ended June 30, 2023. The reduction in the amount of interest received is a reflection of lower daily average cash balance in the second quarter of 2024 versus the second quarter of 2023.

Previous wording

We have incurred losses and cumulative negative cash flows from operations since we commenced operations resulting in an accumulated deficit of approx imately $61.8 millionas of March 31, 2024. We anticipate that we will continue to incur losses for the foreseeable future. We expect that our R&D and G&A expenses will increase to enable the execution of our strategic plan. As a result, we anticipate that we will seek to raise additional capital within the next 12 months to fund our future operations. We will seek to obtain needed capital through a combination of equity offerings, including the usage of our Capital on Demand TM Sales Agreement with JonesTrading, debt financings, strategic collaborations and grant funding. To date, we have funded our operations through net proceeds from the initial public offering of our common stock, net proceeds from sales of our common stock through at-the-market sales programs, private placements of our preferred and common stock, and the net receipt of funds related to our acquisition of camsirubicin. We anticipate that the currently available funds as of April 30, 2024 will fund our planned operations at least through June 30, 2025.

Current wording

We have incurred losses and cumulative negative cash flows from operations since we commenced operations resulting in an accumulated deficit of approx imately $63.6 millionas of June 30, 2024. We anticipate that we will continue to incur losses for the foreseeable future. We expect that our R&D and G&A expenses will increase to enable the execution of our strategic plan. As a result, we anticipate that we will seek to raise additional capital within the next 12 months to fund our future operations. We will seek to obtain needed capital through a combination of equity offerings, including the usage of our Capital on Demand TM Sales Agreement with JonesTrading, debt financings, strategic collaborations and grant funding. To date, we have funded our operations through net proceeds from the initial public offering of our common stock, net proceeds from sales of our common stock through at-the-market sales programs, private placements of our preferred and common stock, and the net receipt of funds related to our acquisition of camsirubicin. We anticipate that the currently available funds as of June 30, 2024 will fund our planned operations at least through August 31, 2025.

Previous wording

The following table provides information regarding our cash flows for the three months ended March 31, 2024 and 2023.

Current wording

The following table provides information regarding our cash flows for the six months ended June 30, 2024 and 2023.

Previous wording

During thethree months ended March 31, 2024 and 2023 we had a net cash inflow of $542,000 and a net cash outflow of $2,460,000, respectively. During thethree months ended March 31, 2024, versus thethree months ended March 31, 2023, the increase in net cash flow of $3,002,000 primarily consisted of (1) a decrease in net cash used in operating activities of $616,000, and (2) an increase in net cash provided by financing activities of $2,377,000 due to the sales of shares of our common stock under at-the-market sales programs.

Current wording

During thesix months ended June 30, 2024 and 2023 we had a net cash outflow of $1,146,000 and $972,000, respectively. During thesix months ended June 30, 2024, versus thesix months ended June 30, 2023, the increase in net cash outflow of $174,000 primarily consistedof a decrease in net cash provided by investing activities of $2,956,000 due to the purchases of investments versus certain investments maturities, partially offset by (1) a decrease in net cash used in operating activities of $1,041,000 and (2) an increase in net cash provided by financing activities of $1,726,000 due to the increased sales of shares of our common stock under at-the-market sales programs.

Previous wording

The decrease of $616,000 in cash flow used in operating activities during thethree months ended March 31, 2024, compared to thethree months ended March 31, 2023, was primarily a result of lower net loss due to lower research and development expenses partially offset by changes in accounts payable, accrued expenses and other current liabilities.

Current wording

The decrease of $1,041,000 in cash flow used in operating activities during thesix months ended June 30, 2024, compared to thesix months ended June 30, 2023, was primarily a result of lower net loss due to a reduction in research and development expenses partially offset by changes in accounts payable, accrued expenses and other current liabilities.

Previous wording

Cash Flow Used in Investing Activities

Current wording

Cash Flow Provided by (Used in) Investing Activities

Previous wording

The cash used in investing activities during thethree months ended March 31, 2024 and 2023 represent our net investment in two money market accounts and U.S. Treasury Bills maturing or invested in during the periods reported.

Current wording

The cash used in investing activities during thesix months ended June 30, 2024 and the cash provided by investing activities during the six months ended June 30, 2023 represent our net investment in two money market accounts and U.S. Treasury Bills maturing or invested in during the periods reported.

Previous wording

The increase in cash flow provided by financing activities during thethree months ended March 31, 2024, compared to thethree months ended March 31, 2023, of $2,377,000 was primarily due to higher net proceeds from sales of our common stock under an at-the-market sales program during thethree months ended March 31, 2024 when compared to the sales of our common stock during thethree months ended March 31, 2023.

Current wording

The increase in cash flow provided by financing activities during thesix months ended June 30, 2024, compared to thesix months ended June 30, 2023, of $1,726,000 was primarily due to higher net proceeds from sales of our common stock under at-the-market sales programs during thesix months ended June 30, 2024 when compared to the sales of our common stock during thesix months ended June 30, 2023.

Previous wording

To date, we have not generated any revenue from product sales. We do not know when, or if, we will generate any revenue from product sales. We do not expect to generate any revenue from product sales or royalties unless and until we obtain regulatory approval of and commercialize any of our current or future drug product candidates or we out-license or sell a drug product candidate to another party. At the same time, we expect our expenses to increase in connection with our ongoing development activities, particularly as we continue the research, development, future preclinical studies and clinical trials of, and seek regulatory approval for, our current and future drug product candidates. If we obtain regulatory approval of any of our current or future drug product candidates, we will need substantial additional funding for commercialization requirements and our continuing drug product development operations.

Current wording

To date, we have not generated any revenue from product sales. We do not know when, or if, we will generate any revenue from product sales. We do not expect to generate any revenue from product sales or royalties unless and until we obtain regulatory approval of and commercialize any of our current or future drug product candidates or we out-license or sell a drug product candidate to another party. At the same time, we expect our expenses to increase in connection with our ongoing development activities, particularly as we continue the research, development, future preclinical studies and clinical trials of, and seek regulatory approval for, our current and future drug product candidates. We will need substantial additional funding for clinical development prior to seeking regulatory approval. If we obtain regulatory approval of any of our current or future drug product candidates, we will need substantial additional funding for commercialization requirements and our continuing drug product development operations.

Previous wording

We have initiated a Phase 1 imaging and dosimetry clinical trial in Australia for our novel radiopharmaceutical imaging agent MNPR-101-Zr (MNPR-101 conjugated to zirconium-89). This trial is now active and recruiting patients with advanced cancers. We intend to continue evaluating drug product candidates for the purpose of growing our pipeline. Identifying and securing high-quality compounds usually takes time and related expenses. Our spending could be significantly accelerated in the future if additional drug product candidates are acquired and enter clinical development. In this event, we may be required to expand our management team, and pay higher contract manufacturing costs, contract research organization fees, other clinical development costs and insurance costs that are not currently projected. Beyond our need to raise additional funding within the next 12 months, substantial additional long-term funding is needed to further develop our radiopharmaceutical programs.

Current wording

We have initiated a Phase 1 imaging and dosimetry clinical trial in Australia for our novel radiopharmaceutical imaging agent MNPR-101-Zr (MNPR-101 conjugated to zirconium-89). This trial has dosed its first patient and is recruiting additional patients with advanced cancers. We intend to continue evaluating drug product candidates for the purpose of growing our pipeline. Identifying and securing high-quality compounds usually takes time and related expenses. Our spending could be significantly accelerated in the future if additional drug product candidates are acquired and enter clinical development. In this event, we may be required to expand our management team, and pay higher contract manufacturing costs, contract research organization fees, other clinical development costs and insurance costs that are not currently projected. Beyond our need to raise additional funding within the next 12 months, substantial additional long-term funding is needed to further develop our radiopharmaceutical programs.

Previous wording

The termination of our Validive clinical trial due to the no-go decision at the end of March 2023 resulted in a decrease in our stock price. The closing bid price of our stock fell below $1.00 for more than 30 consecutive trading days, and on August 28, 2023, we received a notice from Nasdaq stating that we are out of compliance with Nasdaq listing standards giving us 180 days to regain compliance. On February 27, 2024, we were granted a second 180-day period to regain compliance; there can be no assurance that we will regain compliance within Nasdaq’s extended time limits and requirements. If we do not regain compliance, we would face delisting and it may have serious adverse consequences on our ability to raise funds, which may cause us to delay, restructure or otherwise reconsider our operations. If it is necessary to effect a reverse stock split to attempt to cure the bid price deficiency, the impacts on our stock price are uncertain and could be adverse.

Current wording

On August 28, 2023, we received a notice from Nasdaq stating that we are out of compliance with Nasdaq listing standards giving us 180 days to regain compliance with the minimum bid price requirement. On February 27, 2024, we were granted a second 180-day period to regain compliance; there can be no assurance that we will regain compliance within Nasdaq’s extended time limits and requirements. If we do not regain compliance, we will face delisting and it may have serious adverse consequences on our ability to raise funds, which may cause us to delay, restructure or otherwise reconsider our operations. To attempt to cure the bid price deficiency, the Company expects that a reverse stock split at a ratio of 1 for 5 shares will become effective at 5:00 pm on Monday August 12, 2024, and its common stock will begin trading on a split-adjusted basis at the open of trading on Tuesday, August 13, 2024. However, the impacts on our stock price are uncertain and could be adverse.

Previous wording

Pursuant to a non-exclusive license agreement with XOMA Ltd. for the humanization technology used in the development of MNPR-101, we are obligated to pay XOMA Ltd. clinical, regulatory and sales milestones which could reach up to $14.925 million if we achieve all milestones for MNPR-101. The agreement does not require the payment of sales royalties. There can be no assurance that we will achieve any milestones. As of April 30, 2024, we had not reached any milestones and had not been required to pay XOMA Ltd. any funds under this license agreement. The first milestone payment is payable upon first dosing of a human patient in a Phase 2 clinical trial.

Current wording

Pursuant to a non-exclusive license agreement with XOMA Ltd. for the humanization technology used in the development of MNPR-101, we are obligated to pay XOMA Ltd. clinical, regulatory and sales milestones which could reach up to $14.925 million if we achieve all milestones for MNPR-101. The agreement does not require the payment of sales royalties. There can be no assurance that we will achieve any milestones. As of July 31, 2024, we had not reached any milestones and had not been required to pay XOMA Ltd. any funds under this license agreement. The first milestone payment is payable upon first dosing of a human patient in a Phase 2 clinical trial. We are currently conducting a Phase 1 clinical trial and cannot reliably predict when we will be able to commence a Phase 2 clinical trial, if at all.