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MUSTANG BIO, INC.

For the period ended Sep 30, 2026. Filed Nov 5, 2026.

View on SEC.gov

About this filing

A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.

Sep 30, 2026 · Filed Nov 5, 2026

MBIO$0.39+0.2%Stored close · as of Nov 6, 2026

What changed in Risk Factors?

Read the current filing

Previous report: 10-Q

Period ended 2026-06-30; filed 2026-08-05.

0001104659-26-091061

Item 1A. Risk Factors

Current report: 10-Q

Period ended 2026-09-30; filed 2026-11-05.

0001104659-26-123328

Item 1A. Risk Factors

The baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.

Compared 205 previous paragraphs and 206 current paragraphs.

191 unchanged; 13 reworded; 2 added; 1 removed; 0 previous and 0 current paragraphs rearranged.

Tables are not compared: 149 previous and 149 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.

A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.

Added paragraphs (2)

Current report

Pursuant to Nasdaq Listing Rule 5810(c)(3)(A), we were afforded an initial 180-calendar day grace period, or until October 12, 2026, to regain compliance with the Bid Price Requirement. We were unable to demonstrate compliance with the Bid Price Requirement by that date. However, we submitted a request for an additional 180-calendar day grace period based upon (i) our belief that, as of October 12, 2026, we satisfied the continued listing requirement for market value of publicly held shares and all other applicable requirements for initial listing on The Nasdaq Capital Market, except for the Bid Price Requirement, and (ii) our written notice to Nasdaq of our intention to cure the deficiency during the second grace period by effecting a reverse stock split, if necessary.

Current report

We intend to closely monitor the closing bid price of our common stock and to take all reasonable measures available to regain compliance under the Nasdaq Listing Rules and remain listed on Nasdaq, including effecting a reverse stock split, if necessary. However, there can be no assurance that we will ultimately regain compliance with all applicable requirements for continued listing.
Removed paragraphs (1)

Previous report

If the Company does not regain compliance with the Bid Price Rule by October 12, 2026, the Company may be eligible for an additional 180-calendar day compliance period so long as it satisfies the criteria for initial listing on Nasdaq and the continued listing requirement for market value of publicly held shares and the Company provides written notice to Nasdaq of its intention to cure the deficiency during the second compliance period by effecting a reverse stock split, if necessary. In the event the Company is not eligible for the second grace period, Nasdaq staff will provide written notice that the Company’s common stock is subject to delisting; however, the Company may request a hearing before the Nasdaq Hearings Panel (the “Panel”), which request, if timely made, would stay any further suspension or delisting action by the Staff pending the conclusion of the hearing process and expiration of any extension that may be granted by the Panel.
Reworded paragraphs (13)

Previous wording

*Investing in our common stock or any other type of equity or debt securities we may offer (together, our “Securities”) involves a high degree of risk. The following information sets forth risk factors that could cause our actual results to differ materially from those contained in forward-looking statements we have made in this Form 10-Q and those we may make from time to time. You should carefully consider the risks described below, in addition to the other information contained in this Form 10-Q,**including our consolidated financial statements and the related notes and “Management’s Discussion and Analysis of Financial Condition and Results of Operations”*before making an investment decision. Our business, financial condition or results of operations could be harmed by any of these risks. The risks and uncertainties described below are not the only ones we face. Additional risks not presently known to us or other factors not perceived by us to present significant risks to our business at this time also may impair our business operations. Some of the statements in the following risk factors constitute forward-looking statements. Please see the section titled “Special Cautionary Note Regarding Forward-Looking Statements.”

Current wording

*Investing in our common stock or any other type of equity or debt securities we may offer (together, our “Securities”) involves a high degree of risk. The following information sets forth risk factors that could cause our actual results to differ materially from those contained in forward-looking statements we have made in this Form 10-Q and those we may make from time to time. You should carefully consider the risks described below, in addition to the other information contained in this Form 10-Q,**including our financial statements and the related notes and “Management’s Discussion and Analysis of Financial Condition and Results of Operations”*before making an investment decision. Our business, financial condition or results of operations could be harmed by any of these risks. The risks and uncertainties described below are not the only ones we face. Additional risks not presently known to us or other factors not perceived by us to present significant risks to our business at this time also may impair our business operations. Some of the statements in the following risk factors constitute forward-looking statements. Please see the section titled “Special Cautionary Note Regarding Forward-Looking Statements.”

Previous wording

We have a limited operating history. We have focused primarily on organizing, acquiring, developing and securing our proprietary technology and identifying and obtaining preclinical data for various product candidates, with the goal of supporting regulatory approval for these product candidates. We have incurred losses since our inception in March 2015. Our net losses were $2.0 million and $0.9 million for the six months ended June 30, 2026 and 2025, respectively, and we had an accumulated deficit of $400.7 million as of June 30, 2026. We expect to continue to incur significant operating losses for the foreseeable future. We also do not anticipate that we will achieve profitability for a period of time after generating material revenues, if ever. If we are unable to generate revenues, we will not become profitable and may be unable to continue operations without continued funding.

Current wording

We have a limited operating history. We have focused primarily on organizing, acquiring, developing and securing our proprietary technology and identifying and obtaining preclinical data for various product candidates, with the goal of supporting regulatory approval for these product candidates. We have incurred losses since our inception in March 2015. Our net losses were $3.0 million and $1.4 million for the nine months ended September 30, 2026 and 2025, respectively, and we had an accumulated deficit of $401.6 million as of September 30, 2026. We expect to continue to incur significant operating losses for the foreseeable future. We also do not anticipate that we will achieve profitability for a period of time after generating material revenues, if ever. If we are unable to generate revenues, we will not become profitable and may be unable to continue operations without continued funding.

Previous wording

Since our inception, we have incurred substantial operating losses and expect to continue to incur significant operating losses for the foreseeable future, and we may never become profitable. To date, we have not generated positive cash flows from operations and have funded our operations primarily with the proceeds from sales of equity securities. As of June 30, 2026, we had an accumulated deficit of $400.7 million, and cash and cash equivalents of $15.2 million.

Current wording

Since our inception, we have incurred substantial operating losses and expect to continue to incur significant operating losses for the foreseeable future, and we may never become profitable. To date, we have not generated positive cash flows from operations and have funded our operations primarily with the proceeds from sales of equity securities. As of September 30, 2026, we had an accumulated deficit of $401.6 million, and cash and cash equivalents of $14.3 million.

Previous wording

Under current SEC regulations, if at the time we file our Annual Report on Form 10-K our public float is less than $75 million, and for so long as our public float remains less than $75 million, the amount we can raise through primary public offerings of securities in any twelve-month period using shelf registration statements is limited to an aggregate of one-third of our public float, which is commonly referred to as the “baby shelf rules.” SEC regulations permit us to use the highest closing sales price of our common stock (or the average of the last bid and last ask prices of our common stock) on any day within 60 days of sales under the registration statement to calculate our public float.

Current wording

Under current SEC regulations, if at the time we file our Annual Report on Form 10-K our public float is less than $75 million, and for so long as our public float remains less than $75 million, the amount we can raise through primary public offerings of securities in any twelve-month period using a shelf registration statement on Form S-3 is limited to an aggregate of one-third of our public float, which is commonly referred to as the “baby shelf rules.” SEC regulations permit us to use the highest closing sales price of our common stock (or the average of the last bid and last ask prices of our common stock) on any day within 60 days of sales under the registration statement to calculate our public float.

Previous wording

As of the date of the 2025 Form 10-K, our public float was less than $75 million. As a result, for sales following the date of the 2025 Form 10-K, and until we again have a public float with a value in excess of $75 million, if ever, we only have the capacity to sell an amount of securities up to one-third of our public float under shelf registration statements in any twelve-month period. If our public float decreases, the number of securities we may sell under our Form S-3 shelf registration statements will also decrease.

Current wording

As of the date of the 2025 Form 10-K, our public float was less than $75 million. As a result, for sales following the date of the 2025 Form 10-K, and until we again have a public float with a value in excess of $75 million, if ever, we only have the capacity to sell an amount of securities up to one-third of our public float under a shelf registration statement on Form S-3 in any twelve-month period. If our public float decreases, the number of securities we may sell under our Form S-3 shelf registration statement will also decrease.

Previous wording

We are a smaller reporting company, and we will remain a smaller reporting company until the fiscal year following the determination that our voting and non-voting common shares held by non-affiliates is more than $250 million measured on the last business day of our second fiscal quarter, or our annual revenues are more than $100 million during the most recently completed fiscal year and our voting and non-voting common shares held by non-affiliates is more than $700 million measured on the last business day of our second fiscal quarter. Smaller reporting companies are able to provide simplified executive compensation disclosure, are exempt from the auditor attestation requirements of Section 404, and have certain other reduced disclosure obligations, including, among other things, being required to provide only two years of audited financial statements and not being required to provide selected financial data, supplemental financial information or risk factors.

Current wording

We are a smaller reporting company, and we will remain a smaller reporting company until the fiscal year following the determination that our voting and non-voting common shares held by non-affiliates is $250 million or more measured on the last business day of our second fiscal quarter, and our annual revenues are $100 million or more during the most recently completed fiscal year or our voting and non-voting common shares held by non-affiliates is more than $700 million measured on the last business day of our second fiscal quarter. Smaller reporting companies are able to provide simplified executive compensation disclosure, are exempt from the auditor attestation requirements of Section 404, and have certain other reduced disclosure obligations, including, among other things, being required to provide only two years of audited financial statements and not being required to provide selected financial data, supplemental financial information or risk factors.

Previous wording

The FDA, or other regulatory authorities, may also impose requirements for costly post-marketing studies or clinical trials and surveillance to monitor the safety or efficacy of the product. The FDA and other applicable regulatory authorities closely regulates the post-approval marketing and promotion of drugs to ensure drugs are marketed only for the approved indications and in accordance with the provisions of the approved labeling. The FDA and other applicable regulatory authorities impose stringent restrictions on manufacturers’ communications regarding off-label use and if we market any approved product in a way which is not consistent with the approved labeling, we may be subject to enforcement action for off-label marketing. Violations of the Federal Food, Drug and Cosmetics Act relating to the promotion of prescription drugs may lead to investigations, civil claims, and/or criminal charges alleging violations of federal and state health care fraud and abuse laws, as well as state consumer protection laws.

Current wording

The FDA, or other regulatory authorities, may also impose requirements for costly post-marketing studies or clinical trials and surveillance to monitor the safety or efficacy of the product. The FDA and other applicable regulatory authorities closely regulate the post-approval marketing and promotion of drugs to ensure drugs are marketed only for the approved indications and in accordance with the provisions of the approved labeling. The FDA and other applicable regulatory authorities impose stringent restrictions on manufacturers’ communications regarding off-label use and if we market any approved product in a way which is not consistent with the approved labeling, we may be subject to enforcement action for off-label marketing. Violations of the Federal Food, Drug and Cosmetics Act relating to the promotion of prescription drugs may lead to investigations, civil claims, and/or criminal charges alleging violations of federal and state health care fraud and abuse laws, as well as state consumer protection laws.

Previous wording

If we are unable to maintain compliance with all applicable continued listing requirements and standards of Nasdaq, our common stock may be delisted from Nasdaq.

Current wording

If we are unable to regain compliance with all applicable continued listing requirements and standards of Nasdaq, our common stock may be delisted from Nasdaq.

Previous wording

Our common stock is listed on the Nasdaq Capital Market under the symbol “MBIO.” The Nasdaq Capital Market requires that listed companies satisfy continued listing standards to maintain their listing. We are currently not in compliance with certain standards for continued listing on the Nasdaq Capital Market, namely, Nasdaq Listing Rule 5550(a)(2), which sets forth the minimum bid price requirement for continued listing on the Nasdaq Capital Market (the “Bid Price Rule”), and as described below, we may not be in compliance with the newly adopted minimum Market Value of Listed Securities requirement, if and when such rule becomes effective.

Current wording

Our common stock is listed on the Nasdaq Capital Market under the symbol “MBIO.” The Nasdaq Capital Market requires that listed companies satisfy continued listing standards to maintain their listing. We are currently not in compliance with certain standards for continued listing on the Nasdaq Capital Market, namely, Nasdaq Listing Rule 5550(a)(2), which sets forth the minimum bid price requirement for continued listing on the Nasdaq Capital Market (the “Bid Price Requirement”), and as described below, we may not be in compliance with the newly adopted minimum Market Value of Listed Securities requirement, if and when such rule becomes effective.

Previous wording

On April 15, 2026, we received a notice (the “Letter”) from the Listing Qualifications Department (the “Staff”) of Nasdaq indicating that the bid price of our common stock had closed below $1.00 for 30 consecutive business days and, as a result, we were not in compliance with the Bid Price Rule. The Letter has no immediate effect on the listing of the Company’s Common Stock on Nasdaq.

Current wording

On April 15, 2026, we received a notice (the “Letter”) from the Listing Qualifications Department (the “Staff”) of Nasdaq indicating that the bid price of our common stock had closed below $1.00 for 30 consecutive business days and, as a result, we were not in compliance with the Bid Price Requirement. The Letter had no immediate effect on the listing of the Company’s common stock on Nasdaq.

Previous wording

Pursuant to Nasdaq Listing Rule 5810(c)(3)(A), we have been afforded a 180-calendar day grace period, or until October 12, 2026, to regain compliance with the Bid Price Rule, which necessitates a closing bid price of at least $1.00 per share for a minimum of ten consecutive business days (but generally not more than 20 consecutive business days) by October 12, 2026.

Current wording

On October 13, 2026, we received a letter from the Staff granting our request for an additional 180-calendar day period, or until April 12, 2027, to regain compliance with the Bid Price Requirement. Compliance can be achieved by evidencing a closing bid price of at least $1.00 per share for a minimum of 10 consecutive business days (but generally not more than 20 consecutive business days) during the second 180-calendar day grace period. In the event we do not regain compliance by the end of the second grace period, the Staff will provide written notification that our common stock will be delisted. At that time, we may appeal the Staff’s determination to the Nasdaq Hearings Panel (the “Panel”), although an appeal would not pause any suspension of trading.

Previous wording

In addition to the Bid Price Rule, on July 22, 2026, the Securities and Exchange Commission (the “SEC”) approved a Nasdaq rule change that adopts a new continued listing requirement obligating companies listed on the Nasdaq Capital Market to maintain a minimum Market Value of Listed Securities (“MVLS”) of at least $5 million (the “MVLS Requirement”). Although the SEC subsequently stayed the implementation of the MVLS Requirement on July 29, 2026, it is possible that the new rule may become effective in the near-term. The MVLS Requirement is set forth in new Nasdaq Listing Rule 5550(a)(6).

Current wording

In addition to the Bid Price Requirement, on July 22, 2026, the Securities and Exchange Commission (the “SEC”) approved a Nasdaq rule change that adopts a new continued listing requirement obligating companies listed on the Nasdaq Capital Market to maintain a minimum Market Value of Listed Securities (“MVLS”) of at least $5 million (the “MVLS Requirement”). Although the SEC subsequently stayed the implementation of the MVLS Requirement on July 29, 2026, it is possible that the new rule may become effective in the near-term. The MVLS Requirement is set forth in new Nasdaq Listing Rule 5550(a)(6).

Previous wording

The consequences of failing to comply with the MVLS Requirement differ materially from, and are more severe than, those applicable to the Bid Price Rule. Unlike the Bid Price Rule, a company that fails to comply with the MVLS Requirement is not entitled to any cure or compliance period. Instead, if a company’s MVLS remains below $5 million for a period of 30 consecutive business days, Nasdaq will issue a Staff Delisting Determination and the company’s securities will be immediately subject to suspension and delisting. Furthermore, a timely request for a hearing before the Panel will not stay the suspension of the company’s securities from trading pending the issuance of a written decision by the Panel, and the company’s securities would generally trade in the over-the-counter market during the pendency of any such appeal. Although the Panel may reverse a delisting determination that it finds was made in error, or grant an exception for a period not to exceed 180 days from the Staff Delisting Determination for the company to demonstrate that it meets all requirements for initial listing (which are generally higher than the continued listing requirements), there can be no assurance that the Panel would grant any such exception or that we would be able to satisfy the initial listing standards; and in any event, our stock would not be traded on the Nasdaq Capital Market during such period.

Current wording

The consequences of failing to comply with the MVLS Requirement differ materially from, and are more severe than, those applicable to the Bid Price Requirement. Unlike the Bid Price Requirement, a company that fails to comply with the MVLS Requirement is not entitled to any cure or compliance period. Instead, if a company’s MVLS remains below $5 million for a period of 30 consecutive business days, Nasdaq will issue a Staff Delisting Determination and the company’s securities will be immediately subject to suspension and delisting. Furthermore, a timely request for a hearing before the Panel will not stay the suspension of the company’s securities from trading pending the issuance of a written decision by the Panel, and the company’s securities would generally trade in the over-the-counter market during the pendency of any such appeal. Although the Panel may reverse a delisting determination that it finds was made in error, or grant an exception for a period not to exceed 180 days from the Staff Delisting Determination for the company to demonstrate that it meets all requirements for initial listing (which are generally higher than the continued listing requirements), there can be no assurance that the Panel would grant any such exception or that we would be able to satisfy the initial listing standards; and in any event, our stock would not be traded on the Nasdaq Capital Market during such period.