AVENUE THERAPEUTICS, INC.

Previous wording

Our net loss for the six months ended June 30, 2026 and 2025 was approximately $1.4 million and $1.5 million, respectively. As of June 30, 2026, we had an accumulated deficit of approximately $106.9 million. Substantially all our net losses resulted from costs incurred for research and development, and general and administrative purposes.

Current wording

Our net loss for the nine months ended September 30, 2026 and 2025 was approximately $2.1 million and $2.2 million, respectively. As of September 30, 2026, we had an accumulated deficit of approximately $107.6 million. Substantially all our net losses resulted from costs incurred for research and development, and general and administrative purposes.

Previous wording

Based on this data, Avenue is currently preparing a pre-IND meeting to align with the FDA regarding a pivotal study design for Pompe disease, and subsequent to that meeting, will seek to raise the necessary capital to fund the pivotal study and initiate the trial.

Current wording

Based on this data, Avenue is currently in discussions with the FDA regarding a pivotal study design for Pompe disease, and subsequent to those discussions, will seek to raise the necessary capital to fund the pivotal study and initiate the trial.

Previous wording

We participated in a Type C meeting with the FDA in March 2023 to discuss a proposed study protocol to assess the risk of respiratory depression related to opioid stacking on IV tramadol relative to an approved opioid analgesic. We announced in April 2023 that we received official meeting minutes from the Type C meeting with the FDA. The Type C meeting minutes indicate that we are in agreement with the FDA on a majority of the proposed protocol items and are in active discussion about remaining open items. The minutes indicate that the FDA also agrees that a successful study will support the submission of a complete response to the second Complete Response Letter for IV tramadol pending final agreement on a statistical analysis plan and a full review of the submitted data in the complete response as well as concurrence from the FDA's Division of Anesthesia, Analgesia, and Addiction Products.

Current wording

We participated in a Type C meeting with the FDA in March 2023 to discuss a proposed study protocol to assess the risk of respiratory depression related to opioid stacking on IV tramadol relative to an approved opioid analgesic. We announced in April 2023 that we received official meeting minutes from the Type C meeting with the FDA. The Type C meeting minutes indicated that we were in agreement with the FDA on a majority of the proposed protocol. The minutes indicated that the FDA also agreed that a successful study will support the submission of a complete response to the second Complete Response Letter for IV tramadol pending final agreement on a statistical analysis plan and a full review of the submitted data in the complete response as well as concurrence from the FDA's Division of Anesthesia, Analgesia, and Addiction Products.

Previous wording

In January 2024, we announced that we reached final agreement with the FDA on the Phase 3 safety study protocol and statistical analysis approach, including the primary endpoint. The final non-inferiority study is designed to assess the risk of opioid-induced respiratory depression related to opioid stacking on IV tramadol compared to IV morphine. The study will randomize approximately 300 post bunionectomy patients to IV tramadol or IV morphine for pain relief administered during a 48-hour post-operative period. Of note, this study design was used in the first of two Phase 3 trials. In a Phase 3 safety study to be conducted, patients will have access to IV hydromorphone, a Schedule II opioid, for rescue of breakthrough pain. The primary endpoint is a composite of elements indicative of respiratory depression.

Current wording

In January 2024, we announced that we reached final agreement with the FDA on the Phase 3 safety study protocol and statistical analysis approach, including the primary endpoint. The final non-inferiority study is designed to assess the risk of opioid-induced respiratory depression related to opioid stacking on IV tramadol compared to IV morphine. The study will randomize approximately 300 post bunionectomy patients to IV tramadol or IV morphine for pain relief administered during a 48-hour post-operative period. Of note, this study design was used in the first of two Phase 3 trials. In a Phase 3 safety study, patients would have access to IV hydromorphone, a Schedule II opioid, for rescue of breakthrough pain. The primary endpoint is a composite of elements indicative of respiratory depression.

Previous wording

We are currently evaluating the feasibility of the safety study. The initiation of the study is subject to the Company obtaining the necessary financing or partnership.

Current wording

We are currently evaluating the path forward for IV tramadol as a product candidate. The initiation of the study is subject to the Company obtaining the necessary financing or partnership.

Previous wording

At June 30, 2026, we had an accumulated deficit of $106.9 million. While we may in the future generate revenue from a variety of sources, including license fees, milestone payments, research and development payments in connection with strategic partnerships and/or product sales, our product candidates are still in development and may never be successfully developed or commercialized. Accordingly, we expect to continue to incur substantial losses from operations for the foreseeable future, and there can be no assurance that we will ever generate significant revenues.

Current wording

At September 30, 2026, we had an accumulated deficit of $107.6 million. While we may in the future generate revenue from a variety of sources, including license fees, milestone payments, research and development payments in connection with strategic partnerships and/or product sales, our product candidates are still in development and may never be successfully developed or commercialized. Accordingly, we expect to continue to incur substantial losses from operations for the foreseeable future, and there can be no assurance that we will ever generate significant revenues.

Previous wording

For the three months ended June 30, 2026 and 2025, research and development expenses were $0.2 million and $0.2 million, respectively, reflecting increased consulting costs offset by a decrease in personnel related expenses.

Current wording

For the three months ended September 30, 2026 and 2025, research and development expenses were relatively consistent at approximately $0.2 million and $0.2 million, respectively, reflecting increased consulting costs offset by a decrease in personnel-related expenses.

Previous wording

There was no material change in fair value for the three months ended June 30, 2026. The change in fair value of warrant liabilities was a gain of approximately $1,000 for the three months ended June 30, 2025. Warrants to purchase common stock that are required to be classified as a liability are valued at fair market value at each reporting period. The change in the fair value of warrant liabilities was primarily due to the fluctuation in our stock price.

Current wording

There was no material change in fair value for the three months ended September 30, 2026. The change in fair value of warrant liabilities was a loss of approximately $2,000 for the three months ended September 30, 2025. Warrants to purchase common stock that are required to be classified as a liability are valued at fair market value at each reporting period. The change in the fair value of warrant liabilities was primarily due to the fluctuation in our stock price.

Previous wording

No revenue was recognized for the three months ended June 30, 2026. For the three months ended June 30, 2025, we generated $1.4 million of net revenue related to the AnnJi license termination and program transfer.

Current wording

No revenue was recognized for the nine months ended September 30, 2026. For the nine months ended September 30, 2025, we generated $1.4 million of net revenue related to the AnnJi license termination and program transfer.

Previous wording

For the six months ended June 30, 2026 and 2025, research and development expenses were $0.4 million and $0.6 million, respectively. The decrease of $0.2 million was associated with a $0.2 million decrease in personnel related costs, including salaries, severance, benefits and stock-based compensation.

Current wording

For the nine months ended September 30, 2026 and 2025, research and development expenses were $0.7 million and $0.8 million, respectively. The decrease of $0.1 million was associated with a $0.2 million decrease in personnel related costs, including salaries, benefits and stock-based compensation, partially offset by a $0.1 million increase in consulting costs.

Previous wording

For the six months ended June 30, 2026 and 2025, general and administrative expenses were $1.0 million and $2.4 million, respectively. The decrease of $1.4 million is related to a decrease of $0.9 million in legal expenses due to costs incurred related to the AnnJi License Agreement termination in 2025, a $0.4 million decrease in personnel-related costs, including salaries, severance, benefits and stock-based compensation, and a $0.1 million decrease in professional fees.

Current wording

For the nine months ended September 30, 2026 and 2025, general and administrative expenses were $1.5 million and $3.0 million, respectively. The decrease of $1.5 million is related to a decrease of $0.8 million in legal expenses due to costs incurred related to the AnnJi License Agreement termination in 2025, a $0.5 million decrease in personnel-related costs, including salaries, severance, benefits and stock-based compensation, a $0.1 million decrease in equity fees to Fortress associated with financing activities in 2025, and a $0.1 million decrease in consulting costs.

Previous wording

The change in fair value of warrant liabilities was a gain of approximately $1,000 and $16,000 for the six months ended June 30, 2026 and 2025, respectively. Warrants to purchase common stock that are required to be classified as a liability are valued at fair market value at each reporting period. The change in the fair value of warrant liabilities was primarily due to the fluctuation in our stock price.

Current wording

The change in fair value of warrant liabilities was a gain of approximately $1,000 and $14,000 for the nine months ended September 30, 2026 and 2025, respectively. Warrants to purchase common stock that are required to be classified as a liability are valued at fair market value at each reporting period. The change in the fair value of warrant liabilities was primarily due to the fluctuation in our stock price.

Previous wording

At June 30, 2026, we had $1.9 million in cash and cash equivalents. To date, we have funded our operations primarily with proceeds from various public and private offerings of our common stock. We expect that our expenses will continue for the foreseeable future as we continue to advance our product candidates through clinical development and ultimately regulatory approval, and seek opportunities to license or acquire additional products. We will require additional financing to carry out our business plan and implement our strategy, and continue to analyze various alternatives, including potentially obtaining lines of credit, debt or equity financings. We cannot be sure that any additional funding, if needed, will be available on terms favorable to us or at all. Since March 2025, our common stock has been quoted on the over-the-counter market ("OTCID") under the symbol “ATXI”. Being listed on the OTCID may make it more difficult for us to obtain additional funding. For example, we are no longer eligible to use our shelf registration statement on Form S-3, which means we cannot access our ATM facility under the At the Market Offering Agreement (the “ATM Agreement”) with H.C. Wainwright & Co. LLC dated May 10, 2024. If we obtain funding through a strategic collaboration or licensing arrangement, we may be required to relinquish our rights to our product candidates or marketing territories. Without additional capital, we do not expect our cash will be sufficient to fund our projected operating requirements or allow us to fund our operating plan for more than 12 months from the date of issuance of the accompanying unaudited consolidated financial statements. We regularly evaluate market conditions, our liquidity profile, and various financing alternatives for opportunities to enhance our capital structure.

Current wording

At September 30, 2026, we had $1.5 million in cash and cash equivalents. To date, we have funded our operations primarily with proceeds from various public and private offerings of our common stock. We expect that our expenses will continue for the foreseeable future as we continue to advance our product candidates through clinical development and ultimately regulatory approval, and seek opportunities to license or acquire additional products. We will require additional financing to carry out our business plan and implement our strategy, and continue to analyze various alternatives, including potentially obtaining lines of credit, debt or equity financings. We cannot be sure that any additional funding, if needed, will be available on terms favorable to us or at all. Since March 2025, our common stock has been quoted on the over-the-counter market ("OTCID") under the symbol “ATXI”. Being listed on the OTCID may make it more difficult for us to obtain additional funding. For example, we are no longer eligible to use our shelf registration statement on Form S-3, which means we cannot access our ATM facility under the At the Market Offering Agreement (the “ATM Agreement”) with H.C. Wainwright & Co. LLC dated May 10, 2024. If we obtain funding through a strategic collaboration or licensing arrangement, we may be required to relinquish our rights to our product candidates or marketing territories. Without additional capital, we do not expect our cash will be sufficient to fund our projected operating requirements or allow us to fund our operating plan for more than 12 months from the date of issuance of the accompanying unaudited consolidated financial statements. We regularly evaluate market conditions, our liquidity profile, and various financing alternatives for opportunities to enhance our capital structure.

Previous wording

Cash Flows for the Six Months Ended June 30, 2026 and 2025

Current wording

Cash Flows for the Nine Months Ended September 30, 2026 and 2025

Previous wording

Net cash and cash equivalents used in operating activities was $0.9 million for the six months ended June 30, 2026, primarily comprised of our $1.4 million net loss, partially offset by increases of $0.4 million in operating assets and liabilities and $0.1 million in share-based compensation.

Current wording

Net cash and cash equivalents used in operating activities was $1.3 million for the nine months ended September 30, 2026, primarily comprised of our $2.1 million net loss, partially offset by increases of $0.6 million in operating assets and liabilities and $0.2 million in share-based compensation.

Previous wording

Net cash and cash equivalents used in operating activities was $1.4 million for the six months ended June 30, 2025, primarily comprised of our $1.5 million net loss and a decrease of $0.8 million in receivables from AnnJi, partially offset by an increase of $0.5 million in operating assets and liabilities and $0.4 million in share-based compensation.

Current wording

Net cash and cash equivalents used in operating activities was $1.0 million for the nine months ended September 30, 2025, primarily comprised of our $2.2 million net loss, partially offset by an increase of $0.7 million in operating assets and liabilities and $0.5 million in share-based compensation.

Previous wording

During the six months ended June 30, 2026, no net cash and cash equivalents was used in or provided by financing activities.

Current wording

During the nine months ended September 30, 2026, no net cash and cash equivalents was used in or provided by financing activities.

Previous wording

Net cash and cash equivalents provided by financing activities was $2.1 million for the six months ended June 30, 2025 primarily due to $2.1 million in net proceeds from the sale of common stock pursuant to the ATM Agreement.

Current wording

Net cash and cash equivalents provided by financing activities was $2.1 million for the nine months ended September 30, 2025 primarily due to $2.1 million in net proceeds from the sale of common stock pursuant to the ATM Agreement.

Previous wording

We are party to a share repurchase agreement with InvaGen, which requires us to pay InvaGen seven and a half percent (7.5%) of the proceeds of future financings, as defined in the agreement, up to $4.0 million in aggregate. For the six months ended June 30, 2025, the Company made payments totaling $0.2 million to InvaGen. No such payments were made during the six months ended June 30, 2026. Approximately $1.4 million in aggregate has been paid to InvaGen under the share repurchase agreement as of June 30, 2026.

Current wording

We are party to a share repurchase agreement with InvaGen, which requires us to pay InvaGen seven and a half percent (7.5%) of the proceeds of future financings, as defined in the agreement, up to $4.0 million in aggregate. For the nine months ended September 30, 2025, the Company made payments totaling $0.2 million to InvaGen. No such payments were made during the nine months ended September 30, 2026. Approximately $1.4 million in aggregate has been paid to InvaGen under the share repurchase agreement as of September 30, 2026.