NRF1

- Last patient visit complete in Phase 1b/2a clinical trial of AJ201 for spinal and bulbar muscular atrophy; topline data anticipated in second half of 2024 – - Raised $4.4 million in gross proceeds from a May 2024 warrant exercise transaction - MIAMI, Aug. 09, 2024 (GLOBE NEWSWIRE) -- Avenue Therapeutics, Inc. (Nasdaq: ATXI) (“Avenue” or the “Company”), a specialty pharmaceutical company focused on the development and commercialization of therapies for the treatment of neurologic diseases, today reported financial results and recent corporate highlights for the second quarter ended June 30, 2024. “We continue to make meaningful progress advancing our pipeline of innovative treatments for neurologic diseases,” said Alexandra MacLean, M.D., Chief Executive Officer of Avenue. “In the second quarter, we completed the last patient visit in our Phase 1b/2a trial of AJ201 for the treatment of spinal and bulbar muscular atrophy (“SBMA”), also known as Kennedy’s Disease. AJ201 is the most advanced investigational treatment in development for SBMA in the U.S., and we are pleased to reach this important milestone as we work to bring this novel asset to patients suffering from this rare neurodegenerative disease. We anticipate reading out topline data from our Phase 1b/2a trial of AJ201 in the second half of this year, and we remain focused on our goal of delivering this breakthrough treatment to SBMA patients who currently have no effective, approved therapeutic options.” Recent Corporate Highlights: AJ201 (Nrf1 and Nrf2 activator, androgen receptor degradation enhancer for SBMA) In May 2024, Avenue announced the last patient visit was complete in the Phase 1b/2a clinical trial of AJ201 for the treatment of SBMA, marking the final clinical milestone ahead of the anticipated topline data announcement in the second half of 2024. The 12-week, multicenter, randomized, double-blind Phase 1b/2a clinical trial of AJ201 enrolled 25 patients randomly assigned to AJ201 (600 mg/day) or placebo. The primary endpoint of the study is to assess safety and tolerability of AJ201 in subjects with clinically and genetically defined SBMA. Secondary endpoints include pharmacokinetic and pharmacodynamic data measuring change from baseline in mutant AR protein levels in skeletal muscle and changes from baseline in expression of Nrf2-activated genes in skeletal muscle. Exploratory objectives of the study include changes in the fat and muscle composition as seen on MRI scans. These endpoints are believed to be biomarkers indicating likelihood for longer term clinical improvement. Further details about this study can be found at ClinicalTrials.gov (Identifier: NCT05517603). BAER-101 (GABAA α2/3 positive allosteric modulator) Subject to the receipt of additional financing, Avenue continues plans to initiate a Phase 2a clinical trial of BAER-101 in patients with focal epilepsy and other seizure disorders. Preclinical mouse models have demonstrated BAER-101 as a therapeutic with the ability to fully suppress seizure activity, with the effect being fast in onset and stable throughout the duration of testing. Data from these models were presented earlier this year at the American Society for Experimental Neurotherapeutics (“ASENT”) 2024 Annual Meeting in March and also published in Drug Development Research in February. IV Tramadol Earlier in 2024, Avenue reached final agreement with the U.S. Food and Drug Administration (“FDA”) on the safety study protocol and statistical analysis approach for the Phase 3 study of intravenous (“IV”) tramadol, which is being developed for the treatment of acute post-operative pain in a medically supervised setting. The proposed 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. Patients will have access to IV hydromorphone, a Schedule II opioid, for rescue of breakthrough pain. Avenue aims to initiate the Phase 3 safety study pending additional financing or a partnership. General Corporate In April, the Company raised $4.4 million in gross proceeds from a warrant exercise transaction, before deducting placement agent fees and other expenses payable by Avenue in connection with the transaction. Additionally, the Company effected a 1-for-75 reverse stock split of its issued and outstanding common stock effective April 26, 2024.In May 2024, the Company received formal notice from the Nasdaq Stock Market LLC that it evidenced compliance with all applicable criteria for continued listing on the Nasdaq Capital Market, concluding the previously disclosed listing matter. Financial Results: Cash Position: As of June 30, 2024, cash and cash equivalents totaled $4.9 million, compared to $3.2 million at March 31, 2024 and $1.8 million at December 31, 2023, an increase of $1.7 million compared to the prior quarter and an increase of $3.1 million year-to-date.R&D Expenses: Research and development expenses for the second quarter of 2024 were $1.4 million, compared to $3.0 million for the second quarter of 2023.G&A Expenses: General and administrative expenses for the second quarter of 2024 were $1.5 million, compared to $0.9 million for the second quarter of 2023.Net Loss: Net loss attributable to common stockholders for the second quarter of 2024 was $2.7 million, or $6.43 per share, compared to a net loss of $4.0 million, or $38.74 per share, for the second quarter of 2023. About Avenue Therapeutics Avenue Therapeutics, Inc. (Nasdaq: ATXI) is a specialty pharmaceutical company focused on the development and commercialization of therapies for the treatment of neurologic diseases. It is currently developing three assets including AJ201, a first-in-class asset for spinal and bulbar muscular atrophy, BAER-101, an oral small molecule selective GABAA α2, α3 receptor positive allosteric modulator for CNS diseases, and IV tramadol, which is in Phase 3 clinical development for the management of acute postoperative pain in adults in a medically supervised healthcare setting. Avenue is headquartered in Miami, FL and was founded by Fortress Biotech, Inc. (Nasdaq: FBIO). For more information, visit www.avenuetx.com. Forward-Looking Statements This press release contains predictive or “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements other than statements of current or historical fact contained in this press release, including statements that express our intentions, plans, objectives, beliefs, expectations, strategies, predictions or any other statements relating to our future activities or other future events or conditions are forward-looking statements. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “will,” “should,” “would” and similar expressions are intended to identify forward-looking statements. These statements are based on current expectations, estimates and projections made by management about our business, our industry and other conditions affecting our financial condition, results of operations or business prospects. These statements are not guarantees of future performance and involve risks, uncertainties and assumptions that are difficult to predict. Therefore, actual outcomes and results may differ materially from what is expressed or forecasted in, or implied by, the forward-looking statements due to numerous risks and uncertainties. Factors that could cause such outcomes and results to differ include, but are not limited to, risks and uncertainties arising from: the fact that we currently have no drug products for sale and that our success is dependent on our product candidates receiving regulatory approval and being successfully commercialized; the possibility that serious adverse or unacceptable side effects are identified during the development of our current or future product candidates, such that we would need to abandon or limit development of some of our product candidates; our ability to successfully develop, partner, or commercialize any of our current or future product candidates including AJ201, IV tramadol, and BAER-101; the substantial doubt raised about our ability to continue as a going concern, which may hinder our ability to obtain future financing; the significant losses we have incurred since inception and our expectation that we will continue to incur losses for the foreseeable future; our need for substantial additional funding, which may not be available to us on acceptable terms, or at all, which unavailability of could force us to delay, reduce or eliminate our product development programs or commercialization efforts; our reliance on third parties for several aspects of our operations; our reliance on clinical data and results obtained by third parties that could ultimately prove to be inaccurate, or unreliable, or unacceptable to regulatory authorities; the possibility that we may not receive regulatory approval for any or all of our product candidates, or that such approval may be significantly delayed due to scientific or regulatory reasons; the fact that even if one or more of our product candidates receives regulatory approval, they will remain subject to substantial regulatory scrutiny; the effects of current and future laws and regulations relating to fraud and abuse, false claims, transparency, health information privacy and security, and other healthcare laws and regulations; the effects of competition for our product candidates and the potential for new products to emerge that provide different or better therapeutic alternatives for our targeted indications; the possibility that the government or third-party payors fail to provide adequate coverage and payment rates for our product candidates or any future products; our ability to establish sales and marketing capabilities or to enter into agreements with third parties to market and sell our product candidates; our exposure to potential product liability claims; related to the protection of our intellectual property and our potential inability to maintain sufficient patent protection for our technology and products; our ability to maintain compliance with the obligations under our intellectual property licenses and funding arrangements with third parties, without which licenses and arrangements we could lose rights that are important to our business; the fact that Fortress Biotech, Inc. controls a majority of the voting power of our outstanding capital stock and has rights to receive significant share grants annually; and those risks discussed in our filings which we make with the SEC. Any forward-looking statements speak only as of the date on which they are made, and we undertake no obligation to publicly update or revise any forward-looking statements to reflect events or circumstances that may arise after the date of this press release, except as required by applicable law. Investors should evaluate any statements made by us in light of these important factors. Contact: Jaclyn Jaffe Avenue Therapeutics, Inc. (781) 652-4500 ir@avenuetx.com AVENUE THERAPEUTICS, INC. Unaudited Condensed Consolidated Balance Sheets ($ in thousands, except for share and per share amounts) June 30, December 31, 2024 2023 ASSETS Current assets: Cash and cash equivalents$4,919 $1,783 Prepaid expenses and other current assets 69 67 Total assets$4,988 $1,850 LIABILITIES AND STOCKHOLDERS’ EQUITY Current liabilities: Accounts payable and accrued expenses$714 $287 Accounts payable and accrued expenses - related party 400 323 Warrant liability 47 586 Total current liabilities 1,161 1,196 Total liabilities 1,161 1,196 Commitments and Contingencies Stockholders’ equity Preferred stock ($0.0001 par value), 2,000,000 shares authorized Class A Preferred stock, 250,000 shares issued and outstanding as of June 30, 2024 and December 31, 2023 — — Common stock ($0.0001 par value) 200,000,000 and 75,000,000 shares authorized as of June 30, 2024 and December 31, 2023, respectively Common shares, 1,189,724 and 341,324 shares issued and outstanding as of June 30, 2024 and December 31, 2023, respectively — 3 Additional paid-in capital 102,724 92,507 Accumulated deficit (97,960) (90,928)Total stockholders’ equity attributed to the Company 4,764 1,582 Non-controlling interests (937) (928)Total stockholders’ equity 3,827 654 Total liabilities and stockholders’ equity$4,988 $1,850 AVENUE THERAPEUTICS, INC. Unaudited Condensed Consolidated Statements of Operations ($ in thousands, except for share and per share amounts) For the Three Months Ended June 30, For the Six Months Ended June 30, 2024 2023 2024 2023Operating expenses: Research and development$1,361 $3,027 $3,752 $4,242 Research and development - licenses acquired — — — 4,230 General and administrative 1,462 896 2,778 1,880 Loss from operations (2,823) (3,923) (6,530) (10,352) Other income (expense) Interest income 52 57 100 94 Financing costs – warrant liabilities — — — (332) Loss on settlement of common stock warrant liabilities (185) — (759) — Change in fair value of warrant liabilities 255 (150) 139 (1,028) Total other income (expense) 122 (93) (520) (1,266) Net loss (2,701) (4,016) (7,050) (11,618) Net loss attributable to non-controlling interests (9) (9) (18) (75) Net loss attributable to Avenue$(2,692) $(4,007) $(7,032) $(11,543) Net loss attributable to common stockholders$(7,186) $(4,007) $(15,842) $(11,543) Net loss per common share attributable to common stockholders, basic and diluted$(6.43) $(38.74) $(18.86) $(129.84) Weighted average number of common shares outstanding, basic and diluted 1,117,769 103,442 839,900 88,901

MIAMI, May 16, 2024 (GLOBE NEWSWIRE) -- Avenue Therapeutics, Inc. (Nasdaq: ATXI) (“Avenue” or the “Company”), a specialty pharmaceutical company focused on the development and commercialization of therapies for the treatment of neurologic diseases, today announced the completion of the last patient’s final visit in the Company’s Phase 1b/2a clinical trial of AJ201 for the treatment of spinal and bulbar muscular atrophy (“SBMA”), also known as Kennedy's Disease. Topline data are expected to be reported mid-year 2024. “We are very excited to announce the last patient visit in the Phase 1b/2a clinical trial of AJ201 in SBMA, the final milestone before the anticipated topline data are reported in the middle of this year,” said Alexandra MacLean, M.D., Chief Executive Officer of Avenue. “I want to sincerely thank the trial investigators, the patients, our partner AnnJi Pharmaceutical Co. Ltd., and our internal team for their dedication to completing this study on schedule and for their continued confidence in AJ201. Backed by the drug’s promising preclinical efficacy pro excellent clinical safety data in healthy volunteers, we look forward to further assessing the safety and tolerability of AJ201 in patients with SBMA, as well as AJ201’s effect on potential pharmacokinetic and pharmacodynamic biomarkers of SBMA, including degradation of mutant AR proteins in muscles, MRI changes and neuroinflammation. We remain committed to advancing AJ201 for SBMA patients who currently have no effective, approved treatments available, as we work to achieve our mission of delivering impactful therapies to patients suffering from neurologic diseases.” The 12-week, multicenter, randomized, double-blind Phase 1b/2a clinical trial of AJ201 enrolled 25 patients, randomly assigned to AJ201 (600 mg/day) or placebo (3:1). The primary endpoint of the study is to assess safety and tolerability of AJ201 in subjects with clinically and genetically defined SBMA. Secondary endpoints include pharmacokinetic and pharmacodynamic data measuring change from baseline in mutant AR protein levels in skeletal muscle and changes from baseline in expression of Nrf2-activated genes in skeletal muscle. Exploratory objectives of the study include changes in the fat and muscle composition as seen on MRI scans. These endpoints are believed to be biomarkers indicating likelihood for longer term clinical improvement. Further details about this study can be found at ClinicalTrials.gov (Identifier: NCT05517603). In April 2024, Avenue hosted a virtual key opinion leader (“KOL”) event highlighting expert perspectives on SBMA. The event featured Christopher Grunseich, M.D., Lasker Clinical Research Scholar and Investigator and Head of the Inherited Neuromuscular Diseases Unit at the National Institute of Neurological Disorders and Stroke, and Tahseen Mozaffar, M.D., Professor of Neurology, Pathology and Laboratory Medicine, Director of the Division of Neuromuscular Diseases and Director of the ALS and Neuromuscular Center at the University of California, Irvine. The two featured speakers discussed the characteristics and treatment landscape of SBMA, as well as the trial design and potential of AJ201 in SBMA. A replay of the event can be accessed here. About Spinal and Bulbar Muscular Atrophy Spinal and bulbar muscular atrophy (“SBMA”) is a rare, X-linked genetic neuromuscular disease primarily affecting men. The condition is caused by the trinucleotide CAG repeat expansion in the androgen receptor (“AR”) which leads to production of a mutant polyglutamine (“polyQ”) AR protein that forms aggregates responsible for muscular atrophy focused in the limbs and bulbar region of the body. The weakening of the bulbar muscles affects chewing, speech and swallowing, with patients prone to choking or inhaling foods or liquids, resulting in airway infection. SBMA also affects muscles in the limbs, leading to difficulty walking and injury caused by falling. Although there is a range of cited prevalence rates in scientific literature, a recent study used genetic analysis to estimate disease prevalence of 1:6,887 males. Currently, there are no treatments approved by the U.S. Food and Drug Administration or European Medicines Agency available for patients. For more information about SBMA, also known as Kennedy’s Disease, please visit . About AJ201 AJ201 is a novel, first-in-class asset in development for the treatment of spinal and bulbar muscular atrophy. It was designed to modify SBMA through multiple mechanisms including degradation of the abnormal androgen receptor protein and by stimulating the Nrf1 and Nrf2 pathways, which are involved in protecting cells from oxidative stress which can lead to cell death. A first-in-human Phase 1 study of AJ201 in 72 healthy volunteers revealed an excellent safety and pharmacokinetic profile. It is currently being studied in a Phase 1/2a multicenter, randomized, double-blind clinical trial in six clinical sites across the U.S., which aims to evaluate the safety, PK/PD data and clinical response of AJ201 in patients suffering from SBMA. AJ201 has been granted Orphan Drug Designation by the FDA for multiple polyQ diseases, including SBMA, Huntington’s disease and spinocerebellar ataxia. Avenue exclusively licensed AJ201 from AnnJi Pharmaceuticals for use in the United States, Canada, European Union, Great Britain, and Israel. About Polyglutamine diseases Polyglutamine diseases are a group of neurodegenerative disorders caused by expanded CAG repeats encoding a long polyQ tract in the affected proteins. To date, a total of nine polyQ disorders have been described. Mutant protein aggregation in affected tissues is the pathological hallmark of polyQ diseases. Neuroinflammation, oxidative stress and dysregulated protein quality control are thought to be key pathological factors that are either direct results of mutant protein aggregations and/or exacerbate the severity and progression of the diseases. Modulating multiple cellular pathways in enhancing degradation of mutant AR aggregates, inducing antioxidant and heat shock responses, and increasing proteasome expression simultaneously provide the rationale to develop AJ201 for the treatment of SBMA and potentially other polyQ diseases. About Avenue Therapeutics Avenue Therapeutics, Inc. (Nasdaq: ATXI) is a specialty pharmaceutical company focused on the development and commercialization of therapies for the treatment of neurologic diseases. It is currently developing three assets including AJ201, a first-in-class asset for spinal and bulbar muscular atrophy, BAER-101, an oral small molecule selective GABAA α2, α3 receptor positive allosteric modulator for CNS diseases, and IV tramadol, which is in Phase 3 clinical development for the management of acute post-operative pain in adults in a medically supervised healthcare setting. Avenue is headquartered in Miami, FL and was founded by Fortress Biotech, Inc. (Nasdaq: FBIO). For more information, visit . Forward-Looking Statements This press release contains predictive or “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements other than statements of current or historical fact contained in this press release, including statements that express our intentions, plans, objectives, beliefs, expectations, strategies, predictions or any other statements relating to our future activities or other future events or conditions are forward-looking statements. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “will,” “should,” “would” and similar expressions are intended to identify forward-looking statements. These statements are based on current expectations, estimates and projections made by management about our business, our industry and other conditions affecting our financial condition, results of operations or business prospects. These statements are not guarantees of future performance and involve risks, uncertainties and assumptions that are difficult to predict. Therefore, actual outcomes and results may differ materially from what is expressed or forecasted in, or implied by, the forward-looking statements due to numerous risks and uncertainties. Factors that could cause such outcomes and results to differ include, but are not limited to, risks and uncertainties arising from: the fact that we currently have no drug products for sale and that our success is dependent on our product candidates receiving regulatory approval and being successfully commercialized; the possibility that serious adverse or unacceptable side effects are identified during the development of our current or future product candidates, such that we would need to abandon or limit development of some of our product candidates; our ability to successfully develop, partner, or commercialize any of our current or future product candidates including AJ201, IV tramadol, and BAER-101; the substantial doubt raised about our ability to continue as a going concern, which may hinder our ability to obtain future financing; the significant losses we have incurred since inception and our expectation that we will continue to incur losses for the foreseeable future; our need for substantial additional funding, which may not be available to us on acceptable terms, or at all, which unavailability of could force us to delay, reduce or eliminate our product development programs or commercialization efforts; our reliance on third parties for several aspects of our operations; our reliance on clinical data and results obtained by third parties that could ultimately prove to be inaccurate, or unreliable, or unacceptable to regulatory authorities; the possibility that we may not receive regulatory approval for any or all of our product candidates, or that such approval may be significantly delayed due to scientific or regulatory reasons; the fact that even if one or more of our product candidates receives regulatory approval, they will remain subject to substantial regulatory scrutiny; the effects of current and future laws and regulations relating to fraud and abuse, false claims, transparency, health information privacy and security, and other healthcare laws and regulations; the effects of competition for our product candidates and the potential for new products to emerge that provide different or better therapeutic alternatives for our targeted indications; the possibility that the government or third-party payors fail to provide adequate coverage and payment rates for our product candidates or any future products; our ability to establish sales and marketing capabilities or to enter into agreements with third parties to market and sell our product candidates; our exposure to potential product liability claims; related to the protection of our intellectual property and our potential inability to maintain sufficient patent protection for our technology and products; our ability to maintain compliance with the obligations under our intellectual property licenses and funding arrangements with third parties, without which licenses and arrangements we could lose rights that are important to our business; the fact that Fortress Biotech, Inc. controls a majority of the voting power of our outstanding capital stock and has rights to receive significant share grants annually; and those risks discussed in our filings which we make with the SEC. Any forward-looking statements speak only as of the date on which they are made, and we undertake no obligation to publicly update or revise any forward-looking statements to reflect events or circumstances that may arise after the date of this press release, except as required by applicable law. Investors should evaluate any statements made by us in light of these important factors. Contact: Jaclyn Jaffe Avenue Therapeutics, Inc. (781) 652-4500 ir@avenuetx.com

– Raised a total of $9.4 million in gross proceeds from warrant exercise transactions since January 2024 – MIAMI, May 15, 2024 (GLOBE NEWSWIRE) -- Avenue Therapeutics, Inc. (Nasdaq: ATXI) (“Avenue” or the “Company”), a specialty pharmaceutical company focused on the development and commercialization of therapies for the treatment of neurologic diseases, today reported financial results and recent corporate highlights for the first quarter ended March 31, 2024. “The first quarter was incredibly productive for Avenue, as we’ve successfully executed on key milestones across our pipeline of CNS treatments,” said Alexandra MacLean, M.D., Chief Executive Officer of Avenue. “We made significant strides advancing our lead clinical program, AJ201, in spinal and bulbar muscular atrophy (“SBMA”), also known as Kennedy’s Disease and look forward to reporting topline data in the middle of 2024. Additionally, this quarter we continued to showcase the potential of BAER-101 for the treatment of epilepsy with preclinical data at the American Society for Experimental Neurotherapeutics (ASENT) Annual Meeting and in the publication, Drug Development Research. We believe that with the proper financing or a partnership, BAER-101 has the potential to make a meaningful difference for patients facing great unmet need. Finally, we reached agreement with the U.S. FDA on the safety study design and statistical analysis approach for IV tramadol, setting this program up for a successful Phase 3 study as soon as the necessary funding is acquired. We look forward to progressing our pipeline in the quarters to come as we seek to bring long-term value to our shareholders and provide impactful therapies to patients suffering from neurologic diseases.” Recent Corporate Highlights: AJ201 (Nrf1 and Nrf2 activator, androgen receptor degradation enhancer for SBMA) In April, Avenue hosted a virtual key opinion leader (“KOL”) event highlighting expert perspectives on SBMA. The event featured Christopher Grunseich, M.D., Lasker Clinical Research Scholar and Investigator and Head of the Inherited Neuromuscular Diseases Unit at the National Institute of Neurological Disorders and Stroke, and Tahseen Mozaffar, M.D., Professor of Neurology, Pathology and Laboratory Medicine, Director of the Division of Neuromuscular Diseases and Director of the ALS and Neuromuscular Center at the University of California, Irvine. The two featured speakers discussed the characteristics and treatment landscape of SBMA, as well as the trial design and potential of AJ201 in SBMA. A replay of the event can be accessed here. BAER-101 (GABAA α2/3 positive allosteric modulator) Avenue presented preclinical results for BAER-101, a potentially best-in-class selective GABAA α2,3 positive allosteric modulator, in the publication Drug Development Research in February 2024 and the ASENT Annual Meeting in March 2024. The in vivo data showcase BAER-101’s ability to significantly suppress seizures using the SynapCell’s Genetic Absence Epilepsy Rat from Strasbourg (“GAERS”) model of epilepsy. BAER-101 fully suppressed seizure activity in the GAERS model with a minimal effective dose of 0.3 mg/kg, PO, and the effect was fast in onset and stable throughout the duration of testing. The data also demonstrated BAER-101’s ability to selectively target GABAA α2 and α3 subtypes more than α1 and α5, potentially improving anti-convulsant and anxiolytic activity while minimizing the risk of tolerance and abuse associated with existing treatments in this drug class. Subject to obtaining the necessary financing, which could be provided through a strategic partnership, Avenue plans to initiate a Phase 2a clinical trial of BAER-101 to further study its anti-seizure properties in patients with common or rare epilepsies. IV Tramadol In January, Avenue reached final agreement with the FDA on the safety study protocol and statistical analysis approach for the Phase 3 study of intravenous (“IV”) tramadol, which is being developed for the treatment of acute post-operative pain in a medically supervised setting. The proposed 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. Patients will have access to IV hydromorphone, a Schedule II opioid, for rescue of breakthrough pain. Avenue aims to initiate the Phase 3 safety study as soon as feasible. The Company believes that the study can be completed and submitted to the FDA within 12 months of the study’s initiation. Corporate Highlights In January and May 2024, Avenue raised a total of approximately $9.4 million in gross proceeds from warrant exercise transactions. In April 2024, the Company effected a 1-for-75 reverse stock split of its issued and outstanding common stock which we expect will bring the Company into compliance with Nasdaq’s $1.00 per share minimum bid price requirement for continued listing. Financial Results: Cash Position: As of March 31, 2024, cash and cash equivalents totaled $3.2 million, compared to $1.8 million at December 31, 2023, an increase of $1.4 million. In May 2024, the Company completed a warrant inducement transaction for $4.4 million in gross proceeds. R&D Expenses: Research and development expenses for the first quarter of 2024 were $2.4 million, compared to $1.2 million for the first quarter of 2023. Additionally, there was $4.2 million in expense for the acquisition of the AJ201 license in the first quarter of 2023. G&A Expenses: General and administrative expenses for the first quarter of 2024 were $1.3 million, compared to $1.0 million for the first quarter of 2023. Net Loss: Net loss attributable to common stockholders for the first quarter of 2024 was $4.3 million, or $15.40 per share, compared to a net loss of $7.5 million, or $101.57 per share, for the first quarter of 2023. About Avenue Therapeutics Avenue Therapeutics, Inc. (Nasdaq: ATXI) is a specialty pharmaceutical company focused on the development and commercialization of therapies for the treatment of neurologic diseases. It is currently developing three assets including AJ201, a first-in-class asset for spinal and bulbar muscular atrophy, BAER-101, an oral small molecule selective GABAA α2, α3 receptor positive allosteric modulator for CNS diseases, and IV tramadol, which is in Phase 3 clinical development for the management of acute post-operative pain in adults in a medically supervised healthcare setting. Avenue is headquartered in Miami, FL and was founded by Fortress Biotech, Inc. (Nasdaq: FBIO). For more information, visit . Forward-Looking Statements This press release contains predictive or “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements other than statements of current or historical fact contained in this press release, including statements that express our intentions, plans, objectives, beliefs, expectations, strategies, predictions or any other statements relating to our future activities or other future events or conditions are forward-looking statements. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “will,” “should,” “would” and similar expressions are intended to identify forward-looking statements. These statements are based on current expectations, estimates and projections made by management about our business, our industry and other conditions affecting our financial condition, results of operations or business prospects. These statements are not guarantees of future performance and involve risks, uncertainties and assumptions that are difficult to predict. Therefore, actual outcomes and results may differ materially from what is expressed or forecasted in, or implied by, the forward-looking statements due to numerous risks and uncertainties. Factors that could cause such outcomes and results to differ include, but are not limited to, risks and uncertainties arising from: the fact that we currently have no drug products for sale and that our success is dependent on our product candidates receiving regulatory approval and being successfully commercialized; the possibility that serious adverse or unacceptable side effects are identified during the development of our current or future product candidates, such that we would need to abandon or limit development of some of our product candidates; our ability to successfully develop, partner, or commercialize any of our current or future product candidates including AJ201, IV tramadol, and BAER-101; the substantial doubt raised about our ability to continue as a going concern, which may hinder our ability to obtain future financing; the significant losses we have incurred since inception and our expectation that we will continue to incur losses for the foreseeable future; our need for substantial additional funding, which may not be available to us on acceptable terms, or at all, which unavailability of could force us to delay, reduce or eliminate our product development programs or commercialization efforts; our reliance on third parties for several aspects of our operations; our reliance on clinical data and results obtained by third parties that could ultimately prove to be inaccurate, or unreliable, or unacceptable to regulatory authorities; the possibility that we may not receive regulatory approval for any or all of our product candidates, or that such approval may be significantly delayed due to scientific or regulatory reasons; the fact that even if one or more of our product candidates receives regulatory approval, they will remain subject to substantial regulatory scrutiny; the effects of current and future laws and regulations relating to fraud and abuse, false claims, transparency, health information privacy and security, and other healthcare laws and regulations; the effects of competition for our product candidates and the potential for new products to emerge that provide different or better therapeutic alternatives for our targeted indications; the possibility that the government or third-party payors fail to provide adequate coverage and payment rates for our product candidates or any future products; our ability to establish sales and marketing capabilities or to enter into agreements with third parties to market and sell our product candidates; our exposure to potential product liability claims; related to the protection of our intellectual property and our potential inability to maintain sufficient patent protection for our technology and products; our ability to maintain compliance with the obligations under our intellectual property licenses and funding arrangements with third parties, without which licenses and arrangements we could lose rights that are important to our business; the fact that Fortress Biotech, Inc. controls a majority of the voting power of our outstanding capital stock and has rights to receive significant share grants annually; and those risks discussed in our filings which we make with the SEC. Any forward-looking statements speak only as of the date on which they are made, and we undertake no obligation to publicly update or revise any forward-looking statements to reflect events or circumstances that may arise after the date of this press release, except as required by applicable law. Investors should evaluate any statements made by us in light of these important factors. Contact: Jaclyn Jaffe Avenue Therapeutics, Inc. (781) 652-4500 ir@avenuetx.com AVENUE THERAPEUTICS, INC. Unaudited Condensed Consolidated Balance Sheets ($ in thousands, except for share and per share amounts) March 31, 2024 December 31, 2023 ASSETS Current assets: Cash and cash equivalents $ 3,194 $ 1,783 Prepaid expenses and other current assets 116 67 Total assets $ 3,310 $ 1,850 LIABILITIES AND STOCKHOLDERS’ EQUITY Current liabilities: Accounts payable and accrued expenses $ 647 $ 287 Accounts payable and accrued expenses - related party 352 323 Warrant liability 413 586 Total current liabilities 1,412 1,196 Total liabilities 1,412 1,196 Commitments and Contingencies Stockholders’ equity Preferred stock ($0.0001 par value), 2,000,000 shares authorized Class A Preferred stock, 250,000 shares issued and outstanding as of December 31, 2023 and 2022, respectively — — Common stock ($0.0001 par value) 200,000,000 and 75,000,000 shares authorized as of March 31, 2024 and December 31, 2023, respectively Common shares, 590,188 and 341,324 shares issued and outstanding as of March 31, 2024 and December 31, 2023, respectively — 3 Additional paid-in capital 98,104 92,507 Accumulated deficit (95,268 ) (90,928 ) Total stockholders’ equity attributed to the Company 2,836 1,582 Non-controlling interests (938 ) (928 ) Total stockholders’ equity 1,898 654 Total liabilities and stockholders’ equity $ 3,310 $ 1,850 AVENUE THERAPEUTICS, INC. Unaudited Condensed Consolidated Statements of Operations ($ in thousands, except for share and per share amounts) For the Three Months Ended March 31, 2024 2023 Operating expenses Research and development $ 2,392 $ 1,215 Research and development - licenses acquired — 4,230 General and administrative 1,316 984 Loss from operations (3,708 ) (6,429 ) Interest income 49 37 Financing costs – warrant liabilities — (332 ) Loss on settlement of common stock warrant liabilities (574 ) — Change in fair value of warrant liabilities (116 ) (878 ) Net loss $ (4,349 ) $ (7,602 ) Net loss attributable to non-controlling interests (9 ) (66 ) Net loss attributable to common stockholders $ (4,340 ) $ (7,536 ) Net loss per common share attributable to common stockholders, basic and diluted $ (15.40 ) $ (101.57 ) Weighted average number of common shares outstanding, basic and diluted 562,031 74,198