ALZ-002

PDUFA goal date of November 4, 2024 for DFD-29 for the treatment of inflammatory lesions and erythema of rosacea in adults FDA accepted Biologics License Application resubmission for cosibelimab to treat metastatic or locally advanced cutaneous squamous cell carcinoma; PDUFA goal date of December 28, 2024 MIAMI, Aug. 13, 2024 (GLOBE NEWSWIRE) -- Fortress Biotech, Inc. (Nasdaq: FBIO) (“Fortress”), an innovative biopharmaceutical company focused on acquiring and advancing assets to enhance long-term value for shareholders through product revenue, equity holdings and dividend and royalty revenue, today announced financial results and recent corporate highlights for the second quarter ended June 30, 2024. Lindsay A. Rosenwald, M.D., Fortress’ Chairman, President and Chief Executive Officer, said, “We had a very productive first half of the year and we anticipate an exciting second half, as we have a New Drug Application (“NDA”) and a Biologics License Application (“BLA”) on file with the U.S. Food and Drug Administration (“FDA”) from our diversified portfolio, both with PDUFA goal dates in the fourth quarter, including DFD-29 for rosacea and cosibelimab for metastatic and locally advanced cutaneous squamous cell carcinoma (“cSCC”). Our late-stage candidates could generate up to three regulatory approvals in the next 12 months and a potential fourth BLA submission as early as 2025. Additionally, we had a solid second quarter 2024 of product revenue from our marketed dermatology products of $14.9 million, representing growth of approximately 15% compared to first quarter 2024 product revenues of $13.0 million. We continue to prioritize the development of our candidates and the expansion of our business for long-term success. This involves business development efforts and the growth of additional revenue streams, all aimed at benefiting our shareholders. Our business model provides the potential for significant growth as we acquire new assets and our subsidiary and partner companies grow in value, allowing for the opportunity to collect diversified cashflows such as royalties, milestones, product revenues, cash and stock dividends and through meaningful monetizations.” Recent Corporate Highlights1: Regulatory Updates In March 2024, the FDA accepted the NDA for DFD-29 (Minocycline Hydrochloride Modified Release Capsules, 40 mg) and set a PDUFA goal date of November 4, 2024. If approved, DFD-29 has the potential to be the new treatment paradigm for the millions of patients suffering from inflammatory lesions and erythema of rosacea. Both double blinded, randomized controlled DFD-29 Phase 3 clinical trials achieved their co-primary and all secondary endpoints with subjects completing the 16-week treatment with no significant safety issues. DFD-29 demonstrated statistical superiority compared to both Oracea capsules and placebo for Investigator’s Global Assessment (IGA) treatment success and the reduction in the total inflammatory lesion count in both clinical trials. Additionally, DFD-29 showed significantly superior reduction in Clinicians Erythema Assessment compared to placebo in both of the Phase 3 clinical trials. DFD-29 is currently in development at our partner company, Journey Medical Corporation (Nasdaq: DERM) (“Journey Medical”).In July 2024, the FDA accepted the BLA resubmission for cosibelimab, our investigational anti-PD-L1 antibody, as a treatment for patients with metastatic or locally advanced cSCC who are not candidates for curative surgery or radiation, and set a PDUFA goal date of December 28, 2024. In June 2024, we reached alignment with the FDA on our BLA resubmission strategy for cosibelimab and announced the resubmission of the BLA in July 2024. Cosibelimab is currently in development at our partner company, Checkpoint Therapeutics, Inc. (Nasdaq: CKPT) (“Checkpoint”). Clinical Updates In May 2024, we announced that the last patient had completed dosing in a Phase 1b/2a study evaluating AJ201 in the U.S. for the treatment of spinal and bulbar muscular atrophy (“SBMA”), also known as Kennedy’s Disease. SBMA is a debilitating rare genetic neuromuscular disease primarily affecting men. Topline data for the Phase 1b/2a clinical trial of AJ201 to treat SBMA are currently expected in the second half of 2024. A webcast replay of the Key Opinion Leader event that took place in April 2024 highlighting expert perspectives on SBMA is available on the Events page of Avenue’s website at https://avenuetx.com/. AJ201 is currently in development at our partner company, Avenue Therapeutics, Inc. (Nasdaq: ATXI) (“Avenue”).The Phase 2 clinical trial of Triplex, a cytomegalovirus vaccine, for adults co-infected with Human Immunodeficiency Virus (“HIV”) and CMV is now fully enrolled with topline data anticipated in the fourth quarter of 2024. The study aims to show that vaccination with Triplex can safely elicit a CMV-specific immune response and reduce asymptomatic CMV replication in a population of people with HIV on suppressive antiretroviral therapy. The study will also evaluate whether this intervention might reduce chronic inflammation and immune activation, as compared to placebo, and thus, potentially reduce related mortality and morbidity. Triplex is currently in development at our subsidiary company, Helocyte, Inc.In May 2024, we announced that the first patient was dosed in a multi-center, placebo-controlled, randomized Phase 2 study of Triplex, a vaccine for control of CMV, in patients undergoing liver transplantation. The trial will enroll up to 416 CMV seronegative prospective liver transplant recipients and will be conducted across up to 20 nationally recognized transplant centers in the U.S. The trial is funded by a grant from the National Institute of Allergy and Infectious Diseases of the National Institutes of Health that could provide over $20 million in non-dilutive funding. We believe this data set could ultimately be used to support the approval of Triplex in this setting. Other Updates In July 2024, we announced a collaboration to explore the combined therapeutic potential of cosibelimab, our anti-PD-L1 antibody, with GC Cell’s Immuncell-LC, an innovative autologous Cytokine Induced Killer (“CIK”) T cell therapy composed of cytotoxic T lymphocytes and natural killer T cells.In July 2024, our majority owned and controlled subsidiary company, Urica Therapeutics, Inc. (“Urica”), entered into an asset purchase agreement, royalty agreement, and related agreements (collectively, the “Transaction Documents”) with Crystalys Therapeutics, Inc. (“Crystalys”). Crystalys is a Delaware corporation incorporated in 2022 and seeded by leading life sciences institutional investors. Under the Transaction Documents, Urica transferred rights to its URAT1 inhibitor product candidate in development for the treatment of gout, dotinurad, and related intellectual property, licenses and agreements to Crystalys. In return, Crystalys issued to Urica shares of its common stock equal to 35% of Crystalys’ outstanding equity. The Transaction Documents also grant Urica a securitized three percent (3%) royalty on future net sales of dotinurad to be paid by Crystalys, as well as the right to receive nominal cash reimbursement payments for certain clinical and development costs incurred by Urica related to dotinurad.In October 2023, we announced an exclusive worldwide option agreement with City of Hope (“COH”) to license certain intellectual property relating to a CMV/HIV bi-specific Chimeric Antigen Receptor (“CAR”) (collectively, CMV/HIV-CAR) T cell program for the treatment of adults living with HIV, optionally in combination with Triplex. Additionally, the California Institute for Regenerative Medicine awarded a $11.3 million grant to COH to fund a Phase 1 clinical trial involving the CMV/HIV-CAR T. In preclinical studies, administration of the bi-specific CAR T cells followed by administration of a CMV vaccine successfully eradicated HIV, including from latent reservoirs. Commercial Product Updates Journey Medical’s total net revenues for the second quarter ended June 30, 2024 were $14.9 million, compared to total net revenues of $13.0 million for the first quarter ended March 31, 2024. General Corporate: In April 2024, Avenue announced the exercise of warrants for $4.4 million in gross proceeds and a 1-for-75 reverse split of its issued and outstanding common stock.In May and June 2024, Mustang Bio raised approximately $6.5 million across two offerings of its common stock and warrants.In July 2024, Checkpoint raised $12 million in a registered direct offering priced at-the-market under Nasdaq rules.In July 2024, Fortress’ Board of Directors paused the payment of dividends on the Company’s 9.375% Series A Cumulative Redeemable Perpetual Preferred Stock (the “Series A Preferred Stock”) until further notice. The Company believes pausing the dividend is in the best interest of the Company and its stakeholders to maintain financial flexibility ahead of potentially significant inflection points. Dividends on the Series A Preferred Stock accrue in accordance with their terms; the pausing of these dividends will defer approximately $0.7 million in cash dividend payments each month. The Board intends to revisit its decision regarding the monthly dividend regularly and will assess the profitability and cash flow of the Company to determine whether and when the suspension should be lifted.Also in July 2024, Fortress reduced its total debt by entering into a new loan agreement maturing in July 2027 with funds managed by Oaktree Capital Management, L.P. (“Oaktree”), a leading global investment firm. The Company received an initial tranche of $35 million and is eligible to draw an additional $15 million with Oaktree’s consent. In connection with the new loan agreement, the Company repaid its prior term loan with Oaktree of $50 million resulting in a net paydown of $15 million of debt excluding accrued interest and prepayment fees. Financial Results: As of June 30, 2024, Fortress’ consolidated cash and cash equivalents totaled $76.2 million, compared to $83.8 million as of March 31, 2024 and compared to $80.9 million as of December 31, 2023, a decrease of $7.6 million during the quarter and a decrease of $4.7 million year-to-date.Fortress’ consolidated cash and cash equivalents, totaling $76.2 million as of June 30, 2024, includes $38.2 million attributable to Fortress and the private subsidiaries, $4.9 million attributable to Avenue, $5.0 million attributable to Checkpoint, $4.3 million attributable to Mustang Bio and $23.9 million attributable to Journey Medical. Fortress’ consolidated cash and cash equivalents totaled $80.9 million as of December 31, 2023, which included $40.6 million attributable to Fortress and private subsidiaries, $1.8 million attributable to Avenue, $4.9 million attributable to Checkpoint, $6.2 million attributable to Mustang Bio and $27.4 million attributable to Journey Medical. Fortress’ consolidated net revenue totaled $14.9 million for the second quarter ended June 30, 2024, most of which was generated from our marketed dermatology products. This compares to consolidated revenue totaling $17.4 million for the second quarter of 2023, which included $17.0 million in revenue generated from our marketed dermatology products.Consolidated research and development expenses including license acquisitions totaled $12.7 million for the second quarter ended June 30, 2024, compared to $32.1 million for the second quarter ended June 30, 2023.Consolidated selling, general and administrative costs were $20.8 million for the second quarter ended June 30, 2024, compared to $24.4 million for the second quarter ended June 30, 2023.Consolidated net loss attributable to common stockholders was $(13.3) million, or $(0.73) per share, for the second quarter ended June 30, 2024, compared to net loss attributable to common stockholders of $(26.9) million, or $(3.65) per share for the second quarter ended June 30, 2023. About Fortress Biotech Fortress Biotech, Inc. (“Fortress”) is an innovative biopharmaceutical company focused on acquiring and advancing assets to enhance long-term value for shareholders through product revenue, equity holdings and dividend and royalty revenue. The company has seven marketed prescription pharmaceutical products and over 20 programs in development at Fortress, at its majority-owned and majority-controlled partners and subsidiaries and at partners and subsidiaries it founded and in which it holds significant minority ownership positions. Fortress’ portfolio is being commercialized and developed for various therapeutic areas including oncology, dermatology, and rare diseases. Fortress’ model is focused on leveraging its significant biopharmaceutical industry expertise and network to further expand and advance the company’s portfolio of product opportunities. Fortress has established partnerships with some of the world’s leading academic research institutions and biopharmaceutical companies to maximize each opportunity to its full potential, including AstraZeneca, City of Hope, Fred Hutchinson Cancer Center, Nationwide Children’s Hospital and Sentynl. For more information, visit www.fortressbiotech.com. Forward-Looking StatementsStatements in this press release that are not descriptions of historical facts are “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, as amended. The words “anticipates,” “believes,” “can,” “continue,” “could,” “estimates,” “expects,” “intends,” “may,” “might,” “plans,” “potential,” “predicts,” “should,” or “will” or the negative of these terms or other comparable terminology are generally intended to identify forward-looking statements. These forward-looking statements are based on management’s current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from those currently anticipated include risks relating to: our growth strategy, financing and strategic agreements and relationships; the ongoing UTRF litigation and our indemnification of Caelum in connection therewith; our need for substantial additional funds and uncertainties relating to financings; our ability to identify, acquire, close and integrate product candidates successfully and on a timely basis; our ability to attract, integrate and retain key personnel; the early stage of products under development; the results of research and development activities; uncertainties relating to preclinical and clinical testing; our ability to obtain regulatory approval for products under development; our ability to successfully commercialize products for which we receive regulatory approval or receive royalties or other distributions from third parties; our ability to secure and maintain third-party manufacturing, marketing and distribution of our and our partner companies’ products and product candidates; government regulation; patent and intellectual property matters; competition; as well as other risks described in our SEC filings. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as may be required by law, and we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. The information contained herein is intended to be reviewed in its totality, and any stipulations, conditions or provisos that apply to a given piece of information in one part of this press release should be read as applying mutatis mutandis to every other instance of such information appearing herein. Company Contact:Jaclyn JaffeFortress Biotech, Inc.(781) 652-4500ir@fortressbiotech.com Media Relations Contact:Tony Plohoros6 Degrees(908) 591-2839tplohoros@6degreespr.com FORTRESS BIOTECH, INC. AND SUBSIDIARIESUnaudited 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 $76,201 $80,927 Accounts receivable, net 10,465 15,222 Inventory 9,687 10,206 Other receivables - related party 224 167 Prepaid expenses and other current assets 4,649 10,500 Assets held for sale 2,209 — Total current assets 103,435 117,022 Property, plant and equipment, net 3,546 6,505 Operating lease right-of-use asset, net 14,626 16,990 Restricted cash 2,063 2,438 Intangible assets, net 18,658 20,287 Other assets 3,357 4,284 Total assets $ 145,685 $ 167,526 LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT) Current liabilities Accounts payable and accrued expenses $68,921 $73,562 Income taxes payable 806 843 Common stock warrant liabilities 172 886 Operating lease liabilities, short-term 2,481 2,523 Partner company convertible preferred shares, short-term, net — 3,931 Partner company installment payments - licenses, short-term, net 3,000 3,000 Other short-term liabilities 163 163 Total current liabilities 75,543 84,908 Notes payable, long-term, net 67,007 60,856 Operating lease liabilities, long-term 15,934 18,282 Other long-term liabilities 1,799 1,893 Total liabilities 160,283 165,939 Commitments and contingencies Stockholders’ equity (deficit) Cumulative redeemable perpetual preferred stock, $0.001 par value, 15,000,000 authorized, 5,000,000 designated Series A shares, 3,427,138 shares issued and outstanding as of June 30, 2024 and December 31, 2023, respectively, liquidation value of $25.00 per share 3 3 Common stock, $0.001 par value, 200,000,000 shares authorized, 22,587,038 and 15,093,053 shares issued and outstanding as of June 30, 2024 and December 31, 2023, respectively 23 15 Additional paid-in-capital 739,086 717,396 Accumulated deficit (721,235) (694,870)Total stockholders' equity attributed to the Company 17,877 22,544 Non-controlling interests (32,475) (20,957)Total stockholders' equity (deficit) (14,598) 1,587 Total liabilities and stockholders' equity (deficit) $ 145,685 $ 167,526 FORTRESS BIOTECH, INC. AND SUBSIDIARIESUnaudited Condensed Consolidated Statements of Operations($ in thousands except for share and per share amounts) Three Months Ended June 30, Six Months Ended June 30, 2024 2023 2024 2023Revenue Product revenue, net $14,855 $16,961 $27,885 $29,126 Collaboration revenue — 183 — 364 Revenue - related party 41 31 41 66 Other revenue — 211 — 259 Net revenue 14,896 17,386 27,926 29,815 Operating expenses Cost of goods sold - product revenue 6,541 7,767 13,357 14,216 Research and development 12,671 32,139 37,495 67,415 Research and development - licenses acquired — 3 — 4,233 Selling, general and administrative 20,823 24,439 38,777 49,780 Asset impairment 2,649 3,143 2,649 3,143 Total operating expenses 42,684 67,491 92,278 138,787 Loss from operations (27,788) (50,105) (64,352) (108,972) Other income (expense) Interest income 734 715 1,567 1,751 Interest expense and financing fee (2,122) (6,425) (4,724) (10,721)Change in fair value of warrant liabilities — (512) — 6,166 Gain (loss) on common stock warrant liabilities 70 — (597) — Loss from deconsolidation of subsidiaries — (3,369) — (3,369)Other income (expense) 282 395 260 699 Total other income (expense) (1,036) (9,196) (3,494) (5,474)Net loss (28,824) (59,301) (67,846) (114,446) Net loss attributable to non-controlling interests 17,876 34,525 41,481 68,133 Net loss attributable to Fortress $ (10,948) $ (24,776) $ (26,365) $ (46,313) Net loss attributable to common stockholders $ (13,339) $ (26,917) $ (31,199) $ (50,595) Net loss per common share attributable to common stockholders - basic and diluted $(0.73) $(3.65) $(1.76) $(7.14) Weighted average common shares outstanding - basic and diluted 18,316,874 7,377,332 17,736,299 7,086,482 1 The development programs depicted in this press release include product candidates in development at Fortress, at Fortress’ private subsidiaries (referred to herein as “subsidiaries”), at Fortress’ public subsidiaries (referred to herein as “partner companies”) and at entities with whom one of the foregoing parties has a significant business relationship, such as an exclusive license or an ongoing product-related payment obligation (such entities referred to herein as “partners”). The words “we”, “us” and “our” may refer to Fortress individually, to one or more of our subsidiaries and/or partner companies, or to all such entities as a group, as dictated by context.

- 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