Levothyroxine Sodium

AMPLIFY 230-patient trial aims to improve on efficacy and safety established with thyroid hormone as an adjunctive treatment for MDD; topline data expected in the second half of 2025 ABX-002 deemed safe and well-tolerated in Phase 1 and showed clinical evidence of enhanced target engagement consistent with brain-activating thyroid hormone biology Company on-track to expand ABX-002 depression program with Phase 2 trial for bipolar disorder depression to begin late 2024 SAN DIEGO, CA, USA I September 16, 2024 I Autobahn Therapeutics, a biotechnology company developing restorative treatments for people affected by neuropsychiatric and neuroimmunologic disorders, today announced initiation of AMPLIFY, a Phase 2 clinical trial evaluating ABX-002 as an adjunctive treatment for adults with major depressive disorder (MDD). ABX-002 is a highly potent, oral, thyroid hormone beta receptor (TRβ) selective agonist designed to enhance the CNS benefits of thyroid hormone biology and drug concentrations directly in the brain, for greater potency, efficacy and safety. In a completed Phase 1 trial of ABX-002 , ABX-002 demonstrated clinical evidence of CNS target engagement consistent with brain-activating thyroid effects and was well-tolerated, with no serious adverse events observed. “Among the millions of people in the U.S. suffering from the debilitating effects of depression, more than half experience an inadequate response to their current antidepressant, underscoring the urgent need for treatment options that provide relief for patients,” said Dan Iosifescu, M.D., Professor of Psychiatry at NYU Grossman School of Medicine. “Synthetic thyroid hormone has long been known to provide benefit as an adjunctive treatment for MDD, and a highly potent and selective TRβ agonist may offer the therapeutic benefits of synthetic thyroid hormone, with a safety profile that enables chronic use for optimal patient management.” AMPLIFY is a placebo-controlled, double-blind Phase 2 trial in 230 adults with moderate-to-severe depression. The trial will evaluate the safety, tolerability, efficacy and pharmacodynamic (PD) effects of ABX-002 as an adjunctive treatment to patients’ current selective serotonin reuptake inhibitor (SSRI) or serotonin-noradrenaline reuptake inhibitor (SNRI). The primary endpoint is the change from baseline on the Hamilton Depression Rating Scale-17 (HAMD–17) after six weeks of treatment. Key secondary endpoints include changes from baseline on the HAMD-29 to assess improvements on atypical depression symptoms, the Montgomery–Åsberg Depression Rating Scale (MADRS), and other measures of clinical improvement. “We are thrilled to initiate this Phase 2 trial of ABX-002, marking a substantially evolved profile for Autobahn as a mid-stage development company progressing multiple clinical development candidates,” said Gudarz Davar, M.D., Executive Vice President, Head of Research and Development for Autobahn. “The clinical data we’ve generated with ABX-002 support its promise as a brain-penetrating, centrally active thyromimetic with favorable safety, and give us greater confidence in its potential as a game-changing treatment for depression, especially for patients who remain underserved by today’s treatment options. Our team is dedicated to advancing innovative therapies that have the potential to transform lives, and this milestone with ABX-002 is a significant step toward achieving our vision.” Autobahn anticipates reporting topline data from the AMPLIFY Phase 2 trial of ABX-002 in patients with MDD in the second half of 2025. In addition, by yearend 2024, Autobahn plans to initiate a second Phase 2 trial with ABX-002 in patients with bipolar disorder depression, a chronic and difficult mental health condition. About Autobahn Therapeutics Autobahn Therapeutics is a biotechnology company developing a portfolio of neuropsychiatric and neuroimmunologic clinical candidates leveraging its brain-targeting chemistry platform. Autobahn aims to unlock new therapeutic opportunities through precision tuning of CNS exposure, pursuing validated clinical and biologic targets, and guiding development with biomarkers. The company’s pipeline is led by ABX-002, a thyroid hormone receptor beta (TRβ) agonist being developed as a potential adjunctive treatment for people with major depressive disorder and bipolar disorder depression. Autobahn Therapeutics is based in San Diego. For more information, visit www.autobahntx.com . About ABX-002 ABX-002 is an orally administered, potent and selective thyroid hormone beta receptor (TRβ) agonist designed to enhance the CNS benefits of thyroid hormone biology while also reducing the peripheral liabilities of synthetic thyroid hormone (e.g., triiodothyronine, T3), a treatment which has shown efficacy in numerous placebo-controlled human studies across MDD and bipolar disorder depression. Thyroid hormone agonism has demonstrated activity on cellular energy metabolism pathways, which play an important role on the regulation of brain bioenergetics and may be uniquely suited to address symptoms of atypical depression, a highly prevalent and underserved sub-population of MDD. In nonclinical and clinical studies, ABX-002 has demonstrated optimized PK properties, target engagement in brain regions associated with depression, and an attractive safety and tolerability profile. SOURCE: Autobahn Therapeutics

CHICAGO--( BUSINESS WIRE )--Xeris Biopharma Holdings, Inc. (Nasdaq: XERS), a fast-growing biopharmaceutical company committed to improving patient lives by developing and commercializing innovative products across a range of therapies, today announced financial results for the second quarter and six months ended June 30, 2024 and recent corporate events. “I am very pleased to report that we posted an outstanding quarter of $48 million in total revenue, which included record product revenue of over $46 million driven by strong demand for all three of our products. Our year-over-year product revenue growth of 26% represents the eleventh consecutive quarter of over 20% growth as our diverse product portfolio of Recorlev ® , Gvoke ® , and Keveyis ® all continue to meet important unmet needs for patients,” said John Shannon, CEO of Xeris Biopharma. “Our strong performance leads us to now envision full year results at the high end of our original range, and we’re tightening our guidance to $190-$200 million from the previous $175-$200 million. We also believe that this performance will enable us to perform at the higher end of our year-end cash range, so we’re tightening that guidance to $60-$75 million.” Mr. Shannon continued, “This is an exciting time for Xeris, and I’m thrilled to be leading as CEO for the next phase of our journey building upon the strong foundation we’ve created to drive our revenues and pipeline to new heights.” Second Quarter 2024 Highlights Three Months Ended June 30, Change 2024 2023 $ % Product revenue (in thousands): Gvoke $ 20,046 $ 15,638 $ 4,408 28.2 Keveyis 13,128 14,088 (960 ) (6.8 ) Recorlev 13,338 7,167 6,171 86.1 Product revenue, net 46,512 36,893 9,619 26.1 Royalty, contract and other revenue 1,553 1,115 438 39.3 Total revenue $ 48,065 $ 38,008 $ 10,057 26.5 Commercial Products Gvoke ® : Second quarter net revenue was $20.0 million as compared to $15.6 million in the second quarter of 2023 – an increase of approximately 28%. Gvoke prescriptions topped 65,000 for the first time, growing 27% compared to the same period in 2023. Gvoke’s share of the retail TRx glucagon market grew to approximately 34% at the end of July. Keveyis ® : Second quarter net revenue was $13.1 million as compared to $14.1 million in the second quarter of 2023 - a decrease of approximately 7% due to generic competition. Net revenue was unchanged from the first quarter of 2024. Recorlev ® : Second quarter net revenue was $13.3 million – an increase of 86% compared to the second quarter of 2023. The average number of patients on Recorlev increased 124% from the same period in 2023 . Technologies Programs XeriSol™ levothyroxine (XP-8121) : In May, Xeris announced positive topline results from its Phase 2 multi-center, open label, study of XP-8121 for the treatment of adults with hypothyroidism. The Company anticipates an end-of-Phase 2 meeting with the FDA before year-end. XeriSol™ glucagon for pumps: In May, Xeris entered into an exclusive worldwide collaboration and license agreement with Beta Bionics, Inc. for the development and commercialization of a unique glucagon product for use in Beta Bionics’ proprietary bi-hormonal pump and pump systems. Year-to-Date 2024 Financial Results Six Months Ended June 30, Change 2024 2023 $ % Product revenue (in thousands): Gvoke $ 36,625 $ 30,671 $ 5,954 19.4 Keveyis 26,213 26,843 (630 ) (2.3 ) Recorlev 23,937 11,644 12,293 105.6 Product revenue, net 86,775 69,158 17,617 25.5 Royalty, contract and other revenue 1,928 2,046 (118 ) (5.8 ) Total revenue $ 88,703 $ 71,204 $ 17,499 24.6 Gvoke ® : Net revenue was $36.6 million for the six months ended June 30, 2024, a 19% increase compared to prior year. Gvoke prescriptions for the first half of 2024 were approximately 124,000 TRx’s, growing approximately 27% compared to the same period in 2023. Keveyis ® : Net revenue was $26.2 million for the six months ended June 30, 2024, a 2% decrease from last year due to generic competition. Recorlev ® : Net revenue was $24.0 million for the six months ended June 30,2024, a 106 % increase from last year, driven primarily by increases in the number of patients on therapy. Cost of goods sold remained relatively flat for the three months ended June 30, 2024 compared to the same period ended June 30, 2023. Cost of goods sold increased by $0.9 million for the six months ended June 30, 2024 compared to the same period ended June 30, 2023. The slight increase was attributable to higher product sales, partially offset by favorable product mix driven by higher sales of products with lower cost of goods sold. Research and development (R&D) expenses decreased slightly by $0.3 million for the three months ended June 30, 2024. For six months ended June 30, 2024, R&D increased by $2.7 million primarily due to higher spending for our pipeline and personnel related expenses. Selling, general and administrative (SG&A) expenses increased by $2.4 million and $7.1 million for the three and six months ended 2024, respectively, compared to the same periods ended June 30, 2023, due to higher personnel costs. Net Loss for the three months ended June 30, 2024, was $15.0 million, or $0.10 per share, and a net loss of $34.0 million, or $0.24 per share, for the six months ended June 30, 2024. Cash, cash equivalents, and short-term investments at June 30, 2024 was $77.6 million compared to $72.5 million at December 31, 2023. Total shares outstanding at July 31, 2024 was 148,998,825. Upcoming Investor Conferences Members of the senior management team will be participating in the following investor conferences: Wells Fargo Healthcare Conference, September 4-6, 2024 HC Wainwright Global Investor Conference, September 9-11, 2024 Cantor Global Healthcare Conference, September 17-19, 2024 Please check with each conference sponsor to arrange 1x1 meetings. Conference Call and Webcast Details Xeris will host a conference call and webcast today at 8:30 a.m. Eastern Time to discuss the Company’s financial and operational results. To pre-register for the call, please go to the following link: https://www.netroadshow.com/events/login?show=44e9222b&confId=68537 After registering, a confirmation email will be sent, including dial-in details and a unique code for entry. The Company recommends registering a minimum of ten minutes prior to the start of the call. Following the conference call, a replay will be available until Thursday, August 22, 2024 at US:1 929 458 6194, US Toll Free: 1 866 813 9403, UK: 0204 525 0658, Canada: 1 226 828 7578, or all other locations: +44 204 525 0658 Access Code: 840547 To join the webcast, please visit “Events” on investor relations page of the Company’s website at www.xerispharma.com or use this link: https://events.q4inc.com/attendee/670337574 About Xeris Xeris (Nasdaq: XERS) is a growth-oriented biopharmaceutical company committed to improving patient lives by developing and commercializing innovative products across a range of therapies. Xeris has three commercially available products; Gvoke ® , a ready-to-use liquid glucagon for the treatment of severe hypoglycemia, Keveyis ® , a proven therapy for primary periodic paralysis, and Recorlev ® for the treatment of endogenous Cushing’s syndrome. Xeris also has a robust pipeline of development programs to extend the current marketed products into important new indications and uses and bring new products forward using its proprietary formulation technology platforms, XeriSol™ and XeriJect ® , supporting long-term product development and commercial success. Xeris Biopharma Holdings is headquartered in Chicago, IL. For more information, visit www.xerispharma.com , or follow us on X , LinkedIn , or Instagram . Forward-Looking Statements Any statements in this press release other than statements of historical fact are forward-looking statements. Forward-looking statements include, but are not limited to, statements about future expectations, plans and prospects for Xeris Biopharma Holdings, Inc. including statements regarding the financial outlook for 2024, including projections regarding year-end 2024 cash estimates and total revenue, the potential for growth of revenue, the market and therapeutic potential of its products and product candidates, the potential utility of its formulation platforms, the expected timing of an end-of-Phase 2 meeting with the FDA, its attendance at investor conferences, the composition of its executive team, and other statements containing the words “will,” “would,” “continue,” “expect,” “should,” “anticipate” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on numerous assumptions and assessments made in light of Xeris’ experience and perception of historical trends, current conditions, business strategies, operating environment, future developments, geopolitical factors and other factors it believes appropriate. By their nature, forward-looking statements involve known and unknown risks and uncertainties because they relate to events and depend on circumstances that will occur in the future. The various factors that could cause Xeris’ actual results, performance or achievements, industry results and developments to differ materially from those expressed in or implied by such forward-looking statements, include, but are not limited to, its financial position and need for financing, including to fund its product development programs or commercialization efforts, whether its products will achieve and maintain market acceptance in a competitive business environment, its reliance on third-party suppliers, including single-source suppliers, its reliance on third parties to conduct clinical trials, the ability of its product candidates to compete successfully with existing and new drugs, and its and collaborators’ ability to protect its intellectual property and proprietary technology. No assurance can be given that such expectations will be realized and persons reading this communication are, therefore, cautioned not to place undue reliance on these forward-looking statements. Additional risks and information about potential impacts of financial, operational, economic, competitive, regulatory, governmental, technological, and other factors that may affect Xeris can be found in Xeris’ filings, including its most recently filed Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission, the contents of which are not incorporated by reference into, nor do they form part of, this communication. Forward-looking statements in this communication are based on information available to us, as of the date of this communication and, while we believe our assumptions are reasonable, actual results may differ materially. Subject to any obligations under applicable law, we do not undertake any obligation to update any forward-looking statement whether as a result of new information, future developments or otherwise, or to conform any forward-looking statement to actual results, future events, or to changes in expectations. XERIS BIOPHARMA HOLDINGS, INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (in thousands, except share and per share data) (unaudited) Three Months Ended June 30, Six Months Ended June 30, 2024 2023 2024 2023 Product revenue, net $ 46,512 $ 36,893 $ 86,775 $ 69,158 Royalty, contract and other revenue 1,553 1,115 1,928 2,046 Total revenue 48,065 38,008 88,703 71,204 Costs and expenses: Cost of goods sold 7,790 7,555 13,761 12,874 Research and development 5,759 6,087 13,580 10,925 Selling, general and administrative 39,993 37,635 78,373 71,240 Amortization of intangible assets 2,710 2,710 5,421 5,421 Total costs and expenses 56,252 53,987 111,135 100,460 Loss from operations (8,187 ) (15,979 ) (22,432 ) (29,256 ) Other expense (6,069 ) (4,538 ) (10,497 ) (8,095 ) Net loss before benefit from income taxes (14,256 ) (20,517 ) (32,929 ) (37,351 ) Income tax (expense) benefit (749 ) 675 (1,056 ) 675 Net loss $ (15,005 ) $ (19,842 ) $ (33,985 ) $ (36,676 ) Net loss per common share - basic and diluted $ (0.10 ) $ (0.14 ) $ (0.24 ) $ (0.27 ) Weighted average common shares outstanding - basic and diluted 148,345,549 137,338,071 144,372,512 137,250,465 XERIS BIOPHARMA HOLDINGS, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (in thousands) June 30, 2024 December 31, 2023 (unaudited) Assets Current assets: Cash and cash equivalents $ 57,604 $ 67,449 Short-term investments 19,964 5,002 Trade accounts receivable, net 42,440 39,197 Inventory 42,977 38,838 Prepaid expenses and other current assets 7,355 5,778 Total current assets 170,340 156,264 Property and equipment, net 5,833 5,971 Intangible assets, net 104,343 109,764 Goodwill 22,859 22,859 Operating lease right-of-use assets 22,864 23,204 Other assets 5,494 4,540 Total assets $ 331,733 $ 322,602 Liabilities and Stockholders’ Equity Current liabilities: Accounts payable $ 5,798 $ 11,565 Current operating lease liabilities 5,307 3,495 Other accrued liabilities 23,494 23,510 Accrued trade discounts and rebates 23,275 22,149 Accrued returns reserve 16,197 14,198 Current portion of contingent value rights 420 19,109 Other current liabilities 997 1,167 Total current liabilities 75,488 95,193 Long-term debt, net of unamortized debt issuance costs 230,481 190,932 Non-current contingent value rights — 1,379 Non-current operating lease liabilities 34,016 34,764 Deferred tax liabilities 3,324 2,268 Other liabilities 7,710 4,848 Total liabilities 351,019 329,384 Total stockholders’ equity (deficit) (19,286 ) (6,782 ) Total liabilities and stockholders’ equity (deficit) $ 331,733 $ 322,602