BioAegis Therapeutics Announces Site Activation and Patient Recruitment Underway in 13 Countries in Phase 2b Clinical Trial of Gelsolin, an Immune Regulator, for the Treatment of Acute Respiratory Dis
600-patient study to assess efficacy of rhu-pGSN, an immune system regulator that interrupts the NLRP3 inflammasome and boosts macrophage clearance of pathogens.
Results from this landmark study expected to inform therapeutic strategies beyond ARDS, positioning rhu-pGSN as a promising intervention across a spectrum of acute and chronic inflammatory diseases.
NORTH BRUNSWICK, N.J., May 06, 2025 (GLOBE NEWSWIRE) -- BioAegis Therapeutics, a pioneering biotech company at the forefront of innovative therapies for acute and chronic inflammatory diseases, announces that patient recruiting is underway across all 13 targeted countries for its Phase 2 study of rhu-pGSN for the treatment of ARDS. (NCT05947955). The Company's portfolio is built around gelsolin (GSN), a highly conserved and critical immune regulatory protein which controls dysfunctional inflammation without suppressing immune function.
Large Global Phase 2 Clinical Trial of rhu-pGSN Underway
The randomized, double-blind, placebo-controlled trial of rhu-pGSN added to standard of care will evaluate the efficacy (survival without organ failure on Day 28) of six doses of rhu-pGSN administered intravenously to hospitalized moderate-to-severe ARDS subjects (P/F ratio ≤150) caused by infection. It will also measure the safety and tolerability of treatment along with secondary outcomes.
Sites are recruiting patients in 13 countries including US, Canada, UK and the EU (Belgium, France, Italy, Germany, Netherlands, Spain, and others). Enrollment is targeted for 600 subjects.
This project has been supported in whole or in part with federal funds from the U.S. Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA), under contract number 75A50123C00067.
"We are excited with our significant progress in this important study. Focusing this study on the moderate to severe patient who will have severely depleted plasma gelsolin levels promises to address ARDS with a novel approach employing the protein whose role in the body is to balance the inflammation-healing axis,' stated Susan Levinson, Ph.D., Chief Executive Officer of BioAegis.
Effectively Treating ARDS Will Alleviate Massive Healthcare Burden
ARDS is a condition that can develop as a severe complication of sepsis, trauma, pneumonia or other infectious diseases, resulting in life-threatening lung injury with fluid leakage into the lungs. Breathing becomes difficult, and patients require oxygen, mechanical ventilation and extensive critical care resources, placing a significant burden on the healthcare system.
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Forward-Looking Safe Harbor StatementThis press release contains certain forward-looking statements, as that term is defined in the Private Securities Litigation Reform Act of 1995, including those relating to the Company's focus on enhanced execution of the Company's strategic plan. You can identify these statements by the words 'may,' 'will,' 'could,' 'should,' 'would,' 'plans,' 'expects,' 'anticipates,' 'continue,' 'estimate,' 'project,' 'intend,' 'likely,' 'forecast,' 'probable,' 'potential,' and similar expressions. These forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those projected or anticipated. 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Management believes that exclusion of these items assists in providing a more complete understanding of the Company's underlying results and trends, and management uses these measures along with the corresponding GAAP financial measures to manage the Company's business, to evaluate its performance compared to prior periods and the marketplace, and to establish operational goals. The adjustments to calculate this non-GAAP financial measure, and the basis for such adjustments, are outlined below: Other non-operating adjustments. The Company records other non-operating adjustments such as gains or losses on foreign currency remeasurement, investments and fixed asset sales or disposals among other adjustments. These adjustments may vary from period to period without any direct correlation to underlying operating performance. Interest income and expense. The Company receives interest income on investments and incurs interest expense on loans, financing leases and other financing arrangements. These amounts may vary from period to period due to changes in cash and debt balances and interest rates driven by general market conditions or other circumstances which may be outside of the normal course of the Company's operations. Income taxes. The Company's GAAP tax expense can fluctuate materially from period to period due to tax adjustments that are not directly related to underlying operating performance or to the current period of operations. Depreciation. The Company incurs depreciation expense related to capital assets purchased to support the ongoing operations of the business. These assets are recorded at cost or fair value and are depreciated using the straight-line method over the useful life of the asset. 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The Company may also incur third party costs, such as legal, banking, communications, proxy solicitation, and other third party advisory fees in connection with engagements by activist investors or unsolicited acquisition offers. Although the Company may incur such third party costs and other related charges and adjustments, it is not indicative that any transaction will be consummated. Additionally, the Company incurs unused revolver and bank fees associated with maintaining its credit facility as well as non-cash financing expenses associated with obtaining its credit facility. Management believes these items are outside the normal operations of the Company's business and are not indicative of ongoing operating results. Fair value adjustments from purchase accounting. As a result of applying purchase accounting rules to acquired assets and liabilities, certain fair value adjustments are recorded in the opening balance sheet of acquired companies. These adjustments are then reflected in the Company's income statements in periods subsequent to the acquisition. In addition, the impact of any changes to originally recorded contingent consideration amounts are reflected in the income statements in the period of the change. Management believes these items are outside the normal operations of the Company and are not indicative of ongoing operating results. Litigation and settlement income and expense. The Company periodically receives income and incurs expenses related to pending claims and litigation and associated legal fees and potential case settlements and/or judgments. Although the Company may incur such costs and other related charges and adjustments, it is not indicative of any particular outcome until the matter is fully resolved. Management believes these items are outside the normal operations of the Company's business, often occur in periods other than the period of activity, and are not indicative of ongoing operating results. The Company periodically receives warranty claims from customers and makes warranty claims towards its vendors and supply chain. Management believes the expenses and gains associated with these recurring warranty items are within the normal operations and operating cycle of the Company's business. Therefore, management deems no adjustments are necessary unless under extraordinary circumstances. Stock-based and other non-cash compensation expense. The Company incurs expense related to stock-based compensation included in its GAAP presentation of cost of revenues, selling, general and administrative expense and research and development expense. The Company also incurs non-cash based compensation in the form of pension related expenses and matching contributions to its defined contribution plan. Although stock-based and other non-cash compensation is an expense of the Company and viewed as a form of compensation, these expenses vary in amount from period to period, and are affected by market forces that are difficult to predict and are not within the control of management, such as the market price and volatility of the Company's shares, risk-free interest rates and the expected term and forfeiture rates of the awards, as well as pension actuarial assumptions. Management believes that exclusion of these expenses allows comparisons of operating results to those of other companies, both public, private or foreign, that disclose non-GAAP financial measures that exclude stock-based compensation and other non-cash compensation. Mercury uses adjusted EBITDA as an important indicator of the operating performance of its business. Management excludes the above-described items from its internal forecasts and models when establishing internal operating budgets, supplementing the financial results and forecasts reported to the Company's board of directors, determining a portion of bonus compensation for executive officers and other key employees based on operating performance, evaluating short-term and long-term operating trends in the Company's operations, and allocating resources to various initiatives and operational requirements. The Company believes that adjusted EBITDA permits a comparative assessment of its operating performance, relative to its performance based on its GAAP results, while isolating the effects of charges that may vary from period to period without direct correlation to underlying operating performance. The Company believes that these non-GAAP financial adjustments are useful to investors because they allow investors to evaluate the effectiveness of the methodology and information used by management in its financial and operational decision-making. The Company believes that trends in its adjusted EBITDA are valuable indicators of its operating performance. Adjusted EBITDA is a non-GAAP financial measure and should not be considered in isolation or as a substitute for financial information provided in accordance with GAAP. This non-GAAP financial measure may not be computed in the same manner as similarly titled measures used by other companies. The Company expects to continue to incur expenses similar to the adjusted EBITDA financial adjustments described above, and investors should not infer from the Company's presentation of this non-GAAP financial measure that these costs are unusual, infrequent or non-recurring. The following table reconciles the most directly comparable GAAP financial measure to the non-GAAP financial measure. Fourth Quarters Ended Twelve Months Ended June 27, 2025 June 28, 2024 June 27, 2025 June 28, 2024 Net income (loss) $ 16,370 $ (10,777 ) $ (37,904 ) $ (137,640 ) Other non-operating adjustments, net (4,645 ) (217 ) (7,742 ) (592 ) Interest expense, net 6,659 8,634 29,823 33,816 Income tax expense (benefit) 2,447 (7,824 ) (12,520 ) (51,635 ) Depreciation 9,694 10,080 39,178 40,369 Amortization of intangible assets 10,275 11,311 42,849 47,661 Restructuring and other charges (15 ) 6,781 7,216 26,170 Impairment of long-lived assets — — — — Acquisition, financing and other third party costs 2,126 1,400 6,638 4,370 Fair value adjustments from purchase accounting 131 178 617 710 Litigation and settlement expense, net 4,062 945 13,010 4,927 Stock-based and other non-cash compensation expense 4,165 10,650 38,273 41,257 Adjusted EBITDA $ 51,269 $ 31,161 $ 119,438 $ 9,413 Free cash flow, a non-GAAP measure for reporting cash flow, is defined as cash provided by operating activities less capital expenditures for property and equipment, which includes capitalized software development costs, and, therefore, has not been calculated in accordance with GAAP. Management believes free cash flow provides investors with an important perspective on cash available for investment and acquisitions after making capital investments required to support ongoing business operations and long-term value creation. The Company believes that trends in its free cash flow are valuable indicators of its operating performance and liquidity. Free cash flow is a non-GAAP financial measure and should not be considered in isolation or as a substitute for financial information provided in accordance with GAAP. This non-GAAP financial measure may not be computed in the same manner as similarly titled measures used by other companies. The Company expects to continue to incur expenditures similar to the free cash flow financial adjustment described above, and investors should not infer from the Company's presentation of this non-GAAP financial measure that these expenditures reflect all of the Company's obligations which require cash. The following table reconciles the most directly comparable GAAP financial measure to the non-GAAP financial measure. Fourth Quarters Ended Twelve Months Ended June 27, 2025 June 28, 2024 June 27, 2025 June 28, 2024 Net cash provided by operating activities $ 38,075 $ 71,761 $ 138,851 $ 60,382 Purchases of property and equipment (4,098 ) (10,348 ) (19,803 ) (34,291 ) Free cash flow $ 33,977 $ 61,413 $ 119,048 $ 26,091 UNAUDITED SUPPLEMENTAL INFORMATION RECONCILIATION OF GAAP TO NON-GAAP MEASURES (In thousands, except per share data) Adjusted income and adjusted earnings per share ('adjusted EPS') are non-GAAP measures for reporting financial performance, exclude the impact of certain items and, therefore, have not been calculated in accordance with GAAP. Management believes that exclusion of these items assists in providing a more complete understanding of the Company's underlying results and trends and allows for comparability with its peer company index and industry. These non-GAAP financial measures may not be computed in the same manner as similarly titled measures used by other companies. The Company uses these measures along with the corresponding GAAP financial measures to manage the Company's business and to evaluate its performance compared to prior periods and the marketplace. The Company defines adjusted income as income before other non-operating adjustments, amortization of intangible assets, restructuring and other charges, impairment of long-lived assets, acquisition, financing and other third party costs, fair value adjustments from purchase accounting, litigation and settlement income and expense, and stock-based and other non-cash compensation expense. The impact to income taxes includes the impact to the effective tax rate, current tax provision and deferred tax provision(1). Adjusted EPS expresses adjusted income on a per share basis using weighted average diluted shares outstanding. The following tables reconcile the most directly comparable GAAP financial measures to the non-GAAP financial measures. Fourth Quarters Ended June 27, 2025 June 28, 2024 Net income (loss) and earnings (loss) per share $ 16,370 $ 0.27 $ (10,777 ) $ (0.19 ) Other non-operating adjustments, net (4,645 ) (217 ) Amortization of intangible assets 10,275 11,311 Restructuring and other charges (15 ) 6,781 Impairment of long-lived assets — — Acquisition, financing and other third party costs 2,126 1,400 Fair value adjustments from purchase accounting 131 178 Litigation and settlement expense, net 4,062 945 Stock-based and other non-cash compensation expense 4,165 10,650 Impact to income taxes(1) (4,576 ) (7,033 ) Adjusted income and adjusted earnings per share(2) $ 27,893 $ 0.47 $ 13,238 $ 0.23 Diluted weighted-average shares outstanding 59,540 58,048 (1) Impact to income taxes is calculated by recasting income before income taxes to include the items involved in determining adjusted income and recalculating the income tax provision using this adjusted income from operations before income taxes. The recalculation also adjusts for any discrete tax expense or benefit related to the items. (2) Adjusted earnings per share is calculated using diluted shares whereas Net loss per share or Adjusted loss per share is calculated using basic shares. There was a $0.01 impact to the calculation of adjusted earnings per share as a result of this for the fourth quarters ended June 28, 2024. Twelve Months Ended June 27, 2025 June 28, 2024 Net loss and loss per share $ (37,904 ) $ (0.65 ) $ (137,640 ) $ (2.38 ) Other non-operating adjustments, net (7,742 ) (592 ) Amortization of intangible assets 42,849 47,661 Restructuring and other charges 7,216 26,170 Impairment of long-lived assets — — Acquisition, financing and other third party costs 6,638 4,370 Fair value adjustments from purchase accounting 617 710 Litigation and settlement expense, net 13,010 4,927 Stock-based and other non-cash compensation expense 38,273 41,257 Impact to income taxes(1) (25,091 ) (26,621 ) Adjusted income (loss) and adjusted earnings (loss) per share(2) $ 37,866 $ 0.64 $ (39,758 ) $ (0.69 ) Diluted weighted-average shares outstanding 59,203 57,738 (1) Impact to income taxes is calculated by recasting income before income taxes to include the items involved in determining adjusted income and recalculating the income tax provision using this adjusted income from operations before income taxes. The recalculation also adjusts for any discrete tax expense or benefit related to the items. (2) Adjusted earnings per share is calculated using diluted shares whereas Net loss per share is calculated using basic shares. There was a $0.01 impact to the calculation of adjusted earnings per share as a result of this for the twelve months ended June 27, 2025 and June 28, 2024, respectively. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
