"We started 2025 with strong momentum and a focus on generating impactful clinical data across our in vivo gene editing pipeline. Early this year, data from the OTC-HOPE trial provided the first clinical validation for ARCUS in vivo gene insertion following a complete response in an infant with OTC-deficiency," said Michael Amoroso, Chief Executive Officer of Precision BioSciences. "In addition, the Phase 1 ELIMINATE-B trial evaluating PBGENE-HBV, our lead program for chronic Hepatitis B, is progressing as ...

Exhibit 99.1 Net income for the first quarter of 2025 was $2.0 million compared to $2.2 million during the quarter ended March 31, 2024. Basic earnings per share and diluted earnings per share were $0.22 and $0.20, respectively, compared to $0.23 and $0.21 for the first quarter of 2024. Excluding the impact of elevated merger- and acquisition-related expense for the first quarter of 2025, net income and earnings per share would have been comparable or higher than during the first quarter of 2024. Adjusted E ...

Financial Performance - Earnings per share increased by 30% year-over-year, reaching $0.10 compared to $0.08 in the prior year[2] - Revenue for Q1 2025 was $8.2 million, a decrease of 13% from $9.4 million in Q1 2024, primarily due to a new product sell-in that did not repeat[4] - Gross margin improved to 75.4% in Q1 2025 from 72.0% in Q1 2024, driven by a favorable product mix[6] - Net income rose by 51% to $876.3 thousand in Q1 2025, up from $580.5 thousand in Q1 2024[7] - EBITDA for Q1 2025 was $1.98 million, a 7% increase from $1.85 million in Q1 2024, attributed to lower SG&A expenses[8] - Operating expenses decreased by 15% to $4.2 million in Q1 2025 from $5.0 million in Q1 2024[6] International Expansion - The company is preparing for international expansion into three new markets later in 2025 for its FOCUSfactor brand and Ready-To-Drink beverages[2] - Synergy established a wholly owned subsidiary in Mexico and is onboarding key suppliers and retailers in the region[5] Debt and Cash Flow Management - The company aims to refinance its debt to extend the maturity date to 2029, which is expected to enhance free cash flow[2] - Total liabilities decreased by $1.7 million to $31.3 million as of March 31, 2025, compared to $33.0 million at the end of 2024[9] - Net cash used in operating activities was $(822,781) for the three months ended March 31, 2025, slightly improved from $(858,042) in the same period of 2024[22] - Cash and restricted cash at the end of the period was $277,882, down from $1,010,749 at the end of the same period in 2024, indicating a decrease of 72.5%[22] - Net cash provided by financing activities was $314,678 for the three months ended March 31, 2025, compared to $1,004,620 in the same period of 2024, a decline of 68.7%[22] - Cash paid for interest during the period was $573,529, down from $1,102,781 in the same period of 2024, a decrease of 47.9%[22] - Advances from related party amounted to $135,000, a significant decrease from $1,400,000 in the same period of 2024[22] Asset Management - Accounts receivable increased by $940,519, while inventory decreased by $(629,935) during the three months ended March 31, 2025[22] - The company issued common stock for loan financing amounting to $117,648 during the period[22] Foreign Currency Impact - The company reported a foreign currency transaction loss of $(3,137) for the three months ended March 31, 2025, compared to a gain of $11,178 in the same period of 2024[22] - The effect of exchange rate on cash, cash equivalents, and restricted cash resulted in a loss of $(1,935) for the three months ended March 31, 2025[22]

Exhibit 99.1 Galectin Therapeutics Reports 2024 Financial Results and Provides Business Update NORCROSS, Ga., May 15, 2025 (GLOBE NEWSWIRE) – Galectin Therapeutics, Inc. (NASDAQ: GALT), the leading developer of therapeutics that target galectin proteins, today reported financial results and provided a business update for the three months ended March 31, 2025. Joel Lewis, Chief Executive Officer and President of Galectin Therapeutics, stated "This quarter, we remained laser-focused on advancing additional an ...

Revenue and Sales Performance - TriSalus reported a revenue increase driven primarily by sales of its PEDD infusion systems, particularly the TriNav, with a gross margin that allows for substantial funding of growth and R&D [227][230]. - Revenue increased by $2.7 million, or 42.0%, for the three months ended March 31, 2025, compared to the same period in 2024, primarily due to increased sales of TriNav [239]. Product Development and Clinical Trials - The company launched the TriNav LV Infusion System and TriGuide Guiding Catheter in 2024, expanding its PEDD device portfolio to optimize therapeutic delivery for larger vessels [215][216]. - A registry study called PROTECT aims to enroll 100 patients and is expected to expand the addressable market by approximately 50,000 procedures, representing an incremental $400 million market opportunity [217]. - The company completed Phase I clinical trials for nelitolimod and is exploring partnerships for further development, with data expected in 2025 [218]. - The MDACC Agreement was modified and extended to include a sixth year, enhancing collaboration for ongoing clinical studies [222]. Financial Position and Cash Flow - Cash and cash equivalents were approximately $13.0 million at March 31, 2025, with a minimum cash requirement increased from $5.0 million to $10.0 million [250]. - Net cash used in operating activities was $4.5 million for the three months ended March 31, 2025, compared to $10.9 million for the same period in 2024 [251]. - Net cash provided by financing activities was $9.7 million for the three months ended March 31, 2025, primarily from the First Delayed draw under the OrbiMed Credit Agreement [256]. Expenses and Losses - Gross profit increased by $2.2 million, or 39.8%, for the three months ended March 31, 2025, with gross margin decreasing to 83.7% from 85.0% [241]. - Research and development expenses decreased by $2.5 million, or 43.6%, for the three months ended March 31, 2025, primarily due to reduced clinical trial expenses [242]. - General and administrative expenses increased by $0.3 million, or 7.4%, for the three months ended March 31, 2025, mainly due to professional services related to filing and audit expenses [245]. - Net loss available to common stockholders was $10.4 million for the three months ended March 31, 2025, compared to a net loss of $13.2 million for the same period in 2024 [238]. Funding and Capital Requirements - TriSalus secured a $10 million loan under the OrbiMed Credit Agreement, contingent on achieving a $30 million revenue base [221]. - The company anticipates gross proceeds of approximately $22 million from a private placement of 5.5 million shares at $4.00 per share, closing on May 2, 2025 [225]. - The company expects to finance its cash needs through a combination of securities offerings, debt financings, collaborations, strategic alliances, and licensing arrangements [260]. - There is substantial doubt regarding the company's ability to continue as a going concern as of March 31, 2025, due to its reliance on generating sufficient cash flows or obtaining additional capital [263]. - If the company is unable to raise additional capital, it may have to delay or terminate product development efforts [261]. - The company may face dilution of existing ownership interests if it raises additional capital through equity or convertible debt securities [260]. Regulatory and Compliance Matters - TriSalus received a permanent HCPCS code for the TriNav Infusion System effective January 1, 2024, which may enhance reimbursement clarity and support sales [214]. - The expiration of the TPT payment program in December 2023 poses a risk to maintaining current pricing and gross margins for TriNav [219]. - The company is subject to affirmative and restrictive covenants under the OrbiMed Credit Agreement, which may limit its operational flexibility [260]. - The company does not currently have any off-balance sheet financing arrangements or relationships with unconsolidated entities [266]. - The company’s critical accounting policies have not changed significantly during the three months ended March 31, 2025, compared to the previous year [267]. Other Financial Liabilities - The fair value of the SEPA, warrant, and revenue base redemption liabilities changed by $3.4 million, resulting in a loss of $0.8 million for the three months ended March 31, 2025 [247]. - The company has paid Dynavax $12.0 million as of March 31, 2025, with potential additional payments of up to $158 million upon achieving certain milestones related to nelitolimod [265]. - The company may be required to pay up to $80 million upon achieving certain commercial milestones for nelitolimod, subject to obtaining marketing approval [265].

Financial Performance - Revenue increased by $2.7 million, or 42.0%, for the three months ended March 31, 2025, compared to the same period in 2024, driven by increased sales of TriNav[239]. - Gross profit increased by $2.2 million, or 39.8%, for the three months ended March 31, 2025, with gross margin decreasing to 83.7% from 85.0% due to lower manufacturing efficiencies[241]. - The company incurred net losses of $10.4 million for the three months ended March 31, 2025, and expects to continue incurring net losses due to ongoing investments in R&D and sales[249]. - Net cash used in operating activities was $4.5 million for the three months ended March 31, 2025, compared to $10.9 million for the same period in 2024[251]. - Cash and cash equivalents were approximately $13.0 million at March 31, 2025, with a minimum cash requirement increased from $5.0 million to $10.0 million[250]. Research and Development - TriSalus completed Phase I clinical trials for nelitolimod and is seeking pharmaceutical partners for further development[218]. - Research and development expenses decreased by $2.5 million, or 43.6%, for the three months ended March 31, 2025, primarily due to reduced clinical trial expenses[242]. - The PROTECT registry study aims to enroll 100 patients and could expand the addressable market by approximately 50,000 procedures, representing a $400 million market opportunity[217]. - The company has paid Dynavax $12.0 million as of March 31, 2025, and may owe up to an additional $158 million upon achieving certain development and regulatory milestones for nelitolimod[265]. - The company is obligated to pay up to $80 million upon achieving certain commercial milestones for nelitolimod, subject to obtaining marketing approval[265]. Financing and Capital Structure - The company borrowed $10 million under a credit agreement after achieving a trailing 12-month product revenue base of $30 million in January 2025[221]. - A securities purchase agreement was entered into in April 2025, resulting in gross proceeds of approximately $22 million from the private placement of 5.5 million shares[225]. - The company raised gross proceeds of approximately $22.0 million through a Private Placement subsequent to March 31, 2025, to support liquidity requirements[250]. - The company expects to finance its cash needs through a combination of securities offerings, debt financings, collaborations, strategic alliances, and licensing arrangements[260]. - The company is subject to affirmative and restrictive covenants under the OrbiMed Credit Agreement, which may limit its ability to incur additional debt or make capital expenditures[260]. Operational Developments - TriSalus launched the TriNav LV Infusion System and TriGuide Guiding Catheter in 2024, expanding its portfolio of PEDD devices for larger vessels[215]. - The company received a permanent HCPCS code for the TriNav Infusion System effective January 1, 2024, enhancing reimbursement clarity[214]. - The MDACC Agreement was modified and extended, adding a sixth year to the collaboration for ongoing clinical studies[222]. - The company is focused on maintaining TriNav pricing and gross margins to support growth and R&D activities[219]. Risks and Concerns - There is substantial doubt regarding the company's ability to continue as a going concern as of March 31, 2025, due to its reliance on generating sufficient cash flows or obtaining additional capital[263]. - The company may need to delay or terminate product development if it is unable to raise additional capital when needed[261]. - The company may have to relinquish valuable rights to its technologies or grant licenses on unfavorable terms if it raises funds through collaborations or licensing arrangements[261]. - The fair value of the SEPA, warrant, and revenue base redemption liabilities changed by $3.4 million, resulting in a loss of $0.8 million for the three months ended March 31, 2025[247]. - The company does not currently have any off-balance sheet financing arrangements or relationships with unconsolidated entities[266].

Financial Performance - Total revenue for Q1 2025 was $18,991, an increase of $8,877, or 88%, from $10,114 in Q1 2024, driven by additional patient-pay scans at Radnet facilities [132]. - Total cost of revenue for Q1 2025 was $23,479, an increase of 21% from $19,476 in Q1 2024, attributed to volume-related costs including partner fees [133]. - The company recorded a net loss of $2,037,436 in Q1 2025, an improvement of $361,665 compared to a net loss of $2,399,102 in Q1 2024 [130]. Expenses - Sales and marketing expenses rose to $302,584 in Q1 2025, an increase of $121,528, or 67%, primarily due to the initiation of the CLARITY trial [134]. - Research and development expenses decreased to $198,190 in Q1 2025, down $40,852, or 17%, due to reduced regulatory and quality system work [135]. - General and administrative expenses increased to $986,663 in Q1 2025, up $140,816, or 17%, due to additional financial operations and investor relations support [136]. Cash Flow and Financing - Cash and cash equivalents as of March 31, 2025, totaled $14,760,272, including $10,000 of restricted cash [150]. - The company raised $20.1 million in gross proceeds during Q1 2025 through public offerings and direct offerings [151]. - Cash used in operating activities was $2,510,782 in Q1 2025, compared to $2,238,557 in Q1 2024 [154]. - The company incurred $672,500 in penalties and settlements related to a dispute under an investment banking agreement [141]. - The company sold an aggregate of 100,000 common shares and 143,900,000 pre-funded warrants, generating net proceeds of $13.4 million from the public offering [160]. - The public offering price for each unit was $0.10, with the underwriter exercising an option to purchase an additional 21,000,000 shares and warrants [160]. - As of March 31, 2025, all pre-funded warrants have been exercised, resulting in the issuance of approximately 14.7 million common shares from Series B warrant exercises [162]. - The company redeemed all Series B Preferred Stock for a cash payment of $1,213,590 on January 22, 2025 [163]. - During Q1 2025, holders of Series C warrants exercised 5,685,049 warrants, generating payments of $336,411 [166]. - The company completed a public offering of 5,175,000 units at a price of $0.58 per unit, resulting in gross proceeds of approximately $3.0 million during Q1 2024 [167]. - The remaining outstanding balance of principal and interest on unsecured non-convertible notes was $898,380 after a payment of $300,974 in Q1 2024 [168]. - The company issued 644,142 shares of common stock in exchange for $1,519,779 principal and accrued interest on notes during Q1 2024 [169]. Business Outlook - Developing medical technology products is a costly and uncertain process, indicating a need for substantial additional funds to achieve business objectives [170]. - The company is classified as a smaller reporting company, with a market value of stock held by non-affiliates less than $700 million and annual revenue below $100 million [177].

Clinical Trials and Efficacy - The company has completed randomizations totaling 357 patients in the NAVIGATE trial, a Phase 2b/3 clinical study evaluating the safety and efficacy of belapectin for preventing esophageal varices in NASH cirrhosis patients [97]. - In the intent-to-treat population (N=355), the incidence of varices was reduced by 43.2% in the belapectin 2 mg/kg dose group compared to placebo, although the composite endpoint did not reach statistical significance [98]. - In the per-protocol population (n=287), the incidence of varices was reduced by 49.3% in the belapectin 2 mg/kg dose group, with a p-value of less than 0.05 [98]. - In the U.S. cohort (n=186), the incidence of varices was significantly reduced by 68.1% in patients treated with belapectin 2 mg compared to placebo (4 out of 60 vs 13 out of 62) [98]. - The Phase 2b NASH-CX trial enrolled 162 patients with compensated cirrhosis and portal hypertension, evaluating belapectin's safety and efficacy [113]. - In the NASH-CX trial, the mean change in hepatic venous pressure gradient (HVPG) was -0.37 mm Hg for the 2 mg/kg LBM dose and -0.42 mm Hg for the 8 mg/kg LBM dose, compared to a 0.3 mm Hg change in placebo [114]. - In patients without esophageal varices at baseline, the 2 mg/kg LBM dose of belapectin showed a statistically significant reduction in HVPG of -1.08 mm Hg (p<0.01) [115]. - The NASH-CX trial demonstrated a 0% incidence of new varices in the 2 mg/kg LBM group compared to 18% in the placebo group, indicating a significant clinical benefit [117]. - The NAVIGATE trial reported a 43.2% reduction in the incidence of varices in the belapectin 2 mg/kg group compared to placebo, although the composite endpoint did not reach statistical significance [122]. - In the per-protocol population of the NAVIGATE trial, the incidence of varices was reduced by 49.3% in the belapectin 2 mg/kg group (p<0.05) [122]. - The NAVIGATE trial showed a significant reduction of 68.1% in the incidence of varices in U.S. patients treated with belapectin 2 mg/kg (p=0.02) [122]. Safety Profile - The safety profile of belapectin remains encouraging, with rates of adverse events and serious adverse events comparable to placebo, and no drug-related serious adverse events reported in the NAVIGATE trial [99]. - The safety profile of belapectin in the NAVIGATE trial was comparable to placebo, with no drug-related serious adverse events reported [123]. - The Hepatic Impairment Study indicated that belapectin exposure did not increase with the degree of hepatic insufficiency, supporting its safety profile [130]. Financials and Expenses - Research and development expenses for Q1 2025 were $8,054,000, a decrease of $1,569,000 or 19.5% compared to Q1 2024 [136]. - Clinical activities expenses decreased from $5,872,000 in Q1 2024 to $4,466,000 in Q1 2025, primarily due to the timing of expenditures related to the NAVIGATE clinical trial [137]. - General and administrative expenses decreased by $182,000 or 11.4%, from $1,594,000 in Q1 2024 to $1,412,000 in Q1 2025 [140]. - As of March 31, 2025, the company had $7.4 million in unrestricted cash and cash equivalents, with an additional $11 million available under two lines of credit [141]. - Net cash used in operations decreased by $4,415,000 to $7,689,000 for Q1 2025 compared to $12,105,000 for Q1 2024 [142]. - The company has raised a net total of $314.5 million from public and private offerings since its inception [141]. Product Development and Future Plans - The company has a lead product candidate, belapectin, which has shown promise in treating liver fibrosis, severe skin disease, and cancer, particularly focusing on NASH cirrhosis and head and neck cancer [107]. - The company is pursuing a development pathway for belapectin in immuno-oncology, having filed a new IND with the FDA for advanced or metastatic head and neck cancer in combination with a PD-1 inhibitor [104]. - The company plans to file a Phase 2 trial with the FDA for belapectin in combination with an immune checkpoint inhibitor targeting recurrent or metastatic head and neck cancer [134]. - The company continues to analyze data from approximately 55 patients who completed 36 months of treatment, which may attract interest from potential strategic partners [100]. - The company has established a joint venture subsidiary, Galectin Sciences LLC, to develop small molecules that inhibit galectin-3, potentially expanding the uses of galectin-3 inhibitors beyond belapectin [103]. Combination Therapies - The Phase 1b trial combining belapectin with pembrolizumab (KEYTRUDA) showed a 50% objective response rate in advanced melanoma and a 33% response rate in head and neck cancer patients [133]. - The combination of belapectin with pembrolizumab may reduce autoimmune side effects associated with pembrolizumab [133]. Challenges and Limitations - The company is unable to provide accurate estimates for the costs and timing of bringing a drug candidate to market due to numerous variables [138].

Financial Performance - Gross originations for Q1 2025 were $64.2 million, representing a 15.4% increase year-over-year, while total revenue reached $71.9 million, up 10.6%[8] - Total revenue for Q1 2025 was $71,946,000, representing a 10.3% increase from $65,061,000 in Q1 2024[38] - Net loss for Q1 2025 was $5.7 million, compared to a net loss of $0.6 million in Q1 2024, primarily due to higher costs[8] - Net loss for Q1 2025 was $5,688,000, compared to a net loss of $570,000 in Q1 2024, indicating a significant increase in losses[38] - Adjusted EBITDA for Q1 2025 was $2.2 million, down from $5.6 million in Q1 2024, impacted by increased cost of sales[8] - Adjusted EBITDA for Q1 2025 was $2,240,000, down from $5,630,000 in Q1 2024[43] - Fixed cash operating expenses increased to $10,402,000 in Q1 2025, compared to $9,390,000 in Q1 2024, reflecting a rise of 10.8%[43] Customer Metrics - KPay originations grew by approximately 57% year-over-year, with 35% of total gross originations transacted using KPay[3] - The Katapult app marketplace accounted for ~59% of first quarter gross originations, with total app originations increasing by 42% year-over-year[3] - The repeat customer rate for Q1 2025 was 57.4%, indicating strong customer retention[3] - Customer satisfaction remained high, with a Net Promoter Score of 66 as of March 31, 2025[3] Future Projections - The company expects gross originations to grow at least 20% for the full year 2025, with revenue growth projected at 17% to 20%[12][17] - The company plans to introduce new merchants to the Katapult App Marketplace during 2025 to enhance growth opportunities[7] Financial Position - Cash and cash equivalents at the end of Q1 2025 were $5,965,000, up from $3,465,000 at the end of Q4 2024[39] - Total liabilities increased to $140,222,000 as of March 31, 2025, compared to $139,965,000 at the end of 2024[39] - The company’s accumulated deficit reached $154,139,000 as of March 31, 2025, compared to $148,451,000 at the end of 2024[39] - Write-offs as a percentage of revenue were 9.0% in Q1 2025, within the company's long-term target range of 8% to 10%[8] Shareholder Information - The weighted average common shares outstanding increased to 4,618,000 in Q1 2025 from 4,242,000 in Q1 2024[38]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ____________ to ____________ Commission File Number 001-37471 Palvella Therapeutics, Inc. (Exact name of Registrant as specified in its Charter) Nevada 30-078 ...