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].

Ex. 99.1 Katapult Delivers 15.4% Gross Originations and 10.6% Revenue Growth in the First Quarter, Above Outlook Expects Growth to Accelerate In Second Quarter Reiterates 2025 Guidance PLANO, Texas, May 15, 2025 -- Katapult Holdings, Inc. ("Katapult" or the "Company") (NASDAQ: KPLT), an e-commerce-focused financial technology company, today reported its financial results for the first quarter ended March 31, 2025. "2025 is off to a strong start and we are well positioned to achieve our full year targets," s ...

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 ...

EX-99.1 2 edbl_ex991.htm PRESS RELEASE EXHIBIT 99.1 Edible Garden Reports Q1 2025 Financial Results and Provides Strategic Update Non-Perishable Revenue Grows 15%; Gross Profit Nearly Quadruples Year-over-Year as Company Shifts Focus to Higher Margin, Shelf-Stable Of erings Strategic Product Mix Realignment Driving Operational Ef iciency and Margin Expansion Conference Call to Be Held Today at 8:00 am ET. BELVIDERE, NJ, May 15, 2025 — Edible Garden AG Incorporated ("Edible Garden" or the "Company") (Nasdaq: ...

Boston, Mass. May 15, 2025 – Elevation Oncology, Inc. (Nasdaq: ELEV), an innovative oncology company focused on the discovery and development of selective cancer therapies to treat patients across a range of solid tumors with significant unmet medical needs, today announced financial results for the quarter ended March 31, 2025, and provided recent business updates. "We recently presented preclinical proof-of-concept data for EO-1022, reaffirming its potential as a differentiated HER3 ADC, and supporting ou ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 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 Commission File Number: 001-40881 Pyxis Oncology, Inc. (Exact Name of Registrant as Specified in its Charter) | Delaware | 83-1160910 | | --- | --- | | (State or other jurisdiction of | (I.R. ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 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 001-15771 ABEONA THERAPEUTICS INC. (Exact name of registrant as specified in its charter) (State or Other Jurisdiction of incorporatio ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 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: 001-38841 Precision BioSciences, Inc. (Exact Name of Registrant as Specified in its Charter) Delaware 20-4206017 (State o ...

Share Issuance and Compliance - The Company agrees to sell shares of its common stock at a price of $4.00 per share[54] - The total purchase amount for each Investor is specified in Exhibit A attached to the Agreement[54] - The Closing Date for the sale of shares will occur no earlier than one business day and no later than five business days after the date of the Agreement[55] - The Company will issue the shares in book-entry form, free and clear of all restrictive legends at the Closing[55] - The Company represents that its capitalization disclosure in SEC Reports was accurate in all material respects as of the indicated date[58] - All issued and outstanding shares of Common Stock are fully paid and non-assessable[58] - The Company is not currently under any obligation to register any of its outstanding securities under the Securities Act, except as disclosed in the SEC Reports[59] - The Company has duly authorized the issuance and sale of Shares, ensuring compliance with applicable securities laws[60] - The Shares will be fully paid and non-assessable, issued free of any liens or restrictions, and holders will have all rights accorded to Common Stock[62] - The Company has filed all required forms and reports with the SEC, ensuring compliance with the Exchange Act[66] - The Company is not subject to any disqualification events under Rule 506(d)(1) of Regulation D[92] - The Company will file a Current Report on Form 8-K by 9:00 a.m. New York City time on the first business day following the agreement date, disclosing all material terms of the transactions and non-public information concerning the Company[124] - The Company will not issue shares of Common Stock or Common Stock Equivalents for 60 days post-closing without prior consent from the Investor Majority[137] - The Company will ensure that no conflicting agreements interfere with its obligations to the Investors under the Transaction Agreements[132] - The Company must ensure compliance with all listing requirements for the Common Stock on a National Exchange[147] Financial Performance and Projections - The Company reported a significant increase in revenue, achieving $150 million in Q3 2023, representing a 25% year-over-year growth[1] - User data showed a 40% increase in active users, reaching 2 million by the end of Q3 2023[2] - The Company provided guidance for Q4 2023, expecting revenue to be between $160 million and $170 million, indicating a growth rate of 20% to 30% compared to Q4 2022[3] - New product launches are anticipated to contribute an additional $20 million in revenue in the next quarter[4] Strategic Initiatives and Investments - The Company is investing $10 million in R&D for new technologies aimed at enhancing user experience and product efficiency[5] - Market expansion efforts include entering three new international markets, projected to increase user base by 15%[6] - The Company is exploring potential acquisitions to bolster its market position, with a budget of $50 million allocated for this purpose[7] - A strategic partnership was announced, expected to enhance distribution channels and increase sales by 10% over the next year[8] Operational Compliance and Risk Management - The Company has filed all required tax returns and paid all necessary taxes, with no material tax assessments pending[75] - The Company is in compliance with all applicable Environmental Laws and has received all necessary permits, with no material adverse effects expected from any noncompliance[76] - The Company maintains good and marketable title to all material personal property, free of liens and encumbrances[78] - The Company carries adequate insurance customary for its business, with no notices of cancellation or denial of coverage received since January 1, 2024[79] - The Company has conducted clinical trials in accordance with regulatory protocols, with no notices of required termination or suspension from Regulatory Agencies[83] - The Company is in compliance with all applicable Health Care Laws and has not received any claims or actions alleging violations[84] - The Company maintains a system of internal control over financial reporting designed to ensure reliability and compliance with GAAP[86] - The Company has not engaged in any actions to stabilize or manipulate the price of its Common Stock[87] - The Company must ensure that all representations and warranties are true and correct in all material respects as of the Closing Date[139] - The Company is required to perform all obligations and conditions prior to the Closing Date[140] - The Company must obtain all necessary consents, permits, approvals, registrations, and waivers for the transaction to proceed[141] - No event should occur that would reasonably be expected to have a Material Adverse Effect since the date of the Agreement[142] - The Company must ensure that no stop order or suspension of trading has been imposed by regulatory bodies regarding the Common Stock[147] - The Company must provide a lock-up agreement executed by its officers and directors to the Placement Agent[151] - The Company must execute and deliver the Registration Rights Agreement to the Investors[146] Investor Relations and Support - The Company has entered into Support Agreements with holders of more than 50% of its outstanding Preferred Stock, indicating strong support from key investors[100] - The Company will indemnify and hold harmless each Investor from losses or claims resulting from breaches of representations or warranties made under the Transaction Agreements[133] - The Company will use commercially reasonable efforts to satisfy obligations set forth in the Support Agreements[136] - The Company acknowledges that Investors have relied on independent investigations and SEC Reports in making investment decisions[118] - The Company will not disclose the names of any Investors or their affiliates without prior written consent, except as required by law[124] Corporate Governance and Compliance - The Company has been in compliance with the Sarbanes-Oxley Act of 2002 since January 1, 2024[81] - The Company and its subsidiaries have all necessary governmental authorizations for their operations, with no violations that would have a Material Adverse Effect[71] - The Company owns or has rights to all necessary intellectual property for its business operations, with no known infringements[72] - The Company is in material compliance with all applicable data privacy laws, including HIPAA and GDPR, and has maintained accurate privacy statements to customers and employees[98] Sustainability and Long-term Goals - The Company emphasized its commitment to sustainability, planning to reduce operational costs by 5% through energy-efficient practices[9] - The management team expressed confidence in achieving long-term growth targets, aiming for a 50% increase in overall market share by 2025[10]