UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ Quarterly report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the quarterly period ended June 30, 2025 ☐ Transition report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the transition period from to Commission File No. 001-31791 GALECTIN THERAPEUTICS INC. (State or other jurisdiction of incorporation) (I.R.S. Employer Identification No.) Nevada 04-3562325 4960 Peacht ...

Corporate Update and Highlights [Management Commentary](index=1&type=section&id=Management%20Commentary) The CEO highlights FDA clearance for the NurOwn Phase 3b trial as a key milestone and affirms the company's clinical execution focus - Reached a key milestone in Q2 with **FDA clearance** to initiate the Phase 3b trial for NurOwn, designed to support a potential Biologics License Application (BLA) submission[2](index=2&type=chunk) - Advancing operational activities, including discussions with clinical sites and engagement with CDMO partners to ensure readiness for clinical drug supply[2](index=2&type=chunk) - Supports the FDA's consideration of the Citizen Petition, viewing it as a potential opportunity for a fresh, objective evaluation of NurOwn's scientific evidence[2](index=2&type=chunk) [Recent Highlights](index=1&type=section&id=Recent%20Highlights) The company received FDA clearance for its Phase 3b trial, saw a Citizen Petition filed, and reported positive EAP survival data - The FDA has cleared the company to initiate the Phase 3b clinical trial of NurOwn, known as ENDURANCE, expected to enroll **approximately 200 participants**[3](index=3&type=chunk) - A Citizen Petition was submitted to the FDA by the ALS Community, requesting a new review of the NurOwn data, which the company believes provides a new opportunity to reaffirm NurOwn's potential[7](index=7&type=chunk) - New survival data from the NurOwn Expanded Access Program (EAP) showed that **100% of participants (10/10) survived more than 5 years** from the onset of ALS symptoms[7](index=7&type=chunk) - BrainStorm signed a Letter of Intent (LOI) with Minaris Advanced Therapies, a global CDMO, to manufacture NurOwn for the upcoming Phase 3b clinical trial[7](index=7&type=chunk) - New pharmacogenomic data highlighting the impact of the UNC13A genotype on clinical outcomes were selected for presentation at the ISCT 2025 Annual Meeting[7](index=7&type=chunk) Financial Performance [Second Quarter 2025 Financial Results](index=2&type=section&id=Second%20Quarter%202025%20Financial%20Results) The company reported a net loss of $2.9 million for Q2 2025, with increased R&D expenses and decreased G&A expenses Q2 2025 Financial Highlights | Financial Metric | Q2 2025 | Q2 2024 | | :--- | :--- | :--- | | Cash, cash equivalents, and restricted cash | ~$1.03 million | N/A | | Research and development expenditures, net | $1.1 million | $0.9 million | | General and administrative expenses | ~$1.4 million | ~$2.1 million | | Net loss | ~$2.9 million | ~$2.5 million | | Net loss per share | $0.34 | $0.60 | [Consolidated Financial Statements](index=5&type=section&id=Consolidated%20Financial%20Statements) The statements show total assets of $2.57 million, a stockholders' deficit of $6.06 million, and a Q2 net loss of $2.90 million [Consolidated Balance Sheets](index=5&type=section&id=Consolidated%20Balance%20Sheets) As of June 30, 2025, total assets increased to $2.57 million while the total stockholders' deficit improved to $6.06 million Financial Position Comparison | Balance Sheet Item (in thousands) | June 30, 2025 (Unaudited) | December 31, 2024 (Audited) | | :--- | :--- | :--- | | Cash and cash equivalents | $824 | $187 | | Total current assets | $1,515 | $385 | | Total assets | $2,566 | $1,832 | | Total current liabilities | $8,528 | $8,978 | | Total liabilities | $8,623 | $9,596 | | Total stockholders' deficit | $(6,057) | $(7,764) | [Consolidated Statements of Comprehensive Loss](index=6&type=section&id=Consolidated%20Statements%20of%20Comprehensive%20Loss) The company recorded a net loss of $2.90 million for Q2 2025 and $5.77 million for the six months ended June 30, 2025 Three Months Ended June 30 | Statement of Loss (in thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | | :--- | :--- | :--- | | Research and development, net | $1,120 | $922 | | General and administrative | $1,453 | $2,060 | | Operating loss | $(2,573) | $(2,982) | | Net loss | $(2,903) | $(2,541) | | Basic and diluted net loss per share | $(0.34) | $(0.60) | Six Months Ended June 30 | Statement of Loss (in thousands) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | Research and development, net | $2,424 | $1,883 | | General and administrative | $3,238 | $3,573 | | Operating loss | $(5,662) | $(5,456) | | Net loss | $(5,767) | $(5,942) | | Basic and diluted net loss per share | $(0.77) | $(1.35) | Company and Product Overview [About NurOwn®](index=3&type=section&id=About%20NurOwn%C2%AE) NurOwn® is an investigational autologous stem cell therapy designed to deliver neurotrophic factors to sites of damage - The NurOwn® technology platform uses **autologous MSC-NTF cells** produced from a patient's own bone marrow-derived mesenchymal stem cells (MSCs)[8](index=8&type=chunk) - MSCs are converted into MSC-NTF cells, which are induced to secrete high levels of **neurotrophic factors (NTFs)**[8](index=8&type=chunk) - The therapy aims to deliver NTFs and immunomodulatory cytokines to the site of damage to slow or stabilize disease progression[8](index=8&type=chunk) [About BrainStorm Cell Therapeutics Inc.](index=3&type=section&id=About%20BrainStorm%20Cell%20Therapeutics%20Inc.) BrainStorm is a clinical-stage biotech company developing autologous stem cell therapies for neurodegenerative diseases - BrainStorm is a leading developer of **autologous adult stem cell therapies** for debilitating neurodegenerative diseases[9](index=9&type=chunk) - The lead investigational therapy, NurOwn®, has completed a Phase 3 trial in ALS and is set to launch a **Phase 3b trial** under a Special Protocol Assessment (SPA) with the FDA[10](index=10&type=chunk) - The company is also advancing a proprietary, **allogeneic exosome-based platform** and recently received a Notice of Allowance for a foundational patent[10](index=10&type=chunk) Other Information [Conference Call Information](index=2&type=section&id=Conference%20Call%20Information) The company held a conference call on August 14, 2025, to discuss Q2 results, with a replay available until August 28 - A conference call and webcast were scheduled for **8:30 a.m. Eastern Time on Thursday, August 14, 2025**[1](index=1&type=chunk)[5](index=5&type=chunk) - A replay of the conference call will be available until **August 28**[5](index=5&type=chunk)[6](index=6&type=chunk) [Forward-Looking Statements](index=3&type=section&id=Forward-Looking%20Statements) This section cautions that the press release contains forward-looking statements subject to substantial risks and uncertainties - The press release contains forward-looking statements regarding the clinical development of NurOwn, potential regulatory approval, and the future success of the company[11](index=11&type=chunk) - These statements are subject to inherent uncertainties, risks, and assumptions that are difficult to predict, including the ability to **raise additional capital** and continue as a going concern[11](index=11&type=chunk)

Exhibit 99.1 NeuroOne Reports Third Quarter Fiscal Year 2025 Financial Results; Revenue Increases 105% YoY and Gross Margin Expands to 53.9% Completed Oversubscribed $8.2 Million Capital Raise; Funded Through At Least Fiscal Year 2026 EDEN PRAIRIE, Minn., August 14, 2025 -- NeuroOne Medical Technologies Corporation (Nasdaq: NMTC) ("NeuroOne" or the "Company"), a medical technology company dedicated to transforming the surgical diagnosis and treatment of neurological disorders, has reported financial results ...

EXHIBIT 99.1 CoreCard Corporation Reports Second Quarter 2025 Results NORCROSS, Ga., Aug. 14, 2025 (GLOBE NEWSWIRE) -- CoreCard Corporation (NYSE: CCRD) ("CoreCard" or the "Company"), the leading provider of innovative credit technology solutions and processing services to the financial technology and services market, announced today its financial results for the quarter ended June 30, 2025. Financial Highlights for the three months ended June 30, 2025 Total revenues in the three-month period ended June 30, ...

EXHIBIT 99.1 Cassava Reports Q2 2025 Financials Results and Provides Business Update AUSTIN, Texas, Aug. 14, 2025 (GLOBE NEWSWIRE) -- Cassava Sciences, Inc. (NASDAQ: SAVA, "Cassava", the "Company"), a biotechnology company focused on developing novel, investigational treatments for central nervous system (CNS) disorders such as Tuberous Sclerosis Complex (TSC)-related epilepsy, today reported financial results for the second quarter ended June 30, 2025 and provided a business update. Net loss was $44.2 mill ...

EX-99.1 3 ex991.htm PRESS RELEASE EXHIBIT 99.1 Edible Garden Delivers Strong Performance Across Core and Key Segments, Driven by Strategic Portfolio Transformation Company exits low-margin product lines, invests in higher-margin, innovative CEA-informed better-for-you shelf-stable products, and expands global reach Conference Call to Be Held Today at 8:00 am ET. BELVIDERE, NJ, August XX, 2025 — Edible Garden AG Incorporated ("Edible Garden" or the "Company") (Nasdaq: EDBL, EDBLW), a leader in controlled env ...

[Overview and Highlights](index=1&type=section&id=Xilio%20Therapeutics%20Announces%20Pipeline%20and%20Business%20Updates%20and%20Second%20Quarter%202025%20Financial%20Results) The company announced positive Phase 2 data, progress in its T cell engager programs, and a cash runway through Q3 2026 - Announced updated Phase 2 data for vilastobart at ASCO, demonstrating **deep, durable responses** and a **differentiated safety profile** for an anti-CTLA-4 combination therapy[1](index=1&type=chunk) - The company is **on track to nominate its first development candidates** for wholly owned masked T cell engager programs in the second half of 2025[1](index=1&type=chunk) Financial Position and Runway | Metric | Value | | :--- | :--- | | Cash and cash equivalents (as of June 30, 2025) | $121.6 million | | Anticipated cash runway | Through end of Q3 2026 | [Pipeline and Business Updates](index=1&type=section&id=Pipeline%20and%20Business%20Updates) The company reports progress across its key pipeline assets, including vilastobart, XTX301, XTX501, and masked T cell engagers [Vilastobart (anti-CTLA-4)](index=1&type=section&id=Vilastobart%3A%20tumor-activated%2C%20Fc-enhanced%2C%20high%20af%20inity%20binding%20anti-CTLA-4) Phase 2 data for vilastobart showed a 26% objective response rate in certain CRC patients with a well-tolerated safety profile - Updated Phase 2 data presented at ASCO 2025 demonstrated a preliminary **26% objective response rate (ORR)** in heavily pre-treated metastatic MSS CRC patients without liver metastases[3](index=3&type=chunk) - The therapy showed a **differentiated and well-tolerated safety profile**, with a low incidence of colitis and other immune-related adverse events[3](index=3&type=chunk) - Xilio is actively engaging with strategic partners for potential opportunities to **accelerate and expand the development** of vilastobart[3](index=3&type=chunk) [XTX301 (IL-12)](index=2&type=section&id=XTX301%3A%20tumor-activated%20IL-12) The company is advancing its tumor-activated IL-12, XTX301, under an exclusive license agreement with Gilead - Xilio has an **exclusive license agreement with Gilead Sciences** for its tumor-activated IL-12 program, including XTX301[4](index=4&type=chunk) - **Enrollment in the Phase 1A monotherapy dose escalation** portion of the clinical trial has been completed, with patient evaluation ongoing[4](index=4&type=chunk) [XTX501 (PD-1/IL-2 bispecific)](index=2&type=section&id=XTX501%3A%20masked%20PD-1%2FIL-2%20bispecific) The novel tumor-activated bispecific XTX501 is progressing through IND-enabling studies, with an IND submission planned for mid-2026 - XTX501 is currently **advancing in investigational new drug (IND)-enabling studies**[5](index=5&type=chunk) - The company plans to **submit an IND application for XTX501 in the middle of 2026**[5](index=5&type=chunk) [Masked T Cell Engager Programs](index=2&type=section&id=Masked%20T%20Cell%20Engager%20Programs) The company is developing multiple preclinical masked T cell engager programs using its proprietary ATACR and SEECR formats - The pipeline includes wholly owned programs targeting **PSMA, CLDN18.2, and STEAP1**, plus a collaboration with AbbVie[6](index=6&type=chunk) - The programs utilize two proprietary formats: the bispecific **ATACR** (activated cell engager) and the tri-specific **SEECR** (selective effector-enhanced cell engager)[7](index=7&type=chunk) [Corporate Updates](index=2&type=section&id=Corporate%20Updates) The company provided a development candidate timeline, closed a public offering, and appointed a new board member Development Candidate Nomination Timeline | Program | Format | Anticipated Nomination | | :--- | :--- | :--- | | PSMA | ATACR | Q3 2025 | | CLDN18.2 | ATACR | Q4 2025 | | STEAP1 | SEECR | H1 2026 | - In June 2025, Xilio closed a follow-on public offering, receiving initial gross proceeds of approximately **$50.0 million**, with potential for up to an additional **$100.0 million** if all associated warrants are exercised[9](index=9&type=chunk) - Akintunde (Tunde) Bello, Ph.D., was appointed to the company's board of directors in June 2025[9](index=9&type=chunk) [Second Quarter 2025 Financial Results](index=3&type=section&id=Second%20Quarter%202025%20Financial%20Results) The company reported increased revenue and operating expenses for Q2 2025 and provided financial guidance through Q3 2026 [Q2 2025 Financial Highlights](index=3&type=section&id=Q2%202025%20Financial%20Highlights) Collaboration revenue grew to $8.1 million while net loss increased to $15.8 million, with a strengthened cash position of $121.6 million Q2 2025 Financial Performance (vs. Q2 2024) | Metric | Q2 2025 | Q2 2024 | Change | | :--- | :--- | :--- | :--- | | Collaboration & License Revenue | $8.1M | $2.4M | +238% | | R&D Expenses | $15.3M | $11.2M | +37% | | G&A Expenses | $7.1M | $5.8M | +22% | | Net Loss | $15.8M | $13.9M | +14% | | Net Loss per Share | $(0.16) | $(0.24) | N/A | | Cash & Cash Equivalents (period end) | $121.6M | N/A | N/A | [Financial Guidance](index=3&type=section&id=Financial%20Guidance) The company's current cash position is expected to fund operations and capital expenditures through the end of Q3 2026 - The company expects its cash and cash equivalents as of June 30, 2025, to fund operating expenses and capital expenditure requirements **through the end of Q3 2026**[11](index=11&type=chunk) [Financial Statements](index=7&type=section&id=Financial%20Statements) The report includes condensed consolidated balance sheets and statements of operations for the period ending June 30, 2025 [Condensed Consolidated Balance Sheets](index=7&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets increased to $133.8 million driven by a rise in cash, while total liabilities grew to $126.7 million Balance Sheet Summary (in thousands) | Account | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $121,551 | $55,291 | | Total assets | $133,813 | $71,075 | | **Liabilities & Equity** | | | | Deferred revenue | $70,910 | $32,780 | | Common stock warrant liabilities | $38,550 | $0 | | Total liabilities | $126,744 | $53,477 | | Stockholders' equity | $7,069 | $17,598 | [Condensed Consolidated Statements of Operations](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) The company reported a net loss of $15.8 million for the three months ended June 30, 2025, on revenues of $8.1 million Statement of Operations Summary (in thousands) | Account | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | | :--- | :--- | :--- | | Collaboration and license revenue | $8,084 | $2,357 | | Research and development | $15,330 | $11,216 | | General and administrative | $7,120 | $5,815 | | Total operating expenses | $22,450 | $17,061 | | Loss from operations | $(14,366) | $(14,704) | | Net loss | $(15,844) | $(13,925) | | Net loss per share | $(0.16) | $(0.24) |

EXHIBIT 99.1 MiNK Therapeutics Reports Clinical and Strategic Milestones and Second Quarter 2025 Results NEW YORK, Aug. 14, 2025 (GLOBE NEWSWIRE) -- MiNK Therapeutics, Inc. (NASDAQ: INKT), a clinical-stage biopharmaceutical company pioneering allogeneic, off-the-shelf invariant natural killer T (iNKT) cell therapies, today announced financial results for the second quarter ended June 30, 2025, and provided a business update highlighting major clinical achievements, a strengthened balance sheet, and expanded ...

Advanced Flower Capital Inc. Announces Financial Results for the Second Quarter 2025 Second quarter 2025 GAAP net loss of $(13.2) million or $(0.60) per basic weighted average common share and Distributable Earnings of $3.4 million or $0.15 per basic weighted average common share (1) Announces Intention to Convert from Mortgage REIT to BDC WEST PALM BEACH, FL, August 14, 2025 – Advanced Flower Capital Inc. (Nasdaq: AFCG) ("Advanced Flower Capital", "AFC" or the "Company") today announced its results for the ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 (Exact Name of Registrant as Specified in its Charter) | Delaware | 85-4012572 | | --- | --- | | (State or other jurisdiction of | (I.R.S. Employer | | incorporation or organization) | Identification No.) | 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 June 30, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHAN ...