Galectin Therapeutics Reports Financial Results for the Quarter Ended June 30, 2025 and Provides Business Update
Galectin Therapeutics (NASDAQ:GALT) reported Q2 2025 financial results and provided updates on their NAVIGATE trial for belapectin in MASH cirrhosis patients. The company ended Q2 with $13.8 million in cash and secured an additional $10 million credit line from its chairman in July 2025.
Key financial metrics include a reduced net loss of $7.6 million ($0.12 per share) compared to $12.4 million in Q2 2024, and significantly lower R&D expenses of $3.3 million vs $9.8 million year-over-year. The company presented promising NAVIGATE trial results at EASL 2025, showing sustained efficacy in reducing liver stiffness and fewer patients experiencing clinically meaningful worsening in the belapectin arm.
Galectin Therapeutics (NASDAQ:GALT) ha reso noti i risultati finanziari del Q2 2025 e ha fornito aggiornamenti sullo studio NAVIGATE riguardante belapectin nei pazienti con cirrosi da MASH. La società ha chiuso il secondo trimestre con $13.8 million in cash e ha ottenuto a luglio 2025 una linea di credito aggiuntiva di $10 million dal suo presidente.
Le principali metriche finanziarie includono una perdita netta ridotta a $7.6 million ($0.12 per azione) rispetto a $12.4 million nel Q2 2024, e costi di R&S significativamente inferiori, $3.3 million vs $9.8 million su base annua. Alla EASL 2025 la società ha presentato risultati promettenti dello studio NAVIGATE, che mostrano un'efficacia sostenuta nella riduzione della rigidità epatica e un numero inferiore di pazienti che hanno sperimentato un peggioramento clinicamente significativo nel braccio trattato con belapectin.
Galectin Therapeutics (NASDAQ:GALT) informó los resultados financieros del Q2 2025 y ofreció novedades sobre el ensayo NAVIGATE de belapectin en pacientes con cirrosis por MASH. La compañía cerró el trimestre con $13.8 million in cash y aseguró en julio de 2025 una línea de crédito adicional de $10 million de su presidente.
Las métricas clave incluyen una pérdida neta reducida de $7.6 million ($0.12 por acción) frente a $12.4 million en el Q2 2024, y gastos de I+D notablemente menores, $3.3 million vs $9.8 million interanuales. En EASL 2025 la compañía presentó resultados prometedores del ensayo NAVIGATE, que muestran una eficacia sostenida en la reducción de la rigidez hepática y menos pacientes con un empeoramiento clínicamente significativo en el brazo de belapectin.
Galectin Therapeutics (NASDAQ:GALT)는 2025년 2분기 실적을 발표하고 MASH에 의한 간경변 환자 대상 belapectin의 NAVIGATE 임상 업데이트를 공개했습니다. 회사는 2분기 말에 $13.8 million in cash을 보유했으며 2025년 7월 회장으로부터 추가 $10 million의 신용한도를 확보했습니다.
주요 재무 지표로는 순손실이 $7.6 million ($0.12/주)로 감소하여 2024년 2분기의 $12.4 million에 비해 개선되었고, 연구개발비도 연간 기준으로 크게 줄어 $3.3 million vs $9.8 million을 기록했습니다. 회사는 EASL 2025에서 NAVIGATE의 유망한 결과를 발표했으며, 간 경직도 감소 효과가 지속되고 belapectin 군에서 임상적으로 의미 있는 악화를 겪은 환자 수가 더 적었다고 보고했습니다.
Galectin Therapeutics (NASDAQ:GALT) a publié ses résultats financiers du Q2 2025 et a donné des nouvelles de l'essai NAVIGATE sur le belapectin chez des patients atteints de cirrhose liée au MASH. La société a clôturé le trimestre avec $13.8 million in cash et a obtenu en juillet 2025 une ligne de crédit supplémentaire de $10 million auprès de son président.
Les indicateurs clés montrent une perte nette réduite à $7.6 million ($0.12 par action) contre $12.4 million au Q2 2024, et des dépenses de R&D nettement inférieures, $3.3 million vs $9.8 million en glissement annuel. Lors de l'EASL 2025, la société a présenté des résultats prometteurs de l'essai NAVIGATE, montrant une efficacité soutenue pour réduire la rigidité hépatique et moins de patients ayant une dégradation cliniquement significative dans le bras belapectin.
Galectin Therapeutics (NASDAQ:GALT) veröffentlichte die Finanzergebnisse für Q2 2025 und gab Updates zur NAVIGATE-Studie mit belapectin bei MASH-bedingter Zirrhose. Das Unternehmen schloss das zweite Quartal mit $13.8 million in cash ab und sicherte sich im Juli 2025 eine zusätzliche $10 million Kreditlinie von seinem Vorsitzenden.
Wesentliche Kennzahlen zeigen einen reduzierten Nettoverlust von $7.6 million ($0.12 je Aktie) gegenüber $12.4 million im Q2 2024 sowie deutlich niedrigere F&E-Aufwendungen von $3.3 million vs $9.8 million im Jahresvergleich. Auf der EASL 2025 präsentierte das Unternehmen vielversprechende NAVIGATE-Daten, die eine anhaltende Wirksamkeit bei der Reduktion der Lebersteifigkeit und weniger Patienten mit klinisch bedeutsamer Verschlechterung in der belapectin-Gruppe zeigen.
- Secured additional $10 million credit line to fund operations through June 2026
- Significant reduction in R&D expenses from $9.8M to $3.3M year-over-year
- Reduced net loss from $12.4M to $7.6M compared to previous year
- Positive clinical data showing sustained efficacy of belapectin in NAVIGATE trial
- Continued net losses of $7.6 million in Q2 2025
- Reliance on chairman financing for operational funding
- Limited cash runway only through June 2026
Insights
Galectin's belapectin shows promising sustained efficacy in MASH cirrhosis while securing funding through 2026 despite narrowing losses.
Galectin Therapeutics' Q2 2025 results reveal encouraging progress for their lead candidate belapectin in treating MASH cirrhosis with portal hypertension. The updated NAVIGATE trial data presented at EASL demonstrates clinically significant responses in Fibroscan® measurements, a key biomarker for liver disease progression. Particularly notable is the sustained efficacy in reducing liver stiffness beyond the initial 18-month treatment period, suggesting belapectin's potential as a disease-modifying therapy for this high-risk population.
The data shows that patients receiving the 2mg belapectin dose experienced lower incidence of both liver stiffness progression and varices compared to placebo. This is clinically meaningful because increasing liver stiffness strongly predicts future liver-related complications. The consistency between Fibroscan® improvements and reduced esophageal varices incidence strengthens the overall evidence supporting belapectin's mechanism of action.
On the financial front, Galectin reported cash reserves of
The company has positioned itself at a critical juncture, planning FDA engagement to discuss potential next steps while simultaneously exploring strategic partnership opportunities. The supportive statements from two key opinion leaders reinforce the scientific credibility of belapectin's potential in addressing an unmet medical need in MASH cirrhosis with portal hypertension.
Galectin's Q2 shows 66% R&D cost reduction and extended runway through 2026, positioning for FDA discussions and potential partnerships.
Galectin's Q2 2025 financial results demonstrate significant cost containment following the completion of their NAVIGATE trial. R&D expenses dropped dramatically to
The company reported a quarterly net loss of
Liquidity position appears adequate with
The completion of the NAVIGATE trial represents a critical inflection point for Galectin. The company now has a complete dataset to present to the FDA and potential partners, with promising efficacy signals in liver stiffness reduction and prevention of esophageal varices. The mention of "exploring strategic partnership opportunities" suggests the company is actively seeking commercial validation and additional capital through potential licensing or collaboration agreements, which could significantly transform its financial outlook.
With planned FDA engagement later this year, Galectin is positioning belapectin as a potential first-in-class treatment for MASH cirrhosis with portal hypertension, addressing a significant market opportunity with limited current treatment options.
NORCROSS, Ga., Aug. 14, 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 and six months ended June 30, 2025.
Joel Lewis, Chief Executive Officer and President of Galectin Therapeutics, stated “We are encouraged by the continued analysis of data from our NAVIGATE trial , which further supports the clinical profile of belapectin in patients with MASH cirrhosis. At the European Association for the Study of the Liver (EASL) in May, we presented a clinically significant response in Fibroscan® (a key biomarker in MASH) and additional Fibroscan® data outcomes supporting the NAVIGATE trial’s primary endpoint, the prevention of esophageal varices after 18 months of treatment with belapectin. We believe it is especially promising that these findings remain robust in patients who received belapectin beyond 18 months, reinforcing our belief in the potential of belapectin to modify disease progression in this high-risk population. We are also analyzing additional biomarkers and expect to present those results later this year.”
“In June, we hosted a webcast featuring two prominent key opinion leaders, Dr. Naga Chalasani and Dr. Naim Alkhouri, who provided valuable insight into the NAVIGATE data and evolving treatment landscape. Looking ahead, we remain focused on engaging with the U.S Food and Drug Administration later this year to discuss potential next steps for our program, while also continuing to explore strategic partnership opportunities.
As stated previously, we continue to believe that belapectin has the potential to offer a much-needed new treatment option for the growing number of patients with MASH-associated liver cirrhosis and portal hypertension — a significant area of unmet medical need. Lastly, I again thank Mr. Richard E. Uihlein, our chairman, for his continued support through the additional
Khurram Jamil, M.D., Chief Medical Officer, added, “The 18-month analysis showed a lower incidence of both liver stiffness progression and varices in the 2 mg belapectin arm compared to placebo — an encouraging signal, given that increasing liver stiffness is a well-established predictor of liver-related complications.
We are pleased that these effects were maintained in patients who continued into the second 18-month treatment period. Using all available data and LOCF (Last Observation Carried Forward) methodology, the updated analysis confirms less progression in the belapectin group, further supporting FibroScan® as a meaningful predictive biomarker in this setting.”
Recent Highlights
- In June, Galectin hosted a KOL event featuring two key opinion leaders, Dr. Naga Chalasani and Dr. Naim Alkhouri, who discussed NAVIGATE trial results and the unmet need and current treatment landscape for metabolic dysfunction-associated steatohepatitis (MASH) cirrhosis and portal hypertension.
- In May, Galectin presented NAVIGATE trial results at the European Association for the Study of the Liver (EASL) 2025 Congress. The updated analysis includes subjects who completed the 18 months of treatment, had an endoscopy assessment (i.e., completers) and had at least one FibroScan® assessment during the stage 2 portion of the study. As a reminder, while endoscopy assessments were conducted at months 18 and 36, FibroScan® evaluations were performed every six months throughout the study.
- Belapectin shows sustained efficacy in reducing liver stiffness: In patients who entered the second 18 months of treatment, belapectin 2 mg continued to significantly reduce progression in liver stiffness compared to placebo. Using the LOCF (Last Observation Carried Forward) method, the analysis confirms the durability of effect beyond the initial 18-month period.
- Fewer patients experienced clinically meaningful worsening: A lower proportion of patients in the belapectin arm had >5 kPa or >
30% increases in liver stiffness from baseline, reinforcing the drug’s ability to slow disease progression. This was consistent across both thresholds, as assessed using LOCF. - Liver stiffness outcomes align with reduced varices incidence: The updated FibroScan® findings mirror previously reported reductions in esophageal varices, supporting belapectin’s potential to reduce the risk of portal hypertension-related complications.
- Longitudinal FibroScan® data strengthens clinical confidence: Regular assessments every six months, combined with LOCF methodology, provided a robust dataset across both phases of treatment, enhancing confidence in the consistency and durability of the observed biomarker trends.
Q2 2025 Financial Highlights
- As of June 30, 2025, the Company had
$13.8 million of cash and cash equivalents. Additionally, on July 8, 2025, the Company entered into a new$10 million line of credit provided by its chairman of the board to fund operations. The Company believes it has sufficient cash to fund currently planned operations and research and development activities through June 30, 2026. - Research and development expenses for the quarter ended June 30, 2025 were
$3.3 million compared with$9.8 million for the same period in 2024. The decrease was primarily due to timing of incurrence of expenditures related to our NAVIGATE clinical trial which ended in the first quarter of 2025. - General and administrative expenses for the quarter ended June 30, 2025 were
$1.4 million , compared to$1.5 million for the quarter ended quarter ended June 30, 2024. - For the quarter ended June 30, 2025, the Company reported a net loss applicable to common stockholders of
$7.6 million , or ($0.12) per share, compared to a net loss applicable to common stockholders of$12.4 million , or ($0.20) per share for the quarter ended March 31, 2024. - These results are included in the Company's Quarterly Report on Form 10-Q as of and for the period ended June 30, 2025, which has been filed with the U.S. Securities and Exchange Commission and is available at www.sec.gov.
About Galectin Therapeutics
Galectin Therapeutics is dedicated to developing novel therapies to improve the lives of patients with chronic liver disease and cancer. Galectin’s lead drug belapectin is a carbohydrate-based drug that inhibits the galectin-3 protein, which is directly involved in multiple inflammatory, fibrotic, and malignant diseases, for which it has Fast Track designation by the U.S. Food and Drug Administration. The lead development program is in metabolic dysfunction-associated steatohepatitis (MASH) with cirrhosis, the most advanced form of MASH-related fibrosis. Liver cirrhosis is one of the most pressing medical needs and a significant drug development opportunity. Additional development programs are in treatment of combination immunotherapy for advanced head and neck cancers and other malignancies. Advancement of these additional clinical programs is largely dependent on finding a suitable partner. Galectin seeks to leverage extensive scientific and development expertise as well as established relationships with external sources to achieve cost-effective and efficient development. Additional information is available at www.galectintherapeutics.com.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements relate to future events or future financial performance, and use words such as “may,” “estimate,” “could,” “expect”, “look forward”, “believe”, “hope” and others. They are based on management’s current expectations and are subject to factors and uncertainties that could cause actual results to differ materially from those described in the statements. These statements include those regarding the hope that Galectin’s development program for belapectin will lead to the first therapy for the treatment of MASH with cirrhosis and those regarding the hope that our lead compounds will be successful in cancer immunotherapy and in other therapeutic indications. Factors that could cause actual performance to differ materially from those discussed in the forward-looking statements include, among others, full analysis of the NAVIGATE trial data may not produce positive data; Galectin may not be successful in developing effective treatments and/or obtaining the requisite approvals for the use of belapectin or any of its other drugs in development; the Company may not be successful in scaling up manufacturing and meeting requirements related to chemistry, manufacturing and control matters; the Company’s current clinical trial and any future clinical studies may not produce positive results in a timely fashion, if at all, and could require larger and longer trials, which would be time consuming and costly; plans regarding development, approval and marketing of any of Galectin’s drugs are subject to change at any time based on the changing needs of the Company as determined by management and regulatory agencies; regardless of the results of any of its development programs, Galectin may be unsuccessful in developing partnerships with other companies or raising additional capital that would allow it to further develop and/or fund any studies or trials. Galectin has incurred operating losses since inception, and its ability to successfully develop and market drugs may be impacted by its ability to manage costs and finance continuing operations. For a discussion of additional factors impacting Galectin’s business, see the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, and subsequent filings with the SEC. You should not place undue reliance on forward-looking statements. Although subsequent events may cause its views to change, management disclaims any obligation to update forward-looking statements.
Company Contact:
Jack Callicutt, Chief Financial Officer
(678) 620-3186
ir@galectintherapeutics.com
Investors Relations Contacts:
Kevin Gardner
kgardner@lifesciadvisors.com
Galectin Therapeutics and its associated logo is a registered trademark of Galectin Therapeutics Inc. Belapectin is the USAN assigned name for Galectin Therapeutics’ galectin-3 inhibitor belapectin.
Condensed Consolidated Statements of Operations
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||
| (in thousands, except per share data) | ||||||||||||
| Operating expenses: | ||||||||||||
| Research and development | $ | 3,261 | $ | 9,813 | $ | 9,746 | $ | 17,867 | ||||
| General and administrative | 1,364 | 1,478 | 2,776 | 3,072 | ||||||||
| Total operating expenses | 4,625 | 11,291 | 12,522 | 20,939 | ||||||||
| Total operating loss | (4,625 | ) | (11,291 | ) | (12,522 | ) | (20,939 | ) | ||||
| Other income (expense): | ||||||||||||
| Interest income | 26 | 80 | 62 | 160 | ||||||||
| Interest expense | (1,826 | ) | (1,269 | ) | (3,570 | ) | (2,321 | ) | ||||
| Change in fair value of derivative | (1,096 | ) | 109 | (1,122 | ) | (760 | ) | |||||
| Total other income | (2,896 | ) | (1,080 | ) | (4,630 | ) | (2,921 | ) | ||||
| Net loss | $ | (7,521 | ) | $ | (12,371 | ) | $ | (17,152 | ) | $ | (23,860 | ) |
| Preferred stock dividends | (63 | ) | (64 | ) | (37 | ) | (72 | ) | ||||
| Warrant modification | ||||||||||||
| Net loss applicable to common stock | $ | (7,584 | ) | $ | (12,435 | ) | $ | (17,189 | ) | $ | (23,932 | ) |
| Basic and diluted net loss per share | $ | (0.12 | ) | $ | (0.20 | ) | $ | (0.27 | ) | $ | (0.39 | ) |
| Shares used in computing basic and diluted net loss per share | 63,447 | 62,233 | 63,326 | 62,104 | ||||||||
Condensed Consolidated Balance Sheet Data
| June 30, 2025 | December 31, 2024 | |||||
| (in thousands) | ||||||
| Cash and cash equivalents …… | $ | 13,771 | $ | 15,120 | ||
| Total assets……………………...… | 15,602 | 17,495 | ||||
| Total current liabilities…..….. | 10,774 | 35,409 | ||||
| Total liabilities.………………..….. | 132,769 | 120,565 | ||||
| Total redeemable, convertible preferred stock…. | 1,723 | 1,723 | ||||
| Total stockholders’ equity (deficit) ….. | $ | (118,890 | ) | $ | (104,793 | ) |
FAQ
What were Galectin Therapeutics (GALT) Q2 2025 financial results?
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