Edesa Biotech Reports Fiscal 1st Quarter 2025 Results
Edesa Biotech (NASDAQ:EDSA) reported its fiscal Q1 2025 results and provided business updates. The company is advancing EB06, an anti-CXCL10 monoclonal antibody for vitiligo treatment, with FDA data submission planned for mid-2025. A Phase 2 study for moderate-to-severe nonsegmental vitiligo patients is anticipated, with topline results expected 12-18 months after FDA clearance.
Financial highlights include unchanged total operating expenses at $1.9 million, with R&D expenses increasing to $1.0 million and G&A expenses decreasing to $0.9 million. The company reported a net loss of $1.6 million ($0.48 per share) compared to $1.7 million ($0.54 per share) in the previous year. Post-quarter, Edesa secured $15.0 million in gross proceeds through a private placement of preferred and common shares.
Edesa Biotech (NASDAQ:EDSA) ha riportato i risultati finanziari del primo trimestre fiscale 2025 e fornito aggiornamenti aziendali. L'azienda sta sviluppando EB06, un anticorpo monoclonale anti-CXCL10 per il trattamento del vitiligine, con una presentazione dei dati all'FDA prevista per metà 2025. È atteso uno studio di Fase 2 per pazienti con vitiligine non segmentale da moderata a grave, con risultati preliminari attesi tra 12 e 18 mesi dopo l'approvazione dell'FDA.
I punti salienti finanziari includono spese operative totali invariati a $1.9 milioni, con le spese per ricerca e sviluppo aumentate a $1.0 milioni e le spese generali e amministrative diminuite a $0.9 milioni. L'azienda ha riportato una perdita netta di $1.6 milioni ($0.48 per azione) rispetto a $1.7 milioni ($0.54 per azione) dell'anno precedente. Dopo il trimestre, Edesa ha ottenuto $15.0 milioni di proventi lordi attraverso un collocamento privato di azioni privilegiate e comuni.
Edesa Biotech (NASDAQ:EDSA) informó sus resultados financieros del primer trimestre fiscal 2025 y proporcionó actualizaciones comerciales. La compañía está avanzando en EB06, un anticuerpo monoclonal anti-CXCL10 para el tratamiento del vitiligo, con la presentación de datos a la FDA prevista para mediados de 2025. Se anticipa un estudio de Fase 2 para pacientes con vitiligo no segmentario de moderado a severo, con resultados preliminares esperados entre 12 y 18 meses después de la aprobación de la FDA.
Los aspectos financieros destacados incluyen gastos operativos totales sin cambios de $1.9 millones, con gastos de I+D aumentando a $1.0 millones y gastos generales y administrativos disminuyendo a $0.9 millones. La compañía reportó una pérdida neta de $1.6 millones ($0.48 por acción) en comparación con $1.7 millones ($0.54 por acción) el año anterior. Después del trimestre, Edesa aseguró $15.0 millones en ingresos brutos a través de una colocación privada de acciones preferentes y comunes.
Edesa Biotech (NASDAQ:EDSA)는 2025 회계연도 1분기 실적을 발표하고 사업 업데이트를 제공했습니다. 이 회사는 백반증 치료를 위한 항-CXCL10 단일클론 항체인 EB06를 개발 중이며, 2025년 중반에 FDA 데이터 제출을 계획하고 있습니다. 중등도에서 중증 비분절 백반증 환자를 위한 2상 연구가 예상되며, FDA 승인이 난 후 12-18개월 내에 주요 결과가 나올 것으로 기대됩니다.
재무 하이라이트에는 총 운영 비용이 $1.9백만으로 변동이 없고, 연구개발 비용이 $1.0백만으로 증가하며, 일반 관리 비용이 $0.9백만으로 감소한 것이 포함됩니다. 회사는 지난해 $1.7백만 ($0.54 per 주)와 비교하여 $1.6백만 ($0.48 per 주)의 순손실을 보고했습니다. 분기 후, Edesa는 우선주 및 보통주 사모 배치를 통해 $15.0백만의 총 수익을 확보했습니다.
Edesa Biotech (NASDAQ:EDSA) a publié ses résultats financiers du premier trimestre de l'exercice 2025 et a fourni des mises à jour sur ses activités. L'entreprise progresse avec EB06, un anticorps monoclonal anti-CXCL10 pour le traitement du vitiligo, avec une soumission de données à la FDA prévue pour la mi-2025. Une étude de phase 2 pour des patients atteints de vitiligo non segmentaire modéré à sévère est anticipée, avec des résultats préliminaires attendus 12 à 18 mois après l'approbation de la FDA.
Les points forts financiers incluent des dépenses d'exploitation totales inchangées à 1,9 million de dollars, avec des dépenses de R&D augmentant à 1,0 million de dollars et des dépenses générales et administratives diminuant à 0,9 million de dollars. L'entreprise a enregistré une perte nette de 1,6 million de dollars (0,48 $ par action) par rapport à 1,7 million de dollars (0,54 $ par action) l'année précédente. Après le trimestre, Edesa a sécurisé 15,0 millions de dollars de produits bruts grâce à un placement privé d'actions privilégiées et ordinaires.
Edesa Biotech (NASDAQ:EDSA) hat seine finanziellen Ergebnisse für das erste Quartal des Geschäftsjahres 2025 veröffentlicht und Geschäftsaktualisierungen bereitgestellt. Das Unternehmen entwickelt EB06, einen anti-CXCL10-Monoklonalen Antikörper zur Behandlung von Vitiligo, mit einer Datenübermittlung an die FDA, die für Mitte 2025 geplant ist. Eine Phase-2-Studie für Patienten mit moderater bis schwerer nicht-segmentaler Vitiligo wird erwartet, wobei die vorläufigen Ergebnisse 12-18 Monate nach der Genehmigung durch die FDA erwartet werden.
Die finanziellen Highlights umfassen unveränderte Gesamtausgaben von 1,9 Millionen US-Dollar, während die F&E-Ausgaben auf 1,0 Millionen US-Dollar gestiegen sind und die allgemeinen und administrativen Ausgaben auf 0,9 Millionen US-Dollar gesunken sind. Das Unternehmen berichtete von einem Nettoverlust von 1,6 Millionen US-Dollar (0,48 US-Dollar pro Aktie) im Vergleich zu 1,7 Millionen US-Dollar (0,54 US-Dollar pro Aktie) im Vorjahr. Nach dem Quartal sicherte sich Edesa 15,0 Millionen US-Dollar an Bruttoeinnahmen durch eine Privatplatzierung von Vorzugs- und Stammaktien.
- Secured $15.0 million in gross proceeds from private placement
- Reduced net loss per share from $0.54 to $0.48 year-over-year
- EB05 development fully funded by U.S. government
- Decreased G&A expenses by $0.3 million
- Operating loss of $1.6 million in Q1 2025
- Low working capital of $0.2 million as of December 31, 2024
- Increased R&D expenses by $0.3 million
Insights
The Q1 FY2025 results present a strategically significant period for Edesa Biotech, marked by careful cost management and a transformative
The working capital position has improved dramatically post-quarter end. From a concerning
A particularly astute strategic element is the U.S. government's full funding of the EB05 program, effectively creating a 'free option' for shareholders while allowing management to concentrate resources on the potentially lucrative vitiligo market. This arrangement optimizes capital allocation and reduces development risk across the portfolio.
The vitiligo program represents a compelling market opportunity, targeting an underserved condition affecting millions globally. The lack of systemic treatments addressing the underlying disease mechanism creates a significant market gap. EB06's positioning as a targeted immunotherapy, potentially offering advantages over existing JAK inhibitors, could represent substantial commercial potential if successful in clinical trials.
TORONTO, Feb. 14, 2025 (GLOBE NEWSWIRE) -- Edesa Biotech, Inc. (Nasdaq:EDSA), a clinical-stage biopharmaceutical company focused on developing host-directed therapeutics for immuno-inflammatory diseases, today reported financial results for the three months ended December 31, 2024 and provided an update on its business.
During the quarter, the company advanced its main asset, EB06, an anti-CXCL10 monoclonal antibody candidate being developed for the effective and durable treatment of vitiligo. Preparation for the manufacturing campaign is underway, with data anticipated to be submitted to regulators at the U.S. Food and Drug Administration (FDA) during the middle of 2025. The company intends to pursue an investigational new drug (IND) application for a Phase 2 study in moderate-to-severe nonsegmental vitiligo patients. Edesa anticipates topline results could be available within as few as 12 to 18 months following regulatory clearance by the FDA. Health Canada has previously granted approval to initiate this Phase 2 clinical study. The company also reported recently that the development of its anti-TLR4 drug candidate, EB05 (paridiprubart), is fully funded by the U.S. government in a Phase 2 study investigating novel threat-agnostic host-directed therapeutics. As a result of this trial being sponsored and run by the U.S. government, Edesa can prioritize the development of EB06 as a vitiligo therapy.
“Our goal is to be in a position to rapidly launch our vitiligo clinical trial following regulatory clearance,” said Par Nijhawan, MD, Chief Executive Officer of Edesa Biotech. “Vitiligo significantly impacts the lives of millions worldwide, yet there are no approved drugs that address the systemic nature of the disease. We believe that a targeted immunotherapy, like EB06, that interrupts the disease process on a key point in vitiligo pathogenesis (further downstream from JAK inhibitors) could offer a safe and efficacious treatment.”
Edesa's Chief Financial Officer Stephen Lemieux reported that financial results for the first quarter of fiscal year 2025 were in line with management’s expectations and benefited from a subsequent equity financing. "With a stronger balance sheet, which includes
Financial Results for the Three Months Ended December 31, 2024
Total operating expenses were unchanged at
- Research and development expenses increased by
$0.3 million to$1.0 million for the three months ended December 31, 2024 compared to$0.7 million for the same period last year primarily due to increased external research expenses related to manufacturing the company’s investigational drug, paridiprubart. - General and administrative expenses decreased by
$0.3 million to$0.9 million for the three months ended December 31, 2024 compared to$1.2 million for the same period last year primarily due to a decrease in salaries and related costs, noncash share-based compensation and professional service fees.
Total other income increased by
For the quarter ended December 31, 2024, Edesa reported a net loss of
Working Capital
At December 31, 2024, Edesa had cash and cash equivalents of
Calendar
Edesa plans to participate in the American Academy of Dermatology Annual Meeting from March 7- 11, 2025, BIO Europe Spring 2025 from March 17-19, 2025, and the H.C. Wainwright Autoimmune & Inflammatory Disease Virtual Conference on March 27, 2025. Attendees interested in meeting with company representatives can request meetings through the conference organizers or by contacting Edesa directly at investors@edesabiotech.com.
About Edesa Biotech, Inc.
Edesa Biotech, Inc. (Nasdaq: EDSA) is a clinical-stage biopharmaceutical company developing innovative ways to treat inflammatory and immune-related diseases. Its clinical pipeline is focused on two therapeutic areas: Medical Dermatology and Respiratory. In Medical Dermatology, Edesa is developing EB06, an anti-CXCL10 monoclonal antibody candidate, as therapy for vitiligo, a common autoimmune disorder that causes skin to lose its color in patches. Its medical dermatology assets also include EB01 (
Edesa Forward-Looking Statements
This press release may contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements may be identified by the use of words such as "anticipate," "believe," "plan," "estimate," "expect," "intend," "may," "will," "would," "could," "should," "might," "potential," or "continue" and variations or similar expressions, including statements related to: the company’s preparations for a manufacturing campaign of its anti- CXCL10 monoclonal antibody candidate with data anticipated to be submitted to regulators at the FDA during the middle of 2025; the company’s plans to submit data from the planned manufacturing campaign will U.S. regulators as part of an IND application for a Phase 2 study in vitiligo patients; the company’s anticipation that topline results could be available within as few as 12 to 18 months following regulatory clearance in the U.S; the company’s plans for future funding to support the vitiligo development program; the company’s plans to redeploy more resources to its vitiligo drug development program; the company’s goal to be in a position to rapidly launch its vitiligo clinical trial following regulatory clearance; the company’s belief that a targeted immunotherapy, like EB06, that interrupts the disease process on a key point in vitiligo pathogenesis (further downstream from JAK inhibitors) could offer a safe and efficacious treatment; the company’s belief that first quarter results were in line with management’s expectations, and benefited from a subsequent equity financing; the company’s belief that with a stronger balance sheet, which includes
Contact:
Gary Koppenjan
Edesa Biotech, Inc.
(289) 800-9600
investors@edesabiotech.com
| Condensed Interim Consolidated Statements of Operations | |||||||||
| (Unaudited) | |||||||||
| Three Months Ended | |||||||||
| December 31, 2024 | December 31,2023 | ||||||||
| Expenses: | |||||||||
| Research and development | 1,019,818 | 704,458 | |||||||
| General and administrative | 878,871 | 1,152,971 | |||||||
| Loss from operations | (1,898,689 | ) | (1,857,429 | ) | |||||
| Other Income (Loss): | |||||||||
| Reimbursement grant income | 301,195 | 120,834 | |||||||
| Other income (loss) | (19,759 | ) | 58,144 | ||||||
| Net loss | (1,617,253 | ) | (1,678,451 | ) | |||||
| Exchange differences on translation | 18,656 | (572 | ) | ||||||
| Net comprehensive loss | $ | (1,598,597 | ) | $ | (1,679,023 | ) | |||
| Weighted average number of common shares | 3,345,135 | 3,128,024 | |||||||
| Loss per common share - basic and diluted | $ | (0.48 | ) | $ | (0.54 | ) | |||
| Condensed Interim Consolidated Balance Sheets | |||||||
| (Unaudited) | |||||||
| December 31, 2024 | September 30, 2024 | ||||||
| Assets: | |||||||
| Cash and cash equivalents | $ | 1,563,502 | $ | 1,037,320 | |||
| Other current assets | 508,426 | 638,302 | |||||
| Non-current assets | 2,092,253 | 2,138,360 | |||||
| Total Assets | $ | 4,164,181 | $ | 3,813,982 | |||
| Liabilities and shareholders' equity: | |||||||
| Current liabilities | $ | 1,900,219 | $ | 1,832,827 | |||
| Shareholders' equity | 2,263,962 | 1,981,155 | |||||
| Total liabilities and shareholders' equity | $ | 4,164,181 | $ | 3,813,982 | |||
| Condensed Interim Consolidated Statements of Cash Flows | |||||||||
| (Unaudited) | |||||||||
| Three Months Ended | |||||||||
| December 31, 2024 | December 31,2023 | ||||||||
| Cash flows from operating activities: | |||||||||
| Net loss | $ | (1,617,253 | ) | $ | (1,678,451 | ) | |||
| Adjustments for non-cash items | 124,292 | 229,388 | |||||||
| Change in working capital items | (24,242 | ) | 42,535 | ||||||
| Net cash used in operating activities | (1,517,203 | ) | (1,406,528 | ) | |||||
| Net cash provided by financing activities | 2,071,545 | 305,742 | |||||||
| Effect of exchange rate changes on cash and cash equivalents | (28,160 | ) | 7,176 | ||||||
| Net change in cash and cash equivalents | 526,182 | (1,093,610 | ) | ||||||
| Cash and cash equivalents, beginning of period | 1,037,320 | 5,361,397 | |||||||
| Cash and cash equivalents, end of period | $ | 1,563,502 | $ | 4,267,787 | |||||
FAQ
What were Edesa Biotech's (EDSA) Q1 2025 financial results?
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