Edesa Biotech Reports Fiscal Year 2024 Results
Edesa Biotech (NASDAQ:EDSA) reported fiscal year 2024 results, highlighting a strategic pivot of its anti-TLR4 drug candidate (EB05) to a U.S. government-funded study for ARDS treatment. The company reduced operating expenses by over 20%, with total expenses decreasing to $7.0 million from $9.2 million year-over-year. Research and development expenses fell to $2.9 million from $4.8 million.
The company reported a net loss of $6.2 million ($1.93 per share) compared to $8.4 million ($2.93 per share) in the previous year. As of September 30, 2024, Edesa had $1.0 million in cash and negative working capital of $0.2 million. Post-fiscal year, the company secured $1.5 million from its CEO-affiliated entity and $0.6 million through an at-the-market offering.
Edesa Biotech (NASDAQ:EDSA) ha riportato i risultati dell'anno fiscale 2024, evidenziando una svolta strategica del suo candidato farmaco anti-TLR4 (EB05) verso uno studio finanziato dal governo degli Stati Uniti per il trattamento dell'ARDS. L'azienda ha ridotto le spese operative di oltre il 20%, con spese totali che sono diminuite a 7 milioni di dollari rispetto ai 9,2 milioni dell'anno precedente. Le spese per ricerca e sviluppo sono scese a 2,9 milioni di dollari da 4,8 milioni.
L'azienda ha riportato una perdita netta di 6,2 milioni di dollari (1,93 dollari per azione) rispetto agli 8,4 milioni di dollari (2,93 dollari per azione) dell'anno precedente. Al 30 settembre 2024, Edesa aveva 1 milione di dollari in cassa e un capitale circolante negativo di 0,2 milioni di dollari. Dopo l'anno fiscale, l'azienda ha ottenuto 1,5 milioni di dollari da un'entità affiliata al suo CEO e 0,6 milioni di dollari attraverso un'offerta sul mercato.
Edesa Biotech (NASDAQ:EDSA) reportó los resultados del año fiscal 2024, destacando un cambio estratégico de su candidato a fármaco anti-TLR4 (EB05) hacia un estudio financiado por el gobierno de EE.UU. para el tratamiento del ARDS. La compañía redujo los gastos operativos en más del 20%, con gastos totales disminuyendo a 7,0 millones de dólares desde 9,2 millones interanualmente. Los gastos en investigación y desarrollo cayeron a 2,9 millones de dólares desde 4,8 millones.
La compañía reportó una pérdida neta de 6,2 millones de dólares (1,93 dólares por acción) en comparación con 8,4 millones de dólares (2,93 dólares por acción) en el año anterior. Al 30 de septiembre de 2024, Edesa tenía 1,0 millones de dólares en efectivo y un capital de trabajo negativo de 0,2 millones de dólares. Posteriormente al año fiscal, la compañía aseguró 1,5 millones de dólares de una entidad afiliada a su CEO y 0,6 millones de dólares a través de una oferta en el mercado.
Edesa Biotech (NASDAQ:EDSA)는 2024 회계연도 결과를 발표하며, ARDS 치료를 위한 미국 정부 자금 지원 연구로의 항-TLR4 약물 후보(EB05)의 전략적 전환을 강조했습니다. 이 회사는 운영 비용을 20% 이상 줄였으며, 총 비용은 작년의 9.2백만 달러에서 7.0백만 달러로 감소했습니다. 연구 및 개발 비용은 4.8백만 달러에서 2.9백만 달러로 줄어들었습니다.
회사는 전년 대비 8.4백만 달러(주당 2.93달러)에 비해 6.2백만 달러(주당 1.93달러)의 순손실을 보고했습니다. 2024년 9월 30일 기준으로 Edesa는 100만 달러의 현금과 20만 달러의 부정적인 운영 자본을 보유하고 있었습니다. 회계연도 후, 이 회사는 CEO 관련 법인으로부터 150만 달러를 확보하고, 시장에서 60만 달러를 조달했습니다.
Edesa Biotech (NASDAQ:EDSA) a publié les résultats de l'exercice fiscal 2024, mettant en lumière un pivot stratégique de son candidat médicament anti-TLR4 (EB05) vers une étude financée par le gouvernement américain pour le traitement de l'ARDS. L'entreprise a réduit ses dépenses d'exploitation de plus de 20 %, les dépenses totales ayant chuté à 7 millions de dollars contre 9,2 millions l'année précédente. Les dépenses en recherche et développement sont tombées à 2,9 millions de dollars contre 4,8 millions.
L'entreprise a enregistré une perte nette de 6,2 millions de dollars (1,93 dollar par action) contre 8,4 millions de dollars (2,93 dollars par action) l'année précédente. Au 30 septembre 2024, Edesa avait 1 million de dollars en liquidités et un fonds de roulement négatif de 0,2 millions de dollars. Après l'exercice, l'entreprise a sécurisé 1,5 million de dollars d'une entité affiliée à son PDG et 0,6 million de dollars grâce à une offre sur le marché.
Edesa Biotech (NASDAQ:EDSA) berichtete über die Ergebnisse des Geschäftsjahres 2024 und hob dabei einen strategischen Kurswechsel seines Anti-TLR4-Arztkandidaten (EB05) zu einer von der US-Regierung finanzierten Studie zur Behandlung von ARDS hervor. Das Unternehmen reduzierte die Betriebskosten um über 20%, wobei die Gesamtausgaben von 9,2 Millionen Dollar im Vorjahr auf 7,0 Millionen Dollar sanken. Die Ausgaben für Forschung und Entwicklung fielen von 4,8 Millionen Dollar auf 2,9 Millionen Dollar.
Das Unternehmen meldete einen Nettoverlust von 6,2 Millionen Dollar (1,93 Dollar pro Aktie) im Vergleich zu 8,4 Millionen Dollar (2,93 Dollar pro Aktie) im Vorjahr. Am 30. September 2024 verfügte Edesa über 1,0 Millionen Dollar in bar und ein negatives Working Capital von 0,2 Millionen Dollar. Nach dem Geschäftsjahr sicherte sich das Unternehmen 1,5 Millionen Dollar von einer mit dem CEO verbundenen Gesellschaft und 0,6 Millionen Dollar durch ein Angebot am Markt.
- 20% reduction in operating expenses from $9.2M to $7.0M
- Secured U.S. government funding for EB05 development
- Decreased net loss from $8.4M to $6.2M
- Post-fiscal year funding of $2.1M secured
- Negative working capital of $0.2M as of September 30, 2024
- Low cash position of $1.0M at fiscal year-end
- EB06 clinical trial progression dependent on additional funding
- Continued net losses despite cost reductions
Insights
TORONTO, Dec. 13, 2024 (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 fiscal year ended September 30, 2024 and provided an update on its business.
During the fiscal year, the company pivoted the in-house development of its anti-TLR4 drug candidate, EB05 (paridiprubart), to a U.S. government-funded study investigating novel threat-agnostic host-directed therapeutics in patients with Acute Respiratory Distress Syndrome (ARDS). Given this opportunity, Edesa is also amending a development and drug manufacturing project for the same asset that is supported by the Government of Canada. The company said that the goal is to maximize synergies between the two government-funded projects. For its anti-CXCL10 program, Edesa intends to manufacture EB06 and submit related data to the U.S. Food and Drug Administration as part of an investigational new drug (IND) application. The manufacturing of clinical-grade drug batches and initiation of the patient enrollment is subject to funding. Edesa anticipates topline results for this Phase 2 study could be available within as few as 12 to 18 months following regulatory clearance in the U.S. The study is currently approved in Canada.
“This year, Edesa maintained its momentum despite the headwinds in the drug development sector, and we once again validated our TLR4 technology with a third competitive government award,” said Par Nijhawan, MD, Chief Executive Officer of Edesa Biotech. “I have maintained my strategic support financially and I believe that our team can continue to advance and expand our development pipeline and partnerships.”
Edesa's Chief Financial Officer Stephen Lemieux reported that financial results for the fiscal year benefited from prudent use of working capital and effective financial management, including a more than
Financial Results for the Fiscal Year Ended September 30, 2024
Total operating expenses decreased by
- Research and development expenses decreased by
$1.9 million to$2.9 million for the year ended September 30, 2024 compared to$4.8 million for the prior year primarily due to decreased external research expenses related to the company’s completed dermatitis study and a reduction in labor costs and noncash share-based compensation, which were partially offset by an increase in expenses related to manufacturing of paridiprubart. - General and administrative expenses decreased by
$0.3 million to$4.1 million for year ended September 30, 2024 compared to$4.4 million for the prior year primarily due to a decrease in noncash share-based compensation, which was partially offset by an increase salaries and related costs.
Total other income was unchanged at
For the year ended September 30, 2024, Edesa reported a net loss of
Working Capital
At September 30, 2024, Edesa had cash and cash equivalents of
Calendar
Edesa management plans to participate in one-on-one meetings during JP Morgan week, which begins on January 13, 2025, in San Francisco, California. Attendees interested in meeting with management 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: Edesa’s ability to pivot the in-house development of its anti-TLR4 drug candidate; the company’s plans to amend its contribution agreement with the Government of Canada; the company’s goal to maximize synergies between two government-funded projects; Edesa plans to manufacture EB06 and submit related data to the FDA as part of an IND application; the company’s plans to manufacture clinical-grade drug and initiate patient enrollment; the company’s plans to finance clinical and manufacturing activities; the company’s estimate that topline results for its Phase 2 vitiligo study could be available within as few as 12 to 18 months following regulatory clearance; the company’s belief that in 2024 it maintained its momentum despite the headwinds in the drug development sector and once again validated its TLR4 technology with a third competitive government award; the company’s belief that its team can continue to advance and expand its development pipeline and partnerships; the company’s belief that its fiscal year financial results benefited from prudent use of working capital and effective financial management; the company’s belief that with two governments funding the advancement of its anti-TLR4 technology, it has improved its position for future financing, potential strategic arrangements and alternatives as well as other opportunities to advance its pipeline; and the company's timing and plans regarding its clinical studies in general. Readers should not unduly rely on these forward-looking statements, which are not a guarantee of future performance. There can be no assurance that forward-looking statements will prove to be accurate, as all such forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause actual results or future events to differ materially from the forward-looking statements. Such risks include: the ability of Edesa to obtain regulatory approval for or successfully commercialize any of its product candidates, the risk that access to sufficient capital to fund Edesa's operations may not be available or may be available on terms that are not commercially favorable to Edesa, the risk that Edesa's product candidates may not be effective against the diseases tested in its clinical trials, the risk that Edesa fails to comply with the terms of license agreements with third parties and as a result loses the right to use key intellectual property in its business, Edesa's ability to protect its intellectual property, the timing and success of submission, acceptance and approval of regulatory filings, and the impacts of public health crises. Many of these factors that will determine actual results are beyond the company's ability to control or predict. For a discussion of further risks and uncertainties related to Edesa's business, please refer to Edesa's public company reports filed with the U.S. Securities and Exchange Commission and the British Columbia Securities Commission. All forward-looking statements are made as of the date hereof and are subject to change. Except as required by law, Edesa assumes no obligation to update such statements.
Consolidated Statements of Operations | |||||||
Years Ended | |||||||
September 30, 2024 | September 30, 2023 | ||||||
Expenses: | |||||||
Research and development | $ | 2,881,967 | $ | 4,794,549 | |||
General and administrative | 4,132,777 | 4,428,209 | |||||
Loss from operations | (7,014,744 | ) | (9,222,758 | ) | |||
Other Income (Loss): | |||||||
Reimbursement grant income | 698,277 | 581,039 | |||||
Other income (loss) | 147,222 | 268,104 | |||||
Income tax expense | 800 | 800 | |||||
Net loss | (6,170,045 | ) | (8,374,415 | ) | |||
Exchange differences on translation | (27,965 | ) | (1,046 | ) | |||
Net comprehensive loss | $ | (6,198,010 | ) | $ | (8,375,461 | ) | |
Weighted average number of common shares | 3,197,423 | 2,858,929 | |||||
Loss per common share - basic and diluted | $ | (1.93 | ) | $ | (2.93 | ) | |
Consolidated Balance Sheets | |||||
September 30, 2024 | September 30, 2023 | ||||
Assets: | |||||
Cash and cash equivalents | $ | 1,037,320 | $ | 5,361,397 | |
Other current assets | 638,302 | 1,075,455 | |||
Non-current assets | 2,138,360 | 2,453,585 | |||
Total Assets | $ | 3,813,982 | $ | 8,890,437 | |
Liabilities and shareholders' equity: | |||||
Current liabilities | $ | 1,832,827 | $ | 1,821,864 | |
Non-current liabilities | - | 19,773 | |||
Shareholders' equity | 1,981,155 | 7,048,800 | |||
Total liabilities and shareholders' equity | $ | 3,813,982 | $ | 8,890,437 | |
Consolidated Statements of Cash Flows | |||||||
Years Ended | |||||||
September 30, 2024 | September 30, 2023 | ||||||
Cash flows from operating activities: | |||||||
Net loss | $ | (6,170,045 | ) | $ | (8,374,415 | ) | |
Adjustments for non-cash items | 708,775 | 1,429,928 | |||||
Change in working capital items | 571,065 | 308,004 | |||||
Net cash used in operating activities | (4,890,205 | ) | (6,636,483 | ) | |||
Net cash provided by financing activities | 592,031 | 4,830,111 | |||||
Effect of exchange rate changes on cash and cash equivalents | (25,903 | ) | 76,850 | ||||
Net change in cash and cash equivalents | (4,324,077 | ) | (1,729,522 | ) | |||
Cash and cash equivalents, beginning of year | 5,361,397 | 7,090,919 | |||||
Cash and cash equivalents, end of year | $ | 1,037,320 | $ | 5,361,397 |
FAQ
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