Can-Fite Reports First Half 2024 Financial Results & Progress in Two Pivotal Phase III Clinical Studies
Can-Fite BioPharma (NYSE American: CANF) reported financial results and clinical updates for H1 2024. Key highlights include:
1. Exercise of warrants for $5.0 million in gross proceeds
2. Positive results from Piclidenoson's osteoarthritis study in dogs
3. Namodenoson's Phase 3 liver cancer study now has 31 recruiting centers
4. FDA granted IND clearance for Namodenoson in MASH treatment
Financial results: Revenues were $0.32 million, down from $0.39 million in H1 2023. Net loss decreased to $3.95 million from $4.22 million. Cash and equivalents stood at $4.72 million as of June 30, 2024.
Can-Fite BioPharma (NYSE American: CANF) ha riportato i risultati finanziari e gli aggiornamenti clinici per il primo semestre del 2024. I punti salienti includono:
1. Esercizio delle warrant per 5,0 milioni di dollari in proventi lordi
2. Risultati positivi dallo studio sull'osteoartrite di Piclidenosone nei cani
3. Lo studio di Fase 3 di Namodenosone per il cancro al fegato ha ora 31 centri di reclutamento
4. L'FDA ha concesso l'autorizzazione IND per Namodenosone nel trattamento della MASH
Risultati finanziari: Le entrate sono state pari a 0,32 milioni di dollari, in calo rispetto a 0,39 milioni nel primo semestre del 2023. La perdita netta è diminuita a 3,95 milioni di dollari da 4,22 milioni di dollari. Liquidità e mezzi equivalenti erano pari a 4,72 milioni di dollari al 30 giugno 2024.
Can-Fite BioPharma (NYSE American: CANF) informó sobre los resultados financieros y las actualizaciones clínicas para el primer semestre de 2024. Los aspectos destacados incluyen:
1. Ejercicio de garantías por 5,0 millones de dólares en ingresos brutos
2. Resultados positivos del estudio de osteoartritis de Piclidenoson en perros
3. El estudio de Fase 3 de Namodenoson para el cáncer de hígado ya cuenta con 31 centros de reclutamiento
4. La FDA otorgó la aprobación IND para Namodenoson en el tratamiento de la MASH
Resultados financieros: Los ingresos fueron de 0,32 millones de dólares, una disminución con respecto a 0,39 millones en el primer semestre de 2023. La pérdida neta se redujo a 3,95 millones de dólares desde 4,22 millones. El efectivo y equivalentes eran 4,72 millones de dólares al 30 de junio de 2024.
Can-Fite BioPharma (NYSE American: CANF)는 2024년 상반기 재무 결과 및 임상 업데이트를 보고했습니다. 주요 하이라이트는 다음과 같습니다:
1. 500만 달러의 총 수익을 위한 워런트 행사
2. 개에서 Piclidenoson의 골관절염 연구에서 긍정적인 결과
3. Namodenoson의 3상 간암 연구가 현재 31개의 모집 센터를 보유하고 있음
4. FDA가 MASH 치료를 위한 Namodenoson에 대해 IND 승인을 부여함
재무 결과: 수익은 32만 달러로, 2023년 상반기 39만 달러에서 감소하였습니다. 순손실은 395만 달러로, 422만 달러에서 감소하였습니다. 2024년 6월 30일 기준 현금 및 현금성 자산은 472만 달러입니다.
Can-Fite BioPharma (NYSE American: CANF) a rapporté des résultats financiers et des mises à jour cliniques pour le premier semestre 2024. Les faits saillants incluent:
1. Exercice de bons de souscription pour 5,0 millions de dollars de produits bruts
2. Résultats positifs de l'étude sur l'arthrose de Piclidenoson chez les chiens
3. L'étude de Phase 3 sur Namodenoson pour le cancer du foie compte maintenant 31 centres de recrutement
4. La FDA a accordé une autorisation IND pour Namodenoson dans le traitement de la MASH
Résultats financiers: Les revenus ont été de 0,32 million de dollars, en baisse par rapport à 0,39 million de dollars au premier semestre 2023. La perte nette a diminué à 3,95 millions de dollars contre 4,22 millions de dollars. La trésorerie et équivalents s'élevaient à 4,72 millions de dollars au 30 juin 2024.
Can-Fite BioPharma (NYSE American: CANF) hat Finanzergebnisse und klinische Updates für das erste Halbjahr 2024 berichtet. Die wichtigsten Höhepunkte sind:
1. Ausübung von Warrants für 5,0 Millionen Dollar an Bruttoeinnahmen
2. Positive Ergebnisse aus der Studie zu Piclidenoson bei Osteoarthritis bei Hunden
3. Die Phase-3-Studie von Namodenoson für Leberkrebs verfügt jetzt über 31 Rekrutierungszentren
4. Die FDA hat die IND-Freigabe für Namodenoson zur Behandlung von MASH erteilt
Finanzergebnisse: Die Einnahmen betrugen 0,32 Millionen Dollar, ein Rückgang von 0,39 Millionen Dollar im ersten Halbjahr 2023. Der Nettoverlust verringerte sich auf 3,95 Millionen Dollar von 4,22 Millionen Dollar. Die liquiden Mittel beliefen sich zum 30. Juni 2024 auf 4,72 Millionen Dollar.
- Exercise of warrants generated $5.0 million in gross proceeds
- Positive results from Piclidenoson's osteoarthritis study in dogs
- Namodenoson's Phase 3 liver cancer study expanded to 31 recruiting centers
- FDA granted IND clearance for Namodenoson in MASH treatment
- Net loss decreased to $3.95 million from $4.22 million in H1 2023
- Revenues decreased to $0.32 million from $0.39 million in H1 2023
- Cash and equivalents declined to $4.72 million from $8.90 million at end of 2023
Insights
Can-Fite's H1 2024 results show a mixed financial picture. While revenues slightly decreased to
The company's cash position has weakened, with cash and short-term deposits at
Can-Fite's pipeline progress is noteworthy, particularly for Namodenoson. The drug's Phase 3 pivotal study for liver cancer has expanded to 31 recruiting centers across multiple countries, bolstered by Orphan Drug and Fast Track designations. The initiation of a Phase IIa study for pancreatic cancer and the FDA's IND clearance for a Phase IIb MASH study demonstrate pipeline diversification.
Piclidenoson's positive results in a veterinary osteoarthritis study, conducted by partner Vetbiolix, open up potential new revenue streams. However, investors should note that clinical progress, while promising, does not guarantee regulatory approval or commercial success. The company's focus on "multi-billion markets with unmet needs" suggests significant potential, but also high competition and regulatory hurdles.
RAMAT GAN, Israel, Aug. 29, 2024 (GLOBE NEWSWIRE) -- Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address oncological and inflammatory diseases, today announced financial results and clinical updates for H1 2024.
H1 2024 Highlights
- Exercise of Warrants for Approximately
$5.0 Million in Gross Proceeds – in August, the Company announced the exercise of certain outstanding warrants to purchase up to an aggregate of 2,857,143 American Depositary Shares (ADSs), having an exercise price of$1.75 per ADS, issued by Can-Fite in January 2023 and November 2023. In consideration for the immediate exercise of the warrants for cash, the Company issued new unregistered warrants to purchase up to 5,714,286 ADSs. - Piclidenoson Drug Candidate -
Positive Results from an Osteoarthritis clinical study in dogs were reported by Can-Fite’s partner Vetbiolix, who is developing Piclidenoson for veterinary indications. Vetbiolix concluded successfully the study interim analysis and can now exercise an option to enter into a full in license agreement with Can-Fite. Based on the agreement between the two companies, if it exercises the option, Vetbiolix will be obligated to pay Can-Fite upfront and milestone payments, in addition to royalties on sales upon regulatory approval. - Namodenoson Drug Candidate -
Liver Cancer – the Company’s Phase 3 pivotal study now has 31 recruiting medical centers in Europe, Israel and the US. Namodenoson has Orphan Drug status with both the U.S. Food and Drug Administration (FDA) and European Medicines Agency, as well as Fast Track Status with the FDA. A compassionate use program has also been ongoing in Israel and Romania. In addition, two scientific articles, one describing long-term complete response to Namodenoson in a patient with advanced liver cancer and the other presents Namodenoson as a promising drug candidate to treat advanced liver cancer and MASH, were published.
Pancreatic Cancer – the Company received approval from the Institutional Review Board (IRB) of Rabin Medical Center, a leading medical institution in Israel, for a Phase IIa study for the treatment of pancreatic cancer. The Company awaits now the approval of the Ministry of Health (MOH). In addition, the Company submitted an application to the U.S. Food and Drug Administration (FDA) for Orphan Drug Designation for Namodenoson in the treatment of pancreatic carcinoma.
MASH (metabolic dysfunction-associated steatohepatitis) – the FDA granted IND clearance for Namodenoson to treat MASH patients in a Phase IIb study. Currently Can-Fite is enrolling patients for a Phase IIb clinical study in Europe and in Israel and the IND approval by FDA allows for the recruitment of patients in the US.
“With two drugs in advanced clinical studies we continue to enroll patients and push forward towards a positive conclusion of each program. We continue to position our drugs for multi-billion markets with unmet needs,” stated Can-Fite CEO & CFO Motti Farbstein.
Financial Results
Revenues for the six months ended June 30, 2024 were
Research and development expenses for the six months ended June 30, 2024 were
General and administrative expenses were
Financial income, net for the six months ended June 30, 2024 was
Net loss for the six months ended June 30, 2024 was
As of June 30, 2024, Can-Fite had cash and cash equivalents and short term deposits of
The Company’s condensed consolidated financial results for the six months ended June 30, 2024 are presented in accordance with US GAAP Reporting Standards.
| CONDENSED CONSOLIDATED BALANCE SHEETS | ||||||||
| U.S dollars in thousands (except for share and per share data) | ||||||||
| June 30, | December 31, | |||||||
| 2024 | 2023 | |||||||
| Unaudited | ||||||||
| ASSETS | ||||||||
| CURRENT ASSETS: | ||||||||
| Cash and cash equivalents | $ | 4,719 | $ | 4,278 | ||||
| Short term deposits | - | 4,625 | ||||||
| Prepaid expenses and other current assets | 1,100 | 986 | ||||||
| Short-term investment | 9 | 19 | ||||||
| Total current assets | 5,828 | 9,908 | ||||||
| NON-CURRENT ASSETS: | ||||||||
| Operating lease right of use assets | 62 | 52 | ||||||
| Property, plant and equipment, net | 32 | 29 | ||||||
| Total non-current assets | 94 | 81 | ||||||
| Total assets | $ | 5,922 | $ | 9,989 | ||||
| CONDENSED CONSOLIDATED BALANCE SHEETS | ||||||||
| U.S dollars in thousands (except for share and per share data) | ||||||||
| June 30, | December 31, | |||||||
| 2024 | 2023 | |||||||
| Unaudited | ||||||||
| LIABILITIES AND SHAREHOLDERS’ EQUITY | ||||||||
| CURRENT LIABILITIES: | ||||||||
| Trade payables | $ | 885 | $ | 427 | ||||
| Current maturity of operating lease liability | 36 | 27 | ||||||
| Deferred revenues | 636 | 622 | ||||||
| Other accounts payable | 430 | 944 | ||||||
| Total current liabilities | 1,987 | 2,020 | ||||||
| NON-CURRENT LIABILITIES: | ||||||||
| Long - term operating lease liability | 21 | 13 | ||||||
| Deferred revenues | 1,435 | 1,713 | ||||||
| Total long-term liabilities | 1,456 | 1,726 | ||||||
| CONTINGENT LIABILITIES AND COMMITMENTS | ||||||||
| SHAREHOLDERS’ EQUITY: | ||||||||
| Ordinary shares of no-par value - Authorized: 5,000,000,000 shares at June 30, 2024 and December 31, 2023; Issued and outstanding: 1,671,728,493 and 1,359,837,393 shares as of June 30, 2024 and December 31, 2023, respectively | - | - | ||||||
| Additional paid-in capital | 163,790 | 163,597 | ||||||
| Accumulated other comprehensive income | 1,127 | 1,127 | ||||||
| Accumulated deficit | (162,438 | ) | (158,481 | ) | ||||
| Total shareholders’ equity | 2,479 | 6,243 | ||||||
| Total liabilities and shareholders’ equity | $ | 5,922 | $ | 9,989 | ||||
| CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS | ||||||||
| U.S dollars in thousands (except for share and per share data) | ||||||||
| Six months ended June 30, | ||||||||
| 2024 | 2023 | |||||||
| Unaudited | ||||||||
| Revenues | $ | 316 | $ | 392 | ||||
| Research and development expenses | (2,885 | ) | (3,417 | ) | ||||
| General and administrative expenses | (1,525 | ) | (1,471 | ) | ||||
| Operating loss | (4,094 | ) | (4,496 | ) | ||||
| Financial income, net | 137 | 276 | ||||||
| Comprehensive loss | (3,957 | ) | (4,220 | ) | ||||
| Basic and diluted net loss per share | (0.00 | ) | (0.00 | ) | ||||
| Weighted average number of ordinary shares used in computing basic and diluted net loss per share | 1,821,304,184 | 1,202,110,110 | ||||||
About Can-Fite BioPharma Ltd.
Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF) is an advanced clinical stage drug development Company with a platform technology that is designed to address multi-billion dollar markets in the treatment of cancer, liver, and inflammatory disease. The Company's lead drug candidate, Piclidenoson recently reported topline results in a Phase III trial for psoriasis and is expected to commence a pivotal Phase III. Can-Fite's cancer and liver drug, Namodenoson, is being evaluated in a Phase IIb trial for the treatment metabolic dysfunction-associated steatohepatitis (MASH), a Phase III pivotal trial for hepatocellular carcinoma (HCC), and the Company is planning a Phase IIa study in pancreatic cancer. Namodenoson has been granted Orphan Drug Designation in the U.S. and Europe and Fast Track Designation as a second line treatment for HCC by the U.S. Food and Drug Administration. Namodenoson has also shown proof of concept to potentially treat other cancers including colon, prostate, and melanoma. CF602, the Company's third drug candidate, has shown efficacy in the treatment of erectile dysfunction. These drugs have an excellent safety profile with experience in over 1,600 patients in clinical studies to date. For more information please visit: www.canfite.com.
Forward-Looking Statements
This press release may contain forward-looking statements, about Can-Fite’s expectations, beliefs or intentions regarding, among other things, its product development efforts, business, financial condition, results of operations, strategies or prospects. All statements in this communication, other than those relating to historical facts, are “forward-looking statements”. Forward-looking statements can be identified by the use of forward-looking words such as “believe,” “expect,” “intend,” “plan,” “may,” “should” or “anticipate” or their negatives or other variations of these words or other comparable words or by the fact that these statements do not relate strictly to historical or current matters. Forward-looking statements relate to anticipated or expected events, activities, trends or results as of the date they are made. Because forward-looking statements relate to matters that have not yet occurred, these statements are inherently subject to known and unknown risks, uncertainties and other factors that may cause Can-Fite’s actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Important factors that could cause actual results, performance or achievements to differ materially from those anticipated in these forward-looking statements include, among other things, our history of losses and needs for additional capital to fund our operations and our inability to obtain additional capital on acceptable terms, or at all; uncertainties of cash flows and inability to meet working capital needs; the initiation, timing, progress and results of our preclinical studies, clinical trials and other product candidate development efforts; our ability to advance our product candidates into clinical trials or to successfully complete our preclinical studies or clinical trials; our receipt of regulatory approvals for our product candidates, and the timing of other regulatory filings and approvals; the clinical development, commercialization and market acceptance of our product candidates; our ability to establish and maintain strategic partnerships and other corporate collaborations; the implementation of our business model and strategic plans for our business and product candidates; the scope of protection we are able to establish and maintain for intellectual property rights covering our product candidates and our ability to operate our business without infringing the intellectual property rights of others; competitive companies, technologies and our industry; risks related to any resurgence of the COVID-19 pandemic and the war between Israel and Hamas; risks related to not satisfying the continued listing requirements of NYSE American; and statements as to the impact of the political and security situation in Israel on our business. More information on these risks, uncertainties and other factors is included from time to time in the “Risk Factors” section of Can-Fite’s Annual Report on Form 20-F filed with the SEC on March 28, 2024 and other public reports filed with the SEC and in its periodic filings with the TASE. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Can-Fite undertakes no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by any applicable securities laws.
Contact
Can-Fite BioPharma
Motti Farbstein
info@canfite.com
+972-3-9241114
FAQ
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