Citius Pharmaceuticals, Inc. Reports Fiscal Full Year 2024 Financial Results and Provides Business Update
Citius Pharmaceuticals (CTXR) reported fiscal year 2024 results, highlighting key achievements including FDA approval of LYMPHIR™ for CTCL treatment and positive Phase 3 trial results for Mino-Lok®. The company reported cash and equivalents of $3.3 million as of September 30, 2024. Financial results show R&D expenses decreased to $11.9 million from $14.8 million, while G&A expenses increased to $18.2 million from $15.3 million. Net loss widened to $39.4 million ($5.97 per share) compared to $32.5 million ($5.57 per share) in 2023. The company completed merger of its oncology subsidiary to form Citius Oncology (CTOR) and plans LYMPHIR commercial launch in first half of 2025.
Citius Pharmaceuticals (CTXR) ha riportato i risultati dell'anno fiscale 2024, evidenziando i principali traguardi tra cui l'approvazione della FDA per LYMPHIR™ nel trattamento del CTCL e i risultati positivi della fase 3 per Mino-Lok®. L'azienda ha registrato disponibilità liquide e equivalenti di $3.3 milioni al 30 settembre 2024. I risultati finanziari mostrano che le spese per ricerca e sviluppo sono diminuite a $11.9 milioni da $14.8 milioni, mentre le spese generali e amministrative sono aumentate a $18.2 milioni da $15.3 milioni. La perdita netta è aumentata a $39.4 milioni ($5.97 per azione) rispetto ai $32.5 milioni ($5.57 per azione) del 2023. L'azienda ha completato la fusione della sua controllata oncologica per formare Citius Oncology (CTOR) e prevede il lancio commerciale di LYMPHIR nella prima metà del 2025.
Citius Pharmaceuticals (CTXR) reportó los resultados del año fiscal 2024, destacando logros clave como la aprobación de la FDA de LYMPHIR™ para el tratamiento de CTCL y resultados positivos de ensayos de Fase 3 para Mino-Lok®. La empresa reportó efectivo y equivalentes de $3.3 millones al 30 de septiembre de 2024. Los resultados financieros muestran que los gastos en I+D disminuyeron a $11.9 millones desde $14.8 millones, mientras que los gastos generales y administrativos aumentaron a $18.2 millones desde $15.3 millones. La pérdida neta se amplió a $39.4 millones ($5.97 por acción) en comparación con $32.5 millones ($5.57 por acción) en 2023. La compañía completó la fusión de su filial oncológica para formar Citius Oncology (CTOR) y planea el lanzamiento comercial de LYMPHIR en la primera mitad de 2025.
Citius Pharmaceuticals (CTXR)는 2024 회계 연도 결과를 발표하며, CTCL 치료를 위한 LYMPHIR™의 FDA 승인이 포함된 주요 성과와 Mino-Lok®의 긍정적인 3상 시험 결과를 강조했습니다. 이 회사는 2024년 9월 30일 기준으로 현금 및 현금성 자산이 $3.3 백만이라고 보고했습니다. 재무 결과에 따르면 R&D 비용은 $11.9 백만에서 $14.8 백만으로 감소했으며, G&A 비용은 $18.2 백만에서 $15.3 백만으로 증가했습니다. 순손실은 2023년의 $32.5 백만($5.57 주당)에서 $39.4 백만 ($5.97 주당)으로 확대되었습니다. 이 회사는 종양학 자회사를 합병하여 Citius Oncology (CTOR)를 형성했으며 2025년 상반기에 LYMPHIR의 상업 출시를 계획하고 있습니다.
Citius Pharmaceuticals (CTXR) a rapporté les résultats de l'année fiscale 2024, mettant en évidence des réalisations clés, y compris l'approbation de la FDA de LYMPHIR™ pour le traitement du CTCL et des résultats positifs des essais de phase 3 pour Mino-Lok®. L'entreprise a annoncé des liquidités et équivalents de $3.3 millions au 30 septembre 2024. Les résultats financiers montrent que les dépenses de R&D ont diminué à $11.9 millions contre $14.8 millions, tandis que les dépenses générales et administratives ont augmenté à $18.2 millions contre $15.3 millions. La perte nette a augmenté à $39.4 millions ($5.97 par action) par rapport à $32.5 millions ($5.57 par action) en 2023. L'entreprise a terminé la fusion de sa filiale en oncologie pour former Citius Oncology (CTOR) et prévoit le lancement commercial de LYMPHIR au cours du premier semestre de 2025.
Citius Pharmaceuticals (CTXR) hat die Ergebnisse des Geschäftsjahres 2024 veröffentlicht und dabei wichtige Erfolge hervorgehoben, darunter die FDA-Zulassung von LYMPHIR™ zur Behandlung von CTCL und positive Ergebnisse der Phase-3-Studie für Mino-Lok®. Das Unternehmen berichtete über einen Stand von Bargeld und Äquivalenten in Höhe von $3.3 Millionen zum 30. September 2024. Die finanziellen Ergebnisse zeigen, dass die Ausgaben für Forschung und Entwicklung von $14.8 Millionen auf $11.9 Millionen gesenkt wurden, während die allgemeinen und administrativen Ausgaben von $15.3 Millionen auf $18.2 Millionen erhöht wurden. Der Nettoverlust vergrößerte sich auf $39.4 Millionen ($5.97 pro Aktie) im Vergleich zu $32.5 Millionen ($5.57 pro Aktie) im Jahr 2023. Das Unternehmen hat die Fusion seiner Onkologie-Tochtergesellschaft abgeschlossen, um Citius Oncology (CTOR) zu gründen, und plant den kommerziellen Start von LYMPHIR in der ersten Hälfte des Jahres 2025.
- FDA approval obtained for LYMPHIR™ immunotherapy
- Successful completion of Phase 3 Mino-Lok® trial meeting primary and secondary endpoints
- R&D expenses decreased by 19.6% to $11.9 million
- Strategic formation of publicly traded Citius Oncology (CTOR)
- Cash position decreased to $3.3 million, requiring additional capital raising
- Net loss increased by 21.2% to $39.4 million
- G&A expenses increased by 18.9% to $18.2 million
- Stock-based compensation expense increased by 78.8% to $11.8 million
Insights
Clinical and regulatory success in 2024 expected to drive value in 2025
Fiscal Full Year 2024 Business Highlights and Subsequent Developments
- Achieved
U.S. Food and Drug Administration (FDA) approval of LYMPHIR™ (denileukin diftitox-cxdl), an immunotherapy for the treatment of adults with relapsed or refractory cutaneous T-cell lymphoma (CTCL); - Advanced manufacturing, marketing and sales activities in preparation for commercial launch of LYMPHIR in the first half of 2025;
- Completed the merger of Citius Pharma's oncology subsidiary with TenX Keane to form Citius Oncology, Inc., a standalone publicly traded company which began trading on the Nasdaq exchange under the ticker symbol CTOR on August 13, 2024;
- Supported two investigator-initiated trials to explore LYMPHIR's potential as an immuno-oncology combination therapy being conducted at the University of Pittsburgh Medical Center and the University of
Minnesota ; - Shared interim trial results with the clinical community at the Society for Immunotherapy of Cancer Conference (SITC) of University of Pittsburgh Medical Center's Phase I trial of LYMPHIR with checkpoint inhibitor pembrolizumab; and,
- Met primary and secondary endpoints in the Phase 3 Pivotal Trial of Mino-Lok®, demonstrating a statistically significant improvement in time to catheter failure of infected catheters compared to other physician-selected anti-infective lock solutions.
Financial Highlights
- Cash and cash equivalents of
$3.3 million - R&D expenses were
$11.9 million $14.8 million - G&A expenses were
$18.2 million $15.3 million - Stock-based compensation expense was
$11.8 million $6.6 million - Net loss was
$39.4 million $5.97 $32.5 million $5.57
"In fiscal year 2024 we drove tremendous progress in our pipeline. It was a transformative year, marked by our first FDA approval and significant clinical milestones. The approval of LYMPHIR™ and the positive Phase 3 results for Mino-Lok® underscore our commitment to developing innovative therapies. Our team successfully responded to FDA comments related to the biologics license application for LYMPHIR and ultimately gained FDA approval. Productive engagement with the FDA regarding the positive results of our Phase 3 Mino-Lok® trial and Phase 2 Halo-Lido trial clarified our next steps for both programs. We anticipate continued engagement with the agency in the coming year and look forward to their guidance. Additionally, we are exploring strategic partnerships and licensing opportunities to maximize the potential of our portfolio and bring these important therapies to market efficiently," stated Leonard Mazur, Chairman and CEO of Citius Pharma.
"Looking ahead, our priorities for fiscal year 2025 include launching LYMPHIR™ through our majority-owned subsidiary, Citius Oncology, driving the clinical and regulatory strategies for Mino-Lok® and Halo-Lido, fortifying our financial position, and applying a disciplined approach to resource allocation. We expect to launch LYMPHIR in the first half of 2025 and distribute CTOR shares to Citius Pharma shareholders by the end of the year, pending favorable market conditions. Our goal remains to deliver value for patients, healthcare providers, and shareholders. With a clear vision and a strong team, we are well-positioned to execute on our mission of bringing innovative therapies to market," added Mazur.
FULL YEAR 2024 FINANCIAL RESULTS:
Liquidity
As of September 30, 2024, the Company had
As of September 30, 2024, the Company had 7,247,243 common shares outstanding, as adjusted for the 1-for-25 reverse stock split of the Company's common stock, effected on November 25, 2024.
During the year ended September 30, 2024, the Company received net proceeds of
Research and Development (R&D) Expenses
R&D expenses were
We expect research and development expenses to decrease in fiscal year 2025 as we continue to focus on the commercialization of LYMPHIR through our majority-owned subsidiary, Citius Oncology and because we have completed the Phase 3 trial for Mino-Lok.
General and Administrative (G&A) Expenses
G&A expenses were
Stock-based Compensation Expense
For the full year ended September 30, 2024, stock-based compensation expense was
Net loss
Net loss was
About Citius Pharmaceuticals, Inc.
Citius Pharma is a biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products. In August 2024, the FDA approved LYMPHIR™, a targeted immunotherapy for an initial indication in the treatment of cutaneous T-cell lymphoma. Citius Pharma's late-stage pipeline also includes Mino-Lok®, an antibiotic lock solution to salvage catheters in patients with catheter-related bloodstream infections, and CITI-002 (Halo-Lido), a topical formulation for the relief of hemorrhoids. A Pivotal Phase 3 Trial for Mino-Lok and a Phase 2b trial for Halo-Lido were completed in 2023. Mino-Lok met primary and secondary endpoints of its Phase 3 Trial. Citius Pharma is actively engaged with the FDA to outline next steps for both programs. For more information, please visit www.citiuspharma.com.
Forward-Looking Statements
This press release may contain "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements are made based on our expectations and beliefs concerning future events impacting Citius Pharma. You can identify these statements by the fact that they use words such as "will," "anticipate," "estimate," "expect," "plan," "should," and "may" and other words and terms of similar meaning or use of future dates. Forward-looking statements are based on management's current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from those currently anticipated, and, unless noted otherwise, that apply to Citius Pharma are: our ability to raise additional money to fund our operations for at least the next 12 months as a going concern; our ability to commercialize LYMPHIR through our majority-owned subisity and any of our other product candidates that may be approved by the FDA; the estimated markets for our product candidates and the acceptance thereof by any market; the ability of our product candidates to impact the quality of life of our target patient populations; risks related to research using our assets but conducted by third parties; risks relating to the results of research and development activities, including those from our existing and any new pipeline assets; our ability to maintain compliance with Nasdaq's continued listing standards; our dependence on third-party suppliers; our ability to procure cGMP commercial-scale supply; our ability to obtain, perform under and maintain financing and strategic agreements and relationships; uncertainties relating to preclinical and clinical testing; the early stage of products under development; market and other conditions; risks related to our growth strategy; patent and intellectual property matters; our ability to identify, acquire, close and integrate product candidates and companies successfully and on a timely basis; government regulation; competition; as well as other risks described in our Securities and Exchange Commission ("SEC") filings. These risks have been and may be further impacted by any future public health risks. Accordingly, these forward-looking statements do not constitute guarantees of future performance, and you are cautioned not to place undue reliance on these forward-looking statements. Risks regarding our business are described in detail in our SEC filings which are available on the SEC's website at www.sec.gov, including in Citius Pharma's Annual Report on Form 10-K for the year ended September 30, 2024, filed with the SEC on December 27, 2024, as updated by our subsequent filings with the SEC. These forward-looking statements speak only as of the date hereof, and we expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law.
Investor Contact:
Ilanit Allen
ir@citiuspharma.com
908-967-6677 x113
Media Contact:
STiR-communications
Greg Salsburg
Greg@STiR-communications.com
-- Financial Tables Follow –
CITIUS PHARMACEUTICALS, INC. CONSOLIDATED BALANCE SHEETS SEPTEMBER 30, 2024 AND 2023 | ||||||||
2024 | 2023 | |||||||
ASSETS | ||||||||
Current Assets: | ||||||||
Cash and cash equivalents | $ | 3,251,880 | $ | 26,480,928 | ||||
Inventory | 8,268,766 | — | ||||||
Prepaid expenses | 2,700,000 | 7,889,506 | ||||||
Total Current Assets | 14,220,646 | 34,370,434 | ||||||
Property and equipment, net | — | 1,432 | ||||||
Operating lease right-of-use asset, net | 246,247 | 454,426 | ||||||
Other Assets: | ||||||||
Deposits | 38,062 | 38,062 | ||||||
In-process research and development | 92,800,000 | 59,400,000 | ||||||
Goodwill | 9,346,796 | 9,346,796 | ||||||
Total Other Assets | 102,184,858 | 68,784,858 | ||||||
Total Assets | $ | 116,651,751 | $ | 103,611,150 | ||||
LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
Current Liabilities: | ||||||||
Accounts payable | $ | 4,927,211 | $ | 2,927,334 | ||||
License payable | 28,400,000 | — | ||||||
Accrued expenses | 17,027 | 476,300 | ||||||
Accrued compensation | 2,229,018 | 2,156,983 | ||||||
Operating lease liability | 241,547 | 218,380 | ||||||
Total Current Liabilities | 35,814,803 | 5,778,997 | ||||||
Deferred tax liability | 6,713,800 | 6,137,800 | ||||||
Operating lease liability – non current | 21,318 | 262,865 | ||||||
Total Liabilities | 42,549,921 | 12,179,662 | ||||||
Commitments and Contingencies | ||||||||
Stockholders' Equity: | ||||||||
Preferred stock - | — | — | ||||||
Common stock - | 7,247 | 6,354 | ||||||
Additional paid-in capital | 271,440,421 | 253,056,133 | ||||||
Accumulated deficit | (201,370,218) | (162,231,379) | ||||||
Total Citius Pharmaceuticals, Inc. Stockholders' Equity | 70,077,450 | 90,831,108 | ||||||
Non-controlling interest | 4,024,380 | 600,380 | ||||||
Total Equity | 74,101,830 | 91,431,488 | ||||||
Total Liabilities and Equity | $ | 116,651,751 | $ | 103,611,150 | ||||
Reflects a 1-for-25 reverse stock split effective November 25, 2024. | ||||||||
CITIUS PHARMACEUTICALS, INC. CONSOLIDATED STATEMENTS OF OPERATIONS FOR THE YEARS ENDED SEPTEMBER 30, 2024 AND 2023 | ||||||||
2024 | 2023 | |||||||
Revenues | $ | — | $ | — | ||||
Operating Expenses: | ||||||||
Research and development | 11,906,601 | 14,819,729 | ||||||
General and administrative | 18,249,402 | 15,295,584 | ||||||
Stock-based compensation – general and administrative | 11,839,678 | 6,616,705 | ||||||
Total Operating Expenses | 41,995,681 | 36,732,018 | ||||||
Operating Loss | (41,995,681) | (36,732,018) | ||||||
Other Income: | ||||||||
Interest income, net | 758,000 | 1,179,417 | ||||||
Gain on sale of | 2,387,842 | 3,585,689 | ||||||
Total Other Income Net | 3,145,842 | 4,765,106 | ||||||
Loss before Income Taxes | (38,849,839) | (31,966,912) | ||||||
Income tax expense | 576,000 | 576,000 | ||||||
Net Loss | (39,425,839) | (32,542,912) | ||||||
Net loss attributable to non-controlling interest | 287,000 | - | ||||||
Deemed dividend on warrant extension | (1,047,312) | (1,151,208) | ||||||
Net Loss Applicable to Common Stockholders | $ | (40,186,151) | (33,694,120) | |||||
Net Loss Per Share Applicable to Common Stockholders - Basic and Diluted | $ | (5.97) | (5.57) | |||||
Weighted Average Common Shares Outstanding | ||||||||
Basic and diluted | 6,726,999 | 6,051,789 | ||||||
Reflects a 1-for-25 reverse stock split effective November 25, 2024. | ||||||||
CITIUS PHARMACEUTICALS, INC. CONSOLIDATED STATEMENTS OF CASH FLOWS FOR THE YEARS ENDED SEPTEMBER 30, 2024 AND 2023 | ||||||||
2024 | 2023 | |||||||
Cash Flows From Operating Activities: | ||||||||
Net loss | $ | (39,425,839) | $ | (32,542,912) | ||||
Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
Stock-based compensation | 11,839,678 | 6,616,705 | ||||||
Issuance of common stock for services | 284,176 | 102,000 | ||||||
Amortization of operating lease right-of-use asset | 208,179 | 191,648 | ||||||
Depreciation | 1,432 | 2,668 | ||||||
Deferred income tax expense | 576,000 | 576,000 | ||||||
Changes in operating assets and liabilities: | ||||||||
Inventory | (2,133,871) | - | ||||||
Prepaid expenses | (945,389) | (5,036,926) | ||||||
Accounts payable | 1,999,877 | 1,761,956 | ||||||
Accrued expenses | (459,273) | (929,094) | ||||||
Accrued compensation | 72,035 | 394,732 | ||||||
Operating lease liability | (218,380) | (196,989) | ||||||
Net Cash Used In Operating Activities | (28,201,375) | (29,060,212) | ||||||
Cash Flows From Investing Activities: | ||||||||
License payment | (5,000,000) | - | ||||||
Net Cash Used In Investing Activities | (5,000,000) | - | ||||||
Cash Flows From Financing Activities: | ||||||||
Proceeds from common stock option exercises | - | 31,267 | ||||||
Merger, net | (3,831,357) | |||||||
Net proceeds from registered direct offerings | 13,803,684 | 13,798,183 | ||||||
Net Cash Provided By Financing Activities | 9,972,327 | 13,829,450 | ||||||
Net Change in Cash and Cash Equivalents | (23,229,048) | (15,230,762) | ||||||
Cash and Cash Equivalents – Beginning of Year | 26,480,928 | 41,711,690 | ||||||
Cash and Cash Equivalents – End of Year | $ | 3,251,880 | $ | 26,480,928 | ||||
Supplemental Disclosures of Cash Flow Information and Non-cash Activities: | ||||||||
IPR&D Milestones included in License Payable | $ | 28,400,000 | $ | - | ||||
Prepaid Manufacturing transferred to Inventory | $ | 6,134,895 | $ | - | ||||
Reflects a 1-for-25 reverse stock split effective November 25, 2024. | ||||||||
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SOURCE Citius Pharmaceuticals, Inc.
FAQ
What were CTXR's key FDA approvals in fiscal 2024?
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What were the results of CTXR's Phase 3 Mino-Lok® trial?
