Citius Pharmaceuticals, Inc. Reports Fiscal Second Quarter 2024 Financial Results and Provides Business Update
Citius Pharmaceuticals (CTXR) reported its fiscal Q2 2024 financial results and provided a business update. Key highlights include:
- The FDA accepted LYMPHIR's BLA with a PDUFA target date of Aug 13, 2024.
- Topline results for Mino-Lok’s Phase 3 trial expected in Q2 2024.
- Continued engagement with FDA for Halo-Lido’s development.
- Merger with TenX Keane Acquisition progressing, awaiting SEC and TENK shareholder approval.
- Completed a $15M direct offering in April 2024, extending cash runway to Dec 2024.
Financial highlights:
- $12.6M in cash as of Mar 31, 2024.
- R&D expenses decreased to $3.6M from $4.7M YoY; G&A expenses slightly decreased to $4.3M from $4.8M YoY.
- Net loss improved to $8.5M, $0.05 per share, from $10.5M, $0.07 per share YoY.
- FDA accepted LYMPHIR's BLA with a PDUFA target date of Aug 13, 2024.
- Topline results for Mino-Lok's Phase 3 trial expected in Q2 2024.
- Completed $15M direct offering in April 2024, extending cash runway to Dec 2024.
- R&D expenses decreased to $3.6M from $4.7M YoY.
- Net loss improved to $8.5M, $0.05 per share, from $10.5M, $0.07 per share YoY.
- Increased stock-based compensation expense to $3.1M from $1.2M YoY.
- Net loss for the six months ended Mar 31, 2024, increased to $17.8M from $14.1M YoY.
- G&A expenses for the six months ended Mar 31, 2024, increased to $7.9M from $7.4M YoY.
- Need to raise additional capital beyond Dec 2024.
The fiscal second quarter financial results of Citius Pharmaceuticals highlight a mixed performance. The company reported a
The company's cash position has improved slightly with
For retail investors, the decrease in net losses and the successful raising of capital are positive signs, but the continuing need for additional funding could pose risks. Investors should be cautious about the potential dilution and monitor the company's ability to advance its pipeline products to revenue-generating stages.
The acceptance of the LYMPHIR BLA by the FDA with a PDUFA date set for August 13, 2024, is a significant milestone for Citius Pharmaceuticals. LYMPHIR (denileukin diftitox) is targeted at IL-2 receptors, which are common in oncology therapies. This drug's potential approval could open a new revenue stream for the company and establish it in a niche market segment. The anticipation of topline results from the Mino-Lok Phase 3 trial also adds a layer of optimism. If the results are positive, Mino-Lok could fill a critical gap in catheter-related bloodstream infections, providing an alternative to the current painful and costly treatments.
Furthermore, the ongoing engagement with the FDA for the Halo-Lido treatment could diversify Citius' product pipeline, addressing hemorrhoid treatment. Combining these developments, the company's pipeline shows promise, but it is essential to be cautious of the risks associated with FDA approvals and clinical trial results. Positive outcomes could significantly enhance the company's valuation, while setbacks could delay revenue generation and impact investor sentiment.
The strategic move to merge Citius' oncology subsidiary with TenX Keane Acquisition to form a publicly listed Citius Oncology, Inc. could potentially attract more investment by increasing the visibility and valuation of the oncology assets. This move aligns with the industry trend of creating specialized subsidiaries to streamline operations and focus on niche markets.
Additionally, the $15 million registered direct offering extending the company's cash runway indicates sound financial management amid challenging capital markets for pre-revenue companies. This reflects strategic planning and foresight in maintaining operational stability.
Retail investors should closely watch the completion of this merger and the subsequent market reception. This restructuring could unlock shareholder value if executed well, but the success largely depends on the operational synergy and successful capital deployment in developing oncology assets.
Mino-Lok data analysis on track with topline results anticipated this quarter
LYMPHIR biologics license application accepted with PDUFA target action date set for August 13, 2024
Second Quarter 2024 Business Highlights and Subsequent Developments
- LYMPHIR™ (denileukin diftitox) biologics license application (BLA) accepted by the
U.S. Food and Drug Administration (FDA) with August 13, 2024, assigned as Prescription Drug User Fee Act (PDUFA) target action date; - Data analysis underway for completed Mino-Lok® Pivotal Phase 3 trial with topline results anticipated in calendar 2Q 2024;
- Continued engagement with FDA following end of Phase 2b meeting to determine next phase in the development of Halo-Lido for the treatment of hemorrhoids;
- Merger of our wholly owned subsidiary with TenX Keane Acquisition (Nasdaq: TENK) to form publicly listed Citius Oncology, Inc. is progressing and pending review by Securities and Exchange Commission (SEC) and TENK shareholder approval;
- Robert Smith elected to the Citius Board of Directors at the Annual Meeting of Stockholders; and,
- Completed
$15 million
Financial Highlights
- Cash and cash equivalents of
$12.6 million $15 million - R&D expenses were
$3.6 million $6.2 million $4.7 million $8.2 million - G&A expenses were
$4.3 million $7.9 million $4.8 million $7.4 million - Stock-based compensation expense was
$3.1 million $6.1 million $1.2 million $2.4 million - Net loss was
$8.5 million $17.8 million $0.05 $0.11 $10.5 million $14.1 million $0.07 $0.10
"I am pleased to share that we made solid progress this quarter as we focused on execution and managing our finances. The data analysis of our late-stage asset, Mino-Lok, the only treatment of its kind in development to salvage infected catheters, remains on track. We look forward to reporting the topline results later this quarter. Once we review the results, we plan to engage with the FDA to determine the optimal next steps in the program and look forward to advancing this much-needed alternative to the current standard of care, which often involves painful and costly catheter removal and replacement," stated Leonard Mazur, Chairman and CEO of Citius.
"Importantly, the BLA submission for LYMPHIR, our novel IL-2 receptor targeted oncology therapy, was accepted by the FDA, and assigned a late summer 2024 PDUFA target action date. In anticipation of potential approval, we continue to align the organization for a successful launch," added Mazur.
"Despite a tough capital market environment for pre-revenue companies, we successfully completed a
SECOND QUARTER 2024 FINANCIAL RESULTS:
Liquidity
As of March 31, 2024, the Company had
As of March 31, 2024, the Company had 159,094,781 common shares outstanding.
Based on our cash and cash equivalents as of March 31, 2024, and after giving effect to a capital raising that closed on April 30, 2024, we expect to have sufficient funds to continue our operations through December 2024. We expect to raise additional capital in the future to support our operations beyond December 2024.
Research and Development (R&D) Expenses
R&D expenses were
We expect that research and development expenses will stabilize at current levels in fiscal 2024 as we focus on the commercialization of LYMPHIR, complete our Phase 3 trial for Mino-Lok, and analyze the data from our Phase 2b trial and begin planning our Phase 3 trial for Halo-Lido
General and Administrative (G&A) Expenses
G&A expenses were
For the six months ended March 31, 2024, G&A expenses were
General and administrative expenses consist primarily of compensation costs, professional fees for legal, regulatory, accounting, and corporate development services, and investor relations expenses.
Stock-based Compensation Expense
For the quarter ended March 31, 2024, stock-based compensation expense was
Net loss
Net loss was
Net loss was
About Citius Pharmaceuticals, Inc.
Citius Pharma is a late-stage biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products. The Company's diversified pipeline includes two late-stage product candidates. At the end of 2023, Citius completed enrollment in a Phase 3 pivotal superiority trial of Mino-Lok®, an antibiotic lock solution to salvage catheters in patients with catheter-related bloodstream infections. The Biologics License Application for LYMPHIR™, a novel IL-2R immunotherapy for an initial indication in cutaneous T-cell lymphoma, is currently under review by the FDA with August 13, 2024 assigned as the PDUFA target action date. Citius previously announced plans to form Citius Oncology, a standalone publicly traded company with LYMPHIR as its primary asset. LYMPHIR received orphan drug designation by the FDA for the treatment of CTCL and PTCL. In addition, Citius completed enrollment in its Phase 2b trial of CITI-002 (Halo-Lido), a topical formulation for the relief of hemorrhoids. 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. 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 are: risks relating to the results of research and development activities, including those from existing and new pipeline assets; our need for substantial additional funds; uncertainties relating to preclinical and clinical testing; the FDA may not approve LYMPHIR; our ability to commercialize our products if approved by the FDA; our dependence on third-party suppliers; our ability to procure cGMP commercial-scale supply; 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; our ability to obtain, perform under and maintain financing and strategic agreements and relationships; the early stage of products under development; market and other conditions; our ability to attract, integrate, and retain key personnel; risks related to our growth strategy; our ability to realize some or all of the benefits expected to result from the anticipated spinoff of Citius Oncology or the delay of such benefits; our ongoing businesses which may be adversely affected and subject to certain risks and consequences as a result of the anticipated spinoff transaction; 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 SEC filings. These risks have been and may be further impacted by Covid-19 and could be 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 our Annual Report on Form 10-K for the year ended September 30, 2023, filed with the SEC on December 29, 2023, and 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 Relations for Citius Pharmaceuticals:
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. CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited) | ||||||||
March 31, | September 30, | |||||||
2024 | 2023 | |||||||
ASSETS | ||||||||
Current Assets: | ||||||||
Cash and cash equivalents | $ | 12,559,607 | $ | 26,480,928 | ||||
Prepaid expenses | 9,014,124 | 7,889,506 | ||||||
Total Current Assets | 21,573,731 | 34,370,434 | ||||||
Property and equipment, net | 275 | 1,432 | ||||||
Operating lease right-of-use asset, net | 352,505 | 454,426 | ||||||
Deposits | 38,062 | 38,062 | ||||||
In-process research and development | 59,400,000 | 59,400,000 | ||||||
Goodwill | 9,346,796 | 9,346,796 | ||||||
Total Assets | $ | 90,711,369 | $ | 103,611,150 | ||||
LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
Current Liabilities: | ||||||||
Accounts payable | $ | 2,669,507 | $ | 2,927,334 | ||||
Accrued expenses | 151,204 | 476,300 | ||||||
Accrued compensation | 1,123,076 | 2,156,983 | ||||||
Operating lease liability | 229,733 | 218,380 | ||||||
Total Current Liabilities | 4,173,520 | 5,778,997 | ||||||
Deferred tax liability | 6,425,800 | 6,137,800 | ||||||
Operating lease liability – noncurrent | 145,098 | 262,865 | ||||||
Total Liabilities | 10,744,418 | 12,179,662 | ||||||
Commitments and Contingencies | ||||||||
Stockholders' Equity: | ||||||||
Preferred stock – | — | — | ||||||
Common stock – shares issued and outstanding at March 31, 2024 and September 30, 2023, respectively | 159,095 | 158,858 | ||||||
Additional paid-in capital | 259,214,194 | 252,903,629 | ||||||
Accumulated deficit | (180,006,718) | (162,231,379) | ||||||
Total Citius Pharmaceuticals, Inc. Stockholders' Equity | 79,366,571 | 90,831,108 | ||||||
Non-controlling interest | 600,380 | 600,380 | ||||||
Total Equity | 79,966,951 | 91,431,488 | ||||||
Total Liabilities and Equity | $ | 90,711,369 | $ | 103,611,150 | ||||
CITIUS PHARMACEUTICALS, INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS FOR THE THREE AND SIX MONTHS ENDED MARCH 31, 2024 AND 2023 (Unaudited) | ||||||||||||||||
Three Months Ended | Six Months Ended | |||||||||||||||
March 31, | March 31, | March 31, | March 31, | |||||||||||||
2024 | 2023 | 2024 | 2023 | |||||||||||||
Revenues | $ | — | $ | — | $ | — | $ | — | ||||||||
Operating Expenses | ||||||||||||||||
Research and development | 3,605,898 | 4,726,855 | 6,227,808 | 8,172,370 | ||||||||||||
General and administrative | 4,285,911 | 4,792,850 | 7,946,639 | 7,396,137 | ||||||||||||
Stock-based compensation – general and administrative | 3,078,392 | 1,165,595 | 6,136,577 | 2,366,676 | ||||||||||||
Total Operating Expenses | 10,970,201 | 10,685,300 | 20,311,024 | 17,935,183 | ||||||||||||
Operating Loss | (10,970,201) | (10,685,300) | (20,311,024) | (17,935,183) | ||||||||||||
Other Income | ||||||||||||||||
Interest income | 182,205 | 303,275 | 435,843 | 517,824 | ||||||||||||
Gain on sale of | 2,387,842 | — | 2,387,842 | 3,585,689 | ||||||||||||
Total Other Income | 2,570,047 | 303,275 | 2,823,685 | 4,103,513 | ||||||||||||
Loss before Income Taxes | (8,400,154) | (10,382,025) | (17,487,339) | (13,831,670) | ||||||||||||
Income tax expense | 144,000 | 144,000 | 288,000 | 288,000 | ||||||||||||
Net Loss | $ | (8,544,154) | $ | (10,526,025) | $ | (17,775,339) | $ | (14,119,670) | ||||||||
Net Loss Per Share - Basic and Diluted | $ | (0.05) | $ | (0.07) | $ | (0.11) | $ | (0.10) | ||||||||
Weighted Average Common Shares Outstanding | ||||||||||||||||
Basic and diluted | 159,072,239 | 146,251,945 | 159,013,769 | 146,231,313 | ||||||||||||
CITIUS PHARMACEUTICALS, INC. CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS FOR THE SIX MONTHS ENDED MARCH 31, 2024 AND 2023 (Unaudited) | ||||||||
2024 | 2023 | |||||||
Cash Flows From Operating Activities: | ||||||||
Net loss | $ | (17,775,339) | $ | (14,119,670) | ||||
Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
Stock-based compensation expense | 6,136,577 | 2,366,676 | ||||||
Issuance of common stock for services | 174,225 | 102,000 | ||||||
Amortization of operating lease right-of-use asset | 101,921 | 93,869 | ||||||
Depreciation | 1,157 | 1,461 | ||||||
Deferred income tax expense | 288,000 | 288,000 | ||||||
Changes in operating assets and liabilities: | ||||||||
Prepaid expenses | (1,124,618) | (2,983,022) | ||||||
Accounts payable | (257,827) | 1,560,215 | ||||||
Accrued expenses | (325,096) | 845,442 | ||||||
Accrued compensation | (1,033,907) | (736,474) | ||||||
Operating lease liability | (106,414) | (95,932) | ||||||
Net Cash Used In Operating Activities | (13,921,321) | (12,677,435) | ||||||
Cash Flows From Financing Activities: | ||||||||
Proceed from common stock option exercise | — | 31,267 | ||||||
Net Cash Provided By Financing Activities | — | 31,267 | ||||||
Net Change in Cash and Cash Equivalents | (13,921,321) | (12,646,168) | ||||||
Cash and Cash Equivalents - Beginning of Period | 26,480,928 | 41,711,690 | ||||||
Cash and Cash Equivalents - End of Period | $ | 12,559,607 | $ | 29,065,522 | ||||
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SOURCE Citius Pharmaceuticals, Inc.
FAQ
What is the PDUFA target date for LYMPHIR (CTXR)?
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