Citius Pharmaceuticals, Inc. Reports Fiscal Third Quarter 2024 Financial Results and Provides Business Update

Rhea-AI Summary

Citius Pharmaceuticals (CTXR) reported fiscal Q3 2024 results and key developments:

• FDA approval of LYMPHIR™ for cutaneous T-cell lymphoma treatment
• Completed merger of oncology subsidiary with TenX Keane; Citius Oncology (CTOR) to start trading on Nasdaq
• Achieved primary and secondary endpoints in Mino-Lok® Phase 3 Trial
• $17.9 million cash as of June 30, 2024
• Net loss of $10.6 million ($0.06 per share) for Q3, compared to $8.5 million ($0.06 per share) in Q3 2023
• R&D expenses decreased to $2.8 million from $3.8 million year-over-year
• G&A expenses increased to $4.8 million from $3.7 million year-over-year

CEO Leonard Mazur highlighted the FDA approval of LYMPHIR and successful Mino-Lok trial as key milestones.

Positive

• FDA approval of LYMPHIR for cutaneous T-cell lymphoma treatment
• Successful completion of Mino-Lok Phase 3 Trial, meeting primary and secondary endpoints
• Merger of oncology subsidiary with TenX Keane, creating publicly traded Citius Oncology
• $15 million raised through registered direct offering in April 2024
• Decrease in R&D expenses from $3.8 million to $2.8 million year-over-year

Negative

• Net loss increased to $10.6 million in Q3 2024 from $8.5 million in Q3 2023
• G&A expenses increased to $4.8 million from $3.7 million year-over-year
• Stock-based compensation expense increased significantly to $3.1 million from $1.2 million year-over-year
• Cash runway only extends through December 2024, requiring additional funding
• Dilution of shareholders due to increase in outstanding shares to 158,857,798

Financial Analyst

The Q3 2024 results for Citius Pharmaceuticals highlight significant progress but also financial challenges. FDA approval of LYMPHIR for CTCL treatment marks a important milestone, transitioning the company towards commercialization. The completion of Mino-Lok's Phase 3 trial with positive results is another key achievement.

However, financials reveal concerns. $17.9 million cash balance, even after a $15 million offering, only extends runway through December 2024. The net loss increased to $10.6 million ($0.06 per share) from $8.5 million year-over-year, primarily due to higher G&A and stock-based compensation expenses. This 24.7% increase in net loss, despite R&D cost reductions, suggests challenges in cost management during the transition to commercialization.

Investors should closely monitor the company's ability to secure additional funding and successfully launch LYMPHIR to ensure long-term viability.

Oncology Doctor

The FDA approval of LYMPHIR (denileukin diftitox-cxdl) for cutaneous T-cell lymphoma (CTCL) is a significant advancement in the field. CTCL is a rare, challenging-to-treat cancer with therapeutic options. LYMPHIR, as an immunotherapy, offers a targeted approach that could potentially improve outcomes for patients who have exhausted other treatments.

The successful completion of Mino-Lok's Phase 3 trial, designed to salvage central venous catheters in patients with catheter-related bloodstream infections, is also noteworthy. If approved, this could significantly reduce the need for catheter replacement procedures, decreasing patient risk and healthcare costs.

However, it's important to see real-world data on LYMPHIR's efficacy and safety profile post-launch. The oncology community will be keenly watching for any unexpected side effects or superior efficacy compared to existing treatments.

Market Research Analyst

The spin-off of Citius Oncology (CTOR) is a strategic move that could unlock value for shareholders. By separating the oncology assets, particularly the newly approved LYMPHIR, from the broader Citius portfolio, each entity can focus on its core competencies and attract specialized investors.

The CTCL market, while niche, has significant potential. With an estimated global market size of $1.5 billion by 2027, LYMPHIR could capture a substantial share if it demonstrates superior efficacy or safety compared to existing treatments.

However, the company faces challenges in commercialization. The onboarding of a National Sales Director is a positive step, but building a sales force and market presence from scratch is resource-intensive. The cash runway through December 2024 adds pressure to generate revenue quickly or secure additional funding.

Investors should watch for early adoption rates of LYMPHIR and any partnerships or licensing deals that could provide non-dilutive capital.

Granted FDA approval of LYMPHIR™ for the treatment of cutaneous T-cell lymphoma

Completed merger of oncology subsidiary with TenX Keane; Citius Oncology expected to begin trading on Nasdaq on August 13, 2024, under ticker CTOR

Achieved primary and secondary endpoints of Mino-Lok^® Phase 3 Trial

CRANFORD, N.J., Aug. 12, 2024 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius Pharma" or the "Company") (Nasdaq: CTXR), a late-stage biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products today reported business and financial results for the fiscal third quarter 2024 ended June 30, 2024.

Third Quarter 2024 Business Highlights and Subsequent Developments

• Announced FDA Approval of LYMPHIR™ (denileukin diftitox-cxdl), an immunotherapy for the treatment of cutaneous T-cell lymphoma (CTCL);
• Completed the merger of our wholly owned subsidiary with TenX Keane to form publicly listed Citius Oncology, Inc. on August 12, 2024; trading of Citius Oncology, Inc. (Nasdaq: CTOR) stock expected to begin on August 13, 2024;
• Achieved primary and secondary endpoints in Phase 3 Pivotal Trial of Mino-Lok^®, designed to salvage central venous catheters in patients with catheter-related bloodstream infections;
• Onboarded National Sales Director to recruit and lead the sales organization in preparation for the anticipated launch of LYMPHIR;
• Continued engagement with the FDA following end of Phase 2b meeting to determine next steps in the development of Halo-Lido for the treatment of hemorrhoids; and,
• Completed $15 million registered direct offering in April 2024.

Financial Highlights

• Cash and cash equivalents of $17.9 million as of June 30, 2024;
• $15 million in gross proceeds from a registered direct offering on April 30, 2024, extends the Company's cash runway through December 2024;
• R&D expenses were $2.8 million and $9.0 million for the three and nine months ended June 30, 2024, respectively, compared to $3.8 million and $11.9 million for the three and nine months ended June 30, 2023, respectively;
• G&A expenses were $4.8 million and $12.8 million for the three and nine months ended June 30, 2024, respectively, compared to $3.7 million and $11.1 million for the three and nine months ended June 30, 2023, respectively;
• Stock-based compensation expense was $3.1 million and $9.2 million for the three and nine months ended June 30, 2024, respectively, compared to $1.2 million and $3.5 million for the three and nine months ended June 30, 2023, respectively; and,
• Net loss was $10.6 million and $28.7 million, or ($0.06) and ($0.17) per share for the three and nine months ended June 30, 2024, respectively, compared to a net loss of $8.5 million and $22.6 million, or ($0.06) and ($0.15) per share for the three and nine months ended June 30, 2023, respectively.

"We continued to achieve multiple value-driving milestones during and since the end of the quarter. Last week, LYMPHIR was approved by the FDA for the treatment of a rare and incurable cancer. This is the first FDA-approved product in our portfolio and paves the way for Citius Oncology to transition from a development stage company to a commercial biopharmaceutical organization," stated Leonard Mazur, CEO of Citius Pharma and Citius Oncology.

"The completion of our Phase 3 Pivotal Trial for Mino-Lok, followed by highly statistically significant topline results that met primary and secondary endpoints, further underscores our commitment to developing life-saving treatments. Operationally, we secured $15 million in additional funding to extend our runway, continued expanding our organizational resources to support the planned launch of LYMPHIR, and completed the spin-off of this asset into our majority-owned standalone, publicly traded oncology company. This should provide us with access to a broader investment community and enable both companies to begin to focus on their respective development and commercialization paths. In addition to the spin-off, Citius is evaluating opportunities to optimize the Company's capital allocation, current cash runway, future cash needs, and potential non-dilutive sources of capital. We believe Citius is poised for a transformative second half of 2024," concluded Mazur.

THIRD QUARTER 2024 FINANCIAL RESULTS:

Liquidity

As of June 30, 2024, the Company had $17.9 million in cash and cash equivalents.

As of June 30, 2024, the Company had 158,857,798 common shares outstanding.

Based on our cash and cash equivalents as of June 30, 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 identify additional sources of capital in the future to support our operations beyond December 2024.

Research and Development (R&D) Expenses

R&D expenses were $2.8 million for the quarter ended June 30, 2024, compared to $3.8 million for the quarter ended June 30, 2023. For the nine months ended June 30, 2024, R&D expenses were $9.0 million as compared to $11.9 million during the nine months ended June 30, 2023, a decrease of $2.9 million. The decrease primarily reflects incremental costs related to the completion of the Mino-Lok Phase 3 trial and remediation activities for the LYMPHIR BLA resubmission, offset by lower costs in the current period due to the completion of the Halo-Lido Phase 2b trial.

We expect that research and development expenses will stabilize at current levels in fiscal 2024 as we focus on the commercialization of LYMPHIR, prepare a submission to the FDA and schedule a Type B meeting 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 $4.8 million for the quarter ended June 30, 2024, compared to $3.7 million for the quarter ended June 30, 2023. The increase was primarily due to lower costs for pre-launch and market research activities associated with LYMPHIR during the period.

For the nine months ended June 30, 2024, G&A expenses were $12.8 million as compared to $11.1 million during the nine months ended June 30, 2023. The primary reason for the increase was higher costs for pre-launch and market research activities associated with LYMPHIR.

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 June 30, 2024, stock-based compensation expense was $3.1 million as compared to $1.2 million for the quarter ended June 30, 2023. For the nine months ended June 30, 2024, stock-based compensation expense was $9.2 million as compared to $3.5 million for the nine months ended June 30, 2023. The increase is primarily due to the Citius Oncology stock plan.

Net loss

Net loss was $10.6 million, or ($0.06) per share for the quarter ended June 30, 2024, compared to a net loss of $8.5 million, or ($0.06) per share for the quarter ended June 30, 2023. The $2.1 million increase in the net loss was primarily due to increases of $1.0 million in general and administrative expenses and $1.9 million in stock-based compensation expense, partially offset by the $1.0 million decrease in research and development expenses.

Net loss was $28.3 million, or ($0.17) per share for the nine months ended June 30, 2024, compared to a net loss of $22.6 million, or ($0.15) per share for the nine months ended June 30, 2023. The increase in the net loss was primarily due to the increase in stock-based compensation expense.

About Citius Pharmaceuticals, Inc.

Citius Pharmaceuticals, Inc. 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 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. 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 that apply to Citius Pharma and Citius Oncology as our majority owned subsidiary, are: the anticipated benefits of the transaction between TenX Keane Acquisition and Citius Pharma to form Citius Oncology may not be realized fully, if at all, or may take longer to realize than expected; Citius Oncology's ability to commercialize LYMPHIR; our need for substantial additional funds; risks relating to the results of research and development activities, including those from existing and new pipeline assets; uncertainties relating to preclinical and clinical testing; our ability to commercialize our other product candidates 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 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 may be further impacted by any future public health risks or geopolitical events. 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)
		June 30,				September 30,
		2024				2023
ASSETS
Current Assets:
Cash and cash equivalents		$	17,911,192			$	26,480,928
Prepaid expenses			10,094,597				7,889,506
Total Current Assets			28,005,789				34,370,434
Property and equipment, net			—				1,432
Operating lease right-of-use asset, net			299,932				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		$	97,090,579			$	103,611,150
LIABILITIES AND STOCKHOLDERS' EQUITY
Current Liabilities:
Accounts payable		$	1,663,336			$	2,927,334
Accrued expenses			550,485				476,300
Accrued compensation			1,702,668				2,156,983
Operating lease liability			235,581				218,380
Total Current Liabilities			4,152,070				5,778,997
Deferred tax liability			6,569,800				6,137,800
Operating lease liability – noncurrent			84,430				262,865
Total Liabilities			10,806,300				12,179,662
Commitments and Contingencies
Stockholders' Equity:
Preferred stock – $0.001 par value; 10,000,000 shares authorized; no shares issued      and outstanding			—				—
Common stock – $0.001 par value; 400,000,000 shares authorized; 180,725,407     and 158,857,798 shares issued and outstanding at June 30, 2024 and September      30, 2023, respectively			180,725				158,858
Additional paid-in capital			276,083,228				252,903,629
Accumulated deficit			(190,580,054)				(162,231,379)
Total Citius Pharmaceuticals, Inc. Stockholders' Equity			85,683,899				90,831,108
Non-controlling interest			600,380				600,380
Total Equity			86,284,279				91,431,488
Total Liabilities and Equity		$	97,090,579			$	103,611,150

 

CITIUS PHARMACEUTICALS, INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS FOR THE THREE AND NINE MONTHS ENDED JUNE 30, 2024 AND 2023 (Unaudited)
		Three Months Ended								Nine Months Ended
		June 30,				June 30,				June 30,				June 30,
		2024				2023				2024				2023
Revenues		$	—			$	—			$	—			$	—
Operating Expenses
Research and development			2,763,865				3,764,675				8,991,673				11,937,045
General and administrative			4,808,551				3,733,326				12,755,190				11,129,463
Stock-based compensation – general and administrative			3,061,763				1,174,111				9,198,340				3,540,787
Total Operating Expenses			10,634,179				8,672,112				30,945,203				26,607,295
Operating Loss			(10,634,179)				(8,672,112)				(30,945,203)				(26,607,295)
Other Income
Interest income			204,843				336,780				640,686				854,604
Gain on sale of New Jersey net operating losses			—				—				2,387,842				3,585,689
Total Other Income			204,843				336,780				3,028,528				4,440,293
Loss before Income Taxes			(10,429,336)				(8,335,332)				(27,916,675)				(22,167,002)
Income tax expense			144,000				144,000				432,000				432,000
Net Loss			(10,573,336)				(8,479,332)				(28,348,675)				(22,599,002)
Deemed dividend on warrant extension			321,559				—				321,559				—
Net Loss Applicable to Common Stockholders		$	(10,894,895)			$	(8,479,332)			$	(28,670,234)			$	(22,599,002)
Net Loss Per Share - Basic and Diluted		$	(0.06)			$	(0.06)			$	(0.17)			$	(0.15)
Weighted Average Common Shares Outstanding
Basic and diluted			173,856,960				153,775,380				163,947,311				148,746,002

 

CITIUS PHARMACEUTICALS, INC. CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS FOR THE NINE MONTHS ENDED JUNE 30, 2024 AND 2023 (Unaudited)
		2024				2023
Cash Flows From Operating Activities:
Net loss		$	(28,348,675)			$	(22,599,002)
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation expense			9,198,340				3,540,787
Issuance of common stock for services			284,175				102,000
Amortization of operating lease right-of-use asset			154,494				142,257
Depreciation			1,432				2,090
Deferred income tax expense			432,000				432,000
Changes in operating assets and liabilities:
Prepaid expenses			(2,205,091)				(4,979,740)
Accounts payable			(1,263,998)				1,914,289
Accrued expenses			74,185				(512,520)
Accrued compensation			(454,315)				(156,806)
Operating lease liability			(161,234)				(145,352)
Net Cash Used In Operating Activities			(22,288,687)				(22,259,997)
Cash Flows From Financing Activities:
Net proceeds from registered direct offering			13,718,951				13,798,870
Proceeds from common stock option exercise			—				31,267
Net Cash Provided By Financing Activities			13,718,951				13,830,137
Net Change in Cash and Cash Equivalents			(8,569,736)				(8,429,860)
Cash and Cash Equivalents - Beginning of Period			26,480,928				41,711,690
Cash and Cash Equivalents - End of Period		$	17,911,192			$	33,281,830

 

 

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SOURCE Citius Pharmaceuticals, Inc.

FAQ

What was Citius Pharmaceuticals' (CTXR) net loss for Q3 2024?

Citius Pharmaceuticals reported a net loss of $10.6 million, or $0.06 per share, for the third quarter of fiscal 2024 ended June 30, 2024.

When did Citius Pharmaceuticals (CTXR) receive FDA approval for LYMPHIR?

Citius Pharmaceuticals announced FDA approval of LYMPHIR for the treatment of cutaneous T-cell lymphoma in the third quarter of 2024.

What was the outcome of Citius Pharmaceuticals' (CTXR) Mino-Lok Phase 3 Trial?

Citius Pharmaceuticals achieved both primary and secondary endpoints in the Phase 3 Pivotal Trial of Mino-Lok, designed to salvage central venous catheters in patients with catheter-related bloodstream infections.

How much cash does Citius Pharmaceuticals (CTXR) have as of June 30, 2024?

Citius Pharmaceuticals reported cash and cash equivalents of $17.9 million as of June 30, 2024.

When is Citius Oncology (CTOR) expected to begin trading on Nasdaq?

Citius Oncology (CTOR) is expected to begin trading on Nasdaq on August 13, 2024, following the merger of Citius Pharmaceuticals' oncology subsidiary with TenX Keane.