Citius Pharmaceuticals, Inc. Reports Fiscal Full Year 2023 Financial Results and Provides Business Update
- Completed enrollment in Mino-Lok® Pivotal Phase 3 trial with topline results anticipated in 2Q 2024
- Initiated remediation activities to address FDA comments on LYMPHIR BLA resubmission
- Advanced investigator-initiated trials for LYMPHIR's potential as an immuno-oncology combination therapy
- Published positive preclinical results for LYMPHIR in combination with anti-PD-1
- Completed Halo-Lido Phase 2b trial with an expected end of Phase 2 meeting with FDA in early 2024
- Executed definitive agreement to merge subsidiary with TenX Keane Acquisition to form publicly listed Citius Oncology, Inc.
- Raised gross proceeds of $15 million in a registered direct offering in May 2023
- Cash and cash equivalents of $26.5 million as of September 30, 2023, with a runway through August 2024
- Net loss decreased to $32.5 million for the full year ended September 30, 2023, compared to $33.6 million for the full year ended September 30, 2022
- Increased G&A expenses for the full year ended September 30, 2023
- Stock-based compensation expense increased to $6.6 million for the full year ended September 30, 2023
Insights
The completion of enrollment in Citius Pharmaceuticals' Mino-Lok® Phase 3 trial and the upcoming topline data release represent significant milestones that could catalyze the company's stock performance. The anticipated resubmission of the LYMPHIR BLA in early 2024, following FDA feedback, suggests a proactive approach to regulatory hurdles, potentially reducing the time to market. The financial runway, extending through August 2024, indicates a relatively stable short-term liquidity position, reducing immediate dilution risks for shareholders. However, the increased G&A expenses, reflecting pre-launch activities, signal an investment phase that could pressure the bottom line in the short term but may be necessary for commercial success.
The strategic focus on the development of LYMPHIR as an immuno-oncology therapy, in combination with pembrolizumab and prior to CAR-T therapies, highlights Citius' commitment to expanding the therapeutic potential of its pipeline. The publication of positive preclinical results in 'Frontiers in Immunology' enhances the scientific credibility of LYMPHIR, which may facilitate future clinical adoption. The definitive agreement to form Citius Oncology, Inc. through a subsidiary merger with TenX Keane Acquisition indicates a targeted approach to resource allocation and value creation within the oncology segment. This could lead to more efficient development and potentially expedite the commercialization process for oncology assets.
The biopharmaceutical sector is highly competitive and Citius' strategic initiatives, such as the planned end-of-Phase 2 meeting with the FDA for Halo-Lido and the intellectual property pursuits, are critical for maintaining a competitive edge. The company's proactive engagement with the FDA and the remediation activities following the CRL for LYMPHIR indicate an understanding of regulatory challenges and a commitment to overcoming them. The announced spin-off aligns with industry trends of creating focused entities that can attract specialized investment and partnerships, potentially leading to enhanced shareholder value.
Mino-Lok® Pivotal Phase 3 trial enrollment completed; topline data expected 2Q 2024
LYMPHIR™ BLA resubmission on track for early 2024
Fiscal Full Year 2023 Business Highlights and Subsequent Developments
- Completed enrollment in the Mino-Lok® Pivotal Phase 3 trial; topline results anticipated in 2Q 2024;
- Initiated remediation activities in the second half of 2023 to address comments in the complete response letter (CRL) received from the
U.S. Food and Drug Administration (FDA) related to our LYMPHIR biologics license application (BLA); BLA resubmission planned for early 2024; - Advanced two investigator-initiated trials to investigate LYMPHIR's potential as an immuno-oncology combination therapy with checkpoint inhibitor pembrolizumab at the University of Pittsburgh Medical Center, and prior to CAR-T therapies at the University of
Minnesota , Masonic Cancer Center; - Announced publication in the journal Frontiers in Immunology of positive results from a preclinical solid tumor study (liver cancer and colon cancer) of LYMPHIR in combination with anti-PD-1 (to assess the contribution that transient depletion of Tregs has on the anti-tumor activity of checkpoint inhibition);
- Completed Halo-Lido Phase 2b trial; end of Phase 2 meeting with FDA expected in early 2024;
- Executed definitive agreement to merge our wholly owned subsidiary with TenX Keane Acquisition (Nasdaq: TENKU) to form publicly listed Citius Oncology, Inc.; and,
- Raised gross proceeds of
$15 million
Financial Highlights
- Cash and cash equivalents of
$26.5 million - R&D expenses were
$14.8 million $17.7 million - G&A expenses were
$15.3 million $11.8 million - Stock-based compensation expense was
$6.6 million $3.9 million - Net loss was
$32.5 million $0.22 $33.6 million $0.23
"In 2023, we made substantial progress in our pipeline, positioning us for an exciting 2024. Concentrating on execution, we completed enrollment in two trials. With the Mino-Lok pivotal Phase 3 trial enrollment completed, we expect topline results to be available in the second quarter of 2024. We also completed the Halo-Lido Phase 2b trial in 2023. Based on the data from the trial, in which more patients receiving the high dose formulation reported meaningful improvement compared to either lidocaine or halobetasol alone, Citius filed patent applications for the formulation and is actively pursuing intellectual property protections for the groundbreaking fit for purpose PRO instrument. In early 2024, we plan to meet with the FDA to discuss the results of the trial and next steps in the Halo-Lido program," stated Leonard Mazur, Chairman and CEO of Citius.
"Despite receiving a complete response letter at the end of July 2023 for our LYMPHIR BLA, we were encouraged that the items noted by the FDA were addressable in a timely manner and unrelated to clinical efficacy or safety. Over the past several months, our team has engaged with the FDA and endeavored to remediate the agency's concerns. Consistent with progress on this front, we plan to resubmit the BLA in early 2024 with a subsequent PDUFA date expected this year. Concurrently, we announced a definitive agreement to merge our oncology subsidiary with TenX Kean Acquisition to form a separate publicly traded company. Now undergoing SEC review, the intent of the spin-out is to align our oncology-related resources and unlock value for Citius shareholders," added Mazur.
"As we begin 2024, Citius will continue to focus on execution. With anticipated topline results for Mino-Lok, the LYMPHIR BLA resubmission and potential approval, additional clarity in our development plan for Halo-Lido, and the planned spin-off of our oncology subsidiary, we believe Citius is well-positioned to deliver value to shareholders in 2024," concluded Mazur.
Full Year 2022 Financial Results:
Liquidity
As of September 30, 2023, the Company had
As of September 30, 2023, the Company had 158,857,798 common shares outstanding.
The Company estimates that its available cash resources will be sufficient to fund its operations through August 2024.
Research and Development (R&D) Expenses
R&D expenses were
We expect that research and development expenses will continue to stabilize in fiscal 2024 as we continue to focus on the commercialization of LYMPHIR and complete the Phase 3 trial for Mino-Lok and the Phase 2b trial for Halo-Lido.
General and Administrative (G&A) Expenses
G&A expenses were
Stock-based Compensation Expense
For the full year ended September 30, 2023, stock-based compensation expense was
At September 30, 2023, unrecognized total compensation cost related to unvested options for Citius Pharma common stock of
Net loss
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. Citius is preparing to resubmit the Biologics License Application for LYMPHIR, a novel IL-2R immunotherapy for an initial indication in cutaneous T-cell lymphoma, in early 2024, and 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: the cost and timing of the resubmission of the BLA for LYMPHIR; the FDA may not approve LYMPHIR; risks relating to the results of research and development activities, including those from the Mino-Lok Phase 3 trial and other existing and new pipeline assets; our need for substantial additional funds; 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; uncertainties relating to preclinical and clinical testing; 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; 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 Securities and Exchange Commission ("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 Securities and Exchange Commission. 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. | |||||||
CONSOLIDATED BALANCE SHEETS | |||||||
SEPTEMBER 30, 2023 AND 2022 | |||||||
2023 | 2022 | ||||||
ASSETS | |||||||
Current Assets: | |||||||
Cash and cash equivalents | $ | 26,480,928 | $ | 41,711,690 | |||
Prepaid expenses | 7,889,506 | 2,852,580 | |||||
Total Current Assets | 34,370,434 | 44,564,270 | |||||
Property and equipment, net | 1,432 | 4,100 | |||||
Operating lease right-of-use asset, net | 454,426 | 646,074 | |||||
Other Assets: | |||||||
Deposits | 38,062 | 38,062 | |||||
In-process research and development | 59,400,000 | 59,400,000 | |||||
Goodwill | 9,346,796 | 9,346,796 | |||||
Total Other Assets | 68,784,858 | 68,784,858 | |||||
Total Assets | $ | 103,611,150 | $ | 113,999,302 | |||
LIABILITIES AND STOCKHOLDERS' EQUITY | |||||||
Current Liabilities: | |||||||
Accounts payable | $ | 2,927,334 | $ | 1,165,378 | |||
Accrued expenses | 476,300 | 1,405,394 | |||||
Accrued compensation | 2,156,983 | 1,762,251 | |||||
Operating lease liability | 218,380 | 196,989 | |||||
Total Current Liabilities | 5,778,997 | 4,530,012 | |||||
Deferred tax liability | 6,137,800 | 5,561,800 | |||||
Operating lease liability – non current | 262,865 | 481,245 | |||||
Total Liabilities | 12,179,662 | 10,573,057 | |||||
Commitments and Contingencies | |||||||
Stockholders' Equity: | |||||||
Preferred stock - | — | — | |||||
Common stock - | 158,858 | 146,211 | |||||
shares issued and outstanding at September 30, 2023 and 2022, respectively | |||||||
Additional paid-in capital | 252,903,629 | 232,368,121 | |||||
Accumulated deficit | (162,231,379) | (129,688,467) | |||||
Total Citius Pharmaceuticals, Inc. Stockholders' Equity | 90,831,108 | 102,825,865 | |||||
Non-controlling interest | 600,380 | 600,380 | |||||
Total Equity | 91,431,488 | 103,426,245 | |||||
Total Liabilities and Equity | $ | 103,611,150 | $ | 113,999,302 | |||
CITIUS PHARMACEUTICALS, INC. | |||||||
CONSOLIDATED STATEMENTS OF OPERATIONS | |||||||
FOR THE YEARS ENDED SEPTEMBER 30, 2023 AND 2022 | |||||||
2023 | 2022 | ||||||
Revenues | $ | — | $ | — | |||
Operating Expenses: | |||||||
Research and development | 14,819,729 | 17,655,482 | |||||
General and administrative | 15,295,584 | 11,754,609 | |||||
Stock-based compensation – general and administrative | 6,616,705 | 3,905,954 | |||||
Total Operating Expenses | 36,732,018 | 33,316,045 | |||||
Operating Loss | (36,732,018) | (33,316,045) | |||||
Other Income: | |||||||
Interest income | 1,179,417 | 251,399 | |||||
Gain on sale of | 3,585,689 | — | |||||
Total Other Income | 4,765,106 | 251,399 | |||||
Loss before Income Taxes | (31,966,912) | (33,064,646) | |||||
Income tax expense | 576,000 | 576,000 | |||||
Net Loss | (32,542,912) | (33,640,646) | |||||
Deemed dividend on warrant extension | 1,151,208 | — | |||||
Net Loss Applicable to Common Stockholders | $ | (33,694,120) | (33,640,646) | ||||
Net Loss Per Share Applicable to Common Stockholders - Basic and Diluted | $ | (0.22) | (0.23) | ||||
Weighted Average Common Shares Outstanding | |||||||
Basic and diluted | 151,294,729 | 146,082,399 | |||||
CITIUS PHARMACEUTICALS, INC. CONSOLIDATED STATEMENTS OF CASH FLOWS FOR THE YEARS ENDED SEPTEMBER 30, 2023 AND 2022 | ||||||||
2023 | 2022 | |||||||
Cash Flows From Operating Activities: | ||||||||
Net loss | $ | (32,542,912) | $ | (33,640,646) | ||||
Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
Stock-based compensation | 6,616,705 | 3,905,954 | ||||||
Issuance of common stock for services | 102,000 | 378,204 | ||||||
Amortization of operating lease right-of-use asset | 191,648 | 176,754 | ||||||
Depreciation | 2,668 | 2,923 | ||||||
Deferred income tax expense | 576,000 | 576,000 | ||||||
Changes in operating assets and liabilities: | ||||||||
Prepaid expenses | (5,036,926) | (111,176) | ||||||
Accounts payable | 1,761,956 | (111,717) | ||||||
Accrued expenses | (929,094) | 783,434 | ||||||
Accrued compensation | 394,732 | (143,749) | ||||||
Operating lease liability | (196,989) | (177,237) | ||||||
Net Cash Used In Operating Activities | (29,060,212) | (28,361,256) | ||||||
Cash Flows From Financing Activities: | ||||||||
Proceeds from common stock option exercises | 31,267 | — | ||||||
Net proceeds from registered direct offerings | 13,798,183 | — | ||||||
Net Cash Provided By Financing Activities | 13,829,450 | — | ||||||
Net Change in Cash and Cash Equivalents | (15,230,762) | (28,361,256) | ||||||
Cash and Cash Equivalents – Beginning of Year | 41,711,690 | 70,072,946 | ||||||
Cash and Cash Equivalents – End of Year | $ | 26,480,928 | $ | 41,711,690 | ||||
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SOURCE Citius Pharmaceuticals, Inc.
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