Citius Pharmaceuticals, Inc. Reports Fiscal Third Quarter 2024 Financial Results and Provides Business Update
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
Achieved primary and secondary endpoints of Mino-Lok® Phase 3 Trial
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. onAugust 12, 2024 ; trading ofCitius Oncology, Inc. (Nasdaq: CTOR) stock expected to begin onAugust 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 inApril 2024 .
Financial Highlights
- Cash and cash equivalents of
$17.9 million as ofJune 30, 2024 ; -
$15 million in gross proceeds from a registered direct offering onApril 30, 2024 , extends the Company's cash runway throughDecember 2024 ; - R&D expenses were
$2.8 million and$9.0 million for the three and nine months endedJune 30, 2024 , respectively, compared to$3.8 million and$11.9 million for the three and nine months endedJune 30, 2023 , respectively; - G&A expenses were
$4.8 million and$12.8 million for the three and nine months endedJune 30, 2024 , respectively, compared to$3.7 million and$11.1 million for the three and nine months endedJune 30, 2023 , respectively; - Stock-based compensation expense was
$3.1 million and$9.2 million for the three and nine months endedJune 30, 2024 , respectively, compared to$1.2 million and$3.5 million for the three and nine months endedJune 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 endedJune 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 endedJune 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
"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
THIRD QUARTER 2024 FINANCIAL RESULTS:
Liquidity
As of
As of
Based on our cash and cash equivalents as of
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, 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
For the nine months ended
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
Net loss
Net loss was
Net loss was
About
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
Investor Relations for
Investor Contact:
ir@citiuspharma.com
908-967-6677 x113
Media Contact:
STiR-communications
Greg@STiR-communications.com
-- Financial Tables Follow –
CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited) |
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2024 |
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2023 |
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ASSETS |
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Current Assets: |
|
|
|
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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 |
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|
59,400,000 |
|
|
|
|
9,346,796 |
|
|
|
9,346,796 |
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|
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Total Assets |
|
$ |
97,090,579 |
|
|
$ |
103,611,150 |
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LIABILITIES AND STOCKHOLDERS' EQUITY |
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Current Liabilities: |
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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 |
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Commitments and Contingencies |
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Stockholders' Equity: |
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Preferred stock – |
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— |
|
|
|
— |
|
Common stock – |
|
|
180,725 |
|
|
|
158,858 |
|
Additional paid-in capital |
|
|
276,083,228 |
|
|
|
252,903,629 |
|
Accumulated deficit |
|
|
(190,580,054) |
|
|
|
(162,231,379) |
|
|
|
|
85,683,899 |
|
|
|
90,831,108 |
|
Non-controlling interest |
|
|
600,380 |
|
|
|
600,380 |
|
Total Equity |
|
|
86,284,279 |
|
|
|
91,431,488 |
|
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|
|
|
|
|
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Total Liabilities and Equity |
|
$ |
97,090,579 |
|
|
$ |
103,611,150 |
|
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
FOR THE THREE AND NINE MONTHS ENDED (Unaudited) |
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Three Months Ended |
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Nine Months Ended |
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2024 |
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|
2023 |
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|
2024 |
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|
2023 |
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Revenues |
|
$ |
— |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
— |
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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 |
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|
|
|
|
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|
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|
|
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Operating Loss |
|
|
(10,634,179) |
|
|
|
(8,672,112) |
|
|
|
(30,945,203) |
|
|
|
(26,607,295) |
|
|
|
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|
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Other Income |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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Interest income |
|
|
204,843 |
|
|
|
336,780 |
|
|
|
640,686 |
|
|
|
854,604 |
|
Gain on sale of |
|
|
— |
|
|
|
— |
|
|
|
2,387,842 |
|
|
|
3,585,689 |
|
Total Other Income |
|
|
204,843 |
|
|
|
336,780 |
|
|
|
3,028,528 |
|
|
|
4,440,293 |
|
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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 |
|
|
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Net Loss |
|
|
(10,573,336) |
|
|
|
(8,479,332) |
|
|
|
(28,348,675) |
|
|
|
(22,599,002) |
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Deemed dividend on warrant extension |
|
|
321,559 |
|
|
|
— |
|
|
|
321,559 |
|
|
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— |
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Net Loss Applicable to Common Stockholders |
|
$ |
(10,894,895) |
|
|
$ |
(8,479,332) |
|
|
$ |
(28,670,234) |
|
|
$ |
(22,599,002) |
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Net Loss Per Share - Basic and Diluted |
|
$ |
(0.06) |
|
|
$ |
(0.06) |
|
|
$ |
(0.17) |
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|
$ |
(0.15) |
|
|
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Weighted Average Common Shares Outstanding |
|
|
|
|
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|
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|
|
|
|
|
|
|
|
|
Basic and diluted |
|
|
173,856,960 |
|
|
|
153,775,380 |
|
|
|
163,947,311 |
|
|
|
148,746,002 |
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CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
FOR THE NINE MONTHS ENDED (Unaudited) |
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|
2024 |
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|
2023 |
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Cash Flows From Operating Activities: |
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Net loss |
|
$ |
(28,348,675) |
|
|
$ |
(22,599,002) |
|
Adjustments to reconcile net loss to net cash used in operating activities: |
|
|
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Stock-based compensation expense |
|
|
9,198,340 |
|
|
|
3,540,787 |
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Issuance of common stock for services |
|
|
284,175 |
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|
|
102,000 |
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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) |
|
|
|
|
(22,288,687) |
|
|
|
(22,259,997) |
|
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|
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|
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Cash Flows From Financing Activities: |
|
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|
|
|
|
|
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 |
|
|
|
|
|
|
|
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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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