Citius Pharmaceuticals, Inc. Reports Fiscal Second Quarter 2024 Financial Results and Provides Business Update
Mino-Lok data analysis on track with topline results anticipated this quarter
LYMPHIR biologics license application accepted with PDUFA target action date set for
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) withAugust 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
(Nasdaq: TENK) to form publicly listedTenX Keane Acquisition Citius Oncology, Inc. is progressing and pending review bySecurities 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 registered direct offering inApril 2024 extending the Company's cash runway.
Financial Highlights
- Cash and cash equivalents of
$12.6 million as ofMarch 31, 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
$3.6 million and$6.2 million for the three and six months endedMarch 31, 2024 , respectively, compared to$4.7 million and$8.2 million for the three and six months endedMarch 31, 2023 , respectively; - G&A expenses were
$4.3 million and$7.9 million for the three and six months endedMarch 31, 2024 , respectively, compared to$4.8 million and$7.4 million for the three and six months endedMarch 31, 2023 , respectively; - Stock-based compensation expense was
$3.1 million and$6.1 million for the three and six months endedMarch 31, 2024 , respectively, compared to$1.2 million and$2.4 million for the three and six months endedMarch 31, 2023 , respectively; and, - Net loss was
$8.5 million and$17.8 million , or ($0.05 ) and ($0.11 ) per share for the three and six months endedMarch 31, 2024 , respectively, compared to a net loss of$10.5 million and$14.1 million , or ($0.07 ) and ($0.10 ) per share for the three and six months endedMarch 31, 2023 , respectively.
"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
"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
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, 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
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
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
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
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 |
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$ |
12,559,607 |
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$ |
26,480,928 |
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Prepaid expenses |
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9,014,124 |
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7,889,506 |
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Total Current Assets |
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21,573,731 |
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34,370,434 |
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Property and equipment, net |
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275 |
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1,432 |
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Operating lease right-of-use asset, net |
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352,505 |
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|
454,426 |
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Deposits |
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38,062 |
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|
38,062 |
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In-process research and development |
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|
59,400,000 |
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59,400,000 |
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9,346,796 |
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9,346,796 |
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Total Assets |
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$ |
90,711,369 |
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$ |
103,611,150 |
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LIABILITIES AND STOCKHOLDERS' EQUITY |
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Current Liabilities: |
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Accounts payable |
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$ |
2,669,507 |
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$ |
2,927,334 |
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Accrued expenses |
|
|
151,204 |
|
|
|
476,300 |
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Accrued compensation |
|
|
1,123,076 |
|
|
|
2,156,983 |
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Operating lease liability |
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|
229,733 |
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|
218,380 |
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Total Current Liabilities |
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|
4,173,520 |
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|
5,778,997 |
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Deferred tax liability |
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|
6,425,800 |
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|
6,137,800 |
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Operating lease liability – noncurrent |
|
|
145,098 |
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|
262,865 |
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Total Liabilities |
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10,744,418 |
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|
|
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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— |
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— |
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Common stock –
shares issued and outstanding at |
|
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159,095 |
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|
158,858 |
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Additional paid-in capital |
|
|
259,214,194 |
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|
252,903,629 |
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Accumulated deficit |
|
|
(180,006,718) |
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|
|
(162,231,379) |
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|
|
|
79,366,571 |
|
|
|
90,831,108 |
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Non-controlling interest |
|
|
600,380 |
|
|
|
600,380 |
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Total Equity |
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|
79,966,951 |
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|
|
91,431,488 |
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Total Liabilities and Equity |
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$ |
90,711,369 |
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|
$ |
103,611,150 |
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CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
FOR THE THREE AND SIX MONTHS ENDED (Unaudited) |
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Three Months Ended |
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Six 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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$ |
— |
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$ |
— |
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$ |
— |
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$ |
— |
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Operating Expenses |
|
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|
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|
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Research and development |
|
|
3,605,898 |
|
|
|
4,726,855 |
|
|
|
6,227,808 |
|
|
|
8,172,370 |
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General and administrative |
|
|
4,285,911 |
|
|
|
4,792,850 |
|
|
|
7,946,639 |
|
|
|
7,396,137 |
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Stock-based compensation – general and administrative |
|
|
3,078,392 |
|
|
|
1,165,595 |
|
|
|
6,136,577 |
|
|
|
2,366,676 |
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Total Operating Expenses |
|
|
10,970,201 |
|
|
|
10,685,300 |
|
|
|
20,311,024 |
|
|
|
17,935,183 |
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Operating Loss |
|
|
(10,970,201) |
|
|
|
(10,685,300) |
|
|
|
(20,311,024) |
|
|
|
(17,935,183) |
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Other Income |
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|
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Interest income |
|
|
182,205 |
|
|
|
303,275 |
|
|
|
435,843 |
|
|
|
517,824 |
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Gain on sale of |
|
|
2,387,842 |
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|
|
— |
|
|
|
2,387,842 |
|
|
|
3,585,689 |
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Total Other Income |
|
|
2,570,047 |
|
|
|
303,275 |
|
|
|
2,823,685 |
|
|
|
4,103,513 |
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Loss before Income Taxes |
|
|
(8,400,154) |
|
|
|
(10,382,025) |
|
|
|
(17,487,339) |
|
|
|
(13,831,670) |
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Income tax expense |
|
|
144,000 |
|
|
|
144,000 |
|
|
|
288,000 |
|
|
|
288,000 |
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Net Loss |
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$ |
(8,544,154) |
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|
$ |
(10,526,025) |
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|
$ |
(17,775,339) |
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$ |
(14,119,670) |
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Net Loss Per Share - Basic and Diluted |
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$ |
(0.05) |
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$ |
(0.07) |
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$ |
(0.11) |
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$ |
(0.10) |
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Weighted Average Common Shares Outstanding |
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|
|
|
|
|
|
|
|
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Basic and diluted |
|
|
159,072,239 |
|
|
|
146,251,945 |
|
|
|
159,013,769 |
|
|
|
146,231,313 |
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CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
FOR THE SIX 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 |
|
$ |
(17,775,339) |
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|
$ |
(14,119,670) |
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Adjustments to reconcile net loss to net cash used in operating activities: |
|
|
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|
|
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Stock-based compensation expense |
|
|
6,136,577 |
|
|
|
2,366,676 |
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Issuance of common stock for services |
|
|
174,225 |
|
|
|
102,000 |
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Amortization of operating lease right-of-use asset |
|
|
101,921 |
|
|
|
93,869 |
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Depreciation |
|
|
1,157 |
|
|
|
1,461 |
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Deferred income tax expense |
|
|
288,000 |
|
|
|
288,000 |
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Changes in operating assets and liabilities: |
|
|
|
|
|
|
|
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Prepaid expenses |
|
|
(1,124,618) |
|
|
|
(2,983,022) |
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Accounts payable |
|
|
(257,827) |
|
|
|
1,560,215 |
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Accrued expenses |
|
|
(325,096) |
|
|
|
845,442 |
|
Accrued compensation |
|
|
(1,033,907) |
|
|
|
(736,474) |
|
Operating lease liability |
|
|
(106,414) |
|
|
|
(95,932) |
|
|
|
|
(13,921,321) |
|
|
|
(12,677,435) |
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Cash Flows From Financing Activities: |
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Proceed from common stock option exercise |
|
|
— |
|
|
|
31,267 |
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Net Cash Provided By Financing Activities |
|
|
— |
|
|
|
31,267 |
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|
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Net Change in Cash and Cash Equivalents |
|
|
(13,921,321) |
|
|
|
(12,646,168) |
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Cash and Cash Equivalents - Beginning of Period |
|
|
26,480,928 |
|
|
|
41,711,690 |
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Cash and Cash Equivalents - End of Period |
|
$ |
12,559,607 |
|
|
$ |
29,065,522 |
|
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