CTXR 8-K
Citius Pharmaceuticals, Inc. (CTXR)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d) of
the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported)
(Exact name of registrant as specified in its charter)
(State or other jurisdiction of incorporation)
| (Commission File Number) | (IRS Employer Identification No.) |
| (Address of principal executive offices) | (Zip Code) |
Registrant's telephone number, including area code
(
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||
| The |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02 Results of Operations and Financial Condition.
On February 13, 2026, Citius Pharmaceuticals, Inc. (the “Company,” “we” or “our”) issued a press release announcing our results of operations for the first quarter of fiscal 2026. A copy of the press release is furnished as Exhibit 99.1 to this report and is incorporated herein by reference.
The information in this Item 2.02 (including Exhibit 99.1) shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act, except as expressly set forth by specific reference in such a filing.
Item 3.01. Notice of Delisting or Failure to Satisfy a Continued Listing Rule or Standard; Transfer of Listing.
On February 9, 2026, Nasdaq Stock Market LLC (“Nasdaq”) notified the Company that for the last 30 consecutive business days, the bid price for the Company’s common stock had closed below the minimum $1.00 per share requirement for continued inclusion on the Nasdaq Capital Market pursuant to Nasdaq Listing Rule 5550(a)(2) (the “Bid Price Rule”).
In accordance with Nasdaq Listing Rule 5810(c)(3)(A), the Company has a compliance period of 180 calendar days, or until August 10, 2026, to regain compliance with the Bid Price Rule. If at any time before August 10, 2026, the bid price of the Company's common stock closes at $1.00 per share or more for a minimum of ten consecutive business days, Nasdaq will provide the Company with written confirmation of compliance with the Bid Price Rule.
If the Company does not regain compliance with the Bid Price Rule by August 10, 2026, the Company may be eligible for an additional 180-day compliance period. To qualify, the Company would be required to meet the continued listing requirement for market value of publicly held shares and all other initial listing standards for the Nasdaq Capital Market, with the exception of the Bid Price Rule, and would need to provide written notice of its intention to cure the bid price deficiency during the second compliance period by effecting a reverse stock split, if necessary.
If the Company does not regain compliance with the Bid Price Rule when required, Nasdaq will provide written notification to the Company that its common stock is subject to delisting. At that time, the Company may appeal the delisting determination to a Nasdaq hearings panel.
The notice from Nasdaq has no immediate effect on the listing of the Company’s common stock and its common stock will continue to be listed on the Nasdaq Capital Market under the symbol “CTXR”. The Company is currently evaluating its options for regaining compliance. There can be no assurance that the Company will regain compliance with the Bid Price Rule or maintain compliance with any of the other Nasdaq continued listing requirements.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
| Exhibit No. | Description | |
| 99.1 | Press release, dated February 13, 2026. | |
| 104 | Cover Page Interactive Data File, formatted in Inline Extensible Business Reporting Language (iXBRL). |
1
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Date: February 13, 2026 | CITIUS PHARMACEUTICALS, INC. | |
| By: | /s/ Leonard Mazur | |
| Leonard Mazur | ||
| Chairman and Chief Executive Officer | ||
2
Exhibit 99.1
Citius Pharmaceuticals, Inc. Announces First Reported Revenue Following Successful Launch of LYMPHIR™
Company reports $3.9 million in revenue generated from initial sales in December 2025 and provides first fiscal quarter 2026 financial results
CRANFORD, N.J., February 13, 2026– Citius Pharmaceuticals, Inc. (“Citius Pharma” or the “Company”) (Nasdaq: CTXR), a biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products today reported business and financial results for the fiscal first quarter ended December 31, 2025, and provided a business update, including progress at its majority-owned subsidiary, Citius Oncology, Inc. (Nasdaq: CTOR)..
“I am thrilled to report that we have successfully transitioned to a revenue generating company following Citius Oncology’s December 2025 launch of LYMPHIR. We recorded $3.9 million in revenue during the quarter, reflecting the initial sales at Citius Oncology’s nationwide network of distributors. This milestone is the result of years of focused execution designed to translate innovation into tangible value for the cutaneous T-cell community and Citius stakeholders alike. I congratulate the entire Citius team on an outstanding effort to bring LYMPHIR to market,” said Leonard Mazur, Chairman and Chief Executive Officer of Citius Oncology and Citius Pharma.
“While we are still in the early stages of the launch, we expect momentum to build as we continue to stand up the full commercial organization and more fully deploy our technology-driven platform to expand patient access and drive market penetration. Looking ahead, we see multiple avenues for growth, including encouraging early signals from investigator-initiated studies, opportunities to expand access in international markets, and the potential to build a durable oncology franchise. Most importantly, LYMPHIR now offers patients living with cutaneous T-cell lymphoma a meaningful new treatment option and a more hopeful future,” added Mazur.
“We remain committed to financial stewardship to sustain this momentum, and focused execution to advance our late-stage pipeline, which includes Mino-Lok and Halo-Lido. Our goal remains to serve our community with first-in-class critical care products, and in so doing maximize long-term shareholder value,” concluded Mazur.
Business Highlights and Subsequent Developments
| ● | Commercial inflection achieved through majority-owned subsidiary: Citius Oncology successfully launched LYMPHIR™ (denileukin diftitox-cxdl) in the U.S. in December 2025 for adult patients with relapsed or refractory Stage I–III cutaneous T-cell lymphoma (CTCL) following at least one prior systemic therapy; |
| ● | Early physician adoption underway: Initial specialty distributor sales were completed nationwide, enabling product availability across U.S. treatment centers. Patients have begun receiving LYMPHIR at leading cancer centers; |
| ● | Commercial execution supported by technology: Citius Oncology deployed an AI-enabled commercial platform to support targeted physician engagement and efficient penetration of a highly concentrated prescriber base in this rare oncology market; |
| ● | International patient access advancing: Agreements have been negotiated with regional partners to enable patient access to LYMPHIR utilizing Named Patient Programs (NPPs) where permitted in territories throughout European and the Middle East; |
| ● | Continued support of promising upside opportunities for LYMPHIR: Preliminary topline data from two investigator-initiated Phase I combination studies evaluating the potential to expand clinical utility and future label expansion opportunities. include: |
| o | use in combination with pembrolizumab in patients with recurrent solid tumors; |
| o | incorporation as part of lymphodepletion regimens prior to CAR-T therapy; |
| ● | Late-stage pipeline progress maintained: Citius Pharma continues to advance Mino-Lok®, an antibiotic lock solution to salvage catheters when treating catheter-related bloodstream infections, and Halo-Lido (CITI-002), a topical prescription formulation for hemorrhoids. The Company remains engaged with the FDA regarding both programs. |
First Quarter 2026 Financial Highlights
| ● | Cash and cash equivalents totaled $7.7 million as of December 31, 2025; |
| ● | Generated net proceeds of approximately $20.9 million from equity financings during the quarter, including capital raised at both Citius Pharma and Citius Oncology; |
| ● | Consolidated revenue was $3.9 million, reflecting initial U.S. sales of LYMPHIR at Citius Oncology; |
| ● | Research and development expenses were $1.6 million, compared to $2.1 million in the prior-year period, reflecting reduced clinical development activity; |
| ● | General and administrative expenses totaled $5.7 million, compared to $5.4 million in the prior-year period; |
| ● | Stock-based compensation expense totaled $4.3 million, compared to $2.5 million in the prior-year period; and, |
| ● | Net loss applicable to common stockholders was $8.2 million, or $(0.41) per share, compared to a net loss of $9.8 million, or $(1.30) per share, in the prior-year period. |
About Citius Pharmaceuticals, Inc.
Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) is a biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products. Citius Pharma owns approximately 74.8% of Citius Oncology. In December 2025, Citius Oncology launched LYMPHIR, a targeted immunotherapy for the treatment of adults with relapsed or refractory Stage I–III CTCL who had had at least one prior systemic therapy. Citius Pharma’s late-stage pipeline also includes Mino-Lok®, a catheter 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 Pharma is actively engaged with the FDA to outline next steps for both programs. For more information, please visit www.citiuspharma.com.
2
About Citius Oncology, Inc.
Citius Oncology, Inc. (Nasdaq: CTOR) is a platform to develop and commercialize novel targeted oncology therapies. In December 2025, Citius Oncology launched LYMPHIR, approved by the FDA for the treatment of adults with relapsed or refractory Stage I–III CTCL who had had at least one prior systemic therapy. Management estimates the initial market for LYMPHIR currently exceeds $400 million, is growing, and is underserved by existing therapies. Robust intellectual property protections that span orphan drug designation, complex technology, trade secrets and pending patents for immuno-oncology use as a combination therapy with checkpoint inhibitors would further support Citius Oncology’s competitive positioning. For more information, please visit www.citiusonc.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 Oncology. 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: our ability to successfully commercialize LYMPHIR and establish a sustainable revenue stream; the estimated markets for LYMPHIR and our product candidates and the acceptance thereof by any market; our ability to secure strategic partnerships and expand international access to LYMPHIR; our ability to use the latest technology to support our commercialization efforts for LYMPHIR; physician and patient acceptance of LYMPHIR in a competitive treatment landscape; the ability of LYMPHIR and our product candidates to impact the quality of life of our target patient populations; our need for substantial additional funds and our ability to raise additional money to fund our operations for at least the next 12 months as a going concern; our ability to maintain Nasdaq’s continued listing standards; our reliance on third-party logistics providers, distributors, and specialty pharmacies to support commercial operations; our ability to educate providers and payers, secure adequate reimbursement, and maintain uninterrupted product supply; post-marketing requirements and ongoing regulatory compliance related to LYMPHIR; risks relating to the results of research and development activities, including those from any new pipeline assets; our ability to procure cGMP commercial-scale supply; our ability to obtain, perform under and maintain financing and strategic agreements and relationships; market and other conditions; risks related to our growth strategy; patent and intellectual property matters; government regulation; as well as other risks described in our Securities and Exchange Commission (“SEC”) filings. These risks have been and may be further 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 Citius Oncology’s Annual Report on Form 10-K for the year ended September 30, 2025, filed with the SEC on December 23, 2025. 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 Contact:
Ilanit Allen
908-967-6677 x113
Media Contact:
STiR-communications
Greg Salsburg
-- Financial Tables Follow –
3
CITIUS PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited)
| December 31, | September 30, | |||||||
| 2025 | 2025 | |||||||
| ASSETS | ||||||||
| Current Assets: | ||||||||
| Cash and cash equivalents | $ | 7,721,393 | $ | 4,252,290 | ||||
| Accounts receivable, net of allowances | 4,049,111 | - | ||||||
| Inventory | 22,639,342 | 22,286,693 | ||||||
| Prepaid expenses | 3,535,287 | 1,395,490 | ||||||
| Total Current Assets | 37,945,133 | 27,934,473 | ||||||
| Operating lease right-of-use asset, net | 835,177 | 818,694 | ||||||
| Deposits | 38,062 | 38,062 | ||||||
| In-process research and development, net of accumulated amortization | 92,226,562 | 92,800,000 | ||||||
| Goodwill | 9,346,796 | 9,346,796 | ||||||
| Total Other Assets | 101,611,420 | 102,184,858 | ||||||
| Total Assets | $ | 140,391,730 | $ | 130,938,025 | ||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
| Current Liabilities: | ||||||||
| Accounts payable | $ | 11,021,412 | $ | 13,693,692 | ||||
| License payable | 18,250,000 | 22,650,000 | ||||||
| Accrued expenses | 4,693,307 | 4,190,253 | ||||||
| Accrued compensation | 3,094,395 | 3,292,447 | ||||||
| Note payable | 1,000,000 | 1,000,000 | ||||||
| Operating lease liability | 148,006 | 88,348 | ||||||
| Total Current Liabilities | 38,207,120 | 44,914,740 | ||||||
| Deferred tax liability | 8,035,000 | 7,770,760 | ||||||
| Operating lease liability – noncurrent | 681,640 | 724,925 | ||||||
| Total Liabilities | 46,923,760 | 53,410,425 | ||||||
| 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; 250,000,000 shares authorized; 22,376,427 and 18,067,744 shares issued and outstanding at December 31, 2025 and September 30, 2025, respectively | 22,376 | 18,068 | ||||||
| Additional paid-in capital | 326,960,700 | 306,336,239 | ||||||
| Accumulated deficit | (247,024,914 | ) | (238,804,129 | ) | ||||
| Total Citius Pharmaceuticals, Inc. Stockholders’ Equity | 79,958,162 | 67,550,178 | ||||||
| Non-controlling interest | 13,509,808 | 9,977,422 | ||||||
| Total Equity | 93,467,970 | 77,527,600 | ||||||
| Total Liabilities and Equity | $ | 140,391,730 | $ | 130,938,025 | ||||
4
CITIUS PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
FOR THE THREE MONTHS ENDED DECEMBER 31, 2025 AND 2024
(Unaudited)
| Three Months Ended | ||||||||
| December 31, | December 31, | |||||||
| 2025 | 2024 | |||||||
| Revenue | $ | 3,944,111 | — | |||||
| Cost of revenues | (789,208 | ) | — | |||||
| Gross Profit | 3,154,903 | — | ||||||
| Operating Expenses | ||||||||
| Research and development | 1,599,719 | 2,127,038 | ||||||
| Amortization of in-process research and development | 573,438 | — | ||||||
| General and administrative | 5,720,727 | 5,387,752 | ||||||
| Stock-based compensation – general and administrative | 4,280,227 | 2,524,824 | ||||||
| Total Operating Expenses | 12,174,111 | 10,039,614 | ||||||
| Operating Loss | (9,019,208 | ) | (10,039,614 | ) | ||||
| Other Income (Expense) | ||||||||
| Interest income | 45,097 | 22,608 | ||||||
| Interest expense | (155,538 | ) | — | |||||
| Total Other Income (Expense) | (110,441 | ) | 22,608 | |||||
| Loss before Income Taxes | (9,129,649 | ) | (10,017,006 | ) | ||||
| Income tax expense | 264,240 | 264,240 | ||||||
| Net Loss | (9,393,889 | ) | (10,281,246 | ) | ||||
| Net loss attributable to non-controlling interest | 1,173,104 | 513,000 | ||||||
| Net loss applicable to common stockholders | $ | (8,220,785 | ) | $ | (9,768,246 | ) | ||
| Net Loss Per Share - Basic and Diluted | $ | (0.38 | ) | $ | (1.30 | ) | ||
| Weighted Average Common Shares Outstanding | ||||||||
| Basic and diluted (include pre-funded warrants from the October 2025 offering) | 21,495,274 | 7,492,460 | ||||||
5
CITIUS PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
FOR THE THREE MONTHS ENDED DECEMBER 31, 2025 AND 2024
(Unaudited)
| 2025 | 2024 | |||||||
| Cash Flows From Operating Activities: | ||||||||
| Net loss | $ | (9,393,889 | ) | $ | (10,281,246 | ) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| Stock-based compensation expense | 4,280,227 | 2,524,824 | ||||||
| Issuance of common stock for services | 107,510 | — | ||||||
| Issuance of common stock warrant | 68,597 | — | ||||||
| Amortization of in-process research and development | 573,438 | — | ||||||
| Amortization (accretion) of operating lease right-of-use asset | (16,483 | ) | 54,835 | |||||
| Deferred income tax expense | 264,240 | 264,240 | ||||||
| Changes in operating assets and liabilities: | ||||||||
| Accounts receivable, net of allowances | (4,049,111 | ) | — | |||||
| Inventory | (352,649 | ) | (6,112,603 | ) | ||||
| Prepaid expenses | (2,139,797 | ) | (145,739 | ) | ||||
| Accounts payable | (2,672,280 | ) | 2,436,909 | |||||
| Accrued expenses | 503,054 | 6,225,151 | ||||||
| Accrued compensation | (198,052 | ) | 366,073 | |||||
| Operating lease liability | 16,373 | (58,296 | ) | |||||
| Net Cash Used In Operating Activities | (13,008,822 | ) | (4,725,852 | ) | ||||
| Cash Flows From Investing Activities: | ||||||||
| License fee payments | (4,400,000 | ) | — | |||||
| Net Cash Used in Investing Activities | (4,400,000 | ) | — | |||||
| Cash Flows From Financing Activities: | ||||||||
| Net proceeds from common stock offerings | 20,877,925 | 2,574,051 | ||||||
| Net Cash Provided By Financing Activities | 20,877,925 | 2,574,051 | ||||||
| Net Change in Cash and Cash Equivalents | 3,469,103 | (2,151,801 | ) | |||||
| Cash and Cash Equivalents - Beginning of Period | 4,252,290 | 3,251,880 | ||||||
| Cash and Cash Equivalents - End of Period | $ | 7,721,393 | $ | 1,100,079 | ||||
| Supplemental Disclosures of Cash Flow Information and Non-cash Transactions: | ||||||||
| Interest paid | $ | 14,460 | $ | — | ||||
6