# EDGAR Filing Document

**Accession Number:** 0001506251
**File Stem:** 0001213900-23-010323
**Filing Date:** 2023-2
**Character Count:** 19865
**Document Hash:** 03566955d46a635a115b7f4dfaf3d639
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001213900-23-010323.hdr.sgml**: 20230210

**ACCESSION NUMBER**: 0001213900-23-010323

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 14

**CONFORMED PERIOD OF REPORT**: 20230210

**ITEM INFORMATION**: Results of Operations and Financial Condition

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20230210

**DATE AS OF CHANGE**: 20230210

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** Citius Pharmaceuticals, Inc.
- **CENTRAL INDEX KEY:** 0001506251
- **STANDARD INDUSTRIAL CLASSIFICATION:** PHARMACEUTICAL PREPARATIONS [2834]
- **IRS NUMBER:** 273425913
- **STATE OF INCORPORATION:** NV
- **FISCAL YEAR END:** 0930

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-38174
- **FILM NUMBER:** 23612684

**BUSINESS ADDRESS:**
- **STREET 1:** 11 COMMERCE DRIVE
- **STREET 2:** 1ST FLOOR
- **CITY:** CRANFORD
- **STATE:** NJ
- **ZIP:** 07016
- **BUSINESS PHONE:** (908) 967-6676

**MAIL ADDRESS:**
- **STREET 1:** 11 COMMERCE DRIVE
- **STREET 2:** 1ST FLOOR
- **CITY:** CRANFORD
- **STATE:** NJ
- **ZIP:** 07016

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** Trail One, Inc.
- **DATE OF NAME CHANGE:** 20110314

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** TrailOne, Inc.
- **DATE OF NAME CHANGE:** 20101119

?xml version="1.0" encoding="utf-8"?

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

**FORM 8-K**

CURRENT REPORT

Pursuant to Section 13 or 15(d) of

the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported) <u>February 10, 2023</u>

**<u>Citius Pharmaceuticals, Inc.</u>**

(Exact name of registrant as specified in its charter)

<u>Nevada</u>

(State or other jurisdiction of incorporation)

---

| | |
|:---|:---|
| 001-38174 | 27-3425913 |
| (Commission File Number) | (IRS Employer Identification No.) |
| 11 Commerce Drive, 1st Floor, Cranford, NJ | 07016 |
| (Address of principal executive offices) | (Zip Code) |

---

Registrant's telephone number, including area code <u>(908) 967-6677</u> 

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<br> on which registered |
| Common stock, $0.001 par value | CTXR | The Nasdaq Capital Market |

---

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 10, 2023, we issued a press release announcing our results of operations for the first quarter of fiscal 2023. 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 9.01. Financial Statements and Exhibits.**

&nbsp;&nbsp;&nbsp;&nbsp;(d) Exhibits

<u>Exhibit No.</u> <u>Description</u> <br> 99.1 [Press release, dated February 10, 2023.](ea173123ex99-1_citiuspharma.htm) <br> 104 Cover Page Interactive Data File (embedded within the Inline XBRL document)

SIGNATURE

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.

---

| | |
|:---|:---|
|  | **CITIUS PHARMACEUTICALS, INC.** |
| Date: <u>February 10, 2023</u> | /s/ Leonard Mazur |
|  | Leonard Mazur |
|  | Chairman and Chief Executive Officer |

---

## Exhibit 99.1

**Exhibit 99.1**

![](ex99-1_001.jpg)

**Citius Pharmaceuticals, Inc. Reports Fiscal First Quarter 2023 Financial Results and Provides Business Update**

$36.9 million in cash and cash equivalents as of December 31, 2022; runway through February 2024

Uptick in patient recruitment for Mino-Lok® Phase 3 trial

Halo-Lido Phase 2b trial nearing completion

**CRANFORD, N.J.**, February 10, 2023 -- Citius Pharmaceuticals, Inc. ("Citius" 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 first quarter ended December 31, 2022.

**Fiscal Q1 2023 Business Highlights and Subsequent Developments**

- I/ONTAK (E7777) biologics license application (BLA) under review by the U.S. Food and Drug Administration (FDA) with Prescription Drug User Fee Act (PDUFA) target decision date of July 28, 2023;

- Mino-Lok<sup>®</sup>Phase 3 trial progressing with additional enrollment and events in the U.S. and India;

- Phase 2b trial of Halo-Lido for the treatment of hemorrhoids on track with healthy momentum in patient recruitment; and,

- On February 7, 2023, Dennis M. McGrath was elected to the Citius Board of Directors at the Annual Meeting of Stockholders, replacing Director Dr. William Kane.

**Financial Highlights** 

Cash and cash equivalents of $36.9 million as of December 31, 2022;

R&D expenses were $3.4 million for the first quarter ended December 31, 2022, compared to $5.5 million for the first quarter ended December 31, 2021;

G&A expenses were $2.6 million for the first quarter ended December 31, 2022, compared to $2.9 million for the first quarter ended December 31, 2021;

Stock-based compensation expense was $1.2 million for the first quarter ended December 31, 2022, compared to $0.9 million for the first quarter ended December 31, 2021; and,

Net loss was $3.6 million, or ($0.02) per share for the first quarter ended December 31, 2022, compared to a net loss of $9.2 million, or ($0.06) per share for the first quarter ended December 31, 2021.

"As we entered 2023, Citius continued to build momentum across the pipeline. Our Mino-Lok Phase 3 trial is actively enrolling patients in the U.S. and India. We believe the recent uptick in recruitment at clinical sites will aid in completing the trial this year. Regarding our I/ONTAK (E7777) BLA, we anticipate the FDA's decision in late July. Accordingly, we remain focused on ensuring that our regulatory, commercial and manufacturing activities are positioned to support a successful launch, if approved. Moreover, our team has worked diligently to align resources to support the Phase 2b Halo-Lido trial as it nears completion," stated Leonard Mazur, Chairman and CEO of Citius.

"In addition to the progress we are making on the clinical front, we continue to strengthen our corporate infrastructure. On February 7, 2023, shareholders approved the nomination of Dennis McGrath to our Board of Directors. We are very fortunate to have a seasoned leader of Dennis's caliber join our Board. His deep public company, financial and strategic expertise will help guide our path forward. Dennis assumes the Board position formerly held by Dr. William Kane. Since March 2014, Dr. Kane has shared his expertise and insights as a valued member of our Board. We are grateful for his contributions and support through the years. With multiple value-creating catalysts anticipated this year, I look forward to updating shareholders as we work to achieve these milestones," concluded Mazur.

**First quarter 2023 Financial Results:**

**Liquidity**

As of December 31, 2022, the Company had $36.9 million in cash and cash equivalents.

As of December 31, 2022, the Company had 146,211,130 common shares outstanding.

The Company estimates that its available cash resources will be sufficient to fund its operations through February 2024.

**Research and Development (R&D) Expenses**

R&D expenses were $3.4 million for the first quarter ended December 31, 2022, compared to $5.5 million for the first quarter ended December 31, 2021. The decrease primarily reflects the completion of the I/ONTAK (E7777) Phase 3 trial and lower Halo-Lido Phase 2b study costs, offset by incremental Mino-Lok Phase 3 trial costs related to the expansion of the trial to include clinical sites outside the U.S.

We expect that research and development expenses will stabilize in fiscal 2023 as we focus on the commercialization of I/ONTAK and complete our Phase 3 trial for Mino-Lok and our Phase 2b trial for Halo-Lido.

**General and Administrative (G&A) Expenses**

G&A expenses were $2.6 million for the first quarter ended December 31, 2022, compared to $2.9 million for the first quarter ended December 31, 2021. The decrease was primarily due to reduced costs for performance bonuses and investor relations expenses. 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 first quarter ended December 31, 2022, stock-based compensation expense was $1.2 million as compared to $0.9 million for the prior year. The increase reflects expenses related to new grants made under the Citius and NoveCite equity incentive plans and new grants made to employees (including new hires), directors and consultants.

**Net loss**

Net loss was $3.6 million, or ($0.02) per share for the year ended December 31, 2022, compared to a net loss of $9.2 million, or ($0.06) per share for the year ended December 31, 2021. The $5.6 million decrease in the net loss was primarily due to an increase in other income and a decrease in research and development expenses.

**About Citius Pharmaceuticals, Inc.**

Citius is a late-stage biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products, with a focus on oncology, anti-infectives in adjunct cancer care, unique prescription products, and stem cell therapies. The Company's diversified pipeline includes two late-stage product candidates, Mino-Lok®, an antibiotic lock solution for the treatment of patients with catheter-related bloodstream infections, which is currently enrolling patients in a Phase 3 Pivotal superiority trial, and I/ONTAK (E7777), a novel IL-2R immunotherapy for an initial indication in CTCL, for which a BLA is under review by the FDA. Mino-Lok® was granted Fast Track designation by the FDA. I/ONTAK has received orphan drug designation by the FDA for the treatment of CTCL and PTCL. In the first half of 2022, Citius initiated a Phase 2b trial for Halo-Lido, a topical formulation for the relief of hemorrhoids. For more information, please visit www.citiuspharma.com.

**Safe Harbor**

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: our ability to successfully undertake and complete clinical trials and the results from those trials for our product candidates; 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; the early stage of products under development; our need for substantial additional funds; our dependence on third-party suppliers; 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 commercialize our products if approved by the FDA; our ability to procure cGMP commercial-scale supply; 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 attract, integrate, and retain key personnel; our ability to obtain, perform under and maintain financing and strategic agreements and relationships; 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. 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, 2022, filed with the SEC on December 22, 2022 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**

**(unaudited)**

---

| | | |
|:---|:---|:---|
|  | **December 31,**<br>**2022** | **September 30,**<br>**2022** |
| **ASSETS** |  |  |
| **Current Assets:** |  |  |
| Cash and cash equivalents | $36887251 | $41711690 |
| Prepaid expenses | 5430125 | 2852580 |
| &nbsp;&nbsp;&nbsp;**Total Current Assets** | 42317376 | 44564270 |
| Property and equipment, net | 3370 | 4100 |
| Operating lease right-of-use asset, net | 599617 | 646074 |
| **Other Assets:** |  |  |
| Deposits | 38062 | 38062 |
| In-process research and development | 59400000 | 59400000 |
| Goodwill | 9346796 | 9346796 |
| &nbsp;&nbsp;&nbsp;**Total Other Assets** | 68784858 | 68784858 |
| &nbsp;&nbsp;&nbsp;**Total Assets** | $111705221 | $113999302 |
| **LIABILITIES AND STOCKHOLDERS' EQUITY** |  |  |
| **Current Liabilities:** |  |  |
| Accounts payable | $1537578 | $1165378 |
| Accrued expenses | 690402 | 1405394 |
| Accrued compensation | 2107014 | 1762251 |
| Operating lease liability | 202178 | 196989 |
| &nbsp;&nbsp;&nbsp;**Total Current Liabilities** | 4537172 | 4530012 |
| Deferred tax liability | 5705800 | 5561800 |
| Operating lease liability – noncurrent | 428568 | 481245 |
| &nbsp;&nbsp;&nbsp;**Total Liabilities** | 10671540 | 10573057 |
| **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; 146,211,130 shares issued and outstanding at December 31, 2022 and September 30, 2022 | 146211 | 146211 |
| Additional paid-in capital | 233569202 | 232368121 |
| Accumulated deficit | (133282112) | (129688467) |
| **Total Citius Pharmaceuticals, Inc. Stockholders' Equity** | 100433301 | 102825865 |
| Non-controlling interest | 600380 | 600380 |
| &nbsp;&nbsp;&nbsp;**Total Equity** | 101033681 | 103426245 |
| &nbsp;&nbsp;&nbsp;**Total Liabilities and Equity** | $111705221 | $113999302 |

---

**CITIUS PHARMACEUTICALS, INC.**

**CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS**

**FOR THE THREE MONTHS ENDED DECEMBER 31, 2022 AND 2021**

**(Unaudited)**

---

| | | |
|:---|:---|:---|
|  | **Three Months Ended** | **Three Months Ended** |
|  | **December 31,**<br>**2022** | **December 31,**<br>**2021** |
| **Revenues** | $— | $— |
| **Operating Expenses** |  |  |
| Research and development | 3445515 | 5457849 |
| General and administrative | 2603287 | 2896749 |
| Stock-based compensation – general and administrative | 1201081 | 904604 |
| **Total Operating Expenses** | 7249883 | 9259202 |
| **Operating Loss** | (7249883) | (9259202) |
| **Other Income** |  |  |
| Interest income | 214549 | 33982 |
| Gain on sale of New Jersey net operating losses | 3585689 |  |
| **Total Other Income** | 3800238 | 33982 |
| **Loss before Income Taxes** | (3449645) | (9225220) |
| Income tax expense | 144000 |  |
| **Net Loss** | $(3593645) | $(9225220) |
| **Net Loss Per Share - Basic and Diluted** | $(0.02) | $(0.06) |
| **Weighted Average Common Shares Outstanding** |  |  |
| Basic and diluted | 146211130 | 146012169 |

---

**CITIUS PHARMACEUTICALS, INC.**

**CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS**

**FOR THE THREE MONTHS ENDED DECEMBER 31, 2022 AND 2021**

**(Unaudited)**

---

| | | |
|:---|:---|:---|
|  | **2022** | **2021** |
| **Cash Flows From Operating Activities:** |  |  |
| Net loss | $(3593645) | $(9225220) |
| Adjustments to reconcile net loss to net cash used in operating activities: |  |  |
| &nbsp;&nbsp;&nbsp;Stock-based compensation expense | 1201081 | 904604 |
| &nbsp;&nbsp;&nbsp;Issuance of common stock for services |  | 95884 |
| &nbsp;&nbsp;&nbsp;Amortization of operating lease right-of-use asset | 46457 | 42879 |
| &nbsp;&nbsp;&nbsp;Depreciation | 730 | 730 |
| &nbsp;&nbsp;&nbsp;Deferred income tax expense | 144000 |  |
| Changes in operating assets and liabilities: |  |  |
| &nbsp;&nbsp;&nbsp;Prepaid expenses | (2577545) | 217852 |
| &nbsp;&nbsp;&nbsp;Accounts payable | 372200 | 512108 |
| &nbsp;&nbsp;&nbsp;Accrued expenses | (714992) | 2514649 |
| &nbsp;&nbsp;&nbsp;Accrued compensation | 344763 | 327690 |
| &nbsp;&nbsp;&nbsp;Operating lease liability | (47488) | (42698) |
| **Net Cash Used In Operating Activities** | (4824439) | (4651522) |
| **Net Cash Used In Investing Activities** |  |  |
| **Net Cash Provided By Financing Activities** |  |  |
| **Net Change in Cash and Cash Equivalents** | (4824439) | (4651522) |
| **Cash and Cash Equivalents - Beginning of Period** | 41711690 | 70072946 |
| **Cash and Cash Equivalents - End of Period** | $36887251 | $65421424 |

---