Overview
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- TickerCTXR on Nasdaq2
- IndustryPharmaceutical Preparations2
- HeadquartersCranford, United States2
- Incorporated inNV4
- Business address11 Commerce Drive, 1St Floor, Cranford, Nj 070164
- Filer categoryNon-accelerated filer, Smaller reporting company4
- Legal formProfit Corporation2
- LEI5493005C10W36P4KQP402
- StatusActive2
- LEI statusLapsed (not renewed)2
- Registered addressC/O CSC Services of Nevada, Inc., 89119 Las Vegas, United States2
- Registered withBusiness Center (Secretary of State), E0436102010-42
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Co., Ltd. (“Eisai”) and the related asset purchase agreement with Dr. Reddy’s Laboratories SA, a subsidiary of Dr.5 From its latest annual report
Financials
From the company’s reports to the SEC. Every number links to the filing it came from.
Key numbers, fiscal 2022
Where the money goes
Where each dollar of revenue went, fiscal 2022
- Research and development97¢$17.7M
- Income tax3¢$576.0K
Out of $90.0K in revenue.76 The company lost money this year.
Financial statements
Every line of the income statement as filed: the last 2 fiscal years, latest first.3
| Period ending | 2025-09-30 | 2024-09-30 |
|---|---|---|
| Research and development | $9.2M | $11.9M |
| General and administrative | $18.5M | $18.2M |
| Stock-based compensation general and administrative | $10.8M | $11.8M |
| Total Operating Expenses | $38.5M | $42.0M |
| Operating Loss | -$38.5M | -$42.0M |
| Interest income | $110.1K | $758.0K |
| Interest expense | -$267.8K | |
| Gain on sale of New Jersey net operating losses | $2.4M | |
| Total Other Income (Expense), Net | -$157.7K | $3.1M |
| Loss before Income Taxes | -$38.7M | -$38.8M |
| Income tax expense | $1.1M | $576.0K |
| Net Loss | -$39.7M | -$39.4M |
| Net loss attributable to non-controlling interest | $2.3M | $287.0K |
| Deemed dividend on warrant extension | -$1.0M | |
| Net Loss Applicable to Common Stockholders | -$37.4M | -$40.2M |
| Net Loss Per Share Applicable to Common Stockholders - Basic (in Dollars per share) | -$3.38 | -$5.97 |
| Net Loss Per Share Applicable to Common Stockholders - Diluted (in Dollars per share) | -$3.38 | -$5.97 |
| Basic (in Shares) | 11.1M shares | 6.7M shares |
| Diluted (in Shares) | 11.1M shares | 6.7M shares |
No quarter-by-quarter statement was filed.
Every line of the balance sheet as filed: the last 3 fiscal years (annual) or 3 quarters (quarterly), latest first.3
| Period ending | 2025-09-30 | 2024-09-30 | 2023-09-30 |
|---|---|---|---|
| Cash and cash equivalents | $4.3M | $3.3M | |
| Inventory | $22.3M | $8.3M | |
| Prepaid expenses | $1.4M | $2.7M | |
| Total Current Assets | $27.9M | $14.2M | |
| Operating lease right-of-use asset, net | $818.7K | $246.2K | |
| Deposits | $38.1K | $38.1K | |
| In-process research and development | $92.8M | $92.8M | |
| Goodwill | $9.3M | $9.3M | |
| Total Other Assets | $102.2M | $102.2M | |
| Total Assets | $130.9M | $116.7M | |
| Accounts payable | $13.7M | $4.9M | |
| License payable | $22.6M | $28.4M | |
| Accrued expenses | $4.2M | $17.0K | |
| Accrued compensation | $3.3M | $2.2M | |
| Note payable | $1.0M | ||
| Operating lease liability | $88.3K | $241.5K | |
| Total Current Liabilities | $44.9M | $35.8M | |
| Deferred tax liability | $7.8M | $6.7M | |
| Operating lease liability non current | $724.9K | $21.3K | |
| Total Liabilities | $53.4M | $42.5M | |
| Common stock - $0.001 par value; 250,000,000 and 16,000,000 shares authorized at September 30, 2025 and 2024, respectively; 18,067,744 and 7,247,243 shares issued and outstanding at September 30, 2025 and 2024, respectively | $18.1K | $7.2K | |
| Additional paid-in capital | $306.3M | $271.4M | |
| Accumulated deficit | -$238.8M | -$201.4M | |
| Total Citius Pharmaceuticals, Inc. Stockholders Equity | $67.6M | $70.1M | |
| Non-controlling interest | $10.0M | $4.0M | |
| Total Equity | $77.5M | $74.1M | $91.4M |
| Total Liabilities and Equity | $130.9M | $116.7M | |
| Preferred stock, par value (in Dollars per share) | $0.00 | $0.00 | |
| Preferred stock, shares authorized (in Shares) | 10.0M shares | 10.0M shares | |
| Common stock, par value (in Dollars per share) | $0.00 | $0.00 | |
| Common stock, shares authorized (in Shares) | 250.0M shares | 16.0M shares | |
| Common stock, shares issued (in Shares) | 18.1M shares | 7.2M shares | |
| Common stock, shares outstanding (in Shares) | 18.1M shares | 7.2M shares |
| Period ending | 2025-09-30 | 2024-09-30 | 2023-09-30 |
|---|---|---|---|
| Cash and cash equivalents | $4.3M | $3.3M | |
| Inventory | $22.3M | $8.3M | |
| Prepaid expenses | $1.4M | $2.7M | |
| Total Current Assets | $27.9M | $14.2M | |
| Operating lease right-of-use asset, net | $818.7K | $246.2K | |
| Deposits | $38.1K | $38.1K | |
| In-process research and development | $92.8M | $92.8M | |
| Goodwill | $9.3M | $9.3M | |
| Total Other Assets | $102.2M | $102.2M | |
| Total Assets | $130.9M | $116.7M | |
| Accounts payable | $13.7M | $4.9M | |
| License payable | $22.6M | $28.4M | |
| Accrued expenses | $4.2M | $17.0K | |
| Accrued compensation | $3.3M | $2.2M | |
| Note payable | $1.0M | ||
| Operating lease liability | $88.3K | $241.5K | |
| Total Current Liabilities | $44.9M | $35.8M | |
| Deferred tax liability | $7.8M | $6.7M | |
| Operating lease liability non current | $724.9K | $21.3K | |
| Total Liabilities | $53.4M | $42.5M | |
| Common stock - $0.001 par value; 250,000,000 and 16,000,000 shares authorized at September 30, 2025 and 2024, respectively; 18,067,744 and 7,247,243 shares issued and outstanding at September 30, 2025 and 2024, respectively | $18.1K | $7.2K | |
| Additional paid-in capital | $306.3M | $271.4M | |
| Accumulated deficit | -$238.8M | -$201.4M | |
| Total Citius Pharmaceuticals, Inc. Stockholders Equity | $67.6M | $70.1M | |
| Non-controlling interest | $10.0M | $4.0M | |
| Total Equity | $77.5M | $74.1M | $91.4M |
| Total Liabilities and Equity | $130.9M | $116.7M | |
| Preferred stock, par value (in Dollars per share) | $0.00 | $0.00 | |
| Preferred stock, shares authorized (in Shares) | 10.0M shares | 10.0M shares | |
| Common stock, par value (in Dollars per share) | $0.00 | $0.00 | |
| Common stock, shares authorized (in Shares) | 250.0M shares | 16.0M shares | |
| Common stock, shares issued (in Shares) | 18.1M shares | 7.2M shares | |
| Common stock, shares outstanding (in Shares) | 18.1M shares | 7.2M shares |
Cash flow is reported year to date, not quarter by quarter, so there are no separate quarterly figures.
Every line of the cash flow as filed: the last 2 fiscal years, latest first.3
| Period ending | 2025-09-30 | 2024-09-30 |
|---|---|---|
| Net loss | -$39.7M | -$39.4M |
| Stock-based compensation | $10.8M | $11.8M |
| Issuance of common stock for services | $26.6K | $284.2K |
| Amortization of operating lease right-of-use asset | $214.2K | $208.2K |
| Depreciation | $1.4K | |
| Deferred income tax expense | $1.1M | $576.0K |
| Inventory | -$12.6M | -$2.1M |
| Prepaid expenses | -$64.2K | -$945.4K |
| Accounts payable | $8.8M | $2.0M |
| Accrued expenses | $4.2M | -$459.3K |
| Accrued compensation | $1.1M | $72.0K |
| Operating lease liability | -$236.3K | -$218.4K |
| Net Cash Used In Operating Activities | -$26.6M | -$28.2M |
| License payment | -$5.8M | -$5.0M |
| Net Cash Used In Investing Activities | -$5.8M | -$5.0M |
| Proceeds from note payable and advance from employee | $1.3M | |
| Repayment of advance from employee | -$300.0K | |
| Merger, net | -$3.8M | |
| Net proceeds from common stock offerings | $32.3M | $13.8M |
| Net Cash Provided By Financing Activities | $33.3M | $10.0M |
| Net Change in Cash and Cash Equivalents | $1.0M | -$23.2M |
| IPR&D Milestones included in License Payable | $28.4M | |
| Net Prepaid Manufacturing transferred to Inventory | $1.4M | $6.1M |
| Operating lease right-of-use asset and liability recorded | $786.7K | |
| Interest paid | $187.4K |
No quarter-by-quarter statement was filed.
Corporate structure
Citius Pharmaceuticals, Inc. sits at the top of its group. 1 entity, 1 country on record. Switch between the flow chart and the network, and select any entity to see its details.
Major holders of Citius Pharmaceuticals, Inc.
- CVI Investments, Inc. Filed SCHEDULE 13G/A on Citius Pharmaceuticals, Inc., latest Aug 14, 2026 (3 filings since Oct 27, 2025)
- Leonard L. Mazur Filed SC 13D/A on Citius Pharmaceuticals, Inc., latest Nov 27, 2024 (2 filings since Feb 18, 2022)
- Myron Z. Holubiak Filed SC 13D/A on Citius Pharmaceuticals, Inc., latest Feb 18, 2022
- ARMISTICE CAPITAL, LLC Filed SC 13G/A on Citius Pharmaceuticals, Inc., latest Feb 15, 2022
- Citius Pharmaceuticals, Inc. Cranford, New Jersey, United States
Built from parent and subsidiary links from GLEIF, the Global Legal Entity Identifier Foundation (CC0); major holders from Schedules 13D and 13G. Each entity in the chart links to its source.
What it owns
What Citius Pharmaceuticals, Inc. reports owning in its annual reports to the SEC: buildings, land and equipment, real estate and locations, investments, intangible assets and inventory, at the end of its latest fiscal year and a year before.
Property and equipment
| Item | Latest | A year before | Change |
|---|---|---|---|
| Operating-lease assets (leased space) | $818.7K3 Sep 30, 2025 | $246.2K3 Sep 30, 2024 | +232.5% |
Investments
Intangibles and goodwill
Inventory
| Item | Latest | A year before | Change |
|---|---|---|---|
| Inventory, total | $22.3M3 Sep 30, 2025 | $8.3M3 Sep 30, 2024 | +169.5% |
| Work in process | $11.7M3 Sep 30, 2025 | $2.1M3 Sep 30, 2024 | +448.7% |
| Finished goods | $10.6M3 Sep 30, 2025 | $6.1M3 Sep 30, 2024 | +72.4% |
Properties, in its own words
We lease our offices at 11 Commerce Drive, First Floor, Cranford, New Jersey 07016. The lease runs until February 28, 2030.
Item 2 of the 10-K filed Dec 23, 2025.5
Leadership
Who has led Citius Pharmaceuticals, Inc., and when. Pick a name to see everywhere that person has worked.
Chief executive
Chief financial officer
Chief operating officer
- Chief executive officerMyron Z. Holubiak Apr 8, 2016 to Oct 13, 202113
- Chief executive officerLeonard L. Mazur Oct 28, 2015 to Apr 8, 201614
- ChairLeonard L. Mazur Aug 10, 2017 to Nov 15, 202215
- PresidentMyron Z. Holubiak Apr 8, 2016 to Oct 13, 202113
- PresidentLeonard L. Mazur Oct 28, 2015 to Oct 28, 201514
- Chief financial officerJaime Bartushak Dec 13, 2017 to now16
- Chief operating officerLeonard L. Mazur Oct 28, 2015 to Oct 28, 201514
Board members and other officers (9)
- Vice chairMyron Z. Holubiak Oct 6, 2022 to now17
- Chief Medical OfficerMyron Czuczman Jul 15, 2020 to now18
- Board memberDennis M. McGrath Feb 9, 2023 to now19
- Board memberHoward Safir Apr 11, 2016 to Oct 6, 202220
- Board memberCarol Webb Apr 15, 2016 to now21
- Board memberEugene Myron Holuka Jun 29, 2016 to now22
- Board memberMyron Z. Holubiak Oct 27, 2015 to now23
- Board memberLeonard L. Mazur Oct 28, 2015 to now14
- Board memberSuren G. Dutia Nov 4, 2015 to now24
Former names
Timeline
- Aug 21, 20268-K Listing notice or transfer25
- Aug 14, 20268-K Results of operations26
- Aug 5, 20268-K Other events27
- Jun 1, 20268-K Other events28
- May 15, 20268-K Results of operations29
- May 8, 20268-K Entered a material agreement30
- Apr 29, 20268-K Unregistered sale of shares; Other events31
- Apr 24, 20268-K Entered a material agreement; Other events32
- Apr 6, 20268-K Shareholder vote33
- Mar 31, 20268-K Other events34
- Mar 10, 20268-K Other events35
- Mar 4, 20268-K Other events36
- Apr 8, 2016New chief executive Myron Z. Holubiak becomes CEO13
- Oct 28, 2015New chief executive Leonard L. Mazur becomes CEO14
Calendar
Coming up
- Around Nov 13, 2026Next results, estimated About a quarter after its last report. The company hasn't announced the date.
When it reported results
- Aug 14, 2026Reported quarterly or annual results26
- May 15, 2026Reported quarterly or annual results29
- Feb 13, 2026Reported quarterly or annual results37
- Dec 23, 2025Reported quarterly or annual results38
- Aug 12, 2025Reported quarterly or annual results39
- May 14, 2025Reported quarterly or annual results40
- Dec 27, 2024Reported quarterly or annual results41
- Aug 12, 2024Reported quarterly or annual results42
Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). The full markets calendar
Filings
215 filings to the SEC since October 2021: 7 annual reports, 15 quarterly reports, 91 major events, 48 insider forms, 16 large holders, 38 other. The latest 20:
- Aug 21, 20268-K CURRENT REPORT EDGAR
- Aug 14, 2026SCHEDULE 13G/A EDGAR
- Aug 14, 202610-Q QUARTERLY REPORT EDGAR
- Aug 14, 20268-K CURRENT REPORT EDGAR
- Aug 10, 2026UPLOAD EDGAR
- Aug 5, 20268-K CURRENT REPORT EDGAR
- Jun 4, 2026SCHEDULE 13D/A EDGAR
- Jun 2, 2026EFFECT EDGAR
- Jun 1, 20268-K CURRENT REPORT EDGAR
- May 29, 2026CORRESP EDGAR
- May 22, 2026S-3 REGISTRATION STATEMENT EDGAR
- May 15, 20268-K CURRENT REPORT EDGAR
- May 15, 202610-Q QUARTERLY REPORT EDGAR
- May 8, 20268-K CURRENT REPORT EDGAR
- Apr 29, 20268-K CURRENT REPORT EDGAR
- Apr 24, 20268-K CURRENT REPORT EDGAR
- Apr 24, 2026424B5 PROSPECTUS SUPPLEMENT EDGAR
- Apr 6, 20268-K CURRENT REPORT EDGAR
- Mar 31, 20268-K CURRENT REPORT EDGAR
- Mar 10, 20268-K CURRENT REPORT EDGAR
The 215 filings since October 2021 can be filtered by form type and year here when JavaScript is on.
Every filing from the last five years, summarized. The full record is on SEC EDGAR.
Major holders
Investors who own more than 5% of the shares must tell the SEC: a 13D if they may seek to influence the company, a 13G if they hold passively.
- CVI Investments, Inc.SCHEDULE 13G/A, 3 filings Oct 27, 2025 to Aug 14, 202643
- Leonard L. MazurSC 13D/A, 2 filings Feb 18, 2022 to Nov 27, 202444
- Myron Z. HolubiakSC 13D/A, 1 filing Feb 18, 202245
- ARMISTICE CAPITAL, LLCSC 13G/A, 1 filing Feb 15, 202246
Executive pay
What the company paid its top executives, from the summary compensation table in its proxy statement. Total pay includes salary, bonus, stock and option awards and other pay, as the company valued them.
| Year | Executive | Age | Salary | Total pay |
|---|---|---|---|---|
| 2025 | Leonard Mazur | 81 | $475.0K | $4.5M47 |
| 2025 | Myron Holubiak | 78 | $450.0K | $2.5M47 |
| 2025 | Dr. Myron Czuczman | 66 | $450.0K | $2.5M47 |
| 2024 | Chief Executive Officer and Executive Chairman | $475.0K | $3.5M47 | |
| 2024 | Executive ViceChairman | $450.0K | $2.2M47 | |
| 2024 | Chief Medical Officer | $450.0K | $1.7M47 |
Held by these funds
The largest holders among investment managers' 13F reports for the quarter ending Jun 30, 2026, the top 25 of 43. Change is in shares since the quarter before.
| Fund | Shares | Value | Share of the fund | Change |
|---|---|---|---|---|
| Geode Capital Management, LLC | 215,537 | $130.3K | 0.0% | −30,621 |
| Vanguard Capital Management LLC | 197,364 | $119.4K | 0.0% | +29,626 |
| Miller Financial Services LLC | 130,000 | $78.6K | 0.1% | +116,000 |
| Citadel Advisors LLC | 124,910 | $75.5K | 0.0% | New |
| Jane Street Group, LLC | 122,837 | $74.3K | 0.0% | +100,314 |
| Vanguard Fiduciary Trust Co | 77,755 | $47.0K | 0.0% | No change |
| BlackRock, Inc. | 69,850 | $42.2K | 0.0% | −1 |
| Northern Trust Corp | 62,742 | $37.9K | 0.0% | +18,768 |
| XTX Topco Ltd | 59,199 | $35.8K | 0.0% | +37,904 |
| Asset Advisory Group, Inc. | 59,011 | $35.7K | 0.0% | No change |
| BostonPremier Wealth LLC | 28,000 | $16.9K | 0.0% | New |
| UBS Group AG | 26,335 | $15.9K | 0.0% | −28,690 |
| LPL Financial LLC | 25,445 | $15.4K | 0.0% | +400 |
| State Street Corp | 23,271 | $14.1K | 0.0% | No change |
| Arkadios Wealth Advisors | 20,000 | $12.1K | 0.0% | No change |
| Two Sigma Investments, LP | 17,494 | $10.6K | 0.0% | +4,356 |
| Sanctuary Advisors, LLC | 11,810 | $7.1K | 0.0% | New |
| Susquehanna International Group, Llp | 11,795 | $7.1K | 0.0% | −25,043 |
| R Squared Ltd | 11,033 | $6.7K | 0.0% | New |
| Two Sigma Securities, LLC | 10,006 | $6.0K | 0.0% | New |
| SBI Securities Co., Ltd. | 9,519 | $5.8K | 0.0% | +3,000 |
| Chelsea Counsel Co | 4,626 | $2.8K | 0.0% | No change |
| Quent Capital, LLC | 4,232 | $2.6K | 0.0% | −33 |
| IFP Advisors, Inc | 4,183 | $2.5K | 0.0% | −2,900 |
| Tower Research Capital LLC (TRC) | 2,724 | $1.6K | 0.0% | −61 |
13F reports cover disclosed long positions in U.S. stocks only.
SEC filer profile
How Citius Pharmaceuticals, Inc. is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.
- Name on EDGARCitius Pharmaceuticals, Inc.1
- CIK0001506251
- Employer ID (EIN)27-34259135
- Filer statusNon-accelerated filer not an emerging growth company; a smaller reporting company; not a shell company5
- Incorporated inNevada5
- Fiscal year endsSeptember 301
- Industry code (SIC)2834 Pharmaceutical Preparations1
- SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance1
- Business address11 Commerce Drive, 1St Floor, Cranford, NJ 070161
- Phone(908) 967-66761
- Shares outstanding27,452,570 as of Aug 13, 202612
- Public float$11.4M as of Mar 31, 20255
- AuditorWolf & Company, P.C., Boston, Massachusetts PCAOB ID 392; no auditor attestation of internal control over financial reporting5
- On EDGAR sinceNov 23, 20101
- Filings636 in all: 8-K (185), 4 (113), 10-Q (46), CORRESP (34), UPLOAD (28), 424B3 (25), EFFECT (21), S-1/A (19)1
All 47 form types
424B5 (16), 10-K (14), 3 (12), DEF 14A (12), S-1 (11), DEFA14A (10), SC 13G/A (8), D (7), S-3 (7), SC 13G (7), 424B4 (4), NT 10-Q (4), PRE 14A (4), S-8 (4), SCHEDULE 13D/A (4), 8-K/A (3), ARS (3), NT 10-K (3), POS AM (3), SC 13D (3), SC 13D/A (3), 10-K/A (2), FWP (2), S-3/A (2), SCHEDULE 13G/A (2), SEC STAFF LETTER (2), 10-KT (1), 25-NSE (1), 3/A (1), 4/A (1), 425 (1), 8-A12B (1), 8-A12G (1), CERTNAS (1), CT ORDER (1), D/A (1), PRER14A (1), S-3MEF (1), SCHEDULE 13G (1)
- Latest filingsAnnual report (10-K) Dec 23, 2025
Quarterly report (10-Q) Aug 14, 2026
Proxy statement (DEF 14A) Feb 24, 2026
Latest 8-K (8-K) Aug 21, 2026
Securities registered for trading
| Class | Symbol | Exchange |
|---|---|---|
| Common Stock, par value $0.001 per share | CTXR | NASDAQ |
From the cover page of the 10-K filed Dec 23, 2025 (Section 12(b) of the Exchange Act).5
Risk factors and legal proceedings
The risks Citius Pharmaceuticals, Inc. names in Item 1A of its 10-K filed Dec 23, 2025: 56 risks under these headings, as written.5
- If any of the following risks, or other risks not presently known to us or that we currently believe to not be significant, develop into actual events, then our business, financial condition, results of operations or prospects could be materially adversely affected. If that happens, the market price of our securities could decline, and stockholders may lose all or part of their investment.
- Risks Related to Our Financial Position and Need for Additional Capital
- Our independent registered public accounting firm’s report includes an explanatory paragraph stating that there is substantial doubt about our ability to continue as a going concern.
- We require substantial additional funding in the near future to support our operations, complete the commercialization of LYMPHIR, and continue the development of our other product candidates, which capital may not be available on acceptable terms, or at all.
- We have a history of net losses and expect to incur losses for the foreseeable future. We may never generate revenues or, if we are able to generate revenues, achieve profitability.
- Our and Citius Oncology’s ongoing explorations of alternative strategic paths may not result in entering into or completing transactions, when necessary, and the process of reviewing alternative strategic paths or their conclusion could adversely affect our stock price.
- In the event we or Citius Oncology do not successfully complete a strategic transaction, should this be deemed necessary, our Board may decide to pursue a dissolution and liquidation of our Company. In such an event, the amount of cash available for distribution to our stockholders will depend heavily on the timing of such liquidation as well as the amount of cash that will need to be reserved for commitments and contingent liabilities.
- Risks Related to Our Business and our Industry
- If we are unable to execute our commercial strategy for LYMPHIR, fail to satisfy the conditions of our marketing approval for LYMPHIR, or if we experience significant delays in accomplishing such goals, our business will be materially harmed.
- We need to secure additional financing in the future to complete the development of our other current product candidates and support our operations.
- We are primarily a commercial and late-stage development company with an unproven business strategy and may never achieve commercialization of all our therapeutic product candidates or profitability.
- We have a limited operating history upon which to evaluate our ability to successfully commercialize our product candidates.
The other 46 risks
- We may choose not to continue developing any of our product candidates at any time during development, which would reduce or eliminate our potential return on investment for those product candidates.
- We face significant risks in our product candidate development efforts.
- We, through Citius Oncology, may be required to make milestone payments to the licensor and former licensee of the LYMPHIR intellectual property in connection with its development and commercialization of LYMPHIR, which could adversely affect the profitability of LYMPHIR.
- A material breach or default under any of our license agreements, including failure to make timely payments when due, gives the licensor party to such agreement the right to terminate the license agreement, which termination would materially harm our business.
- We rely exclusively on third parties to formulate and manufacture our product candidates. Our failure to abide by our contractual obligations with these third parties, including timely payment, could result in a delay or the loss of necessary third-party support.
- While our business strategy generally is to focus on the development of late-stage product candidates to lessen the development risk, there is still significant risk to successfully developing a product candidate.
- The results of pre-clinical studies and completed clinical trials are not necessarily predictive of future results, and our current product candidates may not have favorable results in later studies or trials.
- If we are unable to file for approval of Mino-Lok or Halo-Lido under Section 505(b)(2) of the Federal Food, Drug and Cosmetic Act, or if we are required to generate additional data related to safety and efficacy in order to obtain approval of Mino-Lok or Halo-Lido under Section 505(b)(2), we may be unable to meet our anticipated development and commercialization timelines.
- Two of our product candidates, Mino-Lok and Halo-Lido, are combination products consisting of components that have each been separately approved by the FDA for other indications and which are commercially available and marketed by other companies. Our approval under Section 505(b)(2), if received, would not preclude physicians, pharmacists, and patients from obtaining individual drug products and titrating the dosage of these drug products as close to our approved dose as possible.
- Any fast track designation or grant of priority review status by the FDA may not actually lead to a faster development or regulatory review or approval process, nor will it assure FDA approval of our product candidates. Additionally, our product candidates may treat indications that do not qualify for priority review vouchers.
- We do not own Citius Oncology or NoveCite, Inc. outright and will share any benefits from the commercialization of LYMPHIR and the development of the NoveCite product candidate with the other stockholders.
- Because our NoveCite product candidate is based on novel technologies, it is difficult to predict the regulatory approval process and the time, the cost and our ability to successfully initiate, conduct and complete clinical development, and obtain the necessary regulatory and reimbursement approvals, required for commercialization of our NoveCite product candidate.
- NoveCite has assumed that the biological capabilities of iPSCs and adult-donor derived cells are likely to be comparable. If it is discovered that this assumption is incorrect, the NoveCite product candidate research and development activities could be harmed.
- Any FDA programs related to the development and approval of treatments for COVID-19 and its symptoms may not be available to us or actually lead to a faster development or regulatory review or approval process for NoveCite, our proposed treatment for ARDS, nor will it assure FDA approval of such a treatment.
- Even if we receive regulatory approval to commercialize a product candidate, that product may not gain market acceptance among physicians, patients, healthcare payers or the medical community and may not generate significant revenue.
- Even if approved for marketing by applicable regulatory bodies, we will not be able to create a market for any of our product candidates if we fail to establish marketing, sales, and distribution capabilities, either on our own or through arrangements with third parties.
- Our projections regarding the market opportunity for our LYMPHIR may not be accurate, and the actual market for LYMPHIR may be smaller than we estimate.
- Physicians and patients might not accept and use any of our product candidates for which regulatory approval is obtained.
- Our ability to generate product revenues will be diminished if any of our product candidates that may be approved sell for inadequate prices or patients are unable to obtain adequate levels of reimbursement.
- The FDA and other regulatory agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses.
- The markets in which we operate are highly competitive and we might be unable to compete successfully against new entrants or established companies.
- Healthcare reform measures could hinder or prevent our product candidates’ commercial success.
- We are and will be dependent on third-party contract research organizations to conduct all of our clinical trials.
- Any termination, or breach by, or conflict with our strategic partners could harm our business.
- We rely on the significant experience and specialized expertise of our executive management and other key personnel and the loss of any of our executive management or key personnel or our inability to successfully hire their successors could harm our business.
- If we are unable to retain or hire additional qualified personnel, our ability to grow our business might be harmed.
- We expect to need to increase the size of our organization to further develop our product candidates, and we may experience difficulties in managing growth.
- We are subject to information technology and cyber-security threats which could have an adverse effect on our business and results of operations.
- We plan to grow and develop our business through acquisitions of or investment in new or complementary businesses, products or technologies, and the failure to manage these acquisitions or investments, or the failure to integrate them with our existing business, could have a material adverse effect on us.
- Conflicts of interest may arise from our relationship with Citius Oncology and NoveCite.
- Risks Related to Our Regulatory and Legal Environment
- We might not obtain the necessary U.S. or foreign regulatory approvals to commercialize any current product candidates.
- Following any regulatory approval of any product candidate, we will be subject to ongoing regulatory obligations and restrictions, which may result in significant expense and limit our ability to commercialize our other product candidates.
- We could be forced to pay substantial damage awards if product liability claims that may be brought against us are successful.
- Risks Related to Our Intellectual Property
- Our business depends on protecting our intellectual property.
- We rely on trade secret protections through confidentiality agreements with our employees and other parties, and the breach of these agreements could adversely affect our business and prospects.
- If we infringe the rights of third parties we might have to forego developing and/or selling any approved products, pay damages, or defend against litigation.
- The U.S. government could have “march-in rights” to certain of our intellectual property.
- If our trademarks and trade names are not adequately protected, then we may not be able to build name recognition and our business, financial condition and results of operations may be adversely affected.
- Risks Related to the Recently Completed Merger of Citius Oncology
- We may be unable to achieve some or all of the benefits that we expect to achieve from the Merger.
- A planned distribution by Citius Pharma to its stockholders of shares of Citius Oncology could result in significant tax liability to Citius Pharma and our stockholders.
- Risks Related to Our Common Stock
- Our failure to maintain compliance with Nasdaq’s continued listing requirements could result in the delisting of our common stock.
- The market price of our common stock is highly volatile, and you may lose some or all of your investment.
- You may experience dilution of your ownership interests because of the future issuance of additional shares of our common stock or securities convertible into common stock.
- Our Certificate of Incorporation allows for our Board to create new series of preferred stock without further approval by our stockholders, which could adversely affect the rights of the holders of the common stock.
- We have not paid cash dividends in the past and we do not expect to pay cash dividends in the foreseeable future. Any return on investment may be limited to the capital appreciation, if any, of our common stock.
- Provisions in our Amended and Restated Articles of Incorporation, as amended, and under Nevada law could discourage a takeover that stockholders may consider favorable and may lead to entrenchment of management.
Legal proceedings
We are not involved in any litigation that we believe could have a material adverse effect on our financial position or results of operations. There is no action, suit, proceeding, inquiry, or investigation before or by any court, public board, government agency, self-regulatory organization or body pending or, to the knowledge of our executive officers, threatened against or affecting our Company or our officers or directors in their capacities as such.
In the future, we might from time to time become involved in litigation relating to claims arising from our ordinary course of business.
The opening of Item 3, Legal Proceedings.5
Sources
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- 15SEC EDGARLeonard L. Mazur, Chair
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- 17SEC EDGARMyron Z. Holubiak, Vice chair
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- 19SEC EDGARDennis M. McGrath, Board member
- 20SEC EDGARHoward Safir, Board member
- 21SEC EDGARCarol Webb, Board member
- 22SEC EDGAREugene Myron Holuka, Board member
- 23SEC EDGARMyron Z. Holubiak, Board member
- 24SEC EDGARSuren G. Dutia, Board member
- 25SEC EDGARListing notice or transfer
- 26SEC EDGARResults of operations
- 27SEC EDGAROther events
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- 29SEC EDGARResults of operations
- 30SEC EDGAREntered a material agreement
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- 33SEC EDGARShareholder vote
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