U.S. SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 10-Q

 

(Mark One) 

 QUARTERLY REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the quarterly period ended: December 31, 2019

 

OR

 

 TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the transition period from ______________ to ______________

 

Commission File Number 001-38174

 

Citius Pharmaceuticals, Inc.

(Exact name of registrant as specified in its charter)

 

Nevada   27-3425913
(State or other jurisdiction of
incorporation or organization
)
  (IRS Employer
Identification No.
)

 

11 Commerce Drive, First Floor, Cranford, NJ 07016

(Address of principal executive offices and zip code)

 

(908) 967-6677

(Registrant’s telephone number, including area code)

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of Each Class   Trading Symbol(s)   Name of Each Exchange on
Which Registered
Common stock, $0.001 par value   CTXR   Nasdaq Capital Market
Warrants to purchase common stock   CTXRW   Nasdaq Capital Market

 

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to filed such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐

 

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (Section 232.405 of this chapter) during the preceding 12 months (or such shorter period that the registrant was required to submit such files). Yes ☒ No ☐

 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

 

Large accelerated filer           ☐ Accelerated filer                   ☐
Non-accelerated filer             ☒ Smaller reporting company  ☒
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. ☐

  

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).  Yes ☐ No ☒

 

As of February 7, 2020, there were 31,493,389 shares of common stock, $0.001 par value, of the registrant issued and outstanding.

  

 

 

 

 

Citius Pharmaceuticals, Inc.

FORM 10-Q

TABLE OF CONTENTS

December 31, 2019

 

    Page
PART I. FINANCIAL INFORMATION:  
     
Item 1. Financial Statements (Unaudited) 1
  Condensed Consolidated Balance Sheets at December 31, 2019 and September 30, 2019 1
  Condensed Consolidated Statements of Operations for the Three Months Ended December 31, 2019 and 2018 2
  Condensed Consolidated Statements of Changes in Stockholders’ Equity for the Three Months Ended December 31, 2019 and 2018 3
  Condensed Consolidated Statements of Cash Flows for the Three Months Ended December 31, 2019 and 2018 4
  Notes to Condensed Consolidated Financial Statements 5
     
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations 13
Item 3. Quantitative and Qualitative Disclosures about Market Risk 16
Item 4. Controls and Procedures 16
     
PART II. OTHER INFORMATION  
     
Item 1. Legal Proceedings 17
Item 1A. Risk Factors 17
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds 17
Item 3. Defaults Upon Senior Securities 17
Item 4. Mine Safety Disclosures 17
Item 5. Other Information 17
Item 6. Exhibits 17
     
  SIGNATURES 18

  

i

 

 

EXPLANATORY NOTE

 

In this Quarterly Report on Form 10-Q, and unless the context otherwise requires, the “Company,” “we,” “us” and “our” refer to Citius Pharmaceuticals, Inc. and its wholly owned subsidiaries, Citius Pharmaceuticals, LLC and Leonard-Meron Biosciences, Inc., taken as a whole.

 

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

 

This Quarterly Report on Form 10-Q contains “forward-looking statements.” Forward-looking statements include, but are not limited to, statements that express our intentions, beliefs, expectations, strategies, predictions or any other statements relating to our future activities or other future events or conditions. These statements are based on current expectations, estimates and projections about our business based, in part, on assumptions made by management. These statements are not guarantees of future performance and involve risks, uncertainties and assumptions that are difficult to predict. Therefore, actual outcomes and results may, and are likely to, differ materially from what is expressed or forecasted in the forward-looking statements due to numerous factors discussed from time to time in this report and in other documents which we file with the Securities and Exchange Commission. In addition, such statements could be affected by risks and uncertainties related to:

 

  our ability to raise funds for general corporate purposes and operations, including our clinical trials;

 

  the cost, timing and results of our clinical trials;

 

  our ability to obtain and maintain required regulatory approvals for our product candidates;

 

  the commercial feasibility and success of our technology;

 

  our ability to recruit qualified management and technical personnel to carry out our operations; and

 

  the other factors discussed in the “Risk Factors” section of our most recent Annual Report on Form 10-K and elsewhere in this report.

 

Any forward-looking statements speak only as of the date on which they are made, and except as may be required under applicable securities laws, we do not undertake any obligation to update any forward-looking statement to reflect events or circumstances after the filing date of this report.

  

ii

 

 

PART I - FINANCIAL INFORMATION

 

Item 1. Financial Statements

 

CITIUS PHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(Unaudited)

 

   December 31,   September 30, 
   2019   2019 
ASSETS        
Current Assets:        
Cash and cash equivalents  $2,779,650   $7,893,804 
Prepaid expenses   55,747    48,111 
Total Current Assets   2,835,397    7,941,915 
           
Property and equipment, net   413    590 
           
Operating lease right-of-use asset, net   1,103,155     
           
Other Assets:          
Deposits   57,093    57,093 
In-process research and development   19,400,000    19,400,000 
Goodwill   1,586,796    1,586,796 
Total Other Assets   21,043,889    21,043,889 
           
Total Assets  $24,982,854   $28,986,394 
           
LIABILITIES AND STOCKHOLDERS’ EQUITY          
Current Liabilities:          
Accounts payable  $1,547,261   $2,713,542 
Accrued expenses   209,118    246,225 
Accrued compensation   1,475,983    1,400,688 
Accrued interest – related parties   78,288    74,297 
Notes payable – related parties   172,970    172,970 
Operating lease liability   146,244     
Total Current Liabilities   3,629,864    4,607,722 
           
Operating lease liability – non current   976,198     
Total Liabilities   4,606,062    4,607,722 
           
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; 200,000,000 shares authorized; 30,177,674 and 28,930,493 shares issued and outstanding at December 31, 2019 and September 30, 2019, respectively   30,178    28,930 
Additional paid-in capital   80,488,966    80,169,724 
Accumulated deficit   (60,142,352)   (55,819,982)
Total Stockholders’ Equity   20,376,792    24,378,672 
           
Total Liabilities and Stockholders’ Equity  $24,982,854   $28,986,394 

 

See notes to unaudited condensed consolidated financial statements.

  

1

 

 

CITIUS PHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

FOR THE THREE MONTHS ENDED DECEMBER 31, 2019 AND 2018

(Unaudited)

 

   Three Months Ended 
   December 31,   December 31, 
   2019   2018 
         
Revenues  $   $ 
           
Operating Expenses          
Research and development   2,664,546    2,113,101 
General and administrative   1,562,995    1,588,124 
Stock-based compensation – general and administrative   220,384    171,249 
Total Operating Expenses   4,447,925    3,872,474 
           
Operating Loss   (4,447,925)   (3,872,474)
           
Other Income (Expense)          
Other income   110,207     
Interest income   19,339    1,747 
Interest expense   (3,991)   (4,003)
Total Other Income (Expense), Net   125,555    (2,256)
           
Net Loss  $(4,322,370)  $(3,874,730)
           
Net Loss Per Share - Basic and Diluted  $(0.15)  $(0.22)
           
Weighted Average Common Shares Outstanding          
Basic and diluted   29,197,980    17,764,008 

 

See notes to unaudited condensed consolidated financial statements.

  

2

 

 

CITIUS PHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY

FOR THE THREE MONTHS ENDED DECEMBER 31, 2019 AND 2018

(Unaudited)

 

               Additional         
   Preferred   Common Stock   Paid-In   Accumulated     
   Stock   Shares   Amount   Capital   Deficit   Total 
Balance, October 1, 2019  $    28,930,493   $28,930   $80,169,724   $(55,819,982)  $24,378,672 
Issuance of common stock upon exercise of warrants       1,060,615    1,061    (955)       106 
Issuance of common stock for services       186,566    187    99,813        100,000 
Stock-based compensation expense               220,384        220,384 
Net loss                   (4,322,370)   (4,322,370)
Balance, December 31, 2019  $    30,177,674   $30,178   $80,488,966   $(60,142,352)  $20,376,792 
                               
Balance, October 1, 2018  $    16,198,791   $16,199   $68,107,323   $(40,257,838)  $27,865,684 
Issuance of common stock upon exercise of warrants       1,600,000    1,600    14,400        16,000 
Stock-based compensation expense               171,249        171,249 
Net loss                   (3,874,730)   (3,874,730)
Balance, December 31, 2018  $    17,798,791   $17,799   $68,292,972   $(44,132,568)  $24,178,203 

 

See notes to unaudited condensed consolidated financial statements.

  

3

 

 

CITIUS PHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

FOR THE THREE MONTHS ENDED DECEMBER 31, 2019 AND 2018

(Unaudited)

 

   2019   2018 
Cash Flows From Operating Activities:        
Net loss  $(4,322,370)  $(3,874,730)
Adjustments to reconcile net loss to net cash used in operating activities:          
Stock-based compensation expense   220,384    171,249 
Issuance of common stock for services   100,000     
Amortization of operating lease right-of-use asset   34,569     
Depreciation   177    235 
Changes in operating assets and liabilities:          
Other receivables       818,343 
Prepaid expenses   (7,636)   11,109 
Accounts payable   (1,166,281)   509,988 
Accrued expenses   (37,107)   18,773 
Accrued compensation   75,295    182,500 
Accrued interest - related parties   3,991    4,003 
Operating lease liability   (15,282)    
Net Cash Used In Operating Activities   (5,114,260)   (2,158,530)
           
Cash Flows From Financing Activities:          
Proceeds from common stock warrant exercises   106    16,000 
Net Cash Provided By Financing Activities   106    16,000 
           
Net Change in Cash and Cash Equivalents   (5,114,154)   (2,142,530)
Cash and Cash Equivalents - Beginning of Period   7,893,804    9,184,003 
           
Cash and Cash Equivalents - End of Period  $2,779,650   $7,041,473 
           
Supplemental Disclosures Of Cash Flow Information and Non-cash Activities:          
Operating lease right-of-use asset and liability recorded upon adoption of ASC 842  $1,137,724   $ 

 

See notes to unaudited condensed consolidated financial statements.

  

4

 

 

CITIUS PHARMACEUTICALS, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

FOR THE THREE MONTHS ENDED DECEMBER 31, 2019 AND 2018

(Unaudited)

 

1. NATURE OF OPERATIONS, BASIS OF PRESENTATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

 

Business

 

Citius Pharmaceuticals, Inc. (“Citius” or the “Company”) is a specialty pharmaceutical company dedicated to the development and commercialization of critical care products targeting important medical needs with a focus on anti-infective products in adjunct cancer care and unique prescription products.

 

On March 30, 2016, Citius acquired Leonard-Meron Biosciences, Inc. (“LMB”) as a wholly-owned subsidiary. The Company acquired all of the outstanding stock of LMB by issuing shares of its common stock. The net assets acquired included identifiable intangible assets of $19,400,000 related to in-process research and development. The Company recorded goodwill of $1,586,796 for the excess of the purchase price over the net assets.

 

In-process research and development represents the value of LMB’s leading drug candidate which is an antibiotic solution used to treat catheter-related bloodstream infections (Mino-Lok®) and is expected to be amortized on a straight-line basis over a period of eight years commencing upon revenue generation. Goodwill represents the value of LMB’s industry relationships and its assembled workforce. Goodwill will not be amortized but will be tested at least annually for impairment.

 

Citius is subject to a number of risks common to companies in the pharmaceutical industry including, but not limited to, risks related to the development by Citius or its competitors of research and development stage product candidates, market acceptance of its product candidates that might be approved, competition from larger companies, dependence on key personnel, dependence on key suppliers and strategic partners, the Company’s ability to obtain additional financing and the Company’s compliance with governmental and other regulations.

 

Basis of Presentation and Summary of Significant Accounting Policies

 

Basis of Preparation — The accompanying condensed consolidated financial statements include the operations of Citius Pharmaceuticals, Inc., and its wholly-owned subsidiaries, Citius Pharmaceuticals, LLC, and LMB. All significant inter-company balances and transactions have been eliminated in consolidation.

 

The accompanying unaudited condensed consolidated financial statements of the Company have been prepared on the same basis as the annual consolidated financial statements and, in the opinion of management, reflect all adjustments, which include only normal recurring adjustments, necessary to fairly state the condensed consolidated financial position of the Company as of December 31, 2019, the results of its operations and cash flows for the three-month periods ended December 31, 2019 and 2018, and are not necessarily indicative of the results that may be expected for the year ending September 30, 2020. These unaudited condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto included in the Company’s Annual Report on Form 10-K for the year ended September 30, 2019 filed with the Securities and Exchange Commission.

 

Recently Adopted Accounting Standards

 

In February 2016, the FASB issued Accounting Standards Update (“ASU”) No. 2016-02, Leases (Topic 842). ASU 2016-02 requires a lessee to record a right-of-use asset and a corresponding lease liability, initially measured at the present value of the lease payments, on the balance sheet for all leases with terms longer than 12 months, as well as the disclosure of key information about leasing arrangements. Leases will be classified as either finance leases or operating leases, with classification affecting the pattern of expense recognition in the statement of operations. In January, July and December 2018, the FASB issued ASU No’s. 2018-01, 2018-10, 2018-11, 2018-20 and 2019-01, which were targeted improvements to ASU No. 2016-02 (collectively, with ASU No. 2016-02, “ASC 842”) and provided entities with an additional (and optional) transition method to adopt the new lease standard, and provided clarifications to address potential narrow-scope implementation issues. The Company adopted ASU 2016-02 effective October 1, 2019 and elected the optional transition method for adoption. The Company also took advantage of the transition package of practical expedients permitted within ASU 2016-02, which among other things, allowed it to carryforward historical lease classifications. The Company also elected to keep leases with an initial term of 12 months or less off of the balance sheet as a policy election and will recognize those lease payments in the consolidated statements of operations on a straight-line basis over the lease term. As of the adoption date, the Company identified one operating lease arrangement in which it is a lessee. The adoption of this ASU resulted in the recognition of a right-of-use asset and lease liability of $1,137,724.

  

5

 

 

In June 2018, the FASB issued ASU No. 2018-07, Compensation - Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment Accounting which is intended to reduce cost and complexity and to improve financial reporting for nonemployee share-based payments. The amendment is effective for fiscal years beginning after December 15, 2018, including interim periods within that fiscal year. The Company adopted ASU 2018-07 on October 1, 2019 and it did not have a material effect on the Company’s financial position, results of operations or disclosures.

 

There have been no other recently issued accounting pronouncements that have had or are expected to have a material impact on the Company’s consolidated financial statements.

 

Use of Estimates — Our accounting principles require our management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of assets and liabilities at the date of the financial statements, and reported amounts of revenues and expenses during the reporting period. Estimates having relatively higher significance include stock-based compensation, accounting for leases, valuation of warrants, and income taxes. Actual results could differ from those estimates and changes in estimates may occur.

 

Basic and Diluted Net Loss per Common Share — Basic and diluted net loss per common share is computed by dividing net loss in each period by the weighted average number of shares of common stock outstanding during such period. For the periods presented, common stock equivalents, consisting of stock options and warrants were not included in the calculation of the diluted loss per share because they were anti-dilutive.

 

2. GOING CONCERN UNCERTAINTY AND MANAGEMENT’S PLAN

 

The accompanying condensed consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. The Company experienced negative cash flows from operations of $5,114,260 for the three months ended December 31, 2019. The Company has generated no operating revenue to date and has principally raised capital through the issuance of debt and equity instruments to finance its operations. At December 31, 2019, the Company had a working capital deficit of $794,467.  The Company estimates cash resources, including proceeds in January 2020 from the cash exercise of warrants issued in September 2019, will be sufficient to fund its operations into the third quarter of fiscal year 2020. This raises substantial doubt about the Company’s ability to continue as a going concern.

 

The Company plans to raise capital through equity financings from outside investors as well as raise additional funds from existing investors and continued borrowings under related party debt agreements. There is no assurance, however, that the Company will be successful in raising the needed capital and, if funding is available, that it will be available in amounts sufficient for and on terms acceptable to the Company. The accompanying condensed consolidated financial statements do not include any adjustments that might result from the outcome of the above uncertainty.

 

3. PATENT AND TECHNOLOGY LICENSE AGREEMENTS

 

Patent and Technology License Agreement – Mino-Lok

 

LMB has a patent and technology license agreement with Novel Anti-Infective Therapeutics, Inc. (“NAT”) to develop and commercialize Mino-Lok® on an exclusive, worldwide sub licensable basis, as amended. LMB pays an annual maintenance fee each June until commercial sales of a product subject to the license commence. The annual fee paid in June 2019 was $90,000 (at which level it will remain for as long as it is due) and the annual fee paid in June 2018 was $75,000.

 

6

 

 

LMB will also pay annual royalties on net sales of licensed products, with royalties ranging from the mid-single digits to the low double digits or, in the event the licensed product is not subject to a valid patent claim, the royalty is reduced to mid- to lower-single digits. In limited circumstances in which the licensed product is not subject to a valid patent claim and a competitor is selling a competing product, the royalty rate is in the low single digits. After a commercial sale is obtained, LMB must pay minimum aggregate annual royalties of $100,000 in the first commercial year which is prorated for a less than 12-month period, increasing $25,000 per year to a maximum of $150,000 annually. LMB must also pay NAT up to $1,100,000 upon achieving specified regulatory and sales milestones. Finally, LMB must pay NAT a specified percentage of payments received from any sub licensees.

 

Unless earlier terminated by NAT, based on the failure by the Company to achieve certain development and commercial milestones or for various breaches by the Company, the license agreement remains in effect until the date that all patents licensed under the agreement have expired and all patent applications within the licensed patent rights have been cancelled, withdrawn or expressly abandoned. 

 

Patent and Technology License Agreement – Mino-Wrap

 

On January 2, 2019, we entered into a patent and technology license agreement with the Board of Regents of the University of Texas System on behalf of the University of Texas M. D. Anderson Cancer Center (“Licensor”), whereby we in-licensed exclusive worldwide rights to the patented technology for any and all uses relating to breast implants.  We intend to develop a liquefying gel-based wrap containing minocycline and rifampin for the reduction of infections associated with breast implants following breast reconstructive surgeries (“Mino-Wrap”).  We are required to use commercially reasonable efforts to commercialize Mino-Wrap under several regulatory scenarios and achieve milestones associated with these regulatory options leading to an approval from the U.S. Food and Drug Administration (“FDA”). 

 

Under the license agreement, the Company paid a nonrefundable upfront payment of $125,000 which was recorded as research and development expense during the year ended September 30, 2019. We are obligated to pay an annual maintenance fee of $30,000, commencing in January 2020, which increases annually by $15,000 per year up to a maximum of $90,000. Annual maintenance fees cease on the first sale of product. We also must pay up to an aggregate of $2.1 million in milestone payments, contingent on the achievement of various regulatory and commercial milestones. Under the terms of the license agreement, we also must pay a royalty of mid- to upper-single digit percentages of net sales, depending on the amount of annual sales, and subject to downward adjustment to lower- to mid-single digit percentages in the event there is no valid patent for the product in the United States at the time of sale. After the first sale of product, we will owe an annual minimum royalty payment of $100,000 that will increase annually by $25,000 for the duration of the term.  We will be responsible for all patent expenses incurred by Licensor for the term of the agreement although Licensor is responsible for filing, prosecution and maintenance of all patents. Unless earlier terminated by Licensor, based upon the failure by us to achieve certain development and commercial milestones or for various breaches by us, the agreement expires on the later of the expiration of the patents or January 2, 2034.

 

4. NOTES PAYABLE – RELATED PARTIES

 

The aggregate principal balance as of December 31, 2019 consists of notes payable held by our Chairman, Leonard Mazur, in the amount of $160,470 and notes payable held by our Chief Executive Officer, Myron Holubiak, in the amount of $12,500. Notes with an aggregate principal balance of $104,000 accrue interest at the prime rate plus 1.0% per annum and notes with an aggregate principal balance of $68,970 accrue interest at 12% per annum.

 

Interest expense on notes payable – related parties was $3,991 and $4,003, respectively, for the three months ended December 31, 2019 and 2018.

 

5. COMMON STOCK, STOCK OPTIONS AND WARRANTS

 

Registered Direct/Private Placement Offerings

 

On April 3, 2019, the Company closed a registered direct offering with several institutional and accredited investors for the sale of 3,430,421 shares of common stock at $1.545 per share for gross proceeds of $5,300,001. Simultaneously, the Company also privately sold and issued 3,430,421 immediately exercisable two-year unregistered warrants to the investors with an exercise price of $1.42 per share. The Company paid the placement agent for the offering a fee of 7% of the gross proceeds totaling $371,000 and issued the placement agent 240,130 immediately exercisable two-year warrants with an exercise price of $1.93125 per share. The Company also reimbursed the placement agent for $85,000 in expenses and incurred $10,000 in other expenses. Net proceeds from the offering were $4,834,001. The estimated fair value of the 3,430,421 warrants issued to the investors was $2,709,467 and the estimated fair value of the 240,130 warrants issued to the placement agent was $169,854.

 

On September 27, 2019, Citius closed an underwritten at-the-market offering of (i) 6,760,615 units, each unit consisting of one share of common stock and one immediately exercisable five-year warrant to purchase one share at $0.77 per share, and (ii) 1,060,615 pre-funded units, each pre-funded unit consisting of one pre-funded warrant to purchase one share and one immediately exercisable five-year warrant to purchase one share at $0.77 per share. The pre-funded warrants included in the pre-funded units are immediately exercisable at a price of $0.0001 per share and do not expire. The offering price was $0.8951 per unit and $0.895 per pre-funded unit. The net proceeds of the offering were $6,290,335. The Company issued the underwriter immediately exercisable five-year warrants to purchase up to 547,486 shares at $1.118875 per share with an estimated fair value of $323,414. The estimated fair value of the 1,060,615 pre-funded warrants was $809,145, and the estimated fair value of the 7,821,230 warrants included in the units and the pre-funded units issued to the investors was $4,845,341.

  

7

 

 

Common Stock Issued for Services

 

On February 13, 2019, the Company issued 125,000 shares of common stock for investor relations services and expensed the $117,500 fair value of the common stock issued.

 

On September 16, 2019, the Company issued 94,097 shares of common stock for investor relations services and expensed the $94,097 fair value of the common stock issued.

 

On November 4, 2019, the Company issued 186,566 shares of common stock for strategic consulting and corporate development services and expensed the $100,000 fair value of the common stock issued.

 

Stock Option Plans

 

Pursuant to its 2014 Stock Incentive Plan (the “2014 Plan”) the Company reserved 866,667 shares of common stock for issuance to employees, directors and consultants. The Board of Directors (or committees and/or executive officers delegated by the Board of Directors) may grant stock options, stock appreciation rights, restricted stock, restricted stock units, other stock-based awards and cash-based awards under the 2014 Plan. As of December 31, 2019, there were options to purchase an aggregate of 861,838 shares of common stock outstanding under the 2014 Plan, options to purchase 4,829 shares were exercised, and no shares remain available for future grants.

 

On February 7, 2018, our stockholders approved the 2018 Omnibus Stock Incentive Plan (the “2018 Plan”) and the Company reserved 2,000,000 shares of common stock for issuance to employees, directors and consultants. Pursuant to the 2018 Plan, the Board of Directors (or committees and/or executive officers delegated by the Board of Directors) may grant stock options, stock appreciation rights, restricted stock, restricted stock units, other stock-based awards and cash-based awards. As of December 31, 2019, there were options to purchase an aggregate of 1,890,000 shares of common stock outstanding under the 2018 Plan and 110,000 shares available for future grants.

 

The fair value of each stock option award is estimated on the date of grant using the Black-Scholes option pricing model. Due to its limited operating history and limited number of sales of its common stock, the Company estimated its volatility in consideration of a number of factors including the volatility of comparable public companies through December 31, 2018. Since January 1, 2019, the Company has estimated its volatility using the trading activity of its common stock. The risk-free interest rate is based on the U.S. Treasury yield curve in effect at the time of grant commensurate with the expected term assumption. The expected term of stock options granted, all of which qualify as “plain vanilla,” is based on the average of the contractual term (generally 10 years) and the vesting period. For non-employee options, the expected term is the contractual term.

  

8

 

 

A summary of option activity under the 2014 Plan and 2018 Plan is presented below:

 

   Option
Shares
   Weighted-
Average
Exercise
Price
   Weighted-
Average
Remaining
Contractual
Term
  Aggregate
Intrinsic
Value
 
Outstanding at October 1, 2019   1,771,039   $4.03         
Granted   980,799    0.67         
Exercised                
Forfeited or expired                
Outstanding at December 31, 2019   2,751,838   $2.831   8.3 years  $416,892 
Exercisable at December 31, 2019   1,199,509   $5.18   6.9 years  $67,461 

 

On October 8, 2019, the Board of Directors granted stock options to purchase a total of 705,799 shares to employees, 125,000 shares to directors and 125,000 shares to consultants at $0.67 per share. On October 28, 2019, the Board of Directors granted stock options to purchase a total of 25,000 shares to a consultant at $0.55 per share. All of these options vest over terms of 12 to 36 months and have a term of 10 years.

 

Stock-based compensation expense for the three months ended December 31, 2019 and 2018 was $220,384 and $171,249, respectively.

 

At December 31, 2019, unrecognized total compensation cost related to unvested awards of $1,208,053 is expected to be recognized over a weighted average period of 1.9 years.

 

Warrants

 

As of December 31, 2019, the Company has reserved shares of common stock for the exercise of outstanding warrants. The following table summarizes the warrants outstanding:

 

   Exercise
price
   Number   Expiration Dates
Investor Warrants  $9.00    202,469   March 19, 2020 – September 14, 2020
Investor Warrants   9.00    307,778   November 5, 2020 – April 25, 2021
LMB Warrants   6.15    38,771   November 20, 2020 – March 2, 2021
LMB Warrants   9.90    4,985   January 8, 2020
LMB Warrants   20.70    2,668   March 6, 2020
LMB Warrants   7.50    73,883   August 18, 2020 – March 14, 2021
LMB Warrants   7.50    53,110   March 24, 2022 – April 29, 2022
Financial Advisor Warrants   3.00    25,833   August 15, 2021
2016 Offering Warrants   4.13    140,819   November 23, 2021 – February 27, 2022
2017 Public Offering Warrants   4.13    1,622,989   August 2, 2022
2017 Public Offering Underwriter Warrants   4.54    65,940   February 2, 2023
December 2017 Registered Direct/Private Placement Offering Investor Warrants   4.63    640,180   June 19, 2023
December 2017 Registered Direct/Private Placement Offering Placement Agent Warrants   5.87    89,625   December 19, 2022
March 2018 Registered Direct/Private Placement Offering Investor Warrants   2.86    669,504   October 2, 2023
March 2018 Registered Direct/Private Placement Offering Placement Agent Warrants   3.73    46,866   March 28, 2023
August 2018 Offering Investor Warrants   1.15    7,843,138   August 14, 2023
August 2018 Offering Agent Warrants   1.59    549,020   August 8, 2023
April 2019 Registered Direct/Private Placement Offering Investor Warrants   1.42    3,430,421   April 5, 2021
April 2019 Registered Direct/Private Placement Offering Placement Agent Warrants   1.93    240,130   April 5, 2021
September 2019 Offering Investor Warrants   0.77    7,821,230   September 27, 2024
September 2019 Offering Underwriter Warrants   1.12    547,486   September 27, 2024
         24,416,845    

 

9

 

 

During the three months ended December 31, 2018, 1,600,000 of the August 2018 Offering Pre-Funded Unit Warrants were exercised at $0.01 per share for net proceeds of $16,000.

 

During the three months ended December 31, 2019, 1,060,615 of the September 2019 Offering Pre-Funded Unit Warrants were exercised at $0.0001 per share for net proceeds of $106.

 

At December 31, 2019, the weighted average remaining life of the outstanding warrants is 3.49 years, all warrants are exercisable, and the aggregate intrinsic value of the warrants outstanding was $1,955,308. 

 

Common Stock Reserved 

 

A summary of common stock reserved for future issuances as of December 31, 2019 is as follows:

 

Stock plan options outstanding   2,751,838 
Stock plan shares available for future grants   110,000 
Warrants outstanding   24,416,845 
Unit purchase options outstanding   201,334 
Total   27,480,017 

 

6. RELATED PARTY TRANSACTIONS

 

Our Chairman of the Board, Leonard Mazur, was the cofounder and Vice Chairman of Akrimax Pharmaceuticals, LLC (“Akrimax”), a privately held pharmaceutical company specializing in producing cardiovascular and general pharmaceutical products. The Company leased office space from Akrimax through April 30, 2019 (see Note 7).

 

The Company has outstanding debt due to Leonard Mazur (Chairman of the Board) and Myron Holubiak (Chief Executive Officer) (see Note 4).

 

In connection with the April 2019 registered direct/private placement offering (See Note 5), Mr. Mazur purchased 1,165,048 shares of common stock at $1.545 per share and received 1,165,048 warrants with an exercise price of $1.42 per share, and Mr. Holubiak purchased 129,450 shares of common stock at $1.545 per share and received 129,450 warrants with an exercise price of $1.42 per share. The purchases were made on the same terms as for all other investors.

 

In connection with the September 2019 offering (See Note 5), Mr. Mazur purchased 2,234,700 shares of common stock at $0.8951 per share and received 2,234,700 warrants exercisable at $0.77 per share, and Mr. Holubiak purchased 558,597 shares of common stock at $0.8951 per share and received 558,597 warrants exercisable at $0.77 per share. The purchases were made on the same terms as for all other investors.

  

10

 

 

7. OPERATING LEASE

 

LMB leased office space from Akrimax (see Note 6) in Cranford, New Jersey at a monthly rental rate of $2,167 pursuant to an agreement which expired on April 30, 2019. Rent expense for the three months ended December 31, 2018 was $6,501.

 

Effective July 1, 2019, Citius entered into a 76-month lease for office space in Cranford, NJ.

 

As of September 30, 2019, minimum future lease payments under non-cancellable leases (consisting of the Cranford lease only) were as follows:

 

Year Ending September 30,    
2020  $210,557 
2021   234,447 
2022   239,306 
2023   244,165 
2024   249,024 
Thereafter   275,343 
Total  $1,452,842 

 

Citius will also pay its proportionate share of real estate taxes and operating expenses in excess of the base year expenses. These costs are considered to be variable lease payments and are not included in the determination of the lease’s right-of-use asset or lease liability. 

 

The Company identified and assessed the following significant assumptions in recognizing its right-of-use assets and corresponding lease liabilities:

 

As the Company’s current Cranford lease does not provide an implicit rate, the Company estimated the incremental borrowing rate in calculating the present value of the lease payments. The Company has estimated its incremental borrowing rate based on electing the remaining lease term as of the adoption date.
Since the Company elected to account for each lease component and its associated non-lease components as a single combined component, all contract consideration was allocated to the combined lease component.
The expected lease terms include noncancelable lease periods

 

The elements of lease expense are as follows:

  

Lease cost  Three Months
Ended
December 31,
2019
 
Operating lease cost  $57,349 
Short-term lease cost    
Variable lease cost    
Total lease cost  $57,349 
      
Other information     
Weighted-average remaining lease term - operating leases   5.8 Years 
Weighted-average discount rate - operating leases   8.0%

 

Maturities of lease liabilities due under the Company’s current Cranford lease as of December 31, 2019 is as follows:

 

Leases  As of
December 31,
2019
 
2020 (excluding the 3 months ended December 31, 2019)  $172,494 
2021   234,447 
2022   239,306 
2023   244,165 
2024   249,024 
Thereafter   275,343 
Total lease payments   1,414,779 
Less: interest   (292,337)
Present value of lease liabilities  $1,122,442 

 

11

 

 

Leases  Classification  As of
December 31,
2019
 
Assets       
Lease asset  Operating  $1,103,155 
Total lease assets     $1,103,155 
         
Liabilities        
Current  Operating  $146,244 
Non-current  Operating   976,198 
Total lease liabilities     $1,122,442 

 

Interest expense on the lease liability was $22,780 for the three months ended December 31, 2019.

 

8. FDA REFUND

 

In November 2019, the Company received an additional $110,207 refund from the FDA for 2016 product and establishment fees because the fees paid by the Company exceeded the costs of the FDA’s review of the associated applications. The Company recorded the $110,207 as other income during the three months ended December 31, 2019.

 

9. SUBSEQUENT EVENTS

 

Nasdaq Listing

 

On October 30, 2019, Citius had received notice from The Nasdaq Stock Market, (“NASDAQ”), indicating that, because the closing bid price for the common stock had fallen below $1.00 per share for 30 consecutive business days, the Company no longer complied with the $1.00 minimum bid price requirement for continued listing. On January 31, 2020, Citius received notice from NASDAQ stating that because the closing bid price of the Company’s common stock was $1.00 per share or greater for 10 consecutive business days, the Company had regained compliance with the Listing Rule requirements of NASDAQ.

 

Warrant Exercises

 

In January 2020, investors who participated in the September 2019 Offering exercised 1,315,715 warrants to purchase 1,315,715 shares of common stock. The exercise price of each warrant was $0.77 per share resulting in net proceeds of $1,013,101 to the Company.

 

Annual Meeting

 

On February 10, 2020, the Company’s stockholders approved the 2020 Omnibus Stock Incentive Plan (“2020 Stock Plan”). The 2020 Stock Plan authorizes a maximum of 3,110,000 shares. The 2020 Stock Plan provides incentives to employees, directors, and consultants of the Company in form of granting an option, SAR, dividend equivalent right, restricted stock, restricted stock unit, or other right or benefit under the 2020 Stock Plan.

  

12

 

 

Item 2.  Management’s Discussion and Analysis of Financial Condition and Results of Operations

 

The following discussion and analysis of our financial condition and results of operations for the three months ended December 31, 2019 should be read together with our unaudited consolidated financial statements and related notes included elsewhere in this report and in conjunction with the audited financial statements of Citius Pharmaceuticals, Inc. included in our Annual Report on Form 10-K for the year ended September 30, 2019. The following discussion contains “forward-looking statements” that reflect our future plans, estimates, beliefs and expected performance. Our actual results may differ materially from those currently anticipated and expressed in such forward-looking statements as a result of a number of factors. We caution that assumptions, expectations, projections, intentions or beliefs about future events may, and often do, vary from actual results and the differences can be material. Please see “Cautionary Note Regarding Forward-Looking Statements.”

  

Historical Background

 

Citius Pharmaceuticals, Inc. (“Citius” or the “Company”) is a specialty pharmaceutical company dedicated to the development and commercialization of critical care products targeting important medical needs with a focus on anti-infective products in adjunct cancer care and unique prescription products. On September 12, 2014, we acquired Citius Pharmaceuticals, LLC as a wholly-owned subsidiary and on March 30, 2016, we acquired Leonard-Meron Biosciences, Inc. (“LMB”) as a wholly-owned subsidiary.

 

In-process research and development represents the value of LMB’s leading drug candidate, Mino-Lok®, which is an antibiotic solution used to treat catheter-related bloodstream infections.  Goodwill represents the value of LMB’s industry relationships and its assembled workforce. In-process research and development is expected to be amortized on a straight-line basis over a period of eight years commencing upon revenue generation. Goodwill will not be amortized, but will be tested at least annually for impairment.

 

Through December 31, 2019, the Company has devoted substantially all of its efforts to business planning, acquiring our proprietary technology, research and development, recruiting management and technical staff, and raising capital. We are developing three proprietary products: Mino-Lok, an antibiotic lock solution used to treat patients with catheter-related bloodstream infections by salvaging the infected catheter; Mino-Wrap, a liquifying gel-based wrap for reduction tissue expander infections following breast reconstructive surgeries; and Halo-Lido, a corticosteroid-lidocaine topical formulation that is intended to provide anti-inflammatory and anesthetic relief to persons suffering from hemorrhoids. We believe these unique markets for our products are large, growing, and underserved by the current prescription products or procedures.

 

Patent and Technology License Agreements

 

Mino-Lok® - LMB has a patent and technology license agreement with Novel Anti-Infective Therapeutics, Inc. (“NAT”) to develop and commercialize Mino-Lok® on an exclusive, worldwide sub-licensable basis, as amended. Since May 2014, LMB has paid an annual maintenance fee, which began at $30,000 and that increased over five years to $90,000, where it will remain until the commencement of commercial sales of a product subject to the license commence. LMB will also pay annual royalties on net sales of licensed products, with royalties ranging from the mid-single digits to the low double digits or, in the event the licensed product is not subject to a valid patent claim, the royalty is reduced to mid- to lower-single digits. In limited circumstances in which the licensed product is not subject to a valid patent claim and a competitor is selling a competing product, the royalty rate is in the low single digits. After a commercial sale is obtained, LMB must pay minimum aggregate annual royalties that increase in subsequent years. LMB must also pay NAT up to $1,100,000 upon achieving specified regulatory and sales milestones. Finally, LMB must pay NAT a specified percentage of payments received from any sub licensees.

 

Mino-Wrap - On January 2, 2019, we entered into a patent and technology license agreement with the Board of Regents of the University of Texas System on behalf of the University of Texas M. D. Anderson Cancer Center (“Licensor”), whereby we in-licensed exclusive worldwide rights to the patented technology for any and all uses relating to breast implants.  We intend to develop a liquefying gel-based wrap containing minocycline and rifampin for the reduction of infections associated with breast implants following breast reconstructive surgeries (“Mino-Wrap”).  We are required to use commercially reasonable efforts to commercialize Mino-Wrap under several regulatory scenarios and achieve milestones associated with these regulatory options leading to an approval from the Food and Drug Administration (“FDA”). 

  

Under the license agreement, the Company paid a nonrefundable upfront payment of $125,000. We are obligated to pay an annual maintenance fee of $30,000, commencing in January 2020, that increases annually by $15,000 per year up to a maximum of $90,000. Annual maintenance fees cease on the first sale of product. We also must pay up to an aggregate of $2.1 million in milestone payments, contingent on the achievement of various regulatory and commercial milestones. Under the terms of the license agreement, we also must pay a royalty of mid- to upper-single digit percentages of net sales, depending on the amount of annual sales, and subject to downward adjustment to lower- to mid-single digit percentages in the event there is no valid patent for the product in the United States at the time of sale. After the first sale of product, we will owe an annual minimum royalty payment of $100,000 that will increase annually by $25,000 for the duration of the term.  We will be responsible for all patent expenses incurred by Licensor for the term of the agreement although Licensor is responsible for filing, prosecution and maintenance of all patents.

 

13

 

 

RESULTS OF OPERATIONS

 

Three months ended December 31, 2019 compared with the three months ended December 31, 2018

 

   Three Months Ended
December 31,
2019
   Three Months Ended
December 31,
2018
 
Revenues  $   $ 
           
Operating expenses:          
Research and development   2,664,546    2,113,101 
General and administrative   1,562,995    1,588,124 
Stock-based compensation expense   220,384    171,249 
Total operating expenses   4,447,925    3,872,474 
Operating loss   (4,447,925)   (3,872,474)
Interest income   19,339    1,747 
Other income   110,207     
Interest expense   (3,991)   (4,003)
Net loss  $(4,322,370)  $(3,874,730)

 

Revenues

 

We did not generate any revenues for the three months ended December 31, 2019 or 2018.

 

Research and Development Expenses

 

For the three months ended December 31, 2019, research and development expenses were $2,664,546 as compared to $2,113,101 during the three months ended December 31, 2018, an increase of $551,445. Research and development costs for Mino-Lok® increased by $118,902 to $2,113,005 for the three months ended December 31, 2019 as compared to $1,994,103 for the three months ended December 31, 2018. Research and development costs for our Halo-Lido product candidate increased by $431,043 to $550,041 for the three months ended December 31, 2019 as compared to $118,998 for the three months ended December 31, 2018. We incurred $1,500 in research and development costs on our Mino-Wrap in the three months ended December 31, 2019. We expect that research and development expenses will continue to increase in fiscal 2020 as we continue to focus on our Phase 3 trial for Mino-Lok® and commence our research and development efforts related to Mino-Wrap. We are actively seeking to raise additional capital in order to fund our research and development efforts.

 

14

 

 

On December 19, 2019, the Company announced a positive outcome of the pre-specified interim futility analysis for the Phase 3 clinical trial of Mino-Lok® versus the standard-of-care antibiotic locks. The analysis was conducted by the Mino-Lok trial Data Monitoring Committee (“DMC”), an independent panel of experts charged with periodically monitoring the safety and efficacy of the progress of the pivotal trial. The Company reached and completed the prespecified 40% enrollment required for the interim futility analysis in late September and, based on the analysis of the data and recommendations of the DMC, will proceed with the current trial as planned. Topline data from the superior efficacy interim analysis, the next major milestone in the Mino-Lok trial, is expected in the first half of 2020.

  

General and Administrative Expenses

 

For the three months ended December 31, 2019, general and administrative expenses were $1,562,995 as compared to $1,588,124 during the three months ended December 31, 2018. General and administrative expenses decreased by $25,129 in comparison with the prior period. General and administrative expenses consist primarily of compensation costs, consulting fees incurred for financing activities and corporate development services, and investor relations expenses.

 

Stock-based Compensation Expense

 

For the three months ended December 31, 2019, stock-based compensation expense was $220,384 as compared to $171,249 for the three months ended December 31, 2018. Stock-based compensation expense includes options granted to directors, employees and consultants. Stock-based compensation expense for the most recently completed quarter increased by $49,135 as the Company granted new options this quarter under its stock option plans.

 

Other Income (Expense)

 

Interest income for the three months ended December 31, 2019 was $19,339 compared to interest income of $1,747 for the prior period. We have invested some of the proceeds of our recent equity offerings in money market accounts.

 

In November 2019, we received an additional $110,207 refund from the Food and Drug Administration (“FDA”) for 2016 product and establishment fees because the fees paid by the Company exceeded the costs of the FDA’s review of the associated applications. The Company recorded the $110,207 as other income during the three months ended December 31, 2019.

 

Interest expense on notes payable – related parties for the three months ended December 31, 2019 was $3,991 compared to $4,003 for the three months ended December 31, 2018.

 

Net Loss

 

For the three months ended December 31, 2019, we incurred a net loss of $4,322,370 compared to a net loss for the three months ended December 31, 2018 of $3,874,730. The $447,640 increase in the net loss was primarily due to the increase of $551,445 in research and development expenses.

   

LIQUIDITY AND CAPITAL RESOURCES

 

Going Concern Uncertainty and Working Capital

 

Citius has incurred operating losses since inception and incurred a net loss of $4,322,370 for the three months ended December 31, 2019. At December 31, 2019, Citius had an accumulated deficit of $60,142,352. Citius’ net cash used in operations during the three months ended December 31, 2019 was $5,114,260.

 

Our September 30, 2019 consolidated financial statements contains an emphasis of a matter regarding substantial doubt about our ability to continue as a going concern and that the consolidated financial statements have been prepared assuming we will continue as a going concern and do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets, or the amounts and classification of liabilities that may result if we do not continue as a going concern.

 

15

 

 

As of December 31, 2019, Citius had a working capital deficit of $794,467. Our limited working capital is attributable to the operating losses incurred by the Company since inception offset by our capital raising activities. At December 31, 2019, Citius had cash and cash equivalents of $2,779,650 available to fund its operations. The Company’s primary sources of cash flow since inception have been from financing activities. Our primary uses of operating cash were for product development and commercialization activities, employee compensation, consulting fees, legal and accounting fees, insurance and investor relations expenses.

 

In January 2020, investors who participated in the September 2019 Offering exercised 1,315,715 warrants to purchase 1,315,715 shares of common stock. The exercise price of each warrant was $0.77 per share resulting in net proceeds of $1,013,101 to the Company.

 

Based on our cash and cash equivalents at December 31, 2019 and the proceeds from the January 2020 warrant exercises, we expect that we will have sufficient funds to continue our operations through March 2020. We plan to raise additional capital in the future to support our operations. There is no assurance, however, that we will be successful in raising the needed capital or that the proceeds will be received in an amount or in a timely manner to support our operations.

 

Inflation

 

Our management believes that inflation has not had a material effect on our results of operations.

 

Off Balance Sheet Arrangements

 

We do not have any off-balance sheet arrangements.

 

Critical Accounting Policies and Estimates

 

The preparation of our financial statements and related disclosures in conformity with accounting principles generally accepted in the United States of America requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, and the disclosure of contingent assets and liabilities as of the date of the financial statements and the amounts of revenues and expenses recorded during the reporting periods. We base our estimates on historical experience, where applicable, and other assumptions that we believe are reasonable under the circumstances. Actual results may differ from our estimates under different assumptions or conditions.

 

Our critical accounting policies and use of estimates are discussed in, and should be read in conjunction with, the annual consolidated financial statements and notes included in the Company’s Annual Report on Form 10-K for the year ended September 30, 2019 as filed with the SEC.

 

Item 3. Quantitative and Qualitative Disclosures About Market Risk

 

Not applicable.

 

Item 4. Controls and Procedures

 

Evaluation of Disclosure Controls and Procedures

 

We maintain disclosure controls and procedures designed to provide reasonable assurance that information required to be disclosed in reports filed under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), is recorded, processed, summarized and reported within the specified time periods and accumulated and communicated to our management, including our principal executive officer and principal financial officer, as appropriate to allow timely decisions regarding disclosure.

 

Our Chief Executive Officer (who is our principal executive officer) and Chief Financial Officer (who is our principal financial officer and principal accounting officer), evaluated the effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) promulgated under the Exchange Act) as of December 31, 2019. In designing and evaluating disclosure controls and procedures, we recognize that any disclosure controls and procedures, no matter how well designed and operated, can only provide reasonable assurance of achieving the desired control objective. As of December 31, 2019, based on the evaluation of these disclosure controls and procedures, our Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures were effective in ensuring that information required to be disclosed by us in reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms.

 

Changes In Internal Control Over Financial Reporting

 

There were no changes in our internal control over financial reporting during the quarter ended December 31, 2019 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

 

16

 

 

PART II - OTHER INFORMATION

 

Item 1. Legal Proceedings

 

None.

 

Item 1A. Risk Factors

 

There has been no change in the Company’s risk factors since the Company’s Form 10-K filed with the SEC on December 16, 2019.

 

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds

 

None.

 

Item 3. Defaults Upon Senior Securities

 

None.

 

Item 4. Mine Safety Disclosures

 

Not applicable.

 

Item 5. Other Information

 

None.

 

Item 6. Exhibits

 

10.1  

Citius Pharmaceuticals, Inc. 2020 Omnibus Stock Incentive Plan (incorporated herein by reference to Appendix A to the definitive proxy statement on Schedule 14A filed on December 20, 2019).

10.2   Form of Notice of Stock Option Grant and Stock Option Award Agreement.*
31.1   Certification of the Principal Executive Officer pursuant to Exchange Act Rule 13a-14(a).*
31.2   Certification of the Principal Financial Officer pursuant to Exchange Act Rule 13a-14(a).*
32.1   Certification of the Principal Executive and Principal Financial Officer pursuant to 18 U.S.C. 1350, as adopted pursuant to Section 906 of the Sarbanes Oxley Act of 2002.*
EX-101.INS   XBRL INSTANCE DOCUMENT*
EX-101.SCH   XBRL TAXONOMY EXTENSION SCHEMA DOCUMENT*
EX-101.CAL   XBRL TAXONOMY EXTENSION CALCULATION LINKBASE*
EX-101.DEF   XBRL TAXONOMY EXTENSION DEFINITION LINKBASE*
EX-101.LAB   XBRL TAXONOMY EXTENSION LABELS LINKBASE*
EX-101.PRE   XBRL TAXONOMY EXTENSION PRESENTATION LINKBASE*

 

*Filed herewith.

 

17

 

 

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, thereunto duly authorized.

 

  CITIUS PHARMACEUTICALS, INC.
     
Date: February 13, 2020 By: /s/ Myron Holubiak
    Myron Holubiak
    Chief Executive Officer
(Principal Executive Officer)
     
Date: February 13, 2020 By: /s/ Jaime Bartushak
    Jaime Bartushak
    Chief Financial Officer
(Principal Financial and Accounting Officer)

 

 

18