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    CRMD   US21900C3088

CORMEDIX INC.

(CRMD)
  Report
Delayed Nasdaq  -  04:00 2022-08-05 pm EDT
7.130 USD   +8.85%
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CORMEDIX INC. Management's Discussion and Analysis of Financial Condition and Results of Operations. (form 10-Q)

05/12/2022 | 04:32pm EDT

The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our 2021 Annual Report on Form 10-K, filed with the Securities and Exchange Commission, or the SEC, on March 29, 2022.




Forward Looking Statements



This Quarterly Report on Form 10-Q contains "forward-looking statements" that involve risks and uncertainties, as well as assumptions that, if they never materialize or prove incorrect, could cause our results to differ materially from those expressed or implied by such forward-looking statements. The statements contained in this Quarterly Report on Form 10-Q that are not purely historical are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, referred to herein as the Exchange Act. Forward-looking statements are often identified by the use of words such as, but not limited to, "anticipate," "believe," "can," "continue," "could," "estimate," "expect," "intend," "may," "will," "plan," "project," "seek," "should," "target," "will," "would" and similar expressions or variations intended to identify forward-looking statements. These statements are based on the beliefs and assumptions of our management based on information currently available to management. Such forward-looking statements are subject to risks, uncertainties and other important factors that could cause actual results and the timing of certain events to differ materially from future results expressed or implied by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those identified below and those discussed in the section titled "Risk Factors" included in our most recent annual report on Form 10-K, as well as any amendments thereto, as filed with the SEC and which are incorporated herein by reference. Furthermore, such forward-looking statements speak only as of the date of this report. Except as required by law, we undertake no obligation to update any forward-looking statements to reflect events or circumstances after the date of such statements. Set forth below is a summary of the principal risks we face:

? We have a history of operating losses, expect to incur additional operating

losses in the future, and may never be profitable;

? Our cost of operations could increase significantly more than what we expect

depending on the costs to complete our development program for DefenCath and

Neutrolin;

? We will need to finance our future cash needs through public or private equity

offerings, debt financings or corporate collaboration and licensing

arrangements. Any additional funds that we obtain may not be on terms favorable

to us or our stockholders and may require us to relinquish valuable rights;

? The FDA considers the resubmission of the NDA for DefenCath, our lead product

candidate, complete, but the onsite inspection by the FDA and subsequent

approval may be delayed and cannot be guaranteed;

? Our only product Neutrolin is only approved in Europe and is still in

development in the United States, we do not have, and may never obtain, the

regulatory approvals we need to market our product candidates outside of the

European Union;

? Final approval by regulatory authorities of our product candidates for

commercial use may be delayed, limited or prevented, any of which would

adversely affect our ability to generate operating revenues;

? Successful development and commercialization of our other products is

uncertain;

? If we fail to comply with environmental, health and safety laws and

regulations, we could become subject to fines or penalties or incur costs that

could harm our business;

? The successful commercialization of Neutrolin will depend on obtaining coverage

and reimbursement for use of Neutrolin from third-party payors;

? Changes in funding for the FDA and other government agencies or future

government shutdowns or disruptions could cause delays in the submission and

regulatory review of marketing applications, which could negatively impact our

business or prospects;

? The ongoing COVID-19 pandemic, or other pandemic, epidemic or outbreak of an

infectious disease may materially and adversely impact our business, including

our preclinical studies and clinical trials;

? Clinical trials required for our product candidates may be expensive and

time-consuming, and their outcome is uncertain;

? Even if approved, our products will be subject to ongoing government regulation

and regulatory approvals;

? Competition and technological change may make our product candidates and

technologies less attractive or obsolete;

? Healthcare policy changes, including reimbursement policies for drugs and

medical devices, may have an adverse effect on our business, financial

condition and results of operations;




                                       22



? If we lose key management or scientific personnel, cannot recruit qualified

employees, directors, officers, or other personnel or experience increases in

compensation costs, our business may materially suffer;

? If we are unable to hire additional qualified personnel, our ability to grow

our business may be harmed;

? We face the risk of product liability claims and the amount of insurance

coverage we hold now or in the future may not be adequate to cover all

liabilities we might incur;

? We may be exposed to liability claims associated with the use of hazardous

materials and chemicals;

? Negative U.S. and global economic conditions may pose challenges to our

business strategy, which relies on funding from the financial markets or

collaborators;

? If we materially breach or default under any of our license agreements, the

licensor party to such agreement will have the right to terminate the license

agreement, which termination may materially harm our business;

? If we and our licensors do not obtain protection for and successfully defend

our respective intellectual property rights, competitors may be able to take

advantage of our research and development efforts to develop competing

products;

? Ongoing and future intellectual property disputes could require us to spend

time and money to address such disputes and could limit our intellectual

property rights;

? The decisions by the European and German patent offices may affect patent

rights in other jurisdictions;

? If we infringe the rights of third parties we could be prevented from selling

products and forced to pay damages and defend against litigation;

? We currently have no internal marketing and sales organization and currently

rely and intend to continue to rely on third parties to market, sell, and

distribute Neutrolin outside of the U.S. We may seek a sales partner in the

U.S. if DefenCath receives FDA approval or we may undertake marketing and sales

of DefenCath in the U.S. on our own. If we are unable to enter into or maintain

agreements with third parties to market and sell DefenCath or any other product

after approval or are unable to find a sales partner or establish our own

marketing and sales capabilities, we may not be able to generate significant or

any product revenues;

? If we or our collaborators are unable to manufacture our products in sufficient

quantities or are unable to obtain regulatory approvals for a manufacturing

facility, we may be unable to meet demand for our products and we may lose

potential revenues;

? Corporate and academic collaborators may take actions that delay, prevent, or

undermine the success of our products;

? Data provided by collaborators and others upon which we rely that has not been

independently verified could turn out to be false, misleading, or incomplete;

? We rely on third parties to conduct our clinical trials and pre-clinical

studies. If those parties do not successfully carry out their contractual

duties or meet expected deadlines, our product candidates may not advance in a

timely manner or at all;

? We will depend on third party suppliers and contract manufacturers for the

manufacturing of our product candidates and have no direct control over the

cost of manufacturing our product candidates. Increases in the cost of

manufacturing our product candidates would increase our costs of conducting

clinical trials and could adversely affect our future profitability;




                                       23



? We will need additional financing to fund our activities in the future, which

likely will dilute our stockholders;

? Our executive officers and directors may sell shares of their stock, and these

sales could adversely affect our stock price;

? Our common stock price has fluctuated considerably and is likely to remain

volatile, in part due to the limited market for our common stock and you could

lose all or a part of your investment;

? A significant number of additional shares of our common stock may be issued at

a later date, and their sale could depress the market price of our common

stock;

? Provisions in our corporate charter documents and under Delaware law could make

an acquisition of us, which may be beneficial to our stockholders, more

difficult;

? Security breaches and other disruptions could compromise our information and

expose us to liability, which would cause our business and reputation to

   suffer; and



? Because do not intend to pay cash dividends on our common stock, our

stockholders will not be able to receive a return on their shares unless the

value of our common stock appreciates and they sell their shares.




Overview


CorMedix Inc. and our wholly owned German subsidiaries, CorMedix Europe GmbH and CorMedix Spain, S.L.U., (collectively referred to herein as "we," "us," "our" and the "Company"), is a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory diseases.

Our primary focus is on the development of our lead product candidate, DefenCath™, for potential commercialization in the United States, or U.S., and other key markets as a catheter lock solution, or CLS. We have in-licensed the worldwide rights to develop and commercialize DefenCath and Neutrolin®. The name DefenCath is the U.S. proprietary name conditionally approved by the U.S. Food and Drug Administration, or FDA, while the name Neutrolin® is currently used in the European Union, or EU, and other territories where we received CE-Mark approval for the commercial distribution of Neutrolin as a CLS regulated as a medical device. DefenCath/Neutrolin is a novel anti-infective solution (a formulation of taurolidine 13.5 mg/mL and heparin 1000 USP Units/mL) intended for the reduction and prevention of catheter-related infections and thrombosis in patients requiring central venous catheters in clinical settings such as hemodialysis, total parenteral nutrition, and oncology. Infection and thrombosis represent key complications among hemodialysis, total parenteral nutrition and oncology patients with central venous catheters. These complications can lead to treatment delays and increased costs to the healthcare system when they occur due to hospitalizations, need for intravenous, or IV antibiotic treatment, long-term anticoagulation therapy, removal/replacement of the central venous catheter, related treatment costs and increased mortality. We believe DefenCath addresses a significant unmet medical need and a potential large market opportunity.



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In January 2015, the FDA designated DefenCath as a Qualified Infectious Disease Product, or QIDP, for prevention of catheter-related blood stream infections in patients with end stage renal disease receiving hemodialysis through a central venous catheter. Catheter-related blood stream infections and clotting can be life-threatening. The QIDP designation provides five years of market exclusivity in addition to the five years granted for a New Chemical Entity upon approval of a New Drug Application, or NDA. In addition, in January 2015, the FDA granted Fast Track designation to DefenCath Catheter Lock Solution, a designation intended to facilitate development and expedite review of drugs that treat serious and life-threatening conditions so that the approved drug can reach the market expeditiously. The Fast Track designation of DefenCath provides us with the opportunity to meet with the FDA on a more frequent basis during the development process, and also ensures eligibility to request priority review of the marketing application.

In December 2015, we launched our Phase 3 Prospective, Multicenter, Double-blind, Randomized, Active Control Study to Demonstrate Safety & Effectiveness of DefenCath/Neutrolin in Preventing Catheter-related Bloodstream Infection in Subjects on Hemodialysis for End Stage Renal Disease, or LOCK-IT-100, in patients with hemodialysis catheters in the U.S. The clinical trial was designed to demonstrate the safety and effectiveness of DefenCath compared to the standard of care CLS, Heparin, in preventing CRBSIs. The primary endpoint for the trial assessed the incidence of CRBSI and time to CRBSI for each study subject. Secondary endpoints were catheter patency, which was defined as required use of tPA, or removal of catheter due to dysfunction, and removal of catheter for any reason.

As previously agreed with the FDA, an interim efficacy analysis was performed when the first 28 potential CRBSI cases were identified in our LOCK-IT-100 study that occurred through early December 2017. Based on these first 28 cases, there was a highly statistically significant 72% reduction in CRBSI by DefenCath relative to the active control of heparin (p=0.0034). Because the pre-specified level of statistical significance was reached for the primary endpoint and efficacy had been demonstrated with no safety concerns, the LOCK-IT-100 study was terminated early. The study continued enrolling and treating subjects until study termination, and the final analysis was based on a total of 795 subjects. In a total of 41 cases, there was a 71% reduction in CRBSI by DefenCath relative to heparin, which was highly statistically significant (p=0.0006), with a good safety profile.

The FDA granted our request for a rolling submission and review of the NDA, which is designed to expedite the approval process for products being developed to address an unmet medical need. Although the FDA usually requires two pivotal clinical trials to provide substantial evidence of safety and effectiveness for approval of an NDA, the FDA will in some cases accept one adequate and well-controlled trial, where it is a large multicenter trial with a broad range of subjects and study sites that has demonstrated a clinically meaningful and statistically very persuasive effect on a disease with potentially serious outcome.

In March 2020, we began the modular submission process for the NDA for DefenCath for the prevention of CRBSI in hemodialysis patients, and in August 2020, the FDA accepted for filing the DefenCath NDA. The FDA also granted our request for priority review, which provides for a six-month review period instead of the standard ten-month review period. As we announced in March 2021, the FDA informed us in its Complete Response Letter, or CRL, that it could not approve the NDA for DefenCath in its present form. The FDA noted concerns at the third-party manufacturing facility after a review of records requested by the FDA and provided by the contract manufacturing organization, or CMO. Additionally, the FDA required a manual extraction study to demonstrate that the labeled volume can be consistently withdrawn from the vials despite an existing in-process control to demonstrate fill volume within specifications.

In April 2021, we and the CMO met with the FDA to discuss proposed resolutions for the deficiencies identified in the CRL to us and the Post-Application Action Letter, or PAAL, received by the CMO from the FDA for the NDA for DefenCath. There was an agreed upon protocol for the manual extraction study identified in the CRL, which has been successfully completed. Addressing the FDA's concerns regarding the qualification of the filling operation necessitated adjustments in the process and generation of additional data on operating parameters for manufacture of DefenCath. We and the CMO determined that additional process qualification was needed with subsequent validation to address these issues. The FDA did not request additional clinical data and did not identify any deficiencies related to the data submitted on the efficacy or safety of DefenCath from LOCK-IT-100. In draft labeling discussed with the FDA, the FDA added that the initial approval will be for the limited population of patients with kidney failure receiving chronic hemodialysis through a central venous catheter. This is consistent with our request for approval pursuant to the Limited Population Pathway for Antibacterial and Antifungal Drugs, or LPAD. LPAD, passed as part of the 21st Century Cures Act, is a new program intended to expedite the development and approval of certain antibacterial and antifungal drugs to treat serious or life-threatening infections in limited populations of patients with unmet needs. LPAD provides for a streamlined clinical development program involving smaller, shorter, or fewer clinical trials and is intended to encourage the development of safe and effective products that address unmet medical needs of patients with serious bacterial and fungal infections. We believe that LPAD will provide additional flexibility for the FDA to approve DefenCath to reduce CRBSIs in the limited population of patients with kidney failure receiving hemodialysis through a central venous catheter.



                                       25




On February 28, 2022, we resubmitted the NDA for DefenCath to address the CRL issued by the FDA. In parallel, our third-party manufacturer submitted responses to the deficiencies identified at the manufacturing facility in the PAAL issued by the FDA concurrently with the CRL. On March 28, 2022, we announced that the resubmission of the NDA for DefenCath has been accepted for filing by the FDA. The FDA considers the resubmission as a complete, Class 2 response with a six-month review cycle. The CMO has been notified that an onsite inspection by FDA will be scheduled during the review. There may be delays if travel restrictions are again imposed due to the ongoing COVID-19 pandemic.

We intend to pursue additional indications for DefenCath use as a CLS in populations with an unmet medical need that also represent potentially significant market opportunities. While we are continuing to assess these areas, potential future indications may include use as a CLS to reduce CRBSIs in total parenteral nutrition patients using a central venous catheter and in oncology patients using a central venous catheter.

The FDA regards taurolidine as a new chemical entity and therefore an unapproved new drug. Consequently, there is no appropriate predicate medical device currently marketed in the U.S. on which a 510(k) approval process could be based. As a result, we will be required to submit a premarket approval application, or PMA, for marketing authorization for any medical device indications that we may pursue. In the event that an NDA for DefenCath is approved by the FDA, the regulatory pathway for these medical device product candidates may be revisited with the FDA. Although there may be no appropriate predicate, de novo Class II designation can be proposed, based on a risk assessment and a reasonable assurance of safety and effectiveness.

In the European Union, or EU, Neutrolin is regulated as a Class 3 medical device. In July 2013, we received CE Mark approval for Neutrolin. In December 2013, we commercially launched Neutrolin in Germany for the prevention of CRBSI, and maintenance of catheter patency in hemodialysis patients using a tunneled, cuffed central venous catheter for vascular access. To date, Neutrolin is registered and may be sold in certain European Union countries for such treatment.

In September 2014, the TUV-SUD and The Medicines Evaluation Board of the Netherlands, or MEB, granted a label expansion for Neutrolin to include use in oncology patients receiving chemotherapy, intravenous, or IV, hydration and IV medications via CVC for the EU. In December 2014, we received approval from the Hessian District President in Germany to expand the label for these same expanded indications. The expansion also adds patients receiving medication and IV fluids via CVC in intensive or critical care units (cardiac care unit, surgical care unit, neonatal critical care unit, and urgent care centers). An indication for use in total parenteral nutrition was also approved.

In September 2019, our registration with the Saudi Arabia Food and Drug Administration, or the SFDA, expired. As a result, we cannot sell Neutrolin in Saudi Arabia and we do not intend to pursue renewal of our registration with the SFDA.

In May 2022, we announced that we expect to begin winding down our operations in the EU and discontinue Neutrolin sales in both the EU and the Middle East.

The COVID-19 pandemic and government measures taken in response have had a significant impact, both direct and indirect, on businesses and commerce. In response to the COVID-19 pandemic, public health measures to reduce the spread of the virus have been implemented across much of the United States, Europe and Asia, including in the locations of our offices, clinical trial sites, key vendors and partners. Such public health measures, including "shelter-in-place" orders, were previously lifted, at least partially, in many locations. However, an increase in the spread of COVID-19 and variants has led, and may continue to lead, to the re-imposition by many nations and U.S. of quarantine requirements for travelers from other regions and may lead to the re-imposition of "shelter-in-place" or other similar orders. Our program timelines may be negatively affected by COVID-19, which could materially and adversely affect its business, financial conditions and results of operations.



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Since our inception, our operations have been primarily limited to conducting clinical trials and establishing manufacturing for our product candidates, licensing product candidates, business and financial planning, research and development, seeking regulatory approval for our products, initial commercialization activities for DefenCath in the U.S. and Neutrolin in the EU and other foreign markets, and maintaining and improving our patent portfolio. We have funded our operations primarily through debt and equity financings. We have generated significant losses to date, and we expect to use substantial amounts of cash for our operations as we prepare our pre-launch commercial activities for DefenCath for the U.S. market and commercialize Neutrolin in the EU and other foreign markets, pursue business development activities, and incur additional legal costs to defend our intellectual property. As of March 31, 2022, we had an accumulated deficit of approximately $252.7 million. We are unable to predict the extent of any future losses or when we will become profitable, if ever.

Financial Operations Overview



Revenue


We have not generated substantial revenue since our inception. Through March 31, 2022, we have funded our operations primarily through debt and equity financings.

Research and Development Expense

Research and development, or R&D, expense consists of: (i) internal costs associated with our development activities; (ii) payments we make to third party contract research organizations, or CRO, contract manufacturers, investigative sites, and consultants; (iii) technology and intellectual property license costs; (iv) manufacturing development costs; (v) personnel related expenses, including salaries, stock-based compensation expense, benefits, travel and related costs for the personnel involved in drug development; (vi) activities relating to regulatory filings and the advancement of our product candidates through preclinical studies and clinical trials; (vii) facilities and other allocated expenses, which include direct and allocated expenses for rent, facility maintenance, as well as laboratory and other supplies; and (viii) costs related to the manufacturing of the product that could potentially be available to support the commercial launch prior to marketing approval. All R&D is expensed as incurred.

Conducting a significant amount of development is central to our business model. Product candidates in later-stage clinical development generally have higher development costs than those in earlier stages of development, primarily due to the significantly increased size and duration of the clinical trials.

The process of conducting pre-clinical studies and clinical trials necessary to obtain regulatory approval is costly and time consuming. The probability of success for each product candidate and clinical trial may be affected by a variety of factors, including, among others, the quality of the product candidate's early clinical data, investment in the program, competition, manufacturing capabilities and commercial viability. As a result of the uncertainties associated with clinical trial enrollments and the risks inherent in the development process, we are unable to determine the duration and completion costs of current or future clinical stages of our product candidates or when, or to what extent, we will generate revenues from the commercialization and sale of any of our product candidates.



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Development timelines, probability of success and development costs vary widely. We are currently focused on securing the marketing approval for DefenCath in the U.S. as well as on continuing sales in foreign markets where Neutrolin is approved. In December 2015, we signed an agreement with a clinical research organization, or CRO, to help us conduct our LOCK-IT-100 Phase 3 clinical trial in hemodialysis patients with central venous catheters to demonstrate the efficacy and safety of DefenCath in preventing catheter-related bloodstream infections and blood clotting in subjects receiving hemodialysis therapy as treatment for end stage renal disease. Our LOCK-IT-100 study was completed and all costs related to the agreement with the CRO has been paid.

We were granted a deferral by the FDA under the Pediatric Research Equity Act, or PREA, that requires sponsors to conduct pediatric studies for NDAs for a new active ingredient, such as taurolidine in DefenCath, unless a waiver or deferral is obtained from the FDA. A deferral acknowledges that a pediatric assessment is required but permits the applicant to submit the pediatric assessment after the submission of an NDA. We have made a commitment to conduct the pediatric study after approval of the NDA for use in adult hemodialysis patients. Pediatric studies for an approved product conducted under PREA may qualify for pediatric exclusivity, which if granted would provide an additional six months of marketing exclusivity. DefenCath would then have the potential to receive a total marketing exclusivity period of 10.5 years, including exclusivity pursuant to NCE and QIDP.

In addition to DefenCath, we are involved in a pre-clinical research collaboration for the use of taurolidine as a possible treatment for rare orphan pediatric tumors. In February 2018, the FDA granted orphan drug designation to taurolidine for the treatment of neuroblastoma in children. We may seek one or more strategic partners or other sources of capital to help us develop and commercialize taurolidine for the treatment of neuroblastoma in children. We are also evaluating opportunities for the possible expansion of taurolidine as a platform compound for use in certain medical devices. Patent applications have been filed in several indications, including wound closure, surgical meshes, and wound management. Based on initial feasibility work, we are advancing pre-clinical studies for taurolidine-infused surgical meshes, suture materials and hydrogels. We will seek to establish development and commercial partnerships if these programs advance.

We are pursuing additional opportunities to generate value from taurolidine, an active component of DefenCath. Based on initial feasibility work, we have completed an initial round of pre-clinical studies for taurolidine-infused surgical meshes, suture materials, and hydrogels, which require a PMA regulatory pathway for approval.

Selling, General and Administrative Expense

Selling, general and administrative, or SG&A, expense includes costs related to commercial personnel, medical education professionals, marketing and advertising, salaries and other related costs, including stock-based compensation expense, for persons serving in our executive, sales, finance and accounting functions. Other SG&A expense includes facility-related costs not included in R&D expense, promotional expenses, costs associated with industry and trade shows, and professional fees for legal services and accounting services.

Foreign Currency Exchange Transaction Gain (Loss)

Foreign currency exchange transaction gain (loss) is the result of re-measuring transactions denominated in a currency other than our functional currency and is reported in the condensed consolidated statement of operations as a separate line item within other income (expense). The intercompany loans outstanding between our company based in New Jersey and our subsidiary based in Germany are not expected to be repaid in the foreseeable future and the nature of the funding advanced is of a long-term investment nature. As such, unrealized foreign exchange movements related to long-term intercompany loans are recorded in other comprehensive income (loss).



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Interest Income


Interest income consists of interest earned on our cash and cash equivalents and short-term investments.



Interest Expense


Interest expense consists of interest incurred on our convertible debt, amortization of debt discount and on financing of expenditures.



Results of Operations


Three months ended March 31, 2022 compared to three months ended March 31, 2021




The following is a tabular presentation of our condensed consolidated operating
results (in thousands):



                                        For the Three Months         % of Change
                                           Ended March 31,            Increase
                                         2022            2021        (Decrease)
Revenue                               $         8      $     88               (91 )%
Cost of sales                                  (2 )         (61 )             (98 )%
Gross profit                                    6            27               (77 )%
Operating Expenses:
Research and development                   (2,288 )      (2,636 )             (13 )%
Selling, general and administrative        (4,751 )      (4,601 )               3 %
Total operating expenses                   (7,039 )      (7,237 )              (3 )%
Loss from operations                       (7,033 )      (7,210 )              (2 )%
Interest income                                14             3               274 %
Foreign exchange transaction loss             (10 )          (5 )             108 %
Interest expense                               (5 )          (5 )               4 %
Net loss                                   (7,034 )      (7,217 )              (3 )%
Other comprehensive loss                      (37 )          (3 )           1,070 %
Comprehensive loss                    $    (7,071 )    $ (7,220 )              (2 )%



Revenue. Revenue for the three months ended March 31, 2022 was $8,000 as compared to $88,000 in the same period last year, a decrease of $80,000. The decrease was attributable to lower sales in the Middle East and European Union countries in 2022 as compared to the same period in 2021.

Cost of Sales. Cost of sales was $2,000 for the three months ended March 31, 2022 compared to $61,000 in the same period last year, a decrease of $59,000. The decrease was primarily attributable to the net decrease in cost of materials as a result of lower sales in 2022 as compared to the same period in 2021.

Research and Development Expense. R&D expense was $2,288,000 for the three months ended March 31, 2022, a decrease of $348,000, or 13%, from $2,636,000 for the same period in 2021. The decrease was driven by net decreases in personnel expenses and non-cash charges for stock-based compensation of $304,000 and $178,000, respectively, offset by an increase in costs related to the manufacturing of DefenCath prior to its potential marketing approval of $163,000.



                                       29




Selling, General and Administrative Expense. SG&A expense was $4,751,000 for the three months ended March 31, 2022, an increase of $150,000, or 3%, from $4,601,000 for the same period in 2021. The increase was primarily attributable to an increase in legal fees of $479,000, mainly due to the securities litigation, an increase in personnel expenses of $270,000, an increase in recruitment fees of $153,000 related to the search for chief executive officer and increases in general office expenses of $128,000. These increases were partially offset, among others of lesser significance, by a decrease in non-cash charges for stock-based compensation of $415,000, reduced costs related to marketing research studies in preparation for the potential marketing approval of DefenCath of $250,000, and a decrease in consulting fees of $225,000.

Interest Income. Interest income was $14,000 for the three months ended March 31, 2022 compared to $3,000 for the same period last year, an increase of $11,000. The increase was attributable to higher average of interest-bearing cash equivalents and short-term investments during the first quarter of 2022 as compared to the same period in 2021.

Foreign Exchange Transaction Gain (Loss). A foreign exchange transaction loss of $10,000 was recorded for the three months ended March 31, 2022 compared to a loss of $5,000 for the same period last year. These losses occur due to the re-measuring of transactions denominated in a currency other than our functional currency.

Interest Expense. Interest expense was $5,000 for the three months ended March 31, 2022 and 2021.

Other Comprehensive Loss. Unrealized foreign exchange movements related to long-term intercompany loans, the translation of the foreign affiliate financial statements to U.S. dollars and unrealized movements related to short-term investment resulted in losses of $37,000 and $3,000 for the three months ended March 31, 2022 and 2021, respectively.

Liquidity and Capital Resources



Sources of Liquidity


As a result of our cost of sales, R&D and SG&A expenditures and the lack of substantial product sales revenue, our ongoing operations have not been profitable since our inception. During the three months ended March 31, 2022, we received net proceeds of $3,004,000 from the issuance of 641,542 shares of common stock under our at-the-market-issuance sales agreement, or ATM program, as compared to $41,456,000 net proceeds for the same period in 2021 from the issuance of 3,737,862 shares of common stock. For the same period in 2021, we also received $125,000 from the exercise of warrants. We will continue to be reliant on external sources of cash for the foreseeable future until we are able to generate revenue.

Net Cash Used in Operating Activities

Net cash used in operating activities for the three months ended March 31, 2022 was $6,744,000 as compared to $6,691,000 for the same period in 2021, an increase of $53,000, primarily driven by a decrease in non-cash stock-based compensation, partially offset by, among others of lesser significance, changes in accrued expenses, accounts payable, and prepaid expenses and other current assets.

Net Cash Provided by (Used in) Investing Activities

Cash used in investing activities for the three months ended March 31, 2022 was $4,188,000 as compared to $526,000 provided by in the same period in 2021. The net cash used in investing activities during the three months ended March 31, 2022 was mainly driven by increased amounts invested in short-term investments as compared to the same period in 2021.

Net Cash Provided by Financing Activities

Net cash provided by financing activities for the three months ended March 31, 2022 was $3,004,000 as compared to $41,581,000 for the same period in 2021, a decrease of $38,577,000. During the three months ended March 31, 2022, we generated net proceeds of $3,004,000 from the sale of our common stock in our ATM program as compared to $41,456,000 net proceeds during the same period in 2021. Additionally, during the same period in 2021, we generated net proceeds of $125,000 from the exercise of warrants.



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Funding Requirements and Liquidity

Our total cash on hand and short-term investments as of March 31, 2022 was $61,687,000, excluding restricted cash of $231,000, compared with $65,466,000 at December 31, 2021, excluding $234,000 restricted cash. As of March 31, 2022, we have approximately $46,880,000 available under our ATM program and $150,000,000 under the 2021 Shelf Registration statement for the issuance of equity, debt or equity-linked securities.

Because our business has not generated positive operating cash flow, we will need to raise additional capital in order to continue to fund our research and development activities, as well as to fund operations generally. Our continued operations are focused primarily in activities leading to the pre-launch and commercialization for DefenCath and will depend on our ability to raise sufficient funds through various potential sources, such as equity, debt financings, and/or strategic relationships and potential strategic transactions. We can provide no assurances that financing or strategic relationships will be available on acceptable terms, or at all.

We expect to continue to fund operations from cash on hand and through capital raising sources as previously described, which may be dilutive to existing stockholders, through revenues from the licensing of our products, or through strategic alliances. We expect to continue to utilize our ATM program, if conditions allow, to support our ongoing funding requirements. Additionally, we may seek to sell additional equity or debt securities through one or more discrete transactions, or enter into a strategic alliance arrangement, but can provide no assurances that any such financing or strategic alliance arrangement will be available on acceptable terms, or at all. Moreover, the incurrence of indebtedness would result in increased fixed obligations and could contain covenants that would restrict our operations. Raising additional funds through strategic alliance arrangements with third parties may require significant time to complete and could force us to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates, or to grant licenses on terms that may not be favorable to us or our stockholders. Our actual cash requirements may vary materially from those now planned due to a number of factors, any change in the focus and direction of our research and development programs, any acquisition or pursuit of development of new product candidates, competitive and technical advances, the costs of commercializing any of our product candidates, and costs of filing, prosecuting, defending and enforcing any patent claims and any other intellectual property rights.

Sales of Neutrolin outside the U.S. are not expected to generate significant product revenues for the foreseeable future, and we expect to grow product sales for DefenCath in the U.S., should we receive FDA approval. In the absence of significant revenue, we are likely to continue generating operating cash flow deficits. We will continue to use cash as we increase other activities leading to the commercialization of DefenCath upon approval, pursue business development activities, and incur additional legal costs to defend our intellectual property.

We currently estimate that we have sufficient cash on hand to fund operations at least through the first half of 2023. Additional financing may be required to build out our commercial infrastructure should we receive FDA approval and to continue our operations should we decide to market and sell DefenCath in the U.S. on our own. If we are unable to raise additional funds when needed, we may be forced to slow or discontinue our preparations for the commercial launch of DefenCath. We may also be required to delay, scale back or eliminate some or all of our research and development programs. Each of these alternatives would likely have a material adverse effect on our business.



                                       31





Contractual Obligations


We entered into a seven-year operating lease agreement in March 2020 for an office space at 300 Connell Drive, Berkeley Heights, New Jersey 07922. The lease agreement, with a monthly average cost of approximately $17,000, commenced on September 16, 2020.

Critical Accounting Policies and Estimates

Our management's discussion and analysis of our financial condition and results of operations is based on our condensed consolidated financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States, or GAAP. The preparation of these condensed consolidated financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities and expenses. On an ongoing basis, we evaluate these estimates and judgments, including those described below. We base our estimates on our historical experience and on various other assumptions that we believe to be reasonable under the circumstances. These estimates and assumptions form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results and experiences may differ materially from these estimates.

For the three-month period ended March 31, 2022, there were no significant changes to our critical accounting policies and estimates as identified in our Annual Report on Form 10-K for the year ended December 31, 2021.

© Edgar Online, source Glimpses

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Financials (USD)
Sales 2022 0,64 M - -
Net income 2022 -36,5 M - -
Net cash 2022 118 M - -
P/E ratio 2022 -8,20x
Yield 2022 -
Capitalization 279 M 279 M -
EV / Sales 2022 253x
EV / Sales 2023 8,14x
Nbr of Employees 30
Free-Float 98,7%
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Managers and Directors
Joseph Todisco Chief Executive Officer & Director
Mathew T. David Chief Financial Officer & Executive Vice President
Myron Lawrence Kaplan Chairman
Antony E. Pfaffle Secretary & Chief Scientific Officer
Elizabeth Masson-Hurlburt Executive VP-Clinical & Medical Affairs
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