RMTI Rockwell Medical Inc

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Rockwell Medical, Inc. (the "Company", "Rockwell", "we", or "us") is a healthcare company that develops, manufactures, commercializes, and distributes a portfolio of hemodialysis products for dialysis providers worldwide.

Rockwell is a revenue-generating business and the second largest supplier of liquid and powder acid and bicarbonate concentrates for dialysis patients in the United States. Hemodialysis is the most common form of end-stage kidney disease treatment and is typically performed at freestanding outpatient dialysis centers, hospital-based outpatient centers, skilled nursing facilities, or in a patient’s home.

Rockwell provides the hemodialysis community with products controlled by a Quality Management System regulated by the U.S. Food and Drug Administration ("FDA"). Rockwell manufactures hemodialysis concentrates at its facilities in Michigan, South Carolina, and Texas totaling approximately 175,000 square feet, and manufactures its dry acid concentrate mixers at its facility in Iowa. Rockwell delivers the majority of its hemodialysis concentrates products and mixers to dialysis clinics throughout the United States and internationally utilizing its own delivery trucks and third-party carriers.

On July 10, 2023, the Company executed and consummated the transactions contemplated by an Asset Purchase Agreement (the “Purchase Agreement”) with Evoqua Water Technologies LLC ("Evoqua") (the "Evoqua Acquisition"). Subject to the terms and conditions of the Purchase Agreement, at the closing of the transaction (the “Closing”), the Company purchased customer relationships, equipment and inventory from Evoqua, which were related to its manufacturing and selling of hemodialysis concentrates products, all of which are manufactured under a contract manufacturing agreement with a third-party organization. See Note 4 for further detail.

In addition to its primary focus on hemodialysis concentrates, Rockwell also has a proprietary parenteral iron product, Triferic® (ferric pyrophosphate citrate ("FPC")), which is indicated to maintain hemoglobin in adult patients with hemodialysis-dependent chronic kidney disease. While Rockwell has discontinued commercialization of Triferic in the United States, the Company has established international partnerships with companies seeking to develop and commercialize Triferic outside the United States and is working closely with these international partners to develop and commercialize Triferic in their respective regions. During the third quarter of 2023, the ongoing Triferic development effort was terminated resulting in an acceleration of the corresponding deferred license revenue (see Note 10) and a reserve on the non-current inventory (see Note 7). Additionally, Rockwell continues to evaluate the viability of its FPC platform and FPC's potential to treat iron deficiency, iron deficiency anemia, and acute heart failure.

Rockwell was incorporated in the state of Michigan in 1996 and re-domiciled to the state of Delaware in 2019. Rockwell's headquarters is located at 30142 Wixom Road, Wixom, Michigan 48393.

As of September 30, 2023, Rockwell had approximately $11.7 million of cash, cash equivalents and investments available-for-sale, and working capital of $6.8 million. Net cash used in operating activities for the nine months ended September 30, 2023 was approximately $9.4 million. Based on the currently available working capital, management believes the Company currently has sufficient funds to meet its operating requirements for at least the next twelve months from the date of the filing of this report.

The Company continues to review its operational plans and execute on the acquisition of new customers, and has implemented cost containment activities. The Company may require additional capital to sustain its operations and make the investments it needs to execute its strategic plan. Additionally, the Company's operational plans include raising capital, if needed, by using its at-the-market ("ATM") facility or other methods or forms of financings, subject to existing limitations.

If the Company attempts to obtain additional debt or equity financing, the Company cannot assume such financing will be available on favorable terms, if at all.

In 2023, the Company is no longer subject to the "baby shelf" limitations under Form S-3, which limit the amount the Company may offer pursuant to its registration statement on Form S-3.

The Company is subject to certain covenants and cure provisions under its Loan Agreement with Innovatus. As of the date of this report, the Company is in compliance with all covenants (See Note 15 for further detail).

In addition, the global macroeconomic environment is uncertain, and could be negatively affected by, among other things, increased U.S. trade tariffs and trade disputes with other countries, instability in the global capital and credit markets, recent bank failures in the United States, supply chain weaknesses, and instability in the geopolitical environment, including as a result of the Russian invasion of Ukraine, Israel-Hamas conflict and other political tensions, and lingering effects of the COVID-19 pandemic. Such challenges have caused, and may continue to cause, recession fears, rising interest rates, foreign exchange volatility and inflationary pressures. At this time, the Company is unable to quantify the potential effects of this economic instability on our future operations.

Rockwell has utilized a range of financing methods to fund its operations in the past; however, current conditions in the financial and credit markets may limit the availability of funding, refinancing or increase the cost of funding. Due to the rapidly evolving nature of the global situation, it is not possible to predict the extent to which these conditions could adversely affect the Company's liquidity and capital resources in the future.

The accompanying condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) for interim financial information and pursuant to the instructions to Form 10-Q and Rule 10-01 of Regulation S-X of the U. S. Securities and Exchange Commission (“SEC”) and on the same basis as the Company prepares its annual audited consolidated financial statements.

The condensed consolidated balance sheet at September 30, 2023, and the condensed consolidated statements of operations, comprehensive loss, and changes in stockholders' equity for the three and nine months ended September 30, 2023 and cash flows for the nine months ended September 30, 2023 are unaudited, but include all adjustments, consisting of normal recurring adjustments the Company considers necessary for a fair presentation of the financial position, operating results and cash flows for the periods presented. The results for the three and nine months ended September 30, 2023 are not necessarily indicative of results to be expected for the year ending December 31, 2023 or for any future interim period. The condensed consolidated balance sheet at December 31, 2022 has been derived from audited financial statements, however, it does not include all of the information and notes required by U.S. GAAP for complete financial statements. The accompanying condensed consolidated financial statements should be read in conjunction with the audited financial statements for the year ended December 31, 2022 and notes thereto included in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2022 as filed with the SEC on March 30, 2023. The Company’s consolidated subsidiaries consist of its wholly-owned subsidiaries, Rockwell Transportation, Inc. and Rockwell Medical India Private Limited.

The accompanying condensed consolidated interim financial statements include the accounts of the Company and its subsidiaries. All material intercompany balances and transactions have been eliminated in consolidation.

Use of Estimates

The preparation of the condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that may affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and reported amounts of expenses during the reporting period. Actual results could differ from those estimates.

Restatement of Loss Per Share

Loss per share for the three and nine months ended September 30, 2022 have been recalculated and restated and is presented on a comparable basis with the three and nine months ended September 30, 2023. In the first quarter of 2023, the Company determined it should have included pre-funded warrants issued in the second quarter of 2022 in the earnings per share calculation in accordance with Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC") 260-10-45-13, which treats shares of common stock exercisable for little to no consideration as included in the denominator of both the basic and diluted earnings per share calculations. While the Company has determined the impact of including the pre-funded warrants in the earnings per share calculations does not have a material impact on previously issued financial statements, the Company has recalculated and restated amounts presented on a comparative and consistent basis with current period results. The table below summarizes previously reported and restated amounts on a comparative basis. See the table presentation of loss per share calculations as of September 30, 2023 and 2022 in the "Loss Per Share" section below.

						Three Months Ended September 30,												Nine Months Ended September 30,
									2022												2022
As Previously Reported:
Net loss per share attributable to common stockholders - basic and diluted									$	(0.40)											$	(1.75)
Weighted average number of shares of common stock outstanding - basic and diluted									10,528,148												9,299,788
As Restated:
Net loss per share attributable to common stockholders - basic and diluted									$	(0.23)											$	(1.26)
Weighted average number of shares of common stock outstanding - basic and diluted									18,463,673												12,902,890

Loss Per Share

Basic and diluted net loss per share for the three and nine months ended September 30, 2023 and 2022, after giving effect to the restatement discussed above, was calculated as follows:

			Three Months Ended September 30,												Nine Months Ended September 30,
(In Thousands, Except Share and Per Share Amounts)			2023						2022						2023						2022
Numerator:
Net loss			$	(1,872)					$	(4,190)					$	(6,927)					$	(16,317)
Net loss attributable to common stockholders for basic and diluted loss per share			$	(1,872)					$	(4,190)					$	(6,927)					$	(16,317)
Denominator:
Weighted average number of shares of common stock outstanding - basic and diluted			27,521,088						18,463,673						21,526,978						12,902,890
Net loss per share attributable to common stockholders - basic and diluted			$	(0.07)					$	(0.23)					$	(0.32)					$	(1.26)

Included within the weighted average shares of common stock outstanding for the three and nine months ended September 30, 2022 are 7,311,000 shares of common stock issuable upon the exercise of pre-funded warrants (See Note 11), as the warrants are exercisable at any time for nominal consideration and, as such, the shares are considered outstanding for the purpose of calculating basic and diluted net loss per share attributable to common stockholders.

The Company’s potentially dilutive securities include stock options, restricted stock awards and units, convertible preferred stock and warrants. These securities were excluded from the computations of diluted net loss per share for the three and nine months ended September 30, 2023 and 2022, as the effect would be to reduce the net loss per share. The following table includes the potential shares of common stock, presented based on amounts outstanding at each period end, that were excluded from the computation of diluted net loss per share attributable to common stockholders for the periods indicated because including them would have had an anti-dilutive effect:

			As of September 30,
			2023						2022
Options to Purchase Common Stock			1,367,493						1,311,691
Unvested Restricted Stock Awards			891						891
Unvested Restricted Stock Units			287,400						125,000
Convertible Preferred Stock			1,363,636						1,363,636
Warrants to Purchase Common Stock			4,045,278						17,507,268
Total			7,064,698						20,308,486

Adoption of Recent Accounting Pronouncements

The Company continually assesses new accounting pronouncements to determine their applicability. When it is determined a new accounting pronouncement affects the Company’s financial reporting, the Company undertakes a review to determine the consequences of the change to its consolidated financial statements and assures there are sufficient controls in place to ascertain the Company’s consolidated financial statements properly reflect the change.

In June 2016, the FASB issued Accounting Standards Update ("ASU") 2016-13, Financial Instruments - Credit Losses (Topic 326), which introduced an impairment model that is based on expected credit losses, rather than incurred losses, to estimate credit losses on certain types of financial instruments (e.g., loan commitments). The expected credit losses should consider historical information, current information, and reasonable and supportable forecasts, including estimates of prepayments, over the contractual term. Financial instruments with similar risk characteristics may be grouped together when estimating expected credit losses. In addition, ASC 326 requires expected credit related losses for trade accounts receivable, as well as available-for-sale debt securities, which are to be recorded through an allowance for credit losses, while non-credit related losses will continue to be recognized through other comprehensive income. The Company adopted the new guidance, as of January 1, 2023, and it did not have a material impact on the condensed consolidated financial statements.

On July 10, 2023, the Company completed the Evoqua Acquisition. At the Closing, the Company purchased customer relationships, equipment and inventory from Evoqua, which were related to manufacturing and selling of hemodialysis concentrates products, all of which are manufactured under a contract manufacturing agreement with a third-party organization.

Pursuant to the Purchase Agreement, total consideration was $17.4 million, comprising a cash payment at Closing of $12.2 million (inclusive of transaction costs) and two $2.5 million deferred payments, the first to be paid on the one-year anniversary of the Closing, which is included as a current liability on the Company's condensed consolidated balance sheet, and the second to be paid on the second anniversary of the Closing (collectively, the “deferred consideration”).

The transaction was accounted for as an asset acquisition, as the acquired assets did not meet the definition of a business as defined by ASC 805, Business Combinations.

The purchase price was allocated, on a relative fair value basis, to the assets acquired at the July 10, 2023 acquisition date as follows (table in thousands):

Consideration
Cash Payment						$	12,233
Deferred Consideration						5,000
Transaction Costs						128
Total Consideration						$	17,361
Assets Acquired
Customer Relationships Intangible Asset						$	11,035
Equipment						5,093
Inventory						1,233
Total Assets Acquired						$	17,361

The fair value of the customer relationships intangible asset was determined using a multi-period excess earnings method, a form of the income approach, which incorporates the estimated future cash flows to be generated from the customer base. Key assumptions included discounted cash flow, estimated life cycle and customer attrition rates. Customer relationships are being amortized over a period of 20 years. Given the recency of the purchase of the equipment in which the assets were recorded at fair value, the Company determined the fair value of the equipment using a cost approach, which considered

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assumptions over the equipment's current replacement cost and useful life. Inventory was purchased directly from the contract manufacturer holding the inventory, which approximated fair value.

During the three and nine months ended September 30, 2023, the Company recorded amortization of its customer relationship intangible asset of $0.1 million, resulting in a net intangible asset of $10.9 million as of September 30, 2023.

Estimated future amortization expense on the Company's customer relationships intangible asset as of September 30, 2023 is as follows (table in thousands):

Year ended December 31:
2023 (remainder of year)									$	138
2024									552
2025									552
2026									552
2027									552
Thereafter									8,551
Total									$	10,897

The Company recognizes revenue under ASC 606, Revenue from Contracts with Customers. The core principle of the revenue standard is that a company should recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the company expects to be entitled in exchange for those goods or services. The following five steps are applied to achieve that core principle:

•Step 1: Identify the contract with the customer

•Step 2: Identify the performance obligations in the contract

•Step 3: Determine the transaction price

•Step 4: Allocate the transaction price to the performance obligations in the contract

•Step 5: Recognize revenue when the company satisfies a performance obligation

Taxes assessed by a governmental authority that are both imposed on and concurrent with a specific revenue-producing transaction, that are collected by us from a customer, are excluded from revenue.

Shipping and handling costs associated with outbound freight related to contracts with customers are accounted for as a fulfillment cost and are included in cost of sales when control of the goods transfers to the customer.

Nature of goods and services

The following is a description of principal activities from which the Company generates its revenue.

The Company currently operates in one market segment, the hemodialysis market, which involves the manufacture, sale and distribution of hemodialysis products to hemodialysis clinics, including pharmaceutical, dialysis concentrates, dialysis kits and other ancillary products used in the dialysis process. Rockwell's customer mix is diverse, with most customer sales concentrations under 10% and one customer, DaVita, Inc. ("DaVita"), at approximately 50% of total net product sales for each of the three and nine months ended September 30, 2023. Rockwell's accounts receivable from this customer were approximately 31% and 30% of the total net consolidated accounts receivable balance at September 30, 2023 and December 31, 2022, respectively.

Product sales – The Company accounts for individual products and services separately if they are distinct (i.e., if a product or service is separately identifiable from other items and if a customer can benefit from it on its own or with other resources that are readily available to the customer). The consideration, including any discounts, is allocated between separate products and services based on their stand-alone selling prices. The stand-alone selling prices are determined based on the cost plus margin approach.

Drug and dialysis concentrates products are sold directly to dialysis clinics and to wholesale distributors in both domestic and international markets. Distribution and license agreements for which upfront fees are received are evaluated upon execution or modification of the agreement to determine if the agreement creates a separate performance obligation from the underlying product sales.  For all existing distribution and license agreements, the distribution and license agreement is not a distinct performance obligation from the product sales.  In instances where regulatory approval of the product has not been established and the Company does not have sufficient experience with the foreign regulatory body to conclude regulatory approval is probable, the revenue for the performance obligation is recognized over the term of the license agreement (over time recognition). Conversely, when regulatory approval already exists or is probable, revenue is recognized at the point in time control of the product transfers to the customer.

The Company received upfront fees under five distribution and license agreements that have been deferred as a contract liability.  The amounts received from Wanbang Biopharmaceuticals Co., Ltd. (“Wanbang”), Sun Pharmaceutical Industries Ltd. ("Sun Pharma"), Jeil Pharmaceutical Co., Ltd. ("Jeil Pharma") and Drogsan Pharmaceuticals ("Drogsan Pharma") are recognized as revenue over the estimated term of the applicable distribution and license agreement as regulatory approval was not received and the Company did not have sufficient experience in China, India, South Korea and Turkey, respectively, to determine regulatory approval was probable as of the execution of the agreement.  The amounts received from Baxter Healthcare Corporation (“Baxter”) were deferred and recognized as revenue at the point in time the estimated product sales under the agreement occurred. During the three months ended September 30, 2023, the amounts received from Wanbang were accelerated out of deferred license revenue and into revenue upon notice that the development effort was terminated (see Note 10).

In November 2022, Rockwell reacquired its distribution rights to its hemodialysis concentrates products from Baxter and terminated the exclusive distribution agreement. Under the exclusive distribution agreement, Baxter distributed and commercialized Rockwell’s hemodialysis concentrates products and provided customer service and order delivery to nearly all U.S. customers. Following the reacquisition of these rights, Rockwell is now unrestricted in its ability to sell its hemodialysis concentrates products to dialysis clinics throughout the U.S. and around the world. For additional information, see Note 10.

Rockwell agreed to pay Baxter a fee for the reacquisition of its distribution rights which was reflected as an expense at that time. This fee was payable in two equal installments on January 1, 2023 and April 1, 2023. As of September 30, 2023, all payments were completed.

On September 18, 2023, the Company and its long-time partner, DaVita, a leading provider of kidney care, entered into an Amended and Restated Products Purchase Agreement (the "Amended Agreement"), which amends and restates the Product Purchase Agreement, dated July 1, 2019, as amended, under which the Company supplies DaVita with certain dialysis concentrates. Under the Amended Agreement, the Company and DaVita agreed to an increase in product pricing, effective September 1, 2023 and a one-time payment to Rockwell on or after December 1, 2023. The term of the Amended Agreement will expire on December 31, 2024. DaVita will have the right, in its sole discretion upon written notice to the Company given no later than September 30, 2024, to further extend the term through December 31, 2025. In the event of such an extension, product pricing will be increased for the extended term. In addition, DaVita is required to provide the Company with nine-month purchasing forecasts and a commitment to purchase at least the forecasted amounts. In the event that DaVita does not meet its forecasts, it is required to pay the Company for the amount forecasted, purchase additional product, or the Company may terminate the Amended Agreement. Upon expiration or termination of the Amended Agreement, and upon request by DaVita, the Company has agreed to provide transition services to DaVita during a transition period.

Additionally during the third quarter of 2023, the Company entered into several long-term product purchase agreements, which include supply and purchasing commitments from certain parties.

For the majority of the Company’s U.S. and international customers, the Company recognizes revenue at the shipping point, which is generally the Company’s plant or warehouse. For other business, the Company recognizes revenue based on when the customer takes control of the product. The amount of revenue recognized is based on the purchase order less returns and adjusted for any rebates, discounts, chargebacks or other amounts paid to customers estimated at the time of sale. There were no such adjustments for the periods reported. Customers typically pay for the product based on customary business practices with payment terms averaging 30 days, while a small subset of customers have payment terms averaging 60 days.

Disaggregation of revenue

Revenue is disaggregated by primary geographical market, major product line, and timing of revenue recognition.

In thousands			Three Months Ended September 30, 2023																		Nine Months Ended September 30, 2023
Products By Geographic Area			Total						U.S.						Rest of World						Total						U.S.						Rest of World
Drug Revenues
Product Sales – Point-in-time			$	—					$	—					$	—					$	—					$	—					$	—
License Fee – Over time			2,197						—						2,197						2,327						—						2,327
Total Drug Products			2,197						—						2,197						2,327						—						2,327
Concentrates Products
Product Sales – Point-in-time			21,574						19,741						1,833						57,720						52,326						5,394
License Fee – Over time			—						—						—						1,472						1,472						—
Total Concentrate Products			21,574						19,741						1,833						59,192						53,798						5,394
Net Revenue			$	23,771					$	19,741					$	4,030					$	61,519					$	53,798					$	7,721

In thousands			Three Months Ended September 30, 2022																		Nine Months Ended September 30, 2022
Products By Geographic Area			Total						U.S.						Rest of World						Total						U.S.						Rest of World
Drug Revenues
Product Sales – Point-in-time			$	193					$	193					$	—					$	834					$	561					$	273
License Fee – Over time			65						—						65						192						—						192
Total Drug Products			258						193						65						1,026						561						465
Concentrates Products
Product Sales – Point-in-time			17,953						16,619						1,334						51,035						46,334						4,701
License Fee – Over time			480						480						—						1,436						1,436						—
Total Concentrate Products			18,433						17,099						1,334						52,471						47,770						4,701
Net Revenue			$	18,691					$	17,292					$	1,399					$	53,497					$	48,331					$	5,166

Contract balances

The following table provides information about receivables, contract assets, and contract liabilities from contracts with customers.

In thousands			September 30, 2023						December 31, 2022
Accounts Receivable, net			$	9,361					$	6,259
Contract Liabilities, which are included in deferred license revenue			$	533					$	4,331

There were no other material contract assets recorded on the condensed consolidated balance sheets as of September 30, 2023 and December 31, 2022.  The Company does not generally accept returns of its concentrates products and no material reserve for returns of concentrates products was established as of September 30, 2023 or December 31, 2022. 

The contract liabilities primarily relate to upfront payments and consideration received from customers in advance of the customer assuming control of the related products.

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Investments available-for-sale consisted of the following as of September 30, 2023 and December 31, 2022 (table in thousands):

			September 30, 2023
			Amortized Cost						Unrealized Gain						Unrealized Loss						Accrued Interest						Fair Value
Available-for-Sale Securities
Debt securities			$	3,898					$	73					$	—					$	—					$	3,971

			December 31, 2022
			Amortized Cost						Unrealized Gain						Unrealized Loss						Accrued Interest						Fair Value
Available-for-Sale Securities
Debt securities			$	11,315					$	75					$	—					$	—					$	11,390

The fair value of investments available-for-sale are determined using quoted market prices from daily exchange-traded markets based on the closing price as of the balance sheet date and are classified as a Level 1 measurement under ASC 820 Fair Value Measurements.

As of September 30, 2023 and December 31, 2022, all of our available-for-sale securities were all due within one year.

Components of inventory, net of reserves, as of September 30, 2023 and December 31, 2022 are as follows (table in thousands):

			September 30, 2023						December 31, 2022
Inventory - Current Portion
Raw Materials			$	2,335					$	3,351
Work in Process			337						351
Finished Goods			2,814						2,112
Total Current Inventory			5,486						5,814
Inventory - Long Term (1)			178						1,276
Total Inventory			$	5,664					$	7,090

__________

1.Represents inventory related to Triferic raw materials. This Triferic inventory will be utilized for the Company's international partnerships. In September 2022, the Company discontinued its New Drug Applications ("NDAs") for Triferic (dialysate) and Triferic AVNU in the United States. During the three months ended September 30, 2023, the Company reserved $1.1 million of long-term inventory as a result of the termination of the Wanbang development effort.

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As of September 30, 2023 and December 31, 2022, the Company’s property and equipment consisted of the following (table in thousands):

			September 30, 2023						December 31, 2022
Leasehold Improvements			$	1,423					$	1,256
Machinery and Equipment			11,085						5,922
Information Technology & Office Equipment			1,845						1,845
Laboratory Equipment			807						807
Total Property and Equipment			15,160						9,830
Accumulated Depreciation and Amortization			(8,389)						(7,636)
Property and Equipment, net			$	6,771					$	2,194

Depreciation and amortization expense for the three months ended September 30, 2023 and 2022 was $0.4 million and $0.1 million, respectively. Depreciation and amortization expense for the nine months ended September 30, 2023 and 2022 was $0.8 million and $0.4 million, respectively.

Accrued liabilities as of September 30, 2023 and December 31, 2022 consisted of the following (table in thousands):

			September 30, 2023						December 31, 2022
Accrued Compensation and Benefits			$	2,240					$	2,568
Accrued Unvouchered Receipts			1,947						585
Accrued Manufacturing Expense			732						—
Accrued Workers Compensation			202						306
Accrued Research & Development Expense			—						43
Other Accrued Liabilities			1,587						4,200
Total Accrued Liabilities			$	6,708					$	7,702

In October 2014, the Company entered into an exclusive distribution agreement with Baxter, which had a term of 10 years and received an upfront fee of $20 million. The upfront fee was recorded as deferred license revenue and was being recognized based on the proportion of product shipments to Baxter in each period, compared with total expected sales volume over the term of the distribution agreement. On November 9, 2022, Rockwell reacquired its distribution rights to its hemodialysis concentrates products from Baxter and terminated the distribution agreement. Exclusivity and other provisions associated with the distribution agreement terminated November 9, 2022 and the remaining operational elements of the agreement terminated December 31, 2022. Rockwell agreed to provide certain services to a group of Baxter's customers until March 31, 2023. Under the distribution agreement, Baxter distributed and commercialized Rockwell’s hemodialysis concentrates products and provided customer service and order delivery to nearly all United States customers. Following the reacquisition of these rights, Rockwell is now unrestricted in its ability to sell its hemodialysis concentrates products to dialysis clinics throughout the United States and around the world. The Company recognized the remaining revenue of $1.5 million during the three months ended March 31, 2023.

In 2016, the Company entered into a distribution agreement with Wanbang (the "Wanbang Agreement") and received an upfront fee of $4.0 million. The upfront fee was recorded as deferred license revenue and is being recognized as revenue based on the agreement term. On August 7, 2023, Rockwell was informed by Wanbang that the main efficacy results of Wanbang’s clinical trial for Triferic (dialysate) compared with placebo were not obtained and Wanbang will not bring the product forward to registration. As a result, the Company recognized all remaining revenue under the Wangbang Agreement of approximately $2.2 million during the third quarter of 2023. Additionally, in connection with these events, the Company

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established a reserve for related Triferic long-term inventory of $1.1 million, resulting in a net increase in gross profit of $1.1 million.

In January 2020, the Company entered into license and supply agreements with Sun Pharma (the "Sun Pharma Agreements"), for the rights to commercialize Triferic (dialysate) in India. In consideration for the license, the Company received an upfront fee of $0.1 million. The upfront fee was recorded as deferred license revenue and is being recognized as revenue based on the agreement term. The Company recognized revenue of approximately $2,500 and $7,500 for the three and nine months ended September 30, 2023 and 2022, respectively. Deferred license revenue related to the Sun Pharma Agreement totaled $62,500 and $70,000 as of September 30, 2023 and December 31, 2022, respectively.

In September 2020, the Company entered into a license and supply agreements with Jeil Pharmaceutical (the "Jeil Agreements"), for the rights to commercialize Triferic (dialysate) in South Korea. In consideration for the license, the Company received an upfront fee of $0.2 million. In May 2022, Jeil Pharmaceutical obtained regulatory approval in South Korea and paid the Company $0.2 million in consideration of reaching the milestone. The upfront fee and milestone payments were recorded as deferred license revenue and are being recognized as revenue based on the agreement term. The Company recognized revenue of $5,200 and $15,600 for the three and nine months ended September 30, 2023 and 2022, respectively. Deferred license revenue related to the Jeil Agreement totaled approximately $0.4 million as of both September 30, 2023 and December 31, 2022.

In June 2021, the Company entered into license and supply agreements with Drogsan Pharmaceuticals (the "Drogsan Agreements"), for the rights to commercialize Triferic (dialysate) and Triferic AVNU in Turkey. In consideration for the license, the Company received an upfront fee of $0.15 million. The upfront fee was recorded as deferred license revenue and will be recognized as revenue based on the agreement term. The Company recognized revenue of $3,750 and $11,250 for the three and nine months ended September 30, 2023 and 2022, respectively. Deferred license revenue related to the Drogsan Agreements totaled approximately $0.1 million as of each of September 30, 2023 and December 31, 2022. In April 2023, Drogsan submitted a Marketing Authorization application and GMP application for Triferic AVNU to the Turkish Medicines and Medical Devices Agency, for which Drogsan received priority status and high priority status, respectively. Drogsan is responsible for all regulatory approval and commercialization activities.

The Company held its annual meeting of stockholders on May 23, 2023 (the “Annual Meeting”). At the Annual Meeting, the Company’s stockholders approved the amendment and restatement of the Rockwell Medical, Inc. 2018 Long Term Incentive Plan to increase the number of shares of common stock issuable thereunder by 1,600,000 shares (the “Amended 2018 Plan”).

Preferred Stock

On April 6, 2022, the Company and DaVita entered into the Securities Purchase Agreement (the "SPA"), which provided for the issuance by the Company of up to $15 million of preferred stock to DaVita. On April 6, 2022, the Company issued 7,500 shares of Series X Preferred Stock for gross proceeds of $7.5 million. On June 16, 2022 the Company issued an additional 7,500 shares of the Series X Preferred Stock to DaVita for gross proceeds of $7.5 million.

The Series X Preferred Stock was issued for a price of $1,000 per share (the "Face Amount"), subject to accretion at a rate of 1% per annum, compounded annually. If the Company’s common stock trades above $22.00 for a period of 30 calendar days, the accretion will thereafter cease. As of September 30, 2023, the Series X Preferred Stock accreted a total $150,000.

The Series X Convertible Preferred Stock is convertible to common stock at a rate equal to the Face Amount, divided by a conversion price of $11.00 per share (subject to adjustment for future stock splits, reverse stock splits and similar recapitalization events). As a result, each share of Series X Preferred Stock will initially convert into approximately 91 shares of common stock. DaVita’s right to convert to common stock is subject to a beneficial ownership limitation, which is initially set at 9.9% of the outstanding common stock, which limitation may be reset (not to exceed 19.9%) at DaVita’s option and upon providing prior written notice to the Company. In addition, any debt financing is limited by the terms of our Securities Purchase Agreement with DaVita. Specifically, until DaVita owns less than 50% of its investment, the Company may only incur additional debt in the form of a purchase money loan, a working capital line of up to $5 million or to refinance existing debt, unless DaVita consents.

Additionally, the Series X Preferred Stock has a deemed liquidation event and redemption clause which could be triggered if the sale of all or substantially all of the Company's assets relating to the Company's dialysis concentrates business line. Since the Series X Preferred Stock may be redeemed if certain assets are sold at the option of the holder, but is not mandatorily redeemable and the sale of the assets that would allow for redemption is within the control of the Company, the preferred stock has been classified as permanent equity and initially recognized at fair value of $15 million (the proceeds on the date of issuance) less issuance costs of $0.1 million, resulting in an initial value of $14.9 million. The Company will assess at each reporting period whether conditions have changed to now meet the mandatory redemption definition which could trigger liability classification.

As of both September 30, 2023 and December 31, 2022, there were 2,000,000 shares of preferred stock, $0.0001 par value per share, authorized and 15,000 shares of preferred stock issued and outstanding.

Common Stock

As of September 30, 2023 and December 31, 2022, there were 170,000,000 shares of common stock, $0.0001 par value per share, authorized and 28,489,663 and 12,163,673 shares issued and outstanding, respectively.

As of September 30, 2023 and 2022, the Company reserved for issuance the following shares of common stock related to the potential exercise of employee stock options, unvested restricted stock, convertible preferred stock, pre-funded warrants and all other warrants (collectively, "common stock equivalents"):

			As of September 30,
Common stock and common stock equivalents:			2023						2022
Common stock			28,489,663						11,152,673
Common stock issuable upon exercise of pre-funded warrants			—						7,311,000
Common stock and pre-funded stock warrants			28,489,663						18,463,673
Options to Purchase Common Stock			1,367,493						1,311,691
Unvested Restricted Stock Awards			891						891
Unvested Restricted Stock Units			287,400						125,000
Convertible Preferred Stock			1,363,636						1,363,636
Warrants to Purchase Common Stock			4,045,278						17,507,268
Total			35,554,361						38,772,159

During the three months ended September 30, 2023 and 2022, 1,793,000 and 477,480 pre-funded warrants were exercised, respectively. During the nine months ended September 30, 2023 and 2022, 6,300,000 and 477,480 pre-funded warrants were exercised, respectively.

During the three and nine months ended September 30, 2023 and 2022, no vested employee stock options were exercised.

Controlled Equity Offering

On April 8, 2022, the Company entered into the Sales Agreement (the "ATM facility") with Cantor Fitzgerald & Co. as Agent, pursuant to which the Company may offer and sell from time to time up to $12.2 million of shares of Company’s common stock through the Agent. The offering and sale of such shares has been registered under the Securities Act of 1933, as amended.

During the quarter ended September 30, 2023, no sales were made pursuant to the Sales Agreement. Approximately $12.2 million remains available for sale under the ATM facility.

Registered Direct Offering

On May 30, 2022, the Company entered into the Registered Direct Purchase Agreement (the "Agreement") with the Purchaser, pursuant to which the Company issued and sold, in a registered direct offering (the “Offering”), 844,613 shares of its common stock at price of $1.39 per share, and pre-funded warrants to purchase up to an aggregate of 7,788,480 shares of common stock (the “Pre-Funded Warrants” and the shares of common stock underlying the Pre-Funded Warrants, the “Warrant Shares”). The purchase price of each Pre-Funded Warrant is equal to the price at which a share of common stock was sold to the public in the Offering, minus $0.0001, and the exercise price of each Pre-Funded Warrant is $0.0001 per share.

A holder (together with its affiliates) may not exercise any portion of the Pre-Funded Warrants to the extent the holder would own more than 9.99% of the Company’s outstanding common stock immediately after exercise, as such percentage ownership is determined in accordance with the terms of the Pre-Funded Warrant. The Agreement contains customary representations and warranties and agreements of the Company and the Purchaser and customary indemnification rights and obligations of the parties.

On July 5, 2023, all of the remaining Pre-Funded Warrants to purchase 1,793,000 shares of common stock were exercised. The exercise price of each Pre-Funded Warrant was $0.0001 per share and resulted in gross proceeds to the Company of $179.

Private Placement

Also on May 30, 2022, concurrent with the Offering, the Company entered into the private investment in public equity "PIPE" Purchase Agreement relating to the offering and sale (the “Private Placement”) of warrants to purchase up to a total of 9,900,990 shares of common stock (the "PIPE Warrants") and pre-funded warrants to purchase up to a total of 1,267,897 shares of common stock (the “Pre-Funded PIPE Warrants”). Each warrant was sold at a price of $0.125 per underlying warrant share and is exercisable at an exercise price of $1.39 per share. The purchase price of each Pre-Funded Warrant was equal to the price at which a share of common stock was sold to the public in the Offering, minus $0.0001, and the exercise price of each Pre-Funded Warrant is $0.0001 per share. As of December 2022, all Pre-Funded PIPE Warrants have been exercised.

On July 10, 2023, the Company entered into a letter agreement (the “Letter Agreement”) with Armistice Capital Master Fund Ltd. (“Armistice”), which held a warrant (the “Prior Warrant”) to purchase 9,900,990 shares of common stock of the Company (the “Common Stock”) with an exercise price of $1.39 per share, offering Armistice the opportunity to exercise the Prior Warrant for cash, provided the Prior Warrant was exercised for cash on or prior to 5:00 P.M. Eastern Time on July 10, 2028 (the “End Date”). In addition, Armistice would receive a “reload” warrant (the “Reload Warrant”) to purchase 3,750,000 shares of Common Stock with an exercise price of $5.13 per share, the closing price as reported by the Nasdaq Capital Market on July 7, 2023. The terms of the Reload Warrant and Letter Agreement provide for customary resale registration rights. The Letter Agreement also provides that for a period of 45 days after the issuance of the Reload Warrant, the Company’s may not sell shares of Common Stock pursuant to its sales agreement with Cantor Fitzgerald & Co., dated as of April 8, 2022, at price per share less than $6.25. The Reload Warrant may be exercised at all times prior to the 54 months month anniversary of its issuance date. The Prior Warrant and the Reload Warrant both provide that a holder (together with its affiliates) may not exercise any portion of the Prior Warrant or the Reload Warrant to the extent that the holder would own more than 9.99% of the Company’s outstanding Common Stock immediately after exercise, as such percentage ownership is determined in accordance with the terms of such warrant. To the extent the exercise of the Prior Warrant would result in Armistice holding more than 9.99% of the Company’s outstanding Common Stock, such shares of Common Stock in excess of 9.99% will be held in abeyance. The Letter Agreement amended the Prior Warrant to extend the expiration date thereof to one year following the original expiration date set forth therein.

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The Company recognized total stock-based compensation expense during the three and nine months ended September 30, 2023 and 2022 as follows (table in thousands):

			Three Months Ended September 30,												Nine Months Ended September 30,
			2023						2022						2023						2022
Service-based awards:
Restricted Stock Units			$	112					$	46					$	276					$	84
Stock Option Awards			100						130						438						401
Total Service Based Awards			212						176						714						485
Performance-based awards:
Restricted Stock Awards			—						—						—						(391)
Total			$	212					$	176					$	714					$	94

Performance Based Restricted Stock

A summary of the Company’s restricted stock awards during the nine months ended September 30, 2023 is as follows:

			Number of Shares						Weighted Average Grant-Date Fair Value
Unvested at January 1, 2023			891						$	62.70
Unvested at September 30, 2023			891						$	62.70

A summary of the Company’s restricted stock awards during the nine months ended September 30, 2022 is as follows:

			Number of Shares						Weighted Average Grant-Date Fair Value
Unvested at January 1, 2022			7,118						$	62.70
Forfeited (1)			(6,227)						$	62.70
Unvested at September 30, 2022			891						$	62.70

__________

1.These forfeited awards were due to the resignation of the Company's Chief Development Officer on March 25, 2022 and reduced stock-based compensation expense by $0.4 million in 2022.

Restricted stock awards are measured based on their fair value on the date of grant and amortized over the vesting period of 20 months.

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Service-Based Restricted Stock Units

A summary of the Company’s service-based restricted stock units during the nine months ended September 30, 2023 is as follows:

			Number of Shares						Weighted Average Grant-Date Fair Value
Unvested at January 1, 2023			125,000						$	1.47
Granted			313,065						1.87
Vested			(125,000)						1.47
Forfeited			(25,665)						1.37
Unvested at September 30, 2023			287,400						$	1.85

A summary of the Company’s service-based restricted stock units during the nine months ended September 30, 2022 is as follows:

			Number of Shares						Weighted Average Grant-Date Fair Value
Unvested at January 1, 2022			29,289						$	12.87
Granted			125,000						1.47
Vested			(23,515)						11.33
Forfeited			(5,774)						19.00
Unvested at September 30, 2022			125,000						$	1.47

Service based restricted stock units are measured based on their fair value on the date of grant and amortized over the vesting period. The vesting periods range from 1 to 3 years. Stock-based compensation expense of $0.1 million and $46,000 was recognized for the three months ended September 30, 2023 and 2022, respectively. Stock-based compensation expense of $0.3 million and $0.1 million was recognized for the nine months ended September 30, 2023 and 2022, respectively. As of September 30, 2023, the unrecognized stock-based compensation expense was $0.4 million, which is expected to be recognized over an estimated weighted average remaining term of less than 1.4 years.

Service-Based Stock Options

The fair value of the service-based stock options granted for the nine months ended September 30, 2023 were based on the following assumptions:

			Nine Months Ended September 30, 2023
Exercise price			$1.37 - $2.83
Expected stock price volatility			81.6% - 81.8%
Risk-free interest rate			3.41% - 3.46%
Term (years)			5.6 - 6

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A summary of the Company’s service-based stock option activity for the nine months ended September 30, 2023 is as follows:

			Shares Underlying Options						Weighted Average Exercise Price						Weighted Average Remaining Contractual Term						Aggregate Intrinsic Value
															in years						in thousands
Outstanding at January 1, 2023			1,206,905						$	8.32
Granted			382,745						1.48
Forfeited			(143,430)						2.82
Expired			(78,727)						26.74
Outstanding at September 30, 2023			1,367,493						$	5.93					8.4						$	680
Exercisable at September 30, 2023			444,836						$	14.64					7						$	114

A summary of the Company’s service-based stock option activity for the nine months ended September 30, 2022 is as follows:

			Shares Underlying Options						Weighted Average Exercise Price						Weighted Average Remaining Contractual Term
															in years
Outstanding at January 1, 2022			528,591						$	32.01					7.5
Granted			898,659						1.49						5.5
Forfeited			(30,093)						15.11						—
Expired			(85,466)						82.09						—
Outstanding at September 30, 2022			1,311,691						$	8.23					9.1
Exercisable at September 30, 2022			243,973						$	29.31					6.9

The aggregate intrinsic value is calculated as the difference between the closing price of the Company's common stock and the exercise price of the stock options that had strike prices below the closing price. The intrinsic value of the outstanding options as of September 30, 2022 was not significant.

Stock-based compensation expense recognized for service-based stock options was $0.1 million and $0.1 million for the three months ended September 30, 2023 and 2022, respectively. Stock-based compensation expense recognized for service-based stock options was $0.4 million and $0.4 million for the nine months ended September 30, 2023 and 2022, respectively. As of September 30, 2023, total stock-based compensation expense related to unvested options not yet recognized totaled approximately $0.7 million, which is expected to be recognized over an estimated weighted average remaining term of 3.2 years. Forfeitures are recorded in the period of occurrence and compensation expense is adjusted accordingly.

Product License Agreements

The Company is a party to a Licensing Agreement between the Company and Charak, LLC ("Charak") dated January 7, 2002 (the "2002 Agreement") that grants the Company exclusive worldwide rights to certain patents and information related to our Triferic product. On October 7, 2018, the Company entered into a Master Services and IP Agreement (the “Charak MSA”) with Charak and Dr. Ajay Gupta, a former Officer of the Company. Pursuant to the MSA, the parties entered into three additional agreements described below related to the license of certain soluble ferric pyrophosphate (“SFP”) intellectual property owned by Charak. As of September 30, 2023 and December 31, 2022, the Company has accrued $85,400 relating to

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certain IP reimbursement expenses and certain sublicense royalty fees, which is included within accrued liabilities on the condensed consolidated balance sheet.

Pursuant to the Charak MSA, the aforementioned parties entered into an Amendment, dated as of October 7, 2018 (the “Charak Amendment”), to the 2002 Agreement, under which Charak granted the Company an exclusive, worldwide, non-transferable license to commercialize SFP for the treatment of patients with renal failure. The Charak Amendment amends the royalty payments due to Charak under the 2002 Agreement such that the Company is liable to pay Charak royalties on net sales by the Company of products developed under the license, which includes the Company’s Triferic product, at a specified rate until December 31, 2021 and thereafter at a reduced rate from January 1, 2022 until February 1, 2034. Additionally, the Company is required to pay Charak a percentage of any sublicense income during the term of the agreement, which amount cannot be less than a minimum specified percentage of net sales of the licensed products by the sublicensee in jurisdictions where there exists a valid claim, on a country-by-country basis, and be no less than a lower rate of the net sales of the licensed products by the sublicensee in jurisdictions where there exists no valid claim, on a country-by-country basis.

Also pursuant to the Charak MSA, the Company and Charak entered into a Commercialization and Technology License Agreement I.V. Triferic dated as of October 7, 2018 (the “IV Agreement”), under which Charak granted the Company an exclusive, sub-licensable, royalty-bearing license to SFP for the purpose of commercializing certain intravenous-delivered products incorporating SFP for the treatment of iron disorders worldwide for a term that expires on the later of February 1, 2034 or upon the expiration or termination of a valid claim of a licensed patent. The Company was liable to pay Charak royalties on net sales by the Company of products developed under the license at a specified rate until December 31, 2021. From January 1, 2022 until February 1, 2034, the Company is liable to pay Charak a base royalty at a reduced rate on net sales and an additional royalty on net sales while there exists a valid claim of a licensed patent, on a country-by-country basis. The Company shall also pay to Charak a percentage of any sublicense income received during the term of the IV Agreement, which amount shall not be less than a minimum specified percentage of net sales of the licensed products by the sublicensee in jurisdictions where there exists a valid claim, on a country-by-country basis, and not be less than a lower rate of the net sales of the licensed products by the sublicensee in jurisdictions where there exists no valid claim, on a country-by-country basis.

Also pursuant to the Charak MSA, the Company and Charak entered into a Technology License Agreement TPN Triferic dated as of October 7, 2018 (the “TPN Agreement”), pursuant to which Charak granted the Company an exclusive, sub-licensable, royalty-bearing license to SFP for the purpose of commercializing worldwide certain TPN products incorporating SFP. The license grant under the TPN Agreement continues for a term that expires on the later of February 1, 2034 or upon the expiration or termination of a valid claim of a licensed patent. During the term of the TPN Agreement, the Company is liable to pay Charak a base royalty on net sales and an additional royalty on net sales while there exists a valid claim of a licensed patent, on a country-by-country basis. The Company shall also pay to Charak a percentage of any sublicense income received during the term of the TPN Agreement, which amount shall not be less than a minimum royalty on net sales of the licensed products by the sublicensee in jurisdictions where there exists a valid claim, on a country-by-country basis, and not be less than a lower rate of the net sales of the licensed products by the sublicensee in jurisdictions where there exists no valid claim, on a country-by-country basis.

The potential sub-license milestone payments are not yet considered probable, and no milestone payments have been accrued as of September 30, 2023 and December 31, 2022.

Rockwell leases its production facilities and administrative offices as well as certain equipment used in its operations including leases on transportation equipment used in the delivery of its products. The lease terms range from monthly to six years. Rockwell occupies a 51,000 square foot facility and a 17,500 square foot facility in Wixom, Michigan under a lease expiring in August 2024. Rockwell also occupies two other manufacturing facilities, a 51,000 square foot facility in Grapevine, Texas under a lease expiring in December 2025, and a 57,000 square foot facility in Greer, South Carolina under a lease expiring February 2026. In addition, Rockwell occupied 4,100 square feet of office space in Hackensack, New Jersey under a lease expiring on October 31, 2024. This lease was subleased on December 15, 2021 with an expiration date of October 31, 2024.

At September 30, 2023, the Company had operating and finance lease liabilities of $5.4 million and right-of-use assets of $5.1 million, which are included in the condensed consolidated balance sheet.

At December 31, 2022, the Company had operating and finance lease liabilities of $6.7 million and right-of-use assets of $6.4 million, which are included in the condensed consolidated balance sheet.

The following summarizes quantitative information about the Company’s operating and finance leases (table in thousands):

			Three Months Ended September 30, 2023						Three Months Ended September 30, 2022						Nine Months Ended September 30, 2023						Nine Months Ended September 30, 2022
Operating leases
Operating lease cost			$	422					$	410					$	1,281					$	1,289
Variable lease cost			112						101						336						287
Operating lease expense			534						511						1,617						1,576
Finance leases
Non-cash lease expense from right-of-use assets			142						141						424						424
Interest on lease obligations			36						44						113						136
Finance lease expense			178						185						537						560
Short-term lease rent expense			4						5						12						14
Total lease expense			$	716					$	701					$	2,166					$	2,150
Other information
Payments for principal from operating leases			$	461					$	427					$	1,363					$	1,338
Payments for interest from finance leases			$	37					$	44					$	114					$	136
Payments for principal from finance leases			$	130					$	121					$	388					$	359
Weighted-average remaining lease term – operating leases			2.5						3.2						2.5						3.2
Weighted-average remaining lease term – finance leases			3.7						4.7						3.7						4.7
Weighted-average discount rate – operating leases			6.5		%				6.4		%				6.5		%				6.4		%
Weighted-average discount rate – finance leases			6.4		%				6.4		%				6.4		%				6.4		%

Future minimum rental payments under operating and finance lease agreements are as follows (in thousands):

			Operating						Finance
Year ending December 31, 2023 (remaining)			$	439					$	168
Year ending December 31, 2024			1,511						672
Year ending December 31, 2025			1,021						676
Year ending December 31, 2026			362						666
Year ending December 31, 2027			131						311
Total			3,464						2,493
Less present value discount			(259)						(271)
Operating and finance lease liabilities			$	3,205					$	2,222

On March 16, 2020, the Company and Rockwell Transportation, Inc., as Borrowers, entered into a Loan and Security Agreement (the "Loan Agreement") with Innovatus Life Sciences Lending Fund I, LP ("Innovatus"), as collateral agent and the lenders party thereto, pursuant to which Innovatus, as a lender, agreed to make certain term loans to the Company in the aggregate principal amount of up to $35.0 million (the "Term Loans"). Funding of the first $22.5 million tranche was completed on March 16, 2020. The Company is no longer eligible to draw on additional tranches, which were tied to the achievement of certain milestones. Net draw down proceeds were $21.2 million with closing costs of $1.3 million.

In connection with each funding of the Term Loans, the Company was required to issue to Innovatus a warrant (the “Warrants”) to purchase a number of shares of the Company’s common stock equal to 3.5% of the principal amount of the relevant Term Loan funded divided by the exercise price. In connection with the first tranche of the Term Loans, the Company issued a Warrant to Innovatus, exercisable for an aggregate of 43,388 shares of the Company’s common stock at an exercise price of $18.15 per share. The Warrant may be exercised on a cashless basis and is immediately exercisable through the seventh anniversary of the applicable funding date. The number of shares of common stock for which the Warrant is exercisable and the associated exercise price are subject to certain proportional adjustments as set forth in such Warrant. The Company evaluated the warrant under ASC 470, Debt, and recognized an additional debt discount of approximately $0.5 million based on the relative fair value of the base instruments and warrants. The Company calculated the fair value of the warrant using the Black-Scholes model.

The Term Loans mature on March 16, 2025, and bear interest at the greater of (i) Prime Rate (as defined in the Loan Agreement) and (ii) 4.75%, plus 4.00%, with an initial interest rate of 8.75% per annum and an effective interest rate of 12.5% as of September 30, 2023. The Company has the option, under certain circumstances, to add 1.00% of such interest rate amount to the then outstanding principal balance in lieu of paying such amount in cash. For the three months ended September 30, 2023 and 2022, interest expense amounted to $0.3 million and $0.4 million, respectively. For the nine months ended September 30, 2023 and 2022, interest expense amounted to $0.9 million and $1.2 million, respectively.

The Loan Agreement is secured by all assets of the Company and Rockwell Transportation, Inc. and contains customary representations and warranties and covenants, subject to customary carve outs, and initially included financial covenants related to liquidity and sales of Triferic.

In September 2021, the Company entered into an amendment to the Loan Agreement in which the Company, in exchange for Innovatus lowering the sales covenants, agreed to: (i) prepay an aggregate principal amount of $7.5 million in ten installments commencing on December 1, 2021; (ii) pay an additional prepayment premium of 5% on prepaid amounts if the Company elects to prepay all outstanding Term Loans on or before September 24, 2023 and (iii) maintain minimum liquidity of no less than $5.0 million if the aggregate principal amount of Term Loans is greater than $15 million pursuant to the liquidity covenant in the Loan Agreement.

On November 10, 2022, the Company entered into a Second Amendment to the Loan and Security Agreement (the “Second Amendment”) dated as of November 14, 2022 with Innovatus, which amended the Loan Agreement. Pursuant to the Second Amendment, the Company (i) prepaid an additional aggregate principal amount of $5.0 million in Term Loans in one installment on November 14, 2022; (ii) paid interest only payments until September 2023, at which time it resumed scheduled debt payments. The financial covenant related to the sales of Triferic was replaced with the trailing 6 months revenue of our concentrates products. The Company cannot assure that it can maintain compliance with the covenants under our Loan Agreement, which may result in an event of default. The Company's ability to comply with these covenants may be adversely affected by events beyond its control. If the Company is unable to comply with the covenants under the Loan Agreement, it would pursue all available cure options in order to regain compliance. However, the Company may not be able to mutually agree with Innovatus on appropriate remedies to cure a future breach of a covenant, which could give rise to an event of default. If the Company is unable to avoid an event of default, any required repayments could have an adverse effect on its liquidity.

As of September 30, 2023, the Company was in compliance with all covenants under the Loan Agreement.

As of September 30, 2023, the outstanding balance of the Term Loan was $9.0 million, net of unamortized issuance costs and discount of $0.5 million.

The following table reflects the schedule of principal payments on the Term Loan as of September 30, 2023 (in thousands):

			Principal Payments
2023 (remaining)			$	1,500
2024			6,000
2025			2,000
			$	9,500

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v3.23.3

Cover - shares	9 Months Ended
	Sep. 30, 2023	Nov. 10, 2023
Cover [Abstract]
Document Type	10-Q
Document Quarterly Report	true
Document Period End Date	Sep. 30, 2023
Document Transition Report	false
Entity File Number	000-23661
Entity Registrant Name	ROCKWELL MEDICAL, INC.
Entity Incorporation, State or Country Code	DE
Entity Tax Identification Number	38-3317208
Entity Address, Address Line One	30142 S. Wixom Road
Entity Address, City or Town	Wixom
Entity Address, State or Province	MI
Entity Address, Postal Zip Code	48393
City Area Code	248
Local Phone Number	960-9009
Entity Current Reporting Status	Yes
Entity Interactive Data Current	Yes
Entity Filer Category	Non-accelerated Filer
Entity Small Business	true
Entity Emerging Growth Company	false
Entity Shell Company	false
Title of 12(b) Security	Common Stock, par value $0.0001
Trading Symbol	RMTI
Security Exchange Name	NASDAQ
Entity Common Stock, Shares Outstanding (in shares)		28,489,663
Entity Central Index Key	0001041024
Amendment Flag	false
Current Fiscal Year End Date	--12-31
Document Fiscal Year Focus	2023
Document Fiscal Period Focus	Q3

v3.23.3

UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands	Sep. 30, 2023	Dec. 31, 2022
ASSETS
Cash and Cash Equivalents	$ 7,759	$ 10,102
Investments Available-for-Sale	3,971	11,390
Accounts Receivable, net	9,361	6,259
Inventory, net	5,486	5,814
Prepaid and Other Current Assets	1,596	1,745
Total Current Assets	28,173	35,310
Property and Equipment, net	6,771	2,194
Inventory, Non-Current	178	1,276
Right of Use Assets-Operating, net	3,095	3,943
Right of Use Assets-Financing, net	2,044	2,468
Intangible Asset, net	10,897	0
Goodwill	921	921
Other Non-Current Assets	527	523
Total Assets	52,606	46,635
LIABILITIES AND STOCKHOLDERS’ EQUITY
Accounts Payable	3,929	4,053
Accrued Liabilities	6,708	7,702
Deferred Consideration - Current	2,500	0
Lease Liabilities-Operating - Current	1,529	1,483
Lease Liabilities-Financing - Current	550	522
Deferred License Revenue - Current	46	1,731
Term Loan - Current - Net of Issuance Costs	5,631	1,631
Insurance Financing Note Payable	488	503
Customer Deposits	27	66
Total Current Liabilities	21,408	17,691
Lease Liabilities-Operating - Long-Term	1,676	2,581
Lease Liabilities-Financing - Long-Term	1,672	2,088
Term Loan - Long-Term, net of issuance costs	3,331	7,555
Deferred License Revenue - Long-Term	487	2,600
Deferred Consideration - Long-Term	2,500	0
Long Term Liability - Other	14	14
Total Liabilities	31,088	32,529
Stockholders’ Equity:
Preferred Stock, $0.0001 par value, 2,000,000 shares authorized; 15,000 shares issued and outstanding at September 30, 2023 and December 31, 2022	0	0
Common Stock, $0.0001 par value; 170,000,000 shares authorized; 28,489,663 and 12,163,673 shares issued and outstanding at September 30, 2023 and December 31, 2022, respectively	3	1
Additional Paid-in Capital	417,133	402,701
Accumulated Deficit	(395,686)	(388,759)
Accumulated Other Comprehensive Income	68	163
Total Stockholders’ Equity	21,518	14,106
Total Liabilities and Stockholders’ Equity	$ 52,606	$ 46,635

v3.23.3

UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares	Sep. 30, 2023	Dec. 31, 2022	Sep. 30, 2022
Statement of Financial Position [Abstract]
Preferred shares, par value (in dollars per share)	$ 0.0001	$ 0.0001
Preferred shares, shares authorized (in shares)	2,000,000	2,000,000
Preferred shares, shares issued (in shares)	15,000	15,000
Preferred shares, shares outstanding (in shares)	15,000	15,000
Common shares, par value (in dollars per share)	$ 0.0001	$ 0.0001
Common shares, shares authorized (in shares)	170,000,000	170,000,000
Common shares, shares issued (in shares)	28,489,663	12,163,673
Common shares, shares outstanding (in shares)	28,489,663	12,163,673	11,152,673

v3.23.3

UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) $ in Thousands		3 Months Ended		9 Months Ended
		Sep. 30, 2023	Sep. 30, 2022	Sep. 30, 2023	Sep. 30, 2022
Income Statement [Abstract]
Net Sales		$ 23,771	$ 18,691	$ 61,519	$ 53,497
Cost of Sales		21,569	17,914	55,685	51,760
Gross Profit		2,202	777	5,834	1,737
Research and Product Development		494	469	939	2,963
Selling and Marketing		556	762	1,584	1,743
General and Administrative		2,889	3,254	9,434	11,845
Operating Loss		(1,737)	(3,708)	(6,123)	(14,814)
Other (Expense) Income
Realized Gain on Settlement of Investments		220	0	220	4
Interest Expense		(411)	(476)	(1,193)	(1,497)
Interest and Other Income (Expense) - net		56	(6)	169	(10)
Total Other Expense, net		(135)	(482)	(804)	(1,503)
Net Loss		$ (1,872)	$ (4,190)	$ (6,927)	$ (16,317)
Basic Net Loss per Share (in dollars per share)		$ (0.07)	$ (0.23)	$ (0.32)	$ (1.26)
Diluted Net Loss per Share (in dollars per share)		$ (0.07)	$ (0.23)	$ (0.32)	$ (1.26)
Basic Weighted Average Shares Outstanding (in shares)	[1]	27,521,088	18,463,673	21,526,978	12,902,890
Diluted Weighted Average Shares Outstanding (in shares)	[1]	27,521,088	18,463,673	21,526,978	12,902,890
[1] See Note 3 for more detail related to Basic and Diluted Weighted Average Shares Outstanding

v3.23.3

UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2023	Sep. 30, 2022	Sep. 30, 2023	Sep. 30, 2022
Statement of Comprehensive Income [Abstract]
Net Loss	$ (1,872)	$ (4,190)	$ (6,927)	$ (16,317)
Unrealized (Loss) Gain on Available-for-Sale Investments	(69)	5	(90)	5
Foreign Currency Translation Adjustments	0	0	(4)	(3)
Comprehensive Loss	$ (1,941)	$ (4,185)	$ (7,021)	$ (16,315)

v3.23.3

UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS' EQUITY (DEFICIT) - USD ($) $ in Thousands	Total	Public Offering	At-the-Market Offering	PREFERRED STOCK	COMMON STOCK	COMMON STOCK Public Offering	COMMON STOCK At-the-Market Offering	ADDITIONAL PAID-IN CAPITAL	ADDITIONAL PAID-IN CAPITAL Public Offering	ADDITIONAL PAID-IN CAPITAL At-the-Market Offering	ACCUMULATED DEFICIT	ACCUMULATED OTHER COMPREHENSIVE INCOME
Beginning balance (in shares) at Dec. 31, 2021				0
Beginning balance at Dec. 31, 2021				$ 0
Beginning balance (in shares) at Dec. 31, 2021					8,544,225
Beginning balance at Dec. 31, 2021	$ 2,535				$ 1			$ 372,562			$ (370,080)	$ 52
Increase (Decrease) in Shareholders' Equity
Net Loss	(7,162)										(7,162)
Foreign Currency Translation Adjustments	(1)											(1)
Stock-based Compensation	(179)							(179)
Ending balance (in shares) at Mar. 31, 2022				0
Ending balance at Mar. 31, 2022				$ 0
Ending balance (in shares) at Mar. 31, 2022					8,544,225
Ending balance at Mar. 31, 2022	(4,807)				$ 1			372,383			(377,242)	51
Beginning balance (in shares) at Dec. 31, 2021				0
Beginning balance at Dec. 31, 2021				$ 0
Beginning balance (in shares) at Dec. 31, 2021					8,544,225
Beginning balance at Dec. 31, 2021	2,535				$ 1			372,562			(370,080)	52
Increase (Decrease) in Shareholders' Equity
Net Loss	(16,317)
Unrealized Gain (Loss) on Available-for-Sale Investments	5
Foreign Currency Translation Adjustments	$ (3)
Ending balance (in shares) at Sep. 30, 2022				15,000
Ending balance at Sep. 30, 2022				$ 0
Ending balance (in shares) at Sep. 30, 2022	11,152,673				11,152,673
Ending balance at Sep. 30, 2022	$ 16,136				$ 1			402,480			(386,399)	54
Beginning balance (in shares) at Mar. 31, 2022				0
Beginning balance at Mar. 31, 2022				$ 0
Beginning balance (in shares) at Mar. 31, 2022					8,544,225
Beginning balance at Mar. 31, 2022	(4,807)				$ 1			372,383			(377,242)	51
Increase (Decrease) in Shareholders' Equity
Net Loss	(4,967)										(4,967)
Foreign Currency Translation Adjustments	(2)											(2)
Issuance of stock, net of offering costs (in shares)				15,000		844,613	7,500
Issuance of stock, net of offering costs	14,916	$ 14,893	$ 15					14,916	$ 14,893	$ 15
Vesting of Restricted Stock Units Issued, net of taxes withheld (in shares)					10,958
Stock-based Compensation	97							97
Ending balance (in shares) at Jun. 30, 2022				15,000
Ending balance at Jun. 30, 2022				$ 0
Ending balance (in shares) at Jun. 30, 2022					9,407,296
Ending balance at Jun. 30, 2022	20,145				$ 1			402,304			(382,209)	49
Increase (Decrease) in Shareholders' Equity
Net Loss	(4,190)										(4,190)
Unrealized Gain (Loss) on Available-for-Sale Investments	5											5
Foreign Currency Translation Adjustments	0
Issuance of stock, net of offering costs (in shares)						1,745,377
Issuance of stock, net of offering costs		$ 0				$ 0			$ 0
Stock-based Compensation	$ 176							176
Ending balance (in shares) at Sep. 30, 2022				15,000
Ending balance at Sep. 30, 2022				$ 0
Ending balance (in shares) at Sep. 30, 2022	11,152,673				11,152,673
Ending balance at Sep. 30, 2022	$ 16,136				$ 1			402,480			(386,399)	54
Beginning balance (in shares) at Dec. 31, 2022	15,000			15,000
Beginning balance at Dec. 31, 2022	$ 0			$ 0
Beginning balance (in shares) at Dec. 31, 2022	12,163,673				12,163,673
Beginning balance at Dec. 31, 2022	$ 14,106				$ 1			402,701			(388,759)	163
Increase (Decrease) in Shareholders' Equity
Net Loss	(1,750)										(1,750)
Unrealized Gain (Loss) on Available-for-Sale Investments	(3)											(3)
Foreign Currency Translation Adjustments	(4)											(4)
Issuance of Common Stock in connection with exercise of the Prior Warrant and Pre-Funded Warrants, net of offering costs (in shares)					389,000
Stock-based Compensation	193							193
Ending balance (in shares) at Mar. 31, 2023				15,000
Ending balance at Mar. 31, 2023				$ 0
Ending balance (in shares) at Mar. 31, 2023					12,552,673
Ending balance at Mar. 31, 2023	$ 12,542				$ 1			402,894			(390,509)	156
Beginning balance (in shares) at Dec. 31, 2022	15,000			15,000
Beginning balance at Dec. 31, 2022	$ 0			$ 0
Beginning balance (in shares) at Dec. 31, 2022	12,163,673				12,163,673
Beginning balance at Dec. 31, 2022	$ 14,106				$ 1			402,701			(388,759)	163
Increase (Decrease) in Shareholders' Equity
Net Loss	(6,927)
Unrealized Gain (Loss) on Available-for-Sale Investments	(90)
Foreign Currency Translation Adjustments	$ (4)
Ending balance (in shares) at Sep. 30, 2023	15,000			15,000
Ending balance at Sep. 30, 2023	$ 0			$ 0
Ending balance (in shares) at Sep. 30, 2023	28,489,663				28,489,663
Ending balance at Sep. 30, 2023	$ 21,518				$ 3			417,133			(395,686)	68
Beginning balance (in shares) at Mar. 31, 2023				15,000
Beginning balance at Mar. 31, 2023				$ 0
Beginning balance (in shares) at Mar. 31, 2023					12,552,673
Beginning balance at Mar. 31, 2023	12,542				$ 1			402,894			(390,509)	156
Increase (Decrease) in Shareholders' Equity
Net Loss	(3,305)										(3,305)
Unrealized Gain (Loss) on Available-for-Sale Investments	(18)											(18)
Foreign Currency Translation Adjustments	(1)											(1)
Issuance of Common Stock in connection with exercise of the Prior Warrant and Pre-Funded Warrants, net of offering costs (in shares)					4,118,000
Issuance of Common Stock in connection with exercise of Prior Warrant and Pre-Funded Warrants, net of offering costs	1				$ 1
Vesting of Restricted Stock Units Issued, net of taxes withheld (in shares)					125,000
Stock-based Compensation	309							309
Ending balance (in shares) at Jun. 30, 2023				15,000
Ending balance at Jun. 30, 2023				$ 0
Ending balance (in shares) at Jun. 30, 2023					16,795,673
Ending balance at Jun. 30, 2023	9,528				$ 2			403,203			(393,814)	137
Increase (Decrease) in Shareholders' Equity
Net Loss	(1,872)										(1,872)
Unrealized Gain (Loss) on Available-for-Sale Investments	(69)											(69)
Foreign Currency Translation Adjustments	0
Issuance of Common Stock in connection with exercise of the Prior Warrant and Pre-Funded Warrants, net of offering costs (in shares)					11,693,990
Issuance of Common Stock in connection with exercise of Prior Warrant and Pre-Funded Warrants, net of offering costs	13,719				$ 1			13,718
Stock-based Compensation	$ 212							212
Ending balance (in shares) at Sep. 30, 2023	15,000			15,000
Ending balance at Sep. 30, 2023	$ 0			$ 0
Ending balance (in shares) at Sep. 30, 2023	28,489,663				28,489,663
Ending balance at Sep. 30, 2023	$ 21,518				$ 3			$ 417,133			$ (395,686)	$ 68

v3.23.3

UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands	9 Months Ended
	Sep. 30, 2023	Sep. 30, 2022
Cash Flows From Operating Activities:
Net Loss	$ (6,927)	$ (16,317)
Adjustments To Reconcile Net Loss To Net Cash Used In Operating Activities:
Depreciation and Amortization	894	422
Stock-based Compensation	714	95
Increase in Inventory Reserves	1,098	307
Non-cash Lease Expense from Right of Use Assets	1,529	1,518
Amortization of Debt Financing Costs and Accretion of Debt Discount	276	276
Loss (Gain) on Disposal of Assets	1	(3)
Realized Gain on Sale of Investments	(220)	(4)
Changes in Operating Assets and Liabilities:
Accounts Receivable, net	(3,102)	(1,454)
Inventory	1,561	(921)
Prepaid and Other Assets	875	2,058
Accounts Payable	(124)	(688)
Lease Liabilities	(1,113)	(1,435)
Other Liabilities	(1,033)	756
Deferred License Revenue	(3,798)	(1,427)
Cash Used In Operating Activities	(9,369)	(16,817)
Cash Flows From Investing Activities:
Purchase of Investments Available-for-Sale	(3,752)	(17,389)
Sale of Investments Available-for-Sale	11,301	11,972
Purchase of Equipment	(241)	(197)
Cash Paid in Connection with Evoqua Asset Acquisition	(12,361)	0
Cash Used In Investing Activities	(5,053)	(5,614)
Cash Flows From Financing Activities:
Payments on Debt	(500)	(6,750)
Payments on Insurance Financing Note Payable	(748)	(941)
Payments on Financing Lease Liabilities	(388)	0
Proceeds from Issuance of Common Stock	13,763	15,016
Offering Costs from Issuance of Common Stock	(43)	(106)
Proceeds from Issuance of Preferred Stock	0	15,000
Offering Costs from Issuance of Preferred Stock	0	(85)
Cash Provided by Financing Activities	12,084	22,134
Effect of Exchange Rate Changes on Cash and Cash Equivalents	(5)	(3)
Net Decrease in Cash and Cash Equivalents	(2,343)	(300)
Cash and Cash Equivalents at Beginning of Period	10,102	13,280
Cash and Cash Equivalents at End of Period	7,759	12,980
Supplemental Disclosure of Cash Flow Information:
Cash Paid for Interest	929	1,261
Supplemental Disclosure of Non-cash Operating, Investing and Financing Activities:
Change in Unrealized (Loss) Gain on Investments Available-for-Sale	(90)	5
Increase in Prepaid Assets from Insurance Financing Note Payable	733	0
Deferred Consideration from Evoqua Asset Acquisition	$ 5,000	$ 0

v3.23.3

Description of Business	9 Months Ended
	Sep. 30, 2023
Organization, Consolidation and Presentation of Financial Statements [Abstract]
Description of Business	Description of Business Rockwell Medical, Inc. (the "Company", "Rockwell", "we", or "us") is a healthcare company that develops, manufactures, commercializes, and distributes a portfolio of hemodialysis products for dialysis providers worldwide. Rockwell is a revenue-generating business and the second largest supplier of liquid and powder acid and bicarbonate concentrates for dialysis patients in the United States. Hemodialysis is the most common form of end-stage kidney disease treatment and is typically performed at freestanding outpatient dialysis centers, hospital-based outpatient centers, skilled nursing facilities, or in a patient’s home. Rockwell provides the hemodialysis community with products controlled by a Quality Management System regulated by the U.S. Food and Drug Administration ("FDA"). Rockwell manufactures hemodialysis concentrates at its facilities in Michigan, South Carolina, and Texas totaling approximately 175,000 square feet, and manufactures its dry acid concentrate mixers at its facility in Iowa. Rockwell delivers the majority of its hemodialysis concentrates products and mixers to dialysis clinics throughout the United States and internationally utilizing its own delivery trucks and third-party carriers. On July 10, 2023, the Company executed and consummated the transactions contemplated by an Asset Purchase Agreement (the “Purchase Agreement”) with Evoqua Water Technologies LLC ("Evoqua") (the "Evoqua Acquisition"). Subject to the terms and conditions of the Purchase Agreement, at the closing of the transaction (the “Closing”), the Company purchased customer relationships, equipment and inventory from Evoqua, which were related to its manufacturing and selling of hemodialysis concentrates products, all of which are manufactured under a contract manufacturing agreement with a third-party organization. See Note 4 for further detail. In addition to its primary focus on hemodialysis concentrates, Rockwell also has a proprietary parenteral iron product, Triferic® (ferric pyrophosphate citrate ("FPC")), which is indicated to maintain hemoglobin in adult patients with hemodialysis-dependent chronic kidney disease. While Rockwell has discontinued commercialization of Triferic in the United States, the Company has established international partnerships with companies seeking to develop and commercialize Triferic outside the United States and is working closely with these international partners to develop and commercialize Triferic in their respective regions. During the third quarter of 2023, the ongoing Triferic development effort was terminated resulting in an acceleration of the corresponding deferred license revenue (see Note 10) and a reserve on the non-current inventory (see Note 7). Additionally, Rockwell continues to evaluate the viability of its FPC platform and FPC's potential to treat iron deficiency, iron deficiency anemia, and acute heart failure. Rockwell was incorporated in the state of Michigan in 1996 and re-domiciled to the state of Delaware in 2019. Rockwell's headquarters is located at 30142 Wixom Road, Wixom, Michigan 48393.

v3.23.3

Liquidity and Capital Resources	9 Months Ended
	Sep. 30, 2023
Liquidity and Capital Resources [Abstract]
Liquidity and Capital Resources	Liquidity and Capital Resources As of September 30, 2023, Rockwell had approximately $11.7 million of cash, cash equivalents and investments available-for-sale, and working capital of $6.8 million. Net cash used in operating activities for the nine months ended September 30, 2023 was approximately $9.4 million. Based on the currently available working capital, management believes the Company currently has sufficient funds to meet its operating requirements for at least the next twelve months from the date of the filing of this report. The Company continues to review its operational plans and execute on the acquisition of new customers, and has implemented cost containment activities. The Company may require additional capital to sustain its operations and make the investments it needs to execute its strategic plan. Additionally, the Company's operational plans include raising capital, if needed, by using its at-the-market ("ATM") facility or other methods or forms of financings, subject to existing limitations. If the Company attempts to obtain additional debt or equity financing, the Company cannot assume such financing will be available on favorable terms, if at all. In 2023, the Company is no longer subject to the "baby shelf" limitations under Form S-3, which limit the amount the Company may offer pursuant to its registration statement on Form S-3. The Company is subject to certain covenants and cure provisions under its Loan Agreement with Innovatus. As of the date of this report, the Company is in compliance with all covenants (See Note 15 for further detail). In addition, the global macroeconomic environment is uncertain, and could be negatively affected by, among other things, increased U.S. trade tariffs and trade disputes with other countries, instability in the global capital and credit markets, recent bank failures in the United States, supply chain weaknesses, and instability in the geopolitical environment, including as a result of the Russian invasion of Ukraine, Israel-Hamas conflict and other political tensions, and lingering effects of the COVID-19 pandemic. Such challenges have caused, and may continue to cause, recession fears, rising interest rates, foreign exchange volatility and inflationary pressures. At this time, the Company is unable to quantify the potential effects of this economic instability on our future operations. Rockwell has utilized a range of financing methods to fund its operations in the past; however, current conditions in the financial and credit markets may limit the availability of funding, refinancing or increase the cost of funding. Due to the rapidly evolving nature of the global situation, it is not possible to predict the extent to which these conditions could adversely affect the Company's liquidity and capital resources in the future.

v3.23.3

Basis of Presentation, Summary of Significant Accounting Policies and Recent Accounting Pronouncements	9 Months Ended
	Sep. 30, 2023
Accounting Policies [Abstract]
Basis of Presentation, Summary of Significant Accounting Policies and Recent Accounting Pronouncements	Basis of Presentation, Summary of Significant Accounting Policies and Recent Accounting Pronouncements The accompanying condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) for interim financial information and pursuant to the instructions to Form 10-Q and Rule 10-01 of Regulation S-X of the U. S. Securities and Exchange Commission (“SEC”) and on the same basis as the Company prepares its annual audited consolidated financial statements. The condensed consolidated balance sheet at September 30, 2023, and the condensed consolidated statements of operations, comprehensive loss, and changes in stockholders' equity for the three and nine months ended September 30, 2023 and cash flows for the nine months ended September 30, 2023 are unaudited, but include all adjustments, consisting of normal recurring adjustments the Company considers necessary for a fair presentation of the financial position, operating results and cash flows for the periods presented. The results for the three and nine months ended September 30, 2023 are not necessarily indicative of results to be expected for the year ending December 31, 2023 or for any future interim period. The condensed consolidated balance sheet at December 31, 2022 has been derived from audited financial statements, however, it does not include all of the information and notes required by U.S. GAAP for complete financial statements. The accompanying condensed consolidated financial statements should be read in conjunction with the audited financial statements for the year ended December 31, 2022 and notes thereto included in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2022 as filed with the SEC on March 30, 2023. The Company’s consolidated subsidiaries consist of its wholly-owned subsidiaries, Rockwell Transportation, Inc. and Rockwell Medical India Private Limited. The accompanying condensed consolidated interim financial statements include the accounts of the Company and its subsidiaries. All material intercompany balances and transactions have been eliminated in consolidation. Use of Estimates The preparation of the condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that may affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and reported amounts of expenses during the reporting period. Actual results could differ from those estimates. Restatement of Loss Per Share Loss per share for the three and nine months ended September 30, 2022 have been recalculated and restated and is presented on a comparable basis with the three and nine months ended September 30, 2023. In the first quarter of 2023, the Company determined it should have included pre-funded warrants issued in the second quarter of 2022 in the earnings per share calculation in accordance with Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC") 260-10-45-13, which treats shares of common stock exercisable for little to no consideration as included in the denominator of both the basic and diluted earnings per share calculations. While the Company has determined the impact of including the pre-funded warrants in the earnings per share calculations does not have a material impact on previously issued financial statements, the Company has recalculated and restated amounts presented on a comparative and consistent basis with current period results. The table below summarizes previously reported and restated amounts on a comparative basis. See the table presentation of loss per share calculations as of September 30, 2023 and 2022 in the "Loss Per Share" section below. Three Months Ended September 30, Nine Months Ended September 30, 2022 2022 As Previously Reported: Net loss per share attributable to common stockholders - basic and diluted $ (0.40) $ (1.75) Weighted average number of shares of common stock outstanding - basic and diluted 10,528,148  9,299,788  As Restated: Net loss per share attributable to common stockholders - basic and diluted $ (0.23) $ (1.26) Weighted average number of shares of common stock outstanding - basic and diluted 18,463,673  12,902,890  Loss Per Share Basic and diluted net loss per share for the three and nine months ended September 30, 2023 and 2022, after giving effect to the restatement discussed above, was calculated as follows: Three Months Ended September 30, Nine Months Ended September 30, (In Thousands, Except Share and Per Share Amounts) 2023 2022 2023 2022 Numerator: Net loss $ (1,872) $ (4,190) $ (6,927) $ (16,317) Net loss attributable to common stockholders for basic and diluted loss per share $ (1,872) $ (4,190) $ (6,927) $ (16,317) Denominator: Weighted average number of shares of common stock outstanding - basic and diluted 27,521,088  18,463,673  21,526,978  12,902,890  Net loss per share attributable to common stockholders - basic and diluted $ (0.07) $ (0.23) $ (0.32) $ (1.26) Included within the weighted average shares of common stock outstanding for the three and nine months ended September 30, 2022 are 7,311,000 shares of common stock issuable upon the exercise of pre-funded warrants (See Note 11), as the warrants are exercisable at any time for nominal consideration and, as such, the shares are considered outstanding for the purpose of calculating basic and diluted net loss per share attributable to common stockholders. The Company’s potentially dilutive securities include stock options, restricted stock awards and units, convertible preferred stock and warrants. These securities were excluded from the computations of diluted net loss per share for the three and nine months ended September 30, 2023 and 2022, as the effect would be to reduce the net loss per share. The following table includes the potential shares of common stock, presented based on amounts outstanding at each period end, that were excluded from the computation of diluted net loss per share attributable to common stockholders for the periods indicated because including them would have had an anti-dilutive effect: As of September 30, 2023 2022 Options to Purchase Common Stock 1,367,493  1,311,691  Unvested Restricted Stock Awards 891  891  Unvested Restricted Stock Units 287,400  125,000  Convertible Preferred Stock 1,363,636  1,363,636  Warrants to Purchase Common Stock 4,045,278 17,507,268  Total 7,064,698 20,308,486  Adoption of Recent Accounting Pronouncements The Company continually assesses new accounting pronouncements to determine their applicability. When it is determined a new accounting pronouncement affects the Company’s financial reporting, the Company undertakes a review to determine the consequences of the change to its consolidated financial statements and assures there are sufficient controls in place to ascertain the Company’s consolidated financial statements properly reflect the change. In June 2016, the FASB issued Accounting Standards Update ("ASU") 2016-13, Financial Instruments - Credit Losses (Topic 326), which introduced an impairment model that is based on expected credit losses, rather than incurred losses, to estimate credit losses on certain types of financial instruments (e.g., loan commitments). The expected credit losses should consider historical information, current information, and reasonable and supportable forecasts, including estimates of prepayments, over the contractual term. Financial instruments with similar risk characteristics may be grouped together when estimating expected credit losses. In addition, ASC 326 requires expected credit related losses for trade accounts receivable, as well as available-for-sale debt securities, which are to be recorded through an allowance for credit losses, while non-credit related losses will continue to be recognized through other comprehensive income. The Company adopted the new guidance, as of January 1, 2023, and it did not have a material impact on the condensed consolidated financial statements.

v3.23.3

Asset Acquisition	9 Months Ended
	Sep. 30, 2023
Business Combination and Asset Acquisition [Abstract]
Asset Acquisition	Asset Acquisition On July 10, 2023, the Company completed the Evoqua Acquisition. At the Closing, the Company purchased customer relationships, equipment and inventory from Evoqua, which were related to manufacturing and selling of hemodialysis concentrates products, all of which are manufactured under a contract manufacturing agreement with a third-party organization. Pursuant to the Purchase Agreement, total consideration was $17.4 million, comprising a cash payment at Closing of $12.2 million (inclusive of transaction costs) and two $2.5 million deferred payments, the first to be paid on the one-year anniversary of the Closing, which is included as a current liability on the Company's condensed consolidated balance sheet, and the second to be paid on the second anniversary of the Closing (collectively, the “deferred consideration”). The transaction was accounted for as an asset acquisition, as the acquired assets did not meet the definition of a business as defined by ASC 805, Business Combinations. The purchase price was allocated, on a relative fair value basis, to the assets acquired at the July 10, 2023 acquisition date as follows (table in thousands): Consideration Cash Payment $ 12,233  Deferred Consideration 5,000  Transaction Costs 128  Total Consideration $ 17,361  Assets Acquired Customer Relationships Intangible Asset $ 11,035  Equipment 5,093  Inventory 1,233  Total Assets Acquired $ 17,361  The fair value of the customer relationships intangible asset was determined using a multi-period excess earnings method, a form of the income approach, which incorporates the estimated future cash flows to be generated from the customer base. Key assumptions included discounted cash flow, estimated life cycle and customer attrition rates. Customer relationships are being amortized over a period of 20 years. Given the recency of the purchase of the equipment in which the assets were recorded at fair value, the Company determined the fair value of the equipment using a cost approach, which considered assumptions over the equipment's current replacement cost and useful life. Inventory was purchased directly from the contract manufacturer holding the inventory, which approximated fair value. During the three and nine months ended September 30, 2023, the Company recorded amortization of its customer relationship intangible asset of $0.1 million, resulting in a net intangible asset of $10.9 million as of September 30, 2023. Estimated future amortization expense on the Company's customer relationships intangible asset as of September 30, 2023 is as follows (table in thousands): Year ended December 31: 2023 (remainder of year) $ 138  2024 552  2025 552  2026 552  2027 552  Thereafter 8,551  Total $ 10,897

v3.23.3

Revenue Recognition	9 Months Ended
	Sep. 30, 2023
Revenue from Contract with Customer [Abstract]
Revenue Recognition	Revenue Recognition The Company recognizes revenue under ASC 606, Revenue from Contracts with Customers. The core principle of the revenue standard is that a company should recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the company expects to be entitled in exchange for those goods or services. The following five steps are applied to achieve that core principle: •Step 1: Identify the contract with the customer •Step 2: Identify the performance obligations in the contract •Step 3: Determine the transaction price •Step 4: Allocate the transaction price to the performance obligations in the contract •Step 5: Recognize revenue when the company satisfies a performance obligation Taxes assessed by a governmental authority that are both imposed on and concurrent with a specific revenue-producing transaction, that are collected by us from a customer, are excluded from revenue. Shipping and handling costs associated with outbound freight related to contracts with customers are accounted for as a fulfillment cost and are included in cost of sales when control of the goods transfers to the customer. Nature of goods and services The following is a description of principal activities from which the Company generates its revenue. The Company currently operates in one market segment, the hemodialysis market, which involves the manufacture, sale and distribution of hemodialysis products to hemodialysis clinics, including pharmaceutical, dialysis concentrates, dialysis kits and other ancillary products used in the dialysis process. Rockwell's customer mix is diverse, with most customer sales concentrations under 10% and one customer, DaVita, Inc. ("DaVita"), at approximately 50% of total net product sales for each of the three and nine months ended September 30, 2023. Rockwell's accounts receivable from this customer were approximately 31% and 30% of the total net consolidated accounts receivable balance at September 30, 2023 and December 31, 2022, respectively. Product sales – The Company accounts for individual products and services separately if they are distinct (i.e., if a product or service is separately identifiable from other items and if a customer can benefit from it on its own or with other resources that are readily available to the customer). The consideration, including any discounts, is allocated between separate products and services based on their stand-alone selling prices. The stand-alone selling prices are determined based on the cost plus margin approach. Drug and dialysis concentrates products are sold directly to dialysis clinics and to wholesale distributors in both domestic and international markets. Distribution and license agreements for which upfront fees are received are evaluated upon execution or modification of the agreement to determine if the agreement creates a separate performance obligation from the underlying product sales.  For all existing distribution and license agreements, the distribution and license agreement is not a distinct performance obligation from the product sales.  In instances where regulatory approval of the product has not been established and the Company does not have sufficient experience with the foreign regulatory body to conclude regulatory approval is probable, the revenue for the performance obligation is recognized over the term of the license agreement (over time recognition). Conversely, when regulatory approval already exists or is probable, revenue is recognized at the point in time control of the product transfers to the customer. The Company received upfront fees under five distribution and license agreements that have been deferred as a contract liability.  The amounts received from Wanbang Biopharmaceuticals Co., Ltd. (“Wanbang”), Sun Pharmaceutical Industries Ltd. ("Sun Pharma"), Jeil Pharmaceutical Co., Ltd. ("Jeil Pharma") and Drogsan Pharmaceuticals ("Drogsan Pharma") are recognized as revenue over the estimated term of the applicable distribution and license agreement as regulatory approval was not received and the Company did not have sufficient experience in China, India, South Korea and Turkey, respectively, to determine regulatory approval was probable as of the execution of the agreement.  The amounts received from Baxter Healthcare Corporation (“Baxter”) were deferred and recognized as revenue at the point in time the estimated product sales under the agreement occurred. During the three months ended September 30, 2023, the amounts received from Wanbang were accelerated out of deferred license revenue and into revenue upon notice that the development effort was terminated (see Note 10). In November 2022, Rockwell reacquired its distribution rights to its hemodialysis concentrates products from Baxter and terminated the exclusive distribution agreement. Under the exclusive distribution agreement, Baxter distributed and commercialized Rockwell’s hemodialysis concentrates products and provided customer service and order delivery to nearly all U.S. customers. Following the reacquisition of these rights, Rockwell is now unrestricted in its ability to sell its hemodialysis concentrates products to dialysis clinics throughout the U.S. and around the world. For additional information, see Note 10. Rockwell agreed to pay Baxter a fee for the reacquisition of its distribution rights which was reflected as an expense at that time. This fee was payable in two equal installments on January 1, 2023 and April 1, 2023. As of September 30, 2023, all payments were completed. On September 18, 2023, the Company and its long-time partner, DaVita, a leading provider of kidney care, entered into an Amended and Restated Products Purchase Agreement (the "Amended Agreement"), which amends and restates the Product Purchase Agreement, dated July 1, 2019, as amended, under which the Company supplies DaVita with certain dialysis concentrates. Under the Amended Agreement, the Company and DaVita agreed to an increase in product pricing, effective September 1, 2023 and a one-time payment to Rockwell on or after December 1, 2023. The term of the Amended Agreement will expire on December 31, 2024. DaVita will have the right, in its sole discretion upon written notice to the Company given no later than September 30, 2024, to further extend the term through December 31, 2025. In the event of such an extension, product pricing will be increased for the extended term. In addition, DaVita is required to provide the Company with nine-month purchasing forecasts and a commitment to purchase at least the forecasted amounts. In the event that DaVita does not meet its forecasts, it is required to pay the Company for the amount forecasted, purchase additional product, or the Company may terminate the Amended Agreement. Upon expiration or termination of the Amended Agreement, and upon request by DaVita, the Company has agreed to provide transition services to DaVita during a transition period. Additionally during the third quarter of 2023, the Company entered into several long-term product purchase agreements, which include supply and purchasing commitments from certain parties. For the majority of the Company’s U.S. and international customers, the Company recognizes revenue at the shipping point, which is generally the Company’s plant or warehouse. For other business, the Company recognizes revenue based on when the customer takes control of the product. The amount of revenue recognized is based on the purchase order less returns and adjusted for any rebates, discounts, chargebacks or other amounts paid to customers estimated at the time of sale. There were no such adjustments for the periods reported. Customers typically pay for the product based on customary business practices with payment terms averaging 30 days, while a small subset of customers have payment terms averaging 60 days. Disaggregation of revenue Revenue is disaggregated by primary geographical market, major product line, and timing of revenue recognition. In thousands Three Months Ended September 30, 2023 Nine Months Ended September 30, 2023 Products By Geographic Area Total U.S. Rest of World Total U.S. Rest of World Drug Revenues Product Sales – Point-in-time $ —  $ —  $ —  $ —  $ —  $ —  License Fee – Over time 2,197  —  2,197  2,327  —  2,327  Total Drug Products 2,197  —  2,197  2,327  —  2,327  Concentrates Products Product Sales – Point-in-time 21,574  19,741  1,833  57,720  52,326  5,394  License Fee – Over time —  —  —  1,472  1,472  —  Total Concentrate Products 21,574  19,741  1,833  59,192  53,798  5,394  Net Revenue $ 23,771  $ 19,741  $ 4,030  $ 61,519  $ 53,798  $ 7,721  In thousands Three Months Ended September 30, 2022 Nine Months Ended September 30, 2022 Products By Geographic Area Total U.S. Rest of World Total U.S. Rest of World Drug Revenues Product Sales – Point-in-time $ 193  $ 193  $ —  $ 834  $ 561  $ 273  License Fee – Over time 65  —  65  192  —  192  Total Drug Products 258  193  65  1,026  561  465  Concentrates Products Product Sales – Point-in-time 17,953  16,619  1,334  51,035  46,334  4,701  License Fee – Over time 480  480  —  1,436  1,436  —  Total Concentrate Products 18,433  17,099  1,334  52,471  47,770  4,701  Net Revenue $ 18,691  $ 17,292  $ 1,399  $ 53,497  $ 48,331  $ 5,166  Contract balances The following table provides information about receivables, contract assets, and contract liabilities from contracts with customers. In thousands September 30, 2023 December 31, 2022 Accounts Receivable, net $ 9,361  $ 6,259  Contract Liabilities, which are included in deferred license revenue $ 533  $ 4,331  There were no other material contract assets recorded on the condensed consolidated balance sheets as of September 30, 2023 and December 31, 2022.  The Company does not generally accept returns of its concentrates products and no material reserve for returns of concentrates products was established as of September 30, 2023 or December 31, 2022.  The contract liabilities primarily relate to upfront payments and consideration received from customers in advance of the customer assuming control of the related products.

v3.23.3

Investments - Available-for-Sale	9 Months Ended
	Sep. 30, 2023
Investments, Debt and Equity Securities [Abstract]
Investments - Available-for-Sale	Investments - Available-for-Sale Investments available-for-sale consisted of the following as of September 30, 2023 and December 31, 2022 (table in thousands): September 30, 2023 Amortized Cost Unrealized Gain Unrealized Loss Accrued Interest Fair Value Available-for-Sale Securities Debt securities $ 3,898  $ 73  $ —  $ —  $ 3,971  December 31, 2022 Amortized Cost Unrealized Gain Unrealized Loss Accrued Interest Fair Value Available-for-Sale Securities Debt securities $ 11,315  $ 75  $ —  $ —  $ 11,390  The fair value of investments available-for-sale are determined using quoted market prices from daily exchange-traded markets based on the closing price as of the balance sheet date and are classified as a Level 1 measurement under ASC 820 Fair Value Measurements. As of September 30, 2023 and December 31, 2022, all of our available-for-sale securities were all due within one year.

v3.23.3

Inventory	9 Months Ended
	Sep. 30, 2023
Inventory Disclosure [Abstract]
Inventory	Inventory Components of inventory, net of reserves, as of September 30, 2023 and December 31, 2022 are as follows (table in thousands): September 30, 2023 December 31, 2022 Inventory - Current Portion Raw Materials $ 2,335  $ 3,351  Work in Process 337  351  Finished Goods 2,814  2,112  Total Current Inventory 5,486  5,814  Inventory - Long Term (1) 178  1,276  Total Inventory $ 5,664  $ 7,090  __________ 1.Represents inventory related to Triferic raw materials. This Triferic inventory will be utilized for the Company's international partnerships. In September 2022, the Company discontinued its New Drug Applications ("NDAs") for Triferic (dialysate) and Triferic AVNU in the United States. During the three months ended September 30, 2023, the Company reserved $1.1 million of long-term inventory as a result of the termination of the Wanbang development effort. As of September 30, 2023 and December 31, 2022, Rockwell had total current concentrate inventory aggregating $5.5 million and $5.8 million, respectively, against which Rockwell had reserved $25,000 at both September 30, 2023 and December 31, 2022.

v3.23.3

Property and Equipment, net	9 Months Ended
	Sep. 30, 2023
Property, Plant and Equipment [Abstract]
Property and Equipment, net	Property and Equipment, net As of September 30, 2023 and December 31, 2022, the Company’s property and equipment consisted of the following (table in thousands): September 30, 2023 December 31, 2022 Leasehold Improvements $ 1,423  $ 1,256  Machinery and Equipment 11,085  5,922  Information Technology & Office Equipment 1,845  1,845  Laboratory Equipment 807  807     Total Property and Equipment 15,160  9,830  Accumulated Depreciation and Amortization (8,389) (7,636) Property and Equipment, net $ 6,771  $ 2,194  Depreciation and amortization expense for the three months ended September 30, 2023 and 2022 was $0.4 million and $0.1 million, respectively. Depreciation and amortization expense for the nine months ended September 30, 2023 and 2022 was $0.8 million and $0.4 million, respectively.

v3.23.3

Accrued Liabilities	9 Months Ended
	Sep. 30, 2023
Payables and Accruals [Abstract]
Accrued Liabilities	Accrued Liabilities Accrued liabilities as of September 30, 2023 and December 31, 2022 consisted of the following (table in thousands): September 30, 2023 December 31, 2022 Accrued Compensation and Benefits $ 2,240  $ 2,568  Accrued Unvouchered Receipts 1,947  585  Accrued Manufacturing Expense 732  —  Accrued Workers Compensation 202  306  Accrued Research & Development Expense —  43  Other Accrued Liabilities 1,587  4,200  Total Accrued Liabilities $ 6,708  $ 7,702

v3.23.3

Deferred License Revenue	9 Months Ended
	Sep. 30, 2023
Revenue from Contract with Customer [Abstract]
Deferred License Revenue	Deferred License Revenue In October 2014, the Company entered into an exclusive distribution agreement with Baxter, which had a term of 10 years and received an upfront fee of $20 million. The upfront fee was recorded as deferred license revenue and was being recognized based on the proportion of product shipments to Baxter in each period, compared with total expected sales volume over the term of the distribution agreement. On November 9, 2022, Rockwell reacquired its distribution rights to its hemodialysis concentrates products from Baxter and terminated the distribution agreement. Exclusivity and other provisions associated with the distribution agreement terminated November 9, 2022 and the remaining operational elements of the agreement terminated December 31, 2022. Rockwell agreed to provide certain services to a group of Baxter's customers until March 31, 2023. Under the distribution agreement, Baxter distributed and commercialized Rockwell’s hemodialysis concentrates products and provided customer service and order delivery to nearly all United States customers. Following the reacquisition of these rights, Rockwell is now unrestricted in its ability to sell its hemodialysis concentrates products to dialysis clinics throughout the United States and around the world. The Company recognized the remaining revenue of $1.5 million during the three months ended March 31, 2023. In 2016, the Company entered into a distribution agreement with Wanbang (the "Wanbang Agreement") and received an upfront fee of $4.0 million. The upfront fee was recorded as deferred license revenue and is being recognized as revenue based on the agreement term. On August 7, 2023, Rockwell was informed by Wanbang that the main efficacy results of Wanbang’s clinical trial for Triferic (dialysate) compared with placebo were not obtained and Wanbang will not bring the product forward to registration. As a result, the Company recognized all remaining revenue under the Wangbang Agreement of approximately $2.2 million during the third quarter of 2023. Additionally, in connection with these events, the Company established a reserve for related Triferic long-term inventory of $1.1 million, resulting in a net increase in gross profit of $1.1 million. In January 2020, the Company entered into license and supply agreements with Sun Pharma (the "Sun Pharma Agreements"), for the rights to commercialize Triferic (dialysate) in India. In consideration for the license, the Company received an upfront fee of $0.1 million. The upfront fee was recorded as deferred license revenue and is being recognized as revenue based on the agreement term. The Company recognized revenue of approximately $2,500 and $7,500 for the three and nine months ended September 30, 2023 and 2022, respectively. Deferred license revenue related to the Sun Pharma Agreement totaled $62,500 and $70,000 as of September 30, 2023 and December 31, 2022, respectively. In September 2020, the Company entered into a license and supply agreements with Jeil Pharmaceutical (the "Jeil Agreements"), for the rights to commercialize Triferic (dialysate) in South Korea. In consideration for the license, the Company received an upfront fee of $0.2 million. In May 2022, Jeil Pharmaceutical obtained regulatory approval in South Korea and paid the Company $0.2 million in consideration of reaching the milestone. The upfront fee and milestone payments were recorded as deferred license revenue and are being recognized as revenue based on the agreement term. The Company recognized revenue of $5,200 and $15,600 for the three and nine months ended September 30, 2023 and 2022, respectively. Deferred license revenue related to the Jeil Agreement totaled approximately $0.4 million as of both September 30, 2023 and December 31, 2022. In June 2021, the Company entered into license and supply agreements with Drogsan Pharmaceuticals (the "Drogsan Agreements"), for the rights to commercialize Triferic (dialysate) and Triferic AVNU in Turkey. In consideration for the license, the Company received an upfront fee of $0.15 million. The upfront fee was recorded as deferred license revenue and will be recognized as revenue based on the agreement term. The Company recognized revenue of $3,750 and $11,250 for the three and nine months ended September 30, 2023 and 2022, respectively. Deferred license revenue related to the Drogsan Agreements totaled approximately $0.1 million as of each of September 30, 2023 and December 31, 2022. In April 2023, Drogsan submitted a Marketing Authorization application and GMP application for Triferic AVNU to the Turkish Medicines and Medical Devices Agency, for which Drogsan received priority status and high priority status, respectively. Drogsan is responsible for all regulatory approval and commercialization activities.

v3.23.3

Stockholders’ Equity	9 Months Ended
	Sep. 30, 2023
Equity [Abstract]
Stockholders' Equity	Stockholders’ Equity The Company held its annual meeting of stockholders on May 23, 2023 (the “Annual Meeting”). At the Annual Meeting, the Company’s stockholders approved the amendment and restatement of the Rockwell Medical, Inc. 2018 Long Term Incentive Plan to increase the number of shares of common stock issuable thereunder by 1,600,000 shares (the “Amended 2018 Plan”). Preferred Stock On April 6, 2022, the Company and DaVita entered into the Securities Purchase Agreement (the "SPA"), which provided for the issuance by the Company of up to $15 million of preferred stock to DaVita. On April 6, 2022, the Company issued 7,500 shares of Series X Preferred Stock for gross proceeds of $7.5 million. On June 16, 2022 the Company issued an additional 7,500 shares of the Series X Preferred Stock to DaVita for gross proceeds of $7.5 million. The Series X Preferred Stock was issued for a price of $1,000 per share (the "Face Amount"), subject to accretion at a rate of 1% per annum, compounded annually. If the Company’s common stock trades above $22.00 for a period of 30 calendar days, the accretion will thereafter cease. As of September 30, 2023, the Series X Preferred Stock accreted a total $150,000. The Series X Convertible Preferred Stock is convertible to common stock at a rate equal to the Face Amount, divided by a conversion price of $11.00 per share (subject to adjustment for future stock splits, reverse stock splits and similar recapitalization events). As a result, each share of Series X Preferred Stock will initially convert into approximately 91 shares of common stock. DaVita’s right to convert to common stock is subject to a beneficial ownership limitation, which is initially set at 9.9% of the outstanding common stock, which limitation may be reset (not to exceed 19.9%) at DaVita’s option and upon providing prior written notice to the Company. In addition, any debt financing is limited by the terms of our Securities Purchase Agreement with DaVita. Specifically, until DaVita owns less than 50% of its investment, the Company may only incur additional debt in the form of a purchase money loan, a working capital line of up to $5 million or to refinance existing debt, unless DaVita consents. Additionally, the Series X Preferred Stock has a deemed liquidation event and redemption clause which could be triggered if the sale of all or substantially all of the Company's assets relating to the Company's dialysis concentrates business line. Since the Series X Preferred Stock may be redeemed if certain assets are sold at the option of the holder, but is not mandatorily redeemable and the sale of the assets that would allow for redemption is within the control of the Company, the preferred stock has been classified as permanent equity and initially recognized at fair value of $15 million (the proceeds on the date of issuance) less issuance costs of $0.1 million, resulting in an initial value of $14.9 million. The Company will assess at each reporting period whether conditions have changed to now meet the mandatory redemption definition which could trigger liability classification. As of both September 30, 2023 and December 31, 2022, there were 2,000,000 shares of preferred stock, $0.0001 par value per share, authorized and 15,000 shares of preferred stock issued and outstanding. Common Stock As of September 30, 2023 and December 31, 2022, there were 170,000,000 shares of common stock, $0.0001 par value per share, authorized and 28,489,663 and 12,163,673 shares issued and outstanding, respectively. As of September 30, 2023 and 2022, the Company reserved for issuance the following shares of common stock related to the potential exercise of employee stock options, unvested restricted stock, convertible preferred stock, pre-funded warrants and all other warrants (collectively, "common stock equivalents"): As of September 30, Common stock and common stock equivalents: 2023 2022 Common stock 28,489,663  11,152,673  Common stock issuable upon exercise of pre-funded warrants —  7,311,000  Common stock and pre-funded stock warrants 28,489,663  18,463,673  Options to Purchase Common Stock 1,367,493  1,311,691  Unvested Restricted Stock Awards 891  891  Unvested Restricted Stock Units 287,400  125,000  Convertible Preferred Stock 1,363,636  1,363,636  Warrants to Purchase Common Stock 4,045,278  17,507,268  Total 35,554,361 38,772,159  During the three months ended September 30, 2023 and 2022, 1,793,000 and 477,480 pre-funded warrants were exercised, respectively. During the nine months ended September 30, 2023 and 2022, 6,300,000 and 477,480 pre-funded warrants were exercised, respectively. During the three and nine months ended September 30, 2023 and 2022, no vested employee stock options were exercised. Controlled Equity Offering On April 8, 2022, the Company entered into the Sales Agreement (the "ATM facility") with Cantor Fitzgerald & Co. as Agent, pursuant to which the Company may offer and sell from time to time up to $12.2 million of shares of Company’s common stock through the Agent. The offering and sale of such shares has been registered under the Securities Act of 1933, as amended. During the quarter ended September 30, 2023, no sales were made pursuant to the Sales Agreement. Approximately $12.2 million remains available for sale under the ATM facility. Registered Direct Offering On May 30, 2022, the Company entered into the Registered Direct Purchase Agreement (the "Agreement") with the Purchaser, pursuant to which the Company issued and sold, in a registered direct offering (the “Offering”), 844,613 shares of its common stock at price of $1.39 per share, and pre-funded warrants to purchase up to an aggregate of 7,788,480 shares of common stock (the “Pre-Funded Warrants” and the shares of common stock underlying the Pre-Funded Warrants, the “Warrant Shares”). The purchase price of each Pre-Funded Warrant is equal to the price at which a share of common stock was sold to the public in the Offering, minus $0.0001, and the exercise price of each Pre-Funded Warrant is $0.0001 per share. A holder (together with its affiliates) may not exercise any portion of the Pre-Funded Warrants to the extent the holder would own more than 9.99% of the Company’s outstanding common stock immediately after exercise, as such percentage ownership is determined in accordance with the terms of the Pre-Funded Warrant. The Agreement contains customary representations and warranties and agreements of the Company and the Purchaser and customary indemnification rights and obligations of the parties. On July 5, 2023, all of the remaining Pre-Funded Warrants to purchase 1,793,000 shares of common stock were exercised. The exercise price of each Pre-Funded Warrant was $0.0001 per share and resulted in gross proceeds to the Company of $179. Private Placement Also on May 30, 2022, concurrent with the Offering, the Company entered into the private investment in public equity "PIPE" Purchase Agreement relating to the offering and sale (the “Private Placement”) of warrants to purchase up to a total of 9,900,990 shares of common stock (the "PIPE Warrants") and pre-funded warrants to purchase up to a total of 1,267,897 shares of common stock (the “Pre-Funded PIPE Warrants”). Each warrant was sold at a price of $0.125 per underlying warrant share and is exercisable at an exercise price of $1.39 per share. The purchase price of each Pre-Funded Warrant was equal to the price at which a share of common stock was sold to the public in the Offering, minus $0.0001, and the exercise price of each Pre-Funded Warrant is $0.0001 per share. As of December 2022, all Pre-Funded PIPE Warrants have been exercised. On July 10, 2023, the Company entered into a letter agreement (the “Letter Agreement”) with Armistice Capital Master Fund Ltd. (“Armistice”), which held a warrant (the “Prior Warrant”) to purchase 9,900,990 shares of common stock of the Company (the “Common Stock”) with an exercise price of $1.39 per share, offering Armistice the opportunity to exercise the Prior Warrant for cash, provided the Prior Warrant was exercised for cash on or prior to 5:00 P.M. Eastern Time on July 10, 2028 (the “End Date”). In addition, Armistice would receive a “reload” warrant (the “Reload Warrant”) to purchase 3,750,000 shares of Common Stock with an exercise price of $5.13 per share, the closing price as reported by the Nasdaq Capital Market on July 7, 2023. The terms of the Reload Warrant and Letter Agreement provide for customary resale registration rights. The Letter Agreement also provides that for a period of 45 days after the issuance of the Reload Warrant, the Company’s may not sell shares of Common Stock pursuant to its sales agreement with Cantor Fitzgerald & Co., dated as of April 8, 2022, at price per share less than $6.25. The Reload Warrant may be exercised at all times prior to the 54 months month anniversary of its issuance date. The Prior Warrant and the Reload Warrant both provide that a holder (together with its affiliates) may not exercise any portion of the Prior Warrant or the Reload Warrant to the extent that the holder would own more than 9.99% of the Company’s outstanding Common Stock immediately after exercise, as such percentage ownership is determined in accordance with the terms of such warrant. To the extent the exercise of the Prior Warrant would result in Armistice holding more than 9.99% of the Company’s outstanding Common Stock, such shares of Common Stock in excess of 9.99% will be held in abeyance. The Letter Agreement amended the Prior Warrant to extend the expiration date thereof to one year following the original expiration date set forth therein. Armistice exercised the Prior Warrant on July 10, 2023, and the Company received gross proceeds of approximately $13.8 million from the exercise of the Prior Warrant as a result of such exercise pursuant to the terms of the Letter Agreement.

v3.23.3

Stock-Based Compensation	9 Months Ended
	Sep. 30, 2023
Share-Based Payment Arrangement [Abstract]
Stock-Based Compensation	Stock-Based Compensation The Company recognized total stock-based compensation expense during the three and nine months ended September 30, 2023 and 2022 as follows (table in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 Service-based awards: Restricted Stock Units $ 112  $ 46  $ 276  $ 84  Stock Option Awards 100  130  438  401     Total Service Based Awards 212  176  714  485  Performance-based awards: Restricted Stock Awards —  —  —  (391) Total $ 212  $ 176  $ 714  $ 94  Performance Based Restricted Stock A summary of the Company’s restricted stock awards during the nine months ended September 30, 2023 is as follows: Number of Shares Weighted Average Grant-Date Fair Value Unvested at January 1, 2023 891  $ 62.70  Unvested at September 30, 2023 891  $ 62.70  A summary of the Company’s restricted stock awards during the nine months ended September 30, 2022 is as follows: Number of Shares Weighted Average Grant-Date Fair Value Unvested at January 1, 2022 7,118  $ 62.70  Forfeited (1) (6,227) $ 62.70  Unvested at September 30, 2022 891  $ 62.70  __________ 1.These forfeited awards were due to the resignation of the Company's Chief Development Officer on March 25, 2022 and reduced stock-based compensation expense by $0.4 million in 2022. Restricted stock awards are measured based on their fair value on the date of grant and amortized over the vesting period of 20 months. Service-Based Restricted Stock Units A summary of the Company’s service-based restricted stock units during the nine months ended September 30, 2023 is as follows: Number of Shares Weighted Average Grant-Date Fair Value Unvested at January 1, 2023 125,000  $ 1.47  Granted 313,065  1.87  Vested (125,000) 1.47  Forfeited (25,665) 1.37  Unvested at September 30, 2023 287,400  $ 1.85  A summary of the Company’s service-based restricted stock units during the nine months ended September 30, 2022 is as follows: Number of Shares Weighted Average Grant-Date Fair Value Unvested at January 1, 2022 29,289  $ 12.87  Granted 125,000  1.47  Vested (23,515) 11.33  Forfeited (5,774) 19.00  Unvested at September 30, 2022 125,000  $ 1.47  Service based restricted stock units are measured based on their fair value on the date of grant and amortized over the vesting period. The vesting periods range from 1 to 3 years. Stock-based compensation expense of $0.1 million and $46,000 was recognized for the three months ended September 30, 2023 and 2022, respectively. Stock-based compensation expense of $0.3 million and $0.1 million was recognized for the nine months ended September 30, 2023 and 2022, respectively. As of September 30, 2023, the unrecognized stock-based compensation expense was $0.4 million, which is expected to be recognized over an estimated weighted average remaining term of less than 1.4 years. Service-Based Stock Options The fair value of the service-based stock options granted for the nine months ended September 30, 2023 were based on the following assumptions: Nine Months Ended September 30, 2023 Exercise price $1.37 - $2.83 Expected stock price volatility 81.6% - 81.8% Risk-free interest rate 3.41% - 3.46% Term (years) 5.6 - 6 A summary of the Company’s service-based stock option activity for the nine months ended September 30, 2023 is as follows: Shares Underlying Options Weighted Average Exercise Price Weighted Average Remaining Contractual Term Aggregate Intrinsic Value in years in thousands Outstanding at January 1, 2023 1,206,905  $ 8.32  Granted 382,745  1.48  Forfeited (143,430) 2.82  Expired (78,727) 26.74  Outstanding at September 30, 2023 1,367,493  $ 5.93  8.4 $ 680  Exercisable at September 30, 2023 444,836  $ 14.64  7 $ 114  A summary of the Company’s service-based stock option activity for the nine months ended September 30, 2022 is as follows: Shares Underlying Options Weighted Average Exercise Price Weighted Average Remaining Contractual Term in years Outstanding at January 1, 2022 528,591  $ 32.01  7.5 Granted 898,659  1.49  5.5 Forfeited (30,093) 15.11  —  Expired (85,466) 82.09  —  Outstanding at September 30, 2022 1,311,691  $ 8.23  9.1 Exercisable at September 30, 2022 243,973  $ 29.31  6.9 The aggregate intrinsic value is calculated as the difference between the closing price of the Company's common stock and the exercise price of the stock options that had strike prices below the closing price. The intrinsic value of the outstanding options as of September 30, 2022 was not significant. Stock-based compensation expense recognized for service-based stock options was $0.1 million and $0.1 million for the three months ended September 30, 2023 and 2022, respectively. Stock-based compensation expense recognized for service-based stock options was $0.4 million and $0.4 million for the nine months ended September 30, 2023 and 2022, respectively. As of September 30, 2023, total stock-based compensation expense related to unvested options not yet recognized totaled approximately $0.7 million, which is expected to be recognized over an estimated weighted average remaining term of 3.2 years. Forfeitures are recorded in the period of occurrence and compensation expense is adjusted accordingly.

v3.23.3

Licensing Agreements	9 Months Ended
	Sep. 30, 2023
Organization, Consolidation and Presentation of Financial Statements [Abstract]
Licensing Agreements	Licensing Agreements Product License Agreements The Company is a party to a Licensing Agreement between the Company and Charak, LLC ("Charak") dated January 7, 2002 (the "2002 Agreement") that grants the Company exclusive worldwide rights to certain patents and information related to our Triferic product. On October 7, 2018, the Company entered into a Master Services and IP Agreement (the “Charak MSA”) with Charak and Dr. Ajay Gupta, a former Officer of the Company. Pursuant to the MSA, the parties entered into three additional agreements described below related to the license of certain soluble ferric pyrophosphate (“SFP”) intellectual property owned by Charak. As of September 30, 2023 and December 31, 2022, the Company has accrued $85,400 relating to certain IP reimbursement expenses and certain sublicense royalty fees, which is included within accrued liabilities on the condensed consolidated balance sheet. Pursuant to the Charak MSA, the aforementioned parties entered into an Amendment, dated as of October 7, 2018 (the “Charak Amendment”), to the 2002 Agreement, under which Charak granted the Company an exclusive, worldwide, non-transferable license to commercialize SFP for the treatment of patients with renal failure. The Charak Amendment amends the royalty payments due to Charak under the 2002 Agreement such that the Company is liable to pay Charak royalties on net sales by the Company of products developed under the license, which includes the Company’s Triferic product, at a specified rate until December 31, 2021 and thereafter at a reduced rate from January 1, 2022 until February 1, 2034. Additionally, the Company is required to pay Charak a percentage of any sublicense income during the term of the agreement, which amount cannot be less than a minimum specified percentage of net sales of the licensed products by the sublicensee in jurisdictions where there exists a valid claim, on a country-by-country basis, and be no less than a lower rate of the net sales of the licensed products by the sublicensee in jurisdictions where there exists no valid claim, on a country-by-country basis. Also pursuant to the Charak MSA, the Company and Charak entered into a Commercialization and Technology License Agreement I.V. Triferic dated as of October 7, 2018 (the “IV Agreement”), under which Charak granted the Company an exclusive, sub-licensable, royalty-bearing license to SFP for the purpose of commercializing certain intravenous-delivered products incorporating SFP for the treatment of iron disorders worldwide for a term that expires on the later of February 1, 2034 or upon the expiration or termination of a valid claim of a licensed patent. The Company was liable to pay Charak royalties on net sales by the Company of products developed under the license at a specified rate until December 31, 2021. From January 1, 2022 until February 1, 2034, the Company is liable to pay Charak a base royalty at a reduced rate on net sales and an additional royalty on net sales while there exists a valid claim of a licensed patent, on a country-by-country basis. The Company shall also pay to Charak a percentage of any sublicense income received during the term of the IV Agreement, which amount shall not be less than a minimum specified percentage of net sales of the licensed products by the sublicensee in jurisdictions where there exists a valid claim, on a country-by-country basis, and not be less than a lower rate of the net sales of the licensed products by the sublicensee in jurisdictions where there exists no valid claim, on a country-by-country basis. Also pursuant to the Charak MSA, the Company and Charak entered into a Technology License Agreement TPN Triferic dated as of October 7, 2018 (the “TPN Agreement”), pursuant to which Charak granted the Company an exclusive, sub-licensable, royalty-bearing license to SFP for the purpose of commercializing worldwide certain TPN products incorporating SFP. The license grant under the TPN Agreement continues for a term that expires on the later of February 1, 2034 or upon the expiration or termination of a valid claim of a licensed patent. During the term of the TPN Agreement, the Company is liable to pay Charak a base royalty on net sales and an additional royalty on net sales while there exists a valid claim of a licensed patent, on a country-by-country basis. The Company shall also pay to Charak a percentage of any sublicense income received during the term of the TPN Agreement, which amount shall not be less than a minimum royalty on net sales of the licensed products by the sublicensee in jurisdictions where there exists a valid claim, on a country-by-country basis, and not be less than a lower rate of the net sales of the licensed products by the sublicensee in jurisdictions where there exists no valid claim, on a country-by-country basis. The potential sub-license milestone payments are not yet considered probable, and no milestone payments have been accrued as of September 30, 2023 and December 31, 2022.

v3.23.3

Leases	9 Months Ended
	Sep. 30, 2023
Leases [Abstract]
Leases	Leases Rockwell leases its production facilities and administrative offices as well as certain equipment used in its operations including leases on transportation equipment used in the delivery of its products. The lease terms range from monthly to six years. Rockwell occupies a 51,000 square foot facility and a 17,500 square foot facility in Wixom, Michigan under a lease expiring in August 2024. Rockwell also occupies two other manufacturing facilities, a 51,000 square foot facility in Grapevine, Texas under a lease expiring in December 2025, and a 57,000 square foot facility in Greer, South Carolina under a lease expiring February 2026. In addition, Rockwell occupied 4,100 square feet of office space in Hackensack, New Jersey under a lease expiring on October 31, 2024. This lease was subleased on December 15, 2021 with an expiration date of October 31, 2024. At September 30, 2023, the Company had operating and finance lease liabilities of $5.4 million and right-of-use assets of $5.1 million, which are included in the condensed consolidated balance sheet. At December 31, 2022, the Company had operating and finance lease liabilities of $6.7 million and right-of-use assets of $6.4 million, which are included in the condensed consolidated balance sheet. The following summarizes quantitative information about the Company’s operating and finance leases (table in thousands): Three Months Ended September 30, 2023 Three Months Ended September 30, 2022 Nine Months Ended September 30, 2023 Nine Months Ended September 30, 2022 Operating leases Operating lease cost $ 422  $ 410  $ 1,281  $ 1,289  Variable lease cost 112  101  336  287  Operating lease expense 534  511  1,617  1,576  Finance leases Non-cash lease expense from right-of-use assets 142  141  424  424  Interest on lease obligations 36  44  113  136  Finance lease expense 178  185  537  560  Short-term lease rent expense 4  5  12  14  Total lease expense $ 716  $ 701  $ 2,166  $ 2,150  Other information Payments for principal from operating leases $ 461  $ 427  $ 1,363  $ 1,338  Payments for interest from finance leases $ 37  $ 44  $ 114  $ 136  Payments for principal from finance leases $ 130  $ 121  $ 388  $ 359  Weighted-average remaining lease term – operating leases 2.5 3.2 2.5 3.2 Weighted-average remaining lease term – finance leases 3.7 4.7 3.7 4.7 Weighted-average discount rate – operating leases 6.5  % 6.4  % 6.5  % 6.4  % Weighted-average discount rate – finance leases 6.4  % 6.4  % 6.4  % 6.4  % Future minimum rental payments under operating and finance lease agreements are as follows (in thousands): Operating Finance Year ending December 31, 2023 (remaining) $ 439  $ 168  Year ending December 31, 2024 1,511  672  Year ending December 31, 2025 1,021  676  Year ending December 31, 2026 362  666  Year ending December 31, 2027 131  311  Total 3,464  2,493  Less present value discount (259) (271) Operating and finance lease liabilities $ 3,205  $ 2,222
Leases	Leases Rockwell leases its production facilities and administrative offices as well as certain equipment used in its operations including leases on transportation equipment used in the delivery of its products. The lease terms range from monthly to six years. Rockwell occupies a 51,000 square foot facility and a 17,500 square foot facility in Wixom, Michigan under a lease expiring in August 2024. Rockwell also occupies two other manufacturing facilities, a 51,000 square foot facility in Grapevine, Texas under a lease expiring in December 2025, and a 57,000 square foot facility in Greer, South Carolina under a lease expiring February 2026. In addition, Rockwell occupied 4,100 square feet of office space in Hackensack, New Jersey under a lease expiring on October 31, 2024. This lease was subleased on December 15, 2021 with an expiration date of October 31, 2024. At September 30, 2023, the Company had operating and finance lease liabilities of $5.4 million and right-of-use assets of $5.1 million, which are included in the condensed consolidated balance sheet. At December 31, 2022, the Company had operating and finance lease liabilities of $6.7 million and right-of-use assets of $6.4 million, which are included in the condensed consolidated balance sheet. The following summarizes quantitative information about the Company’s operating and finance leases (table in thousands): Three Months Ended September 30, 2023 Three Months Ended September 30, 2022 Nine Months Ended September 30, 2023 Nine Months Ended September 30, 2022 Operating leases Operating lease cost $ 422  $ 410  $ 1,281  $ 1,289  Variable lease cost 112  101  336  287  Operating lease expense 534  511  1,617  1,576  Finance leases Non-cash lease expense from right-of-use assets 142  141  424  424  Interest on lease obligations 36  44  113  136  Finance lease expense 178  185  537  560  Short-term lease rent expense 4  5  12  14  Total lease expense $ 716  $ 701  $ 2,166  $ 2,150  Other information Payments for principal from operating leases $ 461  $ 427  $ 1,363  $ 1,338  Payments for interest from finance leases $ 37  $ 44  $ 114  $ 136  Payments for principal from finance leases $ 130  $ 121  $ 388  $ 359  Weighted-average remaining lease term – operating leases 2.5 3.2 2.5 3.2 Weighted-average remaining lease term – finance leases 3.7 4.7 3.7 4.7 Weighted-average discount rate – operating leases 6.5  % 6.4  % 6.5  % 6.4  % Weighted-average discount rate – finance leases 6.4  % 6.4  % 6.4  % 6.4  % Future minimum rental payments under operating and finance lease agreements are as follows (in thousands): Operating Finance Year ending December 31, 2023 (remaining) $ 439  $ 168  Year ending December 31, 2024 1,511  672  Year ending December 31, 2025 1,021  676  Year ending December 31, 2026 362  666  Year ending December 31, 2027 131  311  Total 3,464  2,493  Less present value discount (259) (271) Operating and finance lease liabilities $ 3,205  $ 2,222

v3.23.3

Loans and Security Agreement	9 Months Ended
	Sep. 30, 2023
Debt Disclosure [Abstract]
Loans and Security Agreement	Loan and Security Agreement On March 16, 2020, the Company and Rockwell Transportation, Inc., as Borrowers, entered into a Loan and Security Agreement (the "Loan Agreement") with Innovatus Life Sciences Lending Fund I, LP ("Innovatus"), as collateral agent and the lenders party thereto, pursuant to which Innovatus, as a lender, agreed to make certain term loans to the Company in the aggregate principal amount of up to $35.0 million (the "Term Loans"). Funding of the first $22.5 million tranche was completed on March 16, 2020. The Company is no longer eligible to draw on additional tranches, which were tied to the achievement of certain milestones. Net draw down proceeds were $21.2 million with closing costs of $1.3 million. In connection with each funding of the Term Loans, the Company was required to issue to Innovatus a warrant (the “Warrants”) to purchase a number of shares of the Company’s common stock equal to 3.5% of the principal amount of the relevant Term Loan funded divided by the exercise price. In connection with the first tranche of the Term Loans, the Company issued a Warrant to Innovatus, exercisable for an aggregate of 43,388 shares of the Company’s common stock at an exercise price of $18.15 per share. The Warrant may be exercised on a cashless basis and is immediately exercisable through the seventh anniversary of the applicable funding date. The number of shares of common stock for which the Warrant is exercisable and the associated exercise price are subject to certain proportional adjustments as set forth in such Warrant. The Company evaluated the warrant under ASC 470, Debt, and recognized an additional debt discount of approximately $0.5 million based on the relative fair value of the base instruments and warrants. The Company calculated the fair value of the warrant using the Black-Scholes model. The Term Loans mature on March 16, 2025, and bear interest at the greater of (i) Prime Rate (as defined in the Loan Agreement) and (ii) 4.75%, plus 4.00%, with an initial interest rate of 8.75% per annum and an effective interest rate of 12.5% as of September 30, 2023. The Company has the option, under certain circumstances, to add 1.00% of such interest rate amount to the then outstanding principal balance in lieu of paying such amount in cash. For the three months ended September 30, 2023 and 2022, interest expense amounted to $0.3 million and $0.4 million, respectively. For the nine months ended September 30, 2023 and 2022, interest expense amounted to $0.9 million and $1.2 million, respectively. The Loan Agreement is secured by all assets of the Company and Rockwell Transportation, Inc. and contains customary representations and warranties and covenants, subject to customary carve outs, and initially included financial covenants related to liquidity and sales of Triferic. In September 2021, the Company entered into an amendment to the Loan Agreement in which the Company, in exchange for Innovatus lowering the sales covenants, agreed to: (i) prepay an aggregate principal amount of $7.5 million in ten installments commencing on December 1, 2021; (ii) pay an additional prepayment premium of 5% on prepaid amounts if the Company elects to prepay all outstanding Term Loans on or before September 24, 2023 and (iii) maintain minimum liquidity of no less than $5.0 million if the aggregate principal amount of Term Loans is greater than $15 million pursuant to the liquidity covenant in the Loan Agreement. On November 10, 2022, the Company entered into a Second Amendment to the Loan and Security Agreement (the “Second Amendment”) dated as of November 14, 2022 with Innovatus, which amended the Loan Agreement. Pursuant to the Second Amendment, the Company (i) prepaid an additional aggregate principal amount of $5.0 million in Term Loans in one installment on November 14, 2022; (ii) paid interest only payments until September 2023, at which time it resumed scheduled debt payments. The financial covenant related to the sales of Triferic was replaced with the trailing 6 months revenue of our concentrates products. The Company cannot assure that it can maintain compliance with the covenants under our Loan Agreement, which may result in an event of default. The Company's ability to comply with these covenants may be adversely affected by events beyond its control. If the Company is unable to comply with the covenants under the Loan Agreement, it would pursue all available cure options in order to regain compliance. However, the Company may not be able to mutually agree with Innovatus on appropriate remedies to cure a future breach of a covenant, which could give rise to an event of default. If the Company is unable to avoid an event of default, any required repayments could have an adverse effect on its liquidity. As of September 30, 2023, the Company was in compliance with all covenants under the Loan Agreement. As of September 30, 2023, the outstanding balance of the Term Loan was $9.0 million, net of unamortized issuance costs and discount of $0.5 million. The following table reflects the schedule of principal payments on the Term Loan as of September 30, 2023 (in thousands): Principal Payments 2023 (remaining) $ 1,500  2024 6,000  2025 2,000  $ 9,500

v3.23.3

Insurance Financing Note Payable	9 Months Ended
	Sep. 30, 2023
Debt Disclosure [Abstract]
Insurance Financing Note Payable	Insurance Financing Note PayableOn June 3, 2023, the Company entered into a short-term note payable for $0.7 million, bearing interest at 9.59% per annum to finance various insurance policies. Principal and interest payments related to this note began on July 3, 2023 and will be paid on a straight-line amortization over nine months with the final payment due on March 3, 2024. As of September 30, 2023, the outstanding balance was $0.5 million.

v3.23.3

Basis of Presentation, Summary of Significant Accounting Policies and Recent Accounting Pronouncements (Policies)	9 Months Ended
	Sep. 30, 2023
Accounting Policies [Abstract]
Basis of Presentation	The accompanying condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) for interim financial information and pursuant to the instructions to Form 10-Q and Rule 10-01 of Regulation S-X of the U. S. Securities and Exchange Commission (“SEC”) and on the same basis as the Company prepares its annual audited consolidated financial statements. The condensed consolidated balance sheet at September 30, 2023, and the condensed consolidated statements of operations, comprehensive loss, and changes in stockholders' equity for the three and nine months ended September 30, 2023 and cash flows for the nine months ended September 30, 2023 are unaudited, but include all adjustments, consisting of normal recurring adjustments the Company considers necessary for a fair presentation of the financial position, operating results and cash flows for the periods presented. The results for the three and nine months ended September 30, 2023 are not necessarily indicative of results to be expected for the year ending December 31, 2023 or for any future interim period. The condensed consolidated balance sheet at December 31, 2022 has been derived from audited financial statements, however, it does not include all of the information and notes required by U.S. GAAP for complete financial statements. The accompanying condensed consolidated financial statements should be read in conjunction with the audited financial statements for the year ended December 31, 2022 and notes thereto included in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2022 as filed with the SEC on March 30, 2023. The Company’s consolidated subsidiaries consist of its wholly-owned subsidiaries, Rockwell Transportation, Inc. and Rockwell Medical India Private Limited. The accompanying condensed consolidated interim financial statements include the accounts of the Company and its subsidiaries. All material intercompany balances and transactions have been eliminated in consolidation.
Use of Estimates	Use of Estimates The preparation of the condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that may affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and reported amounts of expenses during the reporting period. Actual results could differ from those estimates.
Loss Per Share	The Company’s potentially dilutive securities include stock options, restricted stock awards and units, convertible preferred stock and warrants. These securities were excluded from the computations of diluted net loss per share for the three and nine months ended September 30, 2023 and 2022, as the effect would be to reduce the net loss per share.
Adoption of Recent Accounting Pronouncements	Adoption of Recent Accounting Pronouncements The Company continually assesses new accounting pronouncements to determine their applicability. When it is determined a new accounting pronouncement affects the Company’s financial reporting, the Company undertakes a review to determine the consequences of the change to its consolidated financial statements and assures there are sufficient controls in place to ascertain the Company’s consolidated financial statements properly reflect the change. In June 2016, the FASB issued Accounting Standards Update ("ASU") 2016-13, Financial Instruments - Credit Losses (Topic 326), which introduced an impairment model that is based on expected credit losses, rather than incurred losses, to estimate credit losses on certain types of financial instruments (e.g., loan commitments). The expected credit losses should consider historical information, current information, and reasonable and supportable forecasts, including estimates of prepayments, over the contractual term. Financial instruments with similar risk characteristics may be grouped together when estimating expected credit losses. In addition, ASC 326 requires expected credit related losses for trade accounts receivable, as well as available-for-sale debt securities, which are to be recorded through an allowance for credit losses, while non-credit related losses will continue to be recognized through other comprehensive income. The Company adopted the new guidance, as of January 1, 2023, and it did not have a material impact on the condensed consolidated financial statements.
Revenue recognition	The Company recognizes revenue under ASC 606, Revenue from Contracts with Customers. The core principle of the revenue standard is that a company should recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the company expects to be entitled in exchange for those goods or services. The following five steps are applied to achieve that core principle: •Step 1: Identify the contract with the customer •Step 2: Identify the performance obligations in the contract •Step 3: Determine the transaction price •Step 4: Allocate the transaction price to the performance obligations in the contract •Step 5: Recognize revenue when the company satisfies a performance obligation Taxes assessed by a governmental authority that are both imposed on and concurrent with a specific revenue-producing transaction, that are collected by us from a customer, are excluded from revenue. Shipping and handling costs associated with outbound freight related to contracts with customers are accounted for as a fulfillment cost and are included in cost of sales when control of the goods transfers to the customer.

v3.23.3

Basis of Presentation, Summary of Significant Accounting Policies and Recent Accounting Pronouncements (Tables)	9 Months Ended
	Sep. 30, 2023
Accounting Policies [Abstract]
Summary of Loss Per Share Restated Amounts	See the table presentation of loss per share calculations as of September 30, 2023 and 2022 in the "Loss Per Share" section below. Three Months Ended September 30, Nine Months Ended September 30, 2022 2022 As Previously Reported: Net loss per share attributable to common stockholders - basic and diluted $ (0.40) $ (1.75) Weighted average number of shares of common stock outstanding - basic and diluted 10,528,148  9,299,788  As Restated: Net loss per share attributable to common stockholders - basic and diluted $ (0.23) $ (1.26) Weighted average number of shares of common stock outstanding - basic and diluted 18,463,673  12,902,890
Schedule of Basic and Diluted Net Loss Per Share	Basic and diluted net loss per share for the three and nine months ended September 30, 2023 and 2022, after giving effect to the restatement discussed above, was calculated as follows: Three Months Ended September 30, Nine Months Ended September 30, (In Thousands, Except Share and Per Share Amounts) 2023 2022 2023 2022 Numerator: Net loss $ (1,872) $ (4,190) $ (6,927) $ (16,317) Net loss attributable to common stockholders for basic and diluted loss per share $ (1,872) $ (4,190) $ (6,927) $ (16,317) Denominator: Weighted average number of shares of common stock outstanding - basic and diluted 27,521,088  18,463,673  21,526,978  12,902,890  Net loss per share attributable to common stockholders - basic and diluted $ (0.07) $ (0.23) $ (0.32) $ (1.26)
Summary of Potentially Dilutive Securities	The following table includes the potential shares of common stock, presented based on amounts outstanding at each period end, that were excluded from the computation of diluted net loss per share attributable to common stockholders for the periods indicated because including them would have had an anti-dilutive effect: As of September 30, 2023 2022 Options to Purchase Common Stock 1,367,493  1,311,691  Unvested Restricted Stock Awards 891  891  Unvested Restricted Stock Units 287,400  125,000  Convertible Preferred Stock 1,363,636  1,363,636  Warrants to Purchase Common Stock 4,045,278 17,507,268  Total 7,064,698 20,308,486

v3.23.3

Asset Acquisition (Tables)	9 Months Ended
	Sep. 30, 2023
Business Combination and Asset Acquisition [Abstract]
Schedule of Purchase Price, on a Relative Fair Value Basis, to Assets Acquired	The purchase price was allocated, on a relative fair value basis, to the assets acquired at the July 10, 2023 acquisition date as follows (table in thousands): Consideration Cash Payment $ 12,233  Deferred Consideration 5,000  Transaction Costs 128  Total Consideration $ 17,361  Assets Acquired Customer Relationships Intangible Asset $ 11,035  Equipment 5,093  Inventory 1,233  Total Assets Acquired $ 17,361
Schedule of Future Amortization Expense	Estimated future amortization expense on the Company's customer relationships intangible asset as of September 30, 2023 is as follows (table in thousands): Year ended December 31: 2023 (remainder of year) $ 138  2024 552  2025 552  2026 552  2027 552  Thereafter 8,551  Total $ 10,897

v3.23.3

Revenue Recognition (Tables)	9 Months Ended
	Sep. 30, 2023
Revenue from Contract with Customer [Abstract]
Disaggregation of Revenue	Revenue is disaggregated by primary geographical market, major product line, and timing of revenue recognition. In thousands Three Months Ended September 30, 2023 Nine Months Ended September 30, 2023 Products By Geographic Area Total U.S. Rest of World Total U.S. Rest of World Drug Revenues Product Sales – Point-in-time $ —  $ —  $ —  $ —  $ —  $ —  License Fee – Over time 2,197  —  2,197  2,327  —  2,327  Total Drug Products 2,197  —  2,197  2,327  —  2,327  Concentrates Products Product Sales – Point-in-time 21,574  19,741  1,833  57,720  52,326  5,394  License Fee – Over time —  —  —  1,472  1,472  —  Total Concentrate Products 21,574  19,741  1,833  59,192  53,798  5,394  Net Revenue $ 23,771  $ 19,741  $ 4,030  $ 61,519  $ 53,798  $ 7,721  In thousands Three Months Ended September 30, 2022 Nine Months Ended September 30, 2022 Products By Geographic Area Total U.S. Rest of World Total U.S. Rest of World Drug Revenues Product Sales – Point-in-time $ 193  $ 193  $ —  $ 834  $ 561  $ 273  License Fee – Over time 65  —  65  192  —  192  Total Drug Products 258  193  65  1,026  561  465  Concentrates Products Product Sales – Point-in-time 17,953  16,619  1,334  51,035  46,334  4,701  License Fee – Over time 480  480  —  1,436  1,436  —  Total Concentrate Products 18,433  17,099  1,334  52,471  47,770  4,701  Net Revenue $ 18,691  $ 17,292  $ 1,399  $ 53,497  $ 48,331  $ 5,166
Contract Balances	The following table provides information about receivables, contract assets, and contract liabilities from contracts with customers. In thousands September 30, 2023 December 31, 2022 Accounts Receivable, net $ 9,361  $ 6,259  Contract Liabilities, which are included in deferred license revenue $ 533  $ 4,331

v3.23.3

Investments - Available-for-Sale (Tables)	9 Months Ended
	Sep. 30, 2023
Investments, Debt and Equity Securities [Abstract]
Investments Available-for-Sale	Investments available-for-sale consisted of the following as of September 30, 2023 and December 31, 2022 (table in thousands): September 30, 2023 Amortized Cost Unrealized Gain Unrealized Loss Accrued Interest Fair Value Available-for-Sale Securities Debt securities $ 3,898  $ 73  $ —  $ —  $ 3,971  December 31, 2022 Amortized Cost Unrealized Gain Unrealized Loss Accrued Interest Fair Value Available-for-Sale Securities Debt securities $ 11,315  $ 75  $ —  $ —  $ 11,390

v3.23.3

Inventory (Tables)	9 Months Ended
	Sep. 30, 2023
Inventory Disclosure [Abstract]
Schedule Components of Inventory	Components of inventory, net of reserves, as of September 30, 2023 and December 31, 2022 are as follows (table in thousands): September 30, 2023 December 31, 2022 Inventory - Current Portion Raw Materials $ 2,335  $ 3,351  Work in Process 337  351  Finished Goods 2,814  2,112  Total Current Inventory 5,486  5,814  Inventory - Long Term (1) 178  1,276  Total Inventory $ 5,664  $ 7,090  __________ 1.Represents inventory related to Triferic raw materials. This Triferic inventory will be utilized for the Company's international partnerships. In September 2022, the Company discontinued its New Drug Applications ("NDAs") for Triferic (dialysate) and Triferic AVNU in the United States. During the three months ended September 30, 2023, the Company reserved $1.1 million of long-term inventory as a result of the termination of the Wanbang development effort.

v3.23.3

Property and Equipment, net (Tables)	9 Months Ended
	Sep. 30, 2023
Property, Plant and Equipment [Abstract]
Schedule of Major Classes of Property and Equipment	As of September 30, 2023 and December 31, 2022, the Company’s property and equipment consisted of the following (table in thousands): September 30, 2023 December 31, 2022 Leasehold Improvements $ 1,423  $ 1,256  Machinery and Equipment 11,085  5,922  Information Technology & Office Equipment 1,845  1,845  Laboratory Equipment 807  807     Total Property and Equipment 15,160  9,830  Accumulated Depreciation and Amortization (8,389) (7,636) Property and Equipment, net $ 6,771  $ 2,194

v3.23.3

Accrued Liabilities (Tables)	9 Months Ended
	Sep. 30, 2023
Payables and Accruals [Abstract]
Schedule of Accrued Liabilities	Accrued liabilities as of September 30, 2023 and December 31, 2022 consisted of the following (table in thousands): September 30, 2023 December 31, 2022 Accrued Compensation and Benefits $ 2,240  $ 2,568  Accrued Unvouchered Receipts 1,947  585  Accrued Manufacturing Expense 732  —  Accrued Workers Compensation 202  306  Accrued Research & Development Expense —  43  Other Accrued Liabilities 1,587  4,200  Total Accrued Liabilities $ 6,708  $ 7,702

v3.23.3

Stockholder's Equity (Tables)	9 Months Ended
	Sep. 30, 2023
Equity [Abstract]
Summary of Common Stock Reserved for Issuance	As of September 30, 2023 and 2022, the Company reserved for issuance the following shares of common stock related to the potential exercise of employee stock options, unvested restricted stock, convertible preferred stock, pre-funded warrants and all other warrants (collectively, "common stock equivalents"): As of September 30, Common stock and common stock equivalents: 2023 2022 Common stock 28,489,663  11,152,673  Common stock issuable upon exercise of pre-funded warrants —  7,311,000  Common stock and pre-funded stock warrants 28,489,663  18,463,673  Options to Purchase Common Stock 1,367,493  1,311,691  Unvested Restricted Stock Awards 891  891  Unvested Restricted Stock Units 287,400  125,000  Convertible Preferred Stock 1,363,636  1,363,636  Warrants to Purchase Common Stock 4,045,278  17,507,268  Total 35,554,361 38,772,159

v3.23.3

Stock-Based Compensation (Tables)	9 Months Ended
	Sep. 30, 2023
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]
Schedule of Total Stock-Based Compensation Expense	The Company recognized total stock-based compensation expense during the three and nine months ended September 30, 2023 and 2022 as follows (table in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 Service-based awards: Restricted Stock Units $ 112  $ 46  $ 276  $ 84  Stock Option Awards 100  130  438  401     Total Service Based Awards 212  176  714  485  Performance-based awards: Restricted Stock Awards —  —  —  (391) Total $ 212  $ 176  $ 714  $ 94
Schedule of Stock Option Assumptions	The fair value of the service-based stock options granted for the nine months ended September 30, 2023 were based on the following assumptions: Nine Months Ended September 30, 2023 Exercise price $1.37 - $2.83 Expected stock price volatility 81.6% - 81.8% Risk-free interest rate 3.41% - 3.46% Term (years) 5.6 - 6
Schedule of Stock Options Activity	A summary of the Company’s service-based stock option activity for the nine months ended September 30, 2023 is as follows: Shares Underlying Options Weighted Average Exercise Price Weighted Average Remaining Contractual Term Aggregate Intrinsic Value in years in thousands Outstanding at January 1, 2023 1,206,905  $ 8.32  Granted 382,745  1.48  Forfeited (143,430) 2.82  Expired (78,727) 26.74  Outstanding at September 30, 2023 1,367,493  $ 5.93  8.4 $ 680  Exercisable at September 30, 2023 444,836  $ 14.64  7 $ 114  A summary of the Company’s service-based stock option activity for the nine months ended September 30, 2022 is as follows: Shares Underlying Options Weighted Average Exercise Price Weighted Average Remaining Contractual Term in years Outstanding at January 1, 2022 528,591  $ 32.01  7.5 Granted 898,659  1.49  5.5 Forfeited (30,093) 15.11  —  Expired (85,466) 82.09  —  Outstanding at September 30, 2022 1,311,691  $ 8.23  9.1 Exercisable at September 30, 2022 243,973  $ 29.31  6.9
Restricted stock awards
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]
Schedule of Restricted Stock Awards	A summary of the Company’s restricted stock awards during the nine months ended September 30, 2023 is as follows: Number of Shares Weighted Average Grant-Date Fair Value Unvested at January 1, 2023 891  $ 62.70  Unvested at September 30, 2023 891  $ 62.70  A summary of the Company’s restricted stock awards during the nine months ended September 30, 2022 is as follows: Number of Shares Weighted Average Grant-Date Fair Value Unvested at January 1, 2022 7,118  $ 62.70  Forfeited (1) (6,227) $ 62.70  Unvested at September 30, 2022 891  $ 62.70  __________ 1.These forfeited awards were due to the resignation of the Company's Chief Development Officer on March 25, 2022 and reduced stock-based compensation expense by $0.4 million in 2022.
Restricted stock units - service based awards
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]
Schedule of Restricted Stock Awards	A summary of the Company’s service-based restricted stock units during the nine months ended September 30, 2023 is as follows: Number of Shares Weighted Average Grant-Date Fair Value Unvested at January 1, 2023 125,000  $ 1.47  Granted 313,065  1.87  Vested (125,000) 1.47  Forfeited (25,665) 1.37  Unvested at September 30, 2023 287,400  $ 1.85  A summary of the Company’s service-based restricted stock units during the nine months ended September 30, 2022 is as follows: Number of Shares Weighted Average Grant-Date Fair Value Unvested at January 1, 2022 29,289  $ 12.87  Granted 125,000  1.47  Vested (23,515) 11.33  Forfeited (5,774) 19.00  Unvested at September 30, 2022 125,000  $ 1.47

v3.23.3

Leases (Tables)	9 Months Ended
	Sep. 30, 2023
Leases [Abstract]
Summary of Lease Costs	The following summarizes quantitative information about the Company’s operating and finance leases (table in thousands): Three Months Ended September 30, 2023 Three Months Ended September 30, 2022 Nine Months Ended September 30, 2023 Nine Months Ended September 30, 2022 Operating leases Operating lease cost $ 422  $ 410  $ 1,281  $ 1,289  Variable lease cost 112  101  336  287  Operating lease expense 534  511  1,617  1,576  Finance leases Non-cash lease expense from right-of-use assets 142  141  424  424  Interest on lease obligations 36  44  113  136  Finance lease expense 178  185  537  560  Short-term lease rent expense 4  5  12  14  Total lease expense $ 716  $ 701  $ 2,166  $ 2,150  Other information Payments for principal from operating leases $ 461  $ 427  $ 1,363  $ 1,338  Payments for interest from finance leases $ 37  $ 44  $ 114  $ 136  Payments for principal from finance leases $ 130  $ 121  $ 388  $ 359  Weighted-average remaining lease term – operating leases 2.5 3.2 2.5 3.2 Weighted-average remaining lease term – finance leases 3.7 4.7 3.7 4.7 Weighted-average discount rate – operating leases 6.5  % 6.4  % 6.5  % 6.4  % Weighted-average discount rate – finance leases 6.4  % 6.4  % 6.4  % 6.4  %
Operating Lease Maturities	Future minimum rental payments under operating and finance lease agreements are as follows (in thousands): Operating Finance Year ending December 31, 2023 (remaining) $ 439  $ 168  Year ending December 31, 2024 1,511  672  Year ending December 31, 2025 1,021  676  Year ending December 31, 2026 362  666  Year ending December 31, 2027 131  311  Total 3,464  2,493  Less present value discount (259) (271) Operating and finance lease liabilities $ 3,205  $ 2,222
Finance Lease Maturities	Future minimum rental payments under operating and finance lease agreements are as follows (in thousands): Operating Finance Year ending December 31, 2023 (remaining) $ 439  $ 168  Year ending December 31, 2024 1,511  672  Year ending December 31, 2025 1,021  676  Year ending December 31, 2026 362  666  Year ending December 31, 2027 131  311  Total 3,464  2,493  Less present value discount (259) (271) Operating and finance lease liabilities $ 3,205  $ 2,222

v3.23.3

Loans and Security Agreement (Tables)	9 Months Ended
	Sep. 30, 2023
Debt Disclosure [Abstract]
Schedule of Principal Payments on Term Loan	The following table reflects the schedule of principal payments on the Term Loan as of September 30, 2023 (in thousands): Principal Payments 2023 (remaining) $ 1,500  2024 6,000  2025 2,000  $ 9,500

v3.23.3

Description of Business (Details)	9 Months Ended
	Sep. 30, 2023 ft²
Organization, Consolidation and Presentation of Financial Statements [Abstract]
Operating space	175,000

v3.23.3

Liquidity and Capital Resources (Details) - USD ($) $ in Thousands	9 Months Ended
	Sep. 30, 2023	Sep. 30, 2022
Liquidity and Capital Resources [Abstract]
Cash, cash equivalents and investments available-for-sale	$ 11,700
Working capital	6,800
Net cash used in operating activities	$ 9,369	$ 16,817

v3.23.3

Basis of Presentation, Summary of Significant Accounting Policies and Recent Accounting Pronouncements - Summary of Loss Per Share Restated Amounts (Details) - $ / shares		3 Months Ended		9 Months Ended
		Sep. 30, 2023	Sep. 30, 2022	Sep. 30, 2023	Sep. 30, 2022
Reclassification [Line Items]
Net loss per share attributable to common stockholders - basic (in dollars per share)		$ (0.07)	$ (0.23)	$ (0.32)	$ (1.26)
Net loss per share attributable to common stockholders - diluted (in dollars per share)		$ (0.07)	$ (0.23)	$ (0.32)	$ (1.26)
Weighted average number of common shares outstanding - basic (in shares)	[1]	27,521,088	18,463,673	21,526,978	12,902,890
Weighted average number of common shares outstanding - diluted (in shares)	[1]	27,521,088	18,463,673	21,526,978	12,902,890
Previously Reported
Reclassification [Line Items]
Net loss per share attributable to common stockholders - basic (in dollars per share)			$ (0.40)		$ (1.75)
Net loss per share attributable to common stockholders - diluted (in dollars per share)			$ (0.40)		$ (1.75)
Weighted average number of common shares outstanding - basic (in shares)			10,528,148		9,299,788
Weighted average number of common shares outstanding - diluted (in shares)			10,528,148		9,299,788
[1] See Note 3 for more detail related to Basic and Diluted Weighted Average Shares Outstanding

v3.23.3

Basis of Presentation, Summary of Significant Accounting Policies and Recent Accounting Pronouncements - Schedule of Basic and Diluted Net Loss Per Share (Details) - USD ($) $ / shares in Units, $ in Thousands		3 Months Ended						9 Months Ended
		Sep. 30, 2023	Jun. 30, 2023	Mar. 31, 2023	Sep. 30, 2022	Jun. 30, 2022	Mar. 31, 2022	Sep. 30, 2023	Sep. 30, 2022
Numerator:
Net loss		$ (1,872)	$ (3,305)	$ (1,750)	$ (4,190)	$ (4,967)	$ (7,162)	$ (6,927)	$ (16,317)
Net loss attributable to common stockholders for basic loss per share		(1,872)			(4,190)			(6,927)	(16,317)
Net loss attributable to common stockholders for diluted loss per share		$ (1,872)			$ (4,190)			$ (6,927)	$ (16,317)
Denominator:
Weighted average number of common shares outstanding - basic (in shares)	[1]	27,521,088			18,463,673			21,526,978	12,902,890
Weighted average number of common shares outstanding - diluted (in shares)	[1]	27,521,088			18,463,673			21,526,978	12,902,890
Net loss per share attributable to common stockholders - basic (in dollars per share)		$ (0.07)			$ (0.23)			$ (0.32)	$ (1.26)
Net loss per share attributable to common stockholders - diluted (in dollars per share)		$ (0.07)			$ (0.23)			$ (0.32)	$ (1.26)
[1] See Note 3 for more detail related to Basic and Diluted Weighted Average Shares Outstanding

v3.23.3

Basis of Presentation, Summary of Significant Accounting Policies and Recent Accounting Pronouncements - Summary of Potentially Dilutive Securities (Details) - shares	9 Months Ended
	Sep. 30, 2023	Sep. 30, 2022
Net Earnings per Share
Antidilutive securities (in shares)	7,064,698	20,308,486
Common stock issuable upon exercise of pre-funded warrants
Net Earnings per Share
Warrants outstanding (in shares)	0	7,311,000
Options to Purchase Common Stock
Net Earnings per Share
Antidilutive securities (in shares)	1,367,493	1,311,691
Unvested Restricted Stock Awards
Net Earnings per Share
Antidilutive securities (in shares)	891	891
Unvested Restricted Stock Units
Net Earnings per Share
Antidilutive securities (in shares)	287,400	125,000
Convertible Preferred Stock
Net Earnings per Share
Antidilutive securities (in shares)	1,363,636	1,363,636
Warrants to Purchase Common Stock
Net Earnings per Share
Antidilutive securities (in shares)	4,045,278	17,507,268

v3.23.3

Asset Acquisition - Narrative (Details) $ in Thousands		3 Months Ended	9 Months Ended
	Jul. 10, 2023 USD ($) payment	Sep. 30, 2023 USD ($)	Sep. 30, 2023 USD ($)	Sep. 30, 2022 USD ($)	Dec. 31, 2022 USD ($)
Asset Acquisition [Line Items]
Cash Payment			$ 12,361	$ 0
Amortization of intangible assets		$ 100	100
Intangible Asset, net		$ 10,897	$ 10,897		$ 0
Evoqua Water Technologies LLC
Asset Acquisition [Line Items]
Total Consideration	$ 17,361
Cash Payment	$ 12,233
Number of deferred payments | payment	2
Milestone payments	$ 2,500
Deferred payments, first payment period	1 year
Evoqua Water Technologies LLC | Customer Relationships
Asset Acquisition [Line Items]
Intangible asset, useful life	20 years

v3.23.3

Asset Acquisition - Purchase Price, on a Relative Fair Value Basis, to Assets Acquired (Details) - USD ($) $ in Thousands		9 Months Ended
	Jul. 10, 2023	Sep. 30, 2023	Sep. 30, 2022
Asset Acquisition [Line Items]
Cash Payment		$ 12,361	$ 0
Deferred Consideration		$ 5,000	$ 0
Evoqua Water Technologies LLC
Asset Acquisition [Line Items]
Cash Payment	$ 12,233
Deferred Consideration	5,000
Transaction Costs	128
Total Consideration	17,361
Equipment	5,093
Inventory	1,233
Total Assets Acquired	17,361
Evoqua Water Technologies LLC | Customer Relationships
Asset Acquisition [Line Items]
Customer Relationships Intangible Asset	$ 11,035

v3.23.3

Asset Acquisition - Future Amortization Expense (Details) - Customer Relationships $ in Thousands	Sep. 30, 2023 USD ($)
Asset Acquisition [Line Items]
2023 (remainder of year)	$ 138
2024	552
2025	552
2026	552
2027	552
Thereafter	8,551
Total	$ 10,897

v3.23.3

Revenue Recognition - Nature of Goods and Services (Details)	3 Months Ended	9 Months Ended	12 Months Ended
	Sep. 30, 2023 installment	Sep. 30, 2023 installment agreement segment	Dec. 31, 2022
Revenue Recognition [Line Items]
Number of operating market segments | segment		1
Number of distribution and license agreements | agreement		5
Number of installments | installment	2	2
Customers average payment term		30 days
Distributors average payment term		60 days
Da Vita Healthcare Partners Inc | Revenue Benchmark | Customer Concentration Risk
Revenue Recognition [Line Items]
Customer concentration, percentage	50.00%	50.00%
Da Vita Healthcare Partners Inc | Accounts Receivable | Customer Concentration Risk
Revenue Recognition [Line Items]
Customer concentration, percentage		31.00%	30.00%

v3.23.3

Revenue Recognition - Disaggregation of Revenue (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2023	Sep. 30, 2022	Sep. 30, 2023	Sep. 30, 2022
Disaggregation of Revenue [Line Items]
Net Revenue	$ 23,771	$ 18,691	$ 61,519	$ 53,497
Drug products
Disaggregation of Revenue [Line Items]
Net Revenue	2,197	258	2,327	1,026
Concentrates Products
Disaggregation of Revenue [Line Items]
Net Revenue	21,574	18,433	59,192	52,471
U.S.
Disaggregation of Revenue [Line Items]
Net Revenue	19,741	17,292	53,798	48,331
U.S. | Drug products
Disaggregation of Revenue [Line Items]
Net Revenue	0	193	0	561
U.S. | Concentrates Products
Disaggregation of Revenue [Line Items]
Net Revenue	19,741	17,099	53,798	47,770
Rest of World
Disaggregation of Revenue [Line Items]
Net Revenue	4,030	1,399	7,721	5,166
Rest of World | Drug products
Disaggregation of Revenue [Line Items]
Net Revenue	2,197	65	2,327	465
Rest of World | Concentrates Products
Disaggregation of Revenue [Line Items]
Net Revenue	1,833	1,334	5,394	4,701
Product Sales – Point-in-time | Drug product sales
Disaggregation of Revenue [Line Items]
Net Revenue	0	193	0	834
Product Sales – Point-in-time | Concentrates product sales
Disaggregation of Revenue [Line Items]
Net Revenue	21,574	17,953	57,720	51,035
Product Sales – Point-in-time | U.S. | Drug product sales
Disaggregation of Revenue [Line Items]
Net Revenue	0	193	0	561
Product Sales – Point-in-time | U.S. | Concentrates product sales
Disaggregation of Revenue [Line Items]
Net Revenue	19,741	16,619	52,326	46,334
Product Sales – Point-in-time | Rest of World | Drug product sales
Disaggregation of Revenue [Line Items]
Net Revenue	0	0	0	273
Product Sales – Point-in-time | Rest of World | Concentrates product sales
Disaggregation of Revenue [Line Items]
Net Revenue	1,833	1,334	5,394	4,701
License Fee – Over time | Drug license fee
Disaggregation of Revenue [Line Items]
Net Revenue	2,197	65	2,327	192
License Fee – Over time | Concentrates product license fee
Disaggregation of Revenue [Line Items]
Net Revenue	0	480	1,472	1,436
License Fee – Over time | U.S. | Drug license fee
Disaggregation of Revenue [Line Items]
Net Revenue	0	0	0	0
License Fee – Over time | U.S. | Concentrates product license fee
Disaggregation of Revenue [Line Items]
Net Revenue	0	480	1,472	1,436
License Fee – Over time | Rest of World | Drug license fee
Disaggregation of Revenue [Line Items]
Net Revenue	2,197	65	2,327	192
License Fee – Over time | Rest of World | Concentrates product license fee
Disaggregation of Revenue [Line Items]
Net Revenue	$ 0	$ 0	$ 0	$ 0

v3.23.3

Revenue Recognition - Contract Balances (Details) - USD ($) $ in Thousands	Sep. 30, 2023	Dec. 31, 2022
Revenue from Contract with Customer [Abstract]
Accounts Receivable, net	$ 9,361	$ 6,259
Contract with Customer, Liability	$ 533	$ 4,331

v3.23.3

Revenue Recognition - Narrative (Details) - USD ($)	Sep. 30, 2023	Dec. 31, 2022
Revenue Recognition [Line Items]
Contract assets	$ 0	$ 0
Concentrates Products
Revenue Recognition [Line Items]
Reserve for returns	$ 0	$ 0

v3.23.3

Investments - Available-for-Sale (Details) - USD ($) $ in Thousands	Sep. 30, 2023	Dec. 31, 2022
Investments, Debt and Equity Securities [Abstract]
Amortized Cost	$ 3,898	$ 11,315
Unrealized Gain	73	75
Unrealized Loss	0	0
Accrued Interest	0	0
Fair Value	$ 3,971	$ 11,390

v3.23.3

Inventory - Schedule of Inventory (Details) - USD ($) $ in Thousands	3 Months Ended
	Sep. 30, 2023	Dec. 31, 2022
Inventory - Current Portion
Raw Materials	$ 2,335	$ 3,351
Work in Process	337	351
Finished Goods	2,814	2,112
Total Current Inventory	5,486	5,814
Inventory - Long Term	178	1,276
Total Inventory	5,664	$ 7,090
Triferic Inventory | SEC Schedule, 12-09, Reserve, Inventory
Inventory - Current Portion
Inventory reserve, period increase (decrease)	$ 1,100

v3.23.3

Inventory - Narrative (Details) - USD ($) $ in Thousands	Sep. 30, 2023	Dec. 31, 2022
Inventory Disclosure [Abstract]
Inventory, gross	$ 5,500	$ 5,800
Inventory, reserve	$ 25	$ 25

v3.23.3

Property and Equipment, net (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2023	Sep. 30, 2022	Sep. 30, 2023	Sep. 30, 2022	Dec. 31, 2022
Property and equipment
Gross property and equipment	$ 15,160		$ 15,160		$ 9,830
Accumulated Depreciation and Amortization	(8,389)		(8,389)		(7,636)
Property and Equipment, net	6,771		6,771		2,194
Depreciation expense	400	$ 100	800	$ 400
Leasehold Improvements
Property and equipment
Gross property and equipment	1,423		1,423		1,256
Machinery and Equipment
Property and equipment
Gross property and equipment	11,085		11,085		5,922
Information Technology & Office Equipment
Property and equipment
Gross property and equipment	1,845		1,845		1,845
Laboratory Equipment
Property and equipment
Gross property and equipment	$ 807		$ 807		$ 807

v3.23.3

Accrued Liabilities (Details) - USD ($) $ in Thousands	Sep. 30, 2023	Dec. 31, 2022
Payables and Accruals [Abstract]
Accrued Compensation and Benefits	$ 2,240	$ 2,568
Accrued Unvouchered Receipts	1,947	585
Accrued Manufacturing Expense	732	0
Accrued Workers Compensation	202	306
Accrued Research & Development Expense	0	43
Other Accrued Liabilities	1,587	4,200
Total Accrued Liabilities	$ 6,708	$ 7,702

v3.23.3

Deferred License Revenue (Details) - USD ($)	1 Months Ended					3 Months Ended			9 Months Ended		12 Months Ended
	May 31, 2022	Jun. 30, 2021	Sep. 30, 2020	Jan. 31, 2020	Oct. 31, 2014	Sep. 30, 2023	Mar. 31, 2023	Sep. 30, 2022	Sep. 30, 2023	Sep. 30, 2022	Dec. 31, 2016	Dec. 31, 2022
Disaggregation of Revenue [Line Items]
Contract Liabilities, which are included in deferred license revenue						$ 533,000			$ 533,000			$ 4,331,000
Triferic Inventory | SEC Schedule, 12-09, Reserve, Inventory
Disaggregation of Revenue [Line Items]
Inventory reserve, period increase (decrease)						1,100,000
Baxter Healthcare Organization
Disaggregation of Revenue [Line Items]
Term of agreement					10 years
Upfront payment					$ 20,000,000
Recognized deferred revenue							$ 1,500,000
Wanbang Biopharmaceutical
Disaggregation of Revenue [Line Items]
Upfront payment											$ 4,000,000
Recognized deferred revenue						2,200,000
Wanbang Biopharmaceutical | Triferic Inventory
Disaggregation of Revenue [Line Items]
Inventory reserve, increase in gross profit						1,100,000
Wanbang Biopharmaceutical | Triferic Inventory | SEC Schedule, 12-09, Reserve, Inventory
Disaggregation of Revenue [Line Items]
Inventory reserve, period increase (decrease)						1,100,000
Sun Pharma Agreements
Disaggregation of Revenue [Line Items]
Upfront payment				$ 100,000
Recognized deferred revenue						2,500		$ 7,500	2,500	$ 7,500
Contract Liabilities, which are included in deferred license revenue						62,500			62,500			70,000
Jeil Pharma Agreements
Disaggregation of Revenue [Line Items]
Upfront payment			$ 200,000
Recognized deferred revenue						5,200		15,600	5,200	15,600
Contract Liabilities, which are included in deferred license revenue						400,000			400,000			400,000
Milestone consideration	$ 200,000
Drogsan Agreements
Disaggregation of Revenue [Line Items]
Upfront payment		$ 150,000
Recognized deferred revenue						3,750		$ 11,250	3,750	$ 11,250
Contract Liabilities, which are included in deferred license revenue						$ 100,000			$ 100,000			$ 100,000

v3.23.3

Stockholders’ Equity - Narrative (Details)							3 Months Ended		9 Months Ended
	Jul. 10, 2023 USD ($) $ / shares shares	Jul. 05, 2023 USD ($) $ / shares shares	May 23, 2023 shares	Jun. 16, 2022 USD ($) shares	May 30, 2022 $ / shares shares	Apr. 06, 2022 USD ($) $ / shares shares	Sep. 30, 2023 USD ($) $ / shares shares	Sep. 30, 2022 shares	Sep. 30, 2023 USD ($) $ / shares shares	Sep. 30, 2022 USD ($) shares	Dec. 31, 2022 $ / shares shares	Apr. 08, 2022 USD ($)
Class of Stock [Line Items]
Stock issuance costs | $									$ 43,000	$ 106,000
Preferred shares, shares authorized (in shares)							2,000,000		2,000,000		2,000,000
Preferred shares, par value (in dollars per share) | $ / shares							$ 0.0001		$ 0.0001		$ 0.0001
Preferred shares, shares issued (in shares)							15,000		15,000		15,000
Preferred shares, shares outstanding (in shares)							15,000		15,000		15,000
Common shares, shares authorized (in shares)							170,000,000		170,000,000		170,000,000
Common shares, par value (in dollars per share) | $ / shares							$ 0.0001		$ 0.0001		$ 0.0001
Common shares, shares outstanding (in shares)							28,489,663	11,152,673	28,489,663	11,152,673	12,163,673
Common shares, shares issued (in shares)							28,489,663		28,489,663		12,163,673
Exercise of employee stock options, net of tax (in shares)							0	0	0	0
2018 Long Term Incentive Plan
Class of Stock [Line Items]
Additional common stock issuable (in shares)			1,600,000
PIPE Purchase Agreement Pre-Funded Warrant
Class of Stock [Line Items]
Warrants exercised (in shares)		1,793,000					1,793,000	477,480	6,300,000	477,480
Number of shares of common stock for which warrant is exercisable (in shares)					1,267,897
Discount from stock price (in dollars per share) | $ / shares					$ 0.0001
Exercise price of warrant (in dollars per share) | $ / shares		$ 0.0001			$ 0.0001
Proceeds from Issuance of Common Stock in connection with exercise of Prior Warrant and Pre-Funded Warrants | $		$ 179
Common stock issuable upon exercise of pre-funded warrants
Class of Stock [Line Items]
Number of shares of common stock for which warrant is exercisable (in shares)					7,788,480
Discount from stock price (in dollars per share) | $ / shares					$ 0.0001
Exercise price of warrant (in dollars per share) | $ / shares					$ 0.0001
Ownership threshold					9.99%
PIPE Purchase Agreement Warrant
Class of Stock [Line Items]
Number of shares of common stock for which warrant is exercisable (in shares)					9,900,990
Exercise price of warrant (in dollars per share) | $ / shares					$ 1.39
Warrant price (in dollars per share) | $ / shares					$ 0.125
Armistice Warrant Agreement
Class of Stock [Line Items]
Number of shares of common stock for which warrant is exercisable (in shares)	9,900,990
Exercise price of warrant (in dollars per share) | $ / shares	$ 1.39
Proceeds from Issuance of Common Stock in connection with exercise of Prior Warrant and Pre-Funded Warrants | $	$ 13,800,000
Armistice Reload Warrant Agreement
Class of Stock [Line Items]
Number of shares of common stock for which warrant is exercisable (in shares)	3,750,000
Exercise price of warrant (in dollars per share) | $ / shares	$ 5.13
Warrant expiration period	54 months
Ownership limitation percentage	0.0999
Letter Agreement
Class of Stock [Line Items]
Period after issuance, shares cannot be sold	45 days
Minimum purchase price (in dollars per share) | $ / shares	$ 6.25
Extended expiration date	1 year
Registered Direct Offering
Class of Stock [Line Items]
Number of shares issued (in shares)					844,613
Common stock trading price (in dollars per share) | $ / shares					$ 1.39
Series X Convertible Preferred Stock
Class of Stock [Line Items]
Interest rate percentage						1.00%
Common stock trading price (in dollars per share) | $ / shares						$ 22.00
Common stock trading period						30 days
Accreted amount | $							$ 150,000		$ 150,000
Conversion price (in dollars per share) | $ / shares						$ 11.00
Convertible preferred stock (in shares)						91
Outstanding common stock, percentage						9.90%
Outstanding common stock, not to exceed, percentage						19.90%
Percentage of investment owned						50.00%
Maximum working capital line | $						$ 5,000,000
Consideration received | $						15,000,000
Stock issuance costs | $						100,000
Proceeds from sale of equity, net | $						14,900,000
Da Vita Healthcare Partners Inc | Share Issuance, Tranche One
Class of Stock [Line Items]
Proceeds from issuance of convertible preferred stock | $				$ 7,500,000		7,500,000
Da Vita Healthcare Partners Inc | Series X Convertible Preferred Stock | Private Placement
Class of Stock [Line Items]
Sale of stock, aggregate consideration authorized | $						$ 15,000,000
Common stock trading price (in dollars per share) | $ / shares						$ 1,000
Da Vita Healthcare Partners Inc | Series X Convertible Preferred Stock | Private Placement | Share Issuance, Tranche One
Class of Stock [Line Items]
Number of shares issued (in shares)				7,500		7,500
Cantor Fitzgerald & Co | Controlled Equity Offering
Class of Stock [Line Items]
Sale of stock, aggregate consideration authorized | $							$ 12,200,000		$ 12,200,000			$ 12,200,000

v3.23.3

Stockholder's Equity - Summary of Common Stock Reserved for Issuance (Details) - shares	Sep. 30, 2023	Dec. 31, 2022	Sep. 30, 2022	Dec. 31, 2021
Common stock and common stock equivalents:
Common stock (in shares)	28,489,663	12,163,673	11,152,673
Common stock and pre-funded stock warrants (in shares)	28,489,663		18,463,673
Options to purchase common stock (in shares)	1,367,493		1,311,691
Convertible preferred stock (in shares)	1,363,636		1,363,636
Total (in shares)	35,554,361		38,772,159
Common stock issuable upon exercise of pre-funded warrants
Common stock and common stock equivalents:
Warrants outstanding (in shares)	0		7,311,000
Warrants to Purchase Common Stock
Common stock and common stock equivalents:
Warrants outstanding (in shares)	4,045,278		17,507,268
Unvested Restricted Stock Awards
Common stock and common stock equivalents:
Unvested restricted stock awards/units (in shares)	891		891
Unvested Restricted Stock Units
Common stock and common stock equivalents:
Unvested restricted stock awards/units (in shares)	287,400	125,000	125,000	29,289

v3.23.3

Stock-Based Compensation - Share-Based Compensation Expense (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended		12 Months Ended
	Sep. 30, 2023	Sep. 30, 2022	Sep. 30, 2023	Sep. 30, 2022	Dec. 31, 2022
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]
Total share based compensation expense	$ 212	$ 176	$ 714	$ 94
Total Service Based Awards
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]
Total share based compensation expense	212	176	714	485
Restricted Stock Units
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]
Total share based compensation expense	112	46	276	84
Stock Option Awards
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]
Total share based compensation expense	100	130	438	401
Restricted stock awards - performance based awards
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]
Total share based compensation expense	$ 0	$ 0	$ 0	$ (391)	$ 400

v3.23.3

Stock-Based Compensation - Restricted Stock Awards (Details) - USD ($) $ / shares in Units, $ in Thousands	3 Months Ended		9 Months Ended		12 Months Ended
	Sep. 30, 2023	Sep. 30, 2022	Sep. 30, 2023	Sep. 30, 2022	Dec. 31, 2022
Weighted Average Grant-Date Fair Value
Stock based compensation expenses	$ 212	$ 176	$ 714	$ 94
Restricted stock awards
Number of Shares
Unvested at end of period (in shares)	891	891	891	891
Weighted Average Grant-Date Fair Value
Vesting period			20 months
Restricted stock awards - performance based awards
Number of Shares
Unvested at beginning of period (in shares)			891	7,118	7,118
Forfeited (in shares)				(6,227)
Unvested at end of period (in shares)	891	891	891	891	891
Weighted Average Grant-Date Fair Value
Unvested at beginning of period (in dollars per share)			$ 62.70	$ 62.70	$ 62.70
Forfeited (in dollars per share)				62.70
Unvested at end of period (in dollars per share)	$ 62.70	$ 62.70	$ 62.70	$ 62.70	$ 62.70
Stock based compensation expenses	$ 0	$ 0	$ 0	$ (391)	$ 400

v3.23.3

Stock-Based Compensation - Service Based Restricted Stock Units (Details) - USD ($) $ / shares in Units, $ in Thousands	3 Months Ended		9 Months Ended		12 Months Ended
	Sep. 30, 2023	Sep. 30, 2022	Sep. 30, 2023	Sep. 30, 2022	Dec. 31, 2022
Weighted Average Grant-Date Fair Value
Stock based compensation expenses	$ 212	$ 176	$ 714	$ 94
Restricted stock units - service based awards
Number of Shares
Unvested at beginning of period (in shares)			125,000	29,289	29,289
Granted (in shares)			313,065	125,000
Vested (in shares)			(125,000)	(23,515)
Forfeited (in shares)			(25,665)	(5,774)
Unvested at end of period (in shares)	287,400	125,000	287,400	125,000	125,000
Weighted Average Grant-Date Fair Value
Unvested at beginning of period (in dollars per share)			$ 1.47	$ 12.87	$ 12.87
Granted (in dollars per share)			1.87	1.47
Vested (in dollars per share)			1.47	11.33
Forfeited (in dollars per share)			1.37	19.00
Unvested at end of period (in dollars per share)	$ 1.85	$ 1.47	$ 1.85	$ 1.47	$ 1.47
Stock based compensation expenses	$ 112	$ 46	$ 276	$ 84
Unrecognized stock-based compensation expense	$ 400		$ 400
Unrecognized stock-based compensation expense, weighted average remaining term (in years) (less than)			1 year 4 months 24 days
Restricted stock units - service based awards | Minimum
Weighted Average Grant-Date Fair Value
Vesting period			1 year
Restricted stock units - service based awards | Maximum
Weighted Average Grant-Date Fair Value
Vesting period			3 years

v3.23.3

Stock-Based Compensation - Service Based Stock Options - Fair Value Assumptions (Details) - Stock Option Awards	9 Months Ended
	Sep. 30, 2023 $ / shares
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Expected stock price volatility, minimum	81.60%
Expected stock price volatility, maximum	81.80%
Risk-free interest rate, minimum	3.41%
Risk-free interest rate, maximum	3.46%
Minimum
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Exercise price (in dollars per share)	$ 1.37
Term (years)	5 years 7 months 6 days
Maximum
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Exercise price (in dollars per share)	$ 2.83
Term (years)	6 years

v3.23.3

Stock-Based Compensation - Service Based Stock Options (Details) - USD ($) $ / shares in Units, $ in Thousands	9 Months Ended		12 Months Ended
	Sep. 30, 2023	Sep. 30, 2022	Dec. 31, 2021
Shares Underlying Options
Outstanding at the end of the period (in shares)	1,367,493	1,311,691
Stock Option Awards
Shares Underlying Options
Outstanding at the beginning of the period (in shares)	1,206,905	528,591
Granted (in shares)	382,745	898,659
Forfeited (in shares)	(143,430)	(30,093)
Expired (in shares)	(78,727)	(85,466)
Outstanding at the end of the period (in shares)	1,367,493	1,311,691	528,591
Exercisable at end of period (in shares)	444,836	243,973
Weighted Average Exercise Price
Outstanding at the beginning of the period (in dollars per share)	$ 8.32	$ 32.01
Granted (in dollars per share)	1.48	1.49
Forfeited (in dollars per share)	2.82	15.11
Expired (in dollar per share)	26.74	82.09
Outstanding at the end of the period (in dollars per share)	5.93	8.23	$ 32.01
Exercisable at end of the period (in dollars per share)	$ 14.64	$ 29.31
Weighted Average Remaining Contractual Term
Outstanding	8 years 4 months 24 days	9 years 1 month 6 days	7 years 6 months
Granted		5 years 6 months
Exercisable at end of the period	7 years	6 years 10 months 24 days
Aggregate Intrinsic Value
Outstanding	$ 680
Exercisable at end of the period	$ 114

v3.23.3

Stock-Based Compensation - Service Based Stock Options - Others (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2023	Sep. 30, 2022	Sep. 30, 2023	Sep. 30, 2022
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Stock based compensation expenses	$ 212	$ 176	$ 714	$ 94
Stock Option Awards
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Stock based compensation expenses	100	$ 130	438	$ 401
Unrecognized stock-based compensation expenses	$ 700		$ 700
Unrecognized stock-based compensation expense, weighted average remaining term (in years)			3 years 2 months 12 days

v3.23.3

Licensing Agreements (Details)	Oct. 07, 2018 agreement	Sep. 30, 2023 USD ($)	Dec. 31, 2022 USD ($)
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Number of additional agreements | agreement	3
Master Services And Ip Agreement
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Collaborative arrangement, accrued reimbursement of IP expenses and sublicense royalty fees		$ 85,400	$ 85,400
Milestone payments		$ 0	$ 0

v3.23.3

Leases - Narrative (Details) $ in Millions	Sep. 30, 2023 USD ($) ft² facility	Dec. 31, 2022 USD ($)
Lessee, Lease, Description [Line Items]
Operating lease and finance lease liabilities | $	$ 5.4	$ 6.7
Operating lease and finance lease, right of use assets, net | $	$ 5.1	$ 6.4
Wixom, Michigan | Wixom, Michigan Property One
Lessee, Lease, Description [Line Items]
Facility sqft.	51,000
Wixom, Michigan | Wixom, Michigan Property Two
Lessee, Lease, Description [Line Items]
Facility sqft.	17,500
Texas and South Carolina
Lessee, Lease, Description [Line Items]
Number of manufacturing facilities | facility	2
Grapevine, Texas
Lessee, Lease, Description [Line Items]
Facility sqft.	51,000
Greer, South Carolina
Lessee, Lease, Description [Line Items]
Facility sqft.	57,000
Hackensack, New Jersey
Lessee, Lease, Description [Line Items]
Facility sqft.	4,100
Maximum
Lessee, Lease, Description [Line Items]
Lease term	6 years

v3.23.3

Leases - Summary of Lease Costs (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2023	Sep. 30, 2022	Sep. 30, 2023	Sep. 30, 2022
Operating leases
Operating lease cost	$ 422	$ 410	$ 1,281	$ 1,289
Variable lease cost	112	101	336	287
Operating lease expense	534	511	1,617	1,576
Finance leases
Non-cash lease expense from right-of-use assets	142	141	424	424
Interest on lease obligations	36	44	113	136
Finance lease expense	178	185	537	560
Short-term lease rent expense	4	5	12	14
Total lease expense	716	701	2,166	2,150
Other information
Payments for principal from operating leases	461	427	1,363	1,338
Payments for interest from finance leases	37	44	114	136
Payments for principal from finance leases	$ 130	$ 121	$ 388	$ 359
Weighted-average remaining lease term – operating leases	2 years 6 months	3 years 2 months 12 days	2 years 6 months	3 years 2 months 12 days
Weighted-average remaining lease term – finance leases	3 years 8 months 12 days	4 years 8 months 12 days	3 years 8 months 12 days	4 years 8 months 12 days
Weighted-average discount rate – operating leases	6.50%	6.40%	6.50%	6.40%
Weighted-average discount rate – finance leases	6.40%	6.40%	6.40%	6.40%

v3.23.3

Leases - Finance Lease and Operating Lease Maturities (Details) $ in Thousands	Sep. 30, 2023 USD ($)
Operating
Year ending December 31, 2023 (remaining)	$ 439
Year ending December 31, 2024	1,511
Year ending December 31, 2025	1,021
Year ending December 31, 2026	362
Year ending December 31, 2027	131
Total	3,464
Less present value discount	(259)
Operating lease liabilities	3,205
Finance
Year ending December 31, 2023 (remaining)	168
Year ending December 31, 2024	672
Year ending December 31, 2025	676
Year ending December 31, 2026	666
Year ending December 31, 2027	311
Total	2,493
Less present value discount	(271)
Finance lease liabilities	$ 2,222

v3.23.3

Loans and Security Agreement - Narrative (Details) - Term loan		1 Months Ended	3 Months Ended		9 Months Ended
	Mar. 16, 2020 USD ($) $ / shares shares	Sep. 30, 2021 USD ($) installment	Sep. 30, 2023 USD ($)	Sep. 30, 2022 USD ($)	Sep. 30, 2023 USD ($)	Sep. 30, 2022 USD ($)	Nov. 10, 2022 USD ($)
Term loan
Debt Instrument [Line Items]
Aggregate principal amount	$ 35,000,000	$ 7,500,000					$ 5,000,000
Calculation for number of shares of common stock able to be purchased by warrant, percentage of principal amount of relevant term loan funded	3.50%
Interest rate, base percentage	4.75%
Interest rate, additional percentage added to base percentage	4.00%
Initial interest rate percentage	8.75%
Effective interest rate			12.50%		12.50%
Option to add interest rate amount to outstanding principal balance in lieu of paying such amount in cash, percentage	1.00%
Interest expense			$ 300,000	$ 400,000	$ 900,000	$ 1,200,000
Number of monthly installments | installment		10
Prepayment premium percentage		5.00%
Minimum liquidity floor		$ 5,000,000
Minimum principal amount pursuant to liquidity covenant		$ 15,000,000
Outstanding balance, net of unamortized issuance costs and unaccreted discount			9,000,000		9,000,000
Unamortized issuance costs and unaccreted discount			$ 500,000		$ 500,000
Term loan, first tranche
Debt Instrument [Line Items]
Aggregate principal amount	$ 22,500,000
Net draw down proceeds	21,200,000
Closing costs	$ 1,300,000
Number of shares of common stock for which warrant is exercisable (in shares) | shares	43,388
Exercise price of warrant (in dollars per share) | $ / shares	$ 18.15
Additional debt discount recognized	$ 500,000

v3.23.3

Loans and Security Agreement - Schedule of Principal Payments on Term Loan (Details) - Term loan - Term loan $ in Thousands	Sep. 30, 2023 USD ($)
Debt Instrument [Line Items]
2023 (remaining)	$ 1,500
2024	6,000
2025	2,000
Principal Payments	$ 9,500

v3.23.3

Insurance Financing Note Payable (Details) - 5.40% Note Payable - Notes Payable to Banks - USD ($) $ in Millions	Jun. 03, 2023	Sep. 30, 2023
Short-term Debt [Line Items]
Short-term note payable	$ 0.7
Interest rate, base percentage	9.59%
Amortization period (in months)	9 months
Outstanding amount		$ 0.5

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