The following discussion and analysis should be read in conjunction with the unaudited condensed consolidated financial statements and notes thereto included in Part I, Item 1 of this quarterly report on Form 10Q for the quarter endedMarch 31, 2022 (this "Quarterly Report"). This Quarterly Report contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, such statements are subject to the "safe harbor" created by those sections and involve risks and uncertainties. Forward-looking statements are based on our management's beliefs and assumptions and on information available to our management as of the date hereof. As a result of many factors, such as those set forth under "Item 1A. Risk Factors" included in our 2021 Annual Report and Part II, "Item 1A. Risk Factors" in this Quarterly Report, our actual results may differ materially from those anticipated in these forward-looking statements, accordingly, you should not place undue reliance on these forward-looking statements. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future. Such factors may be amplified by the COVID-19 pandemic and its potential impact on our business and the global economy.
Overview
Lumos Pharma, Inc. is a clinical-stage biopharmaceutical company. References in this Quarterly Report to "us," "we," "our," the "Company," or "Lumos" are toLumos Pharma, Inc. and its wholly-owned subsidiaries. With our principal executive offices located inAustin, Texas and additional executive and administrative offices located inAmes, Iowa , we are engaged in advancing our clinical program and focused on identifying, acquiring, developing, and commercializing novel products and new therapies for people with rare diseases on a global level, for which there is currently a significant unmet need for safe and effective therapies. Our common stock is listed on the Nasdaq Select Market ("Nasdaq") and trades under the ticker symbol "LUMO." We have focused our efforts on the development of our sole product candidate, growth hormone secretagogue ibutamoren ("LUM-201"), a potential oral therapy for pediatric growth hormone deficiency ("PGHD") and other rare endocrine disorders. PGHD is a rare endocrine disorder occurring in approximately one in 3,500 persons aged birth to 17 years. Causes of PGHD can be congenital (children are born with the condition), acquired (brain tumor, head injuries or other causes), iatrogenic (induced by medical treatment) or idiopathic (of unknown cause). Children with untreated PGHD will have significant growth failure, potential adult heights significantly less than five feet, and may have abnormal body composition with decreased bone mineralization, decreased lean body mass, and increased fat mass. The main therapeutic goal in PGHD is to restore growth, enabling short children to achieve normal height and prevent complications that could involve metabolic abnormalities, cognitive deficits and reduced quality of life. The current standard of care for PGHD is limited to daily subcutaneous injections of rhGH with a treatment cycle lasting up to an average of seven years. Poor compliance with daily rhGH injections during treatment can result in an adverse impact on growth. The FDA recently approved a new treatment, Skytrofa, a once-weekly injection that would reduce the number of injections over the course of treatment for a patient, however, we believe that many providers and patients will have a preference for an orally administered treatment, when available. OnMarch 18, 2020 , we closed the business combination (the "Merger") among the Company, formerly known asNewLink Genetics Corporation ("NewLink"),Cyclone Merger Sub, Inc. ("Merger Sub"), a wholly owned subsidiary of NewLink, andLumos Pharma, Inc. , ("Private Lumos") which has since been renamed "Lumos Pharma Sub, Inc. " whereby Merger Sub merged with and into Private Lumos, with Private Lumos surviving as a wholly-owned subsidiary of the Company. Immediately prior to the closing of the Merger, the shares of NewLink common stock were adjusted with a reverse split ratio of 1for9. Under the terms of the Merger, Private Lumos stockholders received an aggregate of 4,146,398 shares of NewLink common stock (after giving effect to the reverse split). Immediately following the reverse stock split and the completion of the Merger, there were 8,292,803 shares of our common stock outstanding, of which approximately 50% was held by each of Private Lumos and NewLink security holders. The Merger was accounted for as a reverse asset acquisition.
LUM-201 Growth Hormone Secretagogue
Our pipeline is focused on the development of an orally administered small molecule, LUM-201, which is a growth hormone ("GH") secretagogue, also called ibutamoren, for rare endocrine disorders where injectable recombinant human growth hormone ("rhGH") is currently approved. LUM-201 is a tablet formulation that will be administered once daily.
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Lumos acquired LUM-201 fromAmmonett Pharma LLC ("Ammonett") inJuly 2018 . LUM-201 received an Orphan Drug Designation ("ODD") inthe United States and theEuropean Union for Growth Hormone Deficiency ("GHD") in 2017.The United States patent "Detecting and Treating Growth Hormone Deficiency" has been issued with an expiration in 2036. Related patents have been issued in theEuropean Union (where validations are ongoing),Australia ,Israel ,Japan ,South Korea , andUkraine with related patent applications pending in multiple other jurisdictions. If approved, LUM-201 has the potential to become the first approved oral GH secretagogue to treat rare endocrine disorders associated with GH deficiencies, starting with PGHD, providing an alternative to the current standard regimen of recombinant growth hormone product injections. A secretagogue is a substance that stimulates the secretion or release of another substance. LUM-201 stimulates the release of GH and is referred to as a GH secretagogue. LUM-201 stimulates GH via the GH secretagogue receptor (GHSR1a), also known as the ghrelin receptor, thus providing a differentiated mechanism of action to treat some rare endocrine disorders (involving a deficiency of GH) by increasing the amplitude of endogenous, pulsatile GH secretion. LUM-201's stimulatory effect is regulated by both circulating levels of GH and its down-stream mediator insulin-like growth factor which at supraphysiological levels feedback or negatively regulate additional release of GH from the pituitary, hence protecting against hyperstimulation of GH release. LUM-201 has been observed to stimulate endogenous GH secretion in patients who have a functional but reduced hypothalamic pituitary GH axis. We believe that a subset of patients with PGHD who have a functional but reduced hypothalamic pituitary GH axis are expected to respond to LUM-201 and represent approximately 60% of PGHD patients. During the fourth quarter of 2020, we launched our OraGrowtH210 Trial (as defined below) program to study the effects of LUM-201 in PGHD and initiated our Phase 2 clinical trial ("OraGrowtH210 Trial" or the "Phase 2 Trial") with the opening of the initial sites participating in this study. The PGHD patient population consists of patients diagnosed with organic PGHD (a more severe GH deficiency) and idiopathic PGHD (a less severe or moderate GH deficiency). The OraGrowtH210 Trial is a global multi-site randomized study evaluating orally administered LUM-201 at three dose levels (0.8, 1.6 and 3.2 mg/kg/day) against a standard dose of daily injectable rhGH in approximately 80 subjects diagnosed with idiopathic PGHD. The primary endpoint of the study is preliminary validation of our predictive enrichment marker ("PEM") patient selection strategy as evidenced by the percentage of selected patients who grow in response to LUM-201. The primary efficacy endpoint is annualized height velocity. Secondary endpoints include selection of a pediatric dose of LUM-201 for future studies including Phase 3 and determination of the degree of repeatability of the PEM selection process in PEM positive patients screened for participation in OraGrowtH210. The OraGrowtH210 Trial currently has sites enrolling inthe United States ,Australia ,New Zealand ,Poland , andIsrael . We had initiated or had planned to initiate sites inRussia andUkraine ; however, due to the ongoing conflict betweenUkraine andRussia and the resulting uncertainty in the region, we are unable to enroll patients inUkraine and all of our clinical sites inRussia are suspended until further notice. No patients had been randomized to treatment in the clinical trial at any of our nine sites inUkraine andRussia . Given the encouraging screening and enrollment trajectory at our other clinical sites, we continue to anticipate the 6-month primary outcome data on all 80 subjects in the second half of 2023. The ongoingUkraine -Russia conflict may, however, adversely impact our business in the future, and it remains too early to evaluate all the potential effects of this crisis. A second concurrent trial of LUM-201 in PGHD exploring the effects of the novel mechanism of action of LUM-201 in amplifying the pulsatile secretion of growth hormone (the "OraGrowtH212 Trial") was initiated in the second quarter of 2021. The OraGrowtH212 Trial in PGHD will run in parallel with the OraGrowtH210 Trial. The OraGrowtH212 Trial is a single site, open-label trial evaluating the pharmacokinetic and pharmacodynamic ("PK/PD") effects of LUM-201 in up to 24 PGHD subjects at two different dose levels, 1.6 and 3.2 mg/kg/day. The objective of OraGrowtH212 is to confirm prior clinical data illustrating the increased pulsatile release of endogenous growth hormone unique to LUM-201 and its potential for this mechanism of action to contribute to efficacy in PGHD. Our OraGrowtH212 Trial is being conducted at a single specialized pediatric center with the capacity to conduct the more frequent sample acquisition and monitoring required for this type of clinical trial. Data from the OraGrowtH212 Trial may be supportive in future regulatory filings; however, this trial is not required for regulatory approval of LUM-201. The primary endpoint for this trial is six months of PK/PD and height velocity data in up to 24 subjects. Subjects will be dosed for a total of 12 months, with a plan to extend the duration of the trial to 23 months total. In response to theFDA's request in a letter datedJuly 16, 2021 , we announced inJuly 2021 that the FDA had restricted treatment with LUM-201 to no more than 12 months. At this time, we extended the treatment period from six months to 12 months to gather additional efficacy data for LUM-201 in PGHD prior to starting our originally planned long-term extension trial (the "OraGrowtH211 trial"). As announced onMay 10, 2022 , after review of preliminary safety and efficacy data from both the OraGrowtH210 and OraGrowtH212 Trials, the FDA has removed the partial hold and will now permit treatment with
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LUM-201 beyond 12 months. As a result, the OraGrowtH210 Trial will be extended to 24 months to allow subjects to continue LUM-201 therapy uninterrupted. Additionally, we plan to extend the OraGrowtH212 Trial for up to 24 months.
The extension of the treatment period will not impact the primary outcome data read out for OraGrowtH210, which will be based on the annualized data from the first six months of treatment. We continue to review the timing of the start of the long-term extension study in context of the OraGrowtH210 Trial extension and gather the requested efficacy data to be reviewed by the FDA prior to initiation. We do not anticipate these protocol changes, on a stand-alone basis, will extend the time to the initiation of our Phase 3 clinical trial. During the first quarter of 2022, we initiated our OraGrowtH213 Trial (the "OraGrowtH213 Trial," and together with the OraGrowtH210 Trial, the OraGrowtH211 Trial (defined below), and the OraGrowtH212 Trial, the "OraGrowtH Trials"), an open-label, multi-center, Phase 2 study evaluating the growth effects and safety of LUM-201 following 12 months of daily rhGH in up to 20 idiopathic PGHD subjects who have completed the OraGrowtH210 Trial. Subjects will be administered LUM-201 at a dose level of 3.2 mg/kg/day for up to 12 months. InApril 2022 , we announced achievement of the 50% randomization milestone for our OraGrowtH210 Trial. Interim data from both the OraGrowtH210 and OraGrowtH212 Trials are anticipated by the end of 2022. Data from the interim analysis for OraGrowtH210 will evaluate the safety and annualized height velocity at three dose levels of LUM-201 against a standard dose of rhGH in a total of 40 subjects at six months on therapy. We believe this data set may be adequate to provide an initial indication of LUM-201's impact on height velocity compared to growth hormone on the PEM positive population selected for in the trial. Our OraGrowtH212 interim analysis will evaluate safety and height velocity data in 10 or more subjects at six months on therapy at either 1.6 or 3.2 mg/kg/day.
The graphic below depicts the clinical development plan for LUM-201.
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Potential expansion of LUM-201 into additional indications
We recently announced a clinical collaboration withMassachusetts General Hospital ("MGH") to evaluate oral LUM-201 in nonalcoholic fatty liver disease ("NAFLD") in an investigator-initiated trial. This investigator-initiated trial will evaluate a dose of 25 mg/day of LUM-201 in 10 men and women with NAFLD. GH is a critical stimulator of lipolysis, and preclinical data suggest that amplifying GH secretion has the potential to reduce hepatic steatosis and prevent NAFLD progression. Enhancing the natural pulsatile release of GH has been shown clinically in short-term studies to be more efficacious in inducing lipolysis than continuous infusions of GH. The primary endpoints will be to determine the changes in intrahepatic lipid content, hepatic inflammation and fibrosis with GH augmentation as measured by H-MRS and Perspectum's LiverMultiScan®. Biopsies will be conducted on a subset of subjects to obtain additional information at the genetic and cellular level in this indication.
We approved an unsolicited grant application for this study and will supply LUM-201 for this pilot trial. Lumos has a pending application for a method-of-use patent for LUM-201 in NAFLD and retains intellectual property rights for LUM-201 in this indication.
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We continue to explore our development path to expand into additional indications for LUM-201. We are actively reviewing the mechanism of action of LUM-201 in a subset of affected patients in other potential indications, including Prader Willi Syndrome, Idiopathic Short Stature, Children Born Small for Gestational Age, and Turners Syndrome, and are working towards developing the clinical plans for additional targeted indications. Timing for the initiation of these plans will be dependent on the outcome of data developed and identification of the most efficacious dose in the OraGrowtH210 Trial and the timing of such data. Ebola Vaccine InNovember 2014 , NewLink entered into the NewLink Merck Agreement with Merck to develop and potentially commercialize its Ebola vaccine rVSV?G-ZEBOV that it licensed from PHAC. rVSV?G-ZEBOV was also eligible to receive a PRV if approval was granted by the FDA, with the Company entitled to 60% of the PRV value obtained through sale, transfer or other disposition of the PRV. OnDecember 20, 2019 , Merck announced that the FDA approved its application for ERVEBO® (Ebola Zaire Vaccine, Live) for the prevention of disease caused by Zaire Ebola virus in individuals 18 years of age and older. Pursuant to the asset purchase agreement, Merck agreed, among other things, to pay us for the PRV in two installments. As required by the agreement, Merck paid us$34.0 million at the closing during the three months endedSeptember 30, 2020 and$26.0 million onJanuary 11, 2021 . We have received and have the potential to continue to earn royalties on sales of the vaccine in certain countries. However, we believe that the market for the vaccine will be limited primarily to areas in the developing world that are excluded from royalty payment or where the vaccine is donated or sold at low or no margin and, therefore, we do not expect to receive material royalty payments from Merck in the foreseeable future.
Oncology Candidates
We have small-molecule product candidates, which we acquired from NewLink in the merger. These product candidates, indoximod,NLG802 (a prodrug of indoximod) andNLG919 (a direct IDO1 enzymatic inhibitor) are indoleamine-2, 3-dioxygenase pathway inhibitors. We also had an additional small molecule product candidate,NLG207 , which is a nanoparticle-drug conjugate consisting of a cyclodextrin-based polymer backbone linked to camptothecin, a topoisomerase 1 inhibitor, which was out-licensed toEllipses Pharma Limited , effectiveDecember 17, 2019 . TwoU.S. patents covering both the salt and prodrug formulations of indoximod were issued inthe United States onAugust 15, 2017 andFebruary 19, 2019 , respectively, providing exclusivity until at least 2036. We are continuing to pursue international patent coverage for these formulations in some countries. We may explore the potential for further development and licensing opportunities for these product candidates; however, we currently do not have any active program for these acquired small molecule product candidates.
Financial Overview
Revenue
We have no products approved for commercial sale and have not generated any revenue from product sales. In the future, we may generate revenue from product sales, royalties on product sales, or license fees, milestones, or other upfront payments if we enter into any collaborations or license agreements. We expect that our future revenue will fluctuate from quarter to quarter for many reasons, including the uncertain timing and amount of any such payments and sales.
Research and Development Expenses
Research and development expenses consist primarily of costs incurred to advance our product candidate, LUM-201. Our research and development expenses include internal personnel expenditures along with external research and development expenses incurred under arrangements with third parties, such as contract research and manufacturing organizations, consultants, and our scientific advisors. We expense research and development costs as incurred. Nonrefundable advance payments for goods and services that will be used in future research and development activities are capitalized as an asset and expensed when the service has been performed or when the goods have been received. We expect our research and development expenses to increase for the foreseeable future as we continue to conduct our clinical trial programs for our product candidates develop our pipeline and pursue regulatory approval of our product candidates.
General and Administrative Expenses
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General and administrative expenses consist primarily of professional fees for legal, auditing, tax and business consulting services, personnel expenses and travel costs. We expect that general and administrative expenses will increase in the future as we expand our operating activities.
Critical Accounting Policies and Significant Judgments and Estimates
We have prepared our condensed consolidated financial statements in accordance withU.S. GAAP, which requires us to make estimates, assumptions and judgments that affect the reported amount of assets, liabilities, expenses. On an ongoing basis, we evaluate these estimates and judgments. We based our estimates on historical experience and on various assumptions that we believe to be reasonable under the circumstances. These estimates and assumptions form the basis for making judgments about the carrying values of assets and liabilities and the recording of expenses that are not readily apparent from other sources. Actual results could, therefore, differ materially from these estimates under different assumptions or conditions. Management believes there have been no material changes to the critical accounting policies from those discussed in "Note 2 - Summary of Significant Accounting Policies and Recent Accounting Pronouncements" of our consolidated financial statements included in our 2021 Annual Report.
COVID-19
The pandemic caused by an outbreak of COVID-19 has resulted, and is likely to continue to result, in significant national and global economic disruption and may continue to adversely affect our operations. We are actively monitoring the potential impact of COVID-19, if any, on the carrying value of certain assets and our continued operations. To date, we have experienced delays related to the progress of our clinical trials as clinical sites adapt their procedures to caring for patients during a pandemic; however, we have not incurred impairment of any assets as a result of COVID-19. The extent to which these events may impact our business, clinical development, regulatory efforts, and the value of our common stock, will depend on future developments, which are highly uncertain and cannot be predicted at this time. The duration and intensity of these impacts and resulting disruption to our operations is uncertain and we will continue to evaluate the impact that these events could have on our operations, financial position, and results of operations and cash flows during fiscal year 2022. Results of Operations
Comparison of the Three Months Ended
Three Months Ended March 31, 2022 2021 Change in $ Change in % (in thousands) (in thousands) Revenues: Royalty revenue $ 111 $ - 111 100 % Total revenues 111 - Operating expenses: Research and development 4,221 4,660 (439) (9) % General and administrative 3,621 3,957 (336) (8) % Total operating expenses 7,842 8,617 Other income, net 11 (14) 25 179 % Net loss$ (7,720) $ (8,631)
Revenues. Revenues increased by
Research and Development Expenses. Research and development expenses decreased by$0.4 million for the three months endedMarch 31, 2022 compared to the same period in 2021 primarily due to decreases of$0.5 million in personnel-related expenses,$0.3 million in stock compensation expenses and$0.1 million in legal and consulting expenses, offset by an increase of$0.5 million in clinical trial and contract manufacturing expenses.
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General and Administrative Expenses. General and administrative expenses decreased by$0.3 million for the three months endedMarch 31, 2022 compared to the same period in 2021 primarily due to decreases of$0.3 million in legal and consulting expenses,$0.2 million in stock compensation expenses, and$0.1 million in depreciation expenses, offset by increases of$0.1 million in licensing expenses and$0.2 million in other expenses.
Other Income, net. Other income, net increased by
Liquidity and Capital Resources
We have historically devoted substantially all our efforts toward research and development and have never earned revenue from commercial sales of our products. We expect to continue to incur additional substantial losses in the foreseeable future as a result of our research and development programs and from general and administrative costs associated with our operations. However, we believe that our existing cash and cash equivalents of approximately$87 million as ofMarch 31, 2022 will be sufficient to allow us to fund our operations through the primary read out of the OraGrowtH210 and OraGrowtH212 Trials for patients with idiopathic (moderate) PGHD and for at least 12 months from the filing date of this Quarterly Report. We may seek to sell additional equity or debt securities or obtain a credit facility from time to time if our available cash and cash equivalents are insufficient to satisfy our liquidity requirements or if we develop additional opportunities to do so. The sale of additional equity and debt securities may result in additional ownership dilution to our stockholders. If we raise additional funds through the issuance of debt securities or preferred stock, these securities could have rights senior to those of our common stock and could contain covenants that would restrict our operations. We may require additional capital beyond our currently forecasted amounts. Any such required additional capital may not be available on reasonable terms, if at all. If we are unable to obtain additional financing, we may be required to reduce the scope of, delay or eliminate some or all of our planned research and development activities, which could harm our business. Because of the numerous risks and uncertainties associated with the research and development of our product candidates, we are unable to estimate the exact amounts of our working capital requirements. Our future funding requirements will depend on many factors, including, but not limited to:
•the scope, progress, results, and costs of clinical trials for our product candidates, and discovery and development activities related to new product candidates;
•the timing of, and the costs involved in, obtaining regulatory approvals for our product candidates;
•the cost of commercialization activities if any of our product candidates are approved for sale, including marketing, sales, facilities, and distribution costs;
•the cost of manufacturing our product candidates and any products we commercialize;
•our ability to establish and maintain strategic collaborations, licensing or other arrangements and the financial terms of such agreements;
•whether, and to what extent, we are required to repay our outstanding government provided loans;
•the costs involved in preparing, filing, prosecuting, maintaining, defending and enforcing patent claims, including litigation costs and the outcome of such litigation; •changes in domestic and global business or macro-economic conditions, including continued adverse impacts from the COVID-19 pandemic or the conflict inUkraine , resulting labor shortages, supply chain disruptions, and inflation; and
•the timing, receipt and amount of sales of, or royalties on, our future products, if any.
OnDecember 30, 2020 , we entered into a Controlled Equity OfferingSM Sales Agreement (the "Sales Agreement") withCantor Fitzgerald & Co. , as agent (the "Agent"), pursuant to which we may offer and sell from time to time through the Agent up to$50.0 million of shares of our common stock (the "Shares"). The offering and sale of the Shares has been registered under the Securities Act. Under the Sales Agreement, the Agent may sell the Shares by any method permitted by law and deemed to be an "at-the-market" offering as defined in Rule 415(a)(4) promulgated under the Securities Act, including sales made directly on or through the Nasdaq, on any other existing trading market for the Shares, in negotiated transactions at market prices prevailing at the time of sale or at prices related to such prevailing market prices and/or any other method permitted by law. We will notify the Agent of the number of Shares to be issued, the time period during which sales are requested to be made, any limitation on the number of Shares that may be sold in any one day and any minimum price below which sales may not be
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made. We intend to use the net proceeds from this offering for working capital and general corporate purposes, which include, but are not limited to, expanding clinical development opportunities for our product candidate into potential additional indications, and general and administrative expenses. We may also use a portion of the net proceeds to invest in future strategic transactions to expand and diversify our product pipeline through the acquisition or licensing of product candidates or technologies that are complementary to our own. We will pay the Agent a commission of up to 3.0% of the gross sales price of the Shares sold through it under the Sales Agreement. In addition, we have agreed to reimburse certain expenses incurred by the Agent in connection with the offering. The Sales Agreement may be terminated by the Agent or by us at any time upon notice to the other party, as set forth in the Sales Agreement, or by the Agent at any time in certain circumstances, including the occurrence of a material and adverse change in our business or financial condition that makes it impractical or inadvisable to market the shares or to enforce contracts for the sale of the Shares. As ofMarch 31, 2022 , no shares have been issued under the Sales Agreement. Cash Flows
The following table sets forth the primary sources and uses of cash for each of the periods set forth below (in thousands):
Three Months Ended
2022 2021 Net cash used in operating activities$ (8,033) $ (10,412) Net cash provided by investing activities - 26,000 Net cash used in financing activities (18) (166) Net increase in cash and equivalents$ (8,051) $ 15,422 For the three months endedMarch 31, 2022 and 2021, our operating activities used cash of$8.0 million and$10.4 million , respectively. The decrease was primarily due to decreases of$2.1 million in the change in working capital and$0.9 million in losses from operations, offset by increases of$0.5 million in stock compensation expenses and$0.1 million in depreciation and amortization. The decrease in the change in working capital is primarily due to an increase in accounts payable as ofMarch 31, 2022 compared toMarch 31, 2021 . For the three months endedMarch 31, 2022 and 2021, our investing activities provided cash of$0 and$26 million , respectively. The decrease resulted from$26.0 million in cash received towards the final installment from sale of the PRV during the three months endedMarch 31, 2021 . For the three months endedMarch 31, 2022 and 2021, our financing activities used net cash of$18,000 and$166,000 , respectively. The decrease was primarily due to$148,000 in expenses related to the common stock offering under our Controlled Equity OfferingSM during the three months endedMarch 31, 2021 .
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