The following Management's Discussion and Analysis of Financial Condition and Results of Operations contains forward-looking statements that involve risks and uncertainties. Our actual results could differ materially from those anticipated in these forward-looking statements as a result of various factors, including those set forth under "Cautionary Note Regarding Forward-Looking Statements" herein and under "Risk Factors" in our 2020 Form 10-K. The following discussion should be read in conjunction with our consolidated financial statements and related notes thereto included elsewhere in this Quarterly Report and in our 2020 Form 10-K. OverviewCaladrius Biosciences, Inc. ("we," "us," "our," "Caladrius" or the "Company") is a clinical-stage biopharmaceutical company dedicated to the development and commercialization of cellular therapies designed to reverse disease and/or promote the regeneration of damaged tissue. We are developing first-in-class therapeutics based on the characteristics of naturally occurring CD34+ cells and their ability to stimulate the growth of new microvasculature. Our technology leverages these cells to enable the body's natural repair mechanisms using formulations unique to each medical indication. Our leadership team has decades of collective biopharmaceutical development experience. Our goal is to develop and commercialize products that address important unmet medical needs based on a broad and versatile portfolio of candidates. Our current product candidates include: •CLBS16, the subject of both a recently completed positive Phase 2a study (ESCaPE-CMD) and a newly initiated Phase 2b (FREEDOM Trial) study inthe United States for the treatment of coronary microvascular dysfunction ("CMD"); •HONEDRA® (CLBS12), recipient of SAKIGAKE designation and eligible for early conditional approval inJapan for the treatment of critical limb ischemia ("CLI") and Buerger's disease based on the results of an ongoing clinical trial. CLBS was the recipient of orphan drug designation inMarch 2021 from theU.S. Food and Drug Administration ("FDA") for Buerger's disease; •CLBS201, designed to assess the safety and efficacy of CD34+ cell therapy as a treatment for patients with pre-dialysis diabetic kidney disease ("DKD"); and •OLOGO™ (CLBS14), a Regenerative Medicine Advanced Therapy ("RMAT") designated Phase 3 ready therapy for treatment of no-option refractory disabling angina ("NORDA"). Ischemic Repair (CD34 Cell Technology) The CD34+ cell was discovered as a result of the deliberate search for a stem cell capable of stimulating the development and/or repair of blood vessels. All tissues in the body maintain their function by replacing cells over time. In addition to the maintenance function, the body must also be capable of building new blood vessels after injury. A CD34+ cell is a stem cell that has the ability to stimulate new blood vessel formation at the level of the microvasculature. No other native cell discovered to date has demonstrated this same capability. Our proprietary cell technology using autologous (a patient's own naturally occurring) CD34+ cells has led to the development of therapeutic product candidates designed to address diseases and conditions caused by ischemia. Ischemia occurs when the supply of oxygenated blood to healthy tissue is restricted. Through the administration of CD34+ cells, we seek to promote the development and formation of new microvasculature and thereby increase blood flow to the impacted area. We believe that a number of conditions caused by underlying ischemic injury can be improved through our CD34+ cell technology including but not limited to Buerger's disease, CLI, CMD, DKD and NORDA. HONEDRA® for Treatment of Critical Limb Ischemia Our randomized and open-label, registration-eligible study of HONEDRA® inJapan for the treatment of CLI has shown positive results to date. The initial responses observed in the subjectswho have reached an endpoint in this open label study are consistent with a positive therapeutic effect and safety profile as reported by previously published clinical trials inJapan . The study's enrollment continues to be curtailed by the COVID-19 pandemic's impact inJapan ; however, we are encouraged by the patient pre-screening pipeline and, despite the continually extending States of Emergency inJapan announced by the Japanese government, continues to make progress, albeit slowly, towards study completion, the exact date of which is impossible to predict given the continuing impact of COVID-19 on clinical trials like ours inJapan . While the final outcome of the trial will depend on all data from all subjects, data, to date, are encouraging. --------------------------------------------------------------------------------
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CLBS16 for Treatment of Coronary Microvascular Dysfunction In 2017, with the assistance of a$1.9 million grant from theNational Institutes of Health (Award Number R44HL135889), we initiated our program for CLBS16 for the treatment of CMD, a disease that afflicts millions of patients with no current targeted treatment options. That study, the ESCaPE-CMD Trial, was a Phase 2a proof-of-concept study that enrolled patients at theMayo Clinic inRochester, MN andCedars-Sinai Medical Center inLos Angeles, CA. That data showed a positive therapeutic effect with a statistically significant improvement in angina frequency, coronary flow reserve, Canadian Cardiovascular Society Angina Class and Seattle Angina Questionnaire scores, as well as an acceptable safety profile. The full data set from that study was presented at the SCAI 2020Scientific Sessions Virtual Conference onMay 14, 2020 by Dr.Timothy Henry , FACC, of theChrist Hospital inCincinnati, Ohio . InDecember 2020 , we commenced enrollment in our Phase 2b FREEDOM Trial of CLBS16 as a therapy for CMD. The first patient in the study was subsequently treated inJanuary 2021 at The Christ Hospital Health Network inCincinnati, Ohio . This 105-patient, double-blind randomized and placebo-controlled clinical trial is designed to further evaluate the efficacy and safety of intracoronary delivery of autologous CD34+ cells in subjects with CMD and without obstructive coronary artery disease. To our knowledge, this is the first controlled regenerative medicine trial in CMD. Investigator and potential subject response to the FREEDOM Trial has been favorable and early enrollment proceeded according to plan. However, the continued impact of the COVID-19 pandemic, including the resurgence of cases occurring in select areas throughoutthe United States , has contributed to a general slowing of enrollment. Further work with investigators and subject feedback also led us to propose to the FDA amendments to the FREEDOM Trial protocol, as originally written, to enhance the breadth and speed of subject enrollment, including by broadening the array of available techniques acceptable for diagnosing CMD. These changes notwithstanding, based on the uncertainty that remains surrounding the future impact of the COVID-19 pandemic on potential patient recruitment, as well as on accessibility of investigator sites, we now project enrollment completion for the FREEDOM Trial to occur in the third quarter of 2022 with final data (based on the six month assessment of all subjects) expected by the second quarter of 2023. CLBS201 for Treatment of Diabetic Kidney Disease We have prepared an initial development plan for the clinical study of CLBS201, a CD34+ investigational product for administration via the renal arteries to slow the deterioration, or, ideally, reverse the decline of, renal function in patients with diabetic kidney disease ("DKD")who , although still pre-dialysis, exhibit rapidly progressive stage 3b disease. Progressive kidney failure is associated with attrition of the microcirculation of the kidney. Pre-clinical studies in kidney disease and injury models have demonstrated that protection or replenishment of the microcirculation results in improved kidney function. A Phase 2 proof of concept, randomized, placebo-controlled study for the stage 3b chronic kidney disease patient population is planned to initiate in the second half of 2021. The protocol, pending final central institutional review board approval, calls for a six subject open-label treatment run-in arm in which patients will be treated sequentially, to be completed, evaluated and cleared for continuation by the study's data safety monitoring board prior to initiating the 40 patient randomized, placebo-controlled, double blinded portion of the trial. We are projecting that safety data for the six subject run-in arm will be complete by the second quarter of 2022. OLOGO™ for Treatment of No Option Refractory Disabling Angina We acquired the rights to data and regulatory filings for a CD34+ cell therapy program for refractory angina that had been advanced to Phase 3 by a previous sponsor. Based on the clinical evidence from the completed studies that a single administration of OLOGO™ reduces mortality, improves angina and increases exercise capacity in patients with otherwise untreatable angina, this product received Regenerative Medicine Advanced Therapy ("RMAT") designation from the FDA. Discussions with the FDA have resulted in a rejection of our efforts to reduce the FDA requirement of a 400-patient phase 3 study for registration (including an arm of 50 standard of care patients and an arm of 150 placebo patients), despite data showing that the NORDA population is orphan in size. Because enrollment of a study of this magnitude and design is projected to take many years, if executable at all, we have decided not to pursue a phase 3 program for OLOGO on our own but will continue to seek a partner to execute the study. Additional Out-licensing Opportunities Our broad intellectual property portfolio of cell therapy assets includes notable programs available for out-licensing in order to continue their clinical development. Our current long-term strategy focuses on advancing our therapies through development with the ultimate objective of obtaining market authorizations and entering commercialization, either alone or with partners, to provide treatment options to patients suffering from life-threatening medical conditions. We believe that we are well-positioned to realize potentially meaningful value increases within our own proprietary pipeline if we are successful in advancing our product candidates to their next significant development milestones. --------------------------------------------------------------------------------
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Coronavirus Considerations InDecember 2019 , a novel strain of coronavirus (SARS-CoV-2), which causes COVID-19, was reported to have surfaced inChina . InMarch 2020 , theWorld Health Organization declared the outbreak of COVID-19 to be a pandemic, and the world's economies began to experience pronounced effects. Despite the FDA approval of multiple COVID-19 vaccines in late 2020, there remains uncertainty around the extent and duration of disruption and any future related financial impact cannot reasonably be estimated at this time. In response to the COVID-19 pandemic, we have implemented universal work from home as well as stringent social distancing and other hygiene policies for employees when they must be in the office. Our clinical study of HONEDRA® inJapan has experienced significant delays in enrollment due to the "State of Emergency" in effect inJapan for most of 2020 and reimplemented inJapan onJanuary 7, 2021 throughMarch 21, 2021 coveringTokyo and other regions in response to an increased number of COVID-19 patients. Due to reported large increases in COVID-19 cases and a low rate of vaccinations inJapan , a "State of Emergency" was renewed onApril 25, 2021 throughMay 11, 2021 and then reimplemented inTokyo fromJuly 12, 2021 throughAugust 22, 2021 . This newly reinstated "State of Emergency" continues negatively to impact enrollment of the ongoing clinical trial. Results of Operations
Three Months Ended
Overall, net losses were$5.7 million for the three months endedJune 30, 2021 , compared to net income of$6.6 million for the three months endedJune 30, 2020 . Operating Expenses For the three months endedJune 30, 2021 , operating expenses totaled$7.1 million , compared to$4.3 million for the three months endedJune 30, 2020 , representing an increase of 67%. Operating expenses comprised the following: •Research and development expenses were approximately$4.3 million for the three months endedJune 30, 2021 , compared to$1.8 million for the three months endedJune 30, 2020 , representing an increase of$2.5 million or 138%. This increase was primarily due to an increase in expenses associated with the enrollment of our CLBS16 Phase 2b study (the FREEDOM Trial). Research and development in both periods focused on the advancement of our ischemic repair platform and related to: •expenses associated with our CLBS16 Phase 2b study (the FREEDOM Trial) which commenced in the fourth quarter of 2020 with the first patient in the study treated inJanuary 2021 ; •ongoing registration-eligible study expenses for HONEDRA® in critical limb ischemia inJapan , whereby we continue to focus spending on our patient enrollment. We have experienced significant delays in enrollment in that study due to the "State of Emergency" in effect inJapan for most of 2020 and reimplemented inJapan onJanuary 7, 2021 throughMarch 21, 2021 coveringTokyo and other regions in response to increased number of COVID-19 patients as well as a severe shortage of beds in intensive care units (and other hospital beds) affecting all of our clinical sites. Due to reported large increases in COVID-19 cases and a low rate of vaccinations inJapan , a "State of Emergency" was renewed onApril 25, 2021 throughMay 11, 2021 and then reimplemented inTokyo fromJuly 12, 2021 throughAugust 22, 2021 . This newly reinstated "State of Emergency" continues negatively to impact enrollment of the on-going clinical trial due to the increased number of COVID-19 patients as well as a severe shortage of beds in intensive care units (and other hospital beds) affecting all of our clinical sites. We continue to make progress towards study completion; and •expenses associated with the preparation of our filing of an IND for the clinical study of CLBS201 for treatment of diabetic kidney disease. A Phase 2 proof of concept, randomized, placebo-controlled study is planned for initiation in the second half of 2021. •General and administrative expenses were approximately$2.8 million for the three months endedJune 30, 2021 , compared to$2.5 million for the three months endedJune 30, 2020 , representing an increase of 14%. This increase was primarily due to an increase in Directors and Officers insurance premiums and strategic consulting expenses. Our general and administrative expenses focus on general corporate-related activities. Historically, to minimize our use of cash, we have used a variety of equity and equity-linked instruments to compensate employees, consultants and other service providers. The use of these instruments has resulted in charges to the results of operations, which have been significant in the past. --------------------------------------------------------------------------------
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Other Income (Expense) Total other income (expense) is comprised of investment income on cash, cash equivalents and marketable securities and a loss on sale of$0.1 million related to the sale of ourNew Jersey net operating losses ("NJ NOLs"). Income Tax Benefit InApril 2020 , we received final approval from theNew Jersey Economic Development Authority ("NJEDA") under the Technology Business Tax Certificate Transfer Program ("Program") to sell a percentage of our NJ NOLs. We subsequently sold a portion of our NJ NOLs to a qualifying and approved buyer pursuant to the Program for net proceeds of$10.9 million . InApril 2021 , we received final approval from the NJEDA under the Program to sell a portion of our NJ NOLs, which were subsequently sold to a qualifying and approved buyer pursuant to the Program for net proceeds of$1.4 million . The$1.5 million of our NJ NOL related tax benefits ("NJ NOL Tax Benefits") have been recorded as a benefit from income taxes and the loss on sale of$0.1 million recorded in other income (expense). Six Months EndedJune 30, 2021 Compared to Six Months EndedJune 30, 2020 Overall, net losses were$13.7 million for the six months endedJune 30, 2021 , compared to net income of$2.6 million for the six months endedJune 30, 2020 . Operating Expenses For the six months endedJune 30, 2021 , operating expenses totaled$15.2 million compared to$8.3 million for the six months endedJune 30, 2020 , representing an increase of 82%. Operating expenses comprised the following: •Research and development expenses were approximately$9.4 million for the six months endedJune 30, 2021 , compared to$3.3 million for the six months endedJune 30, 2020 , representing an increase of$6.1 million or 184%. This increase was primarily due to an increase in expenses associated with the enrollment of our CLBS16 Phase 2b study (the FREEDOM Trial). Research and development in both periods focused on the advancement of our ischemic repair platform and related to: •expenses associated with our CLBS16 Phase 2b study (the FREEDOM Trial) which commenced in the fourth quarter of 2020 with the first patient in the study treated inJanuary 2021 ; •ongoing registration-eligible study expenses for HONEDRA® in critical limb ischemia inJapan , whereby we continue to focus spending on our patient enrollment. We have experienced significant delays in enrollment in that study due to the "State of Emergency" in effect inJapan for most of 2020 and reimplemented inJapan onJanuary 7, 2021 throughMarch 21, 2021 coveringTokyo and other regions in response to increased number of COVID-19 patients as well as a severe shortage of beds in intensive care units (and other hospital beds) affecting all of our clinical sites. Due to reported large increases in COVID-19 cases and a low rate of vaccinations inJapan , a "State of Emergency" was renewed onApril 25, 2021 throughMay 11, 2021 and then reimplemented inTokyo fromJuly 12, 2021 throughAugust 22, 2021 . This newly reinstated "State of Emergency" continues negatively to impact enrollment of the on-going clinical trial due to the increased number of COVID-19 patients as well as a severe shortage of beds in intensive care units (and other hospital beds) affecting all of our clinical sites. We continue to make progress towards study completion; •expenses associated with the preparation of our filing of an IND for the clinical study of CLBS201 for treatment of diabetic kidney disease. A Phase 2 proof of concept, randomized, placebo-controlled study is planned for initiation in the second half of 2021. •General and administrative expenses were approximately$5.8 million for the six months endedJune 30, 2021 , compared to$5.0 million for the six months endedJune 30, 2020 , representing an increase of 16%. This increase was primarily due to an increase in Directors and Officers insurance premiums and strategic consulting expenses. Our general and administrative expenses focus on general corporate-related activities. Historically, to minimize our use of cash, we have used a variety of equity and equity-linked instruments to compensate employees, consultants and other service providers. The use of these instruments has resulted in charges to the results of operations, which have been significant in the past. --------------------------------------------------------------------------------
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Other Income (Expense) Total other income (expense) is comprised of investment income on cash, cash equivalents and marketable securities and a loss on sale of$0.1 million related to the sale of our NJ NOLs. Income Tax Benefit InApril 2020 , we received final approval from theNew Jersey Economic Development Authority ("NJEDA") under the Technology Business Tax Certificate Transfer Program ("Program") to sell a percentage of our NJ NOLs. We subsequently sold a portion of our NJ NOLs to a qualifying and approved buyer pursuant to the Program for net proceeds of$10.9 million . InApril 2021 , we received final approval from the NJEDA under the Program to sell a portion of our NJ NOLs, which were subsequently sold to a qualifying and approved buyer pursuant to the Program for net proceeds of$1.4 million . The$1.5 million of our NJ NOL Tax Benefits have been recorded as a benefit from income taxes and the loss on sale of$0.1 million recorded in other income (expense).
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Analysis of Liquidity and Capital Resources As ofJune 30, 2021 , we had cash, cash equivalents and marketable securities of approximately$106.1 million , working capital of approximately$104.2 million , and stockholders' equity of approximately$104.9 million . During the six months endedJune 30, 2021 , we met our immediate cash requirements through existing cash balances. Additionally, we used equity and equity-linked instruments to pay for services and compensation. Net cash used in or provided by, operating, investing and financing activities were as follows (in thousands): Six
Months Ended
2021 2020 Net cash (used in) provided by operating activities $ (12,602)$ 262 Net cash (used in) provided by investing activities (76,294) 2,855 Net cash provided by financing activities 85,319 9,535 Operating Activities Our cash used in operating activities during the six months endedJune 30, 2021 was$12.6 million , which is comprised of (i) our net loss of$13.7 million , adjusted for non-cash expenses totaling$2.0 million (which includes adjustments for equity-based compensation, depreciation and amortization, and amortization/accretion of marketable securities), and (ii) changes in operating assets and liabilities using approximately$0.9 million . Our cash provided by operating activities during the six months endedJune 30, 2020 was$0.3 million , which is comprised of (i) our net income of$2.6 million , adjusted for non-cash expenses totaling$0.9 million (which includes adjustments for equity-based compensation, depreciation and amortization, and amortization/accretion of marketable securities), and (ii) changes in operating assets and liabilities using approximately$3.3 million . Investing Activities Our cash used in investing activities during the six months endedJune 30, 2021 totaled$76.3 million and was primarily due to net purchases of marketable securities (net of sales of marketable securities). Our cash provided by investing activities during the six months endedJune 30, 2020 totaled$2.9 million and was primarily due to net proceeds from sales of marketable securities (net of purchases of marketable securities). Financing Activities Our cash provided by financing activities during the six months endedJune 30, 2021 primarily consisted of (i) net proceeds of$23.1 million through the issuance of common shares and warrants in ourJanuary 2021 private placement, (ii) net proceeds of$1.8 million in connection with warrant exercises, (iii) net proceeds of$60.6 million through the issuance of common shares and warrants in both of ourFebruary 2021 registered direct offerings, which was partially offset by tax withholding-related payments on net share settlement equity awards to employees. Our cash provided by financing activities during the six months endedJune 30, 2020 primarily consisted of (i) net proceeds of$4.5 million through the issuance of common shares and warrants in ourApril 2020 registered direct offering, (ii) net proceeds of$3.8 million through the issuance of common shares and warrants in ourMay 2020 registered direct offering, and (iii) net proceeds of$1.3 million through the issuance of common shares under our common stock sales agreement withH.C. Wainwright , which was partially offset by tax withholding-related payments on net share settlement equity awards to employees. Liquidity and Capital Requirements Outlook To meet our short and long-term liquidity needs, we expect to use existing cash balances and a variety of other means. Other sources of liquidity could include additional potential issuances of debt or equity securities in public or private financings, partnerships and/or collaborations and/or sale of assets. Our history of operating losses and liquidity challenges may make it difficult for us to raise capital on acceptable terms or at all. The demand for the equity and debt of biopharmaceutical companies like ours is dependent upon many factors, including the general state of the financial markets. During times of extreme market volatility, capital may not be available on favorable terms, if at all. Our inability to obtain such additional capital could materially and adversely affect our business operations. We will also continue to seek, as appropriate, grants for scientific and clinical studies from various governmental agencies and foundations, and other sources of non-dilutive funding. --------------------------------------------------------------------------------
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We believe that our cash on hand will enable us to fund operating expenses for at least the next 12 months following the issuance of our financial statements. OnJune 4, 2021 , the Company entered into an At The Market Offering Agreement (the "ATM Agreement") withH.C. Wainwright & Co., LLC ("HCW"), as sales agent, in connection with an "at the market offering" under which the Company from time to time may offer and sell shares of its common stock, having an aggregate offering price of up to$50.0 million . As ofJune 30, 2021 , the Company had not issued any shares under the ATM Agreement. InFebruary 2021 , the Company received preliminary approval from the NJEDA to participate in the Program. The Program permits qualified companies to sell a percentage of their NJ NOLs to unrelated profitable corporations. OnApril 12, 2021 , the Company received final approval from NJEDA to sell$1.5 million of its NJ NOLs, which was subsequently sold to a qualifying and approved buyer pursuant to the Program for net proceeds of$1.4 million . InFebruary 2021 , we entered into a Securities Purchase Agreement (the "Institutional Purchase Agreement") with certain institutional investors (the "Institutional Purchasers"). Pursuant to the terms of the Institutional Purchase Agreement, we sold to the Institutional Purchasers in a registered direct offering an aggregate of 24,906,134 shares of our common stock and warrants to purchase an aggregate of 12,453,067 shares of our common stock at a combined purchase price equal to$2.45 per share and associated warrant. Each warrant features an exercise price equal to$2.90 per share, is exercisable immediately upon issuance and will expire five years from the issuance date. Additionally, in a concurrent non-brokered registered direct offering, we entered into a Securities Purchase Agreement (the "Additional Purchase Agreement") with certain accredited investors (the "Additional Purchasers"). Pursuant to the terms of the Additional Purchase Agreement, we sold to the Additional Purchasers an aggregate of 1,632,652 shares of our common stock and warrants to purchase an aggregate of 816,326 shares of our common stock at a combined purchase price equal to$2.45 per share and associated warrant. Each warrant features an exercise price equal to$2.90 per share, is exercisable immediately upon issuance and will expire five years from the issuance date. The closing of the offerings occurred onFebruary 17, 2021 . In connection with the registered direct offerings, we received gross proceeds of approximately$65.0 million . OnFebruary 12, 2021 , we suspended the use of the at-the-market transactions facility (the "ATM") and terminated the continuous offering pursuant to the Common Stock Sales Agreement ("Sales Agreement") entered into inFebruary 2018 with HCW. As of termination date ofFebruary 12, 2021 , we had sold an aggregate of 3,784,912 shares of our common stock pursuant to the Sales Agreement for aggregate gross proceeds of$9.5 million . InJanuary 2021 , we entered into a Securities Purchase Agreement (the "January Purchase Agreement") with certain institutional and accredited investors (the "January Purchasers"), pursuant to which the Company issued and sold to the January Purchasers in a private placement an aggregate of (i) 12,500,000 shares of common stock, and (ii) warrants exercisable for up to an aggregate of 6,250,000 shares of common stock at a combined offering price of$2.00 per share of common stock and associated warrant. The warrants have an exercise price of$2.90 per share. Each warrant will be immediately exercisable and will expire five and one-half years from the issuance date. The closing of the offering occurred onJanuary 25, 2021 . We received gross proceeds of$25.0 million in connection with the private placement, before deducting placement agent fees and related offering expenses. InMarch 2019 , we andLincoln Park Capital Fund, LLC ("Lincoln Park") entered into a purchase agreement (the "Purchase Agreement") and a registration rights agreement (the "Registration Rights Agreement"), pursuant to which we have the right to sell to Lincoln Park shares of our common stock having an aggregate value of up to$26.0 million , subject to certain limitations and conditions set forth in the Purchase Agreement (the "Offering"). As consideration for entering into the Purchase Agreement, we issued to Lincoln Park an additional 181,510 shares of common stock as commitment shares. Pursuant to the Purchase Agreement, Lincoln Park purchased 250,000 shares of common stock, at a price of$4.00 per share, for a total gross purchase price of$1.0 million (the "Initial Purchase") upon commencement. Thereafter, as often as every business day from and after one business day following the date of the Initial Purchase and over the 36-month term of the Purchase Agreement, we have the right, from time to time, at our sole discretion and subject to certain conditions, to direct Lincoln Park to purchase up to 100,000 shares of common stock, with such amount increasing as the closing sale price of the common stock increases; provided Lincoln Park's obligation under any single such purchase will not exceed$2,500,000 , unless we and Lincoln Park mutually agree to increase the maximum amount of such single purchase (each, a "Regular Purchase"). If we direct Lincoln Park to purchase the maximum number of shares of common stock it then may sell in a Regular Purchase, then in addition to such Regular Purchase, and subject to certain conditions and limitations in the Purchase Agreement, we may direct Lincoln Park in an "accelerated purchase" to purchase an additional amount of common stock that may not exceed the lesser of (i) 300% the number of shares purchased pursuant to the corresponding Regular Purchase or (ii) 30% of the total number of shares of our common stock traded during a specified period on the applicable purchase date as set forth in the Purchase Agreement. Under certain circumstances and in accordance with the Purchase Agreement, we may direct Lincoln Park to purchase shares in multiple accelerated purchases on the same trading day. As ofJune 30, 2021 , we had not made any sales of common stock to Lincoln Park under the Purchase Agreement other than the Initial Purchase. --------------------------------------------------------------------------------
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While we continue to seek capital through a number of means, there can be no assurance that additional financing will be available on acceptable terms, if at all, and our negotiating position in capital generating efforts may worsen as existing resources are used. Additional equity financing may be dilutive to our stockholders; debt financing, if available, may involve significant cash payment obligations and covenants that restrict our ability to operate as a business; our stock price may not reach levels necessary to induce option or warrant exercises; and asset sales may not be possible on terms we consider acceptable. If we are unable to access capital necessary to meet our long-term liquidity needs, we may have to delay the expansion of our business or raise funds on terms that we currently consider unfavorable.
Seasonality
We do not believe that our operations are seasonal in nature. Off-Balance Sheet Arrangements We do not have any off-balance sheet arrangements. Critical Accounting Policies and Estimates There have been no material changes in our critical accounting policies and estimates during the three and six months endedJune 30, 2021 , compared to those reported in our 2020 Form 10-K.
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