What changed in this filing

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Item 1. Financial Statements

2021-11-04 compared with 2021-08-05 · 109 added, 112 removed, 390 unchanged (36% of the section changed)

4 unchanged sentences

(In thousands, except share data)

September 30,

2021 December 31,

20 unchanged sentences

825,000 shares designated;

issued and outstanding, 10,000 shares at June 30,

2021 and December 31, 2020, respectively

issued and outstanding, 10,000 shares at

September 30, 2021 and December 31, 2020, respectively

Common stock, $ 0.001 par value, authorized 500,000,000 shares;

issued 59,790,935

and 19,389,413 shares at June 30, 2021 and December 31, 2020, respectively;

and outstanding,

59,517,458 and 19,378,333 shares at June 30, 2021 and December 31, 2020, respectively

and 19,389,413 shares at September 30, 2021 and December 31, 2020, respectively;

outstanding, 59,779,855 and 19,378,333 shares at September 30, 2021 and December 31, 2020,

Additional paid-in capital 545,601 458,748

Treasury stock, at cost;

11,080 shares at June 30, 2021 and December 31, 2020

11,080 shares at September 30, 2021 and December 31, 2020

( 708 ) ( 708 )

11 unchanged sentences

(In thousands, except per share data)

Three Months Ended June 30, Six Months Ended June 30,

Three Months Ended September 30, Nine Months Ended September 30,

2021 2020 2021 2020

7 unchanged sentences

Other expense, net — — ( 90 ) —

Total other (expense) income ( 43 ) 22 ( 20 ) 93

Total other income (expense) 41 25 21 118

Net loss before benefit from income taxes and noncontrolling interests ( 6,927 ) ( 5,325 ) ( 22,180 ) ( 13,581 )

Benefit from income taxes — — ( 1,508 ) ( 10,872 )

Net (loss) income $ ( 5,682 ) $ 6,602 $ ( 13,745 ) $ 2,616

Net loss $ ( 6,927 ) $ ( 5,325 ) $ ( 20,672 ) $ ( 2,709 )

Less - net income attributable to noncontrolling interests

Net (loss) income attributable to Caladrius Biosciences, Inc.

Net loss attributable to Caladrius Biosciences, Inc.

common stockholders $ ( 6,927 ) $ ( 5,327 ) $ ( 20,672 ) $ ( 2,719 )

Basic and diluted (loss) income per share

Basic and diluted loss per share

Caladrius Biosciences, Inc.

9 unchanged sentences

(In thousands)

Three Months Ended June 30, Six Months Ended June 30,

Three Months Ended September 30, Nine Months Ended September 30,

2021 2020 2021 2020

Net (loss) income $ ( 5,682 ) $ 6,602 $ ( 13,745 ) $ 2,616

Net loss $ ( 6,927 ) $ ( 5,325 ) $ ( 20,672 ) $ ( 2,709 )

Other comprehensive loss:

1 unchanged sentence

Total other comprehensive loss ( 47 ) ( 14 ) ( 51 ) ( 14 )

Comprehensive (loss) income ( 5,686 ) 6,593 ( 13,749 ) 2,607

Comprehensive loss ( 6,974 ) ( 5,339 ) ( 20,723 ) ( 2,723 )

Comprehensive income attributable to noncontrolling interests — 2 — 10

Comprehensive (loss) income attributable to Caladrius Biosciences, Inc.

Comprehensive loss attributable to Caladrius Biosciences, Inc.

common stockholders

15 unchanged sentences

Shares Amount Shares Amount

Balance at March 31, 2021 10 $ — 59,510 $ 60 $ 544,601 $ ( 72 ) $ ( 433,613 ) $ ( 708 ) $ 110,268 $ ( 254 ) $ 110,014

Balance at June 30, 2021 10 $ — 59,529 $ 60 $ 544,893 $ ( 17 ) $ ( 439,295 ) $ ( 708 ) $ 104,933 $ ( 254 ) $ 104,679

Net loss — — — — — — ( 6,927 ) — ( 6,927 ) — ( 6,927 )

Unrealized gain on marketable securities — — — — — 55 — — 55 — 55

Unrealized loss on marketable securities — — — — — ( 47 ) — — ( 47 ) — ( 47 )

Share-based compensation — — 262 — 708 — — — 708 — 708

Net proceeds from issuance of common stock — 19 — 22 — — — 22 — 22

Balance at June 30, 2021 10 $ — 59,529 $ 60 $ 544,893 $ ( 17 ) $ ( 439,295 ) $ ( 708 ) $ 104,933 $ ( 254 ) $ 104,679

Balance at September 30, 2021 10 $ — 59,791 $ 60 $ 545,601 $ ( 64 ) $ ( 446,222 ) $ ( 708 ) $ 98,667 $ ( 254 ) $ 98,413

Series B Convertible

14 unchanged sentences

Proceeds from option exercises — — 7 — 24 — — — 24 — 24

Balance at June 30, 2021 10 $ — 59,529 $ 60 $ 544,893 $ ( 17 ) $ ( 439,295 ) $ ( 708 ) $ 104,933 $ ( 254 ) $ 104,679

Balance at September 30, 2021 10 $ — 59,791 $ 60 $ 545,601 $ ( 64 ) $ ( 446,222 ) $ ( 708 ) $ 98,667 $ ( 254 ) $ 98,413

Series B Convertible

8 unchanged sentences

Shares Amount Shares Amount

Balance at March 31, 2020 10 $ — 10,639 $ 11 $ 439,330 $ — $ ( 421,390 ) $ ( 708 ) $ 17,243 $ ( 259 ) $ 16,984

Net income — — — — — — 6,598 — 6,598 4 6,602

Balance at June 30, 2020 10 $ — 15,585 $ 16 $ 449,302 $ ( 7 ) $ ( 414,792 ) $ ( 708 ) $ 33,811 $ ( 255 ) $ 33,556

Net loss — — — — — — ( 5,327 ) — ( 5,327 ) 2 ( 5,325 )

Unrealized loss on marketable securities — — — — — ( 5 ) — — ( 5 ) — ( 5 )

1 unchanged sentence

Net proceeds from issuances of common stock and warrants — — 3,847 3 9,029 — — — 9,032 — 9,032

Balance at June 30, 2020 10 $ — 15,585 $ 16 $ 449,302 $ ( 7 ) $ ( 414,792 ) $ ( 708 ) $ 33,811 $ ( 255 ) $ 33,556

Balance at September 30, 2020 10 $ — 19,407 $ 19 $ 458,560 $ ( 12 ) $ ( 420,119 ) $ ( 708 ) $ 37,740 $ ( 253 ) $ 37,487

Series B Convertible

9 unchanged sentences

Balance at December 31, 2019 10 $ — 10,529 $ 11 $ 438,911 $ 2 $ ( 417,400 ) $ ( 708 ) $ 20,816 $ ( 263 ) $ 20,553

Net income — — — — — — 2,608 — 2,608 8 2,616

Net loss — — — — — — ( 2,719 ) — ( 2,719 ) 10 ( 2,709 )

Unrealized loss on marketable securities — — — — — ( 14 ) — — ( 14 ) — ( 14 )

1 unchanged sentence

Net proceeds from issuances of common stock and warrants — — 8,797 8 18,707 — — — 18,715 — 18,715

Balance at Jun 30, 2020 10 $ — 15,585 $ 16 $ 449,302 $ ( 7 ) $ ( 414,792 ) $ ( 708 ) $ 33,811 $ ( 255 ) $ 33,556

Balance at September 30, 2020 10 $ — 19,407 $ 19 $ 458,560 $ ( 12 ) $ ( 420,119 ) $ ( 708 ) $ 37,740 $ ( 253 ) $ 37,487

See accompanying notes to consolidated financial statements.

3 unchanged sentences

(In thousands)

Six Months Ended June 30,

Nine Months Ended September 30,

Cash flows from operating activities:

Net (loss) income $ ( 13,745 ) $ 2,616

Net loss $ ( 20,672 ) $ ( 2,709 )

Adjustments to reconcile net loss to net cash used in operating activities:

6 unchanged sentences

Accounts payable, accrued liabilities and other liabilities 367 ( 2,068 )

Net cash (used in) provided by operating activities ( 12,602 ) 262

Net cash used in operating activities ( 17,641 ) ( 3,256 )

Cash flows from investing activities:

2 unchanged sentences

Purchase of property and equipment ( 60 ) ( 14 )

Net cash (used in) provided by investing activities ( 76,294 ) 2,855

Net cash used in investing activities ( 71,354 ) ( 8,187 )

Cash flows from financing activities:

12 unchanged sentences

Caladrius 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.

The Company is developing first-in-class therapeutics based on the characteristics of naturally occurring CD34+ cells and their ability to stimulate the growth of new microvasculature.

Its technology leverages these cells to enable the body's natural repair mechanisms using formulations unique to each medical indication.

(“we,” “us,” "our," “Caladrius” or the “Company”) is a clinical-stage biopharmaceutical company dedicated to the development of treatments and reversal of severe diseases.

The Company is developing what are intended to be first-in-class therapeutics based on the characteristics of naturally occurring CD34+ cells and their ability to stimulate the growth of new microvasculature.

Its technology is intended to leverage these cells to enable the body's natural repair mechanisms using formulations unique to each medical indication.

The Company's leadership team has decades of collective biopharmaceutical development experience.

1 unchanged sentence

The Company’s 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 in the United States for the treatment of coronary microvascular dysfunction (“CMD”);

• HONEDRA ® (CLBS12), recipient of SAKIGAKE designation and eligible for early conditional approval in Japan for the treatment of critical limb ischemia (“CLI”) and Buerger’s disease based on the results of an ongoing clinical trial.

CLBS12 was the recipient of orphan drug designation in March 2021 from the U.S.

• XOWNA ® (CLBS16), the subject of both a recently completed positive Phase 2a study (ESCaPE-CMD) and a newly initiated Phase 2b (FREEDOM Trial) study in the United States for the treatment of coronary microvascular dysfunction (“CMD”);

Additionally, CLBS12 was the recipient of orphan drug designation in March 2021 from the U.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”);

• OLOGO ™ (CLBS14), a Regenerative Medicine Advanced Therapy (“RMAT”) designated Phase 3 ready therapy for treatment of no-option refractory disabling angina (“NORDA”).

• CLBS201, designed to assess the safety and efficacy of CD34+ cell therapy as a treatment for patients with chronic kidney disease related to type 2 diabetes (diabetic kidney disease or “DKD”).

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.

The CD34+ cell was discovered as a result of the deliberate search for a 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.

A CD34+ cell is an endothelial progenitor 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.

2 unchanged sentences

Through the administration of CD34+ cells, the Company seeks to promote the development and formation of new microvasculature and thereby increase blood flow to the impacted area.

The Company believes 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

The Company's randomized and open-label, registration-eligible study of HONEDRA ® in Japan for the treatment of CLI has shown positive results to date.

The initial responses observed in the subjects who 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 in Japan.

The study's enrollment continues to be curtailed by the COVID-19 pandemic's impact in Japan;

however, the Company is encouraged by the patient pre-screening pipeline and, despite the continually extending States of Emergency in Japan 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 in Japan.

CLBS16 for Treatment of Coronary Microvascular Dysfunction

In 2017, with the assistance of a $ 1.9 million grant from the National Institutes of Health (Award Number R44HL135889), the Company initiated its 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 the Mayo Clinic in Rochester, MN and Cedars-Sinai Medical Center in Los 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.

XOWNA ® for Treatment of Coronary Microvascular Dysfunction

In 2017, with the assistance of a $ 1.9 million grant from the National Institutes of Health (Award Number R44HL135889), the Company initiated its program for XOWNA ® for the treatment of CMD, a disease that afflicts as many as 1.5 million patients in the U.S.

alone, with no current targeted treatment options.

That study, the ESCaPE-CMD Trial, was a Phase 2a proof-of-concept open label study that enrolled patients at the Mayo Clinic in Rochester, MN and Cedars-Sinai Medical Center in Los Angeles, CA.

Those 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 2020 Scientific Sessions Virtual Conference on May 14, 2020 by Dr.

Timothy Henry, FACC, of the Christ Hospital in Cincinnati, Ohio.

In December 2020, the Company commenced enrollment in its Phase 2b FREEDOM Trial of CLBS16 as a therapy for CMD.

The first patient in the study was subsequently treated in January 2021 at The Christ Hospital Health Network in Cincinnati, 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 the Company's 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 throughout the United States, has contributed to a general slowing of enrollment.

Further work with investigators and subject feedback also led the Company 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, the Company now projects enrollment completion for the FREEDOM Trial to occur in the third quarter of 2022 with final data (based on the 6 month assessment of all subjects) expected by the second quarter of 2023.

In December 2020, the Company commenced enrollment in its Phase 2b FREEDOM Trial of XOWNA ® , a double-blind, randomized and placebo-controlled clinical trial 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.

While early enrollment proceeded to plan with the first patient treated in January 2021, the impact of the COVID-19 pandemic contributed to a general slowing of enrollment.

Protocol amendments to the initial FREEDOM Trial protocol, as agreed to by the FDA, were implemented with the goal of enhancing breadth and speed of subject enrollment.

Actual improvement in enrollment rate will be assessed during the fourth quarter of 2021.

As part of program optimization, the Company convened an advisory board meeting of key opinion leaders in the fields

of cardiology, drug development, and payer access and reimbursement in mid-October 2021 with the objective of assuring the most efficient and effective development program for XOWNA ® .

CLBS201 for Treatment of Diabetic Kidney Disease

The Company has 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.

The Company is 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

The Company 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 the Company's 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, the Company has decided not to pursue a phase 3 program for OLOGO on its own but will continue to seek a partner to execute the study.

Based on these observations, the Company proposed an initial development plan for CLBS201 contemplating an adaptive design.

However, after multiple conversations with key opinion leaders in the fields of nephrology and drug development, the Company has elected to move forward with a Phase 1, open-label, proof-of-concept trial evaluating CLBS201 dosed via intra-renal artery injections in subjects with DKD.

This new protocol, pending approval of the Institutional Review Board (the "IRB"), is expected to include six subjects in total with the first two subjects sequentially dosed and followed for a two-week safety observation period.

Clearance by the independent Data Safety Monitoring Board overseeing the study will then permit the treatment of the next four patients, with all patients being followed for safety and therapeutic effect.

A key read-out of data will occur at the six-month follow-up visit for all patients.

The Company projects enrollment of this study will begin in the first quarter of 2022.

A key criterion for continued development of CLBS201 will be its ability to demonstrate a therapeutic effect that will make it competitive in the field of DKD treatment, i.e., kidney function regeneration, as indicated by increased glomerular filtration rate.

HONEDRA ® for Treatment of Critical Limb Ischemia

The Company's randomized, open-label, registration-eligible study of HONEDRA ® in Japan for the treatment of CLI and Buerger's disease continues to demonstrate positive trends in both safety and efficacy.

These data remain consistent with the efficacy and safety from previously published clinical trials in Japan.

The HONEDRA ® study's enrollment, however, has been significantly curtailed by the COVID-19 pandemic's impact in Japan, including the States of Emergency in Japan that have persisted for much of the past 18 months.

Due to the significant and continued operational and financial burden incurred as a result of these COVID-19 delays, coupled with the unpredictability of the timing of site enrollment re-initiation, the Company is suspending further enrollment and focusing its efforts on consummating a partnership with a Japanese company that could complete the study enrollment of the three remaining no-option CLI subjects and/or explore the possibility of submitting the existing data to Japan's Pharmaceuticals and Medical Devices Agency ("PMDA") under the SAKIGAKE designation, which allows for accelerated approval of innovative medical products.

Also, as previously noted, in March 2021 CLBS12 was awarded an orphan designation in the U.S.

by FDA as a potential treatment for Buerger's disease.

However, based on a recent response from the FDA regarding a development plan for U.S.

registration, the Company has decided not to pursue U.S.

development in Buerger's disease at this time.

Additional Out-licensing Opportunities

5 unchanged sentences

In March 2020, the World 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.

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, the Company has implemented universal work from home as well as stringent social distancing and other hygiene policies for employees when they must be in the office.

The Company's clinical study of HONEDRA ® in Japan has experienced significant delays in enrollment due to the “State of Emergency” in effect in Japan for most of 2020 and reimplemented in Japan on January 7, 2021 through March 21, 2021 covering Tokyo and other regions in response to an increased number of COVID-19 patients.

Due to reported increases in COVID-19 cases and a low rate of vaccination in Japan, a "State of Emergency" was renewed on April 25, 2021 through May 11, 2021 and then reimplemented in Tokyo from July 12, 2021 through August 22, 2021.

This newly reinstated “State of Emergency” continues negatively to impact enrollment of the ongoing clinical trial.

Due to reported increases in COVID-19 cases and a low rate of vaccination in Japan, a "State of Emergency" was renewed on April 25, 2021 through May 11, 2021 and then

reimplemented in Tokyo from July 12, 2021 through September 30, 2021.

We expect that COVID-19 in Japan will continue to negatively impact enrollment of the HONEDRA ® clinical trial.

Basis of Presentation

1 unchanged sentence

Accordingly, they do not include all of the information and footnotes required by generally accepted accounting principles for complete financial statements.

In the opinion of management, the accompanying Consolidated Financial Statements of the Company and its subsidiaries, which are unaudited, include all normal and recurring adjustments considered necessary to present fairly the Company’s financial position as of June 30, 2021, and the results of its operations and its cash flows for the periods presented.

In the opinion of management, the accompanying Consolidated Financial Statements of the Company and its subsidiaries, which are unaudited, include all normal and recurring adjustments considered necessary to present fairly the Company’s financial position as of September 30, 2021, and the results of its operations and its cash flows for the periods presented.

The unaudited consolidated financial statements herein should be read together with the historical consolidated financial statements of the Company for the years ended December 31, 2020 and 2019 included in our 2020 Form 10-K.

Operating results for the three and six months ended June 30, 2021 are not necessarily indicative of the results that may be expected for the year ending December 31, 2021.

Operating results for the three and nine months ended September 30, 2021 are not necessarily indicative of the results that may be expected for the year ending December 31, 2021.

Use of Estimates

10 unchanged sentences

In addition to the policies below, the Company's significant accounting policies are described in Note 2 of the Notes to Consolidated Financial Statements included in its 2020 Form 10-K.

There were no changes to these policies during the three and six months ended June 30, 2021.

There were no changes to these policies during the three and nine months ended September 30, 2021.

Concentration of Risks

9 unchanged sentences

For awards with performance-based vesting criteria, the Company estimates the probability of achievement of the performance criteria and recognizes compensation expense related to those awards expected to vest.

The Company determines the fair value of option awards using the Black-Scholes option-

pricing model which uses both historical and current market data to estimate the fair value.

This method incorporates various assumptions such as the risk-free interest rate, expected volatility, expected dividend yield and expected life of the options or warrants.

The Company determines the fair value of option awards using the Black-Scholes option-pricing model which uses both historical and current market data to estimate the fair value.

This method incorporates various assumptions such as the risk-free interest rate, expected volatility, expected dividend yield and expected life of the options or

The fair value of the Company’s restricted stock and restricted stock units is based on the closing market price of the Company’s common stock on the date of grant.

6 unchanged sentences

The following table is a summary of available-for-sale securities recorded in cash and cash equivalents or marketable securities in our Consolidated Balance Sheets (in thousands):

June 30, 2021 December 31, 2020

September 30, 2021 December 31, 2020

Cost Gross Unrealized Gains Gross Unrealized Losses Estimated Fair Value Cost Gross Unrealized Gains Gross Unrealized Losses Estimated Fair Value

5 unchanged sentences

The following table summarizes the classification of the available-for-sale securities in our Consolidated Balance Sheets (in thousands):

June 30, 2021 December 31, 2020

September 30, 2021 December 31, 2020

Cash equivalents $ 9,600 $ 12,676

2 unchanged sentences

The following table summarizes our portfolio of available-for-sale securities by contractual maturity (in thousands):

June 30, 2021

September 30, 2021

Amortized Cost Estimated Fair Value

3 unchanged sentences

Note 4 – Income (Loss) Per Share

For the three and six months ended June 30, 2021, the Company incurred net losses and therefore no common stock equivalents were utilized in the calculation of diluted loss per share as they are anti-dilutive.

For the three and six months ended June 30, 2020, the Company reported net income in each period.

However, no common stock equivalents were utilized in the calculation of diluted income per share since any conversion as of June 30, 2020 would have been anti-dilutive.

At June 30, 2021 and 2020, the Company excluded the following potentially dilutive securities (in thousands):

For the three and nine months ended September 30, 2021 and 2020, the Company incurred net losses and therefore no common stock equivalents were utilized in the calculation of diluted loss per share as they are anti-dilutive.

At September 30, 2021 and 2020, the Company excluded the following potentially dilutive securities (in thousands):

September 30,

Stock Options 2,142 1,105

9 unchanged sentences

The Company’s assessment of the significance of a particular input to the fair value measurement requires judgment and may affect the valuation of the fair value of assets and liabilities and their placement within the fair value hierarchy levels.

The following table sets forth by level within the fair value hierarchy the Company's financial assets that were accounted for at fair value on a recurring basis as of June 30, 2021 and December 31, 2020 (in thousands).

June 30, 2021 December 31, 2020

The following table sets forth by level within the fair value hierarchy the Company's financial assets that were accounted for at fair value on a recurring basis as of September 30, 2021 and December 31, 2020 (in thousands).

September 30, 2021 December 31, 2020

Level 1 Level 2 Level 3 Total Level 1 Level 2 Level 3 Total

2 unchanged sentences

Note 6 – Accrued Liabilities

Accrued liabilities as of June 30, 2021 and December 31, 2020 were as follows (in thousands):

June 30, 2021 December 31, 2020

Accrued liabilities as of September 30, 2021 and December 31, 2020 were as follows (in thousands):

September 30, 2021 December 31, 2020

Salaries, employee benefits and related taxes $ 1,811 $ 1,716

9 unchanged sentences

Operating lease liabilities and right-of-use assets were recorded in the following captions of our balance sheet were as follows (in thousands):

June 30, 2021 December 31, 2020

September 30, 2021 December 31, 2020

Right-of Use Assets:

5 unchanged sentences

Total Operating Lease Liabilities $ 350 $ 624

As of June 30, 2021, the weighted average remaining lease term for our operating leases was 1.3 years, and the weighted average discount rate for our operating leases was 9.625 %.

Future minimum lease payments under the lease agreements as of June 30, 2021 were as follows (in thousands):

As of September 30, 2021, the weighted average remaining lease term for our operating leases was 1.1 years, and the weighted average discount rate for our operating leases was 9.625 %.

Future minimum lease payments under the lease agreements as of September 30, 2021 were as follows (in thousands):

Years ended Operating Leases

18 unchanged sentences

The Company has the right to terminate the Purchase Agreement at any time, at no cost to the Company.

As of June 30, 2021, the Company had not made any sales of common stock to Lincoln Park under the Purchase Agreement other than the Initial Purchase.

As of September 30, 2021, the Company had not made any sales of common stock to Lincoln Park under the Purchase Agreement other than the Initial Purchase.

Common Stock Sales Agreement

4 unchanged sentences

As of the termination of the Sales Agreement on February 12, 2021, the Company had sold an aggregate of 3,784,912 shares of its common stock pursuant to the Sales Agreement for net proceeds of $ 9.5 million.

During the six months ended June 30, 2021, the Company had no t issued any shares under the Sales Agreement.

During the nine months ended September 30, 2021, the Company had no t issued any shares under the Sales Agreement.

At The Market Offering Agreement

On June 4, 2021, the Company entered into an At The Market Offering Agreement (the “ATM Agreement”) with 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.

During the three months ended June 30, 2021, the Company had no t issued any shares under the ATM Agreement.

During the nine months ended September 30, 2021, the Company had no t issued any shares under the ATM Agreement.

Registered Direct Offerings

15 unchanged sentences

Stock Options and Warrants

The following table summarizes the activity for stock options and warrants for the six months ended June 30, 2021:

The following table summarizes the activity for stock options and warrants for the nine months ended September 30, 2021:

Stock Options Warrants

6 unchanged sentences

Expired ( 109,549 ) 34.12 — —

Outstanding at June 30, 2021 1,005,209 $ 10.55 6.63 $ 5.1 21,356,600 $ 2.84 4.88 $ —

Vested at June 30, 2021

Outstanding at September 30, 2021 2,142,199 $ 5.63 8.26 $ — 21,356,600 $ 2.84 4.63 $ —

Vested at September 30, 2021

or expected to vest in the future 2,126,167 $ 5.65 8.26 $ — 21,356,600 $ 2.84 4.63 $ —

Vested at June 30, 2021 743,847 $ 13.31 5.82 $ 0.7 21,356,600 $ 2.84 4.88 $ —

Vested at September 30, 2021 1,122,583 $ 9.26 7.04 $ — 21,356,600 $ 2.84 4.63 $ —

Restricted Stock

During the six months ended June 30, 2021 and 2020, the Company issued restricted stock for services as follows ($ in thousands):

Six Months Ended June 30,

During the nine months ended September 30, 2021 and 2020, the Company issued restricted stock for services as follows ($ in thousands):

Nine Months Ended September 30,

Number of restricted stock issued 612,950 156,184

2 unchanged sentences

Restricted Stock Units

During the six months ended June 30, 2021 and 2020, the Company issued restricted stock units for services as follows ($ in thousands, except share data):

Six Months Ended June 30,

During the nine months ended September 30, 2021 and 2020, the Company issued restricted stock units for services as follows ($ in thousands, except share data):

Nine Months Ended September 30,

Number of restricted stock units issued 458,245 246,383

Value of restricted stock units issued $ 729 $ 743

The weighted average estimated fair value of restricted stock issued for services in the six months ended June 30, 2021 and 2020 was $ 1.59 and $ 3.19 per share, respectively.

The weighted average estimated fair value of restricted stock issued for services in the nine months ended September 30, 2021 and 2020 was $ 1.59 and $ 3.02 per share, respectively.

The fair value of the restricted stock units was determined using the Company’s closing stock price on the date of issuance.

3 unchanged sentences

We utilize share-based compensation in the form of stock options, restricted stock, and restricted stock units.

The following table summarizes the components of share-based compensation expense for the three and six months ended June 30, 2021 and 2020 (in thousands):

Three Months Ended June 30, Six Months Ended June 30,

The following table summarizes the components of share-based compensation expense for the three and nine months ended September 30, 2021 and 2020 (in thousands):

Three Months Ended September 30, Nine Months Ended September 30,

2021 2020 2021 2020

2 unchanged sentences

Total share-based compensation expense $ 773 $ 229 $ 1,639 $ 1,090

Total compensation cost related to non-vested awards not yet recognized and the weighted-average periods over which the awards were expected to be recognized at June 30, 2021 were as follows (in thousands):

Total compensation cost related to non-vested awards not yet recognized and the weighted-average periods over which the awards were expected to be recognized at September 30, 2021 were as follows (in thousands):

Stock Options Restricted Stock Units Restricted Stock

1 unchanged sentence

Expected weighted-average period in years of compensation cost to be recognized 1.82 1.23 1.88

Total fair value of shares vested and the weighted average estimated fair values of shares granted for the six months ended June 30, 2021 and 2020 were as follows (in thousands):

Total fair value of shares vested and the weighted average estimated fair values of shares granted for the nine months ended September 30, 2021 and 2020 were as follows (in thousands):

Stock Options

Six Months Ended June 30,

Nine Months Ended September 30,

Total fair value of shares vested $ 757 $ 535

12 unchanged sentences

The Company received $ 5.7 million in initial funding in May 2017, a $ 1.9 million milestone payment in December 2017, a $ 0.3 million progress payment in March 2018, and a $ 0.2 million progress payment in May 2019, of which the total was amortized over the estimated award period through July 2020 as a reduction to the related research and development expenses, with the final true up payment of $ 46 thousand received in September 2020 and recorded as a reduction to the related research and development expenses.

During the three and six months ended June 30, 2021 and June 30, 2020, the Company amortized and recognized $ 0.0 million and $ 0.7 million in credits, respectively, to research and development related to CIRM funds received.

During the three and nine months ended September 30, 2021, the Company amortized and recognized $ 0.0 million and $ 0.0 million in credits, respectively, to research and development related to CIRM funds received.

During the three and nine months ended September 30, 2020, the Company amortized and recognized $ 0.3 million and $ 1.6 million in credits, respectively, to research and development related to CIRM funds received.

Note 11 – Income Taxes

2 unchanged sentences

As of December 31, 2020, the Company had approximately $ 264 million of federal NOLs available to offset future taxable income expiring from 2030 through 2036.

As of December 31, 2020, the Company had State NOLs available in New Jersey of

$ 99 million, California of $ 70 million, and New York City of $ 13 million to offset future taxable income expiring from 2030 through 2040.

As of December 31, 2020, the Company had State NOLs available in New Jersey of $ 99 million, California of $ 70 million, and New York City of $ 13 million to offset future taxable income expiring from 2030 through 2040.

In accordance with Section 382 of the Internal Revenue code, the usage of the Company’s NOLs could be limited in the event of a change in ownership.

8 unchanged sentences

The Company recognizes interest and penalties associated with uncertain tax positions as a component of income tax expense.

As of June 30, 2021, management does not believe the Company has any material uncertain tax positions that would require it to measure and reflect the potential lack of sustainability of a position on audit in its financial statements.

As of September 30, 2021, management does not believe the Company has any material uncertain tax positions that would require it to measure and reflect the potential lack of sustainability of a position on audit in its financial statements.

The Company will continue to evaluate its uncertain tax positions in future periods to determine if measurement and recognition in its financial statements is necessary.

11 unchanged sentences

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-Q

Item 1. Financial Statements