What changed in this filing

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Item 1A. Risk Factors

2021-02-25 compared with 2020-03-05 · 57 added, 61 removed, 600 unchanged (16% of the section changed)

14 unchanged sentences

Our current operating plan will require significant levels of additional capital to fund the continued development of our cell therapy product candidates and our clinical development activities.

Our clinical activities are expected to continue to grow as our programs are advanced and they will require significant investment over a period of several years before they could potentially be approved by the FDA and commercialized by us, if ever.

Even if data from our current clinical trials for our product candidates were deemed positive, we may be required to conduct additional clinical trials of the product candidates, including larger and more expensive pivotal Phase 3 trials, to pursue commercialization of the candidates.

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To both fund our clinical trials and support our future operations, we would likely seek to raise capital through a variety of different public and/or private financings vehicles.

This could include, but not be limited to, utilization of our at-the-market ("ATM") sales agreement with H.C.

Wainwright & Co., equity sales pursuant to our purchase agreement with Lincoln Park Capital Fund, L.L.C., potential issuances of other debt or equity securities in public or private financings and/or sale or licensing of assets.

If we raise capital through the sale of equity, or securities convertible into equity, it will result in dilution to our

then-existing stockholders.

This could include, but not be limited to, equity sales pursuant to our purchase agreement with Lincoln Park Capital Fund, L.L.C., potential issuances of other debt or equity securities in public or private financings and/or sale or licensing of assets.

If we raise capital through the sale of equity, or securities convertible into

equity, it will result in dilution to our then-existing stockholders.

Servicing the interest and principal repayment obligations under debt we incur, or whether any such debt is called, would divert funds that might otherwise be available to support research and development, clinical or commercialization activities.

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Section 404(b) of the Sarbanes-Oxley Act of 2002 requires an independent registered public accounting firm to test the internal control over financial reporting of public companies, and to report on the effectiveness of such controls, for each fiscal year ending after June 15, 2010.

Under the Dodd Frank Wall Street Reform and Consumer Protection Act of 2010, we

are exempt from Section 404(b) as long as we remain a smaller reporting company or a non-accelerated filer.

Under the Dodd Frank Wall Street Reform and Consumer Protection Act of 2010, we are exempt from Section 404(b) as long as we remain a smaller reporting company or a non-accelerated filer.

If our status as a smaller reporting company changes, we may be required to comply with this auditor attestation requirement.

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RISKS RELATED TO OUR CELL THERAPY PRODUCT DEVELOPMENT EFFORTS

Our future success may be dependent on the timely and successful continued development and commercialization of CLBS12, our experimental product candidate for CLI that is in clinical development in Japan, CLBS16 for CMD and CLBS14 for NORDA, and if we encounter delays or further difficulties in the development of these product candidates, our business prospects would be significantly harmed.

Our future success may be dependent on the timely and successful continued development and commercialization of HONEDRA ® , our experimental product candidate for CLI and Buerger's Disease that is in clinical development in Japan, CLBS16 for CMD, CLBS201 for CKD and OLOGO TM for NORDA, and if we encounter delays or further difficulties in the development of these product candidates, our business prospects would be significantly harmed.

We are dependent upon the successful development, approval and commercialization of our product candidates.

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or international commercialization.

In early 2018, we treated the first patient in a clinical trial in Japan for CLBS12 for use in CLI taking advantage of the paradigm of potential conditional approval for regenerative medicine products established by new regulations in Japan for products that show sufficient safety evidence and some evidence of efficacy.

We also recently reported preliminary top-line data from the 6-month follow-up of patients in a clinical trial using CD34+ cells to treat CMD (CLBS16).

Additionally, we currently have an open IND for CLBS14, a program that is now poised to commence a single Phase 3 confirmatory trial for registration in the U.S.

In early 2018, we treated the first patient in a clinical trial in Japan for HONEDRA ® for use in CLI taking advantage of the paradigm of potential conditional approval for regenerative medicine products established by new regulations in Japan for products that show sufficient safety evidence and some evidence of efficacy.

We also recently reported complete data from the 6-month follow-up of patients in a clinical trial (ESCaPE-CMD) using CD34+ cells to treat CMD (CLBS16).

Additionally, we currently have an open IND for OLOGO TM , a program for which discussions continue with FDA to define phase 3 trial size and scope for registration in the U.S.

in patients with NORDA.

Actual initiation of that trial is contingent upon the acquisition of sufficient funding to give us confidence that we could complete the trial uninterrupted.

Clinical testing is expensive, difficult to design and implement, and can take many years to complete.

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Clinical trial delays could also shorten any periods during which our products have patent protection and may allow our competitors to bring products to market before we do, which could impair our ability to successfully commercialize our product candidates and may harm our business and results of operations.

Pandemics such as the corona virus could have an adverse impact on our developmental programs and our financial condition.

In December 2019, a novel strain of coronavirus was first identified in Wuhan, Hubei Province, China.

Any outbreak of contagious diseases, or other adverse public health developments, could have a material and adverse effect on our business operations.

These could include disruptions or restrictions on our ability to travel, pursue partnerships and other business transactions, conduct clinical trials, make shipments of biologic materials, as well as be impacted by the temporary closure of the facilities of suppliers and clinical trial sites.

Any disruption of suppliers, clinical trial sites or access to patients would likely impact our clinical trial enrollment progress and rates as well as our ability to access capital through the financial markets.

The extent to which the coronavirus may impact our results will depend on future developments, which are highly uncertain and cannot be predicted, including new information which may emerge concerning the severity of the coronavirus.

Our business has been and may continue to be adversely affected by the COVID-19 pandemic.

The COVID-19 pandemic has affected our operations and may materially affect our business.

In response to the pandemic, we have limited operations, including implemented work from home and social distancing policies.

For instance, our clinical trials may suffer from lower than anticipated patient recruitment or enrollment and we may be forced to temporarily delay certain ongoing clinical trials.

In addition, we risk a delay, default and/or nonperformance under our existing agreements arising from force majeure.

The extent to which COVID-19 impacts our results will depend on future developments, which are highly uncertain and cannot be predicted, including new information which may emerge concerning the effectiveness and availability of the COVID-19 vaccines, among others.

In addition, COVID-19 has resulted in significant governmental measures being implemented to control the spread of the virus, including quarantines, travel restrictions, social distancing and business shutdowns.

We have taken temporary precautionary measures intended to help minimize the risk of the virus to our employees, including temporarily allowing all employees to work remotely.

We have already suspended non-essential travel worldwide for our employees and are discouraging employee attendance at other gatherings.

These measures could negatively affect our business.

For instance,

temporarily requiring all employees to work remotely may induce absenteeism, disrupt our operations or increase the risk of a cybersecurity incident.

COVID-19 has also caused volatility in the global financial markets and threatened a slowdown in the global economy, which may negatively affect our ability to raise additional capital on attractive terms or at all.

The extent to which COVID-19 will continue to impact our business will depend on future developments, which are highly uncertain and cannot be predicted with confidence, such as the duration of the pandemic, the severity of COVID-19 or the effectiveness of actions to contain and treat COVID-19, particularly in the geographies where we or our third party suppliers, contract manufacturers, or contract research organizations operate.

We cannot presently predict the scope and severity of any potential business shutdowns or disruptions.

If we or any of the third parties with whom we engage, however, were to experience shutdowns or other business disruptions, our ability to conduct our business in the manner and on the timelines presently planned could be materially and negatively affected, which could have a material adverse impact on our business and our results of operations and financial condition.

Even if we are able to successfully complete our clinical development programs for our product candidates and receive regulatory approval to market one or more of the products, if the commercial opportunities are smaller than we anticipate, our future revenues may be adversely affected, and our business may suffer.

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Moreover, our ability to conduct trials outside of the United States may be constrained by our inability to transport trial materials to foreign destinations within the expiry period of such materials unless and until we commence operation outside of the United States or find another source of supply.

We may face challenges in enrolling patients to participate in our clinical trials due to the novelty of our cell-based therapies, the size of the patient populations and the eligibility criteria for enrollment in the trial.

We may face challenges in enrolling patients to participate in our clinical trials due to the novelty of our cell-based therapies, the size of the patient populations, the eligibility criteria for enrollment in the trial and COVID-19 impact.

Moreover, changes to enrollment criteria may be prohibited by regulating agencies, may have no impact on enrollment rates and may change or harm the outcome of the study.

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We may have other delays in completing our clinical trials and we may not complete them at all.

We have not completed the clinical trials necessary to obtain FDA approval to market CLBS12, CLBS14 or CLBS16 or any of our other product candidates in development.

Our management lacks significant experience in completing Phase 3 pivotal clinical trials and bringing a drug or biological product through commercialization.

We have not completed the clinical trials necessary to obtain FDA approval to market HONEDRA ® , OLOGO TM , CLBS201 or CLBS16 or any of our other product candidates in development.

Our operational team lacks significant experience in completing Phase 3 pivotal clinical trials and bringing a drug or biological product through commercialization.

Clinical trials for products in development may be delayed or terminated as a result of many factors, including the following:

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Consequently, it is possible that conclusions of efficacy or safety may not be acceptable to permit submission of a BLA for any one of the above reasons or a combination of several.

The development of our cell therapy product candidates are subject to uncertainty because autologous cell therapy is inherently variable.

The development of our cell therapy product candidates is subject to uncertainty because autologous cell therapy is inherently variable.

When manufacturing an autologous cell therapy, the number and the composition of the cell population varies from patient to patient.

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To conduct pivotal Phase 3 clinical trials, we are required to have certain validated and established manufacturing controls with respect to the safety, purity and potency of our product when administered to patients.

If we determine that the results

of any Phase 2 clinical trial we may conduct supports Phase 3 development, we expect to initiate and complete one or more pivotal Phase 3 clinical trials for such programs and would need to address any outstanding chemistry, manufacturing and control CMC issues raised by the FDA prior to initiating such trials.

If we determine that the results of any Phase 2 clinical trial we may conduct supports Phase 3 development, we expect to initiate and complete one or more pivotal Phase 3 clinical trials for such programs and would need to address any outstanding chemistry, manufacturing and control CMC issues raised by the FDA prior to initiating such trials.

We may not be successful in our efforts to address any CMC issues raised by the FDA.

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A Fast Track designation by the FDA and other similar regulatory designations may not lead to a faster development, regulatory review or approval process.

We were granted SAKIGAKE designation in Japan and Advanced Therapeutic Medicinal Product ("ATMP") designation in Europe for CLBS12 for the treatment of CLI, and RMAT designation for CLBS14 for the treatment of no-option refractory disabling angina.

We were granted SAKIGAKE designation in Japan and Advanced Therapeutic Medicinal Product ("ATMP") designation in Europe for HONEDRA ® for the treatment of CLI and Buerger's Disease, and RMAT designation for OLOGO TM for the treatment of no-option refractory disabling angina.

However, SAKIGAKE, ATMP and RMAT designations do not ensure that we will experience a faster development, regulatory review or approval process compared to conventional FDA or Japan PMDA procedures.

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Each product candidate must demonstrate an adequate risk versus benefit profile in its intended patient population and for its intended use.

The risk/benefit profile required for product licensure will vary

depending on these factors and may include adequate duration of response, a delay in the progression of the disease, and/or an improvement in survival.

The risk/benefit profile required for product licensure will vary depending on these factors and may include adequate duration of response, a delay in the progression of the disease, and/or an improvement in survival.

For example, response rates from the use of our product candidates may not be sufficient to obtain regulatory approval unless we can also show an adequate duration of response.

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We currently rely on contract manufacturers to provide the cell processing services necessary for clinical production for our various CD34+ cell therapy product candidates.

The Foundation for Biomedical Research and Innovation, a Japanese corporation with its principal place of business in Kobe, Japan ("FBRI") will provide all cell processing services for the CLBS12 CLI trial in Japan.

Hitachi Chemical Advanced Therapeutics Systems ("HCATS") and FBRI also provide services and produce materials for clinical trials on behalf of unaffiliated third parties.

The Foundation for Biomedical Research and Innovation, a Japanese corporation with its principal place of business in Kobe, Japan ("FBRI") provide all cell processing services for the HONEDRA ® CLI trial in Japan.

Minaris Regenerative Medicine and FBRI also provide services and produce materials for clinical trials on behalf of unaffiliated third parties.

To date, neither has produced any products at commercial scale quantities.

We expect that HCATS and FBRI would need to expand significantly their manufacturing capabilities to meet potential commercial demand for CLBS12, CLBS14 and CLBS16 and any other of our product candidates, if approved, as well as any of our other product candidates that might attain regulatory approval.

We expect that Minaris Regenerative Medicine and FBRI would need to expand significantly their manufacturing capabilities to meet potential commercial demand for HONEDRA ® , OLOGO TM , CLBS201 and CLBS16 and any other of our product candidates, if approved, as well as any of our other product candidates that might attain regulatory approval.

Such expansion would require additional regulatory approvals.

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We have limited experience in the areas of cell therapy product development and marketing, and in the related regulatory issues and processes.

Although we have recruited a team that has experience with designing and conducting clinical trials, as a company we have limited experience in conducting clinical trials and no experience in conducting clinical trials through to regulatory approval of any product candidate.

regulatory approval of any product candidate.

In part because of this lack of experience, we cannot be certain that ongoing or planned clinical trials will begin or be completed on time, if at all.

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In general, cell-based or tissue-based products may be susceptible to various risks, including undesirable and unintended side effects, unintended immune system responses, inadequate therapeutic efficacy, or other characteristics that may prevent or limit their approval or commercial use.

Regulatory approval of novel product candidates such as CLBS12, CLBS14 and CLBS16, which are each manufactured using novel and proprietary manufacturing processes, can be more complex and expensive and take longer than other, more well-known or extensively studied pharmaceutical or biopharmaceutical products, due to the FDA’s lack of experience with them.

Regulatory approval of novel product candidates such as HONEDRA ® , OLOGO TM , CLBS201 and CLBS16, which are each manufactured using novel and proprietary manufacturing processes, can be more complex and expensive and take longer than other, more well-known or extensively studied pharmaceutical or biopharmaceutical products, due to the FDA’s lack of experience with them.

To our knowledge, the FDA has only approved five autologous cell therapy products to date.

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We have no internal capacity to manufacture our development product candidates and have no assurance that we will continue to have access to manufacturers in our industry that can effectively make our development products or make them at an affordable, salable or otherwise commercially reasonable price or quantity.

Cell manufacturers have a finite manufacturing capacity, which could inhibit the long-term growth prospects of our business.

We currently have no manufacturing contracts to produce materials for our clinical trials in the United States.

Contract development and manufacturing organizations have a finite cell manufacturing capacity, which could inhibit the long-term growth prospects of our business.

We currently have minimal manufacturing contracts to produce materials for our clinical trials in the United States.

It is possible that the demand for our products could exceed existing manufacturing capacity.

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The development and commercialization of our product candidates are subject to extensive regulation by the FDA and other regulatory agencies in the United States and abroad, and the failure to receive regulatory approvals for our cell therapy product candidates would likely have a material and adverse effect on our business and prospects.

Government authorities in the United States, at the federal, state and local level, and in other countries, extensively regulate, among other things, the research, development, testing, manufacture, including any manufacturing changes, packaging, storage, recordkeeping, labeling, advertising and promotion, distribution, marketing, import and export of pharmaceutical and biological products, such as CLBS12, CLBS14 and CLBS16.

The process of obtaining required regulatory approvals and the subsequent compliance with appropriate statutes and regulations requires the expenditure of substantial time and money, and there is no guarantee that we will successfully complete the steps needed to obtain regulatory approval of CLBS12, CLBS14 or CLBS16 or any future product candidates.

The process of obtaining required regulatory approvals and the subsequent compliance with appropriate statutes and regulations requires the expenditure of substantial time and money, and there is no guarantee that we will successfully complete the steps needed to obtain regulatory approval of HONEDRA ® , OLOGO TM , CLBS201 or CLBS16 or any future product candidates.

There also are extensive and ongoing post-marketing compliance obligations to which we would be subject following FDA approval of any of our product candidates.

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As such, there can be no assurance that we will be able, or will have the resources, to maintain compliance with all applicable biopharmaceutical and health care laws and regulations.

Failure to comply with such biopharmaceutical and health care laws and regulations could result in significant enforcement actions, civil or criminal penalties, which along with the costs associated with such compliance or with enforcement of such biopharmaceutical and health care laws and regulations, may have a material adverse effect on our operations or may require restructuring of our operations or impair our ability to operate profitably.

Failure to comply with such biopharmaceutical and

health care laws and regulations could result in significant enforcement actions, civil or criminal penalties, which along with the costs associated with such compliance or with enforcement of such biopharmaceutical and health care laws and regulations, may have a material adverse effect on our operations or may require restructuring of our operations or impair our ability to operate profitably.

Facilities engaged in the recovery, processing, storage, labeling, packaging or distribution of any human cells, tissues or cellular- and tissue-based products, or the screening or testing of a donor, are required to register with the applicable regulatory agencies.

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Each of these laws are subject to varying interpretations by courts and government agencies, creating complex compliance issues for us.

fail to comply with applicable laws and regulations we could be subject to penalties or sanctions, including criminal penalties if we knowingly obtain individually identifiable health information from a covered entity in a manner that is not authorized or permitted by HIPAA or for aiding and abetting the violation of HIPAA.

If we fail to comply with applicable laws and regulations we could be subject to penalties or sanctions, including criminal penalties if we knowingly obtain individually identifiable health information from a covered entity in a manner that is not authorized or permitted by HIPAA or for aiding and abetting the violation of HIPAA.

Numerous other countries have, or are developing, laws governing the collection, use and transmission of personal information as well.

EU member states and other jurisdictions have adopted data protection laws and regulations, which impose significant compliance obligations.

In May 2016, the European Union formally adopted the General Data Protection Regulation (GDPR), which applies to all EU member states from May 25, 2018 and replaced the EU Data Protection Directive The regulation introduces stringent new data protection requirements in the European Union and substantial fines for breaches of the data protection rules.

In May 2016, the European Union formally adopted the General Data Protection Regulation

(GDPR), which applies to all EU member states from May 25, 2018 and replaced the EU Data Protection Directive The regulation introduces stringent new data protection requirements in the European Union and substantial fines for breaches of the data protection rules.

It has increased our responsibility and liability in relation to personal data that we process and we may be required to put in place additional mechanisms ensuring compliance with the new EU data protection rules.

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In addition, amendments to the Federal False Claims Act, including under health care reform, have made it easier for private parties to bring “ qui tam ” (whistleblower) lawsuits against companies under which the whistleblower may be entitled to receive a percentage of any money paid to the government.

The Federal False Claims Act provides, in part, that an action can be brought against any person or entity that has knowingly presented, or caused to be presented, a false or fraudulent request for payment from the federal government, or who has made a false statement or used a false record to get a claim approved.

The Federal False Claims Act provides, in part,

that an action can be brought against any person or entity that has knowingly presented, or caused to be presented, a false or fraudulent request for payment from the federal government, or who has made a false statement or used a false record to get a claim approved.

The government has taken the position that claims presented in violation of the federal anti-kickback law, Stark Law or other health care-related laws, including laws enforced by the FDA, may be considered a violation of the Federal False Claims Act.

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While we do not believe this legislation will have a direct impact on our business, the legislation requires the adoption of implementing regulations, which may have unintended consequences or indirectly impact our business.

For instance, the scope and implications of the amendments pursuant to the

Fraud Enforcement and Recovery Act of 2009 (“FERA”), have yet to be fully determined or adjudicated and as a result it is difficult to predict how future enforcement initiatives may impact our business.

For instance, the scope and implications of the amendments pursuant to the Fraud Enforcement and Recovery Act of 2009 (“FERA”), have yet to be fully determined or adjudicated and as a result it is difficult to predict how future enforcement initiatives may impact our business.

Also, in some instances our clients may be health insurers that will be subject to limitations on their administrative expenses and federal review of “unreasonable” rate increases that could impact the prices they pay for our services.

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Political, economic and regulatory developments may further complicate pricing negotiations, and pricing negotiations may continue after reimbursement has been obtained.

Reference pricing used by various E.U.

member states and parallel distribution, or arbitrage between low-priced and high-priced member states, can further reduce prices.

Reference pricing used by various EU member states and parallel distribution, or arbitrage between low-priced and high-priced member states, can further reduce prices.

In some countries where we may seek to market our product candidates in the future, we may be required to conduct a clinical trial or other studies that compare the cost-effectiveness of our product candidate to other available therapies in order to obtain or maintain reimbursement or pricing approval.

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If a prolonged government shutdown occurs, it could significantly impact the ability of the FDA to timely review and process our regulatory submissions, which could have a material adverse effect on our business.

Further, upon completion of this offering and in our operations as a public company, future government shutdowns could impact our ability to access the public markets and obtain necessary capital in order to properly capitalize and continue our operations.

Further, upon completion of

this offering and in our operations as a public company, future government shutdowns could impact our ability to access the public markets and obtain necessary capital in order to properly capitalize and continue our operations.

Competitor companies or hospitals may be able to take advantage of EU rules permitting sales of unlicensed medicines for individual patients to sell competing products without a marketing authorization.

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Our commercial success will depend, in part, on obtaining and maintaining patent protection for new technologies, product candidates, products and processes and successfully defending such patents against third-party challenges.

To that end, we file patent applications, and have been issued patents, that are intended to cover certain methods and uses of human cells as well as compositions and methods relating to hematopoietic stem cells.

To that end, we file

patent applications, and have been issued patents, that are intended to cover certain methods and uses of human cells as well as compositions and methods relating to hematopoietic stem cells.

These patent applications may never result in the issuance of patents.

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Parties making claims against us may obtain injunctive or other equitable relief, which could effectively block our ability to further develop and commercialize one or more of our products or services.

Defense of these claims, regardless of their

merit, would involve substantial litigation expense and would be a substantial diversion of employee resources from our business.

Defense of these claims, regardless of their merit, would involve substantial litigation expense and would be a substantial diversion of employee resources from our business.

In the event of a successful claim of infringement against us, we may have to pay substantial damages, including treble damages and attorneys’ fees for willful infringement, pay royalties, redesign our infringing products or obtain one or more licenses from third parties, which may be impossible or require substantial time and monetary expenditure.

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The market price of our common stock has been, and in the future may continue to be, highly volatile.

For example, from January 1, 2019 through March 5, 2020 our common stock traded as low as $2.00 per share and as high as $5.44 per share.

For example, from January 1, 2020 through February 25, 2021 our common stock traded as low as $1.05 per share and as high as $4.89 per share.

The market price for our common stock is highly dependent on, among other things, stock market conditions in general, our clinical development efforts and the growth of our business in general, the amount of our available cash and investments and our level of cash utilization.

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Such supply in excess of demand could cause the market price of our common stock to decline.

Sales of our common stock pursuant to our at-the-market sales agreement with H.C.

Wainwright & Co.

may cause substantial dilution to our existing stockholders and the sale of such shares of common stock could cause the price of our common stock to decline.

We entered into a Common Stock Sales Agreement with H.C.

Wainwright & Co.

in February 2018, which was subsequently amended on August 2, 2018, pursuant to which we may sell up to $25 million of shares of our common stock over the term of that agreement, subject to certain terms and conditions.

In March 2019, subsequent to the filing of our 2018 Form 10-K, the aggregate market value of our outstanding common stock held by non-affiliates was approximately $52.8 million .

Pursuant to General Instruction I.B.6 of Form S-3, since the aggregate market value of our outstanding common stock held by non-affiliates was below $75.0 million at the time of our 2018 Form 10-K filing, the aggregate amount of securities that we were

permitted to offer and sell at such time was reduced to $17.6 million (or a maximum of 4.8 million shares), which was equal to one-third of the aggregate market value of our common stock held by non-affiliates at such time.

Sales by us pursuant to the sales agreement may result in substantial dilution to the interests of other holders of our common stock.

The sale of a substantial number of shares of our common stock, or anticipation of such sales, could make it more difficult for us to sell equity or equity-related securities in the future at a time and at a price that we might otherwise wish to effect sales.

However, we have the right to control the timing and amount of any sales of our shares under the sales agreement and may be terminated by us at any time at our discretion without any cost to us.

Provisions in our amended and restated certificate of incorporation and by-laws and Delaware law may inhibit a takeover of us, which could limit the price investors might be willing to pay in the future for our common stock and could entrench management.

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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-K

Item 1A. Risk Factors