What changed in this filing

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Item 1A. Risk Factors

2020-11-09 compared with 2020-08-10 · 52 added, 62 removed, 91 unchanged (56% of the section changed)

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been no material changes in the assessment of other risk factors set forth in our 2019 Form 10-K, except for the additional risk

factors noted below, which are an update to the risk factors included in Part II, Item 1A of our Quarterly Report on Form 10-Q

for the quarter ended March 31, 2020:

factors noted below, which update the risk factors included in Part II, Item 1A of our Quarterly Reports on Form 10-Q for the

quarters ended March 31, 2020 and June 30, 2020:

COVID-19 pandemic and efforts to reduce its spread has affected our operations and significantly impacted worldwide economic conditions,

and could continue to have a material effect on our operations, business and financial condition.

date, the COVID-19 pandemic resulted in extended shutdowns of non-essential businesses throughout Europe and the U.S., including

date, the COVID-19 pandemic resulted in intermittent shutdowns of non-essential businesses throughout Europe and the U.S., including

in Spain and Australia, where we also conduct operations.

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As a result, our operations at our Cleveland manufacturing facility were significantly scaled

back in the first half of 2020 to ensure that our employees and those around them have the best chance to remain safe and to accommodate

reduced manufacturing and clinical development activities during this uncertain time.

back in the first nine months of 2020 to ensure that our employees and those around them have the best chance to remain safe and

to accommodate reduced manufacturing and clinical development activities during this uncertain time.

COVID-19 pandemic has substantially burdened healthcare systems worldwide, delaying enrollment in and progression of our clinical

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For example, our Phase III VIITAL TM clinical trial was temporarily paused

in March 2020 due to the COVID-19 pandemic, but has resumed in June 2020.

Significant delays in the timing of our clinical trials

and in regulatory reviews could adversely affect our ability to commercialize our product candidates.

we remain committed to advancing our clinical programs, we recognize some delays are inevitable in light of the closure of

non-essential businesses, stay at home orders, and economic impacts related to the COVID-19 pandemic, especially as

healthcare resources are justly redirected to those who need them most.

Many of the third parties with whom we engage,

including suppliers, clinical trial sites, regulators and other third parties with whom we conduct business, are also

experiencing shutdowns or other business disruptions.

Despite our current clinical trial sites gradually resuming activities

on site and us having resumed our EB-101 manufacturing activities, we may continue to experience disruptions that could

severely impact our business, supply chain, manufacturing operations, clinical trials and pre-clinical studies,

in March 2020 due to the COVID-19 pandemic but resumed in June 2020.

Significant delays in the timing of our clinical trials and

in regulatory reviews could adversely affect our ability to commercialize our product candidates.

we remain committed to advancing our clinical programs, we recognize some delays are inevitable in light of the closure of non-essential

businesses, stay at home orders, and economic impacts related to the COVID-19 pandemic, especially as healthcare resources are

justly redirected to those who need them most.

Many of the third parties with whom we engage, including suppliers, clinical trial

sites, regulators and other third parties with whom we conduct business, are also experiencing shutdowns or other business disruptions.

Despite our current clinical trial sites gradually resuming activities on site and us having resumed our EB-101 manufacturing

activities, we may continue to experience disruptions that could severely impact our business, supply chain, manufacturing operations,

clinical trials and pre-clinical studies, including:

interruption of key clinical trial activities, including continued limitations on travel imposed or recommended by federal

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a deferral of payments for the first six months, beginning on May 2, 2020.

We intend to use the proceeds from the PPP Loan for

purposes consistent with the PPP.

While we currently believe that our use of the loan proceeds will meet the conditions for forgiveness

of the PPP Loan, there can be no assurance that forgiveness for any portion of the PPP Loan will be obtained.

We believe that we have used the proceeds from the

PPP Loan for purposes consistent with the PPP.

While we currently believe that our use of the loan proceeds will meet the conditions

for forgiveness of the PPP Loan, there can be no assurance that forgiveness for any portion of the PPP Loan will be obtained.

Additionally,

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If, despite our good faith belief

that we satisfied all eligibility requirements for the PPP loan, the SBA concludes have been ineligible to receive the PPP loan

or in violation of any of the laws or regulations that apply to us in connection with the PPP loan, including the False Claims

that we satisfied all eligibility requirements for the PPP loan, the SBA concludes we have been ineligible to receive the PPP

loan or in violation of any of the laws or regulations that apply to us in connection with the PPP loan, including the False Claims

Act, we may be subject to penalties, including significant civil, criminal and administrative penalties and could be required

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property or technology.

It is possible that such termination may

occur even if we believe that we have complied with our obligations under a license agreement, if a dispute arises between us

and a licensor.

Our license agreement with REGENXBIO had granted us an exclusive worldwide license (subject to certain non-exclusive

rights previously granted for MPS IIIA), with rights to sublicense, to use REGENXBIO’s NAV AAV9 capsid in gene therapies

for treating MPS IIIA, MPS IIIB, CLN1 Disease, and CLN3 Disease.

On May 2, 2020, REGENXBIO terminated the license agreement.

filed an arbitration claim against REGENXBIO relating to $28 million plus interest that REGENXBIO argues remains due following

the agreement’s termination, and that arbitration proceeding is ongoing.

We may not prevail in the arbitration proceeding.

Even if we do prevail, it is possible that REGENXBIO may in the future assert that our proposed products infringe one or more

of REGENXBIO’s AAV9 patent claims, and we still may ultimately need a license to use the AAV9 capsid in our proposed MPS

IIIA, MPS IIIB, CLN1, and CLN3 products.

Absent such a license, if we are found to infringe an AAV9 patent claim, it is possible

that a court may enjoin the sale of one or more of our proposed AAV9-based products, order us to pay a less favorable royalty

rate to REGENXBIO than the royalty rate in the original license agreement, or order us to pay other damages.

is possible that such termination may occur even if we believe that we have complied with our obligations under a license agreement,

if a dispute arises between us and a licensor.

Our license agreement with REGENXBIO had granted us an exclusive worldwide license

(subject to certain non-exclusive rights previously granted for MPS IIIA), with rights to sublicense, to use REGENXBIO’s

NAV AAV9 capsid in gene therapies for treating MPS IIIA, MPS IIIB, CLN1 Disease, and CLN3 Disease.

On May 2, 2020, REGENXBIO terminated

the license agreement.

We filed an arbitration claim against REGENXBIO relating to $28 million plus interest that REGENXBIO argues

remains due following the agreement’s termination, and that arbitration proceeding is ongoing.

We may not prevail in the

arbitration proceeding.

Even if we do prevail, it is possible that REGENXBIO may in the future assert that our proposed products

infringe one or more of REGENXBIO’s AAV9 patent claims, and we still may ultimately need a license to use the AAV9 capsid

in our proposed MPS IIIA, MPS IIIB, CLN1, and CLN3 products.

Absent such a license, if we are found to infringe an AAV9 patent

claim, it is possible that a court may enjoin the sale of one or more of our proposed AAV9-based products, order us to pay a less

favorable royalty rate to REGENXBIO than the royalty rate in the original license agreement, or order us to pay other damages.

Exhibit Index below, which is incorporated by reference herein.

and Restated Bylaws of Abeona Therapeutics Inc.

(incorporated by reference to Exhibit 3.1 of our Form 8-K filed on May 21,

3, dated April 14, 2020, to Letter Agreement, dated January 2, 2020, between the Company and Steven H.

Letter, dated April 15, 2020, between the Company and Brian J.G.

Pereira, M.D.

(incorporated by reference to Exhibit 10.1

of our Form 8-K filed on April 21, 2020).

Letter, dated June 17, 2020, between the Company and Edward Carr (incorporated by reference to Exhibit 10.1 of our Form 8-K

filed on June 23, 2020).

Executive Officer Certification Pursuant to Rule 13a-14(a) of the Securities Exchange Act of 1934.

Financial Officer Certification Pursuant to Rule 13a-14(a) of the Securities Exchange Act of 1934.

Certification

Pursuant to 18 U.S.C.

Principal Executive Officer Certification Pursuant to Rule 13a-14(a) of the Securities Exchange Act of 1934.

Principal Financial Officer Certification Pursuant to Rule 13a-14(a) of the Securities Exchange Act of 1934.

Certification Pursuant to 18 U.S.C.

Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

following materials from Abeona’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2020, formatted in Inline

XBRL (Extensible Business Reporting Language):

(i) Condensed Consolidated Balance Sheets at June 30, 2020 and December 31,

2019, (ii) Condensed Consolidated Statements of Operations and Comprehensive Loss for the three and six months ended June

30, 2020 and 2019, (iii) Condensed Consolidated Statements of Stockholders’ Equity for the three and six months ended

June 30, 2020 and 2019, (iv) Condensed Consolidated Statements of Cash Flows for the six months ended June 30, 2020 and 2019,

and (v) Notes to Condensed Consolidated Financial Statements.

Page Interactive Data File (embedded within the Inline XBRL document and included in

Exhibit 101).

following materials from Abeona’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2020, formatted

in Inline XBRL (Extensible Business Reporting Language):

(i) Condensed Consolidated Balance Sheets at September 30, 2020 and

December 31, 2019, (ii) Condensed Consolidated Statements of Operations and Comprehensive Loss for the three and nine months

ended September 30, 2020 and 2019, (iii) Condensed Consolidated Statements of Stockholders’ Equity for the three and

nine months ended September 30, 2020 and 2019, (iv) Condensed Consolidated Statements of Cash Flows for the nine months ended

September 30, 2020 and 2019, and (v) Notes to Condensed Consolidated Financial Statements.

Page Interactive Data File (embedded within the Inline XBRL document and included in Exhibit 101).

Pursuant to Item 601(b)(32)(ii) of Regulation S-K, this exhibit shall not be deemed “filed” for purposes of Section

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THERAPEUTICS INC.

Executive Officer

Michael Amoroso

Operating Officer

Executive Officer)

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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-Q

Item 1A. Risk Factors