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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT
Pursuant to Section 13 or 15(d)
of The Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): November 5, 2020

Editas Medicine, Inc.

(Exact Name of Registrant as Specified in its Charter)

Delaware

001-37687

46-4097528

(State or Other Jurisdiction of Incorporation)

(Commission File Number)

(IRS Employer Identification No.)

11 Hurley Street
Cambridge, Massachusetts

02141

(Address of Principal Executive Offices)

(Zip Code)

Registrant’s telephone number, including area code: (617401-9000

(Former Name or Former Address, if Changed Since Last Report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

 

 

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

 

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

 

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

 

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

Trading Symbol(s)

Name of each exchange on which registered

Common Stock, $0.0001 par value per share

EDIT

The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.  

 

 

Item 2.02            Results of Operations and Financial Condition.

On November 5, 2020, Editas Medicine, Inc. (the “Company”) issued a press release announcing financial results for the fiscal quarter ended September 30, 2020 and other business highlights. A copy of the press release is being furnished as Exhibit 99.1 to this Current Report on Form 8-K.

The information contained in Item 2.02 in this Current Report on Form 8-K (including Exhibit 99.1) shall not be deemed “Filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act, except as expressly set forth by specific reference in such a filing.

Item 9.01              Financial Statements and Exhibits.

(d) Exhibits

Exhibit
No.

 

Description

99.1

 

Press release issued by the Company on November 5, 2020*

104

Cover Page Interactive Data File (embedded within the Inline XBRL document)

*   This exhibit shall be deemed to be furnished and not filed.

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

EDITAS MEDICINE, INC.

 

 

Date:

November 5, 2020

By:

/s/ Michelle Robertson

 

 

 

Michelle Robertson
Chief Financial Officer

Exhibit 99.1

Graphic

Editas Medicine Announces Third Quarter 2020 Results and Update

EDIT-101 for LCA10 ‒ BRILLIANCE trial adult low-dose cohort completed

EDIT-301 for sickle cell disease ‒ on track for IND filing by end of 2020

EDIT-201 for solid tumors ‒ preclinical data to be presented at SITC and ASH

Cash, cash equivalents, and marketable securities of $541 million as of September 30, 2020

CAMBRIDGE, Mass., November 5, 2020 (GLOBE NEWSWIRE) – Editas Medicine, Inc. (Nasdaq: EDIT), a leading genome editing company, today reported business highlights and financial results for the third quarter of 2020.

“We were pleased to regain full operating control of our ocular programs per our new agreement with AbbVie, which provides us with important flexibility. We have finished dosing the first cohort with EDIT-101 in the landmark BRILLIANCE trial and enrollment remains active,” said Cynthia Collins, Chief Executive Officer of Editas Medicine.

Ms. Collins continued, “The advancements in our ocular portfolio are complemented by the strategic development of our engineered cell medicines. We are on track to file the IND for EDIT-301 for sickle cell disease in the fourth quarter and are eager to present additional data on this potentially best-in-class medicine and our large-scale manufacturing process at the upcoming American Society of Hematology Annual Meeting. Substantial progress has also been made in the development of EDIT-201, an allogeneic NK cell medicine to treat solid tumors. Preclinical data to be presented at ASH show enhanced tumor killing with EDIT-201 compared to unedited NK cells, and additional data on this program will be featured at the upcoming Society for Immunotherapy of Cancer’s Annual Meeting.”

Recent Achievements and Outlook

In Vivo CRISPR Medicines

·

EDIT-101 for LCA10

BRILLIANCE Phase1/2 adult low-dose cohort completed

Editas Medicine (Company) has completed dosing of the first cohort of adult patients with visual light perception only administered the low dose of EDIT-101. Trial enrollment remains active but has experienced a slowdown due to the ongoing impact of the COVID-19 pandemic.

·

Ocular Medicines

Regained full control of ocular medicines
Editas Medicine terminated its 2017 agreement with Allergan, now part of AbbVie, and entered a new agreement with AbbVie that returned development and commercialization rights for


ocular medicines to Editas Medicine. As part of the new agreement, AbbVie has transferred supplier contracts, including with the contract research organization (CRO), as well as sponsorship of the investigational new drug application (IND) for the BRILLIANCE Phase 1/2 clinical trial to Editas Medicine. The Company plans to continue to advance ocular medicines, including EDIT-101 for Leber congenital amaurosis 10 (LCA10).

Ex Vivo CRISPR Cell Medicines

·

EDIT-301 for Sickle Cell Disease and Beta-Thalassemia

On track for IND filing by end of 2020

Editas Medicine continues to prepare for a Phase 1/2 clinical trial evaluating EDIT-301 for the treatment of sickle cell disease. The Company has completed preclinical toxicology studies, identified a lead principal investigator, and engaged a CRO. Clinical trial materials are being manufactured by Editas Medicine. The Company remains on track to file an IND for the treatment of sickle cell disease by the end of 2020.

Granted Rare Pediatric Disease Designation for treatment of sickle cell disease

EDIT-301 was granted Rare Pediatric Disease Designation by the U.S. Food and Drug Administration (FDA). Under the FDA’s Rare Pediatric Disease Designation and Voucher programs, a sponsor who receives approval for a drug or biologic for a rare pediatric disease may be eligible for a voucher that can be redeemed to receive priority review of a subsequent marketing application for a different product.

ASH data to highlight efficient editing with clinical scale manufacturing process

Preclinical data to be presented at the 62nd American Society of Hematology Annual Meeting & Exposition (ASH) show CRISPR/Cas12a editing efficiency of the HBG1/2 promoter exceeding 90 percent after long term engraftment in mice of healthy donor hematopoietic stem cells manufactured at clinical scale.

·

EDIT-201 to Treat Solid Tumors

Data demonstrating enhanced tumor killing to be presented at SITC and ASH

EDIT-201 is comprised of healthy donor natural killer (NK) cells that have been edited using a proprietary CRISPR/Cas12a ribonucleoprotein to knock out the CISH and TGFβR2 genes. At ASH, the Company will present data showing that NK cells with CISH and TGFβR2 knockouts are more potent than unedited cells in vitro. The Company will also show that the combination of therapeutic antibodies with EDIT-201 further enhances tumor killing. Data on EDIT-201 will also be presented at the Society for Immunotherapy of Cancer’s 35th Anniversary Annual Meeting.

·

CRISPR iPSC NK (iNK) Cell Medicines to Treat Solid Tumors

Proprietary CRISPR/Cas12a editing of iPSCs enhances iNK tumor killing

Preclinical data to be presented at ASH detail a CRISPR/Cas12a induced pluripotent stem cell (iPSC) editing platform. The Company will show that knockout of CISH and TGFβR2 with the proprietary CRISPR/Cas12a editing platform enhances iNK cell tumor killing in a spheroid model.

Corporate

·

Intellectual Property
The U.S. Patent and Trademark Office (USPTO) recently issued a decision in the ongoing patent interference between the University of California, the University of Vienna, Emmanuelle


Charpentier (CVC) and the Broad Institute, Inc. (Broad) regarding certain Broad CRISPR/Cas9 patents Editas Medicine exclusively licenses. The USPTO granted Broad’s motion for priority benefit while denying CVC priority benefit to its two earliest provisional patent applications. As a result, Broad enters the priority phase of the interference as “Senior Party” while CVC remains the “Junior Party” for purposes of determining which entity was the first to invent the use of CRISPR/Cas9 for gene editing in eukaryotic cells. The Senior Party is presumed to be the first inventor, thus, the Junior Party, here CVC, has the burden of overcoming this presumption. The Broad patents remain valid and in force. Foundational claims covering the use of CRISPR/Cas9 for gene editing in eukaryotic cells have issued and continue to issue to Broad as patents in the United States, Europe, Japan, China, and other jurisdictions.

·

Balance Sheet

The Company expects that its existing cash, cash equivalents and marketable securities of $541.3 million as of September 30, 2020, and anticipated interest income will enable it to fund its operating expenses and capital expenditures into 2023.

Third Quarter 2020 Financial Results

Cash, cash equivalents, and marketable securities as of September 30, 2020, were $541.3 million, compared to $598.7 million as of June 30, 2020.

For the three months September 30, 2020, net income attributable to common stockholders was $7.8 million, or $0.12 per share, diluted, compared to net loss of $32.9 million, or $0.66 per share, for the same period in 2019.

·

Collaboration and other research and development revenues increased by $59.0 million, to $62.8 million for the three months ended September 30, 2020 from $3.8 million for three months ended September 30, 2019. This increase was primarily attributable to the recognition of $59.9 million of previously deferred revenue as a result of the termination of our strategic alliance with Allergan.

·

Research and development expenses increased by $11.2 million, to $33.9 million for the three months ended September 30, 2020 from $22.7 million for the three months ended September 30, 2019. The $11.2 million increase was primarily attributable to an increase in expenses related to the clinical and manufacturing development of EDIT-101 and our other programs, including a including a one-time in-process research and development expense of $5.0 million for re-acquiring the rights to EDIT-101 from Allergan. In addition, the Company continued to invest in the research and development organization which resulted in an increase in employee and facility related expenses as compared to the prior year.

·

General and administrative expenses increased by $4.2 million to $19.9 million for the three months ended September 30, 2020, from $15.7 million for the same period in 2019. The $4.2 million increase was primarily attributable to an increase in expense for professional service fees incurred by the Company in connection with the termination of the Allergan agreement as well as an increase in employee and facility related expenses.


Upcoming Events

Editas Medicine plans to participate in the following scientific and medical conferences:

·

Society for Immunotherapy of Cancers 35th Anniversary Annual Meeting, November 9-14, Virtual; and

·

62nd American Society of Hematology Annual Meeting & Exposition, December 5-8, Virtual.

Editas Medicine plans to participate in the following investor events:

·

Barclays Gene Editing & Gene Therapy Summit, November 16, 10:15am EST, Virtual.

Conference Call

The Editas Medicine management team will host a conference call and webcast today at 5:00 p.m. ET to provide and discuss a corporate update and financial results for the third quarter 2020. To access the call, please dial (844) 348-3801 (domestic) or (213) 358-0955 (international) and provide the passcode 9992536. A live webcast of the call will be available on the Investors section of the Editas Medicine website at www.editasmedicine.com and a replay will be available approximately two hours after its completion.

About EDIT-101

EDIT-101 is a CRISPR-based experimental medicine under investigation for the treatment of Leber congenital amaurosis 10 (LCA10). EDIT-101 is administered via a subretinal injection to reach and deliver the gene editing machinery directly to photoreceptor cells.

About BRILLIANCE

The BRILLIANCE Phase 1/2 clinical trial of EDIT-101 for the treatment of Leber congenital amaurosis 10 (LCA10) is designed to assess the safety, tolerability, and efficacy of EDIT-101 in up to 18 patients with this disorder. Clinical trial sites are enrolling up to five cohorts testing up to three dose levels in this open label, multi-center study. Both adult and pediatric patients (3 – 17 years old) with a range of baseline visual acuity assessments are eligible for enrollment. Patients receive a single administration of EDIT-101 via subretinal injection in one eye. Additional details are available on www.clinicaltrials.gov (NCT#03872479).

About EDIT-201

EDIT-201 is an experimental, allogeneic natural killer (NK) cell medicine under investigation for the treatment of solid tumor cancers. EDIT-201 is comprised of NK cells derived from pooled healthy donor blood and genetically modified using a highly specific and efficient CRISPR/Cas12a (also known as Cpf1) ribonucleoprotein (RNP) to edit the CISH and TGFβR2 genes. Editing of the CISH and TGFβR2 genes is designed to overcome resistance to therapeutic antibodies and improve NK cell persistence.

About EDIT-301

EDIT-301 is an experimental, autologous cell therapy medicine under investigation for the treatment of sickle cell disease. EDIT-301 is comprised of sickle patient CD34+ cells genetically modified using a highly specific and efficient CRISPR/Cas12a (also known as Cpf1) ribonucleoprotein (RNP) to edit the HBG1/2 promoter region in the beta-globin locus. Red blood cells derived from EDIT-301 CD34+


cells demonstrate a sustained increase in fetal hemoglobin (HbF) production, which has the potential to provide a durable treatment benefit for people living with sickle cell disease.

About Editas Medicine

As a leading genome editing company, Editas Medicine is focused on translating the power and potential of the CRISPR/Cas9 and CRISPR/Cas12a (also known as Cpf1) genome editing systems into a robust pipeline of treatments for people living with serious diseases around the world. Editas Medicine aims to discover, develop, manufacture, and commercialize transformative, durable, precision genomic medicines for a broad class of diseases. For the latest information and scientific presentations, please visit www.editasmedicine.com.

Forward-Looking Statements

This press release contains forward-looking statements and information within the meaning of The Private Securities Litigation Reform Act of 1995. The words ‘‘anticipate,’’ ‘‘believe,’’ ‘‘continue,’’ ‘‘could,’’ ‘‘estimate,’’ ‘‘expect,’’ ‘‘intend,’’ ‘‘may,’’ ‘‘plan,’’ ‘‘potential,’’ ‘‘predict,’’ ‘‘project,’’ ‘‘target,’’ ‘‘should,’’ ‘‘would,’’ and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Forward-looking statements in this press release include statements regarding the Company’s plans with respect to EDIT-101 and filing an IND for EDIT-301 by the end of 2020. The Company may not actually achieve the plans, intentions, or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various factors, including: uncertainties inherent in the initiation and completion of preclinical studies and clinical trials and clinical development of the Company’s product candidates; availability and timing of results from preclinical studies and clinical trials; whether interim results from a clinical trial will be predictive of the final results of the trial or the results of future trials; expectations for regulatory approvals to conduct trials or to market products and availability of funding sufficient for the Company’s foreseeable and unforeseeable operating expenses and capital expenditure requirements. Those risks and uncertainties include, among other things, that the Company's expectations regarding the effects of COVID-19 may be incorrect, that data from the Company's development programs may not support registration or further development of its potential medicines due to safety, efficacy or other reasons, and other risks listed under “Risk Factors” included in the Company’s most recent Quarterly Report on Form 10-Q, which is on file with the Securities and Exchange Commission, and in other filings that the Company may make with the Securities and Exchange Commission in the future. Any forward-looking statements contained in this press release represent Company’s views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. Except as required by law, the Company explicitly disclaims any obligation to update any forward-looking statements.

EDITAS MEDICINE, INC.

Condensed Consolidated Statements of Operations

(unaudited)

(amounts in thousands, except per share and share data)

Three Months Ended

September 30,

2020

2019

Collaboration and other research and development revenues

    

$

62,841

    

$

3,848

Operating expenses:

Research and development

 

33,916

 

22,702


General and administrative

 

19,936

 

15,734

Total operating expenses

 

53,852

 

38,436

Operating income (loss)

 

8,989

 

(34,588)

Other (expense) income, net:

Other (expense) income, net

 

(1,396)

 

(33)

Interest income, net

226

1,680

Total other (expense) income, net

 

(1,170)

 

1,647

Net income (loss)

$

7,819

$

(32,941)

Net income (loss) loss per share attributable to common stockholders, diluted

$

0.12

$

(0.66)

Weighted-average common shares outstanding, diluted

 

62,697,173

 

49,820,455

EDITAS MEDICINE, INC.

Selected Condensed Consolidated Balance Sheet Items

(unaudited)

(amounts in thousands)

September 30,

December 31,

2020

2019

Cash, cash equivalents, and marketable securities

    

$

541,291

    

$

457,140

Working capital

452,011

403,881

Total assets

597,157

508,885

Deferred revenue, net of current portion

80,821

163,207

Total stockholders’ equity

441,152

262,437

Investor Contact

Mark Mullikin

(617) 401-9083

mark.mullikin@editasmed.com

Media Contact

Cristi Barnett

(617) 401-0113

cristi.barnett@editasmed.com