Exicure 8-K 3/30/2020

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): March 30, 2020

____________________

EXICURE, INC.

(Exact name of Registrant as specified in its charter)

____________________



Delaware	001-39011	81-5333008
(State or other jurisdiction of incorporation)	(Commission File Number)	(IRS Employer Identification No.)

8045 Lamon Avenue

Suite 410

Skokie, IL 60077

(Address of principal executive offices)

Registrant’s telephone number, including area code: (847) 673-1700

____________________

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:


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


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


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


o	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, par value $0.0001 per share	XCUR	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 x

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. x

Item 2.02 Results of Operations and Financial Condition.

Exicure, Inc. (the “Company”) preliminarily estimates that its cash, cash equivalents and short-term investments as of February 29, 2020 was approximately $107.7 million. This preliminary estimate is not a comprehensive statement of the Company’s financial results for the quarter ending March 31, 2020 and has not been audited, reviewed, or compiled by its independent registered public accounting firm. This estimate as of February 29, 2020 is not necessarily indicative of the results to be expected for the Company's actual consolidated cash, cash equivalents and short-term investments as of March 31, 2020.

The information provided in this Item 2.02 shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any of the Company’s filings under the Securities Act of 1933, as amended (the “Securities Act”), or the Exchange Act, except as expressly set forth by specific reference in such filing.

Item 7.01 Regulation FD Disclosure.

On March 30, 2020, the Company issued a press release providing a business update regarding the COVID-19 coronavirus pandemic. A copy of the press release is furnished hereto as Exhibit 99.1.

The information provided in this Item 7.01 and Exhibit 99.1 attached hereto shall not be deemed “filed” for purposes of Section 18 of the Exchange Act, or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any of the Company’s filings under the Securities Act, or the Exchange Act, except as expressly set forth by specific reference in such filing.

Item 8.01 Other Events.

Business Update

As of February 29, 2020, the Company has opened seven clinical trial sites for its Phase 1b/2 clinical trial of AST-008 in both patients with advanced or metastatic Merkel cell carcinoma and cutaneous squamous cell carcinoma.

Risk Factor Update

The Company is supplementing and updating the risk factors in its prior filings with the Securities and Exchange Commission (the “SEC”), including those discussed under the heading “Item 1A. Risk Factors,” in the Company’s most recent Annual Report on Form 10-K for the year ended December 31, 2019, filed with the SEC on March 10, 2020 to add the following new risk factor:

Our business could be adversely affected by the effects of health epidemics, including the global COVID‑19 coronavirus pandemic, in regions where we or third parties on which we rely have business operations. The COVID-19 pandemic could materially affect our operations, including at our office in Skokie, Illinois, which is currently subject to a state executive order, and at our clinical trial sites, as well as the business or operations of our CROs or other third parties with whom we conduct business.

Our business could be adversely affected by health epidemics in regions where we have concentrations of clinical trial sites or other business operations, and could cause significant disruption in the operations of third party manufacturers and CROs upon whom we rely. In December 2019, a novel strain of coronavirus, COVID-19, was reported to have surfaced in Wuhan, China. Since then, COVID-19 coronavirus has spread to multiple countries, including the United States, Europe and Canada. Our company headquarters is located in Skokie, Illinois, our CROs are located globally, and our substance and drug product manufacturers are located in the United States and Europe. In March 2020, the World Health Organization declared the COVID-19 outbreak a pandemic, and the U.S. government imposed travel restrictions on travel between the United States, Europe and certain other countries. Further, the President of the United States declared the COVID-19 pandemic a national emergency, invoking powers under the Stafford Act, the legislation that directs federal emergency disaster response. In addition, the Governor of Illinois ordered all individuals living in the State of Illinois to stay at home until at least April 7, 2020 (subject to certain exceptions to facilitate authorized necessary activities) to mitigate the impact of the COVID-19 pandemic. The executive order exempts certain individuals needed to maintain continuity of operations of critical infrastructure sectors as determined by the federal government, and the executive order clarifies that biotechnology companies like us (including operations, research and development, manufacture and supply chain) are considered essential and exempt.

In response to these public health directives and orders, we have implemented work-from-home policies for certain employees. The effects of the executive order and our work-from-home policies may negatively impact productivity, disrupt our business and delay our clinical programs and timelines (for example, our timeline for AST-008, our timeline for XCUR-FXN or timelines for any of our preclinical programs), the magnitude of which will depend, in part, on the length and severity of the restrictions and other limitations on our ability to conduct our business in the ordinary course. These and similar, and perhaps more severe, disruptions in our operations could negatively impact our business, operating results and financial condition.

Quarantines, shelter-in-place and similar government orders, or the perception that such orders, shutdowns or other restrictions on the conduct of business operations could occur, related to COVID-19 or other infectious diseases could impact personnel at third-party manufacturing facilities in the United States and other countries, or the availability or cost of materials, which would disrupt our supply chain.

In addition, our planned clinical trials may be affected by the COVID-19 pandemic, including:


•	delays or difficulties in enrolling patients in our clinical trials, including patients who may not be able to comply with clinical trial protocols if quarantines impede patient movement or interrupt healthcare services;


•	delays or difficulties in clinical site initiation, including difficulties in recruiting clinical site investigators and clinical site staff;

•

diversion or prioritization of healthcare resources away from the conduct of clinical trials and towards the COVID-19 pandemic, including the diversion of hospitals serving as our clinical trial sites and hospital staff supporting the conduct of our clinical trials, and because, who, as healthcare providers, may have heightened exposure to COVID-19 and adversely impact our clinical trial operations;


•	interruption of key clinical trial activities, such as clinical trial site monitoring, due to limitations on travel imposed or recommended by federal or state governments, employers and others; and


•	limitations in employee resources that would otherwise be focused on the conduct of our clinical trials, including because of sickness of employees or their families or the desire of employees to avoid contact with large groups of people.

For our clinical trials that we expect to conduct at sites outside the United States, particularly in countries which are experiencing heightened impact from the COVID-19 coronavirus, in addition to the risks listed above, we may also experience the following adverse impacts:


•	delays in receiving approval from local regulatory authorities to initiate our planned clinical trials;


•	delays in clinical sites receiving the supplies and materials needed to conduct our clinical trials;


•	interruption in global shipping that may affect the transport of clinical trial materials, such as investigational drug product and comparator drugs used in our clinical trials;


•	changes in local regulations as part of a response to the COVID-19 coronavirus outbreak which may require us to change the ways in which our clinical trials are conducted, which may result in unexpected costs, or to discontinue the clinical trials altogether;


•	delays in necessary interactions with local regulators, ethics committees and other important agencies and contractors due to limitations in employee resources or forced furlough of government employees; and


•	the refusal of the FDA to accept data from clinical trials in these affected geographies.

The global outbreak of the COVID-19 coronavirus continues to rapidly evolve. The extent to which the COVID-19 coronavirus may impact our business and clinical trials will depend on future developments, which are highly uncertain and cannot be predicted with confidence, such as the ultimate geographic spread of the disease, the duration of the outbreak, travel restrictions and social distancing in the United States and other countries, business closures or business disruptions and the effectiveness of actions taken in the United States and other countries to contain and treat the disease.

Caution Concerning Forward-Looking Statements

This Current Report on Form 8-K contains forward-looking statements made in reliance upon the safe harbor provisions of Section 27A of the Securities Act and Section 21E of the Exchange Act. Forward-looking statements are statements that do not relate solely to historical or current facts, and can be identified by the use of words such as “may,” “will,” “expect,” “project,” “estimate,” “anticipate,” “plan,” “believe,” “potential,” “should,” “continue” or the negative versions of those words or other comparable words. These forward-looking statements include statements about the clinical development of the Company’s product candidates, expectations regarding future clinical trials, the preliminary financial information as of February 29, 2020 and the Company’s future expectations, plans and prospects. These forward-looking statements are based on information currently available to the Company and its current plans or expectations, and are subject to a number of uncertainties and risks that could significantly affect current plans. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including the uncertainties related to market conditions and the rapidly evolving nature of the COVID-19 pandemic and related containment measures. The Company’s forward-looking statements also involve assumptions that, if they prove incorrect, would cause its results to differ materially from those expressed or implied by such forward-looking statements. These and other risks concerning the Company’s business are described in additional detail in the Company’s Annual Report on Form 10-K for the year ended December 31, 2019 and in the Company’s other reports filed with the SEC. The Company

is under no obligation to, and expressly disclaims any such obligation to, update or alter its forward-looking statements, whether as a result of new information, future events or otherwise.

Item 9.01 Financial Statements and Exhibits.



Exhibit No.		Description
99.1		Press Release issued March 30, 2020.

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.



Date: March 30, 2020	EXICURE, INC.

	By:	/s/ David A. Giljohann
		David A. Giljohann, Ph.D.
		Chief Executive Officer



	Exhibit 99.1

Exicure Provides Business Update Amid COVID-19 Pandemic

- Phase 2 stage of its Phase 1b/2 clinical trial of AST-008 is still expected to begin in 2nd quarter

- Research labs open for critical R&D activity; progress continues on Friedreich’s Ataxia development and collaboration programs

- Preliminary unaudited cash, cash equivalents, and short-term investments as of February 29, 2020 was $107.7 million

CHICAGO and Cambridge, Mass.—March 30, 2020—Exicure, Inc. (NASDAQ:XCUR), the pioneer in gene regulatory and immunotherapeutic drugs utilizing spherical nucleic acid (SNA™) technology, today provided an update on the company’s operations in response to the global COVID-19 pandemic and the company’s current evaluation of the impact the pandemic may have on the company’s clinical trials, preclinical research and development (R&D) and general business operations.

“Exicure is carefully monitoring the developing COVID-19 crisis and we have taken active measures, both as required by government regulation and as judgement suggests, to protect the health of our employees, their families, our communities, as well as clinical trial investigators, patients, and caregivers,” said Dr. David Giljohann, Exicure’s Chief Executive Officer. “While health and safety are our first priorities, we also have a strong commitment to our fundamental mission of serving patients with unmet medical needs. We are taking appropriate actions to continue our critical research and development programs and are grateful to our employees and their families for their commitment to this mission.”

Employees and Business Operations

On March 21, 2020, Governor Pritzker of Illinois announced a “stay-at-home” order restricting all Illinois residents to their homes, with few limited exceptions, until at least April 7, 2020. However, the Governor also designated certain businesses, such as biotechnology companies, as “essential” businesses, thereby permitting Exicure to continue its R&D operations. The Company continues to pursue its pre-clinical development programs and clinical programs as further described below.

AST-008, for Immuno-oncology

Exicure continues to monitor its ongoing trial of AST-008. As previously disclosed, the company is completing the Phase 1b stage of its Phase 1b/2 clinical trial of AST-008 in both Merkel cell carcinoma and in cutaneous squamous cell carcinoma and is preparing to begin the Phase 2 stage of dose expansion for intratumoral AST-008 in patients with advanced or metastatic Merkel cell carcinoma or cutaneous squamous cell carcinoma. At this time, and given the severity of both of these indications, Exicure continues to believe that the Phase 2 stage of the trial will begin as expected in the second quarter of 2020. Exicure currently has seven trial sites open. The company continues to be in close communication with its clinical sites and, among other things, has confirmed that AST-008 is available for conduct of the trial at each of the sites. Exicure remains committed to maintaining its development plans of AST-008 and continues to monitor the rapidly evolving situation.

AST-008, as an immune system adjuvant

In 2015, Exicure scientists published experimental results examining the potential of immuno-stimulatory SNAs such as AST-008 to function as vaccine adjuvants. Those published studies demonstrated that immuno-stimulatory, SNA-based, adjuvants induced a significant and desired immunological memory response to a model peptide in mice, indicating that SNAs may be useful in vaccines. Exicure is considering various tactics for advancing this feature of the SNA platform and the potential for collaboration with government agencies and pharmaceutical companies in the vaccine space.

Neurology

Exicure’s pre-clinical development program in Friedreich’s ataxia is being conducted in the company’s R&D labs. Preclinical research is ongoing. The company affirms its guidance that IND-enabling studies for XCUR-FXN are expected in late 2020.

Collaborations

As previously disclosed, Exicure entered into a collaboration with Allergan Pharmaceuticals International Limited in late 2019 to pursue preclinical research and discovery in two pre-clinical programs related to the treatment of hair loss disorders. R&D activities continue to progress under this collaboration and, as of the date of this press release, there is no current anticipated effect on these activities. In early 2019, Exicure entered into a collaboration agreement with Dermelix Biotherapeutics under which Dermelix will develop a targeted therapy for the treatment of Netherton Syndrome (NS). As of the date of this press release, preclinical R&D activities under this collaboration remain ongoing.

Cash Position

The company is currently evaluating the impact of COVID-19 on its 2020 financial guidance and expects to provide more detail, to the extent practicable, in connection with its first quarter 2020 earnings update.

Exicure does not anticipate a change to its prior guidance and continues to believes its current cash will finance operations into early 2022. Preliminary unaudited cash, cash equivalents and short-term investments as of February 29, 2020 was approximately $107.7 million.

About Exicure

Exicure, Inc. is a clinical-stage biotechnology company developing therapeutics for neurology, immuno-oncology, inflammatory diseases and other genetic disorders based on our proprietary Spherical Nucleic Acid, or SNA technology. Exicure believes that its proprietary SNA architecture has distinct chemical and biological properties that may provide advantages over other nucleic acid therapeutics and may have therapeutic potential to target diseases not typically addressed with other nucleic acid therapeutics. Exicure is in preclinical development of XCUR-FXN, an SNA-based therapeutic candidate for the treatment of Friedreich’s ataxia (FA). Exicure's drug candidate AST-008 is currently in a Phase 1b/2 clinical trial in patients with advanced solid tumors. Exicure is based outside of Chicago, IL and also has an office in Cambridge, MA.

For more information, visit Exicure’s website at www.exicuretx.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical fact could be deemed forward looking including, but not limited to, statements about the company’s financial condition, preliminary unaudited financial information and cash runway; its plans, initiatives and expectations in light of and in response to the COVID-19 pandemic and its impacts on global healthcare systems and business; its plans for development of AST-008, including its Phase 1b/2 clinical trial; the ability for use of AST-008 to function as an immune system vaccine adjuvant as well as the intent and potential to pursue collaborations for further development of AST-008; the timing of the company’s clinical development including its expectation that it will start dosing patients in the Phase 2 stage of its Phase 1b/2 clinical trial in the second quarter of 2020; the anticipated timing of clinical developments and the timing and results of clinical studies, including with respect the impact of COVID-19 on XCUR-FXN; the potential of the company’s collaborations and R&D efforts; the expected timing of guidance on the company’s financial outlook and the assessment and timing of the company’s employees returning to normal work practices. The forward-looking statements in this press release speak only as of the date of this press release, and

the company undertakes no obligation to update these forward-looking statements. Forward-looking statements are based on management’s current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the risks that the COVID-19 pandemic may disrupt the company’s business and/or the global healthcare system more severely than anticipated, which may have the effect of further delaying our ability to enroll and complete our ongoing Phase 1b/2 clinical trial, unexpected costs, charges or expenses that reduce cash runway; that the company’s pre-clinical or clinical programs do not advance or result in approved products on a timely or cost effective basis or at all; the cost, timing and results of clinical trials; that many drug candidates do not become approved drugs on a timely or cost effective basis or at all; the ability to enroll patients in clinical trials; possible safety and efficacy concerns; regulatory developments; and the ability of Exicure to protect its intellectual property rights. Furthermore, data from preclinical studies often fails to be indicative of outcomes in human trials. For a discussion of other risks and uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section entitled “Risk Factors” in our most recent Form 10-K, as well as discussions of potential risks, uncertainties, and other important factors in our subsequent filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and Exicure undertakes no duty to update this information, except as required by law. In addition, the COVID-19 pandemic and the associated containment efforts have had a serious adverse impact on the economy, the severity and duration of which are uncertain. Government stabilization efforts will only partially mitigate the consequences. The extent and duration of the impact on the company’s business and operations is highly uncertain, and that impact includes effects on its clinical trial operations and supply chain. Factors that will influence the impact on the company’s business and operations include the duration and extent of the pandemic, the extent of imposed or recommended containment and mitigation measures, and the general economic consequences of the pandemic. The pandemic could have a material adverse impact on the company’s business, operations and financial results for an extended period of time.

Media Contact:

MacDougall

Karen Sharma

781-235-3060

ksharma@macbiocom.com