AXDX Accelerate Diagnostics Inc

 

 

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)

December 11, 2023

 

Accelerate Diagnostics, Inc.

(Exact name of registrant as specified in its charter)

 

Delaware

(State or other jurisdiction of incorporation)

 

001-31822		84-1072256
(Commission File Number)		(IRS Employer Identification No.)

 

3950 South Country Club Road, Suite 470, Tucson, Arizona		85714
(Address of principal executive offices)		(Zip Code)

 

(520) 365-3100

(Registrant’s telephone number, including area code)

 

Not Applicable

(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:

 

¨	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	Name of each exchange on which registered
Common Stock, $0.001 par value per share	AXDX	The Nasdaq Stock Market LLC (The Nasdaq Capital Market)

 

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 1.01 Entry into a Material Definitive Agreement.

 

On December 12, 2023, Accelerate Diagnostics, Inc. (the “Company”) entered into the First Amendment to Securities Purchase Agreement (the “SPA Amendment”), with the Jack W. Schuler Living Trust (the “Investor”). The SPA Amendment amends the Securities Purchase Agreement between the Company and the Investor, dated as of June 9, 2023 (the “SPA”). The SPA Amendment, among other things, extends the date by which the Investor is required to backstop an underwritten offering by the Company from December 15, 2023 to February 15, 2024. In addition, the SPA Amendment provides that if the Company elects to conduct a public offering of common stock and other investors purchase at least $10.0 million of shares of common stock by February 15, 2024, the Investor has agreed to purchase $2.0 million shares of common stock at the public offering price in the backstopped offering. The previous backstop commitment of $10.0 million has not changed.

 

Additionally, on December 11, 2023, the Company entered into the First Amendment to the Note Purchase Agreement (the “NPA Amendment”), with the investors party thereto constituting Majority Investors (as defined in the NPA Amendment). The NPA Amendment amends the Note Purchase Agreement, dated as of June 9, 2023. Pursuant to the NPA Amendment, the date by which the Company is to consummate the transactions contemplated by the SPA was extended from December 15, 2023 to February 15, 2024.

 

Furthermore, on December 11, 2023, the Company entered into the First Amendment to the Note Exchange Agreement (the “NEA Amendment”), with the investors party thereto constituting Majority Investors (as defined in the NEA Amendment). The NEA Amendment amends the Note Exchange Agreement, dated as of June 9, 2023. Pursuant to the NEA Amendment, the date by which the Company is to consummate the transactions contemplated by the SPA was extended from December 15, 2023 to February 15, 2024.

 

A copy of each of the SPA Amendment, the NPA Amendment and the NEA Amendment is filed with this Current Report on Form 8-K as Exhibits 10.1, 10.2 and 10.3, respectively, and is incorporated herein by reference, and the foregoing descriptions of the SPA Amendment, the NPA Amendment and the NEA Amendment are qualified in their entirety by reference thereto.

 

Item 7.01. Regulation FD Disclosure.

 

The Company is providing an updated corporate presentation to include information regarding the Company’s Accelerate Wave™ system, a copy of which is attached to this Current Report on Form 8-K as Exhibit 99.1.

 

This information contained in this Item 7.01 of this Current Report on Form 8-K and the presentation attached hereto as Exhibit 99.1 are being furnished to the Securities and Exchange Commission and shall not be deemed to be “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, and such information shall not be deemed to be 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.

 

The Company is providing the following update on the Accelerate Wave™ system:

 

While we will continue to seek ways to improve the utility of our existing products, the primary focus of our current research and development efforts is our next generation antibiotic susceptibility testing (“AST”) platform, Accelerate Wave, which is being developed with the goal to have lower cost, higher throughput, and the capability to test a broader set of sample types when compared to our Accelerate Pheno^® system.

 

The Accelerate Wave system, currently in development, performs AST directly from positive blood culture (“PBC”) bottles and bacterial isolate colonies (“Isolates”) to report minimum inhibitory concentrations (“MICs”) with a goal of delivering results within 4.5 hours. The fully automated system is based on the principle of digital holographic microscopy, which allows for simultaneous volumetric imaging of a sample suspension at a high spatial resolution, enabling direct observation of phenotypic responses of individual bacterial cells in relatively short time periods versus more traditional AST methods. The Accelerate Wave system uses a time series of holograms to provide microbial quantitation under antimicrobial stress, enabling rapid determination of minimum inhibitory concentration. Additionally, Accelerate Wave holograms provide morphological information at the level of individual cells. For some bug-drug combinations morphology is a leading indicator of future MIC.

 

 

A key differentiator of the Accelerate Wave system to current on-market and emerging AST competitors is the system’s ability to process PBC as well as Isolates AST diagnostics results. Our initial launch of menu items will include a PBC assay that can be run on the Accelerate Wave system. This will be followed by development of an Isolate assay. Our ability to process Isolates with the Wave system expands our addressable market today with our Accelerate Pheno system and Accelerate Arc^TM Products with PBC samples to include a much larger sample volumes segment of the market, Isolates within the microbiology testing market. Based on our on-market experience with our Accelerate Pheno system, we see significant workflow benefits to microbiology labs by offering consolidated PBC and Isolate susceptibility testing on to a single, rapid, AST diagnostic. Further, recent voice-of-customer interviews highlight the value that Accelerate Wave brings to the global marketplace with a high percentage of interviewed customers expressing interest in evaluating Wave once available. The Accelerate Wave system AST modules will be able to test five-to-ten assays per module and can scale to have 5 modules per system which will address the vast majority of microbiology lab volumes and workflows. Additionally, the cost to produce Accelerate Wave assays will be significantly lower than our standard costing for the Accelerate PhenoTest^TM BC Kit which could improve the Company’s margin profile as we seek FDA regulatory clearance for the Accelerate Wave system and assays.

 

Item 9.01. Financial Statements and Exhibits.

 

(d)              Exhibits.

 

Exhibit  Number		Description
10.1		First Amendment to Securities Purchase Agreement, dated December 12, 2023, between the Company and the Jack W. Schuler Living Trust.
10.2		First Amendment to Note Purchase Agreement, dated December 11, 2023, between the Company and certain investors named therein.
10.3		First Amendment to Note Exchange Agreement, dated December 11, 2023, between the Company and certain investors named therein.
99.1		Accelerate Diagnostics, Inc., Investor Presentation, dated December 2023.
104		Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

 

SIGNATURES

 

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

 

	ACCELERATE DIAGNOSTICS, INC.
	(Registrant)
Date: December 13, 2023
	/s/ David Patience
	David Patience
	Chief Financial Officer

 

 

 

Exhibit 10.1

 

FIRST AMENDMENT TO

SECURITIES PURCHASE AGREEMENT

 

Accelerate Diagnostics, Inc. and Jack W. Schuler Living Trust

 

This amendment (this “Amendment”) to the Securities Purchase Agreement by and among Accelerate Diagnostics, Inc., a Delaware corporation (the “Company”), and the Jack W. Schuler Living Trust (including its successors and assigns, the “Investor”) dated as of June 9, 2023 (the “Agreement”), is dated as of December 12, 2023.

 

WHEREAS, pursuant to Section 6.4 of the Agreement, any provision of the Agreement may be waived or amended if, and only if, such waiver or amendment is in writing and signed by the Company and the Investor;

 

WHEREAS the Investor and the Company wish to extend the Closing Date of the Agreement.

 

NOW, THEREFORE, IN CONSIDERATION of the mutual covenants contained in this Agreement, and for other good and valuable consideration the receipt and adequacy of which are hereby acknowledged, the Company and the Investor agree as follows:

 

1.            Closing Date. The definition of Closing Date set forth in Section 1.1 of the Agreement is hereby amended and restated in its entirety as follows:

 

“Closing Date” means a date on or prior to February 15, 2024, that is (i) in the case of the purchase of the Securities pursuant to the Fixed Commitment, the closing date specified by the Company in its request to the Investor pursuant to Section 2.1(a) (which request shall be made no less than two nor more than 10 Business Days prior to such specified closing date, but no later than 5:00 p.m. Central Standard Time on February 12, 2024), or (ii) in the case of the purchase of the Securities pursuant to the Backstopped Commitment, the closing date of the Backstopped Offering.

 

2.            Backstopped Offering. Sections 2.1(b) and (c) of the Agreement are hereby amended and restated in its entirety as follows:

 

(b)            Provided that the Company has not requested the Investor to purchase shares of Common Stock pursuant to the Fixed Commitment set forth in Section 2.1(a), the Investor shall backstop the underwritten public offering (the “Backstopped Offering”) by the Company of Common Stock for gross proceeds of a maximum of $10 million in accordance with the following provisions (the “Backstop Commitment”):

 

(i)            If the Company shall obtain purchase commitments in such Backstopped Offering and the aggregate amount of such commitments total to at least $10 million by February 15, 2024, then, regardless of the aggregate amount of purchase commitments in such Backstopped Offering, the Investor shall, pursuant to the Backstop Commitment, be required to purchase, at a price per share equal to the public offering price for the Backstopped Offering, a number of shares of Common Stock of the Company equal to the quotient obtained by dividing (x) $2 million, by (y) the public offering price for the Backstopped Offering.

 

 

(ii)            If Company shall obtain purchase commitments in such Backstopped Offering and the aggregate of such commitments total to less than $10 million by February 15, 2024, then the Investor shall, pursuant to the Backstop Commitment, be required to purchase, at a price per share equal to the public offering price for the Backstopped Offering, a number of shares of Common Stock of the Company equal to the quotient obtained by dividing (x) the difference between $10 million and the aggregate dollar amount of the purchase commitments that the Company shall have received from investors pursuant to the Backstopped Offering, by (y) the public offering price for the Backstopped Offering.

 

(iii)            If the Company shall fail to obtain any purchase commitments pursuant to the Backstopped Offering by February 15, 2024, then the Investor shall, pursuant to the Backstop Commitment, purchase such shares of Common Stock equal to the quotient obtained by dividing (x) $10 million, by (y) the public offering price for the Backstopped Offering.

 

The aggregate purchase price paid by the Investor for shares of Common Stock pursuant to the Backstop Commitment is herein referred to as the “Backstopped Amount.”

 

(c)            In the event that the Company shall engage in a Backstopped Offering, the Investor shall have the right, but not the obligation, to purchase, on the Closing Date, at a price per share equal to the public offering price, a number of shares of Common Stock equal to the quotient obtained by dividing (x) the difference between $10 million and the Backstopped Amount, by (y) the public offering price for the Backstopped Offering; provided that if the Backstopped Amount is $10 million, then the Investor shall not have any right to purchase additional shares pursuant to this Section 2.1(c).

 

3.            Termination. Section 6.5 of the Agreement is hereby amended and restated in its entirety as follows:

 

Termination. This Agreement may be terminated prior to the Closing Date by written agreement of the Investor and the Company. In addition, this Agreement shall terminate effective as of February 13, 2024, if by 5:00 p.m. Central Standard Time on February 12, 2024 the Company shall not have requested the Investor to purchase Securities or to fulfill its Backstop Commitment in accordance with the provisions of Section 2.1 hereof. Upon a termination in accordance with this Section 6.5, the Company and the Investor shall not have any further obligation or liability (including as arising from such termination) to the other.

 

 

4.            Capitalized terms not defined herein shall have the meeting set forth in the Agreement. Except as expressly amended by this Amendment, the Agreement shall remain in full force and effect and be enforceable against the parties in accordance with its terms. This Amendment may be executed in any number of counterparts, each of which shall be an original but all of which together shall constitute one and the same instrument, binding on all of the parties notwithstanding that all such parties have not signed the same counterpart. Delivery of an executed counterpart of a signature page to this Agreement by electronic mail transmission of a “.pdf” or other similar data file shall be effective as delivery of a manually executed counterpart to this Amendment. For clarity, this Amendment shall be governed by all provisions of the Agreement (other than as the Agreement is specifically amended herein), unless the context otherwise requires, including (but not limited to) all provisions concerning construction, notices, governing law, jurisdiction, waiver of jury trial and confidentiality, mutatis mutandis.

 

(Signature Page Follows)

 

 

IN WITNESS WHEREOF, the parties hereto have caused this First Amendment to be duly executed by their respective authorized signatories as of December 11, 2023.

	COMPANY:
	ACCELERATE DIAGNOSTICS, INC.,
	a Delaware corporation
	/s/ Jack Phillips
	Name:	Jack Phillips
	Title:	President & CEO
	INVESTOR:
	Jack W. Schuler Living Trust
	/s/ Jack W. Schuler
	Name: Jack W. Schuler

 

 

 

Exhibit 10.2

 

FIRST AMENDMENT TO

NOTE Purchase AGREEMENT

 

This First Amendment to Note Purchase Agreement (this “Amendment”), dated as of December 11, 2023, is entered into by and between Accelerate Diagnostics, Inc., a Delaware corporation (the “Company”), and the undersigned investors constituting Majority Investors.

 

WHEREAS, reference is made to that certain Note Purchase Agreement, dated as of June 9, 2023 (as may have been amended, supplemented or otherwise modified and as may be amended, supplemented or otherwise modified from time to time, the “Note Purchase Agreement”), by and between the Company and the other parties thereto;

 

WHEREAS, all capitalized terms used by not otherwise defined herein shall have the respective meanings ascribed to such terms in the Note Purchase Agreement;

 

WHEREAS, pursuant to Section 7.8 of the Note Purchase Agreement, any provision of the Note Purchase Agreement may be waived or amended if, and only if, such waiver or amendment is in writing and signed by the Company and the Majority Investors; and

 

WHEREAS, the parties desire to amend the Note Purchase Agreement as set forth herein.

 

NOW, THEREFORE, in consideration of the foregoing premises and for other good and valuable consideration, the sufficiency of which is hereby acknowledged, the parties hereto hereby agree to the following:

 

1.            Defined Terms. As used in this Amendment, the following terms shall have the respective meanings set forth below.

 

(a)

“New Securities Purchase Agreement Amendment” shall mean an amendment to the New Securities Purchase Agreement (as defined in the RSA), which will (i) change the “Closing Date” under the New Securities Purchase Agreement to February 15, 2024 and (ii) amend the terms of the Backstopped Offering (as defined in the New Securities Purchase Agreement) in a manner that is acceptable to the Majority Investors.

 

2.            New Securities Purchase Agreement. Section 5.13 of the Note Purchase Agreement is hereby amended and restated as follows:

 

“New Securities Purchase Agreement. The Company shall consummate the transactions envisioned by the New Securities Purchase Agreement (as defined in the RSA) with the Jack W. Schuler Living Trust no later than February 15, 2024, unless such date is amended by the written consent of the Majority Investors.”

 

 

3.             Conditions Precedent to Effectiveness. This Amendment shall be effective on the date (the “Amendment Effective Date”) on which the following conditions shall have been satisfied or waived by the Majority Investors:

 

(a)

This Amendment is duly executed by the Company and the Majority Investors.

 

(b)

The Company shall have entered into the New Securities Purchase Agreement Amendment with the Jack W. Schuler Living Trust in a form and substance acceptable to the Majority Investors.

 

4.             Effect of Amendment. Except as expressly amended by this Amendment, the Note Purchase Agreement shall remain in full force and effect and be enforceable against the Parties in accordance with its terms. This Amendment may be executed in any number of counterparts, each of which shall be an original but all of which together shall constitute one and the same instrument, binding on all of the Parties notwithstanding that all such Parties have not signed the same counterpart. Delivery of an executed counterpart of a signature page to this Agreement by electronic mail transmission of a “.pdf” or other similar data file shall be effective as delivery of a manually executed counterpart to this Amendment. For clarity, this Amendment shall be governed by all provisions of the Purchase Agreement (other than as the Note Purchase Agreement is specifically amended herein), unless the context otherwise requires, including (but not limited to) all provisions concerning construction, notices, governing law, jurisdiction, waiver of jury trial and confidentiality, mutatis mutandis.

 

(Remainder of page intentionally left blank)

 

 

IN WITNESS WHEREOF, each of undersigned has caused this Amendment to be duly executed as of the date written above.

 

	THE COMPANY:
	Accelerate Diagnostics, Inc.
	By:	/s/ Jack Phillips
		Jack Phillips
		President and Chief Executive Officer
	MAJORITY INVESTORS:
	Streeterville Capital, LLC
	By:	/s/ John Fife
		John Fife
		President, Manager, and Secretary
	Indaba Capital Management, L.P.
	By:	/s/ Derek Schrier
		Derek Schrier
		CIO and Partner

 

Signature Page to First Amendment to Note Purchase Agreement

 

 

 

Exhibit 10.3

 

FIRST AMENDMENT TO

Note Exchange AGREEMENT

 

This First Amendment to Note Exchange Agreement (this “Amendment”), dated as of December 11, 2023, is entered into by and between Accelerate Diagnostics, Inc., a Delaware corporation (the “Company”), and the undersigned investors constituting Majority Investors.

 

WHEREAS, reference is made to that certain Note Exchange Agreement, dated as of June 9, 2023 (as may have been amended, supplemented or otherwise modified and as may be amended, supplemented or otherwise modified from time to time, the “Note Exchange Agreement”), by and between the Company and the other parties thereto;

 

WHEREAS, all capitalized terms used by not otherwise defined herein shall have the respective meanings ascribed to such terms in the Note Exchange Agreement;

 

WHEREAS, pursuant to Section 7.8 of the Note Exchange Agreement, any provision of the Note Exchange Agreement may be waived or amended if, and only if, such waiver or amendment is in writing and signed by the Company and the Majority Investors; and

 

WHEREAS, the parties desire to amend the Note Exchange Agreement as set forth herein.

 

NOW, THEREFORE, in consideration of the foregoing premises and for other good and valuable consideration, the sufficiency of which is hereby acknowledged, the parties hereto hereby agree to the following:

 

1.            Defined Terms. As used in this Amendment, the following terms shall have the respective meanings set forth below.

 

(a)

“New Securities Purchase Agreement Amendment” shall mean an amendment to the New Securities Purchase Agreement (as defined in the RSA), which will (i) change the “Closing Date” under the New Securities Purchase Agreement to February 15, 2024 and (ii) amend the terms of the Backstopped Offering (as defined in the New Securities Purchase Agreement) in a manner that is acceptable to the Majority Investors.

 

2.            New Securities Purchase Agreement. Section 5.13 of the Note Exchange Agreement is hereby amended and restated as follows:

 

“New Securities Purchase Agreement. The Company shall consummate the transactions envisioned by the New Securities Purchase Agreement (as defined in the RSA) with the Jack W. Schuler Living Trust no later than February 15, 2024, unless such date is amended by the written consent of the Majority Investors.”

 

 

3.             Conditions Precedent to Effectiveness. This Amendment shall be effective on the date (the “Amendment Effective Date”) on which the following conditions shall have been satisfied or waived by the Majority Investors:

 

(a)

This Amendment is duly executed by the Company and the Majority Investors.

 

(b)

The Company shall have entered into the New Securities Purchase Agreement Amendment with the Jack W. Schuler Living Trust in a form and substance acceptable to the Majority Investors.

 

4.             Effect of Amendment. Except as expressly amended by this Amendment, the Note Exchange Agreement shall remain in full force and effect and be enforceable against the Parties in accordance with its terms. This Amendment may be executed in any number of counterparts, each of which shall be an original but all of which together shall constitute one and the same instrument, binding on all of the Parties notwithstanding that all such Parties have not signed the same counterpart. Delivery of an executed counterpart of a signature page to this Agreement by electronic mail transmission of a “.pdf” or other similar data file shall be effective as delivery of a manually executed counterpart to this Amendment. For clarity, this Amendment shall be governed by all provisions of the Note Exchange Agreement (other than as the Note Exchange Agreement is specifically amended herein), unless the context otherwise requires, including (but not limited to) all provisions concerning construction, notices, governing law, jurisdiction, waiver of jury trial and confidentiality, mutatis mutandis.

 

(Remainder of page intentionally left blank)

 

 

IN WITNESS WHEREOF, each of undersigned has caused this Amendment to be duly executed as of the date written above.

 

	THE COMPANY:
	Accelerate Diagnostics, Inc.
	By:	/s/ Jack Phillips
		Jack Phillips
		President and Chief Executive Officer
	MAJORITY INVESTORS:
	Streeterville Capital, LLC
	By:	/s/ John Fife
		John Fife
		President, Manager, and Secretary
	Indaba Capital Management, L.P.
	By:	/s/ Derek Schrier
		Derek Schrier
		CIO and Partner

 

Signature Page to First Amendment to Note Exchange Agreement

 

 

v3.23.3

Cover	Dec. 11, 2023
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Dec. 11, 2023
Entity File Number	001-31822
Entity Registrant Name	Accelerate Diagnostics, Inc.
Entity Central Index Key	0000727207
Entity Tax Identification Number	84-1072256
Entity Incorporation, State or Country Code	DE
Entity Address, Address Line One	3950 South Country Club Road
Entity Address, Address Line Two	Suite 470
Entity Address, City or Town	Tucson
Entity Address, State or Province	AZ
Entity Address, Postal Zip Code	85714
City Area Code	520
Local Phone Number	365-3100
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Title of 12(b) Security	Common Stock, $0.001 par value per share
Trading Symbol	AXDX
Security Exchange Name	NASDAQ
Entity Emerging Growth Company	false

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