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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 24, 2021

 

 

Aura Biosciences, Inc.

(Exact name of Registrant as Specified in Its Charter)

 

 

Delaware			001-40971	32-0271970
(State or Other Jurisdiction of Incorporation)			(Commission File Number)	(IRS Employer Identification No.)
85 Bolton Street
Cambridge, Massachusetts				02140
(Address of Principal Executive Offices)				(Zip Code)

 

Registrant’s Telephone Number, Including Area Code: 617 500-8864

 

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(s)		Name of each exchange on which registered
Common Stock, $0.00001 par value per share		AURA		The NASDAQ Global 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. ☐

 

 

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Item 2.02 Results of Operations and Financial Condition.

On November 24, 2021, Aura Biosciences Inc, issued a press release announcing its financial results for the quarter ended September 30, 2021. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.

The information in this Form 8-K, including Exhibit 99.1 hereto, 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 in any filing under the Securities Act of 1933, as amended, 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 Dated November 24, 2021
104	Cover Page Interactive Data File (embedded within Inline XBRL document)

 

 

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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 thereunto duly authorized.

 

			Aura Biosciences, Inc.
Date:	November 24, 2021	By:	/s/ Julie Feder
			Julie Feder Chief Financial Officer

 

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Exhibit 99.1

 

Aura Biosciences Reports Third Quarter 2021 Financial Results and Provides Clinical Development and Operational Highlights

 

Presented Final Data from Phase 1b/2 Trial of AU-011 in Choroidal Melanoma at the American Academy of Ophthalmology’s Annual Meeting

 

Completed Initial Public Offering to Fund Pivotal Program for AU-011 in Choroidal Melanoma and Earlier Stage Oncology Pipeline

 

CAMBRIDGE, MA – November 24, 2021 – Aura Biosciences Inc. (NASDAQ: AURA), a clinical-stage biotechnology company developing a novel class of virus-like drug conjugate (VDC) therapies for multiple oncology indications including ocular and urologic cancers, today announced financial results for the third quarter ended September 30, 2021.

 

“We recently completed a successful initial public offering, placing us in a solid financial position to advance our lead VDC, AU-011, through pivotal development for our first indication in the ocular oncology franchise,” said Elisabet de los Pinos, Ph.D., Chief Executive Officer of Aura. “We are very encouraged with the final data from the Phase 1b/2 trial with intravitreal administration that was presented by Dr. Carol Shields at the AAO annual meeting last week, as well as the continued favorable safety and tolerability profile of the ongoing Phase 2 study with suprachoroidal administration. These data support our plan to move into the pivotal program in 2022 with the goal to develop the first targeted therapy for patients with indeterminate lesions and small choroidal melanoma.

 

Dr. Pinos continued: “We are also excited to work toward unlocking the broad oncology potential of the VDC platform and plan to initiate clinical development in non-muscle invasive bladder cancer during the second half of next year. Supporting the advancement of our programs, we have a robust balance sheet and a strong team, which we recently built out with several key additions to our management team and Board of Directors.”

 

Recent Pipeline Developments

 

 

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Recent Corporate Updates

 

 

 

 

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Third Quarter 2021 Financial Results

 

 

 

 

 

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About Aura Biosciences

 

Aura Biosciences, Inc. is a clinical-stage biotechnology company developing a novel class of virus-like drug conjugate (VDC) therapies for multiple oncology indications including ocular and urologic cancers. Aura’s technology utilizes VDCs to target and destroy cancer cells selectively while activating the immune system to create long lasting anti-tumor immunity. The company has the goal of developing this technology in multiple cancer indications with an initial focus in ocular oncology, life-threatening eye cancers, the majority of which have no approved drugs available for treatment. Aura’s lead product candidate belzupacap sarotalocan (AU-011) is currently in Phase 2 development for the first line treatment of indeterminate lesions and small choroidal melanoma, a vision- and life-threatening form of eye cancer where standard of care radioactive treatment leaves patients with major vision loss and severe comorbidities. AU-011 was well tolerated in a Phase 1b/2 trial, demonstrating a statistically significant growth rate reduction in patients with prior active growth and high levels of tumor control with visual acuity preservation in a majority of patients. We believe these data provide the potential to introduce a new standard of care in choroidal melanoma and treat patients with early-identified lesions for whom no treatments are currently available. Future clinical development for AU-011 is planned throughout ocular oncology, including in choroidal metastases where Aura expects to file an IND during the second half of 2022. The unique mechanism of action of Aura’s HSPG-targeting VDCs also enables development of AU-011 as a platform broadly across multiple solid tumors; the first clinical trial of AU-011 outside ocular oncology is planned for the second half of 2022 in non-muscle invasive bladder cancer, a high unmet medical need where patients have poor treatment options and tumor progression leads to cystectomy (bladder removal) and a high risk of metastases. Future pipeline growth is expected to include additional drug conjugates for broad oncology applications. Aura is headquartered in Cambridge, MA.

 

Forward Looking Statement

This press release may contain forward-looking statements and information within the meaning of The Private Securities Litigation Reform Act of 1995 and other federal securities laws. Any statements that are not statements of historical fact may be deemed to be forward looking statements. Words such as “may,” “will,” “could”, “should,” “expects,” “intends,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “projects,” “seeks,” “endeavor,” “potential,” “continue” or the negative of such words or other similar expressions that can be used to identify forward-looking statements. These forward looking statements include express or implied statements regarding Aura’s future expectations, plans and prospects, including, without limitation, statements regarding expectations and plans for presenting clinical data, including of Phase 2 safety and efficacy data of AU-011 in SC administration, projections regarding Aura’s long-term growth, including having a cash runway into 2024, the anticipated timing of Aura’s clinical trials and regulatory filings, including for initiation of a pivotal program of AU-011 in indeterminate lesions and choroidal melanoma and of a Phase 1a trial of AU-011 in non-muscle invasive bladder cancer, the development of Aura’s product candidates and advancement of Aura’s clinical programs.

 

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The express or implied forward-looking statements included in this press release are only predictions and are subject to a number of risks, uncertainties and assumptions, including, without limitation: uncertainties inherent in clinical trials and in the availability and timing of data from ongoing clinical trials; whether interim results from a clinical trial, including the Phase 2 SC administration trial, will be predictive of the final results of the trial; whether results from pre-clinical studies or earlier clinical studies will be predictive of the results of future trials, including regarding AU-011’s ability to offer vision preserving therapy for the first line treatment of choroidal melanoma; the expected timing of the expansion phase of the Phase 2 SC administration trial; the expected timing for submissions for regulatory approval or review by governmental authorities; whether Aura will receive regulatory approvals to conduct trials or to market products; whether Aura’s cash resources will be sufficient to fund its foreseeable and unforeseeable operating expenses and capital expenditure requirements; risks, assumptions and uncertainties regarding the impact of the continuing COVID-19 pandemic on Aura’s business, operations, strategy, goals and anticipated timelines; Aura’s ongoing and planned pre-clinical activities; Aura’s ability to initiate, enroll, conduct or complete ongoing and planned clinical trials, Aura’s timelines for regulatory submissions; and Aura’s financial position. These and other risks and uncertainties are described more fully in the section titled “Risk Factors” set forth in Aura’s filings with the Securities and Exchange Commission. In light of these risks, uncertainties and assumptions, the forward-looking events and circumstances discussed in this press release may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements. You should not rely upon forward-looking statements as predictions of future events. Although Aura believes that the expectations reflected in the forward-looking statements are reasonable, it cannot guarantee that the future results, levels of activity, performance or events and circumstances reflected in the forward-looking statements will be achieved or occur. Moreover, except as required by law, neither Aura nor any other person assumes responsibility for the accuracy and completeness of the forward-looking statements included in this press release. Any forward-looking statement included in this press release speaks only as of the date on which it was made. Aura undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law.

 

Investor and Media Contact:

Matthew DeYoung

Argot Partners

212-600-1902 | aura@argotpartners.com

 

 

 

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Aura Biosciences, Inc.

Condensed Statement of Operations

(in thousands, except share and per share amounts)

 

		Three Months Ended September 30,								Nine Months Ended September 30,
		2021				2020				2021				2020
Operating Expenses:
Research and development		$	6,365			$	2,850			$	17,182			$	14,499
General and administrative			2,530				781				6,441				2,798
Total operating expenses			8,895				3,631				23,623				17,297
Total operating loss			8,895				3,631				23,623				17,297
Other income (expense):
Change in fair value of warrant liability			-				-				1				-
Change in fair value of derivative liability			52				-				-				-
Interest income (expense), including amortization    of discount			5				-				8				(2)
Loss from disposal of assets			-				-				(3)				-
Total other income (expense)			57				-				6				(2)
Net loss and comprehensive loss		$	(8,838)			$	(3,631)			$	(23,617)			$	(17,299)
Net loss attributable to common stockholders—    basic and diluted		$	(12,506)			$	(5,579)			$	(33,244)			$	(23,101)
Net loss per share attributable to common stockholders—    basic and diluted			(28.33)				(14.81)				(77.93)				(63.69)
Weighted average common stock outstanding—    basic and diluted			441,448				376,738				426,604				362,735

 

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Aura Biosciences, Inc.

Condensed Balance Sheets

(in thousands, except share and per share amounts)

 

		As of
		September 30, 2021				December 31, 2020
Assets
Current assets:
Cash and cash equivalents		$	81,829			$	17,393
Restricted cash and deposits			20				19
Prepaid expenses and other current assets			1,609				1,043
Total current assets			83,458				18,455
Restricted cash and deposits, net of current portion			125				75
Right of use assets - operating lease			1,096				-
Property and equipment, net			4,442				3,574
Deferred offering costs			1,583				-
Total Assets		$	90,704			$	22,104
Liabilities, Convertible Preferred Stock, and Stockholders’ Deficit
Current liabilities:
Accounts payable			1,736				611
Current portion of operating lease liabilities			607				-
Accrued expenses and other current liabilities			3,488				2,050
Total current liabilities			5,831				2,661
Deferred rent			-				8
Operating lease liabilities, net of current portion			513				-
Warrant liability			71				72
Total Liabilities			6,415				2,741
Commitments and Contingencies (Note 12)
Series A convertible preferred stock, $0.00001 par value, 1,701,141 shares authorized, issued and outstanding at September 30, 2021 and December 31, 2020, respectively, and a liquidation preference of $3,403 at September 30, 2021 and December 31, 2020, respectively			3,368				3,368
Series A-1 convertible preferred stock, $0.00001 par value, 3,298,732 shares authorized, issued, and outstanding at September 30, 2021 and December 31, 2020, respectively, and a liquidation preference of $8,196 at September 30, 2021 and December 31, 2020, respectively			7,837				7,837
Series A-2 convertible preferred stock, $0.00001 par value, 4,325,021 shares authorized, and 4,324,998 shares issued and outstanding at September 30, 2021 and December 31, 2020, respectively, and a liquidation preference of $5,373 at September 30, 2021 and December 31, 2020, respectively			5,373				5,373
Series B convertible preferred stock, $0.00001 par value, 22,705,646 shares authorized, and 22,531,819 shares issued and outstanding at September 30, 2021 and December 31, 2020, respectively, and a liquidation preference of $38,894 and $37,429 at September 30, 2021 and December 31, 2020, respectively			20,806				20,806
Series C-1 convertible preferred stock, $0.00001 par value, 58,109,711 shares authorized, issued and outstanding at September 30, 2021 and December 31, 2020, respectively, and a liquidation preference of $37,736 and $36,150 at September 30, 2021 and December 31, 2020, respectively			29,353				29,353
Series C-2 convertible preferred stock, $0.00001 par value, 33,218,192 shares authorized, issued and outstanding at September 30, 2021 and December 31, 2020, respectively, and a liquidation preference of $15,332 and $14,697 at September 30, 2021 and December 31, 2020, respectively			11,746				11,746
Series D-1 convertible preferred stock, $0.00001 par value, 57,878,742 shares authorized, issued and outstanding at September 30, 2021 and December 31, 2020, respectively, and a liquidation preference of $46,003 and $43,908 at September 30, 2021 and December 31, 2020, respectively			39,686				39,686
Series D-2 convertible preferred stock, $0.00001 par value, 24,598,481 shares authorized, and 24,598,481 and 14,469,710 issued and outstanding at September 30, 2021 and December 31, 2020, respectively, and a liquidation preference of $17,982 and $10,176 at September 30, 2021 and December 31, 2020, respectively			16,889				9,907
Series E convertible preferred stock, $0.00001 par value, 102,671,041 shares authorized, issued and outstanding at September 30, 2021, and a liquidation preference of $83,525 at September 30, 2021; no shares authorized, issued or outstanding at December 31, 2020, respectively			80,246				-
Stockholders’ Deficit:
Common stock, $0.00001 par value, 470,183,383 and 232,697,999 authorized at September 30, 2021 and December 31, 2020, and 442,717 and 381,123 shares issued and outstanding at September 30, 2021 and December 31, 2020, respectively			-				-
Additional paid-in capital			9,488				8,173
Accumulated deficit			(140,503)				(116,886)
Total Stockholders’ Deficit			(131,015)				(108,713)
Total Liabilities, Convertible Preferred Stock, and Stockholders’ Deficit		$	90,704			$	22,104

 

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