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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, Mass.–(BUSINESS WIRE)–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

Recent Corporate Updates

Third Quarter 2021 Financial Results

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.

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.

 

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

 

 
 

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

 

 

Contacts

Investor and Media Contact:
Matthew DeYoung

Argot Partners

212-600-1902 | aura@argotpartners.com

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