10-Q
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,k

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 20549

 

FORM 10-Q

 

(Mark One)

QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended September 30, 2023

OR

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from ___________________ to ___________________

Commission File Number: 001-40971

 

AURA BIOSCIENCES, INC.

(Exact Name of Registrant as Specified in its Charter)

 

 

Delaware

32-0271970

(State or other jurisdiction of

incorporation or organization)

(I.R.S. Employer
Identification No.)

80 Guest Street

Boston, MA

02135

(Address of principal executive offices)

(Zip Code)

Registrant’s telephone number, including area code: (617) 500-8864

 

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

 

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 $0.00001 per share

 

AURA

 

Nasdaq Global Market LLC

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes No

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes No

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

 

Large accelerated filer

Accelerated filer

Non-accelerated filer

Smaller reporting company

 

 

 

 

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.

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes No

As of November 3, 2023, the registrant had 38,259,879 shares of common stock, $0.00001 par value per share, outstanding.

 

 

 

 


 

Summary of the Material Risks Associated with Our Business

 

Our business is subject to numerous material and other risks and uncertainties that you should be aware of in evaluating our business. These risks are described more fully in Part II, “Item 1A—Risk Factors,” and include, but are not limited to, the following:

We have incurred significant net losses since our inception and anticipate that we will continue to incur losses for the foreseeable future.
Raising additional capital may cause dilution to our existing stockholders, restrict our operations or require us to relinquish proprietary rights to our technologies or product candidates.
Our ability to generate revenue and achieve profitability depends significantly on our ability to achieve our objectives relating to the discovery, development and commercialization of our product candidates.
We are heavily dependent on the success of AU-011 or belzupacap sarotalocan, or bel-sar, our only product candidate to date.
If we are not able to obtain, or if there are delays in obtaining, required regulatory approvals for bel-sar, we will not be able to commercialize, or will be delayed in commercializing, our product candidates, and our ability to generate revenue will be materially impaired.
We have not yet successfully completed any pivotal clinical trials nor commercialized any pharmaceutical products, which may make it difficult to evaluate our future prospects.
If we fail to develop additional product candidates, or obtain additional indications of our first product candidate our commercial opportunity could be limited.
The FDA's agreement to a Special Protocol Assessment with respect to the study design of our Phase 3 clinical trial of bel-sar for the treatment of early-stage choroidal melanoma does not guarantee any particular outcome from regulatory review, including ultimate approval, and may not lead to a successful review or approval process.
We expect to rely on third parties to conduct our clinical trials and some aspects of our research and preclinical testing, and those third parties may not perform satisfactorily, including failing to meet deadlines for the completion of such trials, research or testing.
We currently rely on third-party contract manufacturing organizations, or CMOs, for the production of clinical supply of bel-sar and may continue to rely on CMOs for the production of commercial supply of bel-sar, if approved. This reliance on CMOs increases the risk that we will not have sufficient quantities of such materials, product candidates, or any therapies that we may develop and commercialize, or that such supply will not be available to us at an acceptable cost, which could delay, prevent, or impair our development or commercialization efforts.
If bel-sar or any future product candidates do not achieve broad market acceptance, the revenue that we generate from their sales may be limited, and we may never become profitable.
If the market opportunity for bel-sar is smaller than we estimate or if any regulatory approval that we obtain is based on a narrower definition of the patient population, our revenue and ability to achieve profitability will be adversely affected, possibly materially.
Our ability to compete may decline if we do not adequately protect our proprietary rights, and our proprietary rights do not necessarily address all potential threats to our competitive advantage.
If we lose key management personnel, or if we fail to recruit additional highly skilled personnel, our ability to pursue our business strategy will be impaired, could result in loss of markets or market share and could make us less competitive.
Business disruptions could seriously harm our future revenue and financial condition and increase our costs and expenses.
Our principal stockholders and management own a significant percentage of our stock and will be able to exert significant influence over matters subject to stockholder approval.

 

i


 

Special Note Regarding Forward-Looking Statements

 

This Quarterly Report on Form 10-Q, or the Quarterly Report, contains forward-looking statements which are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, or the or the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act. All statements other than statements of historical facts contained in this Quarterly Report are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “may”, “will”, “should”, “expects”, “intends”, “plans”, “anticipates”, “believes”, “estimates”, “predicts”, “potential”, “continue” or the negative of these terms or other comparable terminology. These statements are not guarantees of future results or performance and involve substantial risks and uncertainties. Forward-looking statements in this Quarterly Report include, but are not limited to, statements about:

the initiation, timing, progress, results, and cost of our research and development programs and our current and future preclinical studies and clinical trials, including statements regarding the timing of initiation and completion of studies or trials and related preparatory work, the period during which the results of the trials will become available, and our research and development programs;
our ability to efficiently develop our existing product candidates and discover new product candidates;
our ability to successfully manufacture our drug substances and product candidates for preclinical use, for clinical trials and on a larger scale for commercial use, if approved;
the ability and willingness of our third-party strategic collaborators to continue research and development activities relating to our development candidates and product candidates;
our ability to obtain funding for our operations necessary to complete further development and commercialization of our product candidates;
our ability to obtain and maintain regulatory approval of our product candidates;
our ability to commercialize our products, if approved;
the pricing and reimbursement of our product candidates, if approved;
the implementation of our business model, and strategic plans for our business and product candidates;
the scope of protection we are able to establish and maintain for intellectual property rights covering our product candidates;
estimates of our future expenses, revenues, capital requirements, and our needs for additional financing;
the potential benefits of strategic collaboration agreements, our ability to enter into strategic collaborations or arrangements, and our ability to attract collaborators with development, regulatory and commercialization expertise;
future agreements with third parties in connection with the commercialization of product candidates and any other approved product;
the size and growth potential of the markets for our product candidates, and our ability to serve those markets;
our financial performance;
the rate and degree of market acceptance of our product candidates;
regulatory developments in the United States and foreign countries;
our ability to produce our products or product candidates with advantages in turnaround times or manufacturing cost;
the success of competing therapies that are or may become available;
our ability to attract and retain key scientific or management personnel;
the impact of laws and regulations;
developments relating to our competitors and our industry;
the effects of macroeconomic conditions, including rising interest rates and inflation, on our business operations; and
other risks and uncertainties, including those listed under the caption “Risk Factors.”

ii


 

Table of Contents

 

 

 

Page

 

 

 

 

SUMMARY OF RISKS

i

 

 

 

PART I.

FINANCIAL INFORMATION

1

 

 

 

Item 1.

Financial Statements (Unaudited)

1

 

Condensed Consolidated Balance Sheets

1

 

Condensed Consolidated Statements of Operations and Comprehensive Loss

2

 

Condensed Consolidated Statements of Stockholders’ Equity

3

 

Condensed Consolidated Statements of Cash Flows

4

 

Notes to Unaudited Condensed Consolidated Financial Statements

5

Item 2.

Management’s Discussion and Analysis of Financial Condition and Results of Operations

17

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

26

Item 4.

Controls and Procedures

26

 

 

 

PART II.

OTHER INFORMATION

27

 

 

27

Item 1.

Legal Proceedings

27

Item 1A.

Risk Factors

27

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

71

Item 3.

Defaults Upon Senior Securities

71

Item 4.

Mine Safety Disclosures

71

Item 5.

Other Information

71

Item 6.

Exhibits

72

 

Signatures

73

 

iii


PART I—FINANCIAL INFORMATION

Item 1. Financial Statements.

Aura Biosciences, Inc.

Condensed Consolidated Balance Sheets

(Unaudited)

(in thousands, except share and per share amounts)

 

 

September 30, 2023

 

 

December 31, 2022

 

Assets

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

Cash and cash equivalents

 

$

55,584

 

 

$

121,582

 

Marketable securities

 

 

93,472

 

 

 

67,229

 

Restricted cash and deposits

 

 

20

 

 

 

20

 

Prepaid expenses and other current assets

 

 

4,812

 

 

 

7,871

 

Total current assets

 

 

153,888

 

 

 

196,702

 

Restricted cash and deposits, net of current portion

 

 

768

 

 

 

768

 

Right of use assets - operating lease

 

 

19,569

 

 

 

20,671

 

Other long-term assets

 

 

685

 

 

 

423

 

Property and equipment, net

 

 

4,856

 

 

 

5,371

 

Total Assets

 

$

179,766

 

 

$

223,935

 

Liabilities and Stockholders’ Equity

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

Accounts payable

 

 

1,490

 

 

 

2,921

 

Short-term operating lease liability

 

 

3,035

 

 

 

2,963

 

Accrued expenses and other current liabilities

 

 

6,369

 

 

 

4,573

 

Total current liabilities

 

 

10,894

 

 

 

10,457

 

Long-term operating lease liability

 

 

17,154

 

 

 

17,895

 

Total Liabilities

 

 

28,048

 

 

 

28,352

 

Commitments and Contingencies (Note 12)

 

 

 

 

 

 

Stockholders’ Equity:

 

 

 

 

 

 

Common stock, $0.00001 par value, 150,000,000 authorized at September 30, 2023 and December 31, 2022, and 38,216,717 and 37,771,918 shares issued and outstanding at September 30, 2023 and December 31, 2022, respectively

 

 

 

 

 

 

Additional paid-in capital

 

 

417,029

 

 

 

406,555

 

Accumulated deficit

 

 

(265,177

)

 

 

(210,900

)

Accumulated other comprehensive loss

 

 

(134

)

 

 

(72

)

Total Stockholders’ Equity

 

 

151,718

 

 

 

195,583

 

Total Liabilities and Stockholders’ Equity

 

$

179,766

 

 

$

223,935

 

 

 

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

1


Aura Biosciences, Inc.

Condensed Consolidated Statements of Operations and Comprehensive Loss

(Unaudited)

(in thousands, except share and per share data)

 

Three Months Ended
September 30,

 

 

 

Nine Months Ended
September 30,

 

 

2023

 

 

2022

 

 

 

2023

 

 

2022

 

Operating Expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

$

15,428

 

 

$

11,293

 

 

 

$

44,952

 

 

$

29,079

 

General and administrative

 

 

5,060

 

 

$

4,762

 

 

 

 

15,256

 

 

 

13,603

 

Total operating expenses

 

 

20,488

 

 

 

16,055

 

 

 

 

60,208

 

 

 

42,682

 

Total operating loss

 

 

(20,488

)

 

 

(16,055

)

 

 

 

(60,208

)

 

 

(42,682

)

Other income (expense):

 

 

 

 

 

 

 

 

 

 

 

 

 

Interest income, including amortization and accretion income

 

 

1,981

 

 

 

483

 

 

 

 

5,981

 

 

 

802

 

Other income (expense)

 

 

(5

)

 

 

(329

)

 

 

 

(50

)

 

 

(324

)

Total other income

 

 

1,976

 

 

 

154

 

 

 

 

5,931

 

 

 

478

 

Net loss

 

 

(18,512

)

 

 

(15,901

)

 

 

 

(54,277

)

 

 

(42,204

)

Net loss per common share—basic and diluted

 

 

(0.48

)

 

 

(0.54

)

 

 

 

(1.43

)

 

 

(1.44

)

Weighted average common stock outstanding—basic and diluted

 

 

38,185,197

 

 

 

29,273,577

 

 

 

 

37,943,139

 

 

 

29,246,449

 

Comprehensive loss:

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss

 

$

(18,512

)

 

$

(15,901

)

 

 

$

(54,277

)

 

$

(42,204

)

Other comprehensive items:

 

 

 

 

 

 

 

 

 

 

 

 

 

Unrealized gain (loss) on marketable securities

 

$

89

 

 

 

(19

)

 

 

 

(62

)

 

 

(147

)

Total other comprehensive income (loss)

 

 

89

 

 

 

(19

)

 

 

 

(62

)

 

 

(147

)

Total comprehensive loss

 

$

(18,423

)

 

$

(15,920

)

 

 

$

(54,339

)

 

$

(42,351

)

 

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

2


 

Aura Biosciences, Inc.

Condensed Consolidated Statements of Stockholders’ Equity

(Unaudited)

(in thousands, except share data)

 

 

 

 

 

Additional

 

 

Accumulated

 

Total

 

Common Stock

 

Paid-In

 

Accumulated

 

Other Comprehensive

 

Stockholders’

 

 

Shares

 

Amount

 

Capital

 

Deficit

 

Loss Amount

 

Equity

 

Balance, December 31, 2022

 

37,771,918

 

 

 

 

406,555

 

 

(210,900

)

 

(72

)

 

195,583

 

Stock-based compensation expense

 

 

 

 

 

1,913

 

 

 

 

 

 

1,913

 

Employee Stock Purchase Plan Issuance

 

6,635

 

 

 

 

56

 

 

 

 

 

 

56

 

Stock option exercises

 

21,549

 

 

 

 

145

 

 

 

 

 

 

145

 

Unrealized gain on marketable securities

 

 

 

 

 

 

 

 

 

27

 

 

27

 

Net loss

 

 

 

 

 

 

 

(17,466

)

 

 

 

(17,466

)

Balance, March 31, 2023

 

37,800,102

 

 

 

 

408,669

 

 

(228,366

)

 

(45

)

 

180,258

 

Stock-based compensation expense

 

 

 

 

 

1,931

 

 

 

 

 

 

1,931

 

Issuance of common stock under ATM facility

 

169,200

 

 

 

 

2,065

 

 

 

 

 

 

2,065

 

Stock option exercises

 

117,304

 

 

 

 

660

 

 

 

 

 

 

660

 

Unrealized loss on marketable securities

 

 

 

 

 

 

 

 

 

(178

)

 

(178

)

Net loss

 

 

 

 

 

 

 

(18,299

)

 

 

 

(18,299

)

Balance, June 30, 2023

 

38,086,606

 

 

 

 

413,325

 

 

(246,665

)

 

(223

)

 

166,437

 

Stock-based compensation expense

 

 

 

 

 

2,325

 

 

 

 

 

 

2,325

 

Employee Stock Purchase Plan Issuance

 

8,276

 

 

 

 

72

 

 

 

 

 

 

72

 

Issuance of common stock under ATM facility

 

92,607

 

 

 

 

1,105

 

 

 

 

 

 

1,105

 

Stock option exercises

 

29,228

 

 

 

 

202

 

 

 

 

 

 

202

 

Unrealized gain on marketable securities

 

 

 

 

 

 

 

 

 

89

 

 

89

 

Net loss

 

 

 

 

 

 

 

(18,512

)

 

 

 

(18,512

)

Balance, September 30, 2023

 

38,216,717

 

 

 

 

417,029

 

 

(265,177

)

 

(134

)

 

151,718

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Additional

 

 

Accumulated

 

Total

 

Common Stock

 

Paid-In

 

Accumulated

 

Other Comprehensive

 

Stockholders’

 

 

Shares

 

Amount

 

Capital

 

Deficit

 

Loss Amount

 

Equity

 

Balance, December 31, 2021

 

29,211,643

 

 

 

 

304,452

 

 

(152,137

)

 

 

 

152,315

 

Stock-based compensation expense

 

 

 

 

 

1,594

 

 

 

 

 

 

1,594

 

Stock option exercises

 

5,593

 

 

 

 

17

 

 

 

 

 

 

17

 

Unrealized loss on marketable securities

 

 

 

 

 

 

 

 

 

(5

)

 

(5

)

Net loss

 

 

 

 

 

 

 

(12,835

)

 

 

 

(12,835

)

Balance, March 31, 2022

 

29,217,236

 

 

 

 

306,063

 

 

(164,972

)

 

(5

)

 

141,086

 

Stock-based compensation expense

 

 

 

 

 

1,287

 

 

 

 

 

 

1,287

 

Stock option exercises

 

49,612

 

 

 

 

309

 

 

 

 

 

 

309

 

Unrealized loss on marketable securities

 

 

 

 

 

 

 

 

 

(123

)

 

(123

)

Net loss

 

 

 

 

 

 

 

(13,468

)

 

 

 

(13,468

)

Balance, June 30, 2022

 

29,266,848

 

 

 

 

307,659

 

 

(178,440

)

 

(128

)

 

129,091

 

Stock-based compensation expense

 

 

 

 

 

1,717

 

 

 

 

 

 

1,717

 

Stock option exercises

 

16,437

 

 

 

 

104

 

 

 

 

 

 

104

 

Other

 

 

 

 

 

62

 

 

 

 

 

 

62

 

Unrealized loss on marketable securities

 

 

 

 

 

 

 

 

 

(19

)

 

(19

)

Net loss

 

 

 

 

 

 

 

(15,901

)

 

 

 

(15,901

)

Balance, September 30, 2022

 

29,283,285

 

 

 

 

309,542

 

 

(194,341

)

 

(147

)

 

115,054

 

 

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

3


 

Aura Biosciences, Inc.

Condensed Consolidated Statements of Cash Flows

(Unaudited)

(in thousands)

 

Nine Months Ended
September 30,

 

 

2023

 

 

2022

 

Cash flows from operating activities:

 

 

 

 

 

 

Net loss

 

$

(54,277

)

 

$

(42,204

)

Adjustments to reconcile net loss to net cash used in operating activities:

 

 

 

 

 

 

Depreciation expense

 

 

971

 

 

 

854

 

Accretion on marketable securities

 

 

(2,853

)

 

 

(299

)

Stock-based compensation expense

 

 

6,169

 

 

 

4,598

 

(Loss) gain on disposal of property and equipment

 

 

1

 

 

 

(318

)

Non-cash lease expense

 

 

1,122

 

 

 

607

 

Changes in operating assets and liabilities:

 

 

 

 

 

 

Prepaid expenses and other assets

 

 

3,059

 

 

 

411

 

Other long-term assets

 

 

(262

)

 

 

 

Accounts payable

 

 

(1,497

)

 

 

(678

)

Accrued expenses and other liabilities

 

 

1,796

 

 

 

935

 

Operating lease liabilities

 

 

(689

)

 

 

(494

)

Net cash used in operating activities

 

 

(46,460

)

 

 

(36,588

)

Cash flows from investing activities:

 

 

 

 

 

 

Purchases of property and equipment

 

 

(392

)

 

 

(736

)

Purchase of marketable securities

 

 

(88,847

)

 

 

(71,266

)

Proceeds from sale of marketable securities

 

 

 

 

 

9

 

Maturities of marketable securities

 

 

65,396

 

 

 

21,000

 

Net cash used in investing activities

 

 

(23,843

)

 

 

(50,993

)

Cash flows from financing activities:

 

 

 

 

 

 

Proceeds from exercise of stock options

 

 

1,007

 

 

 

430

 

Proceeds from issuance of common stock under ATM facility, net of issuance costs

 

 

3,170

 

 

 

 

Proceeds from ESPP purchase

 

 

128

 

 

 

 

Net cash provided by financing activities

 

 

4,305

 

 

 

430

 

Net (decrease) increase in cash, cash equivalents and restricted cash

 

 

(65,998

)

 

 

(87,151

)

Cash, cash equivalents and restricted cash at beginning of period

 

 

122,370

 

 

 

149,211

 

Cash, cash equivalents and restricted cash at end of period

 

$

56,372

 

 

$

62,060

 

Supplemental disclosure of cash flow information:

 

 

 

 

 

 

Purchases of property and equipment in accounts payable and accrued expenses and other liabilities

 

$

65

 

 

$

24

 

Initial measurement of right-of-use assets and lease liabilities

 

$

20

 

 

$

21,210

 

The following table provides a reconciliation of cash, cash equivalents, and restricted cash reported within the balance sheets that sum to the total of the same such amounts shown in the unaudited condensed consolidated statements of cash flows (in thousands):

 

 

 

September 30,

 

 

 

2023

 

 

2022

 

Cash and cash equivalents, end of period

 

$

55,584

 

 

$

61,110

 

Short-term restricted cash, end of period

 

 

20

 

 

 

182

 

Long-term restricted cash, end of period

 

 

768

 

 

 

768

 

Cash, cash equivalents and restricted cash at end of period

 

$

56,372

 

 

$

62,060

 

 

 

 

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

4


 

Aura Biosciences, Inc.

Notes to Unaudited Condensed Consolidated Financial Statements

1. Description of Business

Aura Biosciences, Inc. (the “Company” or “Aura”) is a clinical-stage biotechnology company envisioning a new way to treat cancer. Leveraging its novel targeted oncology platform, the Company has the goal to develop a new standard of care across multiple cancer indications. Within these consolidated financial statements, unless the context otherwise requires, references to the Company or Aura refer to Aura Biosciences, Inc. and its subsidiaries on a consolidated basis. The Company’s initial focus is on ocular and urologic oncology where the disease is diagnosed early and there is a high unmet medical need for targeted local therapies. The Company’s proprietary platform is designed to enable the targeting of a broad range of solid tumors using Virus-Like Particles, or VLPs, that can be conjugated with drugs or loaded with nucleic acids to create Virus-Like Drug Conjugates, or VDCs. The Company’s VDCs are largely agnostic to tumor type and can recognize a subset of modified tumor associated glycosaminoglycans that are part of the heparan sulphate chain of HSPGs expressed on the cell surface of many tumor cells and in the tumor microenvironment. Bel-sar, the Company’s first VDC candidate, is being developed for the first-line treatment of early-stage choroidal melanoma, a rare disease with no drugs approved where the standard of care leaves many patients with blindness. The Company is also developing bel-sar for additional ocular oncology indications, including choroidal metastasis, and in non-muscle invasive bladder cancer, or NMIBC. Aura’s headquarters are located in Boston, Massachusetts.

The Company’s operations to date have consisted primarily of conducting research and development and raising capital.

The Company is subject to risks common to companies in the biotechnology industry, including, but not limited to, the successful development and commercialization of products, fluctuations in operating results and financial risks, need for additional financing or alternative means of financial support or both to fund its current operating plan, protection of proprietary technology and patent risks, compliance with government regulations, dependence on key personnel and collaborative partners, competition, customer demand, management of growth, and the effectiveness of marketing by the Company.

Liquidity

Through September 30, 2023, the Company has funded its operations primarily with proceeds from the initial and additional closings of its convertible preferred stock financings, and through its IPO, follow-on offering and at-the-market offering, or ATM. On November 9, 2023, the Company issued and sold 11,000,000 shares of common stock at a price to the public of $9.00 per share for aggregate gross proceeds of $99.0 million, or the 2023 Follow-On Offering. The Company received approximately $92.6 million in net proceeds from the 2023 Follow-On Offering after deducting underwriting discounts and commissions and estimated offering expenses. In addition, the Company has granted the underwriters a 30-day option to purchase up to 1,650,000 additional shares of common stock at a price of $8.46 per share. On December 5, 2022, the Company issued and sold 7,705,000 shares of common stock, including the full exercise of the underwriters’ option to purchase additional shares at a price to the public of $12.00 per share for aggregate gross proceeds of $92.5 million, or the 2022 Follow-On Offering. The Company received approximately $86.7 million in net proceeds from the 2022 Follow-On Offering after deducting underwriting discounts, commissions and offering expenses. On November 1, 2022, the Company filed a shelf registration statement on Form S-3, or the 2022 Shelf, with the SEC in relation to the registration of up to an aggregate offering price of $250.0 million of common stock, preferred stock, debt securities, warrants and units or any combination thereof. The Company also simultaneously entered into the Open Market Sale AgreementSM, or Sales Agreement, with Jefferies LLC, or the Sales Agent, to provide for the offering, issuance and sale by the Company of up to an aggregate of $75.0 million of common stock from time to time in the ATM under the 2022 Shelf and subject to the limitations thereof. The Company issued 261,807 shares of common stock at an average price of $12.49 for aggregate gross proceeds of $3.3 million during the nine months ended September 30, 2023 under the ATM. In addition, the Company issued 732,189 shares of common stock at an average price of $12.51 for aggregate gross proceeds of $9.2 million as of December 31, 2022 under the ATM. In connection with the 2023 Follow-On Offering, on November 6, 2023, the Company delivered written notice to Jefferies that the Company was suspending and terminating the prospectus related to the shares issuable in the ATM pursuant to the terms of the Sales Agreement. As a result, the Company will not make any sales of its securities pursuant to the Sales Agreement, unless and until a new prospectus, prospectus supplement, or a new registration statement relating to the shares eligible to be sold in the ATM is filed. Other than the termination of the prospectus, the Sales Agreement remains in full force and effect.

5


 

The Company has incurred recurring losses and negative operating cash flows from operations since its inception, including net losses of $54.3 million and $42.2 million for the nine months ended September 30, 2023 and 2022, respectively. As of September 30, 2023, the Company had cash and cash equivalents and marketable securities of $149.1 million and an accumulated deficit of $265.2 million. The Company expects to continue to generate operating losses for the foreseeable future.

As of the issuance date of these unaudited condensed consolidated financial statements for the three and nine months ended September 30, 2023, the Company expects that its cash and cash equivalents and marketable securities will be sufficient to fund its operating expenses and capital expenditure requirements through at least 12 months from the issuance of these consolidated financial statements. The future viability of the Company beyond that point is dependent on its ability to raise additional capital to finance its operations.

2. Summary of Significant Accounting Policies

Basis of Presentation

The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America, or U.S. GAAP. In management’s opinion, the accompanying unaudited condensed consolidated financial statements include all adjustments, consisting of normal recurring adjustments, which are necessary to present fairly the Company’s financial position, results of operations, and cash flows. The financial data and other information disclosed in these notes related to the three and nine months ended September 30, 2023 and 2022 are also unaudited. The unaudited condensed results of operations are not necessarily indicative of the operating results that may occur for the full fiscal year ending December 31, 2023. Certain information and footnote disclosures normally included in annual consolidated financial statements prepared in accordance with U.S. GAAP have been omitted pursuant to instructions, rules, and regulations prescribed by the United States Securities and Exchange Commission, or the SEC. Management believes that the disclosures provided here are adequate to make the information presented not misleading when these unaudited condensed consolidated financial statements are read in conjunction with the audited consolidated financial statements and notes thereto included in the Company’s Annual Report on Form 10-K.

Significant Accounting Policies

The Company’s significant accounting policies are disclosed in the audited consolidated financial statements for the year ended December 31, 2022, in the Company’s Annual Report on Form 10-K filed with the SEC on March 15, 2023. There have been no changes to the Company’s significant accounting policies except as noted below.

Recently Adopted Accounting Pronouncements

In June 2016, the FASB issued ASU No. 2016-13, “Financial Instruments—Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments,” which was subsequently amended in November 2018 through ASU No. 2018-19, “Codification Improvements to Topic 326, Financial Instruments—Credit Losses.” ASU No. 2016-13 will require entities to estimate lifetime expected credit losses for trade and other receivables, net investments in leases, financing receivables, debt securities and other instruments, which will result in earlier recognition of credit losses. Further, the new credit loss model will affect how entities in all industries estimate their allowance for losses for receivables that are current with respect to their payment terms. ASU No. 2018-19 further clarifies that receivables arising from operating leases are not within the scope of Topic 326. Instead, impairment from receivables of operating leases should be accounted for in accordance with Topic 842, Leases. As per the latest ASU 2020-02, FASB deferred the timelines for certain small public and private entities, thus the new guidance was adopted by the Company for the annual reporting period beginning January 1, 2023, including interim periods within that annual reporting period. The standard will apply as a cumulative-effect adjustment to retained earnings as of the beginning of the first reporting period in which the guidance is adopted. The Company adopted the standard on January 1, 2023 and it did not have a material impact on its results of operations, financial condition, and financial statement disclosures.

6


 

3. Fair Value of Assets and Liabilities

The following table presents information about the Company’s financial assets and liabilities measured at fair value on a recurring basis and indicates the level of the fair value hierarchy utilized to determine such fair values as of September 30, 2023 and December 31, 2022 (in thousands):

Description

 

September 30,
2023

 

 

Quoted prices
active
markets
for identical
assets
(Level 1)

 

 

Significant
other
observable
inputs
(Level 2)

 

 

Significant
other
observable
inputs
(Level 3)

 

Financial assets

 

 

 

 

 

 

 

 

 

 

 

 

Cash equivalents:

 

 

 

 

 

 

 

 

 

 

 

 

Money market funds

 

 

55,072

 

 

$

55,072

 

 

$

 

 

$

 

Marketable securities:

 

 

 

 

 

 

 

 

 

 

 

 

  Commercial paper

 

 

33,591

 

 

 

 

 

 

33,591

 

 

 

 

  Corporate bonds

 

 

13,593

 

 

 

 

 

 

13,593

 

 

 

 

  U.S. Government agencies

 

 

42,254

 

 

 

 

 

 

42,254

 

 

 

 

  Yankee bonds

 

 

2,956

 

 

 

 

 

 

2,956

 

 

 

 

  Asset-backed securities

 

 

1,078

 

 

 

 

 

 

1,078