10-Q 1 ubx-20240630.htm 10-Q 10-Q
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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 June 30, 2024

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: 001-38470

 

Unity Biotechnology, Inc.

(Exact Name of Registrant as Specified in its Charter)

 

 

Delaware

26-4726035

(State or other jurisdiction of

incorporation or organization)

(I.R.S. Employer

Identification No.)

 

 

285 East Grand Ave.

South San Francisco, CA

94080

(Address of principal executive offices)

(Zip Code)

Registrant’s telephone number, including area code: (650) 416-1192

 

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

Trading Symbol(s)

Name of each exchange on which registered

Common Stock, par value $0.0001

UBX

The Nasdaq Global Select Market

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, a 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 August 2, 2024, the registrant had 16,847,622 shares of common stock outstanding.

 


 

Special Note Regarding Forward-Looking Statements

 

This Quarterly Report on Form 10-Q contains “forward-looking statements” within the meaning of 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 on Form 10-Q are statements that could be deemed forward-looking statements reflecting the current beliefs and expectations of management with respect to future events or to our future financial performance and involve known and unknown risks, uncertainties, and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by these forward-looking statements. These statements are often identified by the use of words such as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “due,” “estimate,” “expect,” “goal,” “if,” “intend,” “may,” “objective,” “plan,” “predict,” “potential,” “positioned,” “seek,” “should,” “target,” “will,” “would,” “until,” and similar expressions or variations. Forward-looking statements contained in this Quarterly Report on Form 10-Q include, but are not limited to, statements about:

our plans to develop and commercialize UBX1325 or any future product candidates;
our expectations regarding the potential benefits, activity, effectiveness, and safety of our drug candidates;
our ongoing and planned clinical trials, including expectations with regard to the results of our clinical studies, preclinical studies and research and development programs, including the timing and availability of data from such studies;
our predictions about the results of future or ongoing clinical trials, including predictions based on results from a clinical trial;
our preclinical, clinical and regulatory development plans for our drug candidates, including the timing or likelihood of regulatory filings and approvals for our drug candidates;
our expectations with regard to our ability to acquire, discover and develop additional drug candidates and advance such drug candidates into, and successfully complete, clinical studies;
our expectations regarding the potential market size and size of the potential patient populations for our drug candidates, if approved for commercial use;
our intentions and our ability to establish collaborations and/or partnerships;
the timing and amount of any milestone payments we are obligated to make pursuant to our existing license agreements and any future license or collaboration agreements that we may enter into;
our commercialization, marketing and manufacturing capabilities and expectations;
our intentions with respect to the commercialization of our drug candidates;
the pricing and reimbursement of our drug candidates, if approved;
the implementation of our business model and strategic plans for our business and drug candidates, including additional indications that we may pursue;
the scope of protection we are able to establish and maintain for intellectual property rights covering our drug candidates, including the projected terms of patent protection;
estimates of our expenses, future revenue, capital requirements, our needs for additional financing, and our ability to obtain additional capital;
our ability to maintain compliance with the minimum required closing bid price and the other standards for continued listing on the Nasdaq Global Select Market;
our ability to remediate a material weakness in our internal control over financial reporting;
developments and projections relating to our competitors and our industry, including competing therapies;
our financial performance;

2


 

macroeconomic trends and uncertainty, including high interest rates, rising inflation and the potential for local and/or global economic recession; and
other risks and uncertainties, including those listed under the caption “Risk Factors”.

We caution you that the foregoing list may not contain all of the forward-looking statements made in this Quarterly Report on Form 10-Q.

Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. We discuss these risks in greater detail in “Risk Factors” and elsewhere in this Quarterly Report on Form 10-Q. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Also, forward-looking statements represent our management’s beliefs and assumptions only as of the date of this Quarterly Report on Form 10-Q. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future.

 

This Quarterly Report on Form 10-Q also contains estimates, projections, and other information concerning our industry, our business and the markets for certain drugs, including data regarding the estimated size of those markets, their projected growth rates, and the incidence of certain medical conditions. Information that is based on estimates, forecasts, projections or similar methodologies is inherently subject to uncertainties, and actual events or circumstances may differ materially from events and circumstances reflected in this information. Unless otherwise expressly stated, we obtained this industry, business, market, and other data from reports, research surveys, studies, and similar data prepared by third parties, industry, medical and general publications, government data, and similar sources. In some cases, we do not expressly refer to the sources from which this data is derived. In that regard, when we refer to one or more sources of this type of data in any paragraph, you should assume that other data of this type appearing in the same paragraph is derived from the same sources, unless otherwise expressly stated or the context otherwise requires.

 

3


 

Risk Factor Summary

 

Below is a summary of the principal factors that make an investment in our common stock speculative or risky. This summary does not address all of the risks that we face. Additional discussion of the risks summarized in this risk factor summary, and other risks that we face, can be found below under the heading “Risk Factors” and should be carefully considered, together with other information in this Quarterly Report on Form 10-Q and our other filings with the Securities and Exchange Commission, or SEC, before making investment decisions regarding our common stock.

We are a clinical-stage biopharmaceutical company with a limited operating history and no products approved for commercial sale. We have incurred significant losses since our inception, and we anticipate that we will continue to incur losses for the foreseeable future, which, together with our limited operating history, make it difficult to assess our future viability.
We will require substantial additional financing to achieve our goals, and a failure to obtain this capital when needed on acceptable terms, or at all, could force us to delay, limit, reduce or terminate our product development programs, other operations or commercialization efforts.
Our financial condition raises substantial doubt as to our ability to continue as a going concern.
We may not be able to maintain compliance with the continued listing requirements of Nasdaq and, if so, we would be subject to delisting.
Our core therapeutic approach to slow, halt, or reverse diseases of aging is based on our understanding of cellular senescence. Utilizing senolytic molecules to treat diseases of aging is a novel therapeutic approach, which exposes us to unforeseen risks and makes it difficult to predict the time and cost of drug development and potential for regulatory approval.
Our business is currently dependent on the successful development and regulatory approval of UBX1325.
Other than UBX1325, all of our other programs are preclinical and face significant development risk.
We rely on third-party suppliers to manufacture preclinical and clinical supplies of our drug candidates and we intend to continue to rely on third parties to produce such preclinical and clinical supplies as well as commercial supplies of any approved product. The loss of these suppliers, costs and availability of inputs or supplies, supply issues, or the failure of those manufacturers or suppliers to comply with applicable regulatory requirements or to provide us with sufficient quantities at acceptable quality levels or prices, or at all, would materially and adversely affect our business.
We face significant competition in an environment of rapid technological and scientific change, and our drug candidates, if approved, will face significant competition and our failure to effectively compete may prevent us from achieving significant market penetration. Most of our competitors have significantly greater resources than we do, and we may not be able to successfully compete.
Our senolytic medicine platform and any future products that we commercialize could be alleged to infringe patent rights and other proprietary rights of third parties, which may require costly litigation and, if we are not successful, could cause us to pay substantial damages and/or limit our ability to commercialize our products. Even if we obtain regulatory approval for a drug candidate, our products will remain subject to regulatory scrutiny.
We have identified a material weakness in our internal control over financial reporting. This material weakness could continue to adversely affect our ability to accurately report the results of our operations and financial condition. In the future, we may identify additional material weaknesses or otherwise fail to maintain an effective system of internal control over financial reporting or adequate disclosure controls and procedures, which may result in material errors in our financial statements or cause us to fail to meet our period reporting obligations.

 

4


 

UNITY BIOTECHNOLOGY, INC.

QUARTERLY REPORT ON FORM 10-Q

Table of Contents

 

PART I. FINANCIAL INFORMATION

 

Item 1

Condensed Financial Statements

6

 

Condensed Balance Sheets as of June 30, 2024 (unaudited) and December 31, 2023

6

 

Condensed Statements of Operations and Comprehensive Loss for the Three and Six Months Ended June 30, 2024 and 2023 (unaudited)

7

 

Condensed Statements of Stockholders’ Equity for the Three and Six Months Ended June 30, 2024 and 2023 (unaudited)

8

 

Condensed Statements of Cash Flows for the Six Months Ended June 30, 2024 and 2023 (unaudited)

9

 

Notes to Condensed Financial Statements (unaudited)

10

Item 2

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

20

Item 3

Quantitative and Qualitative Disclosures About Market Risk

31

Item 4

Controls and Procedures

31

 

 

 

PART II. OTHER INFORMATION

 

 

 

Item 1

Legal Proceedings

33

Item 1A

Risk Factors

33

Item 2

Unregistered Sales of Equity Securities and Use of Proceeds

74

Item 3

Default Upon Senior Securities

74

Item 4

Mine Safety Disclosures

74

Item 5

Other Information

74

Item 6

Exhibits

75

Signatures

76

 

 

5


 

PART I. FINANCIAL INFORMATION

Item 1. Condensed Financial Statements

 

Unity Biotechnology, Inc.

Condensed Balance Sheets

(In thousands, except for share amounts and par value)

 

 

 

June 30, 2024

 

 

December 31, 2023(1)

 

 

 

(Unaudited)

 

 

 

 

Assets

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

Cash and cash equivalents

 

$

7,584

 

 

$

19,803

 

Short-term marketable securities

 

 

26,400

 

 

 

23,398

 

Prepaid expenses and other current assets

 

 

1,862

 

 

 

3,404

 

Total current assets

 

 

35,846

 

 

 

46,605

 

Property and equipment, net

 

 

4,630

 

 

 

5,082

 

Operating lease right-of-use assets

 

 

11,900

 

 

 

12,981

 

Long-term restricted cash

 

 

896

 

 

 

896

 

Other long-term assets

 

 

250

 

 

 

126

 

Total assets

 

$

53,522

 

 

$

65,690

 

Liabilities and Stockholders’ Equity

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

Accounts payable

 

$

1,456

 

 

$

1,380

 

Accrued compensation

 

 

1,385

 

 

 

1,841

 

Accrued and other current liabilities

 

 

5,977

 

 

 

4,619

 

Total current liabilities

 

 

8,818

 

 

 

7,840

 

Operating lease liability, net of current portion

 

 

21,659

 

 

 

23,539

 

Warrant liability

 

 

3,291

 

 

 

5,913

 

Total liabilities

 

 

33,768

 

 

 

37,292

 

Commitments and contingencies (Note 5)

 

 

 

 

 

 

Stockholders’ equity:

 

 

 

 

 

 

Convertible preferred stock, $0.0001 par value; 10,000,000 shares
   authorized;
no shares issued and outstanding

 

 

 

 

 

 

Common stock, $0.0001 par value; 300,000,000 shares
  authorized as of June 30, 2024 and December 31, 2023;
  
16,847,622 and 16,784,969 shares issued and outstanding
  as of June 30, 2024 and December 31, 2023, respectively

 

 

2

 

 

 

2

 

Additional paid-in capital

 

 

515,209

 

 

 

512,773

 

Accumulated other comprehensive loss

 

 

(35

)

 

 

(24

)

Accumulated deficit

 

 

(495,422

)

 

 

(484,353

)

Total stockholders’ equity

 

 

19,754

 

 

 

28,398

 

Total liabilities and stockholders’ equity

 

$

53,522

 

 

$

65,690

 

 

(1) The balance sheet as of December 31, 2023 is derived from the audited financial statements as of that date.

 

 

See accompanying notes to the condensed financial statements.

6


 

Unity Biotechnology, Inc.

Condensed Statements of Operations and Comprehensive Loss

(In thousands, except share and per share amounts)

(Unaudited)

 

 

 

 

Three Months Ended June 30,

 

 

Six Months Ended June 30,

 

 

 

2024

 

 

2023

 

 

2024

 

 

2023

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

3,463

 

 

 

6,435

 

 

 

7,184

 

 

 

12,195

 

General and administrative

 

 

3,516

 

 

 

5,413

 

 

 

7,394

 

 

 

10,212

 

Total operating expenses

 

 

6,979

 

 

 

11,848

 

 

 

14,578

 

 

 

22,407

 

Loss from operations

 

 

(6,979

)

 

 

(11,848

)

 

 

(14,578

)

 

 

(22,407

)

Interest income

 

 

515

 

 

 

805

 

 

 

1,028

 

 

 

1,660

 

Interest expense

 

 

 

 

 

(883

)

 

 

 

 

 

(1,885

)

Gain (loss) on warrant liability

 

 

1,246

 

 

 

(3,461

)

 

 

2,622

 

 

 

2,030

 

Other income (expense), net

 

 

(61

)

 

 

(69

)

 

 

(141

)

 

 

(133

)

Net loss

 

 

(5,279

)

 

 

(15,456

)

 

 

(11,069

)

 

 

(20,735

)

Other comprehensive (loss) gain

 

 

 

 

 

 

 

 

 

 

 

 

Unrealized gain (loss) on marketable debt securities

 

 

3

 

 

 

14

 

 

 

(11

)

 

 

115

 

Comprehensive loss

 

$

(5,276

)

 

$

(15,442

)

 

$

(11,080

)

 

$

(20,620

)

Net loss per share, basic and diluted

 

$

(0.31

)

 

$

(1.07

)

 

$

(0.66

)

 

$

(1.44

)

Weighted-average number of shares used
in computing net loss per share, basic and
diluted

 

 

16,815,387

 

 

 

14,425,775

 

 

 

16,800,238

 

 

 

14,369,643

 

 

 

See accompanying notes to the condensed financial statements.

7


 

Unity Biotechnology, Inc.

Condensed Statements of Stockholders’ Equity

(In thousands, except share amounts)

(Unaudited)

 

 

 

Common Stock

 

 

Additional
Paid-In

 

 

Accumulated
Other
Comprehensive

 

 

Accumulated

 

 

Total
Stockholders’

 

 

 

Shares

 

 

Amount

 

 

Capital

 

 

(Loss)

 

 

Deficit

 

 

Equity

 

Balances at December 31, 2023

 

 

16,784,969

 

 

$

2

 

 

$

512,773

 

 

$

(24

)

 

$

(484,353

)

 

$

28,398

 

Repurchase of early exercised shares

 

 

(3,336

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Vesting of restricted stock units

 

 

5,014

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Stock-based compensation

 

 

 

 

 

 

 

 

1,394

 

 

 

 

 

 

 

 

 

1,394

 

Unrealized loss on available-for-sale marketable
   securities

 

 

 

 

 

 

 

 

 

 

 

(14

)

 

 

 

 

 

(14

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(5,790

)

 

 

(5,790

)

Balances at March 31, 2024

 

 

16,786,647

 

 

$

2

 

 

$

514,167

 

 

$

(38

)

 

$

(490,143

)

 

$

23,988

 

Issuance of common stock under 2018 ESPP

 

 

52,494

 

 

 

 

 

 

68

 

 

 

 

 

 

 

 

 

68

 

Vesting of restricted stock units

 

 

8,481

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Stock-based compensation

 

 

 

 

 

 

 

 

974

 

 

 

 

 

 

 

 

 

974

 

Unrealized loss on available-for-sale marketable
   securities

 

 

 

 

 

 

 

 

 

 

 

3

 

 

 

 

 

 

3

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(5,279

)

 

 

(5,279

)

Balances at June 30, 2024

 

 

16,847,622

 

 

$

2

 

 

$

515,209

 

 

$

(35

)

 

$

(495,422

)

 

$

19,754

 

 

 

 

 

Common Stock

 

 

Additional
Paid-In

 

 

Accumulated
Other
Comprehensive

 

 

Accumulated

 

 

Total
Stockholders’

 

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Gain (Loss)

 

 

Deficit

 

 

Equity

 

Balances at December 31, 2022

 

 

14,215,302

 

 

$

1

 

 

$

500,827

 

 

$

(251

)

 

$

(444,493

)

 

$

56,084

 

Issuance of common stock, net of issuance costs,
   under at-the-market (“ATM”) offering program

 

 

106,781

 

 

 

 

 

 

274

 

 

 

 

 

 

 

 

 

274

 

Vesting of restricted stock units

 

 

37,131

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Stock-based compensation

 

 

 

 

 

 

 

 

2,175

 

 

 

 

 

 

 

 

 

2,175

 

Unrealized gain on available-for-sale marketable securities

 

 

 

 

 

 

 

 

 

 

 

101

 

 

 

 

 

 

101

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(5,279

)

 

 

(5,279

)

Balances at March 31, 2023

 

 

14,359,214

 

 

$

1

 

 

$

503,276

 

 

$

(150

)

 

$

(449,772

)

 

$

53,355

 

Issuance of common stock, net of issuance costs,
   under ATM offering program

 

 

168,000

 

 

 

 

 

 

518

 

 

 

 

 

 

 

 

 

518

 

Issuance of common stock under 2018 ESPP

 

 

41,497

 

 

 

 

 

 

91

 

 

 

 

 

 

 

 

 

91

 

Vesting of restricted stock units

 

 

26,766

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Stock-based compensation

 

 

 

 

 

 

 

 

2,247

 

 

 

 

 

 

 

 

 

2,247

 

Unrealized gain on available-for-sale marketable securities

 

 

 

 

 

 

 

 

 

 

 

14

 

 

 

 

 

 

14

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(15,456

)

 

 

(15,456

)

Balances at June 30, 2023

 

 

14,595,477

 

 

$

1

 

 

$

506,132

 

 

$

(136

)

 

$

(465,228

)

 

$

40,769

 

 

 

 

See accompanying notes to the condensed financial statements.

8


 

Unity Biotechnology, Inc.

Condensed Statements of Cash Flows

(In thousands)

(Unaudited)

 

 

 

Six Months Ended June 30,

 

 

 

2024

 

 

2023

 

Operating activities

 

 

 

 

 

 

Net loss

 

$

(11,069

)

 

$

(20,735

)

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

 

 

 

 

 

 

Depreciation and amortization

 

 

448

 

 

 

643

 

Amortization of debt issuance costs

 

 

 

 

 

557

 

Net accretion and amortization of premium and discounts on
   marketable securities

 

 

(474

)

 

 

(831

)

Gain on disposal of property and equipment

 

 

(16

)

 

 

 

Stock-based compensation

 

 

2,368

 

 

 

4,422

 

Non-cash rent expense

 

 

(612

)

 

 

(540

)

(Gain) loss on warrant liability

 

 

(2,622

)

 

 

(2,030

)

Changes in operating assets and liabilities:

 

 

 

 

 

 

Prepaid expenses and other current assets

 

 

1,542

 

 

 

(2,134

)

Other long-term assets

 

 

(124

)

 

 

47

 

Accounts payable

 

 

76

 

 

 

(341

)

Accrued compensation

 

 

(456

)

 

 

(1,368

)

Accrued liabilities and other current liabilities

 

 

1,172

 

 

 

(89

)

Net cash used in operating activities

 

 

(9,767

)

 

 

(22,399

)

Investing activities

 

 

 

 

 

 

Purchase of marketable securities

 

 

(21,289

)

 

 

(21,868

)

Maturities of marketable securities

 

 

18,750

 

 

 

53,000

 

Sale of property and equipment

 

 

19

 

 

 

 

Net cash provided by (used in) investing activities

 

 

(2,520

)

 

 

31,132

 

Financing activities

 

 

 

 

 

 

Repayment of term loan debt

 

 

 

 

 

(3,234

)

Proceeds from issuance of common stock under ATM offering program,
   net of issuance costs

 

 

 

 

 

792

 

Proceeds from issuance of common stock under 2018 ESPP

 

 

68

 

 

 

91

 

Net cash provided by (used in) financing activities

 

 

68

 

 

 

(2,351

)

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

 

 

(12,219

)

 

 

6,382

 

Cash, cash equivalents and restricted cash at beginning of the period

 

 

20,699

 

 

 

13,632

 

Cash, cash equivalents and restricted cash at end of the period

 

$

8,480

 

 

$

20,014

 

Supplemental Disclosures of Cash Flow Information:

 

 

 

 

 

 

Cash paid for interest

 

$

 

 

$

1,362

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

7,584

 

 

$

19,118

 

Restricted cash

 

 

896

 

 

 

896

 

Total cash, cash equivalents and restricted cash

 

$

8,480

 

 

$

20,014

 

 

See accompanying notes to the condensed financial statements.

9


 

Unity Biotechnology, Inc.

Notes to Condensed Financial Statements

(Unaudited)

1. Organization

Description of Business

Unity Biotechnology, Inc. (the “Company”) is a biotechnology company engaged in the research and development of therapeutics to slow, halt, or reverse diseases of aging. The Company devotes substantially all of its time and efforts to performing research and development and raising capital. The Company’s headquarters are located in South San Francisco, California. The Company was incorporated in the State of Delaware in 2009.

Liquidity

The accompanying unaudited condensed financial statements have been prepared assuming that the Company will continue as a going concern, which contemplates the realization of assets and the settlement of liabilities and commitments in the normal course of business. The Company has incurred operating losses and has an accumulated deficit as a result of ongoing efforts to develop drug product candidates, including conducting preclinical and clinical trials and providing general and administrative support for these operations. The Company had an accumulated deficit of $495.4 million and $484.4 million as of June 30, 2024 and December 31, 2023, respectively. The Company had net losses of $5.3 million and $15.5 million for the three months ended June 30, 2024 and 2023, respectively, net losses of $11.1 million and $20.7 million for the six months ended June 30, 2024 and 2023, respectively, and net cash used in operating activities of $9.8 million and $22.4 million for the six months ended June 30, 2024 and 2023, respectively. To date, none of the Company’s drug product candidates have been approved for sale, and therefore, the Company has not generated any product revenue. The Company anticipates operating losses and negative operating cash flows to continue for the foreseeable future. The Company has financed its operations primarily through private placements of preferred stock and promissory notes, public equity issuances and more recently, from its ATM Offering Programs, an Equity Purchase Agreement, the sale of common stock and warrants under a Follow-On Offering and the Inducement Offer and will continue to be dependent upon equity and/or debt financing until the Company is able to generate positive cash flows from its operations.

The Company had cash, cash equivalents, and marketable securities of $34.0 million as of June 30, 2024. The Company expects that its cash and cash equivalents as of June 30, 2024 will not be sufficient to fund its current business plan including related operating expenditure requirements through at least 12 months from the date of issuance of these unaudited condensed financial statements are filed with the Securities and Exchange Commission (“SEC”). These conditions raise substantial doubt about the Company’s ability to continue as going concern. The Company plans to seek to address this condition by raising additional capital to finance its operations. The future viability of the Company is dependent on its ability to raise additional capital to finance its operations. Although the Company has been successful in raising capital in the past, there is no assurance that it will be successful in obtaining such additional financing. If sufficient funds on acceptable terms are not available when needed, the Company could be further required to significantly reduce its operating expenses and delay, reduce the scope of, or eliminate one or more of its development programs. Failure to manage discretionary spending or raise additional financing, as needed, may adversely impact the Company’s ability to achieve its intended business objectives, or the Company may be forced to liquidate assets where possible, or to cease operations or file for bankruptcy protection. Therefore, it is not considered probable that the Company’s plans to raise additional capital nor reduce discretionary spending will alleviate the substantial doubt regarding its ability to continue as a going concern.

 

2. Summary of Significant Accounting Policies

Basis of Presentation

These condensed financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) and the rules and regulations of the United States SEC for interim reporting.

Certain information and footnote disclosures normally included in annual financial statements prepared in accordance with GAAP have been condensed or omitted. Accordingly, the unaudited condensed financial statements should be

10


 

read in conjunction with the audited financial statements and the related notes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023 filed with the SEC.

Unaudited Condensed Financial Statements

The accompanying financial information for the three and six months ended June 30, 2024 and 2023 are unaudited. The unaudited condensed financial statements have been prepared on the same basis as the annual audited financial statements and, in the opinion of management, reflect all adjustments, which include only normal recurring adjustments, necessary to present fairly the Company’s financial position as of June 30, 2024 and its results of operations for the three and six months ended June 30, 2024 and 2023 and cash flows for the six months ended June 30, 2024 and 2023. The results for interim periods are not necessarily indicative of the results expected for the full fiscal year or any other periods.

Use of Estimates

The condensed financial statements have been prepared in accordance with GAAP, which requires management to make estimates and assumptions that affect the amounts and disclosures reported in the condensed financial statements and accompanying notes. The Company bases its estimates on historical experience and market-specific or other relevant assumptions that it believes are reasonable under the circumstances. The amounts of assets and liabilities reported in the Company’s condensed balance sheets and the amount of expenses and income reported for each of the periods presented are affected by estimates and assumptions, which are used for, but are not limited to, determining the fair value of assets and liabilities, the fair value of right-of-use assets and lease liabilities, and stock-based compensation. Actual results could differ from such estimates or assumptions.

Estimating fair values of liability-classified financial instruments requires the development of estimates that may, and are likely to, change over the duration of the instrument with related changes in internal and external market factors. As liability-classified financial instruments are initially and subsequently carried at fair value, the Company’s financial results will reflect the volatility in these estimate and assumption changes. Changes in estimated fair value are recognized as a component of "Other income (expense), net" in the Statements of Operations and Comprehensive Loss.

Segments

The Company has one operating segment. The Company’s chief operating decision maker, its Chief Executive Officer, manages the Company’s operations on a consolidated basis for the purposes of allocating resources.

 

Recently Issued Accounting Pronouncements Not Yet Adopted

There have been no new accounting pronouncements issued or effective that are expected to have a material impact on the Company's condensed financial statements.

3. Fair Value Measurements

The carrying amounts of financial instruments such as cash and cash equivalents, restricted cash, prepaid expenses and other current assets, accounts payable, accrued compensation, accrued and other current liabilities approximate the related fair values due to the short maturities of these instruments.

11


 

The Company’s financial assets and liabilities subject to fair value measurements and the level of inputs used in such measurements were as follows (in thousands):

 

 

 

June 30, 2024

 

 

 

Total

 

 

Level 1

 

 

Level 2

 

 

Level 3

 

Assets:

 

 

 

 

 

 

 

 

 

 

 

 

Cash equivalents:

 

 

 

 

 

 

 

 

 

 

 

 

Money market funds

 

$

4,437

 

 

$

4,437

 

 

$

 

 

$

 

Total cash equivalents

 

 

4,437

 

 

 

4,437

 

 

 

 

 

 

 

Short-term marketable securities:

 

 

 

 

 

 

 

 

 

 

 

 

U.S. treasuries

 

 

20,915

 

 

 

 

 

 

20,915

 

 

 

 

U.S. government debt securities

 

 

5,485

 

 

 

 

 

 

5,485

 

 

 

 

Total short-term marketable securities

 

 

26,400

 

 

 

 

 

 

26,400

 

 

 

 

Restricted cash equivalents:

 

 

 

 

 

 

 

 

 

 

 

 

Money market funds

 

 

896

 

 

 

896

 

 

 

 

 

 

 

Total restricted cash equivalents

 

 

896

 

 

 

896

 

 

 

 

 

 

 

Total assets subject to fair value measurements

 

$

31,733

 

 

$

5,333

 

 

$

26,400

 

 

$

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Liabilities:

 

 

 

 

 

 

 

 

 

 

 

 

Warrant Liability

 

$

3,291

 

 

$

 

 

$

 

 

$

3,291

 

Total liabilities subject to fair value measurements
   on a recurring basis

 

$

3,291

 

 

$

 

 

$

 

 

$

3,291

 

 

 

 

December 31, 2023

 

 

 

Total

 

 

Level 1

 

 

Level 2

 

 

Level 3

 

Assets:

 

 

 

 

 

 

 

 

 

 

 

 

Cash equivalents:

 

 

 

 

 

 

 

 

 

 

 

 

Money market funds

 

$

12,864

 

 

$

12,864

 

 

$

 

 

$

 

U.S. treasuries

 

 

2,989

 

 

 

 

 

 

2,989

 

 

 

 

Total cash equivalents

 

 

15,853

 

 

 

12,864

 

 

 

2,989

 

 

 

 

Short-term marketable securities:

 

 

 

 

 

 

 

 

 

 

 

 

U.S. treasuries

 

 

7,849

 

 

 

 

 

 

7,849

 

 

 

 

U.S. government debt securities

 

 

15,549

 

 

 

 

 

 

15,549

 

 

 

 

Total short-term marketable securities

 

 

23,398

 

 

 

 

 

 

23,398

 

 

 

 

Restricted cash equivalents:

 

 

 

 

 

 

 

 

 

 

 

 

Money market funds

 

 

896

 

 

 

896

 

 

 

 

 

 

 

Total restricted cash equivalents

 

 

896

 

 

 

896

 

 

 

 

 

 

 

Total assets subject to fair value measurements

 

$

40,147

 

 

$

13,760

 

 

$

26,387

 

 

$

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Liabilities:

 

 

 

 

 

 

 

 

 

 

 

 

Warrant Liability

 

$

5,913

 

 

$

 

 

$

 

 

$

5,913

 

Total liabilities subject to fair value measurements
   on a recurring basis

 

$

5,913

 

 

$

 

 

$

 

 

$

5,913

 

The Company estimates the fair value of its money market funds, U.S. treasuries, and U.S. government debt securities by taking into consideration valuations obtained from third-party pricing services. The pricing services utilize industry standard valuation models, including both income and market-based approaches, for which all significant inputs are observable, either directly or indirectly, to estimate fair value. These inputs include reported trades of and broker/dealer quotes on the same or similar securities, issuer credit spreads; benchmark securities; prepayment/default projections based on historical data; and other observable inputs.

August 2022 Warrants ("Existing Warrants")

The common stock warrants are classified as a liability on the Balance Sheets and are measured at fair value with the change in fair value recorded within “Gain (loss) on warrant liability” on the Statement of Operations and

12


 

Comprehensive Loss. The estimated fair value of the outstanding common stock warrants was $1.4 million and $2.8 million as of June 30, 2024 and December 31, 2023, respectively.

The Company estimates the fair value of its warrant liability using a Monte Carlo simulation model based on significant inputs not observable in the market, which represents a Level 3 measurement. The Company used the following key assumptions within its valuation. In all scenarios, the Company also applied the likelihood of a fundamental transaction and the related impact on the Company’s common stock price and volatility.

 

 

June 30, 2024

 

Common stock price

 $

 

1.35

 

Exercise price per share

 $

 

8.50

 

Estimated volatility

 

 

80.0

%

Risk-free interest rate

 

 

4.51

%

Contractual term (in years)

 

 

3.14

 

 

November 2023 Inducement Offer ("New Warrants")

In November 2023, the Company issued common stock warrants to purchase an aggregate of 2,143,000 shares of common stock at an exercise price of $1.92 per warrant. Additionally, 128,580 common stock warrants were issued to the Placement Agent ("Placement Agent Warrants") at an exercise price of $2.5563 per warrant. The New Warrants and Placement Agent Warrants are recorded as a liability on the Balance Sheet and are adjusted to estimated fair value at period end within “Gain (loss) on warrant liability” on the Statement of Operations and Comprehensive Loss. The estimated fair value of the New Warrants was $1.9 million and $3.1 million as of June 30, 2024 and December 31, 2023, respectively.

The Company estimates the fair value of its Level 3 warrant liabilities using a Monte Carlo simulation model. The Company used the following key assumptions within its valuation. In all scenarios, the Company also applied the likelihood of a fundamental transaction and the related impact on the Company’s common stock price and volatility.

 

 

June 30, 2024

 

Common stock price

 $

 

1.35

 

Exercise price per share

 $

1.92 - 2.5563

 

Expected volatility

 

 

80.0

%

Risk-free interest rate

 

 

4.39

%

Contractual term (in years)

 

 

4.37

 

 

The following is a roll forward of the fair value of Level 3 warrants for the three months ended June 30, 2024 (in thousands):

 

 

 

Warrant Liability
Fair Value

 

Balance at March 31, 2024

 

$

4,537

 

Change in fair value

 

 

(1,246

)

Balance at June 30, 2024

 

$

3,291

 

 

The following is a roll forward of the fair value of Level 3 warrants for the six months ended June 30, 2024 (in thousands):

 

 

 

Warrant Liability
Fair Value

 

Balance at December 31, 2023

 

$

5,913

 

Change in fair value

 

 

(2,622

)

Balance at June 30, 2024

 

$

3,291

 

 

13


 

4. Marketable Securities

Marketable securities, which are classified as available-for-sale, consisted of the following as of June 30, 2024 (in thousands):

 

 

 

Amortized
Cost Basis

 

 

Unrealized
Gains

 

 

Unrealized
Losses

 

 

Fair
Value

 

Cash equivalents:

 

 

 

 

 

 

 

 

 

 

 

 

Money market funds

 

$

4,437

 

 

$

 

 

$

 

 

$

4,437

 

Total cash equivalents

 

 

4,437

 

 

 

 

 

 

 

 

 

4,437

 

Short-term marketable securities:

 

 

 

 

 

 

 

 

 

 

 

 

U.S. treasuries

 

 

20,941

 

 

 

 

 

 

(26

)

 

 

20,915

 

U.S. government debt securities

 

 

5,494

 

 

 

 

 

 

(9

)

 

 

5,485

 

Total short-term marketable securities

 

 

26,435

 

 

 

 

 

 

(35

)

 

 

26,400

 

Restricted cash equivalents:

 

 

 

 

 

 

 

 

 

 

 

 

Money market funds

 

 

896

 

 

 

 

 

 

 

 

 

896

 

Total restricted cash equivalents

 

 

896

 

 

 

 

 

 

 

 

 

896

 

Total

 

$

31,768

 

 

$

 

 

$

(35

)

 

$

31,733

 

Marketable securities, which are classified as available-for-sale, consisted of the following as of December 31, 2023 (in thousands):

 

 

 

Amortized
Cost Basis

 

 

Unrealized
Gains

 

 

Unrealized
Losses

 

 

Fair
Value

 

Cash equivalents:

 

 

 

 

 

 

 

 

 

 

 

 

Money market funds

 

$

12,864

 

 

$

 

 

$

 

 

$

12,864

 

U.S. treasuries

 

 

2,989

 

 

 

 

 

 

 

 

 

2,989

 

Total cash equivalents

 

 

15,853

 

 

 

 

 

 

 

 

 

15,853

 

Short-term marketable securities:

 

 

 

 

 

 

 

 

 

 

 

 

U.S. treasuries

 

 

7,853

 

 

 

4

 

 

 

(7

)

 

 

7,850

 

U.S. government debt securities

 

 

15,570

 

 

 

1

 

 

 

(22

)

 

 

15,549

 

Total short-term marketable securities

 

 

23,423

 

 

 

5

 

 

 

(29

)