10-Q

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 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 

001-41058

Vaxxinity, Inc.

(Exact name of registrant as specified in its charter) 

Delaware

86-2083865

(State or other jurisdiction of 

incorporation or organization)

(I.R.S. Employer

Identification No.)

505 Odyssey Way

Merritt Island

,

FL

32953

(Address of principal executive offices)

(Zip Code)

(

254

)

244-5739

(Registrant’s telephone number, including area code)

Not Applicable

(Former name, former address and former fiscal year, 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

Class A Common Stock, par value

$0.0001 per share

VAXX

The

Nasdaq

 Global 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, smaller reporting company, or an emerging growth

company. See 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 6, 2023, the registrant had

112,871,792

shares of $0.0001 par value Class A common stock outstanding and

13,874,132

 shares of $0.0001 par value

Class B common stock outstanding.

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

This Quarterly Report on Form 10-Q contains forward-looking statements. Forward-looking statements are neither historical facts nor

assurances of future performance. Instead, they are based on our current beliefs, expectations and assumptions regarding the future of

our business, future plans and strategies and other future conditions. In some cases, you can identify forward-looking statements

because they contain words such as “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “predict,” “project,” “target,”

“potential,” “seek,” “will,” “would,” “could,” “should,” “continue,” “contemplate,” “plan,” other words and terms of similar meaning

and the negative of these words or similar terms.

Forward-looking statements are subject to known and unknown risks and uncertainties, many of which may be beyond our control.

We caution you that forward-looking statements are not guarantees of future performance or outcomes and that actual performance

and outcomes may differ materially from those made in or suggested by the forward-looking statements contained in this Quarterly

Report. In addition, even if our results of operations, financial condition and cash flows, and the development of the markets in which

we operate, are consistent with the forward-looking statements contained in this Quarterly Report, those results or developments may

not be indicative of results or developments in subsequent periods. New factors emerge from time to time that may cause our business

not to develop as we expect, and it is not possible for us to predict all of them. Factors that could cause actual results and outcomes

to differ materially from those reflected in forward-looking statements include, among others, the following:

• the prospects of our product candidates, including the progress, number, scope, cost, results and timing of data from

our development activities, preclinical trials and clinical trials for our product candidates or programs, such as the target

indication(s) for development or approval, the size, design, population, conduct, cost, objective or endpoints of any

clinical trial, or the timing for initiation or completion of or availability of results from any clinical trial, for submission,

review or approval of any regulatory filing, or for meeting with regulatory authorities;

• the potential benefits that may be derived from any of our product candidates;

• the timing of and our ability to obtain and maintain regulatory approval for our existing product candidates, any product

candidates that we may develop, and any related restrictions, limitations, or warnings in the label of any approved

product candidates;

• our ability to develop and commercialize new products and product candidates;

• our ability to leverage our Vaxxine Platform;

• the rate and degree of market acceptance of our products and product candidates;

• estimates of our addressable market and market growth, and expectations about market trends;

• our future operations, financial position, revenues, costs, expenses, uses of cash, capital requirements, our needs

for additional financing or the period for which our existing cash resources will be sufficient to meet our operating

requirements;

• our ability to comply with legal and regulatory requirements relating to privacy, tax, anti-corruption and

other applicable laws;

• our ability to hire and retain key personnel and to manage our future growth effectively;

• our ability to access capital on acceptable terms in a rising interest rate and tighter credit environment;

• expectations regarding our ability to continue as a going concern;

• competitive companies and technologies within our industry and our ability to compete;

• our and our collaborators’, including United Biomedical’s (“UBI”), ability and willingness to obtain, maintain, defend

and enforce our intellectual property protection for our proprietary and collaborative product candidates, and the scope

of such protection;

• the performance of third-party suppliers and manufacturers and our ability to find additional suppliers and

manufacturers and obtain alternative sources of raw materials;

• our ability and the potential to successfully manufacture our product candidates for pre-clinical use, for clinical trials

and, if approved, on a larger scale for commercial use;

• the ability and willingness of our third-party collaborators, including UBI, to continue research and development

activities relating to our product candidates and our ability to attract additional collaborators with development,

regulatory and commercialization expertise;

• general economic, political, demographic and business conditions in the United States, Taiwan and other jurisdictions

where we conduct business or clinical trials;

• the potential effects of government regulation, including regulatory developments in the United

States and other jurisdictions;

• ability to obtain additional financing in future offerings or otherwise;

• the effects of global conflicts, including Russia-Ukraine and Israel-Hamas, and the COVID-19 pandemic on

business operations and the initiation, development and operation of our clinical trials, including patient enrollment

of our clinical trials; and

• our strategies, prospects, plans, expectations, forecasts or objectives.

We discuss many of these and other factors in greater detail under Item 1A. “Risk Factors” in our Annual Report on Form 10-K

for the year ended December 31, 2022 filed with the Securities and Exchange Commission on March 27, 2023. These risk factors

are not exhaustive. Other sections of this report may include additional factors which could adversely impact our business and

financial performance. New risk factors emerge from time to time, and it is not possible to predict all such risk factors, nor can

we assess the impact of all such risk factors on our business or the extent to which any factor or combination of factors may cause

actual results to differ materially from those contained in any forward-looking statements. Forward-looking statements are not

guarantees of performance. Given these uncertainties, you should not place undue reliance on these forward-looking statements,

which speak only as of the date hereof

.

You should read this Quarterly Report and the documents that we reference in this Quarterly Report and have filed as exhibits

completely and with the understanding that our actual future results may be materially different from what we expect. We qualify

all of the forward-looking statements in this Quarterly Report by these cautionary statements. Except as required by law, we

undertake no obligation to publicly update any forward-looking statements, whether as a result of new information, future events

or otherwise.

As used in this Quarterly Report on Form 10-Q, unless otherwise specified or the context otherwise requires, the terms “we,”

“our,” “us,” the “Company” refer to Vaxxinity, Inc. and its subsidiaries. All brand names or trademarks appearing in this Quarterly

Report are the property of their respective owners.

4

Table of Contents

Page

 (Unaudited)

5

 (Income) (Unaudited)

6

 (Unaudited)

7

 (Unaudited)

8

 (Unaudited)

9

21

30

31

32

32

33

5

PART I – FINANCIAL INFORMATION

Item 1. Financial Statements.

VAXXINITY, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands, except share and per share amounts)

(Unaudited)

September 30,

December 31,

2023

2022

Assets

Current assets:

Cash and cash equivalents

$

17,395

$

33,475

Short-term investments

25,124

53,352

Restricted cash

206

1,095

Amounts due from related parties

407

414

Prepaid expenses and other current assets

3,224

5,551

Total current assets

46,356

93,887

Property and equipment, net

11,123

12,512

Total assets

$

57,479

$

106,399

Liabilities and stockholders’ equity

Current liabilities:

Accounts payable

$

2,974

$

5,295

Amounts due to related parties

12,512

12,772

Accrued expenses and other current liabilities

4,744

11,370

Note payable, net of debt issuance cost

402

391

Note payable to related party

929

1,113

Total current liabilities

21,561

30,941

Other liabilities:

Note payable, net of debt issuance cost, net of current portion

9,630

9,933

Note payable to related party, net of current portion

2,347

3,112

Other long-term liabilities

236

236

Total liabilities

33,774

44,222

Commitments and contingencies (Note 14)

(nil)

(nil)

Stockholders’ equity:

Class A common stock, $

0.0001

 par value;

1,000,000,000

 shares authorized,

112,871,792

 and

112,182,750

 shares issued and

outstanding at September 30, 2023 and December 31, 2022, respectively

278

278

Class B common stock, $

0.0001

 par value;

100,000,000

 shares authorized,

13,874,132

 shares issued and outstanding at

September 30, 2023 and December 31, 2022

1

1

Additional paid-in capital

373,678

366,798

Accumulated other comprehensive loss

(7)

(197)

Accumulated deficit

(350,245)

(304,703)

Total stockholders’ equity

23,705

62,177

Total liabilities and stockholders’ equity

$

57,479

$

106,399

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

6

VAXXINITY, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND

OTHER COMPREHENSIVE LOSS (INCOME)

(in thousands, except share and per share amounts)

(Unaudited)

Three Months Ended

September 30,

Nine Months Ended

September 30,

2023

2022

2023

2022

Operating expenses:

Research and development

$

7,910

$

12,468

$

27,679

$

34,609

General and administrative

5,535

7,300

18,956

20,546

Total operating expenses

13,445

19,768

46,635

55,155

Loss from operations

(13,445)

(19,768)

(46,635)

(55,155)

Other (income) expense:

Interest and other expense

176

54

514

264

Interest and other income

(512)

(545)

(1,657)

(625)

(Gain) loss on foreign currency transactions, net

36

(25)

50

(28)

Total other (income), net

(300)

(516)

(1,093)

(389)

Net loss

$

(13,145)

$

(19,252)

$

(45,542)

$

(54,766)

Net loss per share, basic and diluted

$

(0.10)

$

(0.15)

$

(0.36)

$

(0.43)

Weighted average common shares outstanding, basic and

diluted

126,736,784

126,036,865

126,272,546

125,899,557

Other comprehensive (income) loss:

 Unrealized (gain) loss on investments

(11)

215

(190)

215

 Other comprehensive (income) loss

(11)

215

(190)

215

Comprehensive loss

$

(13,134)

$

(19,467)

$

(45,352)

$

(54,981)

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

7

VAXXINITY, INC.

CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY

(in thousands, except share amounts)

(Unaudited)

Common Stock-Class A

Common Stock-Class B

Shares

Amount

Shares

Amount

Additional Paid-

in Capital

Accumulated

Other

Comprehensive

(Loss)

Accumulated

Deficit

Stockholders’

Equity

Balance at December 31, 2022

112,182,750

$

278

13,874,132

$

1

$

366,798

$

(197)

$

(304,703)

$

62,177

Issuance of common stock upon exercise of stock options

6,161

—

—

—

4

—

—

4

Stock-based compensation expense

—

—

—

—

2,225

—

—

2,225

Unrealized gain on investments

—

—

—

—

—

148

—

148

Net loss

—

—

—

—

—

—

(18,421)

(18,421)

Balance at March 31, 2023

112,188,911

$

278

13,874,132

$

1

$

369,026

$

(49)

$

(323,124)

$

46,133

Issuance of common stock upon exercise of stock options

635,001

0

—

—

393

—

—

393

Stock-based compensation expense

—

—

—

—

2,433

—

—

2,433

Unrealized gain on investments

—

—

—

—

—

31

—

31

Net loss

—

—

—

—

—

—

(13,977)

(13,977)

Balance at June 30, 2023

112,823,912

$

278

13,874,132

$

1

$

371,852

$

(18)

$

(337,101)

$

35,012

Issuance of common stock upon exercise of stock options

47,880

—

—

—

57

—

—

57

Stock-based compensation expense

—

—

—

—

1,769

—

—

1,769

Unrealized loss on investments

—

—

—

—

—

11

—

11

Net loss

—

—

—

—

—

—

(13,145)

(13,145)

Balance at September 30, 2023

112,871,792

$

278

13,874,132

$

1

$

373,678

$

(7)

$

(350,245)

$

23,705

Common Stock-Class A

Common Stock-Class B

Shares

Amount

Shares

Amount

Additional Paid-

in Capital

Accumulated

Other

Comprehensive

(Loss)

Accumulated

Deficit

Stockholders’

Equity

Balance at December 31, 2021

111,518,094

$

278

13,874,132

$

1

$

357,821

$

—

$

(229,481)

$

128,619

Issuance of common stock upon exercise of stock options

448,998

—

—

—

121

—

—

121

Stock-based compensation expense

—

—

—

—

2,178

—

—

2,178

Net loss

—

—

—

—

—

—

(18,263)

(18,263)

Balance at March 31, 2022

111,967,092

$

278

13,874,132

$

1

$

360,120

$

—

$

(247,744)

$

112,655

Issuance of common stock upon exercise of stock options

162,613

—

—

—

112

—

—

112

Stock-based compensation expense

—

—

—

—

1,826

—

—

1,826

Net loss

—

—

—

—

—

—

(17,252)

(17,252)

Balance at June 30, 2022

112,129,705

$

278

13,874,132

$

1

$

362,058

$

—

$

(264,996)

$

97,341

Issuance of common stock upon exercise of stock options

52,165

-

-

-

29

-

-

29

Stock-based compensation expense

-

-

-

-

2,357

-

-

2,357

Net loss

-

-

-

-

-

(215)

(19,251)

(19,466)

Balance at September 30, 2022

112,181,870

$

278

13,874,132

$

1

$

364,444

$

(215)

$

(284,247)

$

80,261

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

8

VAXXINITY, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(in thousands)

(Unaudited)

Nine Months Ended September 30,

2023

2022

Cash flows from operating activities:

Net loss

$

(45,542)

$

(54,766)

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

Depreciation expense

1,778

1,144

Amortization of debt issuance costs

39

40

Amortization of discount on short-term investments

(1,222)

(422)

Stock-based compensation expense

6,427

6,361

Changes in operating assets and liabilities:

Amounts due from related parties

7

(7)

Prepaid expenses and other current assets

2,327

3,349

Long-term deposits

—

(2,076)

Accounts payable

(2,321)

127

Amounts due to related parties

(260)

(2,731)

Accrued expenses and other current liabilities

(6,626)

7,530

Net cash used in operating activities

(45,393)

(41,451)

Cash flows from investing activities:

Purchase of short-term investments

(43,587)

(107,526)

Proceeds from maturity of short-term investments

73,227

27,500

Purchases of property and equipment

(389)

(1,574)

Net cash provided by (used in) investing activities

29,251

(81,600)

Cash flows from financing activities:

Repayments of note payable

(331)

(320)

Repayments of note payable with related party

(949)

—

Proceeds from exercise of stock options

453

262

Net cash used in financing activities

(827)

(58)

Change in cash, cash equivalents and restricted cash

(16,969)

(123,109)

Cash, cash equivalents and restricted cash at beginning of period

34,570

145,057

Cash, cash equivalents and restricted cash at end of period

$

17,601

$

21,948

Reconciliation of cash, cash equivalents and restricted cash:

Cash, cash equivalents and restricted cash at end of period

$

17,601

$

21,948

Less restricted cash

(206)

(3,073)

Cash and cash equivalents end of period

$

17,395

$

18,875

Supplemental Disclosure

Cash paid for interest

$

592

$

277

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

VAXXINITY, INC.

NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

9

1. Nature of the Business

Vaxxinity, Inc., a Delaware corporation (“Vaxxinity ,” and together with its subsidiaries, the “Company”), was formed through the

combination of two separate businesses that originated from United Biomedical, Inc. (“UBI”) in two separate transactions: a spin-out

from UBI in 2014 of operations focused on developing chronic disease product candidates that resulted in United Neuroscience (“UNS”),

and a second spin-out from UBI in 2020 of operations focused on the development of a COVID-19 vaccine that resulted in C19 Corp.

(“COVAXX”). On February 2, 2021, Vaxxinity was incorporated for the purpose of reorganizing and combining UNS and COVAXX

and on March 2, 2021, did so by acquiring all of the outstanding equity interests of UNS and COVAXX pursuant to a contribution and

exchange agreement (the “Contribution and Exchange Agreement”) whereby the existing equity holders of UNS and COVAXX

contributed their equity interests in each of UNS and COVAXX in exchange for equity in Vaxxinity (the “Reorganization”). On

December 31, 2022, COVAXX merged with and into Vaxxinity.

The Company is a biotechnology company currently focused on developing product candidates for human use in the fields of neurology,

pain, cardiovascular diseases and coronaviruses utilizing its “Vaxxine Platform”—a synthetic peptide vaccine technology first developed

by UBI and subsequently refined over the last two decades. The Company is engaged in the development of rationally designed

prophylactic and therapeutic vaccines to combat common chronic diseases with large global unmet medical need. The Company is also

developing a heterologous booster vaccine for SARS-Cov-2. UBI is a significant shareholder of the Company and, therefore, considered

a related party.

The Company is subject to risks and uncertainties common to early-stage companies in the biotechnology industry including, but not

limited to, uncertainty of product development and commercialization, lack of marketing and sales history, development by its

competitors of new technological innovations, dependence on key personnel, market acceptance of products, product liability, protection

of proprietary technology, ability to raise additional financing, and compliance with global government regulations. If the Company

does not successfully commercialize or out-license any of its product candidates, it will be unable to generate recurring product revenue

or achieve profitability.

The Company’s product candidates are in development and will require significant additional research and development efforts,

including extensive pre-clinical and clinical testing and regulatory approval prior to commercialization. These efforts require significant

amounts of additional capital, adequate personnel and infrastructure and extensive compliance-reporting capabilities. There can be no

assurance that the Company’s research and development will be successfully completed, that adequate protection for the Company’s

intellectual property will be obtained, that any products developed will obtain necessary government regulatory approval or that any

approved products will be commercially viable. Even if the Company’s product development efforts are successful, it is uncertain when,

if ever, the Company will generate significant revenue from product sales. The Company operates in an environment of rapid change in

technology and is dependent upon the services of its employees and consultants.

Liquidity and Going Concern Assessment

As of September 30, 2023, the Company had $

17.4

 million of cash and cash equivalents and $

25.1

 million of short-term investments to

fund operations. To date, the Company has primarily financed its operations through the sale of convertible preferred stock and common

stock, borrowings under promissory notes (including convertible notes), a portion of which has been raised from related party entities,

and grants from foundations such as the Coalition for Epidemic Preparedness Innovations (CEPI) and the Michael J. Fox Foundation

(MJFF). The Company has experienced significant negative cash flows from operations since inception, and incurred a net loss of $

45.5

million for the nine months ended September 30, 2023. Net cash used in operating activities for the nine months ended September 30,

2023 was $

45.4

 million. In addition, as of September 30, 2023, the Company has an accumulated deficit of $

350.2

 million. The Company

expects to incur substantial operating losses and negative cash flows from operations for the foreseeable future. 

In accordance with ASC 205-40, Presentation of Financial Statements-Going Concern, management is required to evaluate whether

there are conditions or events, considered in the aggregate, that raise substantial doubt about the Company's ability to continue as a

going concern within one year after the date that the financial statements are issued. When management identifies conditions or events,

considered in the aggregate, that raise substantial doubt about the Company's ability to continue as a going concern, management must

consider whether its plans to mitigate those relevant conditions or events will alleviate the substantial doubt. 

Given that the Company has incurred substantial operating losses and negative cash flows from operations since inception and expects

to continue to incur substantial operating losses and negative cash flows from operations for the foreseeable future, management assessed

that there are conditions or events, considered in the aggregate, as of the issue date of these financial statements, which raise substantial

doubt about the Company's ability to continue as a going concern. 

Management considered whether its plans to mitigate those relevant conditions or events will alleviate the substantial doubt about the

Company's ability to continue as a going concern. These plans include raising new capital through public or private equity offerings,

VAXXINITY, INC.

NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

10

strategic collaborations, debt financing and other capital sources or combinations thereof, and as needed cost reduction through attrition,

organization restructuring, and curtailment of certain research and development activities. 

However, there are significant risks and uncertainties as to whether these plans will be achieved or additional funding will be available

on terms acceptable to the Company, or at all.

Due to the risks and uncertainties, management cannot conclude that substantial doubt about the Company's ability to continue as a

going concern has been alleviated. As such, there is substantial doubt about the entity's ability to continue as a going concern within

one year after the date that the financial statements are issued. However, since liquidation is not imminent, the accompanying unaudited

condensed consolidated financial statements have been prepared assuming that the Company will continue as a going concern, which

contemplates the realization of assets and satisfaction of liabilities in the ordinary course of business. The unaudited condensed

consolidated financial statements do not include any adjustments relating to the recoverability and classification of recorded asset

amounts or the amounts and classification of liabilities that might result from the outcome of the uncertainties described above.

2. Summary of Significant Accounting Policies

Basis of presentation

The accompanying interim unaudited condensed consolidated financial statements have been prepared using generally accepted

accounting principles in the United States of America (“GAAP”) and pursuant to the rules and regulations of the United States Securities

and Exchange Commission (“SEC”) for interim financial reporting. 

These interim condensed consolidated financial statements are unaudited and, in the opinion of management, include all normal and

recurring adjustments necessary to fairly present the results of the interim periods. The condensed consolidated balance sheet at

December 31, 2022, has been derived from the audited financial statements at that date. Operating results for the three and nine months

ended September 30, 2023 and cash flows for the nine months ended September 30, 2023 are not necessarily indicative of the results

that may be expected for the fiscal year ending December 31, 2023 or any other future period. Certain information and note disclosures

normally included in annual consolidated financial statements prepared in accordance with GAAP have been omitted in accordance with

the rules and regulations for interim reporting of the SEC. These interim unaudited condensed financial statements should be read in

conjunction with the consolidated financial statements and notes thereto included in our Annual Report on Form 10-K for the year ended

December 31, 2022 filed with the SEC on March 27, 2023 (the “Annual Report”).

Significant accounting policies 

The significant accounting policies used in preparation of these unaudited condensed consolidated financial statements are disclosed in

our annual consolidated financial statements for the year ended December 31, 2022 included in the Annual Report. There have been no

changes to the Company’s significant accounting policies during the three and nine months ended September 30, 2023.

Recently adopted accounting pronouncements 

From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (“FASB”) or other standard

setting bodies and are adopted by the Company as of the specified effective date. 

In June 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2016-13, Financial

Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments (“ASU 2016-13”). ASU 2016-13

significantly changes the impairment model for most financial assets and certain other instruments as it will require immediate

recognition of estimated credit losses expected to occur over the remaining life of many financial assets, which will generally result in

earlier recognition of allowances for credit losses on loans and other financial instruments. On January 1, 2023, the Company adopted

ASU 2016-13. The adoption of this standard did not have a material impact on the Company's consolidated financial statements.

Recently issued accounting pronouncements not yet adopted

In August 2020, the FASB issued ASU 2020-06, Debt - Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives

and Hedging - Contracts in Entity's Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity's

Own Equity, which is intended to simplify the accounting for certain financial instruments with characteristics of liabilities and equity,

including convertible instruments and contracts on an entity's own equity. The guidance allows for either full retrospective adoption or

modified retrospective adoption. The guidance is effective for the Company in the first quarter of fiscal year 2024 and early adoption is

permitted. The Company is in the process of evaluating the effect the amendment will have on the consolidated financial statements.

VAXXINITY, INC.

NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

11

3. Fair Value Measurements

The Company's money market accounts and short-term investments are shown at fair value based on unadjusted quoted market prices

in active markets for identical assets.

The following table presents information about the Company’s financial instruments measured at fair value on a recurring basis and

indicate the level of the fair value hierarchy used to determine such fair values (in thousands):

September 30, 2023

Level 1

Level 2

Level 3

Total

Assets:

Short-term investments

$

25,124

$

—

$

—

$

25,124

Money market accounts

10,925

—

—

10,925

Total assets

$

36,049

$

—

$

—

$

36,049

December 31, 2022

Level 1

Level 2

Level 3

Total

Assets:

Short-term investments

$

53,352

$

—

$

—

$

53,352

Money market account

27,724

—

—

27,724

Total assets

$

81,076

$

—

$

—

$

81,076

During the three and nine months ended September 30, 2023 and the year ended December 31, 2022, there were

no

 transfers between

Level 1, Level 2 and Level 3.

4. Short-Term Investments

The Company’s short-term investments consist of the following (in thousands):

As of September 30, 2023

Amortized Cost

Unrealized

Gains (Losses),

Net

Recorded Basis

U.S. Treasury Securities

$

25,130

$

(6)

$

25,124

Total

$

25,130

$

(6)

$

25,124

As of December 31, 2022

Amortized Cost

Unrealized

Gains (Losses),

Net

Recorded Basis

U.S. Treasury Securities

$

53,549

$

(197)

$

53,352

Total

$

53,549

$

(197)

$

53,352

These securities mature in less than 1 year.

VAXXINITY, INC.

NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

12

5. Prepaid Expenses and Other Current Assets

Prepaid expenses and other current assets consist of the following (in thousands):

September 30,

December 31,

2023

2022

Clinical prepayments

$

1,762

$

2,679

Prepaid insurance

280

1,870

Prepaid materials and supplies

—

248

Deposits

240

232

Other

942

522

$

3,224

$

5,551

Clinical prepayments consist of amounts paid in advance to clinical research organizations (“CROs”) for expenses related to our clinical

trials, primarily UB-612, and included $

1.5

 million on deposit as of September 30, 2023 that will be credited against final UB-612 trial

expenses. The remaining clinical prepayment amounts are amortized to expense as earned by the CRO and clinical trial sites. 

Prepaid insurance consists primarily of $

0.3

 million and $

1.6

 million for the unamortized portion of the Company’s annual D&O

insurance fee as of September 30, 2023 and December 31, 2022, respectively. 

Prepaid materials and supplies consist of amounts paid in advance related to the procurement and/or production of materials for use in

the Company’s clinical trials, primarily UB-612. There were

no

 amounts held by related parties at September 30, 2023 and $

0.2

 million

at December 31, 2022.

6. Property and Equipment, Net

Property and equipment, net consisted of the following (in thousands):

September 30,

December 31,

2023

2022

Airplane

$

11,983

$

11,983

Laboratory and computer equipment

3,310

3,146

Software

426

415

Leasehold improvements

534

403

Facilities, furniture and fixtures

98

37

Vehicles

87

87

Construction in progress

86

65

Total property and equipment

16,524

16,136

Less: accumulated depreciation and amortization

(5,401)

(3,624)

Property and equipment, net

$

11,123

$

12,512

Depreciation expense for the three and nine months ended September 30, 2023 was $

0.7

 million and $

1.8

 million, respectively.

Depreciation expense for the three and nine months ended September 30, 2022 was $

0.4

 million and $

1.1

 million, respectively.

VAXXINITY, INC.

NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

13

7. Accrued Expenses and Other Current Liabilities

Accrued expenses and other current liabilities consisted of the following (in thousands):

September 30,

December 31,

2023

2022

Accrued external research and development

$

1,720

$

6,904

Accrued compensation

2,689

2,568

Accrued professional fees and other

334

1,722

Accrued interest

—

176

$

4,744

$

11,370

8. Other Long-Term Liabilities

Other long-term liabilities consisted of the following (in thousands):

September 30,

December 31,

2023

2022

Accrued taxes

236

236

$

236

$

236

As of September 30, 2023 and December 31, 2022, approximately $

0.2

 million of accrued taxes related to penalties and interest the

Company may be subject to paying for late filing fees related to a foreign subsidiary. The Company expects these amounts to be forgiven

but has accrued for them until the statute of limitations expires and it is appropriate to write them off.

9. Notes Payable

Note Payable—Airplane

In connection with the acquisition of an airplane, the Company entered into a note payable agreement (the “2025 Note”) in June 2020

for $

11.5

 million, with an annual interest rate of

3.4

% and a maturity date of

June 9, 2025

. Principal and interest payments are payable

monthly in the amount of $

0.1

 million with a final payment of $

9.4

 million at maturity. The 2025 Note is guaranteed by the co-founders

of the Company. In addition, the Company incurred debt issuance costs of $

0.3

 million, which are being amortized over the term of the

loan. There are no financial covenants associated with the 2025 Note. 

The carrying value of the 2025 Note is as follows (in thousands):

September 30,

December 31,

2023

2022

Principal

$

10,124

$

10,455

Unamortized debt issuance cost

(92)

(131)

Carrying amount

10,032

10,324

Less: current portion

(402)

(391)

Note payable, net of current portion and debt issuance cost

$

9,630

$

9,933

As of September 30, 2023, the remaining principal payments for the 2025 Note are as follows (in thousands):

Amount

2023 (remaining 3 months)

$

113

2024

458

2025

9,553

$

10,124

Interest expense associated with the 2025 Note was $

0.1

 million and $

0.3

 million for the three and nine months ended September 30,

2023, respectively. Interest expense associated with the 2025 Note was $

0.1

 million and $

0.3

 million for the three and nine months

VAXXINITY, INC.

NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

14

ended September 30, 2022, respectively. Accrued interest of less than $

0.1

 million was included in accrued expenses and other current

liabilities in the accompanying condensed consolidated balance sheets as of September 30, 2023 and December 31, 2022.

Promissory Note with Related Party

In October 2022, the Company entered into a related party unsecured promissory note (the “2022 Promissory Note”) with UBI for $

4.2

million. The 2022 Promissory Note accrues interest at

7.0

% per annum and is due

October 1, 2026

. The 2022 Promissory Note was

issued to satisfy accounts payable to UBI totaling $

4.2

 million.

The carrying value of the 2022 Promissory Note is as follows (in thousands):

September 30,

December 31,

2023

2022

Principal

$

3,276

$

4,225

Less: current portion

(929)

(1,113)

Note payable with related party, net of current portion

$

2,347

$

3,112

As of September 30, 2023, the remaining principal payments for the 2022 Promissory Note are as follows (in thousands):

Amount

2023 (remaining 3 months)

$

165

2024

1,029

2025

1,103

2026

979

$

3,276

Interest expense associated with the 2022 Promissory Note was $

0.1

 million and $

0.2

 million for the three and nine months ended

September 30, 2023, respectively.

10. Common Stock

The Company has reserved shares of Class A common stock for issuance for the following purposes:

September 30,

December 31,

2023

2022

Options and RSUs issued and outstanding

22,000,273

20,716,760

Options available for future grants

6,648,567

6,064,003

Warrants issued and outstanding

1,928,020

1,928,020

30,576,860

28,708,783

11. Stock-Based Compensation

2021 Omnibus Incentive Compensation Plan

In November 2021, the Company established the 2021 Omnibus Incentive Compensation Plan (the “Plan”), which provides for the

Company to grant nonqualified stock options, incentive (qualified) stock options, stock appreciation rights, restricted share awards,

restricted stock units, performance awards, cash incentive awards and other equity-based awards (including fully vested shares).

At inception in November 2021, the maximum number of shares of Class A common stock that could be issued under the Plan was

8,700,000

 shares of Class A common stock. This number increases automatically on January 1 of each year, commencing January 1,

2023, by the number of shares equal to the lesser of (i)

4

% of the outstanding shares of our Class A common stock on the immediately

preceding December 31, (ii) the number of shares determined by the compensation committee of the board of directors, if any such

determination is made, and (iii) the number of shares underlying any awards granted during the preceding calendar year, net of the

shares underlying awards canceled or forfeited under the Plan. On January 1, 2023, in accordance with the automatic “evergreen”

provision of the Plan, the maximum number of shares that can be issued under the plan was increased to

11,886,306

.

VAXXINITY, INC.

NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

15

Stock Options

As of September 30, 2023, there were options to purchase

15,437,818

 shares of Class A stock outstanding and options to purchase

6,362,455

 shares of Class B stock outstanding, of which options to purchase

10,948,474

 shares of Class A common stock and options

to purchase

5,039,459

 shares of Class B common stock were exercisable, respectively. As of September 30, 2023, the maximum number

of stock options awards available for future issuance under the Company’s plan is

6,648,567

.

The following table summarizes stock option activity during the nine months ended September 30, 2023:

Number of Stock

Options

Outstanding

Weighted

Average

Exercise Price

Per Share

Weighted

Average

Remaining

Contractual

Term (years)

Aggregate

Intrinsic Value

(in thousands)

Balance at December 31, 2022

20,416,760

$

5.07

6.8

$

7,166

Granted

3,466,782

2.28

Exercised

(689,042)

0.66

Forfeited

(1,394,227)

7.44

Balance at September 30, 2023

21,800,273

$

4.62

6.2

$

6,421

Options vested and exercisable at September 30, 2023

15,987,933

$

4.50

5.9

$

6,338

The aggregate intrinsic value of options is calculated as the difference between the exercise price of the options and the fair value of the

common stock for those options that had exercise prices lower than the fair value of the common stock as of September 30, 2023.

The intrinsic value of options exercised during the nine months ended September 30, 2023 was $

0.5

 million.

The weighted-average grant-date fair value per share of options granted during the nine months ended September 30, 2023 was $

1.88

.

Restricted Stock Units

The following table summarizes the Company’s restricted stock unit activity for the nine months ended September 30, 2023:

Number of

Shares

Weighted

Average

Grant Date

Fair Value

Per Share

Unvested at December 31, 2022

300,000

$

3.76

Forfeited

(100,000)

$

3.76

Unvested at September 30, 2023

200,000

$

3.76

Stock-Based Compensation Expense

The Company recorded stock-based compensation expense in the following expense categories in the accompanying unaudited

condensed consolidated statements of operations and other comprehensive (income) loss (in thousands):

Three Months Ended September

30,

Nine Months Ended September

30,

2023

2022

2023

2022

General and administrative

$

1,278

$

1,509

$

4,287

$

3,888

Research and development

491

848

2,140

2,473

Total stock-based compensation expense

$

1,769

$

2,357

$

6,427

$

6,361

As of September 30, 2023, total unrecognized compensation cost related to the unvested stock-based awards was $

11.4

 million, which

is expected to be recognized over a weighted average period of

2.0

 years.

VAXXINITY, INC.

NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

16

12. Income Taxes

The Company computes its expected annual effective income tax rate in accordance with FASB Accounting Standards Codification

(“ASC”) 740 , “Income Taxes” and makes changes on a quarterly basis, as necessary, based on certain factors such as changes in

forecasted annual pre-tax income; changes to actual or forecasted permanent book to tax differences; impacts from tax audits with state,

federal or foreign tax authorities; impacts from tax law changes; or change in judgment as to the realizability of deferred tax assets. The

Company identifies items which are unusual and non-recurring in nature and treats these as discrete events. The tax effect of discrete

items is recorded in the quarter in which the discrete events occur. 

The Company’s effective tax rate for the three months ended September 30, 2023 and September 30, 2022 was

0

%, due primarily to

its uncertainty of realizing a benefit from net operating losses incurred during the period.

In assessing the realizability of deferred tax assets, management considers whether it is more-likely-than-not that some or all of the

recorded deferred tax assets will be realized. The ultimate realization of deferred tax assets is dependent on the generation of future

taxable income in the periods in which those temporary differences become deductible. Management considers the scheduled reversal

of deferred tax liabilities, projected future taxable income, and tax planning strategies in making this assessment. Based on these items

and the consecutive years of pretax losses, management determined that enough uncertainty exists relative to the realization of the

deferred income tax asset balances to warrant the application of a full valuation allowance for all taxing jurisdictions.

The Company files income tax returns in the U.S. federal and various state and local jurisdictions. The Company also files returns in

numerous foreign jurisdictions that have varied years remaining open for examination, but generally the statute of limitations is three

to four years from when the return is filed. As of September 30, 2023, the Company has no ongoing audits.

The Company has US net operating loss (“NOL”) carryforwards for federal and state income tax purposes. Use of the NOL

carryforwards is limited under Section 382 of the Internal Revenue Code, as the Company had a change in ownership of more than

50

% of its capital stock over a

three-year

 period as measured under Section 382 of the Internal Revenue Code of 1986, as amended (the

“Code”). These complex changes of ownership rules generally focus on ownership changes involving stockholders owning directly or

indirectly

5

% or more of our stock, including certain public “groups” of stockholders as set forth under Section 382 of the Code,

including those arising from new stock issuances and other equity transactions. Some of these NOL carryforwards will expire if they

are not used within certain periods. At this time, the Company considers it more likely than not that it will not have sufficient taxable

income in the future that will allow us to realize these NOL carryforwards.

13. Net Loss Per Share

The Company’s potentially dilutive securities, which include warrants, options and restricted stock units, have been excluded from the

computation of diluted net loss per share as the effect would be to reduce the net loss per share. Therefore, the weighted average number

of common shares outstanding used to calculate both basic and diluted net loss per share is the same. The Company excluded the

following potential common shares, presented based on amounts outstanding at each period end, from the computation of diluted net

loss per share for the three months ended September 30, 2023 and 2022 because including them would have had an anti-dilutive effect:

September 30,

2023

2022

Options issued and outstanding

21,800,273

20,293,681

Warrants issued and outstanding

1,928,020

1,928,020

Restricted stock units issued and outstanding

200,000

300,000

23,928,293

22,521,701

14. Commitments and Contingencies

Contractual Obligations 

The Company enters into agreements with CROs to conduct clinical trials and preclinical studies and CMOs to produce vaccines and

other potential product candidates. Contracts with CROs and CMOs are generally cancellable, with notice, at the Company’s option. 

As of September 30, 2023, the Company had remaining prepayments to CROs of $

1.5

 million and

no

 remaining prepayments to CMOs

for activities associated with the conduct of its clinical trials and for the production of the Company’s anticipated vaccine product

candidate. 

VAXXINITY, INC.

NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

17

Michael J. Fox Foundation Grant

On November 3, 2021, the Company was awarded a grant from the Michael J. Fox Foundation for Parkinson’s Research (“MJFF”) in

the amount of $

0.8

 million to be used in a project for the exploration of markers for target engagement in individuals immunized with

UB-312, an active

a

-Synuclein (“aSyn”) immunotherapy. The Company will oversee sample management, sample preparation (IgG

fractions) and distribution, as well as characterize the binding properties of the antibodies against pathological forms of aSyn. As funding

is expected to be received in tranches over a two-year period, and the amounts received in each tranche are expected to be utilized within

12 months, the funds received are recognized as a short-term accrued liability. The Company recognizes payments from MJFF as a

reduction of research and development expenses, in the same period as the expenses that the grant is intended to reimburse are incurred.

As of September 30, 2023, there was

no

 balance remaining in the accrued liability related to this grant. For the nine months ended

September 30, 2023 and 2022, the Company did

no

t recognize any reduction of research and development expenses for amounts

reimbursed through the grant.

Coalition for Epidemic Preparedness Innovations (“CEPI”) Grant

In April 2022, the Company entered into an agreement with the Coalition for Epidemic Preparedness Innovations (“CEPI”) whereby

CEPI agreed to provide funding of up to $

9.3

 million to co-fund a Phase 3 clinical trial of the Company’s next generation UB-612

COVID-19 vaccine candidate as a heterologous – or ‘mix-and-match’ – booster dose. The Phase 3 trial, which began in early 2022, is

evaluating the ability of UB-612 to boost COVID-19 immunity against the original strain and multiple variants of concern including

Omicron - in people aged 16 years or older, who have been previously immunized with an authorized COVID-19 vaccine.

The Company will also be performing further manufacturing scale-up work to enable readiness for potential commercialization. Under

the terms of the agreement with CEPI, if successful, a portion of the released doses of the commercial product will be delivered to the

COVID-19 Vaccines Global Access (“COVAX”) consortium for distribution to developing countries at low cost.

Cash payments received in advance under the CEPI Funding Agreement are restricted as to their use until expenditures contemplated in

the funding agreement are incurred. As funding is expected to be received in tranches over an 18-month period, and the amounts received

in each tranche are expected to be utilized within 12 months, the funds received are reflected within restricted cash with a corresponding

short-term accrued liability. As of September 30, 2023, the Company had

no

 remaining restricted cash or accrued liability related to

CEPI funding. The Company recognizes payments from CEPI as a reduction of research and development expenses, in the same period

as the expenses that the grant is intended to reimburse are incurred. For the nine months ended September 30, 2023, the Company

reduced research and development expenses by $

1.8

 million for amounts reimbursed through the grant.

Lease Agreements

The Company has

two

 operating lease agreements for office and laboratory space. The Company is also required to pay certain operating

costs under its leases.

In August 2023, the Company entered into a lease for

9,839

 square feet of lab and office space with Space Florida in Exploration Park,

Florida commencing August 12, 2023. The lease has an initial

one-year

 term with an annual lease obligation of $

0.5

 million, after lessee

credits. Additionally, the lease requires the Company to provide a security deposit in the amount of less than $

0.1

 million. 

In April 2022, the Company entered into a facility lease agreement for

4,419

 square feet of office space in New York, New York. The

lease commenced in April 2022 and will expire in March 2029 with no option to renew. This lease and its terms were reviewed using

the guidance found in ASC 842, “Leases”. Since the lease has a non-cancellable period of

one year

, and after the first year both the

Company and the landlord have the option to early terminate the lease for any or no reason, the Company has elected to apply the short-

term expedient, which does not subject the New York lease to capitalization. 

Rent expense for the three and nine months ended September 30, 2023 was $

0.1

 million and $

0.5

 million, respectively. Rent expense

for the three and nine months ended September 30, 2022 was $

0.2

 million and $

0.4

 million, respectively.

License Agreements

In August 2021, the Company entered into a license agreement (the “Platform License Agreement”) with UBI and certain of its affiliates

that expanded intellectual property rights held under previously issued license agreements with UBI. As part of the agreement, the

Company obtained a worldwide, sublicensable (subject to certain conditions), perpetual, fully paid-up, royalty-free license to research,

develop, make, have made, utilize, import, export, market, distribute, offer for sale, sell, have sold, commercialize or otherwise exploit

peptide-based vaccines in the field of all human prophylactic and therapeutic uses, except for such vaccines related to human

immunodeficiency virus (HIV), herpes simplex virus (HSE) and Immunoglobulin E (IgE). The patents and patent applications licensed

under the Platform License Agreement include claims directed to a CpG delivery system, artificial T helper cell epitopes and certain

VAXXINITY, INC.

NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

18

designer peptides and proteins utilized in UB-612. In consideration for the Platform License Agreement, the Company issued to UBI a

warrant to purchase Class A common stock (the “UBI Warrant”). 

The Company considered ASC 805, “Business Combinations” (“ASC 805”) and ASC 730, “Research and Development” (“ASC 730”)

in determining how to account for the license agreement acquired and the issuance of the UBI Warrant. The majority of the voting

interests in UBI and in the Company were held by a group of immediate family members, at the time of the transaction, and as such the

transaction constitutes a common control transaction, which requires the license to be accounted for at the carrying value in the books

of the transferor and the excess of consideration paid over the carrying value as a capital transaction. 

Indemnification Agreements 

In the ordinary course of business, the Company may provide indemnification of varying scope and terms to employees, consultants,

vendors, lessors, business partners and other parties with respect to certain matters including, but not limited to, losses arising out of

breach of such agreements or from intellectual property infringement claims made by third parties. In addition, the Company has entered

into indemnification agreements with members of its board of directors and executive officers that will require the Company to, among

other things, indemnify them against certain liabilities that may arise by reason of their status or service as directors or officers. The

maximum potential amount of future payments the Company could be required to make under these indemnification agreements is, in

many cases, unlimited. To date, the Company has not incurred any material costs as a result of such indemnification obligations. The

Company is not aware of any indemnification arrangements that could have a material effect on its financial position, results of

operations, or cash flows, and it has

no

t accrued any liabilities related to such obligations as of September 30, 2023 and December 31,

2022. 

Legal Proceedings

From time to time, the Company may become involved in legal proceedings arising in the ordinary course of business. As of

September 30, 2023 and December 31, 2022, the Company was not a party to any material legal matters or claims.

Loss Contingency

In April 2021, the Company engaged United Biopharma, Inc. (“UBP”) to begin acquiring raw materials for use in the production of

GMP grade recombinant protein for UB-612, the Company’s COVID-19 vaccine candidate under an Authorization to Proceed (“ATP”)

agreement for $

3

 million of materials. Through August 2021, $

7.2

 million of materials were ordered by UBP, $

3.0

 million of materials

were received by UBP and paid for with an advance payment from the Company. The Company has recognized $

3.0

 million in expense

for these materials purchases authorized under the ATP.

When the Company asked to pause further manufacture of protein upon rejection of the Emergency Use Authorization application by

Taiwan in August 2021, UBP requested that its suppliers cancel the remaining $

4.2

 million in orders for which it had not taken possession

of the materials. In the fourth quarter of 2022, the Company learned that most of the suppliers refused to cancel the orders, although

some agreed to seek other buyers for the materials. For these orders, management has not yet concluded that a loss for the Company is

probable, or that one amount of loss is a better estimate than any other amount, since they were not originally authorized by the ATP

and UBP’s suppliers may be able to dispose of some amount to other buyers. Hence, an expense has

no

t been recognized for them.

As of November 8, 2023, there is no claim against the Company by UBP related to these orders, no settlement or other agreement has

been reached between the Company and UBP or, to the Company’s knowledge, between UBP and its suppliers. Therefore, the range of

the potential loss is still $

0

 to $

4.2

 million.

15. Benefit Plans

In March 2018, the Company established a defined contribution savings plan under Section 401(k) of the Code. This plan covers

substantially all U.S. employees who meet minimum age and service requirements and allows participants to defer a portion of their

annual compensation on a pre-tax basis. The Company matches employee contributions to the Plan at

100

% up to

4

% of the employee’s

base salary.

The Company offers its Ireland-based employees a Personal Retirement Savings Account (“PRSA”) that allows participants to defer a

portion of their annual compensation. The Company provides contributions equal to

5

% of each participant’s annual salary. During the

three and nine months ended September 30, 2023 and 2022, the Company contributed less than $

0.1

 million to PRSA accounts.

VAXXINITY, INC.

NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

19

16. Related Party Transactions

The Company has related party arrangements with UBI and a number of its affiliated companies namely, United Biomedical, Inc., Asia

(“UBIA”), UBI Pharma, Inc. (“UBI-P”), United BioPharma, Inc (“UBP”) and UBI IP Holding (“UBI-IP”).

As of September 30, 2023, UBI owned

44

% of the Company’s stock. The majority of the voting interests in both UBI and the Company

were held by a group of immediate family members, and as such the entities are under common control.

These related parties are governed by various Master Services Agreements (“MSA”) detailed below. 

UBI MSA - UBI provides research, development and clinical functions to the Company. There is also a purchase arrangement

with UBI for the production and shipment of the Company’s diagnostic test kits.

UBIA MSA - UBI-Asia for manufacturing, quality control, testing, validation, and supply services.

UBP MSA - UBP provides the Company with manufacturing, testing and validation services.

COVID MSA (“COVID MSA”) - COVID MSA provides that UBI acts as COVAXX’s agent with respect to matters relating

the Company’s COVID-19 program and provides research, development, manufacturing and back office administrative

services to the Company.

COVID-19 Relief MSA - A four-company MSA with UBI, UBI-Asia and UBP. The Company is an exclusive licensee of

technologies related to diagnostics, vaccines, and therapies for COVID-19. The MSA established the terms under which UBI-

Asia provides research, development, testing and manufacturing services to the Company and UBP provides contract

development and manufacturing services to the Company.

In August 2021, Vaxxinity entered into a license agreement with UBI and certain of its affiliates (collectively, the “Licensors”) that

expanded intellectual property rights previously licensed under the Original UBI Licenses in exchange for a warrant to purchase

1,928,020

 shares of Vaxxinity Class A common stock. The UBI Warrant is exercisable at an exercise price of $

12.45

 per share (subject

to adjustment pursuant thereto),is not subject to vesting, and has a term of

five years

. See note 14 to the condensed consolidated financial

statements.

The Company also considers Destination Systems, its travel and logistics firm, a related party since its Chief Executive Officer, Landon

Ogilvie, is on the Company’s board of directors.

Total related party operating activity is as follows (in thousands):

September 30,

December 31,

2023

2022

Consolidated balance sheet

Assets

Prepaid expenses and other current assets

$

—

$

237

Amounts due from related parties

407

414

Liabilities

Amounts due to related parties

12,512

12,772

Current portion of note payable

929

1,113

Note payable

2,347

3,112

Accrued interest payable

—

73

VAXXINITY, INC.

NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

20

Three Months Ended September

30,

Nine Months Ended September

30,

2023

2022

2023

2022

Operating expenses

Research and development

Services provided by related parties

 $

67

 $

—

 $

424

 $

1,139

General and administrative

Services provided by related parties

 $

1,076

 $

—

 $

2,133

 $

—

Other income/expense

Related party interest expense

 $

60

 $

—

 $

193

 $

—

21

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.

The following discussion and analysis of our financial condition and results of operations should be read together with our unaudited

condensed consolidated financial statements and related notes and other financial information appearing elsewhere in this Quarterly

Report on Form 10-Q. We intend for this discussion to provide you with information that will assist you in understanding our unaudited

condensed consolidated financial statements, the changes in key items in those unaudited condensed consolidated financial statements

from period to period and the primary factors that accounted for those changes.

Some of the information contained in this discussion

and analysis or set forth elsewhere in this Quarterly Report, including information with respect to our plans and strategy for our business

and related financing, includes forward-looking statements that involve risks, uncertainties and assumptions. See the section of this

Quarterly Report titled “Special Note Regarding Forward-Looking Statements” for a discussion of forward-looking statements. As a

result of many factors, including those factors set forth under

“Risk Factors” in Item 1A of Part I of our Annual Report on Form 10-K

for the year ended December 31, 2022, in Item 1A of Part II of this Quarterly Report on Form 10-Q, or in other filings that we make

with the SEC

, our actual results could differ materially from management’s expectations and the results described in or implied by the

forward-looking statements contained in the following discussion and analysis. Investors and others should note that we routinely use

the Investors section of our website to announce material information to investors and the marketplace. While not all of the information

that we post on the Investors section of our website is of a material nature, some information could be deemed to be material.

Accordingly, we encourage investors, the media, and others interested in us to review the information that we share on the Investors

section of our website, https://vaxxinity.com/.

Overview

We are engaged in the development of rationally designed prophylactic and therapeutic vaccines for chronic disorders and infectious

diseases with large patient populations and unmet medical needs. While vaccines have traditionally been unable to combat such disorders

effectively and safely, we believe our platform could overcome the traditional hurdles facing vaccines in this area. Our Vaxxine Platform

relies on a synthetic peptide vaccine technology first developed by UBI and subsequently refined over the last two decades. We believe

our vaccines have the potential to combat conditions that have not yet been successfully treated, or which have primarily been addressed

with monoclonal antibodies (“mAbs”) which, while generally effective, are extremely costly and cumbersome, and thus have limited

accessibility. Our pipeline primarily consists of five programs focused on chronic disease, spanning neurodegenerative disorders in

addition to other neurology and cardiovascular indications. Given the ongoing need for booster vaccines to address COVID-19 and our

Vaxxine Platform’s applicability to infectious disease, we are also opportunistically advancing a product candidate that addresses SARS-

CoV-2.

Our current pipeline consists of six programs from early to late-stage development, which fall into 3 major areas: Neurodegeneration,

Next Wave Chronic, and Infectious Disease. 

Our Neurodegeneration pipeline consists of UB-311, our leading neurology product candidate, which targets the primary pathological

process of Alzheimer’s disease (“AD”); UB-312, which targets the pathological process of Parkinson’s disease (“PD”) and other so-

called synucleinopathies; and VXX-301, an anti-tau protein product candidate which has the potential to address multiple

neurodegenerative conditions, including AD. Our Next Wave Chronic pipeline consists of UB-313, which targets Calcitonin Gene-

Related Peptide (“CGRP”) to prevent migraines; and VXX-401, which targets proprotein convertase subtilisin/kexin type 9 serine

protease (“PCSK9”) to reduce low-density lipoprotein (“LDL”) cholesterol, a risk factor for atherosclerotic heart disease. Through our

Vaxxine Platform, we believe we may be able to address a wide range of other chronic diseases, including diseases that are or could

potentially be successfully treated by mAbs, which increasingly dominate the treatment paradigm but remain accessible only to a small

proportion of patients who could potentially benefit from them.

In addition to our Neurodegeneration and Next Wave Chronic disease pipelines, given our Vaxxine Platform’s applicability to infectious

disease and the ongoing need for booster vaccines to address SARS-CoV-2, we are advancing an Infectious Disease product candidate,

UB-612, as a heterologous booster against COVID-19. We have reported topline results of a pivotal Phase 3 trial of UB-612 and

completed rolling submissions for conditional/provisional authorization with regulatory authorities in the United Kingdom and Australia

in March 2023.

Our ability to generate revenue sufficient to achieve profitability will depend on the eventual regulatory approval and commercialization

of one or more of our product candidates. We have not yet obtained any regulatory approvals for our product candidates or conducted

sales and marketing activities for our product candidates.

We have principally funded our operations through financing transactions. Through September 30, 2023, we received gross proceeds of

$306.8 million in connection with various financing transactions, including the sale of preferred and common stock, the issuance of

promissory notes (including convertible promissory notes (“Convertible Notes”)), and the entry into simple agreements for future equity

(“SAFEs”).

22

Costs associated with research and development are the most significant component of our expenses. These costs can vary greatly from

period to period depending on the number, timing, size, scope and nature of various trials for our product candidates. We anticipate

incurring greater selling and marketing expenses if we commercialize any of our product candidates in the future and prepare for such

commercialization. Our product candidates are in clinical stage or pre-clinical stage development. We have generated limited revenue

to date and have incurred significant operating losses since inception. Net losses were $13.1 million and $19.3 million for the three

months ended September 30, 2023 and 2022, respectively. Net losses were $45.5 million and $54.8 million for the nine months ended

September 30, 2023 and 2022, respectively. As of September 30, 2023, we had an accumulated deficit of $350.2 million.

We have taken several steps to reduce our rate of cash burn for our research and development and general and administrative activities,

including reducing headcount through attrition and organizational restructuring, limiting use of external consultants and other

professional services, and prioritizing research and development activities for certain programs while deferring other activities. As a

result of these efforts, as of the date of this report we expect our existing cash and cash equivalents and short-term investments will be

sufficient to fund our operating expenses and capital expenditure requirements through early Q4 2024. See Note 1 to the condensed

consolidated financial statements.

Thereafter, our viability will depend on our ability to raise additional capital to finance operations, to successfully commercialize our

product candidates, if approved, or to enter into collaborations with third parties for the development and / or commercialization of our

product candidates. If we are unable to do any of the foregoing, we would be forced to delay, limit, reduce or terminate our product

candidate development or future commercialization efforts. Our estimates are based on a variety of assumptions that may prove to be

wrong, and we could exhaust our available capital resources sooner than expected. See “— Liquidity and Capital Resources.” 

Recent Developments

In August 2023, results from the Phase 2a trial of UB-311 in patients with mild Alzheimer’s disease were published in The Lancet’s

eBioMedicine.

In October 2023, Peter Powchik, MD assumed his role as Vaxxinity’s Executive Vice President, Global Scientific Director, with the

departure of Ulo Palm and Sumita Ray, JD, assumed her role as Vaxxinity’s Chief Legal, Compliance, and Administrative Officer, with

the departure of René Paula.

Also in October 2023, we have expanded the Phase 1 trial of VXX-401 to test higher dose levels, due to VXX-401’s favorable safety

and tolerability profile to date.

Through the second half of 2023, exploratory target engagement and biomarker assays from the Phase 1 clinical trial of UB-312 have

continued to yield encouraging results. UB-312-induced antibodies slowed alpha-synuclein (“aSyn”) aggregation in PD patient

cerebrospinal fluid (“CSF”), demonstrating BBB crossing and clear target engagement

in vivo

. UB-312 reduced aggregated aSyn in PD

patients over time, as compared to placebo, as measured by fluorescence max in a seed amplification assay. A reduction of aggregated

aSyn over time in the CSF of PD patients immunized with UB-312 was also observed, as compared to those on placebo.

Components of Our Unaudited Condensed Consolidated Results of Operations

Revenue 

We recorded no revenue for the three months ended September 30, 2023 and 2022 and the nine months ended September 30, 2023 and

2022. We do not expect to generate any meaningful revenue unless and until we obtain regulatory approval of and commercialize or

out-license at least one of our product candidates, and we do not know when, or if, this will occur. If our development efforts for our

product candidates are successful and result in commercialization, we may generate additional revenue in the future from a combination

of product sales or payments from collaboration or license agreements that we have entered into or may enter into with third parties. We

have incurred significant losses since our inception. We expect to incur losses for the foreseeable future and may never achieve or

maintain profitability.

Cost of Revenue 

We recorded no cost of revenue for the three months ended September 30, 2023 and 2022 and the nine months ended September 30,

2023 and 2022. If our development efforts in respect of our current pipeline of product candidates are successful and result in regulatory

approval, we expect our cost of revenue will increase in relative proportion to the level of our revenue as we commercialize the applicable

product candidate. We expect that the cost of revenue will increase in absolute dollars as and if our revenue grows and will vary from

period to period as a percentage of revenue. 

23

Research and Development Expenses 

The design, initiation and execution of candidate discovery and development programs of our potential future product candidates is key

to our success and involves significant expenses. Prior to initiating these programs, project teams incorporating individuals from the

essential disciplines within the Company scope out the activities, timing, requirements, inclusion and exclusion criteria and the primary

and secondary endpoints. Once we have decided to proceed, our Vaxxine Platform enables the iteration of drug candidates in the

discovery phase through rapid, rational design and formulation. After we have identified drug candidates, the costs of scaling the

formulation from research grade to clinical grade, then to commercial grade, typically consumes significant resources. In addition to

internal research and development, we utilize service providers, including related parties, to complete activities we lack the internal

resources to handle.

Research and development expenses consist primarily of costs incurred for research activities, including drug discovery efforts and the

development of our product candidates. We expense research and development costs as incurred, which include:

•

expenses incurred to conduct the necessary preclinical studies and clinical trials required to obtain regulatory approval;

•

expenses incurred under agreements with CROs that are primarily engaged in the oversight and conduct of our clinical trials,

preclinical studies and drug discovery efforts and contract manufacturers that are primarily engaged to provide preclinical and

clinical drug substance and product for our research and development programs;

•

other costs related to acquiring and manufacturing materials in connection with our drug discovery efforts and preclinical

studies and clinical trial materials, including manufacturing validation batches; 

•

costs related to investigative sites and consultants that conduct our clinical trials, preclinical studies and other scientific

development services;

•

employee-related expenses, including salaries and benefits, travel and stock-based compensation expense for employees

engaged in research and development functions;

•

costs related to compliance with regulatory requirements; and

•

facilities-related costs, depreciation and other expenses, which include rent and utilities.

We recognize external development costs based on an evaluation of the progress to completion of specific tasks using information

provided to us by service providers. This process involves reviewing open contracts and purchase orders, communicating with personnel

to identify services that have been performed on our behalf and estimating the level of service performed and the associated cost incurred

for the service when we have not yet been invoiced or otherwise notified of actual costs. Any nonrefundable advance payments that we

make for goods or services to be received in the future for use in research and development activities are recorded as prepaid expenses.

Such amounts are expensed as the related goods are delivered or the related services are performed, or until it is no longer expected that

the goods will be delivered, or the services rendered, at which point the net remainder is expensed.

We continue to work with related parties for the advancement of our research and development programs, including for manufacturing,

quality control, testing, validation, and supply services. While this related party work has significantly diminished over the last year,

and we expect this trend to continue, we are still reliant on UBIA to provide certain manufacturing-related and prior-conducted clinical

data that will be needed for inclusion in our regulatory applications for UB-612. During the nine months ended September 30, 2023 and

2022, related party expenses were approximately 1.5% and 11.8% of our research and development expenses, respectively. 

Where appropriate, we allocate certain external research and development expenses on a program-by-program basis. These expenses

primarily relate to third-party clinical development services (such as those provided by clinical research organizations and research

laboratories), manufacturing expenses, and consulting and other professional services expenses. The Company's major programs are in

the areas of Neurodegenerative Disease, Chronic Disease and Infectious Disease. Other programs include Platform development

activities and preclinical research. We do not allocate our internal research and development expenses and certain external research and

development expenses, such as personnel expenses, facility costs, laboratory materials and equipment costs, and travel and entertainment

expenses related to research and development activities, to specific programs because, for example, our research and development

personnel work across programs, and programs share common facilities, laboratory materials, and equipment, and any such allocation

would necessarily involve significant estimates and judgments and, accordingly, would be imprecise. When we refer to the research and

development expenses associated with a specific program, these refer exclusively to the allocated third-party expenses associated with

that product candidate. All other research and development costs are referred to as unallocated costs.

Product candidates in later stages of clinical development generally have higher development costs than those in earlier stages of clinical

development, primarily due to the increased size and duration of later-stage clinical trials. Additionally, greater research and

development overhead is required to support broader and more rapid development of our Vaxxine Platform and new product candidates.

24

As a result, we expect that our research and development expenses could increase if we continue our existing and planned clinical trials

and conduct increased pre-clinical and clinical development activities, including submitting regulatory filings for product candidates,

and focus more generally on the development of our chronic disease product candidates.

At this time, we cannot reasonably estimate or know the nature, timing and costs of the efforts that will be necessary to complete the

pre-clinical and clinical development of any of our product candidates or when, if ever, material net cash inflows may commence from

any of our product candidates.

General and Administrative Expenses 

General and administrative expenses consist primarily of salaries and benefits, travel and stock-based compensation expense for

personnel in executive, business development, finance, human resources, legal, information technology, public relations,

communications and administrative functions. General and administrative expenses also include insurance costs and professional fees

for legal, patent, consulting, investor and public relations, accounting and audit services and other general operating expenses not

otherwise classified as research and development expenses. 

In the event UB-612 obtains regulatory approval and we subsequently commence commercialization of this product, we expect general

and administrative expenses will increase. We have incurred and expect to continue to incur public company-related expenses, including

services associated with maintaining compliance with Nasdaq listing and SEC requirements, director and officer liability insurance and

investor and public relations costs.

Other Expense (Income) 

Interest Expense 

Interest expense consists of interest incurred on (i) the note entered into during June 2020 for the acquisition of an airplane (the “2025

Note”) and (ii) the related party promissory note (the “2022 Promissory Note”) entered into during 2022. 

Interest Income

Interest income consists of income earned on our cash and cash equivalents, money market holdings, and short-term investments. 

(Gain) Loss on Foreign Currency Translation, Net 

Our foreign subsidiaries, which are wholly-owned by the Company, use the U.S. dollar as their functional currency and maintain records

in the local currency. Nonmonetary assets and liabilities are remeasured at historical rates and monetary assets and liabilities are

remeasured at exchange rates in effect at the end of the reporting period. Income statement accounts are remeasured at average exchange

rates for the reporting period. The resulting gains or losses are included in foreign currency losses (gains) in the condensed consolidated

financial statements.

Provision for Income Taxes 

We have not recorded any significant amounts related to income tax but have reserved $0.7 million of unrecognized tax benefits against

NOLs. We have not recorded any income tax benefits for the majority of our net losses we incurred to date. 

We account for income taxes using the asset and liability method, which requires the recognition of deferred tax assets and liabilities

for the expected future tax consequences of events that have been included in the consolidated financial statements or our tax returns. 

Deferred tax assets and liabilities are determined based on the difference between the financial statement carrying amounts and tax basis

of existing assets and liabilities and for loss and credit carryforwards, which are measured using the enacted tax rates and laws in effect

in the years in which the differences are expected to reverse. The realization of our deferred tax assets is dependent upon the generation

of future taxable income, the amount and timing of which are uncertain. Valuation allowances are provided if, based upon the weight of

available evidence, it is more likely than not that some or all of the deferred tax assets will not be realized. As of September 30, 2023,

we continue to maintain a full valuation allowance against all of our deferred tax assets based on evaluation of all available evidence.

We file income tax returns in the U.S. federal and state jurisdictions and may become subject to income tax audit and adjustments by

related tax authorities. Our tax return periods (for entities then in existence) for U.S. federal income taxes for the tax years since 2017

remain open to examination under the statute of limitations by the Internal Revenue Service and state jurisdictions. We record reserves

for potential tax payments to various tax authorities related to uncertain tax positions, if any. The nature of uncertain tax positions is

subject to significant judgment by management and subject to change, which may be substantial. These reserves are based on a

determination of whether and how much a tax benefit taken by us in our tax filings or positions is more likely than not to be realized

following the resolution of any potential contingencies related to the tax benefit. We develop our assessment of uncertain tax positions,

and the associated cumulative probabilities, using internal expertise and assistance from third-party experts. As additional information

25

becomes available, estimates are revised and refined. Differences between estimates and final settlement may occur resulting in

additional tax expense. Potential interest and penalties associated with such uncertain tax positions are recorded as a component of our

provision for income taxes. 

Condensed Consolidated Results of Operations

The following is a summary of our unaudited condensed consolidated results of operations: 

Three Months Ended September 30,

Nine Months Ended September 30,

(In thousands)

2023

2022

Change $

2023

2022

Change $

Operating expenses:

Research and development

$

7,910

$

12,468

 $ 

(4,558)

$

27,679

$

34,609

$

(6,930)

General and administrative

5,535

7,300

(1,765)

18,956

20,546

(1,590)

Total operating expenses

13,445

19,768

(6,323)

46,635

55,155

(8,520)

Loss from operations

(13,445)

(19,768)

6,323

(46,635)

(55,155)

8,520

Other (income) expense:

Interest expense

176

54

122

514

264

250

Interest income

(512)

(545)

33

(1,657)

(625)

(1,032)

(Gain) loss on foreign currency translation, net

36

(25)

61

50

(28)

78

Total other (income) expense, net

(300)

(516)

216

(1,093)

(389)

(704)

Net loss

$

(13,145)

$

(19,252)

$

6,107

$

(45,542)

$

(54,766)

$

9,224

Research and Development Expenses 

Comparison of the Three Months Ended September 30, 2023 and 2022

Allocated external research and development expenses decreased from $6.1 million for the three months ended September 30, 2022 to

$4.0 million for the three months ended September 30, 2023.

Neurodegenerative Disease Program expenses increased from $0.3 million for the three months ended September 30, 2022 to $0.5

million for the three months ended September 30, 2023. This increase primarily resulted from a $0.3 million increase in expenses for

UB-312 primarily attributable to our Phase 1 trial entering the completion phase. 

Next Wave Chronic Disease Program expenses increased from $1.6 million for the three months ended September 30, 2022 to $1.8

million for the three months ended September 30, 2023. This increase primarily resulted from a $0.2 million increase in expenses for

VXX-401 primarily attributable to active patient enrollment in the Phase 1 trial during the quarter.

Infectious Disease Program expenses decreased from $4.0 million for the three months ended September 30, 2022 to $1.6 million for

the three months ended September 30, 2023. This decrease primarily resulted from a $2.4 million decrease in expenses for UB-612

primarily attributable to the Phase 3 trial entering the completion phase as all patient visits were completed in Q3 2023.

Unallocated research and development expenses decreased from $6.4 million for the three months ended September 30, 2022 to $3.9

million for the three months ended September 30, 2023. This decrease primarily resulted from a $1.7 million decrease in personnel-

related expenses (including $0.4 million in stock-based compensation) primarily attributable to attrition and internal restructuring, and

a $0.6 million decrease in external consulting services.

Comparison of the Nine Months Ended September 30, 2023 and 2022

Allocated external research and development expenses decreased from $16.7 million for the nine months ended September 30, 2022 to

$12.4 million for the nine months ended September 30, 2023. 

Neurodegenerative Disease Program expenses decreased from $2.2 million for the nine months ended September 30, 2022 to $1.3

million for the nine months ended September 30, 2023. This decrease primarily resulted from a $0.6 million decrease in expenses for

UB-312 primarily attributable to our Phase 1 trial entering the completion phase and a $0.2 million decrease in expenses for VXX-301

primarily attributable to reduced pre-clinical activity. 

Next Wave Chronic Disease Program expenses increased from $5.0 million for the nine months ended September 30, 2022 to $5.8

million for the nine months ended September 30, 2023. This increase primarily resulted from a $0.9 million increase in expenses for

VXX-401 primarily attributable to active patient enrollment in the Phase 1 trial. 

26

Infectious Disease Program expenses decreased from $9.2 million for the nine months ended September 30, 2022 to $5.0 million for the

nine months ended September 30, 2023. This decrease resulted from a $4.2 million decrease in expenses for UB-612 primarily

attributable to the Phase 3 trial entering the completion phase as all patient visits were completed in Q3 2023.

Unallocated research and development expenses decreased from $17.9 million for the nine months ended September 30, 2022 to $15.3

million for the nine months ended September 30, 2023. This decrease primarily resulted from a $2.8 million decrease in personnel-

related expenses (including $0.3 million in stock-based compensation) primarily attributable to attrition and internal restructuring, and

a $1.1 million decrease in external consulting services, partially offset by a $0.8 million increase in facility and laboratory equipment

costs attributable to rental of additional laboratory and office space and increased lab supplies and maintenance costs, and a $0.4 million

increase in other indirect expenses primarily attributable to increased travel and IT services.

General and Administrative Expenses 

Comparison of the Three Months Ended September 30, 2023 and 2022

General and administrative expenses decreased from $7.3 million for the three months ended September 30, 2022 to $5.5 million for

the three months ended September 30, 2023.

The decrease was primarily due to a decrease of $0.7 million in personnel-related expenses (including $0.2 million in stock-based

compensation) primarily attributable to attrition and internal restructuring, a decrease in director and officer insurance expense of $0.5

million, and a $0.3 million decrease in external consulting and professional services. 

Comparison of the Nine Months Ended September 30, 2023 and 2022

General and administrative expenses decreased from $20.5 million for the nine months ended September 30, 2022 to $19.0 million for

the nine months ended September 30, 2023.

The decrease was due to decreases of $1.5 million in director and officer insurance expense, $0.6 million in payroll-related expenses

primarily attributable to attrition and internal restructuring, and $0.3 million in external consulting services, partially offset by a $0.5

million increase in external professional services and a $0.4 million increase in stock-based compensation due to the increase in board

size in early 2023. 

Liquidity and Capital Resources

Sources of Liquidity 

We have not yet obtained regulatory approval for or commercialized any of our product candidates, which are in various phases of pre-

clinical and clinical development. We have financed operations primarily through the issuance of common stock, convertible preferred

stock, borrowings under promissory notes (including the Convertible Notes) and the execution of Simple Agreements for Future Equity

(“SAFEs”). Through September 30, 2023, we received gross proceeds of $306.8 million in connection with various financing

transactions, including the sale of preferred and common stock, the issuance of promissory notes (including Convertible Notes), and the

execution of SAFEs. As of September 30, 2023, we had $42.5 million of cash, cash equivalents and short-term investments compared

to $86.8 million as of December 31, 2022. The decrease in cash, cash equivalents and short-term securities for the periods reported are

primarily due to the factors described under “Cash Flows” below.

In August 2023, we entered into an at-the-market offering program pursuant to which we may issue and sell, from time to time, up to

$100,000,000 of our Class A common stock. For the three months ended September 30, 2023, we did not sell any shares under this

program.

27

Cash Flows

The following table provides information regarding our cash flows for the nine months ended September 30, 2023 and 2022 (in

thousands): 

September 30,

December 31,

2023

2022

Balance Sheet Data:

Cash and cash equivalents

$

17,395

$

33,475

Short-term investments, net

25,124

53,352

Restricted cash

206

1,095

Total assets

57,479

106,399

Total liabilities

33,774

44,222

Total stockholders' equity

$

23,705

$

62,177

Nine Months Ended September 30,

2023

2022

Statement of Cash Flow Data:

Net cash (used in) provided by operating activities

$

(45,393)

$

(41,451)

Net cash (used in) provided by investing activities

29,251

(81,600)

Net cash (used in) provided by financing activities

(827)

(58)

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

$

(16,969)

$

(123,109)

Operating Activities

Net cash used in operating activities for the nine months ended September 30, 2023 was $45.4 million, primarily resulting from a $45.5

million net loss and an unfavorable $6.9 million change in operating assets and liabilities, partially offset by total non-cash items of $7.0

million. The changes in net operating assets and liabilities were primarily due to a $6.6 million decrease in accrued expenses and other

current liabilities and a $2.3 million decrease in accounts payable, offset by a $2.3 million decrease in prepaid expenses. The non-cash

adjustments to net loss primarily consisted of $6.4 million of stock-based compensation and $1.8 million in depreciation, partially offset

by $1.2 million in amortization of discount on short-term investments. 

Net cash used in operating activities for the nine months ended September 30, 2022 was $41.5 million, primarily resulting from a $54.8

million net loss, an unfavorable $6.2 million change in operating assets and liabilities and total non-cash items of $7.1 million. The

changes in net operating assets and liabilities were primarily due to a decrease of $2.7 million in amounts due to related party, a

$7.5

million increase in accrued expenses and other current liabilities

,

a $3.3 million increase in prepaid expenses and a $2.1 million decrease

in long-term deposits. The primary non-cash adjustments to net loss consisted of $6.4 million of stock-based compensation and $1.1

million in depreciation.

Investing Activities

Net cash provided by investing activities totaled $29.3 million for the nine months ended September 30, 2023. The cash provided by

investing activities consisted primarily of the acquisition and redemption of short-term investments, and the acquisition of laboratory

and computer equipment.

Net cash used in investing activities totaled $81.6 million for the nine months ended September 30, 2022. The cash used in investing

activities consisted primarily of the acquisition of short-term investments.

Financing Activities

Net cash used by financing activities was less than $0.8 million for the nine months ended September 30, 2023. We repaid $1.3 million

in notes payable principal and received $0.5 million from the exercise of stock options.

Net cash used in financing activities was $0.1 million for the nine months ended September 30, 2022. We repaid $0.3 million in notes

payable principal and received $0.3 million from the exercise of stock options.

Funding Requirements

We have incurred net losses in each reporting period since inception. We do not expect to generate any revenue unless and until we

obtain regulatory approval of and commercialize our product candidates or enter into collaboration or licensing arrangements with one

28

or more third-party strategic partners. We do not know when, or if, this will occur. We will continue to incur significant losses for the

foreseeable future even if we ultimately receive regulatory approval for one or more of our product candidates and commercialize any

approved products, and we expect the losses to increase as we continue the development of, and seek regulatory approvals for, our

product candidates and begin to commercialize any approved products.

As of the date of this Quarterly Report, we expect our existing cash, cash equivalents and short-term investments, together with expected

savings from cost reduction efforts, will be sufficient to fund our operating expenses through the early Q4 2024. See Note 1 to the

condensed consolidated financial statements. As of September 30, 2023, other than our 2025 Note and the 2022 Promissory Note, we

have no material debt obligations.

We have based our projections of operating capital requirements on assumptions that may prove to be incorrect, and we may use all of

our available capital resources sooner than we expect. Our future capital requirements will depend on many factors, which include:

•

the scope, number, progress, initiation, duration, cost, results and timing of clinical trials, pre-clinical programs and

nonclinical studies of our current or future product candidates;

•

the outcomes and timing of regulatory reviews, approvals or other actions;

•

the timing and manner in which we manufacture our pre-clinical and clinical drug material, the terms on which we can have

such manufacturing completed, and the extent to which we undertake commercialization of any drug products, if approved;

•

the extent to which we establish sales, marketing, medical affairs and distribution infrastructure to commercialize any product

candidates;

•

the timing and extent to which we expand our operational, financial and management systems and infrastructure, and facilities; 

•

the timing and extent to which we increase our personnel to support operations, including necessary increases in headcount to

conduct and expand our clinical trials, commercialize any approved products and support our operations as a public company;

•

the number of patent applications we must file and claims we must defend in order to maintain, expand and protect our

intellectual property portfolio, and the costs of preparing, filing and prosecuting patent applications, maintaining and protecting

our intellectual property rights;

•

our ability to obtain marketing approval for our product candidates;

•

our ability to establish and maintain additional licensing, collaboration or similar arrangements on favorable terms and whether

and to what extent we retain development or commercialization responsibilities under any new licensing, collaboration or

similar arrangement;

•

the success of any other business, product or technology that we acquire or in which we invest; 

•

our ability to maintain, expand and defend the scope of our intellectual property portfolio; 

•

the current and potential impacts of the Russia-Ukraine conflict, inflation and rising interest rates on our business;

•

the costs of acquiring, licensing or investing in businesses, product candidates and technologies; 

•

market acceptance of our product candidates, to the extent any are approved for commercial sale; and

•

the effect of competing technological and market developments.

Until such time, if ever, as we can generate positive cash flows from operations, we expect to finance our cash needs through public or

private equity offerings, strategic collaborations and debt financing. To the extent that we raise additional capital through the sale of our

Class A common stock, convertible securities or other equity securities, stockholders’ ownership interest will be diluted and the terms

of these securities could include liquidation or other preferences and anti-dilution protections. In addition, debt financing, if available,

may result in fixed payment obligations and may involve agreements that include restrictive covenants that limit our ability to take

specific actions, such as incurring additional debt, making capital expenditures, creating liens, redeeming shares or declaring dividends.

If we raise additional funds through strategic collaborations or marketing, distribution or licensing arrangements with third parties, we

may have to relinquish valuable rights to our technologies, future revenue streams or product candidates or grant licenses on terms that

may not be favorable to us. If we are unable to raise additional funds when needed, we may be required to delay, limit, reduce or

29

terminate our product candidate development or future commercialization efforts or grant rights to third parties to develop and market

product candidates that we would otherwise prefer to develop and market ourselves. 

Tax-Related Obligations

We have reserved $0.7 million of unrecognized tax benefits against NOLs. Additionally, as of September 30, 2023, we accrued $0.2

million in interest and penalties related to prior year tax filings.

Off-Balance Sheet Arrangements

We did not have during the periods presented, and do not currently have, any off-balance sheet arrangements, as defined in the rules and

regulations of the SEC. 

Critical Accounting Policies and Estimates

The preparation of financial statements in accordance with GAAP requires management to make estimates and assumptions that affect

the amounts reported in our unaudited condensed consolidated financial statements and accompanying notes. Management bases its

estimates on historical experience, market and other conditions, and various other assumptions it believes to be reasonable. Although

these estimates are based on management’s best knowledge of current events and actions that may impact us in the future, the estimation

process is, by its nature, uncertain given that estimates depend on events over which we may not have control. In addition, if our

assumptions change, we may need to revise our estimates, or take other corrective actions, either of which may also have a material

effect on our unaudited condensed consolidated financial statements. Significant estimates contained within these unaudited condensed

consolidated financial statements include, but are not limited to, the estimated fair value of our common stock, stock-based

compensation, income tax valuation allowance and the accruals of research and development expenses. We base our estimates on

historical experience, known trends and other market-specific or other relevant factors that we believe to be reasonable under the

circumstances. On an ongoing basis, management evaluates its estimates, as there are changes in facts and circumstances. If market and

other conditions change from those that we anticipate, our unaudited condensed consolidated financial statements may be materially

affected.

While our significant accounting policies are described in detail in our annual consolidated financial statements for the year ended

December 31, 2022 included in our Annual Report on Form 10-K for the year ended December 31, 2022, we believe that the following

critical accounting policies and estimates have a higher degree of inherent uncertainty and require our most significant judgments. 

Accrued Research and Development Expenses

As part of the process of preparing our condensed consolidated financial statements, we are required to estimate accrued research and

development expenses. As we advance our programs, we anticipate more complex clinical studies resulting in greater research and

development expenses, which will place even greater emphasis on the accrual. This process involves reviewing open contracts and

purchase orders, communicating with our applicable personnel to identify services that have been performed on our behalf and estimating

the level of service performed and the associated cost incurred for the service when we have not yet been invoiced or otherwise notified

of actual costs. In the past years, UBI and its affiliated companies performed and administered a significant amount of research and

development work on our behalf. Having UBI and its affiliated company act as intermediaries added to the complexity of determining

appropriate accruals, and we have largely moved away from this model. Certain accruals and amounts owed to the UBI entities are still

under review, and these amounts may change as a result of this review.

The majority of our service providers invoice in arrears for services performed, on a pre-determined schedule or when contractual

milestones are met; however, some require advance payments. We make estimates of accrued expenses as of each balance sheet date in

the condensed consolidated financial statements based on facts and circumstances known to us at that time. We periodically confirm the

accuracy of the estimates with the service providers and make adjustments if necessary. Examples of estimated accrued research and

development expenses include fees paid to:

•

vendors, including research laboratories, in connection with pre-clinical development activities;

•

CROs and investigative sites in connection with pre-clinical studies and clinical trials; and

•

contract manufacturers in connection with drug substance and drug product formulation of pre-clinical studies and clinical

trial materials.

We base our expenses related to pre-clinical studies and clinical trials on our estimates of the services received and efforts expended

pursuant to quotes and contracts with multiple research institutions and CROs that supply, conduct and manage pre-clinical studies and

clinical trials on our behalf. The financial terms of these agreements are subject to negotiation, vary from contract to contract and may

result in uneven payment flows. There may be instances in which payments made to our vendors will exceed the level of services

30

provided and result in a prepayment of the expense. Payments under some of these contracts depend on factors such as the successful

enrollment of patients and the completion of clinical trial milestones. In accruing service fees, we estimate the time period over which

services will be performed and the level of effort to be expended in each period. If the actual timing of the performance of services or

the level of effort varies from the estimate, it adjusts the accrual or the prepaid expense accordingly. Although we do not expect our

estimates to be materially different from amounts actually incurred, our understanding of the status and timing of services performed

relative to the actual status and timing of services performed may vary and may result in reporting amounts that are too high or too low

in any particular period. To date, our estimated accruals have not differed materially from actual costs incurred.

Stock-Based Compensation

We measure all stock-based awards granted to employees, directors and non-employees based on their fair value on the date of the grant

and recognize the corresponding compensation expense of those awards over the requisite service period, which is generally the vesting

period of the respective award. Forfeitures are accounted for as they occur. We grant stock options and restricted stock unit awards that

are subject to service vesting conditions.

We classify stock-based compensation expense in our condensed consolidated statements of operations in the same manner in which

the award recipient’s payroll costs are classified or in which the award recipient’s service payments are classified.

We estimate the fair value of each stock option grant using the Black-Scholes option-pricing model, which requires the use of subjective

assumptions that could materially impact the estimation of fair value and related compensation expense to be recognized. These

assumptions include (i) the expected volatility of our stock price, (ii) the periods of time over which recipients are expected to hold their

options prior to exercise (expected lives), (iii) expected dividend yield on our common stock, and (iv) risk-free interest rates, which are

based on quoted U.S. Treasury rates for securities with maturities approximating the options’ expected lives. Developing these

assumptions requires the use of judgment. Both prior to and after our initial public offering (“IPO”), we lacked company-specific

historical and implied volatility information. Therefore, we estimate our expected stock volatility based on the historical volatility of a

publicly traded set of peer companies. The expected term of the Company’s options has been determined utilizing the “simplified”

method for awards that qualify as “plain-vanilla” options. The expected term of options granted to non-employees is equal to the

contractual term of the option award. The expected dividend yield is zero as we have never paid dividends and do not currently anticipate

paying any in the foreseeable future.

Coalition for Epidemic Preparedness (“CEPI”) Grant

In April 2022, we entered into an agreement with the Coalition for Epidemic Preparedness Innovations (“CEPI”) whereby CEPI agreed

to provide funding of up to $9.3 million to co-fund a Phase 3 clinical trial of our UB-612 COVID-19 vaccine candidate as a heterologous

– or ‘mix-and-match’ – booster dose. The Phase 3 trial, which began in early 2022, is evaluating the ability of UB-612 to boost COVID-

19 immunity against the original strain and multiple variants of concern, including Omicron, in people aged 16 years or older who have

been previously immunized with an authorized COVID-19 vaccine.

We will also be performing further manufacturing scale-up work to enable readiness for potential commercialization. Under the terms

of the agreement with CEPI, if successful, a portion of the released doses of the commercial product will be allocated for delivery to the

COVID-19 Vaccines Global Access (“COVAX”) consortium for distribution to developing countries at low cost.

Cash payments received in advance under the CEPI Funding Agreement are restricted as to their use until expenditures contemplated in

the funding agreement are incurred. As funds are received, they are included within restricted cash offset by a corresponding short-term

accrued liability. We recognize payments from CEPI as a reduction of research and development expenses, in the same period as the

expenses that the grant is intended to reimburse are incurred.

Item 3. Quantitative and Qualitative Disclosures About Market Risk.

We are exposed to market risk in the ordinary course of our business. These risks primarily relate to foreign currency and changes in

interest rates. 

Foreign Currency Exchange Risk 

We have limited exposure to foreign currency exchange risk as most of our operating activities are primarily denominated in U.S.

dollars. We believe actual foreign exchange gains and losses did not have a significant impact on our results of operations for any periods

presented herein. The results of the analysis based on our financial position as of September 30, 2023, indicated that a hypothetical 10%

increase or decrease in applicable foreign currency exchange rates would not have a material effect on our financial results.

31

Interest Rate Risk 

We are exposed to market risk related to changes in interest rates. As of September 30, 2023 and December 31, 2022, our cash

equivalents consisted of interest-bearing checking accounts and money market accounts. The 2025 Note we entered into for the year

ended December 31, 2020 bears a fixed annual interest rate of 3.4% and matures in June 2025. Additionally, the 2022 Promissory Note

we entered into for the year ended December 31, 2022 bears a fixed annual interest rate of 7.0% and matures in October 2026. Given

that the 2025 Note and the 2022 Promissory Note bear fixed rates of interest, we believe there is no material exposure to interest rate

risk. The results of the analysis based on our financial position as of September 30, 2023, indicated that a hypothetical 100 basis point

increase or decrease in risk-free rates would not have a material effect on our financial results.

Our measurement of interest rate risk involves assumptions that are inherently uncertain and, as a result, we cannot precisely estimate

the impact of changes in interest rates on net interest revenues. Actual results may differ from simulated results due to changes in the

amount of our cash equivalents and the timing, magnitude, and frequency of interest rate changes, as well as changes in market conditions

and management strategies, including changes in asset and liability mix. 

Item 4. Controls and Procedures.

Evaluation of Disclosure Controls and Procedures

Our management, with the participation of our principal executive officer and principal financial officer, evaluated, as of the end of the

period covered by this Quarterly Report on Form 10-Q, the effectiveness of our disclosure controls and procedures (as defined in Rules

13a-15(e) and 15d-15(e) under the Exchange Act). In designing and evaluating our disclosure controls and procedures, management

recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of

achieving the desired control objectives. In addition, the design of disclosure controls and procedures must reflect the fact that there are

resource constraints, and that management is required to apply judgment in evaluating the benefits of possible controls and procedures

relative to their costs. Based on management’s evaluation, our principal executive officer and principal financial officer concluded that,

as of September 30, 2023, our disclosure controls and procedures were effective at the reasonable assurance level.

Changes in Internal Control over Financial Reporting

There were no changes in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange

Act) during the quarter ended September 30, 2023 that have materially affected, or are reasonably likely to materially affect, our internal

control over financial reporting. 

Inherent Limitations on Effectiveness of Controls

Our management, including the principal executive officer and principal financial officer, does not expect that our disclosure controls

or our internal control over financial reporting will prevent or detect all error and all fraud. A control system, no matter how well

designed and operated, can provide only reasonable, not absolute, assurance that the control system's objectives will be met. The design

of a control system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to

their costs. Further, because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance

that misstatements due to error or fraud will not occur or that all control issues and instances of fraud, if any, have been detected. The

design of any system of controls is based in part on certain assumptions about the likelihood of future events, and there can be no

assurance that any design will succeed in achieving its stated goals under all potential future conditions. Projections of any evaluation

of the effectiveness of controls to future periods are subject to risks. Over time, controls may become inadequate because of changes in

conditions or deterioration in the degree of compliance with policies or procedures.

32

PART II – OTHER INFORMATION

Item 1A. Risk Factors.

We are providing the following information to supplement the risk factors described in our Annual Report on Form 10-K for the year

ended December 31, 2021, filed with the Securities and Exchange Commission on March 27, 2023.

As of September 30, 2023, we had $17.4 million of cash and cash equivalents and $25.1 million of short-term investments. We have

incurred substantial operating losses and negative cash flows from operations since inception and expect to continue to incur substantial

operating losses and negative cash flows from operations for the foreseeable future. See Note 1 to the accompanying financial statements.

We expect to finance our operations by raising new capital through public or private equity offerings, strategic collaborations and debt

financing and other capital sources or combinations thereof, and as needed reduce our costs through overhead reduction, attrition,

organization restructuring, and curtailment of certain research and development activities. 

However, there are significant risks and uncertainties as to whether these plans will be achieved or additional funding will be available

on terms acceptable to the Company, or at all. As such, there is substantial doubt about the entity's ability to continue as a going concern

within one year after the date that the financial statements are issued. A failure to raise additional capital or reduce our expenses could

have a material adverse effect on our ability to operate our company. 

Item 6. Exhibits.

The following exhibits required by Item 601 of Regulation S-K are filed herewith or have been filed previously with the SEC as indicated

below:

Exhibit

No.

Index to Exhibits

3.1

Amended and Restated Certificate of Incorporation of Vaxxinity, Inc. (incorporated by reference to Exhibit 3.1 of our

Current Report on Form 8-K (File No. 001-41058) filed on November 17, 2021).

3.2

Amended and Restated Bylaws of Vaxxinity, Inc. (incorporated by reference to Exhibit 3.2 of our Current Report on

Form 8-K (File No. 001-41058) filed on November 17, 2021).

4.1

Warrant to Purchase Shares of Class A Common Stock of Vaxxinity, Inc. (incorporated by reference to Exhibit 4.1 of

our Registration Statement on Form S-1/A (File No. 333-260163) filed on November 5, 2021).

31.1

Certification of Principal Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002*

31.2

Certification of Principal Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002*

32.1

Certifications of Principal Executive Officer and Principal Financial Officer pursuant to Section 906 of the Sarbanes-

Oxley Act of 2002**

101.INS

Inline XBRL Instance Document*

101.SCH

Inline XBRL Taxonomy Extension Schema Document*

101.CAL

Inline XBRL Taxonomy Extension Calculation Linkbase Document*

101.DEF

Inline XBRL Taxonomy Extension Definition Linkbase Document*

101.LAB

Inline XBRL Taxonomy Extension Label Linkbase Document*

101.PRE

Inline XBRL Taxonomy Extension Presentation Linkbase Document*

104

Cover Page Interactive Data File (the cover page XBRL tags are embedded within the Inline XBRL document).*

__________________________

* Filed herewith.

** Furnished herewith.

33

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 on November 8, 2023.

VAXXINITY, INC.

By:

/s/ Mei Mei Hu

Mei Mei Hu, 

President and Chief Executive Officer

(Principal executive officer)

By:

/s/ Jason Pesile

Jason Pesile

Senior Vice President, Finance & Accounting

(Principal financial officer and principal accounting

officer)

EX-31.1

1

Exhibit 31.1

CERTIFICATION OF PRINCIPAL EXECUTIVE OFFICER PURSUANT TO 

RULES 13a-14(a) AND 15d-14(a) UNDER THE SECURITIES EXCHANGE ACT OF 1934, 

AS ADOPTED PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002

I, Mei Mei Hu, certify that:

1. I have reviewed this Quarterly Report on Form 10-Q of Vaxxinity , Inc.;

2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a

material fact necessary to make the statements made, in light of the circumstances under which such statements were

made, not misleading with respect to the period covered by this report;

3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly

present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for,

the periods presented in this report;

4. The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure

controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial

reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

(a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to

be designed under our supervision, to ensure that material information relating to the registrant, including its

consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in

which this report is being prepared;

 (b) Designed such internal control over financial reporting, or caused such internal control over financial

reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of

financial reporting and the preparation of financial statements for external purposes in accordance with generally

accepted accounting principles;

(c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this

report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the

period covered by this report based on such evaluation; and

(d) Disclosed in this report any change in the registrant’s internal control over financial reporting that

occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an

annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal

control over financial reporting; and

5. The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal

control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors

(or persons performing the equivalent functions):

(a) All significant deficiencies and material weaknesses in the design or operation of internal control over

financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process,

summarize and report financial information; and

(b) Any fraud, whether or not material, that involves management or other employees who have a significant

role in the registrant’s internal control over financial reporting.

Date: November 8, 2023 By: /s/ Mei Mei Hu 

 Mei Mei Hu

 President and Chief Executive Officer

(Principal Executive Officer)

EX-31.2

1

Exhibit 31.2

CERTIFICATION OF PRINCIPAL FINANCIAL OFFICER PURSUANT TO 

RULES 13a-14(a) AND 15d-14(a) UNDER THE SECURITIES EXCHANGE ACT OF 1934, 

AS ADOPTED PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002

I, Jason Pesile, certify that:

1. I have reviewed this Quarterly Report on Form 10-Q of Vaxxinity , Inc.;

2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a

material fact necessary to make the statements made, in light of the circumstances under which such statements were

made, not misleading with respect to the period covered by this report;

3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly

present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for,

the periods presented in this report;

4. The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure

controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial

reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

(a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to

be designed under our supervision, to ensure that material information relating to the registrant, including its

consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in

which this report is being prepared;

 (b) Designed such internal control over financial reporting, or caused such internal control over financial

reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of

financial reporting and the preparation of financial statements for external purposes in accordance with generally

accepted accounting principles;

(c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this

report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the

period covered by this report based on such evaluation; and

(d) Disclosed in this report any change in the registrant’s internal control over financial reporting that

occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an

annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal

control over financial reporting; and

5. The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal

control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors

(or persons performing the equivalent functions):

(a) All significant deficiencies and material weaknesses in the design or operation of internal control over

financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process,

summarize and report financial information; and

(b) Any fraud, whether or not material, that involves management or other employees who have a significant

role in the registrant’s internal control over financial reporting.

Date: November 8, 2023 By: /s/ Jason Pesile 

 Jason Pesile

 Senior Vice President, Finance and Accounting

(Principal Financial and Accounting Officer) 

EX-32.1

1

Exhibit 32.1

CERTIFICATIONS OF PRINCIPAL EXECUTIVE OFFICER AND PRINCIPAL FINANCIAL OFFICER

PURSUANT TO 18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO SECTION 906 OF THE

SARBANES-OXLEY ACT OF 2002

In connection with the Annual Report of Vaxxinity, Inc. (the “Company”) on Form 10-Q for the quarter ended

September 30, 2023, as filed with the Securities and Exchange Commission on the date hereof (the “Report”), the

undersigned hereby certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley

Act of 2002, that, to the best of their knowledge:

1. The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act

of 1934, as amended; and

2. The information contained in the Report fairly presents, in all material respects, the financial condition

and results of operations of the Company.

Date: November 8, 2023 By: /s/ Mei Mei Hu 

 Mei Mei Hu

 President and Chief Executive Officer

(Principal Executive Officer)

Date: November 8, 2023 By: /s/ Jason Pesile 

 Jason Pesile

 Senior Vice President, Finance and Accounting

(Principal Financial and Accounting Officer)

XML

Document and Entity Information - shares	9 Months Ended
	Sep. 30, 2023	Nov. 06, 2023
Document Type	10-Q
Document Quarterly Report	true
Document Period End Date	Sep. 30, 2023
Document Fiscal Period Focus	Q3
Current Fiscal Year End Date	--12-31
Document Fiscal Year Focus	2023
Document Transition Report	false
Entity File Number	001-41058
Entity Registrant Name	Vaxxinity, Inc.
Entity Tax Identification Number	86-2083865
Entity Incorporation, State or Country Code	DE
Entity Address, Address Line One	505 Odyssey Way
Entity Address, State or Province	FL
Entity Address, City or Town	Merritt Island
City Area Code	254
Entity Address, Postal Zip Code	32953
Local Phone Number	244-5739
Title of 12(b) Security	Class A Common Stock, par value $0.0001 per share
Trading Symbol	VAXX
Security Exchange Name	NASDAQ
Entity Current Reporting Status	Yes
Entity Interactive Data Current	Yes
Entity Filer Category	Non-accelerated Filer
Entity Small Business	true
Entity Emerging Growth Company	true
Entity Shell Company	false
Entity Ex Transition Period	false
Entity Central Index Key	0001851657
Amendment Flag	false
Class A Common Stock [Member]
Entity Common Stock, Shares Outstanding		112,871,792
Common Class B [Member]
Entity Common Stock, Shares Outstanding		13,874,132

XML

Condensed Consolidated Balance Sheets - USD ($) $ in Thousands	Sep. 30, 2023	Dec. 31, 2022
Current assets:
Cash and cash equivalents	$ 17,395	$ 33,475
Short-term investments	25,124	53,352
Restricted cash	206	1,095
Amounts due from related parties	407	414
Prepaid expenses and other current assets	3,224	5,551
Total current assets	46,356	93,887
Property and equipment, net	11,123	12,512
Total assets	57,479	106,399
Current liabilities:
Accounts payable	2,974	5,295
Amounts due to related parties	12,512	12,772
Accrued expenses and other current liabilities	4,744	11,370
Note payable, net of debt issuance cost	402	391
Note payable to related party	929	1,113
Total current liabilities	21,561	30,941
Other liabilities:
Note payable, net of debt issuance cost, net of current portion	9,630	9,933
Note payable to related party, net of current portion	2,347	3,112
Other long-term liabilities	236	236
Total liabilities	33,774	44,222
Commitments and contingencies (Note 14)
Stockholders' equity:
Additional paid-in capital	373,678	366,798
Accumulated other comprehensive loss	(7)	(197)
Accumulated deficit	(350,245)	(304,703)
Total stockholders' equity	23,705	62,177
Total liabilities and stockholders' equity	57,479	106,399
Class A Common Stock [Member]
Stockholders' equity:
Common stock:	278	278
Class B Common Stock [Member]
Stockholders' equity:
Common stock:	$ 1	$ 1

XML

Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares	Sep. 30, 2023	Dec. 31, 2022
Class A Common Stock [Member]
Common stock, par value	$ 0.0001	$ 0.0001
Common stock, shares authorized	1,000,000,000	1,000,000,000
Common stock, shares issued	112,871,792	112,182,750
Common stock, shares outstanding	112,871,792	112,182,750
Class B Common Stock [Member]
Common stock, par value	$ 0.0001	$ 0.0001
Common stock, shares authorized	100,000,000	100,000,000
Common stock, shares issued	13,874,132	13,874,132
Common stock, shares outstanding	13,874,132	13,874,132

XML

Condensed Consolidated Statements of Operations and Other Comprehensive Loss (Income) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2023	Sep. 30, 2022	Sep. 30, 2023	Sep. 30, 2022
Operating expenses:
Research and development	$ 7,910	$ 12,468	$ 27,679	$ 34,609
General and administrative	5,535	7,300	18,956	20,546
Total operating expenses	13,445	19,768	46,635	55,155
Loss from operations	(13,445)	(19,768)	(46,635)	(55,155)
Other (income) expense:
Interest and other expense	176	54	514	264
Interest and other income	(512)	(545)	(1,657)	(625)
(Gain) loss on foreign currency transactions, net	36	(25)	50	(28)
Total other (income), net	(300)	(516)	(1,093)	(389)
Net loss	$ (13,145)	$ (19,252)	$ (45,542)	$ (54,766)
Net loss per share, basic	$ (0.10)	$ (0.15)	$ (0.36)	$ (0.43)
Net loss per share, diluted	$ (0.10)	$ (0.15)	$ (0.36)	$ (0.43)
Weighted average common shares outstanding, basic	126,736,784	126,036,865	126,272,546	125,899,557
Weighted average common shares outstanding, diluted	126,736,784	126,036,865	126,272,546	125,899,557
Other comprehensive (income) loss:
Unrealized (gain) loss on investments	$ (11)	$ 215	$ (190)	$ 215
Other comprehensive (income) loss	(11)	215	(190)	215
Comprehensive loss	$ (13,134)	$ (19,467)	$ (45,352)	$ (54,981)

XML

Condensed Consolidated Statements of Stockholders' Equity - USD ($) $ in Thousands	Total	Class A Common Stock [Member]	Class B Common Stock [Member]	Common Stock [Member] Class A Common Stock [Member]	Common Stock [Member] Class B Common Stock [Member]	Additional Paid In Capital [Member]	Accumulated Other Comprehensive (Loss) [Member]	Accumulated Deficit [Member]
Beginning balance at Dec. 31, 2021	$ 128,619			$ 278	$ 1	$ 357,821		$ (229,481)
Beginning balance, common shares at Dec. 31, 2021				111,518,094	13,874,132
Issuance of common stock upon exercise of stock options, shares				448,998
Issuance of common stock upon exercise of stock options	121					121
Stock-based compensation expense	2,178					2,178
Net loss	(18,263)							(18,263)
Ending balance at Mar. 31, 2022	112,655			$ 278	$ 1	360,120		(247,744)
Ending balance, common shares at Mar. 31, 2022				111,967,092	13,874,132
Issuance of common stock upon exercise of stock options, shares				162,613
Issuance of common stock upon exercise of stock options	112					112
Stock-based compensation expense	1,826					1,826
Net loss	(17,252)							(17,252)
Ending balance at Jun. 30, 2022	97,341			$ 278	$ 1	362,058		(264,996)
Ending balance, common shares at Jun. 30, 2022				112,129,705	13,874,132
Issuance of common stock upon exercise of stock options, shares				52,165
Issuance of common stock upon exercise of stock options	29					29
Stock-based compensation expense	2,357					2,357
Net loss	(19,466)						$ (215)	(19,251)
Ending balance at Sep. 30, 2022	80,261			$ 278	$ 1	364,444	(215)	(284,247)
Ending balance, common shares at Sep. 30, 2022				112,871,792	13,874,132
Beginning balance at Dec. 31, 2022	62,177			$ 278	$ 1	366,798	(197)	(304,703)
Beginning balance, common shares at Dec. 31, 2022		112,182,750	13,874,132	112,182,750	13,874,132
Issuance of common stock upon exercise of stock options, shares				6,161
Issuance of common stock upon exercise of stock options	4					4
Stock-based compensation expense	2,225					2,225
Unrealized gain on investments	148						148
Net loss	(18,421)						0	(18,421)
Ending balance at Mar. 31, 2023	46,133			$ 278	$ 1	369,026	(49)	(323,124)
Ending balance, common shares at Mar. 31, 2023				112,188,911	13,874,132
Beginning balance at Dec. 31, 2022	$ 62,177			$ 278	$ 1	366,798	(197)	(304,703)
Beginning balance, common shares at Dec. 31, 2022		112,182,750	13,874,132	112,182,750	13,874,132
Issuance of common stock upon exercise of stock options, shares	689,042
Ending balance at Sep. 30, 2023	$ 23,705			$ 278	$ 1	373,678	(7)	(350,245)
Ending balance, common shares at Sep. 30, 2023		112,871,792	13,874,132	112,871,792	13,874,132
Beginning balance at Mar. 31, 2023	46,133			$ 278	$ 1	369,026	(49)	(323,124)
Beginning balance, common shares at Mar. 31, 2023				112,188,911	13,874,132
Issuance of common stock upon exercise of stock options, shares				635,001
Issuance of common stock upon exercise of stock options	393			$ 0		393
Stock-based compensation expense	2,433					2,433
Unrealized gain on investments	31						31
Net loss	(13,977)							(13,977)
Ending balance at Jun. 30, 2023	35,012			$ 278	$ 1	371,852	(18)	(337,101)
Ending balance, common shares at Jun. 30, 2023				112,823,912	13,874,132
Issuance of common stock upon exercise of stock options, shares				47,880
Issuance of common stock upon exercise of stock options	57					57
Stock-based compensation expense	1,769					1,769
Unrealized gain on investments	11						11
Net loss	(13,145)							(13,145)
Ending balance at Sep. 30, 2023	$ 23,705			$ 278	$ 1	$ 373,678	$ (7)	$ (350,245)
Ending balance, common shares at Sep. 30, 2023		112,871,792	13,874,132	112,871,792	13,874,132

XML

Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands	9 Months Ended
	Sep. 30, 2023	Sep. 30, 2022
Cash flows from operating activities:
Net loss	$ (45,542)	$ (54,766)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation expense	1,778	1,144
Amortization of debt issuance costs	39	40
Amortization of discount on short-term investments	(1,222)	(422)
Stock-based compensation expense	6,427	6,361
Changes in operating assets and liabilities:
Amounts due from related parties	7	(7)
Prepaid expenses and other current assets	2,327	3,349
Long-term deposits	0	(2,076)
Accounts payable	(2,321)	127
Amounts due to related parties	(260)	(2,731)
Accrued expenses and other current liabilities	(6,626)	7,530
Net cash used in operating activities	(45,393)	(41,451)
Cash flows from investing activities:
Purchase of short-term investments	(43,587)	(107,526)
Proceeds from maturity of short-term investments	73,227	27,500
Purchases of property and equipment	(389)	(1,574)
Net cash provided by (used in) investing activities	29,251	(81,600)
Cash flows from financing activities:
Repayments of note payable	(331)	(320)
Repayments of note payable with related party	(949)	0
Proceeds from exercise of stock options	453	262
Net cash used in financing activities	(827)	(58)
Change in cash, cash equivalents and restricted cash	(16,969)	(123,109)
Cash, cash equivalents and restricted cash at beginning of period	34,570	145,057
Cash, cash equivalents and restricted cash at end of period	17,601	21,948
Reconciliation of cash, cash equivalents and restricted cash:
Cash, cash equivalents and restricted cash at end of period	17,601	21,948
Less restricted cash	(206)	(3,073)
Cash and cash equivalents end of period	17,395	18,875
Supplemental Disclosure
Cash paid for interest	$ 592	$ 277

XML

Nature of the Business

9 Months Ended

Sep. 30, 2023

Nature of the Business [Abstract]

Nature of the Business

1. Nature of the Business

Vaxxinity, Inc., a Delaware corporation (“Vaxxinity ,” and together with its subsidiaries, the “Company”), was formed through the

combination of two separate businesses that originated from United Biomedical, Inc. (“UBI”) in two separate transactions: a spin-out

from UBI in 2014 of operations focused on developing chronic disease product candidates that resulted in United Neuroscience (“UNS”),

and a second spin-out from UBI in 2020 of operations focused on the development of a COVID-19 vaccine that resulted in C19 Corp.

(“COVAXX”). On February 2, 2021, Vaxxinity was incorporated for the purpose of reorganizing and combining UNS and COVAXX

and on March 2, 2021, did so by acquiring all of the outstanding equity interests of UNS and COVAXX pursuant to a contribution and

exchange agreement (the “Contribution and Exchange Agreement”) whereby the existing equity holders of UNS and COVAXX

contributed their equity interests in each of UNS and COVAXX in exchange for equity in Vaxxinity (the “Reorganization”). On

December 31, 2022, COVAXX merged with and into Vaxxinity.

The Company is a biotechnology company currently focused on developing product candidates for human use in the fields of neurology,

pain, cardiovascular diseases and coronaviruses utilizing its “Vaxxine Platform”—a synthetic peptide vaccine technology first developed

by UBI and subsequently refined over the last two decades. The Company is engaged in the development of rationally designed

prophylactic and therapeutic vaccines to combat common chronic diseases with large global unmet medical need. The Company is also

developing a heterologous booster vaccine for SARS-Cov-2. UBI is a significant shareholder of the Company and, therefore, considered

a related party.

The Company is subject to risks and uncertainties common to early-stage companies in the biotechnology industry including, but not

limited to, uncertainty of product development and commercialization, lack of marketing and sales history, development by its

competitors of new technological innovations, dependence on key personnel, market acceptance of products, product liability, protection

of proprietary technology, ability to raise additional financing, and compliance with global government regulations. If the Company

does not successfully commercialize or out-license any of its product candidates, it will be unable to generate recurring product revenue

or achieve profitability.

The Company’s product candidates are in development and will require significant additional research and development efforts,

including extensive pre-clinical and clinical testing and regulatory approval prior to commercialization. These efforts require significant

amounts of additional capital, adequate personnel and infrastructure and extensive compliance-reporting capabilities. There can be no

assurance that the Company’s research and development will be successfully completed, that adequate protection for the Company’s

intellectual property will be obtained, that any products developed will obtain necessary government regulatory approval or that any

approved products will be commercially viable. Even if the Company’s product development efforts are successful, it is uncertain when,

if ever, the Company will generate significant revenue from product sales. The Company operates in an environment of rapid change in

technology and is dependent upon the services of its employees and consultants.

Liquidity and Going Concern Assessment

As of September 30, 2023, the Company had $

17.4

 million of cash and cash equivalents and $

25.1

 million of short-term investments to

fund operations. To date, the Company has primarily financed its operations through the sale of convertible preferred stock and common

stock, borrowings under promissory notes (including convertible notes), a portion of which has been raised from related party entities,

and grants from foundations such as the Coalition for Epidemic Preparedness Innovations (CEPI) and the Michael J. Fox Foundation

(MJFF). The Company has experienced significant negative cash flows from operations since inception, and incurred a net loss of $

45.5

million for the nine months ended September 30, 2023. Net cash used in operating activities for the nine months ended September 30,

2023 was $

45.4

 million. In addition, as of September 30, 2023, the Company has an accumulated deficit of $

350.2

 million. The Company

expects to incur substantial operating losses and negative cash flows from operations for the foreseeable future. 

In accordance with ASC 205-40, Presentation of Financial Statements-Going Concern, management is required to evaluate whether

there are conditions or events, considered in the aggregate, that raise substantial doubt about the Company's ability to continue as a

going concern within one year after the date that the financial statements are issued. When management identifies conditions or events,

considered in the aggregate, that raise substantial doubt about the Company's ability to continue as a going concern, management must

consider whether its plans to mitigate those relevant conditions or events will alleviate the substantial doubt. 

Given that the Company has incurred substantial operating losses and negative cash flows from operations since inception and expects

to continue to incur substantial operating losses and negative cash flows from operations for the foreseeable future, management assessed

that there are conditions or events, considered in the aggregate, as of the issue date of these financial statements, which raise substantial

doubt about the Company's ability to continue as a going concern. 

Management considered whether its plans to mitigate those relevant conditions or events will alleviate the substantial doubt about the

Company's ability to continue as a going concern. These plans include raising new capital through public or private equity offerings,

strategic collaborations, debt financing and other capital sources or combinations thereof, and as needed cost reduction through attrition,

organization restructuring, and curtailment of certain research and development activities. 

However, there are significant risks and uncertainties as to whether these plans will be achieved or additional funding will be available

on terms acceptable to the Company, or at all.

Due to the risks and uncertainties, management cannot conclude that substantial doubt about the Company's ability to continue as a

going concern has been alleviated. As such, there is substantial doubt about the entity's ability to continue as a going concern within

one year after the date that the financial statements are issued. However, since liquidation is not imminent, the accompanying unaudited

condensed consolidated financial statements have been prepared assuming that the Company will continue as a going concern, which

contemplates the realization of assets and satisfaction of liabilities in the ordinary course of business. The unaudited condensed

consolidated financial statements do not include any adjustments relating to the recoverability and classification of recorded asset

amounts or the amounts and classification of liabilities that might result from the outcome of the uncertainties described above.

XML

Summary of Significant Accounting Policies

9 Months Ended

Sep. 30, 2023

Summary of Significant Accounting Policies [Abstract]

Summary of Significant Accounting Policies

2. Summary of Significant Accounting Policies

Basis of presentation

The accompanying interim unaudited condensed consolidated financial statements have been prepared using generally accepted

accounting principles in the United States of America (“GAAP”) and pursuant to the rules and regulations of the United States Securities

and Exchange Commission (“SEC”) for interim financial reporting. 

These interim condensed consolidated financial statements are unaudited and, in the opinion of management, include all normal and

recurring adjustments necessary to fairly present the results of the interim periods. The condensed consolidated balance sheet at

December 31, 2022, has been derived from the audited financial statements at that date. Operating results for the three and nine months

ended September 30, 2023 and cash flows for the nine months ended September 30, 2023 are not necessarily indicative of the results

that may be expected for the fiscal year ending December 31, 2023 or any other future period. Certain information and note disclosures

normally included in annual consolidated financial statements prepared in accordance with GAAP have been omitted in accordance with

the rules and regulations for interim reporting of the SEC. These interim unaudited condensed financial statements should be read in

conjunction with the consolidated financial statements and notes thereto included in our Annual Report on Form 10-K for the year ended

December 31, 2022 filed with the SEC on March 27, 2023 (the “Annual Report”).

Significant accounting policies 

The significant accounting policies used in preparation of these unaudited condensed consolidated financial statements are disclosed in

our annual consolidated financial statements for the year ended December 31, 2022 included in the Annual Report. There have been no

changes to the Company’s significant accounting policies during the three and nine months ended September 30, 2023.

Recently adopted accounting pronouncements 

From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (“FASB”) or other standard

setting bodies and are adopted by the Company as of the specified effective date. 

In June 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2016-13, Financial

Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments (“ASU 2016-13”). ASU 2016-13

significantly changes the impairment model for most financial assets and certain other instruments as it will require immediate

recognition of estimated credit losses expected to occur over the remaining life of many financial assets, which will generally result in

earlier recognition of allowances for credit losses on loans and other financial instruments. On January 1, 2023, the Company adopted

ASU 2016-13. The adoption of this standard did not have a material impact on the Company's consolidated financial statements.

Recently issued accounting pronouncements not yet adopted

In August 2020, the FASB issued ASU 2020-06, Debt - Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives

and Hedging - Contracts in Entity's Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity's

Own Equity, which is intended to simplify the accounting for certain financial instruments with characteristics of liabilities and equity,

including convertible instruments and contracts on an entity's own equity. The guidance allows for either full retrospective adoption or

modified retrospective adoption. The guidance is effective for the Company in the first quarter of fiscal year 2024 and early adoption is

permitted. The Company is in the process of evaluating the effect the amendment will have on the consolidated financial statements.

XML

Fair Value Measurements

9 Months Ended

Sep. 30, 2023

Fair Value Measurements [Abstract]

Fair Value Measurements

3. Fair Value Measurements

The Company's money market accounts and short-term investments are shown at fair value based on unadjusted quoted market prices

in active markets for identical assets.

The following table presents information about the Company’s financial instruments measured at fair value on a recurring basis and

indicate the level of the fair value hierarchy used to determine such fair values (in thousands):

During the three and nine months ended September 30, 2023 and the year ended December 31, 2022, there were

no

 transfers between

Level 1, Level 2 and Level 3.

September 30, 2023

Level 1

Level 2

Level 3

Total

Assets:

Short-term investments

$

25,124

$

—

$

—

$

25,124

Money market accounts

10,925

—

—

10,925

Total assets

$

36,049

$

—

$

—

$

36,049

December 31, 2022

Level 1

Level 2

Level 3

Total

Assets:

Short-term investments

$

53,352

$

—

$

—

$

53,352

Money market account

27,724

—

—

27,724

Total assets

$

81,076

$

—

$

—

$

81,076

XML

Short-Term Investments

9 Months Ended

Sep. 30, 2023

Short-Term Investments [Abstract]

Short-Term Investments

4. Short-Term Investments

The Company’s short-term investments consist of the following (in thousands):

These securities mature in less than 1 year.

As of September 30, 2023

Amortized Cost

Unrealized

Gains (Losses),

Net

Recorded Basis

U.S. Treasury Securities

$

25,130

$

(6)

$

25,124

Total

$

25,130

$

(6)

$

25,124

As of December 31, 2022

Amortized Cost

Unrealized

Gains (Losses),

Net

Recorded Basis

U.S. Treasury Securities

$

53,549

$

(197)

$

53,352

Total

$

53,549

$

(197)

$

53,352

XML

Prepaid Expenses and Other Current Assets

9 Months Ended

Sep. 30, 2023

Prepaid Expenses and Other Current Assets [Abstract]

Prepaid Expenses and Other Current Assets

5. Prepaid Expenses and Other Current Assets

Prepaid expenses and other current assets consist of the following (in thousands):

September 30,

December 31,

2023

2022

Clinical prepayments

$

1,762

$

2,679

Prepaid insurance

280

1,870

Prepaid materials and supplies

—

248

Deposits

240

232

Other

942

522

$

3,224

$

5,551

Clinical prepayments consist of amounts paid in advance to clinical research organizations (“CROs”) for expenses related to our clinical

trials, primarily UB-612, and included $

1.5

 million on deposit as of September 30, 2023 that will be credited against final UB-612 trial

expenses. The remaining clinical prepayment amounts are amortized to expense as earned by the CRO and clinical trial sites. 

Prepaid insurance consists primarily of $

0.3

 million and $

1.6

 million for the unamortized portion of the Company’s annual D&O

insurance fee as of September 30, 2023 and December 31, 2022, respectively. 

Prepaid materials and supplies consist of amounts paid in advance related to the procurement and/or production of materials for use in

the Company’s clinical trials, primarily UB-612. There were

no

 amounts held by related parties at September 30, 2023 and $

0.2

 million

at December 31, 2022.

XML

Property and Equipment, Net

9 Months Ended

Sep. 30, 2023

Property and Equipment, Net [Abstract]

Property and Equipment, Net

6. Property and Equipment, Net

Property and equipment, net consisted of the following (in thousands):

September 30,

December 31,

2023

2022

Airplane

$

11,983

$

11,983

Laboratory and computer equipment

3,310

3,146

Software

426

415

Leasehold improvements

534

403

Facilities, furniture and fixtures

98

37

Vehicles

87

87

Construction in progress

86

65

Total property and equipment

16,524

16,136

Less: accumulated depreciation and amortization

(5,401)

(3,624)

Property and equipment, net

$

11,123

$

12,512

Depreciation expense for the three and nine months ended September 30, 2023 was $

0.7

 million and $

1.8

 million, respectively.

Depreciation expense for the three and nine months ended September 30, 2022 was $

0.4

 million and $

1.1

 million, respectively.

XML

Accrued Expenses and Other Current Liabilities

9 Months Ended

Sep. 30, 2023

Accrued Expenses and Other Current Liabilities [Abstract]

Accrued Expenses and Other Current Liabilities

7. Accrued Expenses and Other Current Liabilities

Accrued expenses and other current liabilities consisted of the following (in thousands):

September 30,

December 31,

2023

2022

Accrued external research and development

$

1,720

$

6,904

Accrued compensation

2,689

2,568

Accrued professional fees and other

334

1,722

Accrued interest

—

176

$

4,744

$

11,370

XML

Other Long-Term Liabilities

9 Months Ended

Sep. 30, 2023

Other Long-Term Liabilities [Abstract]

Other Long-Term Liabilities

8. Other Long-Term Liabilities

Other long-term liabilities consisted of the following (in thousands):

September 30,

December 31,

2023

2022

Accrued taxes

236

236

$

236

$

236

As of September 30, 2023 and December 31, 2022, approximately $

0.2

 million of accrued taxes related to penalties and interest the

Company may be subject to paying for late filing fees related to a foreign subsidiary. The Company expects these amounts to be forgiven

but has accrued for them until the statute of limitations expires and it is appropriate to write them off.

XML

Notes Payable

9 Months Ended

Sep. 30, 2023

Notes Payable [Abstract]

Notes Payable

9. Notes Payable

Note Payable—Airplane

In connection with the acquisition of an airplane, the Company entered into a note payable agreement (the “2025 Note”) in June 2020

for $

11.5

 million, with an annual interest rate of

3.4

% and a maturity date of

June 9, 2025

. Principal and interest payments are payable

monthly in the amount of $

0.1

 million with a final payment of $

9.4

 million at maturity. The 2025 Note is guaranteed by the co-founders

of the Company. In addition, the Company incurred debt issuance costs of $

0.3

 million, which are being amortized over the term of the

loan. There are no financial covenants associated with the 2025 Note. 

The carrying value of the 2025 Note is as follows (in thousands):

As of September 30, 2023, the remaining principal payments for the 2025 Note are as follows (in thousands):

Interest expense associated with the 2025 Note was $

0.1

 million and $

0.3

 million for the three and nine months ended September 30,

2023, respectively. Interest expense associated with the 2025 Note was $

0.1

 million and $

0.3

 million for the three and nine months

ended September 30, 2022, respectively. Accrued interest of less than $

0.1

 million was included in accrued expenses and other current

liabilities in the accompanying condensed consolidated balance sheets as of September 30, 2023 and December 31, 2022.

Promissory Note with Related Party

In October 2022, the Company entered into a related party unsecured promissory note (the “2022 Promissory Note”) with UBI for $

4.2

million. The 2022 Promissory Note accrues interest at

7.0

% per annum and is due

October 1, 2026

. The 2022 Promissory Note was

issued to satisfy accounts payable to UBI totaling $

4.2

 million.

The carrying value of the 2022 Promissory Note is as follows (in thousands):

As of September 30, 2023, the remaining principal payments for the 2022 Promissory Note are as follows (in thousands):

Interest expense associated with the 2022 Promissory Note was $

0.1

 million and $

0.2

 million for the three and nine months ended

September 30, 2023, respectively.

September 30,

December 31,

2023

2022

Principal

$

10,124

$

10,455

Unamortized debt issuance cost

(92)

(131)

Carrying amount

10,032

10,324

Less: current portion

(402)

(391)

Note payable, net of current portion and debt issuance cost

$

9,630

$

9,933

Amount

2023 (remaining 3 months)

$

113

2024

458

2025

9,553

$

10,124

September 30,

December 31,

2023

2022

Principal

$

3,276

$

4,225

Less: current portion

(929)

(1,113)

Note payable with related party, net of current portion

$

2,347

$

3,112

Amount

2023 (remaining 3 months)

$

165

2024

1,029

2025

1,103

2026

979

$

3,276

XML

Common Stock

9 Months Ended

Sep. 30, 2023

Common Stock [Abstract]

Common Stock

10. Common Stock

The Company has reserved shares of Class A common stock for issuance for the following purposes:

September 30,

December 31,

2023

2022

Options and RSUs issued and outstanding

22,000,273

20,716,760

Options available for future grants

6,648,567

6,064,003

Warrants issued and outstanding

1,928,020

1,928,020

30,576,860

28,708,783

XML

Stock-Based Compensation

9 Months Ended

Sep. 30, 2023

Stock-Based Compensation [Abstract]

Stock-Based Compensation

11. Stock-Based Compensation

2021 Omnibus Incentive Compensation Plan

In November 2021, the Company established the 2021 Omnibus Incentive Compensation Plan (the “Plan”), which provides for the

Company to grant nonqualified stock options, incentive (qualified) stock options, stock appreciation rights, restricted share awards,

restricted stock units, performance awards, cash incentive awards and other equity-based awards (including fully vested shares).

At inception in November 2021, the maximum number of shares of Class A common stock that could be issued under the Plan was

8,700,000

 shares of Class A common stock. This number increases automatically on January 1 of each year, commencing January 1,

2023, by the number of shares equal to the lesser of (i)

4

% of the outstanding shares of our Class A common stock on the immediately

preceding December 31, (ii) the number of shares determined by the compensation committee of the board of directors, if any such

determination is made, and (iii) the number of shares underlying any awards granted during the preceding calendar year, net of the

shares underlying awards canceled or forfeited under the Plan. On January 1, 2023, in accordance with the automatic “evergreen”

provision of the Plan, the maximum number of shares that can be issued under the plan was increased to

11,886,306

.

Stock Options

As of September 30, 2023, there were options to purchase

15,437,818

 shares of Class A stock outstanding and options to purchase

6,362,455

 shares of Class B stock outstanding, of which options to purchase

10,948,474

 shares of Class A common stock and options

to purchase

5,039,459

 shares of Class B common stock were exercisable, respectively. As of September 30, 2023, the maximum number

of stock options awards available for future issuance under the Company’s plan is

6,648,567

.

The following table summarizes stock option activity during the nine months ended September 30, 2023:

The aggregate intrinsic value of options is calculated as the difference between the exercise price of the options and the fair value of the

common stock for those options that had exercise prices lower than the fair value of the common stock as of September 30, 2023.

The intrinsic value of options exercised during the nine months ended September 30, 2023 was $

0.5

 million.

The weighted-average grant-date fair value per share of options granted during the nine months ended September 30, 2023 was $

1.88

.

Restricted Stock Units

The following table summarizes the Company’s restricted stock unit activity for the nine months ended September 30, 2023:

Stock-Based Compensation Expense

The Company recorded stock-based compensation expense in the following expense categories in the accompanying unaudited

condensed consolidated statements of operations and other comprehensive (income) loss (in thousands):

As of September 30, 2023, total unrecognized compensation cost related to the unvested stock-based awards was $

11.4

 million, which

is expected to be recognized over a weighted average period of

2.0

 years.

Number of Stock

Options

Outstanding

Weighted

Average

Exercise Price

Per Share

Weighted

Average

Remaining

Contractual

Term (years)

Aggregate

Intrinsic Value

(in thousands)

Balance at December 31, 2022

20,416,760

$

5.07

6.8

$

7,166

Granted

3,466,782

2.28

Exercised

(689,042)

0.66

Forfeited

(1,394,227)

7.44

Balance at September 30, 2023

21,800,273

$

4.62

6.2

$

6,421

Options vested and exercisable at September 30, 2023

15,987,933

$

4.50

5.9

$

6,338

Number of

Shares

Weighted

Average

Grant Date

Fair Value

Per Share

Unvested at December 31, 2022

300,000

$

3.76

Forfeited

(100,000)

$

3.76

Unvested at September 30, 2023

200,000

$

3.76

Three Months Ended September

30,

Nine Months Ended September

30,

2023

2022

2023

2022

General and administrative

$

1,278

$

1,509

$

4,287

$

3,888

Research and development

491

848

2,140

2,473

Total stock-based compensation expense

$

1,769

$

2,357

$

6,427

$

6,361

XML

Income Taxes

9 Months Ended

Sep. 30, 2023

Income Taxes [Abstract]

Income Taxes

12. Income Taxes

The Company computes its expected annual effective income tax rate in accordance with FASB Accounting Standards Codification

(“ASC”) 740 , “Income Taxes” and makes changes on a quarterly basis, as necessary, based on certain factors such as changes in

forecasted annual pre-tax income; changes to actual or forecasted permanent book to tax differences; impacts from tax audits with state,

federal or foreign tax authorities; impacts from tax law changes; or change in judgment as to the realizability of deferred tax assets. The

Company identifies items which are unusual and non-recurring in nature and treats these as discrete events. The tax effect of discrete

items is recorded in the quarter in which the discrete events occur. 

The Company’s effective tax rate for the three months ended September 30, 2023 and September 30, 2022 was

0

%, due primarily to

its uncertainty of realizing a benefit from net operating losses incurred during the period.

In assessing the realizability of deferred tax assets, management considers whether it is more-likely-than-not that some or all of the

recorded deferred tax assets will be realized. The ultimate realization of deferred tax assets is dependent on the generation of future

taxable income in the periods in which those temporary differences become deductible. Management considers the scheduled reversal

of deferred tax liabilities, projected future taxable income, and tax planning strategies in making this assessment. Based on these items

and the consecutive years of pretax losses, management determined that enough uncertainty exists relative to the realization of the

deferred income tax asset balances to warrant the application of a full valuation allowance for all taxing jurisdictions.

The Company files income tax returns in the U.S. federal and various state and local jurisdictions. The Company also files returns in

numerous foreign jurisdictions that have varied years remaining open for examination, but generally the statute of limitations is three

to four years from when the return is filed. As of September 30, 2023, the Company has no ongoing audits.

The Company has US net operating loss (“NOL”) carryforwards for federal and state income tax purposes. Use of the NOL

carryforwards is limited under Section 382 of the Internal Revenue Code, as the Company had a change in ownership of more than

50

% of its capital stock over a

three-year

 period as measured under Section 382 of the Internal Revenue Code of 1986, as amended (the

“Code”). These complex changes of ownership rules generally focus on ownership changes involving stockholders owning directly or

indirectly

5

% or more of our stock, including certain public “groups” of stockholders as set forth under Section 382 of the Code,

including those arising from new stock issuances and other equity transactions. Some of these NOL carryforwards will expire if they

are not used within certain periods. At this time, the Company considers it more likely than not that it will not have sufficient taxable

income in the future that will allow us to realize these NOL carryforwards.

XML

Net Loss Per Share

9 Months Ended

Sep. 30, 2023

Net Loss Per Share [Abstract]

Net Loss Per Share

13. Net Loss Per Share

The Company’s potentially dilutive securities, which include warrants, options and restricted stock units, have been excluded from the

computation of diluted net loss per share as the effect would be to reduce the net loss per share. Therefore, the weighted average number

of common shares outstanding used to calculate both basic and diluted net loss per share is the same. The Company excluded the

following potential common shares, presented based on amounts outstanding at each period end, from the computation of diluted net

loss per share for the three months ended September 30, 2023 and 2022 because including them would have had an anti-dilutive effect:

September 30,

2023

2022

Options issued and outstanding

21,800,273

20,293,681

Warrants issued and outstanding

1,928,020

1,928,020

Restricted stock units issued and outstanding

200,000

300,000

23,928,293

22,521,701

XML

Commitments and Contingencies

9 Months Ended

Sep. 30, 2023

Commitments and Contingencies Disclosure [Abstract]

Commitments and Contingencies

14. Commitments and Contingencies

Contractual Obligations 

The Company enters into agreements with CROs to conduct clinical trials and preclinical studies and CMOs to produce vaccines and

other potential product candidates. Contracts with CROs and CMOs are generally cancellable, with notice, at the Company’s option. 

As of September 30, 2023, the Company had remaining prepayments to CROs of $

1.5

 million and

no

 remaining prepayments to CMOs

for activities associated with the conduct of its clinical trials and for the production of the Company’s anticipated vaccine product

candidate. 

Michael J. Fox Foundation Grant

On November 3, 2021, the Company was awarded a grant from the Michael J. Fox Foundation for Parkinson’s Research (“MJFF”) in

the amount of $

0.8

 million to be used in a project for the exploration of markers for target engagement in individuals immunized with

UB-312, an active

a

-Synuclein (“aSyn”) immunotherapy. The Company will oversee sample management, sample preparation (IgG

fractions) and distribution, as well as characterize the binding properties of the antibodies against pathological forms of aSyn. As funding

is expected to be received in tranches over a two-year period, and the amounts received in each tranche are expected to be utilized within

12 months, the funds received are recognized as a short-term accrued liability. The Company recognizes payments from MJFF as a

reduction of research and development expenses, in the same period as the expenses that the grant is intended to reimburse are incurred.

As of September 30, 2023, there was

no

 balance remaining in the accrued liability related to this grant. For the nine months ended

September 30, 2023 and 2022, the Company did

no

t recognize any reduction of research and development expenses for amounts

reimbursed through the grant.

Coalition for Epidemic Preparedness Innovations (“CEPI”) Grant

In April 2022, the Company entered into an agreement with the Coalition for Epidemic Preparedness Innovations (“CEPI”) whereby

CEPI agreed to provide funding of up to $

9.3

 million to co-fund a Phase 3 clinical trial of the Company’s next generation UB-612

COVID-19 vaccine candidate as a heterologous – or ‘mix-and-match’ – booster dose. The Phase 3 trial, which began in early 2022, is

evaluating the ability of UB-612 to boost COVID-19 immunity against the original strain and multiple variants of concern including

Omicron - in people aged 16 years or older, who have been previously immunized with an authorized COVID-19 vaccine.

The Company will also be performing further manufacturing scale-up work to enable readiness for potential commercialization. Under

the terms of the agreement with CEPI, if successful, a portion of the released doses of the commercial product will be delivered to the

COVID-19 Vaccines Global Access (“COVAX”) consortium for distribution to developing countries at low cost.

Cash payments received in advance under the CEPI Funding Agreement are restricted as to their use until expenditures contemplated in

the funding agreement are incurred. As funding is expected to be received in tranches over an 18-month period, and the amounts received

in each tranche are expected to be utilized within 12 months, the funds received are reflected within restricted cash with a corresponding

short-term accrued liability. As of September 30, 2023, the Company had

no

 remaining restricted cash or accrued liability related to

CEPI funding. The Company recognizes payments from CEPI as a reduction of research and development expenses, in the same period

as the expenses that the grant is intended to reimburse are incurred. For the nine months ended September 30, 2023, the Company

reduced research and development expenses by $

1.8

 million for amounts reimbursed through the grant.

Lease Agreements

The Company has

two

 operating lease agreements for office and laboratory space. The Company is also required to pay certain operating

costs under its leases.

In August 2023, the Company entered into a lease for

9,839

 square feet of lab and office space with Space Florida in Exploration Park,

Florida commencing August 12, 2023. The lease has an initial

one-year

 term with an annual lease obligation of $

0.5

 million, after lessee

credits. Additionally, the lease requires the Company to provide a security deposit in the amount of less than $

0.1

 million. 

In April 2022, the Company entered into a facility lease agreement for

4,419

 square feet of office space in New York, New York. The

lease commenced in April 2022 and will expire in March 2029 with no option to renew. This lease and its terms were reviewed using

the guidance found in ASC 842, “Leases”. Since the lease has a non-cancellable period of

one year

, and after the first year both the

Company and the landlord have the option to early terminate the lease for any or no reason, the Company has elected to apply the short-

term expedient, which does not subject the New York lease to capitalization. 

Rent expense for the three and nine months ended September 30, 2023 was $

0.1

 million and $

0.5

 million, respectively. Rent expense

for the three and nine months ended September 30, 2022 was $

0.2

 million and $

0.4

 million, respectively.

License Agreements

In August 2021, the Company entered into a license agreement (the “Platform License Agreement”) with UBI and certain of its affiliates

that expanded intellectual property rights held under previously issued license agreements with UBI. As part of the agreement, the

Company obtained a worldwide, sublicensable (subject to certain conditions), perpetual, fully paid-up, royalty-free license to research,

develop, make, have made, utilize, import, export, market, distribute, offer for sale, sell, have sold, commercialize or otherwise exploit

peptide-based vaccines in the field of all human prophylactic and therapeutic uses, except for such vaccines related to human

immunodeficiency virus (HIV), herpes simplex virus (HSE) and Immunoglobulin E (IgE). The patents and patent applications licensed

under the Platform License Agreement include claims directed to a CpG delivery system, artificial T helper cell epitopes and certain

designer peptides and proteins utilized in UB-612. In consideration for the Platform License Agreement, the Company issued to UBI a

warrant to purchase Class A common stock (the “UBI Warrant”). 

The Company considered ASC 805, “Business Combinations” (“ASC 805”) and ASC 730, “Research and Development” (“ASC 730”)

in determining how to account for the license agreement acquired and the issuance of the UBI Warrant. The majority of the voting

interests in UBI and in the Company were held by a group of immediate family members, at the time of the transaction, and as such the

transaction constitutes a common control transaction, which requires the license to be accounted for at the carrying value in the books

of the transferor and the excess of consideration paid over the carrying value as a capital transaction. 

Indemnification Agreements 

In the ordinary course of business, the Company may provide indemnification of varying scope and terms to employees, consultants,

vendors, lessors, business partners and other parties with respect to certain matters including, but not limited to, losses arising out of

breach of such agreements or from intellectual property infringement claims made by third parties. In addition, the Company has entered

into indemnification agreements with members of its board of directors and executive officers that will require the Company to, among

other things, indemnify them against certain liabilities that may arise by reason of their status or service as directors or officers. The

maximum potential amount of future payments the Company could be required to make under these indemnification agreements is, in

many cases, unlimited. To date, the Company has not incurred any material costs as a result of such indemnification obligations. The

Company is not aware of any indemnification arrangements that could have a material effect on its financial position, results of

operations, or cash flows, and it has

no

t accrued any liabilities related to such obligations as of September 30, 2023 and December 31,

2022. 

Legal Proceedings

From time to time, the Company may become involved in legal proceedings arising in the ordinary course of business. As of

September 30, 2023 and December 31, 2022, the Company was not a party to any material legal matters or claims.

Loss Contingency

In April 2021, the Company engaged United Biopharma, Inc. (“UBP”) to begin acquiring raw materials for use in the production of

GMP grade recombinant protein for UB-612, the Company’s COVID-19 vaccine candidate under an Authorization to Proceed (“ATP”)

agreement for $

3

 million of materials. Through August 2021, $

7.2

 million of materials were ordered by UBP, $

3.0

 million of materials

were received by UBP and paid for with an advance payment from the Company. The Company has recognized $

3.0

 million in expense

for these materials purchases authorized under the ATP.

When the Company asked to pause further manufacture of protein upon rejection of the Emergency Use Authorization application by

Taiwan in August 2021, UBP requested that its suppliers cancel the remaining $

4.2

 million in orders for which it had not taken possession

of the materials. In the fourth quarter of 2022, the Company learned that most of the suppliers refused to cancel the orders, although

some agreed to seek other buyers for the materials. For these orders, management has not yet concluded that a loss for the Company is

probable, or that one amount of loss is a better estimate than any other amount, since they were not originally authorized by the ATP

and UBP’s suppliers may be able to dispose of some amount to other buyers. Hence, an expense has

no

t been recognized for them.

As of November 8, 2023, there is no claim against the Company by UBP related to these orders, no settlement or other agreement has

been reached between the Company and UBP or, to the Company’s knowledge, between UBP and its suppliers. Therefore, the range of

the potential loss is still $

0

 to $

4.2

 million.

XML

Benefit Plans

9 Months Ended

Sep. 30, 2023

Benefit Plans [Abstract]

Benefit Plans

15. Benefit Plans

In March 2018, the Company established a defined contribution savings plan under Section 401(k) of the Code. This plan covers

substantially all U.S. employees who meet minimum age and service requirements and allows participants to defer a portion of their

annual compensation on a pre-tax basis. The Company matches employee contributions to the Plan at

100

% up to

4

% of the employee’s

base salary.

The Company offers its Ireland-based employees a Personal Retirement Savings Account (“PRSA”) that allows participants to defer a

portion of their annual compensation. The Company provides contributions equal to

5

% of each participant’s annual salary. During the

three and nine months ended September 30, 2023 and 2022, the Company contributed less than $

0.1

 million to PRSA accounts.

XML

Related Party Transactions

9 Months Ended

Sep. 30, 2023

Related Party Transactions [Abstract]

Related Party Transactions

16. Related Party Transactions

The Company has related party arrangements with UBI and a number of its affiliated companies namely, United Biomedical, Inc., Asia

(“UBIA”), UBI Pharma, Inc. (“UBI-P”), United BioPharma, Inc (“UBP”) and UBI IP Holding (“UBI-IP”).

As of September 30, 2023, UBI owned

44

% of the Company’s stock. The majority of the voting interests in both UBI and the Company

were held by a group of immediate family members, and as such the entities are under common control.

These related parties are governed by various Master Services Agreements (“MSA”) detailed below. 

UBI MSA - UBI provides research, development and clinical functions to the Company. There is also a purchase arrangement

with UBI for the production and shipment of the Company’s diagnostic test kits.

UBIA MSA - UBI-Asia for manufacturing, quality control, testing, validation, and supply services.

UBP MSA - UBP provides the Company with manufacturing, testing and validation services.

COVID MSA (“COVID MSA”) - COVID MSA provides that UBI acts as COVAXX’s agent with respect to matters relating

the Company’s COVID-19 program and provides research, development, manufacturing and back office administrative

services to the Company.

COVID-19 Relief MSA - A four-company MSA with UBI, UBI-Asia and UBP. The Company is an exclusive licensee of

technologies related to diagnostics, vaccines, and therapies for COVID-19. The MSA established the terms under which UBI-

Asia provides research, development, testing and manufacturing services to the Company and UBP provides contract

development and manufacturing services to the Company.

In August 2021, Vaxxinity entered into a license agreement with UBI and certain of its affiliates (collectively, the “Licensors”) that

expanded intellectual property rights previously licensed under the Original UBI Licenses in exchange for a warrant to purchase

1,928,020

 shares of Vaxxinity Class A common stock. The UBI Warrant is exercisable at an exercise price of $

12.45

 per share (subject

to adjustment pursuant thereto),is not subject to vesting, and has a term of

five years

. See note 14 to the condensed consolidated financial

statements.

The Company also considers Destination Systems, its travel and logistics firm, a related party since its Chief Executive Officer, Landon

Ogilvie, is on the Company’s board of directors.

Total related party operating activity is as follows (in thousands):

September 30,

December 31,

2023

2022

Consolidated balance sheet

Assets

Prepaid expenses and other current assets

$

—

$

237

Amounts due from related parties

407

414

Liabilities

Amounts due to related parties

12,512

12,772

Current portion of note payable

929

1,113

Note payable

2,347

3,112

Accrued interest payable

—

73

Three Months Ended September

30,

Nine Months Ended September

30,

2023

2022

2023

2022

Operating expenses

Research and development

Services provided by related parties

 $

67

 $

—

 $

424

 $

1,139

General and administrative

Services provided by related parties

 $

1,076

 $

—

 $

2,133

 $

—

Other income/expense

Related party interest expense

 $

60

 $

—

 $

193

 $

—

XML

Summary of Significant Accounting Policies (Policy)

9 Months Ended

Sep. 30, 2023

Summary of Significant Accounting Policies [Abstract]

Basis of Presentation

Basis of presentation

The accompanying interim unaudited condensed consolidated financial statements have been prepared using generally accepted

accounting principles in the United States of America (“GAAP”) and pursuant to the rules and regulations of the United States Securities

and Exchange Commission (“SEC”) for interim financial reporting. 

These interim condensed consolidated financial statements are unaudited and, in the opinion of management, include all normal and

recurring adjustments necessary to fairly present the results of the interim periods. The condensed consolidated balance sheet at

December 31, 2022, has been derived from the audited financial statements at that date. Operating results for the three and nine months

ended September 30, 2023 and cash flows for the nine months ended September 30, 2023 are not necessarily indicative of the results

that may be expected for the fiscal year ending December 31, 2023 or any other future period. Certain information and note disclosures

normally included in annual consolidated financial statements prepared in accordance with GAAP have been omitted in accordance with

the rules and regulations for interim reporting of the SEC. These interim unaudited condensed financial statements should be read in

conjunction with the consolidated financial statements and notes thereto included in our Annual Report on Form 10-K for the year ended

December 31, 2022 filed with the SEC on March 27, 2023 (the “Annual Report”).

Recently Adopted Accounting Pronouncements and Recently Issued Accounting Pronouncements Not Yet Adopted

Recently adopted accounting pronouncements 

From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (“FASB”) or other standard

setting bodies and are adopted by the Company as of the specified effective date. 

In June 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2016-13, Financial

Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments (“ASU 2016-13”). ASU 2016-13

significantly changes the impairment model for most financial assets and certain other instruments as it will require immediate

recognition of estimated credit losses expected to occur over the remaining life of many financial assets, which will generally result in

earlier recognition of allowances for credit losses on loans and other financial instruments. On January 1, 2023, the Company adopted

ASU 2016-13. The adoption of this standard did not have a material impact on the Company's consolidated financial statements.

Recently issued accounting pronouncements not yet adopted

In August 2020, the FASB issued ASU 2020-06, Debt - Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives

and Hedging - Contracts in Entity's Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity's

Own Equity, which is intended to simplify the accounting for certain financial instruments with characteristics of liabilities and equity,

including convertible instruments and contracts on an entity's own equity. The guidance allows for either full retrospective adoption or

modified retrospective adoption. The guidance is effective for the Company in the first quarter of fiscal year 2024 and early adoption is

permitted. The Company is in the process of evaluating the effect the amendment will have on the consolidated financial statements.

XML

Fair Value Measurements (Tables)

9 Months Ended

Sep. 30, 2023

Fair Value Measurements [Abstract]

Schedule of Financial Instruments Measured at Fair Value on a Recurring Basis

September 30, 2023

Level 1

Level 2

Level 3

Total

Assets:

Short-term investments

$

25,124

$

—

$

—

$

25,124

Money market accounts

10,925

—

—

10,925

Total assets

$

36,049

$

—

$

—

$

36,049

December 31, 2022

Level 1

Level 2

Level 3

Total

Assets:

Short-term investments

$

53,352

$

—

$

—

$

53,352

Money market account

27,724

—

—

27,724

Total assets

$

81,076

$

—

$

—

$

81,076

XML

Short-Term Investments (Tables)

9 Months Ended

Sep. 30, 2023

Short-Term Investments [Abstract]

Schedule of Short-Term Investments

As of September 30, 2023

Amortized Cost

Unrealized

Gains (Losses),

Net

Recorded Basis

U.S. Treasury Securities

$

25,130

$

(6)

$

25,124

Total

$

25,130

$

(6)

$

25,124

As of December 31, 2022

Amortized Cost

Unrealized

Gains (Losses),

Net

Recorded Basis

U.S. Treasury Securities

$

53,549

$

(197)

$

53,352

Total

$

53,549

$

(197)

$

53,352

XML

Prepaid Expenses and Other Current Assets (Tables)

9 Months Ended

Sep. 30, 2023

Prepaid Expenses and Other Current Assets [Abstract]

Prepaid Expenses and Other Current Assets

September 30,

December 31,

2023

2022

Clinical prepayments

$

1,762

$

2,679

Prepaid insurance

280

1,870

Prepaid materials and supplies

—

248

Deposits

240

232

Other

942

522

$

3,224

$

5,551

XML

Property and Equipment, Net (Tables)

9 Months Ended

Sep. 30, 2023

Property and Equipment, Net [Abstract]

Property and Equipment, Net

September 30,

December 31,

2023

2022

Airplane

$

11,983

$

11,983

Laboratory and computer equipment

3,310

3,146

Software

426

415

Leasehold improvements

534

403

Facilities, furniture and fixtures

98

37

Vehicles

87

87

Construction in progress

86

65

Total property and equipment

16,524

16,136

Less: accumulated depreciation and amortization

(5,401)

(3,624)

Property and equipment, net

$

11,123

$

12,512

XML

Accrued Expenses and Other Current Liabilities (Tables)

9 Months Ended

Sep. 30, 2023

Accrued Expenses and Other Current Liabilities [Abstract]

Accrued expenses and other current liabilities

September 30,

December 31,

2023

2022

Accrued external research and development

$

1,720

$

6,904

Accrued compensation

2,689

2,568

Accrued professional fees and other

334

1,722

Accrued interest

—

176

$

4,744

$

11,370

XML

Other Long-Term Liabilities (Tables)

9 Months Ended

Sep. 30, 2023

Other Long-Term Liabilities [Abstract]

Other Liabilities

September 30,

December 31,

2023

2022

Accrued taxes

236

236

$

236

$

236

XML

Notes payable (Tables)

9 Months Ended

Sep. 30, 2023

Note, 2025 [Member]

Debt Instrument [Line Items]

Carrying Value

September 30,

December 31,

2023

2022

Principal

$

10,124

$

10,455

Unamortized debt issuance cost

(92)

(131)

Carrying amount

10,032

10,324

Less: current portion

(402)

(391)

Note payable, net of current portion and debt issuance cost

$

9,630

$

9,933

Remaining Principal Payments

Amount

2023 (remaining 3 months)

$

113

2024

458

2025

9,553

$

10,124

2022 Promissory Note [Member]

Debt Instrument [Line Items]

Carrying Value

September 30,

December 31,

2023

2022

Principal

$

3,276

$

4,225

Less: current portion

(929)

(1,113)

Note payable with related party, net of current portion

$

2,347

$

3,112

Remaining Principal Payments

Amount

2023 (remaining 3 months)

$

165

2024

1,029

2025

1,103

2026

979

$

3,276

XML

Common Stock (Tables)

9 Months Ended

Sep. 30, 2023

Common Stock [Abstract]

Reserved Shares of Common Stock for Issuance

September 30,

December 31,

2023

2022

Options and RSUs issued and outstanding

22,000,273

20,716,760

Options available for future grants

6,648,567

6,064,003

Warrants issued and outstanding

1,928,020

1,928,020

30,576,860

28,708,783

XML

Stock-Based Compensation (Tables)

9 Months Ended

Sep. 30, 2023

Stock-Based Compensation [Abstract]

Summary of Stock Option Activity

Number of Stock

Options

Outstanding

Weighted

Average

Exercise Price

Per Share

Weighted

Average

Remaining

Contractual

Term (years)

Aggregate

Intrinsic Value

(in thousands)

Balance at December 31, 2022

20,416,760

$

5.07

6.8

$

7,166

Granted

3,466,782

2.28

Exercised

(689,042)

0.66

Forfeited

(1,394,227)

7.44

Balance at September 30, 2023

21,800,273

$

4.62

6.2

$

6,421

Options vested and exercisable at September 30, 2023

15,987,933

$

4.50

5.9

$

6,338

Summary of Restricted Stock Activity

Number of

Shares

Weighted

Average

Grant Date

Fair Value

Per Share

Unvested at December 31, 2022

300,000

$

3.76

Forfeited

(100,000)

$

3.76

Unvested at September 30, 2023

200,000

$

3.76

Schedule of Stock-Based Compensation Expense for Stock Options

Three Months Ended September

30,

Nine Months Ended September

30,

2023

2022

2023

2022

General and administrative

$

1,278

$

1,509

$

4,287

$

3,888

Research and development

491

848

2,140

2,473

Total stock-based compensation expense

$

1,769

$

2,357

$

6,427

$

6,361

XML

Net Loss Per Share (Tables)

9 Months Ended

Sep. 30, 2023

Net Loss Per Share [Abstract]

Schedule of Excluded Potential Common Shares from Computation of Diluted Net Loss Per Share

September 30,

2023

2022

Options issued and outstanding

21,800,273

20,293,681

Warrants issued and outstanding

1,928,020

1,928,020

Restricted stock units issued and outstanding

200,000

300,000

23,928,293

22,521,701

XML

Related Party Transactions (Tables)

9 Months Ended

Sep. 30, 2023

Related Party Transactions [Abstract]

Schedule of Related Party Operating Activity

September 30,

December 31,

2023

2022

Consolidated balance sheet

Assets

Prepaid expenses and other current assets

$

—

$

237

Amounts due from related parties

407

414

Liabilities

Amounts due to related parties

12,512

12,772

Current portion of note payable

929

1,113

Note payable

2,347

3,112

Accrued interest payable

—

73

Three Months Ended September

30,

Nine Months Ended September

30,

2023

2022

2023

2022

Operating expenses

Research and development

Services provided by related parties

 $

67

 $

—

 $

424

 $

1,139

General and administrative

Services provided by related parties

 $

1,076

 $

—

 $

2,133

 $

—

Other income/expense

Related party interest expense

 $

60

 $

—

 $

193

 $

—

XML

Nature of the Business (Narrative) (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2023	Sep. 30, 2022	Sep. 30, 2023	Sep. 30, 2022	Dec. 31, 2022
Nature of Business Disclosures [Line Items]
Cash and cash equivalents	$ 17,395	$ 18,875	$ 17,395	$ 18,875	$ 33,475
Net loss	(13,145)	$ (19,252)	(45,542)	(54,766)
Accumulated deficit	(350,245)		(350,245)		(304,703)
Net Cash Provided By Used In Operating Activities			(45,393)	$ (41,451)
Short Term Investments	$ 25,124		$ 25,124		$ 53,352

XML

Fair Value Measurements (Narrative) (Details) - USD ($)	3 Months Ended	9 Months Ended	12 Months Ended
	Sep. 30, 2023	Sep. 30, 2023	Dec. 31, 2022
Class Of Warrant Or Right [Line Items]
Transfers between fair value hierarchies assets liabilities	$ 0	$ 0	$ 0

XML

Fair Value Measurements (Schedule of Financial Instruments Measured at Fair Value on a Recurring Basis (Details) - USD ($) $ in Thousands	Sep. 30, 2023	Dec. 31, 2022
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Short-term investments	$ 25,124	$ 53,352
Assets	36,049	81,076
Money Market Account [Member]
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Assets	10,925	27,724
Level 1 [Member]
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Short-term investments	25,124	53,352
Assets	36,049	81,076
Level 1 [Member] | Money Market Account [Member]
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Assets	10,925	27,724
Level 2 [Member]
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Short-term investments	0	0
Assets	0	0
Level 2 [Member] | Money Market Account [Member]
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Assets	0	0
Level 3 [Member]
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Short-term investments	0	0
Assets	0	0
Level 3 [Member] | Money Market Account [Member]
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items]
Assets	$ 0	$ 0

XML

Short-Term Investments (Schedule of Short-Term Investments) (Details) - USD ($) $ in Thousands	9 Months Ended	12 Months Ended
	Sep. 30, 2023	Dec. 31, 2022
Cash And Cash Equivalents [Line Items]
Amortized Cost	$ 25,130	$ 53,549
Unrealized Gains (Losses), Net	(6)	(197)
Recorded Basis	25,124	53,352
U S Treasury Securities [Member]
Cash And Cash Equivalents [Line Items]
Amortized Cost	25,130	53,549
Unrealized Gains (Losses), Net	(6)	(197)
Recorded Basis	$ 25,124	$ 53,352

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Prepaid Expenses and Other Current Assets (Narrative) (Details) - USD ($)	Sep. 30, 2023	Dec. 31, 2022
Prepaid Expenses and Other Current Assets [Line Items]
Clinical prepayments	$ 1,762,000	$ 2,679,000
Supplies	0	248,000
Unamortized portion of insurance fee	300,000	1,600,000
Clinical trials, UB-612 [Member]
Prepaid Expenses and Other Current Assets [Line Items]
Clinical prepayments	1,500,000
Related Party [Member]
Prepaid Expenses and Other Current Assets [Line Items]
Supplies	$ 0	$ 200,000

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Prepaid Expenses and Other Current Assets (Prepaid Expenses and Other Current Assets) (Details) - USD ($) $ in Thousands	Sep. 30, 2023	Dec. 31, 2022
Prepaid Expenses and Other Current Assets [Abstract]
Clinical prepayments	$ 1,762	$ 2,679
Prepaid insurance	280	1,870
Prepaid materials and supplies	0	248
Deposits	240	232
Other	942	522
Total	$ 3,224	$ 5,551

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Property and Equipment, Net (Narrative) (Details) - USD ($) $ in Millions	3 Months Ended		9 Months Ended
	Sep. 30, 2023	Sep. 30, 2022	Sep. 30, 2023	Sep. 30, 2022
Property, Plant and Equipment [Line Items]
Depreciation expense	$ 0.7	$ 0.4	$ 1.8	$ 1.1

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Property and Equipment, Net (Property and Equipment, Net) (Details) - USD ($) $ in Thousands	Sep. 30, 2023	Dec. 31, 2022
Property, Plant and Equipment [Line Items]
Total property and equipment	$ 16,524	$ 16,136
Less: accumulated depreciation and amortization	(5,401)	(3,624)
Property and equipment, net	11,123	12,512
Airplane [Member]
Property, Plant and Equipment [Line Items]
Total property and equipment	11,983	11,983
Laboratory And Computer Equipment [Member]
Property, Plant and Equipment [Line Items]
Total property and equipment	3,310	3,146
Software [Member]
Property, Plant and Equipment [Line Items]
Total property and equipment	426	415
Leasehold Improvements [Member]
Property, Plant and Equipment [Line Items]
Total property and equipment	534	403
Facilities, Furniture And Fixtures [Member]
Property, Plant and Equipment [Line Items]
Total property and equipment	98	37
Vehicles [Member]
Property, Plant and Equipment [Line Items]
Total property and equipment	87	87
Construction In Progress [Member]
Property, Plant and Equipment [Line Items]
Total property and equipment	$ 86	$ 65

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Accrued Expenses and Other Current Liabilities (Accrued Expenses and Other Current Liabilities) (Details) - USD ($) $ in Thousands	Sep. 30, 2023	Dec. 31, 2022
Accrued Expenses and Other Current Liabilities [Abstract]
Accrued external research and development	$ 1,720	$ 6,904
Accrued compensation	2,689	2,568
Accrued professional fees and other	334	1,722
Accrued interest	0	176
Total	$ 4,744	$ 11,370

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Other Long-Term Liabilities (Narrative) (Details) - USD ($) $ in Millions	Sep. 30, 2023	Dec. 31, 2022
Other Long-Term Liabilities [Abstract]
Income Tax Examination Penalties And Interest Accrued	$ 0.2	$ 0.2

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Other Long-Term Liabilities (Other Liabilities) (Details) - USD ($) $ in Thousands	Sep. 30, 2023	Dec. 31, 2022
Other Long-Term Liabilities [Abstract]
Accrued taxes	$ 236	$ 236
Total	$ 236	$ 236

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Notes payable (Narrative) (Details) - USD ($) $ in Millions	3 Months Ended		9 Months Ended		12 Months Ended
	Sep. 30, 2023	Sep. 30, 2022	Sep. 30, 2023	Sep. 30, 2022	Dec. 31, 2022	Oct. 31, 2022	Jun. 30, 2020
2025 Note [Member]
Debt Instrument [Line Items]
Notes Payable, Related Parties							$ 11.5
Debt Instrument Interest Rate Stated Percentage							3.40%
Debt maturity date							Jun. 09, 2025
Interest Expense, Debt	$ 0.1	$ 0.1	$ 0.3	$ 0.3
Debt Instrument Periodic Payment Interest			0.1
Debt Instrument Periodic Payment Terms Balloon Payment To Be Paid	9.4		9.4
Payments Of Debt Issuance Costs			0.3
2025 Note [Member] | Maximum [Member]
Debt Instrument [Line Items]
Debt Instrument Increase Accrued Interest			0.1		$ 0.1
2022 Promissory Note [Member]
Debt Instrument [Line Items]
Debt Instrument Interest Rate Stated Percentage						7.00%
Debt maturity date						Oct. 01, 2026
2022 Promissory Note [Member] | Related Party [Member]
Debt Instrument [Line Items]
Notes Payable, Related Parties						$ 4.2
Accounts payable						$ 4.2
Interest Expense, Debt	$ 0.1		$ 0.2

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Notes payable (Carrying Value) (Details) - Notes Payable [Member] - USD ($) $ in Thousands	Sep. 30, 2023	Dec. 31, 2022
2025 Note [Member]
Debt Instrument [Line Items]
Principal	$ 10,124	$ 10,455
Unamortized debt issuance cost	(92)	(131)
Total	10,032	10,324
Less: current portion	(402)	(391)
Note payable, net of current portion and debt issuance cost	9,630	9,933
2022 Promissory Note [Member]
Debt Instrument [Line Items]
Principal	3,276	4,225
Less: current portion	(929)	(1,113)
Note payable, net of current portion and debt issuance cost	$ 2,347	$ 3,112

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Notes payable (Remaining Principal Payments) (Details) - Notes Payable [Member] - USD ($) $ in Thousands	Sep. 30, 2023	Dec. 31, 2022
2025 Note [Member]
Debt Instrument [Line Items]
2023 (remaining 3 months)	$ 113
2024	458
2025	9,553
Total	10,124	$ 10,455
2022 Promissory Note [Member]
Debt Instrument [Line Items]
2023 (remaining 3 months)	165
2024	1,029
2025	1,103
2026	979
Total	$ 3,276	$ 4,225

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Common Stock (Reserved Share of Common Stock for Issuance) (Details) - shares	Sep. 30, 2023	Dec. 31, 2022
Class Of Stock [Line Items]
Options issued and outstanding	21,800,273	20,416,760
Options [Member]
Class Of Stock [Line Items]
Options issued and outstanding	22,000,273	20,716,760
Options available for future grants	6,648,567	6,064,003
Warrants issued and outstanding	1,928,020	1,928,020
Reserved Shares of Common Stock	30,576,860	28,708,783

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Stock-Based Compensation (Narrative) (Details) - USD ($) $ / shares in Units, $ in Millions		9 Months Ended
	Jan. 01, 2023	Sep. 30, 2023	Dec. 31, 2022	Nov. 30, 2021
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Options outstanding		21,800,273	20,416,760
Options exercisable		15,987,933
Weighted-average grant-date fair value per share, Issued		$ 1.88
Total unrecognized compensation cost		$ 11.4
Recognized over a weighted average period		2 years
Options [Member]
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Number of shares available for grant		6,648,567	6,064,003
Options outstanding		22,000,273	20,716,760
Intrinsic value of options exercised		$ 0.5
Class A Common Stock [Member] | Options [Member]
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Options outstanding		15,437,818
Options exercisable		10,948,474
Common Class B [Member] | Options [Member]
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Options outstanding		6,362,455
Options exercisable		5,039,459
2021 Plan [Member] | Maximum [Member]
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Increase in shares available for grant	11,886,306
2021 Plan [Member] | Class A Common Stock [Member]
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Available for issuance under Plan				8,700,000
Percentage increase in shares available for grant				4.00%

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Stock-Based Compensation (Summary of Stock Option Activity) (Details) $ / shares in Units, $ in Thousands	9 Months Ended	12 Months Ended
	Sep. 30, 2023 USD ($) $ / shares shares	Dec. 31, 2022 USD ($) $ / shares shares
Stock-Based Compensation [Abstract]
Number of stock options outstanding, Beginning balance | shares	20,416,760
Number of stock options outstanding, Granted | shares	3,466,782
Number of stock options outstanding, Exercised | shares	(689,042)
Number of stock options outstanding, Forfeited | shares	(1,394,227)
Number of stock options outstanding, Ending balance | shares	21,800,273	20,416,760
Number of stock options outstanding, Vested and exercisable | shares	15,987,933
Weighted average exercise price per share, Beginning balance | $ / shares	$ 5.07
Weighted average exercise price per share, Granted | $ / shares	2.28
Weighted average exercise price per share, Exercised | $ / shares	0.66
Weighted average exercise price per share, Forfeited | $ / shares	7.44
Weighted average exercise price per share, Ending balance | $ / shares	4.62	$ 5.07
Weighted average exercise price per share, Vested and exercisable | $ / shares	$ 4.50
Weighted average remaining contractual term (years)	6 years 2 months 12 days	6 years 9 months 18 days
Weighted average remaining contractual term, Vested and exercisable	5 years 10 months 24 days
Aggregate intrinsic value, Beginning balance | $	$ 7,166
Aggregate intrinsic value, Ending balance | $	6,421	$ 7,166
Aggregate intrinsic value, Vested and exercisable | $	$ 6,338

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Stock-Based Compensation (Summary of Restricted Stock Activity) (Details)	9 Months Ended
	Sep. 30, 2023 $ / shares shares
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Number of shares, Issued | shares	3,466,782
Weighted-average grant-date fair value per share, Issued | $ / shares	$ 1.88
Restricted Stock [Member]
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Unvested, Number of Shares, Beginning Balance | shares	300,000
Forfeited, Number of Shares | shares	(100,000)
Unvested, Number of Shares, Ending Balance | shares	200,000
Unvested, Weighted average grant date fair value per share, beginning balance | $ / shares	$ 3.76
Forfeited, weighted average grant date fair value per share | $ / shares	3.76
Unvested, Weighted average grant date fair value per share, ending balance | $ / shares	$ 3.76

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Stock-Based Compensation (Schedule of Stock-Based Compensation Expense for Stock Options) (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2023	Sep. 30, 2022	Sep. 30, 2023	Sep. 30, 2022
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]
Total stock-based compensation expense	$ 1,769	$ 2,357	$ 6,427	$ 6,361
Research And Development [Member]
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]
Total stock-based compensation expense	491	848	2,140	2,473
General And Administrative [Member]
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]
Total stock-based compensation expense	$ 1,278	$ 1,509	$ 4,287	$ 3,888

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Income Taxes (Narrative) (Details)	3 Months Ended		9 Months Ended
	Sep. 30, 2023	Sep. 30, 2022	Sep. 30, 2023
Operating Loss Carryforwards [Line Items]
Effective Income Tax Rate Continuing Operations	0.00%	0.00%
Capital stock measurement period			3 years
Federal [Member]
Operating Loss Carryforwards [Line Items]
Stockholders owning directly or indirectly percentage of company stock	5.00%		5.00%
Federal [Member] | Minimum [Member]
Operating Loss Carryforwards [Line Items]
Percentage of capital stock with change in ownership	50.00%		50.00%

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Net Loss Per Share (Schedule of Excluded Potential Common Shares from Computation of Diluted Net Loss Per Share) (Details) - shares	3 Months Ended
	Sep. 30, 2023	Sep. 30, 2022
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Excluded potential common shares from computation of diluted net loss per share	23,928,293	22,521,701
Options Issued And Outstanding [Member]
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Excluded potential common shares from computation of diluted net loss per share	21,800,273	20,293,681
Warrants Issued And Outstanding [Member]
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Excluded potential common shares from computation of diluted net loss per share	1,928,020	1,928,020
Restricted Stock Units Issued And Outstanding [Member]
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Excluded potential common shares from computation of diluted net loss per share	200,000	300,000

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Commitments and Contingencies (Narrative) (Details)		1 Months Ended		3 Months Ended			9 Months Ended
	Nov. 03, 2021 USD ($)	Apr. 30, 2022 USD ($) ft²	Aug. 31, 2021 USD ($)	Sep. 30, 2023 USD ($) Item	Dec. 31, 2022 USD ($)	Sep. 30, 2022 USD ($)	Sep. 30, 2023 USD ($) Item	Sep. 30, 2022 USD ($)	Aug. 09, 2023 USD ($)	Aug. 31, 2022 USD ($) ft²	Apr. 30, 2021 USD ($)
Commitments And Contingencies [Line Items]
Rent expense				$ 100,000		$ 200,000	$ 500,000	$ 400,000
Materials Expensed					$ 0
Number Of Operating Lease Agreements | Item				2			2
New York Lease [Member]
Commitments And Contingencies [Line Items]
Lease in square feet | ft²		4,419
Lease, initial term		1 year
Florida Lease [Member]
Commitments And Contingencies [Line Items]
Security deposit										$ 100,000
Lease in square feet | ft²										9,839
Lease, initial term										1 year
Lease obligation										$ 500,000
Indemnification Agreement [Member]
Commitments And Contingencies [Line Items]
Purchase obligation				$ 0	$ 0		$ 0
Expected Claim [Member] | Maximum [Member]
Commitments And Contingencies [Line Items]
Potential loss									$ 4,200,000
Expected Claim [Member] | Minimum [Member]
Commitments And Contingencies [Line Items]
Potential loss									$ 0
Contract Research Organizations [Member]
Commitments And Contingencies [Line Items]
Remaining prepayments				1,500,000			1,500,000
Contract Manufacturing Organizations [Member]
Commitments And Contingencies [Line Items]
Remaining prepayments				0			0
UB-612 [Member]
Commitments And Contingencies [Line Items]
Materials Ordered			$ 7,200,000
Materials Expensed							3,000,000.0
Materials Received			3,000,000.0
Amount Of Material Canceled			$ 4,200,000
Purchase obligation											$ 3,000,000
Michael J. Fox Foundation Grant [Member]
Commitments And Contingencies [Line Items]
Project Grant	$ 800,000
Grant, Accrued Liability, Current				0			0
Reduction In Research And Development							0	$ 0
Coalition for Epidemic Preparedness Innovations ("CEPI") Grant [Member]
Commitments And Contingencies [Line Items]
Project Grant		$ 9,300,000
Restricted Cash And Current Accrued Liability				$ 0			0
Reduction In Research And Development							$ 1,800,000

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Benefit Plans (Narrative) (Details) - USD ($) $ in Millions	3 Months Ended		9 Months Ended
	Sep. 30, 2023	Sep. 30, 2022	Sep. 30, 2023	Sep. 30, 2022
Defined Contribution Plan Disclosure [Line Items]
Company matches employee contributions to the Plan at 100% up to 4%			100.00%
Maximum percentage of employee's base salary employer matches 100%			4.00%
Foreign Plan [Member]
Defined Contribution Plan Disclosure [Line Items]
Company matches employee contributions to the Plan at 100% up to 4%			5.00%
Foreign Plan [Member] | Personal Retirement Savings Account [Member]
Defined Contribution Plan Disclosure [Line Items]
Company contributions	$ 0.1	$ 0.1	$ 0.1	$ 0.1

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Related Party Transactions (Narrative) (Details) - UBI [Member] - $ / shares	1 Months Ended
	Aug. 31, 2021	Sep. 30, 2023
Related Party Transaction [Line Items]
Warrants granted	1,928,020
Warrants, exercise price	$ 12.45
Warrant, contractual term	5 years
UBI1 [Member]
Related Party Transaction [Line Items]
Percent of ownership		44.00%

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Related Party Transactions (Schedule of Related Party Operating Activity) (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2023	Sep. 30, 2022	Sep. 30, 2023	Sep. 30, 2022	Dec. 31, 2022
Related Party Transaction [Line Items]
Prepaid expenses and other current assets	$ 3,224		$ 3,224		$ 5,551
Property and equipment, net	11,123		11,123		12,512
Current portion of note payable	929		929		1,113
Note payable	2,347		2,347		3,112
Accrued interest payable	4,744		4,744		11,370
Other income/expense Related party interest expense	300	$ 516	1,093	$ 389
UBI IP [Member] | Services Provided By Related Parties [Member]
Related Party Transaction [Line Items]
Prepaid expenses and other current assets	0		0		237
Amounts due from related parties	407		407		414
Amounts due to related parties	12,512		12,512		12,772
Current portion of note payable	929		929		1,113
Note payable	2,347		2,347		3,112
Accrued interest payable	0		0		$ 73
Research and development	67	0	424	1,139
General and administrative	1,076	0	2,133	0
Other income/expense Related party interest expense	$ 60	$ 0	$ 193	$ 0