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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 001-37695

 

KINETA, INC.

(Exact name of Registrant as specified in its Charter)

 

Delaware

20-8436652

(State or other jurisdiction of

incorporation or organization)

(I.R.S. Employer

Identification No.)

219 Terry Ave. N., Suite 300

Seattle, WA

98109

(Address of principal executive offices)

(Zip Code)

Registrant’s telephone number, including area code: (206) 378-0400

 

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

 

Title of each class

 

Trading

Symbol(s)

 

Name of each exchange on which registered

Common Stock, par value $0.001 per share

 

KA

 

The Nasdaq Capital 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 the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

 

Large accelerated filer

Accelerated filer

 

 

 

 

Non-accelerated filer

Smaller reporting company

 

 

 

 

 

 

 

Emerging growth company

 

 

 

 

 

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.

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

The number of shares of Registrant’s Common Stock outstanding as of November 1, 2023 was 10,393,567.

 

 

 

 

 


 

Table of Contents

 

Page

 

Special Note Regarding Forward-Looking Statements

1

PART I

FINANCIAL INFORMATION

3

 

 

 

Item 1.

Financial Statements (Unaudited)

3

 

Condensed Consolidated Balance Sheets

3

 

Condensed Consolidated Statements of Operations

4

 

Condensed Consolidated Statements of Shareholders' Equity (Deficit)

5

 

Condensed Consolidated Statements of Cash Flows

7

 

Notes to Unaudited Condensed Consolidated Financial Statements

8

Item 2.

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

25

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

35

Item 4.

Controls and Procedures

35

 

PART II

OTHER INFORMATION

37

 

 

 

Item 1.

Legal Proceedings

37

Item 1A.

Risk Factors

37

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

37

Item 3.

Defaults Upon Senior Securities

37

Item 4.

Mine Safety Disclosures

37

Item 5.

Other Information

37

Item 6.

Exhibits

38

Signatures

 

39

 

 

 

 

i


 

EXPLANATORY NOTE

 

On December 16, 2022, Yumanity Therapeutics, Inc. (“Yumanity”) completed its previously announced merger transaction with Kineta Operating, Inc. (formerly Kineta, Inc.) (“Private Kineta”) in accordance with the terms of the Agreement and Plan of Merger, dated as of June 5, 2022, as amended on December 5, 2022 (the “Merger Agreement”), by and among Yumanity, Private Kineta and Yacht Merger Sub, Inc., a wholly-owned subsidiary of Yumanity (“Merger Sub”), pursuant to which Merger Sub merged with and into Private Kineta, with Private Kineta surviving such merger as a wholly-owned subsidiary of Yumanity (the “Merger”). The surviving corporation from the Merger subsequently merged with and into Kineta Operating, LLC, with Kineta Operating, LLC being the surviving corporation. On December 16, 2022, in connection with, and prior to the completion of, the Merger, Yumanity effected a 1-for-7 reverse stock split of its common stock. Immediately following the Merger, Yumanity changed its name to “Kineta, Inc.”

 

Unless the context otherwise requires, references to the “Company,” “Kineta,” the “combined organization,” “we,” “our” or “us” in this Quarterly Report on Form 10-Q refer to Private Kineta and its subsidiaries prior to completion of the Merger and to Kineta, Inc. and its subsidiaries after completion of the Merger. In addition, references to “Yumanity” refer to the registrant prior to the completion of the Merger.

 

The Merger has been accounted for as a reverse merger and asset acquisition in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”). Under this method of accounting, Private Kineta was deemed to be the accounting acquirer for financial reporting purposes. Following the Merger, the business conducted by Private Kineta became the Company’s primary business.

 

Except as otherwise noted, references to “common stock” in this report refer to common stock, $0.001 par value per share, of the Company.

 

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

 

This Quarterly Report on Form 10-Q contains certain statements that constitute “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and the “safe harbor” provisions of the United States Private Securities Litigation Reform Act of 1995. In some cases, you can identify these forward-looking statements by the use of terms such as “expect,” “will,” “continue,” “believe,” “estimate,” “aim,” “project,” “intend,” “should,” “is to be,” or similar expressions, and variations or negatives of these words, but the absence of these words does not mean that a statement is not forward-looking. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. These forward-looking statements are subject to known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance, or achievements to differ materially from results expressed or implied in this Quarterly Report on Form 10-Q. The following factors, among others, could cause actual results to differ materially from those described in these forward-looking statements:

the timing, progress and results of preclinical studies and clinical trials for our programs and product candidates, including statements regarding the timing of initiation and completion of studies or trials and related preparatory work, the period during which the results of the trials will become available and our research and development programs;
our ability to recruit and enroll suitable patients in our clinical trials;
the potential attributes and benefits of our product candidates;
our ability to develop and advance product candidates into, and successfully complete, clinical studies;
the timing, scope or likelihood of regulatory filings and approvals;
our ability to obtain and maintain regulatory approval for our product candidates, and any related restrictions, limitations or warnings in the label of an approved product candidate;
the implementation of our business model and our strategic plans for our business, product candidates, technology and our discovery engine;
our commercialization, marketing and manufacturing capabilities and strategy;
the pricing and reimbursement of our product candidates, if approved;
the rate and degree of market acceptance of our product candidates, if approved;
our ability to establish or maintain collaborations or strategic relationships or obtain additional funding;
our ability to contract with and rely on third parties to assist in conducting our clinical trials and manufacturing our product candidates;
the size and growth potential of the markets for our product candidates, and our ability to serve those markets, either alone or in partnership with others;
our ability to obtain funding for our operations, including funding necessary to complete further development, approval and, if approved, commercialization of our product candidates;

 

1


 

the period over which we anticipate our existing cash and cash equivalents will be sufficient to fund our operating expenses and capital expenditure requirements;
the potential for our business development efforts to maximize the potential value of our portfolio;
our ability to compete with other companies currently marketing or engaged in the development of treatments for the indications that we are pursuing for our product candidates;
our expectations regarding our ability to obtain and maintain intellectual property protection for our product candidates;
our financial performance;
our ability to retain the continued service of our key professionals and to identify, hire and retain additional qualified professionals;
any statements of the plans, strategies and objectives of management for future operations, including the execution of integration plans and the anticipated timing of filings;
our expectations related to the use of our cash reserves;
our estimates regarding expenses, future revenue, capital requirements and needs for additional financing;
our ability to remediate the material weaknesses in our internal control over financial reporting;
the impact of laws and regulations, including without limitation recently enacted tax reform legislation;
the impact of global economic and political developments on our business, including rising inflation and capital market disruptions, the current conflict in Ukraine and the conflict in Israel and the Gaza Strip, economic sanctions and economic slowdowns or recessions that may result from such developments, which could harm our research and development efforts as well as the value of our common stock and our ability to access capital markets;
the effect of COVID-19 on the foregoing; and
other risks and uncertainties, including those listed under the caption “Risk Factors” in Part II, Item 1A.

 

The forward-looking statements contained in this Quarterly Report on Form 10-Q and the documents incorporated herein by reference are based on our current expectations and beliefs concerning future developments and their potential effects on our business. There can be no assurance that future developments affecting our business will be those that we have anticipated. These forward-looking statements involve a number of risks, uncertainties (some of which are beyond our control) or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to, those factors described under the caption “Risk Factors” in Part II, Item 1A of this Quarterly Report on Form 10-Q and under similar headings in the documents that are incorporated by reference herein. Moreover, we operate in a very competitive and rapidly changing environment.

 

New risks and uncertainties emerge from time to time and it is not possible for us to predict all such risk factors, nor can we assess the effect 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. Should one or more of these risks or uncertainties materialize, or should any of the assumptions prove incorrect, actual results may vary in material respects from those projected in these forward-looking statements.

The forward-looking statements made by us in this Quarterly Report on Form 10-Q and the documents incorporated herein by reference speak only as of the date of such statement. Except to the extent required under the federal securities laws and rules and regulations of the U.S. Securities and Exchange Commission (the “SEC”), we disclaim any obligation to update any forward-looking statement to reflect events or circumstances after the date on which the statement is made or to reflect the occurrence of unanticipated events. In light of these risks and uncertainties, there is no assurance that the events or results suggested by the forward-looking statements will in fact occur, and you should not place undue reliance on these forward-looking statements.

 

Although we undertake no obligation to revise or update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law, you are advised to consult any additional disclosures we make in the documents that we file with the SEC.

 

2


 

PART I—FINANCIAL INFORMATION

 

Item 1. Financial Statements.

 

KINETA, INC.

Condensed Consolidated Balance Sheets

(in thousands)

(Unaudited)

 

 

 

September 30,

 

 

December 31,

 

 

 

2023

 

 

2022

 

Assets

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

Cash

 

$

7,562

 

 

$

13,143

 

Prepaid expenses and other current assets

 

 

281

 

 

 

457

 

Total current assets

 

 

7,843

 

 

 

13,600

 

Property and equipment, net

 

 

3

 

 

 

249

 

Operating right-of-use asset

 

 

664

 

 

 

1,211

 

Rights from Private Placement

 

 

2,070

 

 

 

2,250

 

Restricted cash

 

 

125

 

 

 

125

 

Total assets

 

$

10,705

 

 

$

17,435

 

Liabilities and Stockholders’ Equity

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

Accounts payable

 

$

4,333

 

 

$

6,635

 

Accrued expenses and other current liabilities

 

 

1,857

 

 

 

3,527

 

Deferred revenue

 

 

 

 

 

442

 

Notes payable, current portion

 

 

615

 

 

 

 

Operating lease liability, current portion

 

 

767

 

 

 

843

 

Finance lease liabilities, current portion

 

 

43

 

 

 

40

 

Total current liabilities

 

 

7,615

 

 

 

11,487

 

Notes payable, net of current portion

 

 

150

 

 

 

748

 

Operating lease liability, net of current portion

 

 

 

 

 

547

 

Finance lease liabilities, net of current portion

 

 

51

 

 

 

83

 

Total liabilities

 

 

7,816

 

 

 

12,865

 

Commitments and contingencies (Note 6)

 

 

 

 

 

 

Stockholders’ equity:

 

 

 

 

 

 

Common stock, $0.001 par value; 125,000 shares authorized as of September 30, 2023 and December 31, 2022; 10,215 and 8,318 shares issued and outstanding as of September 30, 2023 and December 31, 2022, respectively

 

 

10

 

 

 

8

 

Additional paid-in capital

 

 

165,839

 

 

 

156,106

 

Accumulated deficit

 

 

(163,135

)

 

 

(151,690

)

Total stockholders’ equity attributable to Kineta, Inc.

 

 

2,714

 

 

 

4,424

 

Noncontrolling interest

 

 

175

 

 

 

146

 

Total stockholders’ equity

 

 

2,889

 

 

 

4,570

 

Total liabilities and stockholders’ equity

 

$

10,705

 

 

$

17,435

 

 

See the accompanying notes to the unaudited condensed consolidated financial statements.

 

3


 

KINETA, INC.

Condensed Consolidated Statements of Operations

(in thousands, except per share amounts)

(Unaudited)

 

 

 

Three Months Ended September 30,

 

 

Nine Months Ended September 30,

 

 

 

2023

 

 

2022

 

 

2023

 

 

2022

 

Revenues:

 

 

 

 

 

 

 

 

 

 

 

 

Collaboration revenues

 

$

 

 

$

 

 

$

442

 

 

$

 

Licensing revenues

 

 

 

 

 

 

 

 

5,000

 

 

 

965

 

Grant revenues

 

 

 

 

 

200

 

 

 

 

 

 

501

 

Total revenues

 

 

 

 

 

200

 

 

 

5,442

 

 

 

1,466

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

1,909

 

 

 

2,605

 

 

 

7,462

 

 

 

10,507

 

General and administrative

 

 

2,077

 

 

 

2,046

 

 

 

9,432

 

 

 

5,480

 

Total operating expenses

 

 

3,986

 

 

 

4,651

 

 

 

16,894

 

 

 

15,987

 

Loss from operations

 

 

(3,986

)

 

 

(4,451

)

 

 

(11,452

)

 

 

(14,521

)

Other (expense) income:

 

 

 

 

 

 

 

 

 

 

 

 

Interest expense (with related parties $0 for the three and nine months ended September 30, 2023 and $465 and $1,366 for the three and nine months ended September 30, 2022, respectively)

 

 

(21

)

 

 

(559

)

 

 

(65

)

 

 

(1,699

)

Change in fair value of rights from Private Placement

 

 

(1,401

)

 

 

 

 

 

(180

)

 

 

 

Change in fair value measurement of notes payable

 

 

(4

)

 

 

(418

)

 

 

(17

)

 

 

(542

)

(Loss) gain on extinguishments of debt, net

 

 

 

 

 

(236

)

 

 

 

 

 

259

 

Other (expense) income, net

 

 

101

 

 

 

(3

)

 

 

298

 

 

 

(17

)

Total other (expense) income, net

 

 

(1,325

)

 

 

(1,216

)

 

 

36

 

 

 

(1,999

)

Net loss

 

$

(5,311

)

 

$

(5,667

)

 

$

(11,416

)

 

$

(16,520

)

Net (loss) income attributable to noncontrolling interest

 

 

69

 

 

 

(82

)

 

 

29

 

 

 

(81

)

Net loss attributable to Kineta, Inc.

 

$

(5,380

)

 

$

(5,585

)

 

$

(11,445

)

 

$

(16,439

)

Net loss per share, basic and diluted

 

$

(0.46

)

 

$

(1.14

)

 

$

(1.09

)

 

$

(3.42

)

Weighted-average shares outstanding, basic and diluted

 

 

11,738

 

 

 

4,891

 

 

 

10,505

 

 

 

4,808

 

 

See the accompanying notes to the unaudited condensed consolidated financial statements.

 

4


 

KINETA, INC.

Condensed Consolidated Statements of Stockholders’ Equity (Deficit)

(in thousands)

(Unaudited)

 

 

 

Common Stock

 

 

Additional Paid-In Capital

 

 

Accumulated

 

 

Total Stockholders’ Deficit Attributable

 

 

Noncontrolling

 

 

Total Stockholders’

 

 

 

Shares

 

 

Amount

 

 

Amount

 

 

Deficit

 

 

to Kineta

 

 

Interest

 

 

Deficit

 

Balance as of January 1, 2022

 

 

4,656

 

 

$

5

 

 

$

76,137

 

 

$

(88,282

)

 

$

(12,140

)

 

$

191

 

 

$

(11,949

)

Issuance of common stock

 

 

3

 

 

 

 

 

 

98

 

 

 

 

 

98

 

 

 

 

 

 

98

 

Issuance of common stock upon
   extinguishment of notes payable and accrued interest

 

 

9

 

 

 

 

 

 

235

 

 

 

 

 

235

 

 

 

 

 

 

235

 

Issuance of common stock upon
   exercise of warrants

 

 

1

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Stock-based compensation

 

 

 

 

 

 

 

 

285

 

 

 

 

 

 

285

 

 

 

 

 

 

285

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

(4,976

)

 

 

(4,976

)

 

 

1

 

 

 

(4,975

)

Balance as of March 31, 2022

 

 

4,669

 

 

$

5

 

 

$

76,755

 

 

$

(93,258

)

 

$

(16,498

)

 

$

192

 

 

$

(16,306

)

Issuance of common stock

 

 

33

 

 

 

 

 

 

905

 

 

 

 

 

 

905

 

 

 

 

 

 

905

 

Issuance of common stock upon
   extinguishment of notes payable and accrued interest

 

 

46

 

 

 

 

 

 

1,064

 

 

 

 

 

 

1,064

 

 

 

 

 

 

1,064

 

Note conversion discount

 

 

 

 

 

 

 

 

174

 

 

 

 

 

 

174

 

 

 

 

 

 

174

 

Issuance of common stock upon
   exercise of warrants

 

 

44

 

 

 

 

 

 

7

 

 

 

 

 

 

7

 

 

 

 

 

 

7

 

Stock-based compensation

 

 

 

 

 

 

 

 

755

 

 

 

 

 

 

755

 

 

 

 

 

 

755

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

(5,878

)

 

 

(5,878

)

 

 

 

 

 

(5,878

)

Balance as of June 30, 2022

 

 

4,792

 

 

$

5

 

 

$

79,660

 

 

$

(99,136

)

 

$

(19,471

)

 

$

192

 

 

$

(19,279

)

Issuance of common stock

 

 

20

 

 

 

 

 

 

553

 

 

 

 

 

 

553

 

 

 

 

 

 

553

 

Issuance of common stock upon
   extinguishment of notes payable and accrued interest

 

 

59

 

 

 

 

 

 

1,622

 

 

 

 

 

 

1,622

 

 

 

 

 

 

1,622

 

Issuance of common stock upon cashless
   exercise of stock options

 

 

10

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Issuance of common stock upon
   exercise of warrants

 

 

3

 

 

 

 

 

 

63

 

 

 

 

 

 

63

 

 

 

 

 

 

63

 

Issuance of warrants for services

 

 

 

 

 

 

 

 

62

 

 

 

 

 

 

62

 

 

 

 

 

 

62

 

Issuance of warrants in connection with notes payable

 

 

 

 

 

 

 

 

47

 

 

 

 

 

 

47

 

 

 

 

 

 

47

 

Stock-based compensation

 

 

 

 

 

 

 

 

477

 

 

 

 

 

 

477

 

 

 

 

 

 

477

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

(5,585

)

 

 

(5,585

)

 

 

(82

)

 

 

(5,667

)

Balance as of September 30, 2022

 

 

4,884

 

 

$

5

 

 

$

82,484

 

 

$

(104,721

)

 

$

(22,232

)

 

$

110

 

 

$

(22,122

)

 

 

5


 

 

 

Common Stock

 

 

Additional Paid-In Capital

 

 

Accumulated

 

 

Total Shareholders’ Equity (Deficit) Attributable

 

 

Noncontrolling

 

 

Total Shareholders’

 

 

 

Shares

 

 

Amount

 

 

Amount

 

 

Deficit

 

 

to Kineta

 

 

Interest

 

 

Equity (Deficit)

 

Balance as of January 1, 2023

 

 

8,318

 

 

$

8

 

 

$

156,106

 

 

$

(151,690

)

 

$

4,424

 

 

$

146

 

 

$

4,570

 

Issuance of common stock

 

 

127

 

 

 

1

 

 

 

751

 

 

 

 

 

752

 

 

 

 

 

752

 

Issuance of common stock upon
  exercise of warrants

 

 

51

 

 

 

 

 

7

 

 

 

 

 

7

 

 

 

 

 

 

7

 

Issuance of common stock upon
   vesting of RSUs

 

 

23

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Issuance of common stock for services

 

 

12

 

 

 

 

 

41

 

 

 

 

 

41

 

 

 

 

 

 

41

 

Stock-based compensation

 

 

 

 

 

 

 

 

1,054

 

 

 

 

 

 

1,054

 

 

 

 

 

 

1,054

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

(6,451

)

 

 

(6,451

)

 

 

(29

)

 

 

(6,480

)

Balance as of March 31, 2023

 

 

8,531

 

 

$

9

 

 

$

157,959

 

 

$

(158,141

)

 

$

(173

)

 

$

117

 

 

$

(56

)

Issuance of common stock

 

 

948

 

 

 

1

 

 

 

5,478

 

 

 

 

 

 

5,479

 

 

 

 

 

5,479

 

Issuance of common stock upon
  exercise of warrants

 

 

144