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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 20549

FORM 10-Q

(Mark One)

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

For the quarterly period ended 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: 001-38869

HOOKIPA PHARMA INC.

(Exact Name of Registrant as Specified in its Charter)

Delaware

81-5395687

(State or other jurisdiction of
incorporation or organization)

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

350 Fifth Avenue, 72nd Floor, Suite 7240
New York, New York

10118

(Address of principal executive offices)

(Zip Code)

Registrant’s telephone number, including area code: +43 1 890 63 60

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

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

HOOK

The Nasdaq Global Select Market

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

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

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, 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 Act).   Yes      No  

As of November 2, 2023, the registrant had 81,550,590 shares of common stock and 2,399,517 shares of Class A common stock outstanding, each $0.0001 par value per share.

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FORWARD-LOOKING STATEMENTS

This Quarterly Report on Form 10-Q contains forward-looking statements which are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). These statements may be identified by such forward-looking terminology as “may,” “should,” “expects,” “intends,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “continue” or the negative of these terms or other comparable terminology. Our forward-looking statements are based on a series of expectations, assumptions, estimates and projections about our company, are not guarantees of future results or performance and involve substantial risks and uncertainty. We may not actually achieve the plans, intentions or expectations disclosed in these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements. Our business and our forward-looking statements involve substantial known and unknown risks and uncertainties, including the risks and uncertainties inherent in our statements regarding:

the success, cost and timing of our product development activities and clinical trials;
the timing, scope or likelihood of regulatory filings and approvals, including timing of Investigational New Drug Application and Biological Licensing Application filings for our current and future product candidates, and final U.S. Food and Drug Administration, European Medicines Agency or other foreign regulatory authority approval of our current and future product candidates;
our ability to develop and advance our current product candidates and programs into, and successfully complete, clinical studies;
our manufacturing, commercialization and marketing capabilities and strategy;
the potential benefits of and our ability to maintain our collaboration with Gilead Sciences, Inc., F. Hoffmann-La Roche Ltd. and Hoffmann-La Roche Inc., and establish or maintain future collaborations or strategic relationships or obtain additional funding;
the rate and degree of market acceptance and clinical utility of our current and future product candidates;
our intellectual property position, including the scope of protection we are able to establish and maintain for intellectual property rights covering our non-replicating and replicating technologies and the product candidates based on these technologies, the validity of intellectual property rights held by third parties, and our ability not to infringe, misappropriate or otherwise violate any third-party intellectual property rights;
future agreements with third parties in connection with the commercialization of our product candidates and any other approved product;
regulatory developments in the United States and foreign countries;
the effects of the recent coronavirus pandemic or other emerging global health threats on business and operations;
competitive companies, technologies and our industry and the success of competing therapies that are or may become available;
our ability to attract and retain key scientific or management personnel;
our ability to obtain funding for our operations, including funding necessary to complete further development and commercialization of our product candidates;
the accuracy of our estimates of our annual total addressable market, future revenue, expenses, capital requirements and needs for additional financing;

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our expectations about market trends; and
our ability to comply with Nasdaq listing rules and our expectations regarding the period during which we qualify as an emerging growth company under the Jumpstart Our Business Startups Act of 2012, as amended.

All of our forward-looking statements are as of the date of this Quarterly Report on Form 10-Q only. In each case, actual results may differ materially from such forward-looking information. We can give no assurance that such expectations or forward-looking statements will prove to be correct. An occurrence of or any material adverse change in one or more of the risk factors or risks and uncertainties referred to in this Quarterly Report on Form 10-Q or included in our other public disclosures or our other periodic reports or other documents or filings filed with or furnished to the Securities and Exchange Commission could materially and adversely affect our business, prospects, financial condition and results of operations. Except as required by law, we do not undertake or plan to update or revise any such forward-looking statements to reflect actual results, changes in plans, assumptions, estimates or projections or other circumstances affecting such forward-looking statements occurring after the date of this Quarterly Report on Form 10-Q, even if such results, changes or circumstances make it clear that any forward-looking information will not be realized. Any public statements or disclosures by us following this Quarterly Report on Form 10-Q that modify or impact any of the forward-looking statements contained in this Quarterly Report on Form 10-Q will be deemed to modify or supersede such statements in this Quarterly Report on Form 10-Q.

Investors and others should note that we announce material financial information to our investors using our investor relations website (https://ir.hookipapharma.com/), Securities and Exchange Commission filings, press releases, public conference calls and webcasts. We use these channels, as well as social media, to communicate with our members and the public about our company, our services and other issues. It is possible that the information we post on social media could be deemed to be material information. Therefore, we encourage investors, the media, and others interested in our company to review the information we post on the U.S. social media channels listed on our investor relations website.

Table of Contents

Table of Contents

 

 

Page

PART I.

FINANCIAL INFORMATION

1

Item 1.

Financial Statements (Unaudited)

1

Condensed Consolidated Balance Sheets as of September 30, 2023 and December 31, 2022

1

Condensed Consolidated Statements of Operations and Comprehensive Loss for the Three and Nine Months Ended September 30, 2023 and 2022

2

Condensed Consolidated Statements of Convertible Preferred Stock and Stockholders’ Equity for the Three and Nine Months Ended September 30, 2023 and 2022

3

Condensed Consolidated Statements of Cash Flows for the Nine Months Ended September 30, 2023 and 2022

7

Notes to Condensed Consolidated Financial Statements

8

Item 2.

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

28

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

43

Item 4.

Controls and Procedures

43

PART II.

OTHER INFORMATION

44

Item 1.

Legal Proceedings

44

Item 1A.

Risk Factors

44

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

44

Item 3.

Defaults Upon Senior Securities

44

Item 4.

Mine Safety Disclosures

44

Item 5.

Other Information

45

Item 6.

Exhibits

46

Signatures

48

Table of Contents

PART I—FINANCIAL INFORMATION

Item 1.      Financial Statements.

HOOKIPA PHARMA INC.

CONDENSED CONSOLIDATED BALANCE SHEETS (UNAUDITED)

(In thousands, except share amounts)

September 30, 

    

December 31, 

2023

2022

Assets

 

  

 

  

Current assets:

 

  

 

  

Cash and cash equivalents

$

107,676

$

112,488

Restricted cash

537

Accounts receivable

 

675

 

6,533

Receivable research incentives

22,375

15,479

Prepaid expenses and other current assets

 

8,745

 

12,159

Total current assets

 

139,471

 

147,196

Non-current assets:

 

  

 

  

Restricted cash

419

419

Property, plant and equipment, net

 

20,167

 

17,970

Operating lease right of use assets

 

2,862

 

4,006

Other non-current assets

 

1,091

 

863

Total non-current assets

 

24,539

 

23,258

Total assets

$

164,010

$

170,454

Liabilities and Stockholders’ Equity

 

  

 

  

Current liabilities

 

  

 

  

Accounts payable

$

8,929

$

5,488

Deferred revenues

 

16,054

 

15,684

Operating lease liabilities, current

1,498

1,688

Accrued expenses and other current liabilities

 

13,069

 

11,178

Loans payable, current

1,026

1,594

Total current liabilities

 

40,576

 

35,632

Non-current liabilities

 

  

 

  

Loans payable, non-current

 

 

911

Operating lease liabilities, non-current

 

1,330

 

2,310

Deferred revenues, non-current

 

23,719

 

25,664

Other non-current liabilities

 

3,334

 

3,420

Total non-current liabilities

 

28,383

 

32,305

Total liabilities

 

68,959

 

67,937

Commitments and contingencies (Note 12)

 

  

 

  

Stockholders’ equity:

 

  

 

  

Preferred stock, $0.0001 par value; 10,000,000 shares authorized at September 30, 2023 and December 31, 2022, respectively; Series A convertible preferred stock, 2,978 shares designated, 370 and 1,697 shares outstanding at September 30, 2023 and December 31, 2022, respectively; Series A-1 convertible preferred stock, 15,800 shares designated, 10,800 and 15,800 shares outstanding at September 30, 2023 and December 31, 2022, respectively; Series A-2 convertible preferred stock, 15,268 shares and no shares designated, and 15,268 and no shares outstanding at September 30, 2023 and December 31, 2022, respectively

0

0

Common stock, $0.0001 par value; 200,000,000 shares authorized at September 30, 2023 and December 31, 2022, respectively; 81,550,590 shares and 52,317,138 shares issued and outstanding at September 30, 2023 and December 31, 2022, respectively

 

8

 

5

Class A common stock, $0.0001 par value; 3,900,000 shares authorized at September 30, 2023 and December 31, 2022, respectively; 2,399,517 shares issued and outstanding at September 30, 2023 and December 31, 2022, respectively

 

0

 

0

Additional paid-in capital

 

445,512

 

397,349

Accumulated other comprehensive loss

 

(6,026)

 

(7,156)

Accumulated deficit

 

(344,443)

 

(287,681)

Total stockholders’ equity

 

95,051

 

102,517

Total liabilities and stockholders’ equity

$

164,010

$

170,454

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

1

Table of Contents

HOOKIPA PHARMA INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (UNAUDITED)

(In thousands, except share and per share amounts)

    

Three months ended September 30, 

    

Nine months ended September 30, 

2023

    

2022

2023

    

2022

Revenue from collaboration and licensing

$

6,867

$

2,230

$

12,722

$

6,421

Operating expenses:

 

 

 

 

Research and development

 

(24,625)

(18,286)

(65,262)

(51,053)

General and administrative

 

(4,912)

(4,937)

(14,259)

(14,935)

Total operating expenses

 

(29,537)

 

(23,223)

 

(79,521)

 

(65,988)

Loss from operations

 

(22,670)

 

(20,993)

 

(66,799)

 

(59,567)

Other income (expense):

 

  

 

  

 

  

 

  

Grant income

$

2,916

$

2,081

$

7,486

$

5,926

Interest income

 

1,570

 

535

 

4,052

 

724

Interest expense

 

(49)

 

(105)

 

(268)

 

(579)

Other income and (expenses), net

 

(833)

 

202

 

(1,029)

 

893

Total other income, net

 

3,604

 

2,713

 

10,241

 

6,964

Net loss before tax

 

(19,066)

 

(18,280)

 

(56,558)

 

(52,603)

Income tax expense

 

0

(0)

(204)

(1)

Net loss

 

(19,066)

 

(18,280)

 

(56,762)

 

(52,604)

Other comprehensive (loss) income:

 

  

 

  

 

  

 

  

Foreign currency translation gain (loss), net of tax

 

1,216

(1,367)

1,130

(2,855)

Comprehensive loss

$

(17,850)

$

(19,647)

$

(55,632)

$

(55,459)

Net loss per share — basic and diluted

$

(0.17)

$

(0.25)

$

(0.64)

$

(0.83)

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

2

Table of Contents

HOOKIPA PHARMA INC.

CONDENSED CONSOLIDATED STATEMENTS OF CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ EQUITY (UNAUDITED)

(In thousands, except share amounts)

Accumulated

Convertible

Common Stock

Additional

Other

Total

Preferred Stock

Common Stock

Class A Common Stock

Paid-In

Comprehensive

Accumulated

Stockholders’

    

Shares

    

Amount

Shares

    

Amount

  

Shares

  

Amount

    

Capital

    

Loss

    

Deficit

    

Equity

Balances as of December 31, 2022

17,497

$

0

52,317,138

$

5

2,399,517

$

0

$

397,349

$

(7,156)

$

(287,681)

$

102,517

Issuance of common stock upon exercise of stock options

5,684

0

1

1

Foreign currency translation adjustment, net of tax

(17)

(17)

Stock-based compensation expense

658

658

Net loss

(19,680)

(19,680)

Balances as of March 31, 2023

17,497

$

0

52,322,822

$

5

 

2,399,517

$

0

$

398,008

$

(7,173)

$

(307,361)

$

83,479

Conversion of Series A convertible preferred stock to common stock

(1,327)

(0)

1,327,000

0

(0)

Conversion of Series A-1 convertible preferred stock to common stock

(5,000)

(0)

5,000,000

1

(1)

Issuance of Series A-2 convertible preferred stock upon public offering at $1,310 per share for cash, net of issuance costs of $1,470

15,268

0

18,531

18,531

Issuance of common stock upon public offering at $1.31 per share for cash, net of issuance costs of $2,205

22,900,768

2

27,793

27,795

ATM costs

(86)

(86)

Foreign currency translation adjustment, net of tax

(69)

(69)

Stock-based compensation expense

696

696

Net loss

(18,016)

(18,016)

Balances as of June 30, 2023

26,438

$

0

81,550,590

$

8

 

2,399,517

$

0

$

444,941

$

(7,242)

$

(325,377)

$

112,330

Issuance costs Series A-2 convertible preferred stock

(1)

(1)

3

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Issuance costs common stock upon public offering

(2)

(2)

Foreign currency translation adjustment, net of tax

1,216

1,216

Stock-based compensation expense

574

574

Net loss

(19,066)

(19,066)

Balances as of September 30, 2023

26,438

$

0

81,550,590

$

8

 

2,399,517

$

0

$

445,512

$

(6,026)

$

(344,443)

$

95,051

4

Table of Contents

Accumulated

Common Stock

Additional

Other

Total

Preferred Stock

Common Stock

Class A Common Stock

Paid-In

Comprehensive

Accumulated

Stockholders’

    

Shares

    

Amount

Shares

    

Amount

  

Shares

  

Amount

    

Capital

    

Income (Loss)

    

Deficit

    

Equity

Balances as of December 31, 2021

 

1,697

$

0

27,383,483

$

3

3,819,732

$

0

$

317,135

$

(4,780)

$

(222,766)

$

89,592

Issuance of Series A-1 convertible preferred stock upon public offering at $2,000 per share for cash, net of issuance costs of $1,975

 

15,800

0

29,625

29,625

Issuance of common stock upon public offering at $2.00 per share for cash, net of issuance costs of $2,713

21,700,000

2

40,685

40,687

Issuance of common stock upon stock purchase agreement with Gilead at $3.00 per share for cash, no issuance costs

 

1,666,666

0

5,000

5,000

Issuance of common stock upon exercise of stock options

 

10,034

0

1

1

Vesting of equity grants

 

112,551

0

(0)

ATM costs

(142)

(142)

Foreign currency translation adjustment, net of tax

(487)

(487)

Stock-based compensation expense

1,621

1,621

Net loss

(17,968)

(17,968)

Balances as of March 31, 2022

 

17,497

$

0

50,872,734

$

5

 

3,819,732

$

0

$

393,925

$

(5,267)

$

(240,734)

$

147,929

Issuance of common stock upon exercise of stock options

12,062

0

1

1

Foreign currency translation adjustment, net of tax

 

(1,001)

(1,001)

Stock-based compensation expense

 

1,381

1,381

Net loss

 

(16,356)

(16,356)

Balances as of June 30, 2022

 

17,497

$

0

50,884,796

$

5

 

3,819,732

$

0

$

395,307

$

(6,268)

$

(257,090)

$

131,954

Conversion of Class A common stock to common stock

 

1,420,215

0

(1,420,215)

(0)

Issuance of common stock upon exercise of stock options

12,127

0

1

1

5

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Foreign currency translation adjustment, net of tax

 

(1,367)

(1,367)

Stock-based compensation expense

1,040

1,040

Net loss

 

(18,280)

(18,280)

Balances as of September 30, 2022

 

17,497

$

0

52,317,138

$

5

 

2,399,517

$

0

$

396,348

$

(7,635)

$

(275,370)

$

113,348

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

6

Table of Contents

HOOKIPA PHARMA INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (UNAUDITED)

(In thousands)

Nine months ended September 30, 

    

2023

    

2022

Operating activities:

Net loss

$

(56,762)

$

(52,604)

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

Stock-based compensation expense

 

1,928

 

4,042

Depreciation and amortization expense

 

2,274

 

2,698

Other non-cash items

 

4

 

(12)

Changes in operating assets and liabilities:

Accounts receivable

 

5,838

 

5,405

Receivable research incentives

(7,227)

(5,383)

Prepaid expenses and other current assets

 

3,507

 

1,743

Other non-current assets

 

(242)

 

251

Accounts payable

 

4,104

 

1,588

Deferred revenues

 

(1,161)

 

10,323

Operating lease liabilities

(819)

(1,223)

Accrued expenses and other liabilities

2,052

(254)

Other non-current liabilities

 

204

 

292

Net cash used in operating activities

 

(46,300)

 

(33,134)

Investing activities:

Purchases of property and equipment

 

(3,737)

 

(4,418)

Net cash used in investing activities

 

(3,737)

 

(4,418)

Financing activities:

Payments related to finance leases

(24)

Proceeds from issuance of convertible preferred stock, net of issuance costs

18,530

29,625

Proceeds from issuance of common stock, net of issuance costs

 

27,794

 

45,691

Payments for deferred offering costs

(149)

Repayments of borrowings

(1,754)

(2,825)

Net cash provided by financing activities

 

44,421

 

72,467

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

 

(5,616)

 

34,915

Cash, cash equivalents and restricted cash at beginning of period

 

113,444

 

66,912

Effect of exchange rate changes on cash, cash equivalents and restricted cash

 

267

 

(1,151)

Cash, cash equivalents and restricted cash at end of period

$

108,095

$

100,676

Supplemental disclosure of cash flow information:

Cash paid for interest

$

(10)

$

(21)

Cash paid for income taxes

$

(204)

$

(1)

Supplemental disclosure of non-cash financing activities:

Property and equipment additions in accounts payable and accrued expenses

$

(121)

$

(239)

Lease assets obtained in exchange for new operating lease liabilities

$

19

$

227

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

7

Table of Contents

HOOKIPA PHARMA INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

1. Nature of the business and organization

HOOKIPA Pharma Inc. (“HOOKIPA” or the “Company”) is a clinical-stage biopharmaceutical company developing a new class of immunotherapeutics based on its proprietary arenavirus platform that is designed to reprogram the body’s immune system.

The Company was incorporated under the name of Hookipa Biotech, Inc. under the laws of the State of Delaware in February 2017 as a fully-owned subsidiary of Hookipa Biotech AG. In June 2018, the Company changed its name from Hookipa Biotech, Inc. to HOOKIPA Pharma Inc. and in order to effectuate the change of the jurisdiction of incorporation, the Company acquired all of the shares of Hookipa Biotech AG, now Hookipa Biotech GmbH. HOOKIPA is headquartered in New York, with European research and preclinical development operations headquartered in Vienna, Austria. In April 2019, the Company closed its initial public offering (“IPO”) and its common stock started trading on the Nasdaq Global Select Market under the ticker symbol “HOOK”.

The Company is subject to risks and uncertainties common to early-stage companies in the biotechnology industry, including, but not limited to, development by competitors of new technological innovations, dependence on key personnel, protection of proprietary technology, compliance with government regulations, the ability to establish clinical- and commercial-scale manufacturing processes and the ability to secure additional capital to fund operations. Product candidates currently under development will require significant additional research and development efforts, including extensive preclinical 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 and may not ultimately lead to a marketing approval and commercialization of a product. Even if the Company’s drug development efforts are successful, it is uncertain if and when the Company will realize significant revenue from product sales.

2. Summary of significant accounting policies

Basis of presentation

The Company’s condensed consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“GAAP”). The accompanying condensed consolidated financial statements include the accounts of the Company and its wholly owned subsidiary. All intercompany accounts and transactions have been eliminated in consolidation.

The consolidated balance sheet as of December 31, 2022 was derived from audited financial statements but does not include all disclosures required by GAAP. The accompanying condensed consolidated balance sheet as of September 30, 2023, the condensed consolidated statements of operations, and comprehensive loss for the three and nine months ended September 30, 2023 and 2022, the condensed consolidated statement of convertible preferred stock and stockholders’ equity for the three and nine mon