10-Q
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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, 2021

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

For the transition period from to

Commission File No. 001-38800

 

Harpoon Therapeutics, Inc.

(Exact name of registrant as specified in its charter)

 

 

Delaware

 

47-3458693

(State or other jurisdiction of

incorporation or organization)

 

(I.R.S. Employer

Identification No.)

 

131 Oyster Point Blvd, Suite 300

South San Francisco, CA 94080

(Address of principal executive offices)

Registrant’s telephone number, including area code: (650) 443-7400

 

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

 

Title of each class

 

Trading Symbol(s)

 

Name of each exchange on which registered

Common stock, par value $0.0001 per share

 

HARP

 

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 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 outstanding shares of the Registrant’s common stock, par value $0.0001, as of October 31, 2021 was 32,748,556.

October703,585

 


 

HARPOON THERAPEUTICS, INC.

QUARTERLY REPORT ON FORM 10-Q

FOR THE QUARTERLY PERIOD ENDED SEPTEMBER 30, 2021

 

TABLE OF CONTENTS

 

Page

 

Special Note Regarding Forward-Looking Statements

3

 

 

 

PART I. FINANCIAL INFORMATION

 

 

 

 

Item

 

 

1.

Condensed Financial Statements (unaudited):

6

 

 

a. Condensed Balance Sheets as of September 30, 2021 and December 31, 2020

6

 

 

b. Condensed Statements of Operations and Comprehensive Loss for the Three and Nine Months Ended September 30, 2021 and 2020

7

 

 

c. Condensed Statements of Stockholders’ Equity for the Three and Nine Months Ended September 30, 2021 and 2020

8

 

 

d. Condensed Statements of Cash Flows for the Nine Months Ended September 30, 2021 and 2020

9

 

 

e. Notes to Condensed Financial Statements

10

2.

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

27

3.

Quantitative and Qualitative Disclosures About Market Risk

37

4.

Controls and Procedures

37

 

 

 

 

PART II. OTHER INFORMATION

 

1.

Legal Proceedings

39

1A.

Risk Factors

39

2.

Unregistered Sales of Equity Securities and Use of Proceeds

88

3.

Defaults Upon Senior Securities

88

4.

Mine Safety Disclosures

88

5.

Other Information

88

6.

Exhibits

89

 

Signatures

90

 

2


 

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

This Quarterly Report on Form 10-Q contains forward-looking statements that involve risks and uncertainties. All statements other than statements of historical facts contained in this Quarterly Report on Form 10-Q are forward-looking statements. In some cases, you can identify forward-looking statements by words such as “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “seek,” “should,” “target,” “will” or “would,” or the negative of these words or other comparable terminology. These forward-looking statements include, but are not limited to, statements about:

the timing of the initiation, progress and expected results of our preclinical studies, clinical trials and our research and development programs;
our ability to advance product candidates into, and successfully complete, preclinical studies and clinical trials;
the timing or likelihood of regulatory filings and approvals;
the commercialization of our product candidates, if approved;
the pricing, coverage and reimbursement of our product candidates, if approved;
the implementation of our business model, strategic plans for our business and product candidates;
the scope of protection we are able to establish and maintain for intellectual property rights covering our technology platforms, including TriTAC, ProTriTAC and TriTAC-XR and our product candidates, including the projected terms of patent protection;
our ability to enter into strategic arrangements and/or collaborations and the potential benefits of such arrangements;
our ability to retain the continued service of our key executives and to identify, hire and retain additional qualified professionals;
our estimates regarding the market opportunity for our product candidates;
our estimates regarding expenses, capital requirements and needs for additional financing and our ability to obtain additional capital;
our financial performance;
the potential effects of the COVID-19 pandemic on our business and operations, results of operations and financial performance; and
developments relating to our competitors and our industry, including competing therapies.

These forward-looking statements are based on our management’s current expectations, estimates, forecasts and projections about our business and the industry in which we operate, and management’s beliefs and assumptions and are not guarantees of future performance or development. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including those described under “Risk Factors” and elsewhere in this report. Moreover, we operate in a very competitive and rapidly changing environment, and new risks emerge from time to time. It is not possible for our management to predict all risks, nor can we assess the impact of all 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 we may make. In light of these risks, uncertainties and assumptions, the forward-looking events and circumstances discussed in this report may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements.

In addition, statements that “we believe” and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based on information available to us as of the date of this report. While we believe that information provides a reasonable basis for these statements, that information may be limited or incomplete. Our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all relevant information.

You should not rely upon forward-looking statements as predictions of future events. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee that the future results, levels of activity, performance, or events and circumstances reflected in the forward-looking statements will be achieved or occur. We undertake no obligation to update publicly any forward-looking statements for any reason after the date of this report to conform these statements to new information, actual results or changes in our expectations, except as required by law.

 

Unless the context otherwise requires, references in this Quarterly Report on Form 10-Q to the “company,” “Harpoon,” “we,” “us” and “our” refer to Harpoon Therapeutics, Inc.“TriTAC” is a registered trademark and “Harpoon Therapeutics,” “Harpoon,” the Harpoon logo and ProTriTAC are among the trademarks owned by Harpoon Therapeutics, Inc. This report also contains trademarks and trade names that are property of their respective owners.

3


 

RISK FACTOR SUMMARY

 

All of our product candidates are in preclinical or early-stage clinical development. Clinical drug development is a lengthy and expensive process with uncertain timelines and uncertain outcomes. If clinical trials of our product candidates are prolonged or delayed, we or any collaborators may be unable to obtain required regulatory approvals, and therefore be unable to commercialize our product candidates on a timely basis or at all.
Interim, topline or preliminary data from our clinical trials that we announce or publish from time to time may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data.
Our TriTAC, ProTriTAC and TriTAC-XR platforms are unproven, novel classes of T cell engagers and may not result in approvable or marketable products, which exposes us to unforeseen risks and makes it difficult for us to predict the time and cost of product development and potential for regulatory approval.
Results of earlier preclinical studies of our product candidates may not be predictive of future trial results.
We depend on enrollment of patients in our clinical trials for our product candidates. If we experience delays or difficulties enrolling in our clinical trials, our research and development efforts and business, financial condition and results of operations could be materially adversely affected.
Our product candidates may have serious adverse, undesirable or unacceptable side effects or other properties which may delay or prevent marketing approval. If such side effects are identified during the development of our product candidates or following approval, if any, we may need to abandon our development of such product candidates, the commercial profile of any approved label may be limited, or we may be subject to other significant negative consequences following marketing approval, if any.
Monitoring safety of patients receiving our product candidates is challenging, which could adversely affect our ability to obtain regulatory approval and commercialize.
We may not be successful in our efforts to use and expand our technology platforms, including TriTAC, ProTriTAC and TriTAC-XR to build a pipeline of product candidates.
We are an early clinical-stage company and have incurred significant losses since our inception. We expect to incur losses for the foreseeable future and may never achieve or maintain profitability.
We will require additional funding in order to complete development of our product candidates and commercialize our products, if approved. If we are unable to raise capital when needed, we could be forced to delay, reduce or eliminate our product development programs or commercialization efforts.
We depend heavily on the success of our current product candidates, and we cannot guarantee that any of these product candidates will receive regulatory approval, which is necessary before they can be commercialized. If we, or any strategic partners we may enter into collaboration agreements with for the development and commercialization of our product candidates, are unable to commercialize our product candidates, or experience significant delays in doing so, our business, financial condition and results of operations will be materially adversely affected.
Our limited operating history may make it difficult for you to evaluate the success of our business to date and to assess our future viability.
Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our technologies or product candidates.
Our business operations and current and future relationships with healthcare professionals, principal investigators, consultants, vendors, customers and third-party payors in the United States and elsewhere are subject to applicable anti-kickback, fraud and abuse, false claims, physician payment transparency, information privacy and security and other healthcare laws and regulations, which could expose us to substantial penalties.
The development and commercialization of biopharmaceutical products is subject to extensive regulation, and the regulatory approval processes of the FDA and comparable foreign authorities are lengthy, time consuming and inherently unpredictable. If we are ultimately unable to obtain regulatory approval for our product candidates on a timely basis if at all, our business will be substantially harmed. An investment in our common stock involves a high degree of risk. Below is a summary of material factors that make an investment in our common stock speculative or risky. Importantly, this summary does not address all of the risks that we face.

 

4


 

Failure or perceived failure to comply with existing or future laws, and regulations, contracts, self-regulatory schemes, standards and other obligations related to data privacy or security could lead to government enforcement actions (which could include civil or criminal fines or penalties), investigations, private litigation, other liabilities, and/or adverse publicity. Compliance or the actual or perceived failure to comply with such laws could increase the costs of our products, could limit their use or adoption, and could otherwise negatively affect our operating results and business.

 

Please refer to the section entitled “Risk Factors” below for additional discussion of the risks summarized in this risk factor summary, as well as other risks that we face.

5


 

PART I. FINANCIAL INFORMATION

Item 1. Financial Statements

 

HARPOON THERAPEUTICS, INC.

Condensed Balance Sheets

(unaudited)

(in thousands, except share and per share data)

 

 

 

September 30,

 

 

December 31,

 

 

 

2021

 

 

2020

 

Assets

 

 

 

 

 

 

Current assets

 

 

 

 

 

 

Cash and cash equivalents

 

$

42,993

 

 

$

21,170

 

Short-term marketable securities

 

 

108,395

 

 

 

104,860

 

Prepaid expenses and other current assets

 

 

4,804

 

 

 

3,724

 

Total current assets

 

 

156,192

 

 

 

129,754

 

Property and equipment, net

 

 

8,657

 

 

 

10,188

 

Long-term marketable securities

 

 

2,841

 

 

 

23,946

 

Operating lease right-of-use asset

 

 

6,279

 

 

 

6,583

 

Other assets

 

 

700

 

 

 

1,121

 

Total assets

 

$

174,669

 

 

$

171,592

 

Liabilities and stockholders' equity

 

 

 

 

 

 

Current liabilities

 

 

 

 

 

 

Accounts payable

 

 

1,598

 

 

 

1,572

 

Accrued liabilities

 

 

14,045

 

 

 

13,845

 

Deferred revenue, current

 

 

38,146

 

 

 

31,299

 

Operating lease liabilities, current

 

 

1,592

 

 

 

1,202

 

Total current liabilities

 

 

55,381

 

 

 

47,918

 

Deferred revenue, noncurrent

 

 

31,345

 

 

 

57,522

 

Operating lease liabilities, net of current portion

 

 

10,973

 

 

 

12,313

 

Total liabilities

 

 

97,699

 

 

 

117,753

 

Commitments and contingencies (Note 6)

 

 

 

 

 

 

Stockholders' equity

 

 

 

 

 

 

Common stock, $0.0001 par value; 150,000,000 shares authorized at September 30, 2021 and December 31, 2020; 32,740,925 shares and 25,553,172 shares issued and outstanding at September 30, 2021 and December 31, 2020, respectively

 

 

4

 

 

 

3

 

Additional paid-in capital

 

 

340,207

 

 

 

221,904

 

Accumulated other comprehensive income

 

 

 

 

 

3

 

Accumulated deficit

 

 

(263,241

)

 

 

(168,071

)

Total stockholders' equity

 

 

76,970

 

 

 

53,839

 

Total liabilities and stockholders' equity

 

$

174,669

 

 

$

171,592

 

 

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

6


 

HARPOON THERAPEUTICS, INC.

Condensed Statements of Operations and Comprehensive Loss

(unaudited)

(in thousands, except share and per share data)

 

 

 

For the Three Months Ended September 30,

 

 

For the Nine Months Ended September 30,

 

 

 

2021

 

 

2020

 

 

2021

 

 

2020

 

Revenue

 

 

 

 

 

 

 

 

 

 

 

 

Collaboration and license revenue

 

$

4,484

 

 

$

3,893

 

 

$

19,329

 

 

$

9,952

 

Total revenue

 

 

4,484

 

 

 

3,893

 

 

 

19,329

 

 

 

9,952

 

Operating expenses

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

16,973

 

 

 

13,057

 

 

 

51,460

 

 

 

37,500

 

General and administrative

 

 

4,186

 

 

 

4,428

 

 

 

13,125

 

 

 

12,286

 

Litigation settlement

 

 

 

 

 

 

 

 

49,954

 

 

 

 

Total operating expenses

 

 

21,159

 

 

 

17,485

 

 

 

114,539

 

 

 

49,786

 

Loss from operations

 

 

(16,675

)

 

 

(13,592

)

 

 

(95,210

)

 

 

(39,834

)

Interest income, net

 

 

48

 

 

 

299

 

 

 

204

 

 

 

1,298

 

Other expense, net

 

 

(55

)

 

 

(14

)

 

 

(163

)

 

 

(15

)

Net loss

 

 

(16,682

)

 

 

(13,307

)

 

 

(95,169

)

 

 

(38,551

)

Other comprehensive loss:

 

 

 

 

 

 

 

 

 

 

 

 

Net unrealized (loss) gain on marketable securities

 

 

1

 

 

 

(115

)

 

 

(3

)

 

 

86

 

Comprehensive loss

 

$

(16,681

)

 

$

(13,422

)

 

$

(95,172

)

 

$

(38,465

)

Net loss per share, basic and diluted

 

 

(0.51

)

 

 

(0.53

)

 

$

(2.96

)

 

$

(1.55

)

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

 

 

32,637,660

 

 

 

25,081,680

 

 

 

32,176,132

 

 

 

24,892,731

 

 

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

7


 

HARPOON THERAPEUTICS, INC.

Condensed Statements of Stockholders’ Equity

(unaudited)

(in thousands, except share data)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Additional

 

 

Accumulated Other

 

 

 

 

 

Total

 

 

Common Stock

 

 

Paid-In

 

 

Comprehensive

 

 

Accumulated

 

 

Stockholders'

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Income (Loss)

 

 

Deficit

 

 

Equity

 

Balances at December 31, 2020

 

25,553,172

 

 

$

3

 

 

$

221,904

 

 

$

3

 

 

$

(168,071

)

 

$

53,839

 

Issuance of common stock in follow-on offering,
   net of underwriter discounts, commissions and
   issuance costs of $
7,400

 

6,764,704

 

 

 

1

 

 

 

107,581

 

 

 

 

 

 

 

 

 

107,582

 

Issuance of common stock under equity incentive plans
   including exercise of stock options

 

113,538

 

 

 

 

 

 

561

 

 

 

 

 

 

 

 

 

561

 

Vesting of early exercised stock options

 

7,319

 

 

 

 

 

 

6

 

 

 

 

 

 

 

 

 

6

 

Stock-based compensation

 

 

 

 

 

 

 

2,136

 

 

 

 

 

 

 

 

 

2,136

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

(61,724

)

 

 

(61,724

)

Unrealized loss on marketable securities

 

 

 

 

 

 

 

 

 

 

(20

)

 

 

 

 

 

(20

)

Balances at March 30, 2021

 

32,438,733

 

 

 

4

 

 

 

332,188

 

 

 

(17

)

 

 

(229,795

)

 

 

102,380

 

Issuance of common stock pursuant to ATM facility,
  net of offering costs

 

138,153

 

 

 

 

 

 

2,767

 

 

 

 

 

 

 

 

 

2,767

 

Issuance of common stock under equity incentive plans
   including exercise of stock options

 

56,934

 

 

 

 

 

 

186

 

 

 

 

 

 

 

 

 

186

 

Vesting of early exercised stock options

 

5,456

 

 

 

 

 

 

5

 

 

 

 

 

 

 

 

 

5

 

Stock-based compensation

 

 

 

 

 

 

 

2,338

 

 

 

 

 

 

 

 

 

2,338

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

(16,764

)

 

 

(16,764

)

Unrealized gain on marketable securities

 

 

 

 

 

 

 

 

 

 

16

 

 

 

 

 

 

16

 

Balances at June 30, 2021

 

32,639,276

 

 

 

4

 

 

 

337,484

 

 

 

(1

)

 

 

(246,559

)

 

 

90,928

 

Issuance of common stock under equity
   incentive plans including exercise
   of stock options

 

99,921

 

 

 

 

 

 

381

 

 

 

 

 

 

 

 

 

381

 

Vesting of early exercised stock options

 

1,728

 

 

 

 

 

 

3

 

 

 

 

 

 

 

 

 

3

 

Stock-based compensation

 

 

 

 

 

 

 

2,339

 

 

 

 

 

 

 

 

 

2,339

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

(16,682

)

 

 

(16,682

)

Unrealized gain on marketable securities

 

 

 

 

 

 

 

 

 

 

1

 

 

 

 

 

 

1

 

Balances at September 30, 2021

 

32,740,925

 

 

$

4

 

 

$

340,207

 

 

$

 

 

$

(263,241

)

 

$

76,970

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Additional

 

 

Accumulated Other

 

 

 

 

 

Total

 

 

Common Stock

 

 

Paid-In

 

 

Comprehensive

 

 

Accumulated

 

 

Stockholders'

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Income

 

 

Deficit

 

 

Equity

 

Balances at December 31, 2019

 

24,850,064

 

 

$

3

 

 

$

212,339

 

 

$

41

 

 

$

(118,163

)

 

$

94,220

 

Issuance of common stock under equity incentive plans
   including exercise of stock options

 

76,619

 

 

 

 

 

 

340

 

 

 

 

 

 

 

 

 

340

 

Vesting of early exercised stock options

 

11,891

 

 

 

 

 

 

9

 

 

 

 

 

 

 

 

 

9

 

Stock-based compensation

 

 

 

 

 

 

 

847

 

 

 

 

 

 

 

 

 

847

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

(12,552

)

 

 

(12,552

)

Unrealized gain on marketable securities

 

 

 

 

 

 

 

 

 

 

430

 

 

 

 

 

 

430

 

Balances at March 31, 2020

 

24,938,574

 

 

 

3

 

 

 

213,535

 

 

 

471

 

 

 

(130,715

)

 

 

83,294

 

Issuance of common stock under equity incentive plans
   including exercise of stock options

 

144,731

 

 

 

 

 

 

347

 

 

 

 

 

 

 

 

 

347

 

Vesting of early exercised stock options

 

8,843

 

 

 

 

 

 

8

 

 

 

 

 

 

 

 

 

8

 

Stock-based compensation

 

 

 

 

 

 

 

1,178

 

 

 

 

 

 

 

 

 

1,178

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

(12,692

)

 

 

(12,692

)

Unrealized loss on marketable securities

 

 

 

 

 

 

 

 

 

 

(229

)

 

 

 

 

 

(229

)

Balances at June 30, 2020

 

25,092,148

 

 

 

3

 

 

 

215,068

 

 

 

242

 

 

 

(143,407

)

 

 

71,906

 

Issuance of common stock under equity incentive plans
   including exercise of stock options

 

167,136

 

 

 

 

 

 

748

 

 

 

 

 

 

 

 

 

748

 

Vesting of early exercised stock options

 

7,319

 

 

 

 

 

 

6

 

 

 

 

 

 

 

 

 

6

 

Stock-based compensation

 

 

 

 

 

 

 

1,504

 

 

 

 

 

 

 

 

 

1,504

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

(13,307

)

 

 

(13,307

)

Unrealized loss on marketable securities

 

 

 

 

 

 

 

 

 

 

(115

)

 

 

 

 

 

(115

)

Balances at September 30, 2020

 

25,266,603

 

 

 

3

 

 

$

217,326

 

 

$

127

 

 

$

(156,714

)

 

$

60,742

 

 

8


 

HARPOON THERAPEUTICS, INC.

Condensed Statements of Cash Flows

(unaudited)

(in thousands)

 

 

 

Nine Months Ended September 30,

 

 

 

2021

 

 

2020

 

Cash flows from operating activities

 

 

 

 

 

 

Net loss

 

$

(95,169

)

 

$

(38,551

)

Adjustments to reconcile net loss to net cash provided by (used in) operating activities

 

 

 

 

 

 

Stock-based compensation expense

 

 

6,813

 

 

 

3,529

 

Depreciation and amortization

 

 

1,632

 

 

 

1,545

 

Non-cash lease expense

 

 

304

 

 

 

312

 

Net amortization of discounts on marketable securities

 

 

1,854

 

 

 

255

 

Changes in operating assets and liabilities

 

 

 

 

 

 

Prepaid expenses and other assets

 

 

(1,081

)

 

 

(372

)

Other assets

 

 

421

 

 

 

(355

)

Accounts payable

 

 

(29

)

 

 

(815

)

Accrued liabilities

 

 

214