10-Q
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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 20549

 

FORM 10-Q

 

(Mark One)

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

For the quarterly period ended September 30, 2021

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: 001-39269

 

ORIC PHARMACEUTICALS, INC.

(Exact Name of Registrant as Specified in its Charter)

 

 

Delaware

47-1787157

(State or other jurisdiction of incorporation or organization)

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

240 E. Grand Ave, 2nd Floor

South San Francisco, CA

94080

(Address of principal executive offices)

(Zip Code)

Registrant’s telephone number, including area code: (650) 388-5600

 

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

Common Stock, $0.0001 par value per share

 

ORIC

 

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 Exchange Act). Yes No ☒

As of November 3, 2021, the registrant had 39,381,866 shares of common stock, $0.0001 par value per share, outstanding.

 

 

 


 

Table of Contents

 

 

 

Page

PART I.

FINANCIAL INFORMATION

 

Item 1.

Financial Statements (Unaudited)

3

 

Balance Sheets

3

 

Statements of Operations and Comprehensive Loss

4

 

Statements of Convertible Preferred Stock and Stockholders’ Equity (Deficit)

5

 

Statements of Cash Flows

6

 

Notes to Unaudited Financial Statements

7

Item 2.

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

15

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

21

Item 4.

Controls and Procedures

22

 

 

 

PART II.

OTHER INFORMATION

 

Item 1.

Legal Proceedings

23

Item 1A.

Risk Factors

23

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

73

Item 3.

Defaults Upon Senior Securities

74

Item 4.

Mine Safety Disclosures

74

Item 5.

Other Information

74

Item 6.

Exhibits

75

SIGNATURES

76

 

 

 

i


 

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

This quarterly report on Form 10-Q contains forward-looking statements. All statements other than statements of historical facts contained in this quarterly report on Form10-Q, including statements regarding our future results of operations and financial position, business strategy, development plans, planned preclinical studies and clinical trials, future results of clinical trials, expected research and development costs, regulatory strategy, timing and likelihood of success, as well as plans and objectives of management for future operations, are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “would,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions. Forward-looking statements contained in this quarterly report on Form 10-Q include, but are not limited to, statements about:

the ability of our clinical trials to demonstrate safety and efficacy of our product candidates, and other positive results;
the timing, progress and results of preclinical studies and clinical trials for ORIC-101, ORIC-533, ORIC-944, ORIC-114 and other product candidates we may develop, 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;
the timing, scope and likelihood of regulatory filings and approvals, including timing of Investigational New Drug, or IND, or Clinical Trial Application, or CTA, applications and final Food and Drug Administration, or FDA, approval of ORIC-101, ORIC-533, ORIC-944, ORIC-114 and any other future product candidates;
the timing, scope or likelihood of foreign regulatory filings and approvals;
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;
our plans relating to commercializing our product candidates, if approved, including the geographic areas of focus and sales strategy;
the need to hire additional personnel and our ability to attract and retain such personnel;
our expectations regarding the impact of the COVID-19 pandemic on our business;
the size of the market opportunity for our product candidates, including our estimates of the number of patients who suffer from the diseases we are targeting;
our expectations regarding the approval and use of our product candidates in combination with other drugs;
our competitive position and the success of competing therapies that are or may become available;
our estimates of the number of patients that we will enroll in our clinical trials;
the beneficial characteristics, safety, efficacy and therapeutic effects of our product candidates;
our ability to obtain and maintain regulatory approval of our product candidates;
our plans relating to the further development of our product candidates, including additional indications we may pursue;
existing regulations and regulatory developments in the United States, Europe and other jurisdictions;
our intellectual property position, including the scope of protection we are able to establish and maintain for intellectual property rights covering ORIC-101, ORIC-533, ORIC-944, ORIC-114 and other product candidates we may develop, including the extensions of existing patent terms where available, 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;
our continued reliance on third parties to conduct additional clinical trials of our product candidates, and for the manufacture of our product candidates for preclinical studies and clinical trials;
our ability to obtain, and negotiate favorable terms of, any collaboration, licensing or other arrangements that may be necessary or desirable to develop, manufacture or commercialize our product candidates;
the pricing and reimbursement of ORIC-101, ORIC-533, ORIC-944, ORIC-114 and other product candidates we may develop, if approved;

1


 

the rate and degree of market acceptance and clinical utility of ORIC-101, ORIC-533, ORIC-944, ORIC-114 and other product candidates we may develop;
our estimates regarding expenses, future revenue, capital requirements and needs for additional financing;
our financial performance;
the period over which we estimate our existing cash, cash equivalents and available-for-sale investments will be sufficient to fund our future operating expenses and capital expenditure requirements;
the impact of laws and regulations;
our expectations regarding the period during which we will qualify as an emerging growth company under the JOBS Act; and
our anticipated use of our existing resources.

We have based these forward-looking statements largely on our current expectations and projections about our business, the industry in which we operate and financial trends that we believe may affect our business, financial condition, results of operations and prospects, and these forward-looking statements are not guarantees of future performance or development. These forward-looking statements speak only as of the date of this quarterly report on Form 10-Q and are subject to a number of risks, uncertainties and assumptions described in the section titled “Risk factors” and elsewhere in this quarterly report on Form 10-Q. Because forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified, you should not rely on these forward-looking statements as predictions of future events. The events and circumstances reflected in our forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events or otherwise.

In addition, statements that “we believe” and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based upon information available to us as of the date of this quarterly report on Form 10-Q, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain and you are cautioned not to unduly rely upon these statements.

 

2


 

Part I – FINANCIAL INFORMATION

 

Item 1. Financial Statements.

 

ORIC PHARMACEUTICALS, INC.

BALANCE SHEETS

(in thousands, except share and per share amounts)

 

 

 

 

 

 

September 30, 2021

 

 

December 31, 2020

 

 

 

(unaudited)

 

 

 

 

Assets

 

Current assets:

 

 

 

 

 

 

Cash and cash equivalents

 

$

241,126

 

 

$

78,446

 

Short-term investments, available-for-sale

 

 

48,393

 

 

 

215,154

 

Prepaid expenses and other current assets

 

 

3,330

 

 

 

3,097

 

Total current assets

 

 

292,849

 

 

 

296,697

 

 

 

 

 

 

 

 

Investments, available-for-sale

 

 

6,956

 

 

 

 

Property and equipment, net

 

 

1,825

 

 

 

1,981

 

Other assets

 

 

12,550

 

 

 

319

 

Total assets

 

$

314,180

 

 

$

298,997

 

 

 

 

 

 

 

 

Liabilities and Stockholders' Equity

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

Accounts payable

 

$

419

 

 

$

757

 

Accrued liabilities

 

 

11,484

 

 

 

8,245

 

Total current liabilities

 

 

11,903

 

 

 

9,002

 

 

 

 

 

 

 

 

Other long-term liabilities

 

 

10,741

 

 

 

219

 

Total liabilities

 

 

22,644

 

 

 

9,221

 

 

 

 

 

 

 

 

Commitments and contingencies (Note 9)

 

 

 

 

 

 

Stockholders' equity:

 

 

 

 

 

 

Preferred stock, $0.0001 par value; 200,000,000 shares authorized; no shares issued and outstanding at September 30, 2021 and December 31, 2020

 

 

 

 

 

 

Common stock, $0.0001 par value; 1,000,000,000 shares authorized; 39,331,585 and 36,672,415 shares issued and outstanding at September 30, 2021 and December 31, 2020, respectively

 

 

4

 

 

 

4

 

Additional paid-in capital

 

 

513,871

 

 

 

456,196

 

Accumulated deficit

 

 

(222,337

)

 

 

(166,393

)

Accumulated other comprehensive loss

 

 

(2

)

 

 

(31

)

Total stockholders' equity

 

 

291,536

 

 

 

289,776

 

Total liabilities and stockholders' equity

 

$

314,180

 

 

$

298,997

 

 

See accompanying notes to unaudited financial statements.

3


 

ORIC PHARMACEUTICALS, INC.

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,

 

 

2021

 

 

2020

 

 

2021

 

 

2020

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

Research and development

$

12,899

 

 

$

8,831

 

 

$

40,113

 

 

$

23,808

 

Acquired in-process research and development

 

 

 

 

12,971

 

 

 

 

 

 

12,971

 

General and administrative

 

5,557

 

 

 

3,800

 

 

 

15,953

 

 

 

9,125

 

Total operating expenses

 

18,456

 

 

 

25,602

 

 

 

56,066

 

 

 

45,904

 

Loss from operations

 

(18,456

)

 

 

(25,602

)

 

 

(56,066

)

 

 

(45,904

)

 

 

 

 

 

 

 

 

 

 

 

 

Other income:

 

 

 

 

 

 

 

 

 

 

 

Interest income, net

 

30

 

 

 

10

 

 

 

107

 

 

 

276

 

Other income

 

 

 

 

44

 

 

 

15

 

 

 

184

 

Total other income

 

30

 

 

 

54

 

 

 

122

 

 

 

460

 

Net loss

$

(18,426

)

 

$

(25,548

)

 

$

(55,944

)

 

$

(45,444

)

Other comprehensive gain (loss):

 

 

 

 

 

 

 

 

 

 

 

 Unrealized (loss) gain on available-for-sale investments

 

(5

)

 

 

(29

)

 

 

29

 

 

 

(29

)

Comprehensive loss

$

(18,431

)

 

$

(25,577

)

 

$

(55,915

)

 

$

(45,473

)

Net loss per share, basic and diluted

$

(0.47

)

 

$

(0.84

)

 

$

(1.49

)

 

$

(2.52

)

Weighted-average shares outstanding, basic and diluted

 

39,008,114

 

 

 

30,314,904

 

 

 

37,471,740

 

 

 

18,022,068

 

 

 

 

 

 

 

 

 

 

 

 

 

 

See accompanying notes to unaudited financial statements.

 

4


 

ORIC PHARMACEUTICALS, INC.

STATEMENTS OF CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ EQUITY (DEFICIT)

(Unaudited)

(in thousands, except share amounts)

 

 

 

 

Convertible
Preferred Stock

 

 

Common Stock

 

 

Additional
Paid-in

 

 

Accumulated

 

 

Accumulated Other Comprehensive

 

 

Total
Stockholders'

 

 

 

Shares

 

 

Amount

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Deficit

 

 

Gain (Loss)

 

 

Equity

 

Balance at December 31, 2020

 

 

 

 

$

 

 

 

36,672,415

 

 

$

4

 

 

$

456,196

 

 

$

(166,393

)

 

$

(31

)

 

$

289,776

 

Exercise of common stock options

 

 

 

 

 

 

 

 

18,411

 

 

 

 

 

 

16

 

 

 

 

 

 

 

 

 

16

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

 

 

 

 

 

 

2,744

 

 

 

 

 

 

 

 

 

2,744

 

Unrealized gain on available-for-sale investments

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

48

 

 

 

48

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(16,509

)

 

 

 

 

 

(16,509

)

Balance at March 31, 2021

 

 

 

 

$

 

 

 

36,690,826

 

 

$

4

 

 

$

458,956

 

 

$

(182,902

)

 

$

17

 

 

$

276,075

 

Exercise of common stock options

 

 

 

 

 

 

 

 

24,786

 

 

 

 

 

 

58

 

 

 

 

 

 

 

 

 

58

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

 

 

 

 

 

 

3,213

 

 

 

 

 

 

 

 

 

3,213

 

Unrealized loss on available-for-sale investments

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(14

)

 

 

(14

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(21,009

)

 

 

 

 

 

(21,009

)

Balance at June 30, 2021

 

 

 

 

$

 

 

 

36,715,612

 

 

$

4

 

 

$

462,227

 

 

$

(203,911

)

 

$

3

 

 

$

258,323

 

Issuance of common stock

 

 

 

 

 

 

 

 

2,597,402

 

 

 

 

 

 

50,000

 

 

 

 

 

 

 

 

 

50,000

 

Issuance costs associated with offering of common stock

 

 

 

 

 

 

 

 

-

 

 

 

 

 

 

(1,852

)

 

 

 

 

 

 

 

 

(1,852

)

Exercise of common stock options

 

 

 

 

 

 

 

 

18,571

 

 

 

 

 

 

99

 

 

 

 

 

 

 

 

 

99

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

 

 

 

 

 

 

3,397

 

 

 

 

 

 

 

 

 

3,397

 

Unrealized loss on available-for-sale investments

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(5

)

 

 

(5

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(18,426

)

 

 

 

 

 

(18,426

)

Balance at September 30, 2021

 

 

 

 

$

 

 

 

39,331,585

 

 

$

4

 

 

$

513,871

 

 

$

(222,337

)

 

$

(2

)

 

$

291,536

 

 

 

 

 

Convertible
Preferred Stock

 

 

Common Stock

 

 

Additional
Paid-in

 

 

Accumulated

 

 

Accumulated Other Comprehensive

 

 

Total
Stockholders'

 

 

 

Shares

 

 

Amount

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Deficit

 

 

 Gain (Loss)

 

 

Equity (Deficit)

 

Balance at December 31, 2019

 

 

19,278,606

 

 

$

178,058

 

 

 

1,984,222

 

 

$

 

 

$

2,606

 

 

$

(92,690

)

 

$

 

 

$

(90,084

)

Exercise of common stock options

 

 

 

 

 

 

 

 

13,433

 

 

 

 

 

 

12

 

 

 

 

 

 

 

 

 

12

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

 

 

 

 

 

 

527

 

 

 

 

 

 

 

 

 

527

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(8,872

)

 

 

 

 

 

(8,872

)

Balance at March 31, 2020

 

 

19,278,606

 

 

$

178,058

 

 

 

1,997,655

 

 

$

 

 

$

3,145

 

 

$

(101,562

)

 

$

 

 

$

(98,417

)

Exercise of common stock options

 

 

 

 

 

 

 

 

23,200

 

 

 

 

 

 

39

 

 

 

 

 

 

 

 

 

39

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

 

 

 

 

 

 

1,381

 

 

 

 

 

 

 

 

 

1,381

 

Initial public offering of common stock

 

 

 

 

 

 

 

 

8,625,000

 

 

 

1

 

 

 

137,999

 

 

 

 

 

 

 

 

 

138,000

 

Issuance costs associated with initial public offering

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(12,790

)

 

 

 

 

 

 

 

 

(12,790

)

Conversion to common stock

 

 

(19,278,606

)

 

 

(178,058

)

 

 

19,278,606

 

 

 

2

 

 

 

178,056

 

 

 

 

 

 

 

 

 

178,058

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(11,024

)

 

 

 

 

 

(11,024

)

Balance at June 30, 2020

 

 

 

 

$

 

 

 

29,924,461

 

 

$

3

 

 

$

307,830

 

 

$

(112,586

)

 

$

 

 

$

195,247

 

Exercise of common stock options

 

 

 

 

 

 

 

 

32,469

 

 

 

 

 

 

53

 

 

 

 

 

 

 

 

 

53

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

 

 

 

 

 

 

1,681

 

 

 

 

 

 

 

 

 

1,681

 

Issuance of common stock related to acquisition

 

 

 

 

 

 

 

 

588,235

 

 

 

 

 

 

12,971

 

 

 

 

 

 

 

 

 

12,971

 

Unrealized loss on available-for-sale investments

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(29

)

 

 

(29

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(25,548

)

 

 

 

 

 

(25,548

)

Balance at September 30, 2020

 

 

 

 

$

 

 

 

30,545,165

 

 

$

3

 

 

$

322,535

 

 

$

(138,134

)

 

$

(29

)

 

$

184,375

 

 

 

 

See accompanying notes to unaudited financial statements.

5


 

ORIC PHARMACEUTICALS, INC.

STATEMENTS OF CASH FLOWS

(Unaudited)

(in thousands)

 

 

Nine Months Ended
September 30,

 

 

 

2021

 

 

2020

 

Cash flows from operating activities:

 

 

 

 

 

 

Net loss

 

$

(55,944

)

 

$

(45,444

)

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

 

 

 

 

 

 

Depreciation

 

 

668

 

 

 

736

 

Stock-based compensation expense

 

 

9,354

 

 

 

3,589

 

Non-cash stock consideration, acquisition