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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 June 30, 2020

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 Stock Market LLC

(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  

Indicate by check mark whether the registrant has filed all documents and reports required to be filed by Sections 12, 13 or 15(d) of the Securities Exchange Act of 1934 subsequent to the distribution of securities under a plan confirmed by a court.     Yes  ☒    No  

As of July 31, 2020, the registrant had 29,956,050 shares of common stock, $0.0001 par value per share, outstanding.

 

 

 

 

 


Table of Contents

 

 

 

Page

PART I.

FINANCIAL INFORMATION

 

Item 1.

Financial Statements (Unaudited)

1

 

Balance Sheets

1

 

Statements of Operations and Comprehensive Loss

2

 

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

3

 

Statements of Cash Flows

4

 

Notes to Unaudited Financial Statements

5

Item 2.

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

13

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

18

Item 4.

Controls and Procedures

19

PART II.

OTHER INFORMATION

 

Item 1.

Legal Proceedings

20

Item 1A.

Risk Factors

20

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

67

Item 3.

Defaults Upon Senior Securities

68

Item 4.

Mine Safety Disclosures

68

Item 5.

Other Information

68

Item 6.

Exhibits

69

SIGNATURES

70

 

 

 

ii


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 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 applications and final FDA approval of ORIC-101, ORIC-533, ORIC-944 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 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 and other product candidates we may develop, if approved;

 

the rate and degree of market acceptance and clinical utility of ORIC-101, ORIC-533, ORIC-944 and other product candidates we may develop;

 

our estimates regarding expenses, future revenue, capital requirements and needs for additional financing;

iii


 

our financial performance;

 

the period over which we estimate our existing cash and cash equivalents 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.

 

 

 

iv


PART I—FINANCIAL INFORMATION

Item 1. Financial Statements.

ORIC PHARMACEUTICALS, INC.

BALANCE SHEETS

(in thousands, except share and per share amounts)

 

 

 

June 30, 2020

 

 

December 31, 2019

 

 

 

(unaudited)

 

 

 

 

 

Assets

 

Current assets:

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

196,642

 

 

$

89,159

 

Prepaid expenses and other current assets

 

 

2,586

 

 

 

840

 

Total current assets

 

 

199,228

 

 

 

89,999

 

 

 

 

 

 

 

 

 

 

Property and equipment, net

 

 

1,978

 

 

 

2,241

 

Deferred offering costs

 

 

 

 

 

1,343

 

Other assets

 

 

319

 

 

 

510

 

Total assets

 

$

201,525

 

 

$

94,093

 

 

 

 

 

 

 

 

 

 

Liabilities, Convertible Preferred Stock and Stockholders' Equity (Deficit)

 

 

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

 

Accounts payable

 

$

1,389

 

 

$

152

 

Accrued other liabilities

 

 

4,389

 

 

 

5,202

 

Total current liabilities

 

 

5,778

 

 

 

5,354

 

 

 

 

 

 

 

 

 

 

Deferred rent - long term

 

 

500

 

 

 

765

 

Total liabilities

 

 

6,278

 

 

 

6,119

 

 

 

 

 

 

 

 

 

 

Commitments and contingencies (Note 8)

 

 

 

 

 

 

 

 

Convertible preferred stock:

 

 

 

 

 

 

 

 

Series A convertible preferred stock, $0.0001 par value; no shares and 3,862,500 authorized, issued and outstanding at June 30, 2020 and December 31, 2019, respectively; $0 and $15,450 aggregate liquidation preference at June 30, 2020 and December 31, 2019, respectively

 

 

 

 

 

15,431

 

Series B convertible preferred stock, $0.0001 par value; no shares and 6,750,000 authorized at June 30, 2020 and December 31, 2019, respectively; no shares and 6,749,999 outstanding at June 30, 2020 and December 31, 2019, respectively; $0 and $54,000 aggregate liquidation preference at June 30, 2020 and December 31, 2019, respectively

 

 

 

 

 

53,906

 

Series C convertible preferred stock, $0.0001 par value; no shares and 4,448,788 authorized at June 30, 2020 and December 31, 2019, respectively; no shares and 4,448,780 outstanding at June 30, 2020 and December 31, 2019, respectively; $0 and $53,385 aggregate liquidation preference at June 30, 2020 and December 31, 2019, respectively

 

 

 

 

 

53,172

 

Series D convertible preferred stock, $0.0001 par value; no shares and 5,287,500 authorized at June 30, 2020 and December 31, 2019, respectively; no shares and 4,217,327 outstanding at June 30, 2020 and December 31, 2019, respectively; $0 and $55,669 aggregate liquidation preference at June 30, 2020 and December 31, 2019, respectively

 

 

 

 

 

55,549

 

Stockholders' equity (deficit):

 

 

 

 

 

 

 

 

Common stock, $0.0001 par value; 1,000,000,000 shares and 26,750,000 shares authorized at June 30, 2020 and December 31, 2019, respectively; 29,924,461 shares and 1,984,222 shares issued and outstanding at June 30, 2020 and December 31, 2019, respectively

 

 

3

 

 

 

 

Additional paid-in capital

 

 

307,830

 

 

 

2,606

 

Accumulated deficit

 

 

(112,586

)

 

 

(92,690

)

Total stockholders' equity (deficit)

 

 

195,247

 

 

 

(90,084

)

Total liabilities, preferred stock and stockholders' equity (deficit)

 

$

201,525

 

 

$

94,093

 

 

See accompanying notes to unaudited financial statements.

1


ORIC PHARMACEUTICALS, INC.

STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

(Unaudited)

(in thousands, except share and per share amounts)

 

 

 

Three Months Ended June 30,

 

 

Six Months Ended June 30,

 

 

2020

 

 

2019

 

 

2020

 

 

2019

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

$

7,723

 

 

$

5,040

 

 

$

14,977

 

 

$

10,252

 

General and administrative

 

3,400

 

 

 

1,315

 

 

 

5,325

 

 

 

2,449

 

Total operating expenses

 

11,123

 

 

 

6,355

 

 

 

20,302

 

 

 

12,701

 

Loss from operations

 

(11,123

)

 

 

(6,355

)

 

 

(20,302

)

 

 

(12,701

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Other income:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Interest income, net

 

25

 

 

 

317

 

 

 

266

 

 

 

578

 

Other income

 

74

 

 

 

73

 

 

 

140

 

 

 

143

 

Total other income

 

99

 

 

 

390

 

 

 

406

 

 

 

721

 

Net loss and comprehensive loss

$

(11,024

)

 

$

(5,965

)

 

$

(19,896

)

 

$

(11,980

)

Net loss per share, basic and diluted

$

(0.51

)

 

$

(3.19

)

 

$

(1.68

)

 

$

(6.51

)

Weighted-average shares outstanding, basic and diluted

 

21,627,361

 

 

 

1,872,309

 

 

 

11,808,103

 

 

 

1,841,233

 

See accompanying notes to unaudited financial statements.

 

 

2


 

ORIC PHARMACEUTICALS, INC.

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

(Unaudited)

(in thousands, except share amounts)

 

 

 

Series A

Convertible

Preferred Stock

 

 

Series B

Convertible

Preferred Stock

 

 

Series C

Convertible

Preferred Stock

 

 

Series D

Convertible

Preferred Stock

 

 

Common Stock

 

 

Additional

Paid-in

 

 

Accumulated

 

 

Total

Stockholders'

 

 

 

Shares

 

 

Amount

 

 

Shares

 

 

Amount

 

 

Shares

 

 

Amount

 

 

Shares

 

 

Amount

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Deficit

 

 

Deficit

 

Balance at December 31, 2018

 

 

3,862,500

 

 

$

15,431

 

 

 

6,749,999

 

 

$

53,906

 

 

 

3,177,271

 

 

$

37,929

 

 

 

 

 

$

 

 

 

1,802,134

 

 

$

 

 

$

1,381

 

 

$

(65,807

)

 

$

(64,426

)

Issuance of Series C Preferred Stock, net of issuance costs of $213

 

 

 

 

 

 

 

 

 

 

 

 

 

 

1,271,509

 

 

 

15,243

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Exercise of common stock options and vesting of early exercised common stock options

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

26,159

 

 

 

 

 

 

21

 

 

 

 

 

 

21

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

191

 

 

 

 

 

 

191

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(6,015

)

 

 

(6,015

)

Balance at March 31, 2019

 

 

3,862,500

 

 

$

15,431

 

 

 

6,749,999

 

 

$

53,906

 

 

 

4,448,780

 

 

$

53,172

 

 

 

 

 

$

 

 

 

1,828,293

 

 

$

 

 

$

1,593

 

 

$

(71,822

)

 

$

(70,229

)

Issuance of Series D Preferred Stock

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

3,777,564

 

 

 

49,864

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Exercise of common stock options and vesting of early exercised common stock options

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

111,884

 

 

 

 

 

 

59

 

 

 

 

 

 

59

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

190

 

 

 

 

 

 

190

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(5,965

)

 

 

(5,965

)

Balance at June 30, 2019

 

 

3,862,500

 

 

$

15,431

 

 

 

6,749,999

 

 

$

53,906

 

 

 

4,448,780

 

 

$

53,172

 

 

 

3,777,564

 

 

$

49,864

 

 

 

1,940,177

 

 

$

 

 

$

1,842

 

 

$

(77,787

)

 

$

(75,945

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance at December 31, 2019

 

 

3,862,500

 

 

$

15,431

 

 

 

6,749,999

 

 

$

53,906

 

 

 

4,448,780

 

 

$

53,172

 

 

 

4,217,327

 

 

$

55,549

 

 

 

1,984,222

 

 

$

 

 

$

2,606

 

 

$

(92,690

)

 

$

(90,084

)

Exercise of common stock options and vesting of early exercised common stock options

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

13,433

 

 

 

 

 

 

12

 

 

 

 

 

 

12

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

527

 

 

 

 

 

 

527

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(8,872

)

 

 

(8,872

)

Balance at March 31, 2020

 

 

3,862,500

 

 

$

15,431

 

 

 

6,749,999

 

 

$

53,906

 

 

 

4,448,780

 

 

$

53,172

 

 

 

4,217,327

 

 

$

55,549

 

 

 

1,997,655

 

 

$

 

 

$

3,145

 

 

$

(101,562

)

 

$

(98,417

)

Exercise of common stock options and vesting of early exercised 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

 

 

(3,862,500

)

 

 

(15,431

)

 

 

(6,749,999

)

 

 

(53,906

)

 

 

(4,448,780

)

 

 

(53,172

)

 

 

(4,217,327

)

 

 

(55,549

)

 

 

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

 

 

See accompanying notes to unaudited financial statements.

 

3


 

ORIC PHARMACEUTICALS, INC.

STATEMENTS OF CASH FLOWS

(Unaudited)

(in thousands)

 

 

Six Months Ended June 30,

 

 

 

2020

 

 

2019

 

Cash flows from operating activities:

 

 

 

 

 

 

 

 

Net loss

 

$

(19,896

)

 

$

(11,980

)

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

 

 

 

 

 

 

 

 

Depreciation

 

 

496

 

 

 

488

 

Share-based compensation expense

 

 

1,908

 

 

 

381

 

Loss on fixed asset disposal

 

 

 

 

 

3

 

Changes in operating assets and liabilities:

 

 

 

 

 

 

 

 

Prepaid expenses and other current assets

 

 

(1,746

)

 

 

(129

)

Accounts payable and accrued other liabilities

 

 

1,375

 

 

 

212

 

Net cash used in operating activities

 

 

(17,863

)

 

 

(11,025

)