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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, 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: 001-40656

 

TENAYA THERAPEUTICS, INC.

(Exact name of registrant as specified in its charter)

 

 

Delaware

81-3789973

(State or other jurisdiction of

incorporation or organization)

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

171 Oyster Point Boulevard, 5th Floor

South San Francisco, CA

94080

(Address of principal executive offices)

(Zip Code)

 

(650) 825-6900

(Registrant’s telephone number, including area code)

 

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

 

TNYA

 

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 September 2, 2021, the registrant had 41,279,800 shares of common stock, $0.0001 par value per share, outstanding.

 

 

 


 

 

Table of Contents

 

 

 

 

Page

 

 

PART I—FINANCIAL INFORMATION

 

 

 

 

 

Item 1.

 

Financial Statements (Unaudited)

5

 

 

Condensed Balance Sheets

5

 

 

Condensed Statements of Operations and Comprehensive Loss

6

 

 

Condensed Statements of Convertible Preferred Stock and Stockholders’ Deficit

7

 

 

Condensed Statements of Cash Flows

9

 

 

Notes to Unaudited Condensed Financial Statements

10

Item 2.

 

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

21

Item 3.

 

Quantitative and Qualitative Disclosures About Market Risk

28

Item 4.

 

Controls and Procedures

29

 

 

 

 

 

 

PART II—OTHER INFORMATION

 

Item 1.

 

Legal Proceedings

30

Item 1A.

 

Risk Factors

30

Item 2.

 

Unregistered Sales of Equity Securities and Use of Proceeds

93

Item 3.

 

Defaults Upon Senior Securities

93

Item 4.

 

Mine Safety Disclosures

93

Item 5.

 

Other Information

93

Item 6.

 

Exhibits

94

SIGNATURES

95

 

 

 


 

SPECIAL NOTE REGARDING FORWARD LOOKING STATEMENTS

 

This Quarterly Report on Form 10-Q, or Quarterly Report, contains forward-looking statements. All statements other than statements of historical facts contained in this Quarterly Report, 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, investors 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. These forward-looking statements include, but are not limited to, statements about:

 

the ability of our preclinical studies and planned clinical trials to demonstrate safety and efficacy of our product candidates, and other positive results;

 

the timing, progress and results of preclinical studies and planned clinical trials for our current product candidates and other product candidates we may develop;

 

the timing, scope and likelihood of regulatory filings and approvals, including timing of INDs, CTAs, FDA approvals, and final regulatory approval of our current product candidates and any other 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 and the timing of our facilities becoming operational;

 

our plans relating to commercializing our product candidates, if approved;

 

the need to hire additional personnel and our ability to attract and retain such personnel;

 

our competitive position and the success of competing therapies that are or may become available;

 

our plans relating to the further development of our product candidates, including additional indications and targets we may pursue;

 

the impact of existing laws and regulations and regulatory developments in the United States, Europe and other jurisdictions;

 

our expectations regarding the impact of the COVID-19 pandemic on our business, including our preclinical studies and clinical trials;

 

our intellectual property position, including the scope of protection we are able to establish and maintain for intellectual property rights covering our current product candidates 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 preclinical studies and planned clinical trials of our product candidates, and for the development and manufacture of our product candidates for preclinical studies and clinical trials; our ability to obtain, and negotiate favorable terms of, any collaboration, partnership, licensing or other arrangements that may be necessary or desirable to develop, manufacture or commercialize our product candidates;

 

the pricing and reimbursement of our current product candidates and other product candidates we may develop, if approved, including any increase in demand as a result of the availability of reimbursement from the government and third-party payors;

 

the rate and degree of market acceptance and clinical utility of our current product candidates 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 and cash equivalents will be sufficient to fund our future operating expenses and capital expenditure requirements; and

 

our expectations regarding the period during which we will remain an emerging growth company under the JOBS Act.

 

3


 

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 and are subject to a number of risks, uncertainties and assumptions described in the section titled “Risk Factors” and elsewhere in this Quarterly Report. Because forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified, investors 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, 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 investors are cautioned not to unduly rely upon these statements.

 

4


 

PART I – FINANCIAL INFORMATION

Item 1. Financial Statements.

TENAYA THERAPEUTICS, INC.

Condensed Balance Sheets

(In thousands)

 

 

 

June 30,

 

 

December 31,

 

 

 

2021

 

 

2020

 

ASSETS

 

(Unaudited)

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

111,886

 

 

$

128,535

 

Prepaid expenses and other current assets

 

 

1,336

 

 

 

1,429

 

Total current assets

 

 

113,222

 

 

 

129,964

 

Property and equipment, net

 

 

24,910

 

 

 

17,185

 

Operating lease right-of-use assets

 

 

12,315

 

 

 

 

Restricted cash, non-current

 

 

547

 

 

 

547

 

Other non-current assets

 

 

5,901

 

 

 

465

 

Total assets

 

$

156,895

 

 

$

148,161

 

LIABILITIES, CONVERTIBLE PREFERRED STOCK AND

   STOCKHOLDERS’ DEFICIT

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

 

Accounts payable

 

$

5,020

 

 

$

1,017

 

Accrued expenses and other current liabilities

 

 

3,143

 

 

 

3,161

 

Deferred rent and other lease liabilities, current

 

 

 

 

 

863

 

Operating lease liabilities, current

 

 

1,637

 

 

 

 

Total current liabilities

 

 

9,800

 

 

 

5,041

 

Deferred rent and other lease liabilities, non-current

 

 

 

 

 

3,662

 

Operating lease liabilities, non-current

 

 

14,893

 

 

 

 

Other non-current liabilities

 

 

3

 

 

 

19

 

Total liabilities

 

 

24,696

 

 

 

8,722

 

Commitments and contingencies (Note 6)

 

 

 

 

 

 

 

 

Convertible preferred stock

 

 

240,735

 

 

 

220,754

 

Stockholders’ deficit:

 

 

 

 

 

 

 

 

Common stock

 

 

 

 

 

 

Additional paid-in capital

 

 

2,596

 

 

 

1,584

 

Notes receivable from stockholders

 

 

(12

)

 

 

(87

)

Accumulated deficit

 

 

(111,120

)

 

 

(82,812

)

Total stockholders’ deficit

 

 

(108,536

)

 

 

(81,315

)

Total liabilities, convertible preferred stock and stockholders’ deficit

 

$

156,895

 

 

$

148,161

 

 

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

5


TENAYA THERAPEUTICS, INC.

Condensed Statements of Operations and Comprehensive Loss

(In thousands, except share and per share data)

(Unaudited)

 

 

 

Three Months Ended

June 30,

 

 

Six Months Ended

June 30,

 

 

 

2021

 

 

2020

 

 

2021

 

 

2020

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

$

10,906

 

 

$

6,958

 

 

$

20,496

 

 

$

14,255

 

General and administrative

 

 

4,331

 

 

 

1,914

 

 

 

7,846

 

 

 

3,883

 

Total operating expenses

 

 

15,237

 

 

 

8,872

 

 

 

28,342

 

 

 

18,138

 

Loss from operations

 

 

(15,237

)

 

 

(8,872

)

 

 

(28,342

)

 

 

(18,138

)

Other income (expense), net:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Interest income

 

 

9

 

 

 

18

 

 

 

18

 

 

 

75

 

Change in fair value of convertible preferred stock tranche

   liability

 

 

 

 

 

(57

)

 

 

 

 

 

(76

)

Other income (expense), net

 

 

18

 

 

 

180

 

 

 

16

 

 

 

357

 

Total other income (expense), net

 

 

27

 

 

 

141

 

 

 

34

 

 

 

356

 

Net loss before income tax expense

 

 

(15,210

)

 

 

(8,731

)

 

 

(28,308

)

 

 

(17,782

)

Income tax expense

 

 

 

 

 

 

 

 

 

 

 

 

Net loss and comprehensive loss

 

$

(15,210

)

 

$

(8,731

)

 

$

(28,308

)

 

$

(17,782

)

Net loss per share, basic and diluted

 

$

(13.26

)

 

$

(9.21

)

 

$

(25.21

)

 

$

(19.32

)

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

   basic and diluted

 

 

1,147,471

 

 

 

948,403

 

 

 

1,122,775

 

 

 

920,196

 

 

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

 

6


 

TENAYA THERAPEUTICS, INC.

Condensed Statements of Convertible Preferred Stock and Stockholders’ Deficit

(In thousands, except share data)

(Unaudited)

 

 

 

Convertible Preferred Stock

 

 

 

Common Stock

 

 

Additional

Paid-In

 

 

Notes

Receivable

from

 

 

Accumulated

 

 

Total

Stockholders’

 

 

 

Shares

 

 

Amount

 

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Stockholders

 

 

Deficit

 

 

Deficit

 

Balance as of January 1, 2021

 

 

24,493,528

 

 

$

220,754

 

 

 

 

1,210,306

 

 

$

 

 

$

1,584

 

 

$

(87

)

 

$

(82,812

)

 

$

(81,315

)

Issuance of Series C convertible preferred

   stock, net of issuance costs of $20

 

 

1,608,750

 

 

 

19,981

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Issuance of common stock upon exercise

   of stock options

 

 

 

 

 

 

 

 

 

12,508

 

 

 

 

 

 

29

 

 

 

 

 

 

 

 

 

29

 

Repurchase of common stock related to

   early exercise of options

 

 

 

 

 

 

 

 

 

(365

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Vesting of early exercised stock options

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

9

 

 

 

 

 

 

 

 

 

9

 

Stock-based compensation

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

432

 

 

 

 

 

 

 

 

 

432

 

Net loss and other comprehensive loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(13,098

)

 

 

(13,098

)

Balance March 31, 2021

 

 

26,102,278

 

 

$

240,735

 

 

 

 

1,222,449

 

 

$

 

 

$

2,054

 

 

$

(87

)

 

$

(95,910

)

 

$

(93,943

)

Issuance of common stock upon exercise

   of stock options

 

 

 

 

 

 

 

 

 

12,173

 

 

 

 

 

 

31

 

 

 

 

 

 

 

 

 

31

 

Repurchase of common stock related to

   early exercise of options

 

 

 

 

 

 

 

 

 

(11,980

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Vesting of early exercised stock options

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

9

 

 

 

 

 

 

 

 

 

9

 

Notes receivable from stockholders

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

75

 

 

 

 

 

 

75

 

Stock-based compensation

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

502

 

 

 

 

 

 

 

 

 

502

 

Net loss and other comprehensive loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(15,210

)

 

 

(15,210

)

Balance June 30, 2021

 

 

26,102,278

 

 

$

240,735

 

 

 

 

1,222,642

 

 

$

 

 

$

2,596

 

 

$

(12

)

 

$

(111,120

)

 

$

(108,536

)

 

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

 

 

7


 

 

TENAYA THERAPEUTICS, INC.

Condensed Statements of Convertible Preferred Stock and Stockholders’ Deficit

(In thousands, except share data)

(Unaudited)

 

 

 

Convertible Preferred Stock

 

 

 

Common Stock

 

 

Additional

Paid-In

 

 

Notes

Receivable

from

 

 

Accumulated

 

 

Total

Stockholders’

 

 

 

Shares

 

 

Amount

 

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Stockholders

 

 

Deficit

 

 

Deficit

 

Balance as of January 1, 2020

 

 

11,403,077

 

 

$

73,042

 

 

 

 

1,193,488

 

 

$

 

 

$

764

 

 

$

(86

)

 

$

(44,417

)

 

$

(43,739

)

Issuance of Series B convertible preferred

   stock, net of issuance costs of $23 and

   partial settlement of convertible

   preferred stock tranche liability of $27

 

 

3,086,415

 

 

 

30,671

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Issuance of common stock upon exercise

   of stock options

 

 

 

 

 

 

 

 

 

3,333

 

 

 

 

 

 

3

 

 

 

 

 

 

 

 

 

3

 

Repurchase of common stock related to

   early exercise of options

 

 

 

 

 

 

 

 

 

(612

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Vesting of early exercised stock options

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

11

 

 

 

 

 

 

 

 

 

11

 

Notes receivable from stockholders

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

1

 

 

 

 

 

 

1

 

Stock-based compensation

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

154

 

 

 

 

 

 

 

 

 

154

 

Net loss and other comprehensive loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(9,051

)

 

 

(9,051

)

Balance March 31, 2020

 

 

14,489,492

 

 

$

103,713

 

 

 

 

1,196,209

 

 

$

 

 

$

932

 

 

$

(85

)

 

$

(53,468

)

 

$

(52,621

)

Issuance of common stock upon exercise

   of stock options

 

 

 

 

 

 

 

 

 

1,793

 

 

 

 

 

 

2

 

 

 

 

 

 

 

 

 

2

 

Vesting of early exercised stock options

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

11

 

 

 

 

 

 

 

 

 

11

 

Stock-based compensation

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

185

 

 

 

 

 

 

 

 

 

185

 

Net loss and other comprehensive loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(8,731

)

 

 

(8,731

)

Balance June 30, 2020

 

 

14,489,492

 

 

$

103,713

 

 

 

 

1,198,002

 

 

$

 

 

$

1,130

 

 

$

(85

)

 

$

(62,199

)

 

$

(61,154

)

 

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

 

8


 

 

TENAYA THERAPEUTICS, INC.

Condensed Statements of Cash Flows

(In thousands)

(Unaudited)

 

 

 

Six Months Ended June 30,

 

 

 

2021

 

 

2020

 

Cash flows from operating activities:

 

 

 

 

 

 

 

 

Net loss

 

$

(28,308

)

 

$

(17,782

)

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

 

 

 

 

 

 

 

 

Depreciation and amortization

 

 

1,424

 

 

 

1,194

 

Stock-based compensation

 

 

934

 

 

 

339

 

Loss on disposal of property and equipment

 

 

 

 

 

35

 

Non-cash operating lease expense

 

 

434

 

 

 

 

Change in fair value of convertible preferred stock tranche liability

 

 

 

 

 

76

 

Changes in operating assets and liabilities:

 

 

 

 

 

 

 

 

Prepaid expenses and other current assets

 

 

93

 

 

 

342

 

Other non-current assets

 

 

(2,954

)

 

 

(181

)

Accounts payable

 

 

1,363

 

 

 

422

 

Accrued expenses and other current liabilities

 

 

(33

)

 

 

430

 

Deferred rent and other lease liabilities

 

 

 

 

 

(371

)

Operating lease liabilities

 

 

(745

)

 

 

 

Other non-current liabilities

 

 

(16

)

 

 

(16

)

Net cash used in operating activities

 

 

(27,808

)

 

 

(15,512

)

Cash flows from investing activities:

 

 

 

 

 

 

 

 

Purchases of property and equipment

 

 

(7,559

)

 

 

(1,424

)

Proceeds from maturities of marketable securities

 

 

 

 

 

2,753

 

Net cash (used in) provided by investing activities

 

 

(7,559

)

 

 

1,329

 

Cash flows from financing activities:

 

 

 

 

 

 

 

 

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

 

 

 

 

 

30,644

 

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

 

 

19,981

 

 

 

 

Proceeds from exercise of stock options

 

 

60

 

 

 

5

 

Repurchases of common stock

 

 

(10

)

 

 

 

Proceeds from repayments on notes receivable from stockholders

 

 

75