SEC Filing | Tenaya Therapeutics, Inc.

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10-Q

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, 2022


☐	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) 825-6990

(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.

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 2, 2022, the registrant had 41,374,508 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 as of September 30, 2022 and December 31, 2021	5
	Condensed Statements of Operations and Comprehensive Loss for the three and nine months ended September 30, 2022 and 2021	6
	Condensed Statements of Convertible Preferred Stock and Stockholders’ Equity (Deficit) for the three and nine months ended September 30, 2022 and 2021	7
	Condensed Statements of Cash Flows for the nine months ended September 30, 2022 and 2021	9
	Notes to Unaudited Condensed Financial Statements	10
Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	18
Item 3.	Quantitative and Qualitative Disclosures About Market Risk	24
Item 4.	Controls and Procedures	25

	PART II—OTHER INFORMATION
Item 1.	Legal Proceedings	26
Item 1A.	Risk Factors	26
Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	84
Item 3.	Defaults Upon Senior Securities	84
Item 4.	Mine Safety Disclosures	84
Item 5.	Other Information	84
Item 6.	Exhibits	85
SIGNATURES		87

SPECIAL NOTE REGARDING FORWARD LOOKING STATEMENTS

This Quarterly Report on Form 10-Q, or Quarterly Report, contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Act of 1934. 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 ongoing preclinical studies and ongoing or 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 ongoing or 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 investigational new drugs (INDs), clinical trial applications (CTAs), Food and Drug Administration (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 trials;

•

our manufacturing, commercialization, and marketing capabilities and strategy;

•

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 effects of the ongoing 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 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, operating losses, future revenue, capital requirements and needs for additional financing;

•

our financial performance;

•

the period over which we estimate our existing cash, cash equivalents and investments in marketable securities 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.

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.

PART I – FINANCIAL INFORMATION

Item 1. Financial Statements.

TENAYA THERAPEUTICS, INC.

Condensed Balance Sheets

(In thousands)


	September 30,			December 31,
	2022			2021
ASSETS	(Unaudited)
Current assets:
Cash and cash equivalents	$	34,494		$	38,129
Investments in marketable securities		114,956			213,171
Prepaid expenses and other current assets		7,617			4,058
Total current assets		157,067			255,358
Property and equipment, net		52,194			43,020
Operating lease right-of-use assets		12,399			11,685
Other noncurrent assets		4,650			4,126
Total assets	$	226,310		$	314,189
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable	$	5,312		$	10,721
Accrued and other current liabilities		8,388			9,059
Operating lease liabilities, current		4,016			1,994
Total current liabilities		17,716			21,774
Operating lease liabilities, noncurrent		12,043			13,707
Other noncurrent liabilities		223			182
Total liabilities		29,982			35,663
Commitments and contingencies (Note 6)
Stockholders’ equity:
Common stock		4			4
Additional paid-in capital		442,773			434,196
Accumulated other comprehensive loss		(767	)		(141	)
Accumulated deficit		(245,682	)		(155,533	)
Total stockholders’ equity		196,328			278,526
Total liabilities and stockholders’ equity	$	226,310		$	314,189

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

TENAYA THERAPEUTICS, INC.

Condensed Statements of Operations and Comprehensive Loss

(In thousands, except share and per share data)

(Unaudited)


	Three Months Ended September 30,						Nine Months Ended September 30,
	2022			2021			2022			2021
Operating expenses:
Research and development	$	23,758		$	12,944		$	68,789		$	33,440
General and administrative		7,540			5,356			22,282			13,202
Total operating expenses		31,298			18,300			91,071			46,642
Loss from operations		(31,298	)		(18,300	)		(91,071	)		(46,642	)
Other income (expense), net:
Interest income		596			23			917			41
Other income (expense), net		6			15			5			31
Total other income (expense), net		602			38			922			72
Net loss before income tax expense		(30,696	)		(18,262	)		(90,149	)		(46,570	)
Income tax expense		—			—			—			—
Net loss		(30,696	)		(18,262	)		(90,149	)		(46,570	)
Other comprehensive loss:
Net unrealized loss on marketable securities		(28	)		(23	)		(626	)		(23	)
Comprehensive loss	$	(30,724	)	$	(18,285	)	$	(90,775	)	$	(46,593	)
Net loss per share, basic and diluted	$	(0.74	)	$	(0.68	)	$	(2.18	)	$	(4.75	)
Weighted-average shares used in computing net loss per share, basic and diluted		41,358,296			26,895,716			41,309,812			9,808,162

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

TENAYA THERAPEUTICS, INC.

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

(In thousands, except share data)

(Unaudited)


	Common Stock					Additional Paid-In		Accumulated Other Comprehensive			Accumulated			Total Stockholders’ Equity
	Shares			Amount		Capital		Loss			Deficit			(Deficit)
Balance as of January 1, 2022		41,291,374		$	4	$	434,196	$	(141	)	$	(155,533	)	$	278,526
Issuance of common stock upon exercise of stock options		7,652			—		17		—			—			17
Vesting of early exercised stock options		—			—		6		—			—			6
Stock-based compensation		—			—		2,094		—			—			2,094
Other comprehensive loss		—			—		—		(490	)		—			(490	)
Net loss		—			—		—		—			(31,056	)		(31,056	)
Balance as of March 31, 2022		41,299,026		$	4	$	436,313	$	(631	)	$	(186,589	)	$	249,097
Issuance of common stock upon exercise of stock options		13,186			—		28		—			—			28
Issuance of common stock pursuant to employee stock purchase plan		51,608			—		230		—			—			230
Vesting of early exercised stock options		—			—		5		—			—			5
Stock-based compensation		—			—		3,012		—			—			3,012
Other comprehensive loss		—			—		—		(108	)		—			(108	)
Net loss		—			—		—		—			(28,397	)		(28,397	)
Balance as of June 30, 2022		41,363,820		$	4	$	439,588	$	(739	)	$	(214,986	)	$	223,867
Issuance of common stock upon exercise of stock options and vesting of restricted stock units		10,869	—		—		6		—			—			6
Vesting of early exercised stock options		—	—		—		5		—			—			5
Stock-based compensation		—	—		—		3,174		—			—			3,174
Other comprehensive loss		—	—		—		—		(28	)		—			(28	)
Net loss		—	—		—		—		—			(30,696	)		(30,696	)
Balance as of September 30, 2022		41,374,689		$	4	$	442,773	$	(767	)	$	(245,682	)	$	196,328


	Convertible Preferred Stock				Common Stock					Additional Paid-In		Notes Receivable from			Accumulated Other Comprehensive		Accumulated			Total Stockholders’ Equity
	Shares		Amount		Shares			Amount		Capital		Stockholders			Loss		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		—		—		—			—		—		—			—		(13,098	)		(13,098	)
Balance as of 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	—			—		—