November 10, 2021 - 10-Q: Quarterly report pursuant to Section 13 or 15(d)

Form: 10-Q

Documents

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

☐	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: 001-40532

GRAPHITE BIO, INC.

(Exact Name of Registrant as Specified in its Charter)

Delaware	84-4867570
( State or other jurisdiction of incorporation or organization)	(I.R.S. Employer Identification No.)
201 Haskins Way, Suite 210 South San Francisco, CA	94080
(Address of principal executive offices)	(Zip Code)

Registrant’s telephone number, including area code: (650) 484-0886

279 East Grand Avenue, Suite 430, South San Francisco, CA 94080

(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, par value $0.00001 per share

GRPH

The Nasdaq Global 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 ☒

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 November 8, 2021, the registrant had 58,079,002 shares of common stock, $0.00001 par value per share, outstanding.

Summary of Risk Factors

Our business is subject to a number of risks of which you should be aware before making an investment decision. These risks are discussed more fully in the “Risk Factors” section of this Quarterly Report on Form 10-Q. These risks include, but are not limited to, the following:

•

We have incurred significant losses since inception. We expect to incur losses for the foreseeable future and may never achieve or maintain profitability.

•

Our limited operating history may make it difficult for you to evaluate the performance of our business to date and to assess our future viability.

•

We have never generated revenue from product sales, may never generate any revenue from product sales and may never become profitable.

•

We will need substantial additional funding. If we are unable to raise capital when needed on acceptable terms, or at all, we would be forced to delay, reduce, or terminate our research and product development programs, future commercialization efforts or other operations.

•

We face risks related to health epidemics, pandemics and other widespread outbreaks of contagious disease, including the ongoing COVID-19 pandemic, which could significantly disrupt our operations, impact our financial results or otherwise adversely impact our business.

•

We are very early in our development efforts. Other than GPH101, which is in early clinical development, all of our product candidates are still in preclinical development or earlier stages and it will be many years before we or our collaborators commercialize a product candidate, if ever. If we are unable to advance our product candidates through clinical development, obtain regulatory approval and ultimately commercialize our product candidates, or experience significant delays in doing so, our business will be materially harmed.

•

Our gene editing technology is not approved for human therapeutic use. The approaches we are taking to discover and develop novel therapeutics may never lead to marketable products.

•

If serious adverse events, undesirable side effects, or unexpected characteristics are identified with respect to our product candidates, we may need to abandon or limit our clinical development or commercialization of those product candidates.

•

We face significant competition in an environment of rapid technological change, and there is a possibility that our competitors may achieve regulatory approval before us or develop therapies that are safer, less expensive or more advanced or effective than ours, which may harm our financial condition and our ability to successfully market or commercialize our product candidates.

•

Adverse public perception of genetic medicines and gene editing in particular, may negatively impact regulatory approval of, and/or demand for, our potential products, if approved.

•

We contract with third parties for the manufacture of materials for our research programs and preclinical studies and expect to continue to do so for clinical trials and for commercialization of our product candidates. This reliance on third parties increases the risk that we will not have sufficient quantities of such materials, product candidates, or any products that we may develop and commercialize, or that such supply will not be available to us at an acceptable cost or timelines, which could delay, prevent, or impair our development or commercialization efforts.

•

If we are unable to obtain and maintain patent and other intellectual property protection for any product candidates we develop and for our gene editing platform technology, or if the scope of the patent and other intellectual property protection obtained is not sufficiently broad, our competitors could develop and commercialize products and technology similar or identical to ours, and our ability to successfully commercialize our product candidates, and our gene editing platform technology may be adversely affected.

•

Our rights to develop and commercialize our gene editing platform technology and product candidates are subject, in part, to the terms and conditions of licenses granted to us by others, and we may lose rights to these licenses if we fail to comply with the applicable license terms or otherwise incur significant expenses to comply with our obligations under such licenses.

•

The intellectual property landscape around gene editing technology is highly dynamic, and third parties may initiate legal proceedings alleging that we are infringing, misappropriating, or otherwise violating their intellectual property rights, the outcome of which would be uncertain and may prevent, delay or otherwise interfere with our product discovery and development efforts.

•

Our owned and in-licensed patents and other intellectual property may be subject to priority disputes or inventorship disputes or we may be subject to claims that we have infringed, misappropriated or otherwise violated the intellectual property of a third party and similar proceedings. If we or our licensors are unsuccessful in any of these proceedings, we may be required to obtain licenses from third parties, which may not be available on commercially reasonable terms or at all, or to cease the development, manufacture, and commercialization of one or more of our product candidates, which could have a material adverse impact on our business.

Cautionary Note Regarding Forward-Looking Statements

This Quarterly Report on Form 10-Q, including its section entitled “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” contains express or implied forward-looking statements that are based on our management’s belief and assumptions and on information currently available to our management. Although we believe that the expectations reflected in these forward-looking statements are reasonable, these statements relate to future events or our future operational or financial performance, and involve known and unknown risks, uncertainties, and other factors that may cause our actual results, performance, or achievements to be materially different from any future results, performance, or achievements expressed or implied by these forward-looking statements. Forward-looking statements in this Form 10-Q may include, but are not limited to, statements about:

•

the success, cost and timing of our product development activities and clinical trials of our lead product candidates, GPH101, GPH201 and GPH301, including the initiation and progress of, and results from, our Phase 1/2 clinical trial of GPH101 and whether the clinical trial will support the intended uses for treatment of sickle cell disease, and future clinical trials or these and any of our other product candidates;

•

the therapeutic potential of our product candidates, and the disease indications for which we intend to develop our product candidates;

•

the timing and likelihood of, and our ability to obtain and maintain, regulatory clearance of our Investigational New Drug (“IND”) applications for and regulatory approval of our product candidates;

•

our ability and the ability of third-party suppliers upon which we rely to manufacture our product candidates for clinical development and, if approved, for commercialization, and the timing and costs of such manufacture;

•

estimates of our expenses, ongoing losses, future revenue, capital requirements and our need for or ability to obtain additional funding before we can expect to generate any revenue from product sales;

•

our ability to compete with companies currently marketing or the development and commercialization of targeted gene integration therapies or other treatments for disease indications that our product candidates are intended to address;

•

our ability to establish or maintain licenses, collaborations, partnerships or strategic relationships;

•

our ability to create a pipeline of product candidates;

•

our ability to advance any product candidate into, and successfully complete clinical trials;

•

our ability to obtain and maintain intellectual property protection for our current and future product candidates, the duration of such protection and our ability to operate our business without infringing on the intellectual property rights of others;

•

our ability to retain and recruit key personnel;

•

our expectations regarding use of our cash and cash equivalents, including the proceeds from our initial public offering;

•

our financial performance;

•

our competitive position and the development of and projections relating to our competitors or our industry, including in gene editing and gene therapy;

•

the impact of the COVID-19 pandemic on our business or operations;

•

the impact of laws and regulations in the United States and foreign countries; and

•

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

In some cases, forward-looking statements can be identified by terminology such as “will,” “may,” “should,” “could,” “expects,” “intends,” “plans,” “aims,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “continue,” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. These statements are only predictions. You should not place undue reliance on forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, which are, in some cases, beyond our control and which could materially affect results. Factors that may cause actual results to differ materially from current expectations include, among other things, those listed under the section entitled “Risk Factors” and elsewhere in this Form 10-Q. If one or more of these risks or uncertainties occur, or if our underlying assumptions prove to be incorrect, actual events or results may vary significantly from those expressed or implied by the forward-looking statements. No forward-looking statement is a promise or a guarantee of future performance.

The forward-looking statements in this Form 10-Q represent our views as of the date of this Form 10-Q. We anticipate that subsequent events and developments will cause our views to change. However, while we may elect to update these forward-looking statements at some point in the future, we have no current intention of doing so except to the extent required by applicable law. You should therefore not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this Form 10-Q.

This Form 10-Q may include statistical and other industry and market data that we obtained from industry publications and research, surveys, and studies conducted by third parties. Industry publications and third-party research, surveys, and studies generally indicate that their information has been obtained from sources believed to be reliable, although they do not guarantee the accuracy or completeness of such information. We have not independently verified the information contained in such sources.

Table of Contents

		Page
PART I.	FINANCIAL INFORMATION
Item 1.	Financial Statements (Unaudited)
	Condensed Balance Sheets	1
	Condensed Statements of Operations and Comprehensive Loss	2
	Condensed Statements of Redeemable Convertible Preferred Stock and Stockholders’ Equity (Deficit)	3
	Condensed Statements of Cash Flows	5
	Notes to Condensed Financial Statements	6
Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	24
Item 3.	Quantitative and Qualitative Disclosures About Market Risk	35
Item 4.	Controls and Procedures	35
PART II.	OTHER INFORMATION	36
Item 1.	Legal Proceedings	36
Item 1A.	Risk Factors	36
Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	89
Item 3.	Defaults Upon Senior Securities	89
Item 4.	Mine Safety Disclosures	89
Item 5.	Other Information	89
Item 6.	Exhibits	90
Signatures		91

Graphite Bio, Inc.

Condensed Balance Sheets

(in thousands, except share and per share data)

	September 30, 2021			December 31, 2020
	(unaudited)
Assets
Current assets:
Cash and cash equivalents	$	394,804		$	19,782
Restricted cash		149			35
Prepaid expenses and other current assets		6,276			1,286
Total current assets		401,229			21,103
Property, plant and equipment, net		5,834			1,461
Operating lease right-of-use assets		9,077			—
Other assets		12			—
Total assets	$	416,152		$	22,564
Liabilities, redeemable convertible preferred stock, and stockholders’ equity (deficit)
Current liabilities:
Accounts payable	$	1,763		$	630
Accrued compensation		1,659			466
Accrued research costs		1,730			1,764
Accrued expenses and other current liabilities		1,314			126
Current portion of operating lease liabilities		4,806			—
Series A redeemable convertible preferred stock tranche liability		—			29,062
Total current liabilities		11,272			32,048
Non-current operating lease liabilities		4,684			—
Other liabilities		64			316
Total liabilities		16,020			32,364
Commitments and contingencies (Note 7)
Series A redeemable convertible preferred stock, $0.00001 par value; zero and 45,024,986 shares authorized as of September 30, 2021 and December 31, 2020, respectively; zero and 30,019,945 shares issued and outstanding as of September 30, 2021 and December 31, 2020, respectively; aggregate liquidation preference of $30,020 as of December 31, 2020		—			55,608
Stockholders’ equity (deficit):
Preferred stock, $0.00001 par value, 10,000,000 and zero shares authorized as of September 30, 2021 and December 31, 2020, respectively; and no shares issued and outstanding as of September 30, 2021 and December 31, 2020, respectively;		—			—
Common stock, $0.00001 par value, 300,000,000 and 80,000,000 shares authorized as of September 30, 2021 and December 31, 2020, respectively; 58,079,002 and 10,279,102 shares issued and outstanding as of September 30, 2021 and December 31, 2020, respectively		1			—
Additional paid-in-capital		522,552			5,183
Accumulated deficit		(122,421	)		(70,591	)
Total stockholders’ equity (deficit)		400,132			(65,408	)
Total liabilities, redeemable convertible preferred stock, and stockholders’ equity (deficit)	$	416,152		$	22,564

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

Graphite Bio, 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,
	2021			2020			2021			2020
Operating expenses:
Research and development	$	8,683		$	2,310		$	26,727		$	2,733
General and administrative		5,919			1,454			14,776			2,444
Total operating expenses		14,602			3,764			41,503			5,177
Loss from operations		(14,602	)		(3,764	)		(41,503	)		(5,177	)
Other income (expense), net:
Other income (expense), net		10			—			14			—
Related party convertible note interest expense		—			—			—			(40	)
Change in fair value of the Series A redeemable convertible preferred stock tranche liability		—			380			(10,341	)		380
Total other income (expense), net		10			380			(10,327	)		340
Net loss and comprehensive loss	$	(14,592	)	$	(3,384	)	$	(51,830	)	$	(4,837	)
Net loss per share attributable to common stockholders—basic and diluted	$	(0.28	)	$	(1.00	)	$	(2.51	)	$	(2.53	)
Weighted-average shares used in computing net loss per share— basic and diluted		52,769,916			3,382,118			20,668,560			1,908,759

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

Graphite Bio, Inc.

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

(in thousands, except share data)

(unaudited)

																							Total
	Redeemable Convertible Preferred Stock												Common					Additional					Stockholders’
	Series A						Series B						Stock					Paid in		Accumulated			Equity
	Shares			Amount			Shares			Amount			Shares			Amount		Capital		Deficit			(Deficit)
Balance at December 31, 2020		30,019,945		$	55,608			—		$	—			10,279,102		$	—	$	5,183	$	(70,591	)	$	(65,408	)
Issuance of Series A redeemable convertible preferred stock for cash, net of issuance costs of $4		15,000,000			14,997			—			—			—			—		—		—			—
Issuance of Series B redeemable convertible preferred stock for cash, net of issuance costs of $226		—			—			29,792,487			150,524			—			—		—		—			—
Stock-based compensation expense		—			—			—			—			—			—		1,033		—			1,033
Common stock shares issued upon early exercise of options		—			—			—			—			918,825			—		—		—			—
Vesting of early exercised stock options		—			—			—			—			—			—		7		—			7
Reclassification of tranche liability upon settlement		—			39,403			—			—			—			—		—		—			—
Net loss and comprehensive loss		—			—			—			—			—			—		—		(19,709	)		(19,709	)
Balance at March 31, 2021		45,019,945		$	110,008			29,792,487		$	150,524			11,197,927		$	—	$	6,223	$	(90,300	)	$	(84,077	)
Common shares issued upon exercise of stock options		—			—			—			—			3,383			—		21		—			21
Issuance of common shares in connection with License Agreement with Stanford		—			—			—			—			640,861			—		—		—			—
Repurchase of common shares in connection with terms of License Agreement with Stanford		—			—			—			—			(624,845	)		—		—		—			—
Issuance of common stock upon initial public offering, net of issuance costs		—			—			—			—			14,000,000			—		218,177		—			218,177
Conversion of redeemable convertible preferred stock to common stock at closing of initial public offering		(45,019,945	)		(110,008	)		(29,792,487	)		(150,524	)		30,761,676			1		260,531		—			260,532
Vesting of early exercised stock options		—			—			—			—			—			—		42		—			42
Stock-based compensation expense		—			—			—			—			—			—		2,018		—			2,018
Net loss and comprehensive loss		—			—			—			—			—			—		—		(17,529	)		(17,529	)
Balance at June 30, 2021		—		$	—			—		$	—			55,979,002		$	1	$	487,012	$	(107,829	)	$	379,184
Issuance of common stock upon initial public offering, net of issuance costs		—			—			—			—			2,100,000			—		33,146		—			33,146
Vesting of early exercised stock options		—			—			—			—			—			—		20		—			20
Stock-based compensation expense		—			—			—			—			—			—		2,374		—			2,374
Net loss and comprehensive loss		—			—			—			—			—			—		—		(14,592	)		(14,592	)
Balance at September 30, 2021		—		$	—			—		$	—			58,079,002		$	1	$	522,552	$	(122,421	)	$	400,132

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

Graphite Bio, Inc.

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

(in thousands, except share data)

(unaudited)

	Redeemable Convertible Preferred Stock												Additional					Total
	Series A				Series B				Common Stock				Paid in		Accumulated			Stockholders’
	Shares		Amount		Shares		Amount		Shares		Amount		Capital		Deficit			Deficit
Balance at December 31, 2019		—	$	—		—	$	—		—	$	—	$	—	$	(2,218	)	$	(2,218	)
Net loss and comprehensive loss		—		—		—		—		—		—		—		(141	)		(141	)
Balance at March 31, 2020		—	$	—		—	$	—		—	$	—	$	—	$	(2,359	)	$	(2,359	)
Common shares issued to founders and investor		—		—		—		—		8,548,517		—		—		—			—
Issuance of restricted common shares		—

Large accelerated filer

Accelerated filer

Non-accelerated filer

Smaller reporting company

Emerging growth company