SANA Sana Biotechnology Inc

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the

Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): August 8, 2024

 

SANA BIOTECHNOLOGY, INC.

(Exact name of registrant as specified in its charter)

 

Delaware		001-39941		83-1381173
(State or other jurisdiction of incorporation)		(Commission File Number)		(IRS Employer Identification Number)

188 East Blaine Street, Suite 400

Seattle, Washington 98102

(Address of principal executive offices, including Zip Code)

 

Registrant’s telephone number, including area code: (206) 701-7914

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

	☐	Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
	☐	Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
	☐	Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
	☐	Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

 

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		SANA		The Nasdaq Stock Market LLC

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

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. ☐

 

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Item 2.02 Results of Operations and Financial Condition.

On August 8, 2024, Sana Biotechnology, Inc. (the “Company”) issued a press release announcing its financial results for the quarter ended June 30, 2024. A copy of the press release is attached hereto as Exhibit 99.1.

The information in this Item 2.02, including the attached Exhibit 99.1, is being furnished and shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any filing made by the Company under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

 

Exhibit No.		Description
99.1		Press release of Sana Biotechnology, Inc. dated August 8, 2024
104		Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

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SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

	SANA BIOTECHNOLOGY, INC.
Date: August 8, 2024	By:	/s/ Nathan Hardy
		Nathan Hardy
		Executive Vice President and Chief Financial Officer

 

 

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Exhibit 99.1

Sana Biotechnology Reports Second Quarter 2024 Financial Results and Business Updates

 

Continue to advance hypoimmune technology in four trials across seven indications in oncology, B-cell mediated autoimmune diseases, and type 1 diabetes

Enrolling patients in the GLEAM trial for SC291 in B-cell mediated autoimmune diseases; expect to report initial clinical data in 2024

Enrolling patients in two oncology trials – ARDENT for SC291 in B-cell malignancies and VIVID for SC262 in relapsed/refractory B-cell malignancies; expect to report additional clinical data in 2024

Enrolling patients in the investigator-sponsored trial with hypoimmune-modified primary islet cells; expect to report initial clinical data in 2024

Publication in Nature Biotechnology shows that healthy transplanted human glial cells replaced diseased glial cell population in a preclinical model

Cash position of $251.6 million and expected 2024 operating cash burn below $200 million

 

 

SEATTLE — August 8, 2024 — Sana Biotechnology, Inc. (NASDAQ: SANA), a company focused on creating and delivering engineered cells as medicines, today reported financial results and business highlights for the second quarter 2024.

 

“The hypoimmune platform addresses one of the fundamental challenges with allogeneic cell transplantation and has the opportunity to impact a broad range of diseases,” said Steve Harr, Sana’s President and Chief Executive Officer. “We have four ongoing trials and are pleased with the progress and encouraged by our learnings in the clinic to-date. We are accelerating investments to build our pivotal-ready supply chain, decrease our reliance on external manufacturing given ongoing geopolitical uncertainty, and increase our clinical trial site footprint globally. We continue the dose escalation phases of our studies, which makes predicting the numbers of patients and release date for data an inexact science, but we look forward to reporting clinical data in each therapeutic area later this year with the goal of an initial understanding of the safety and efficacy profiles.”

Recent Corporate Highlights

Advancing four clinical programs across seven indications, including an allogeneic CAR T program targeting CD19+ cancers, an allogeneic CAR T program for B-cell mediated autoimmune diseases, an allogeneic CAR T program for cancer patients that have failed a CD19-targeted therapy, and a gene-modified primary islet cell therapy in type 1 diabetes:

Published preclinical data in Nature Biotechnology showing that healthy transplanted human glial progenitor cells replaced diseased glial cell population in a preclinical model:

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Second Quarter 2024 Financial Results

GAAP Results

Non-GAAP Measures

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A discussion of non-GAAP measures, including a reconciliation of GAAP and non-GAAP measures, is presented below under “Non-GAAP Financial Measures.”

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About Sana

Sana Biotechnology, Inc. is focused on creating and delivering engineered cells as medicines for patients. We share a vision of repairing and controlling genes, replacing missing or damaged cells, and making our therapies broadly available to patients. We are a passionate group of people working together to create an enduring company that changes how the world treats disease. Sana has operations in Seattle, Cambridge, South San Francisco, and Rochester.

Cautionary Note Regarding Forward-Looking Statements

 

This press release contains forward-looking statements about Sana Biotechnology, Inc. (the “Company,” “we,” “us,” or “our”) within the meaning of the federal securities laws, including those related to the company’s vision, progress, and business plans; expectations for its development programs, product candidates and technology platforms, including its preclinical, clinical and regulatory development plans and timing expectations; expectations regarding the timing, substance, significance, and impact of data from clinical trials of the Company’s product candidates and an IST utilizing HIP-modified primary islet cells in patients with type 1 diabetes; the potential impact of accelerating our investments on our ability to decrease our reliance on external manufacturing, build out our pivotal-ready supply chain, and increase our clinical site footprint globally for our trials; expectations regarding the Company’s 2024 operating cash burn; the potential ability to dose safely, achieve the desired immune evasion profile, and achieve clinical efficacy with SC291 in patients with B-cell malignancies; and the potential of SC379 as a potential therapy to deliver healthy allogeneic GPCs to patients with certain central nervous system disorders. All statements other than statements of historical facts contained in this press release, including, among others, statements regarding the Company’s strategy, expectations, cash runway and future financial condition, future operations, and prospects, are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “design,” “due,” “estimate,” “expect,” “goal,” “intend,” “may,” “objective,” “plan,” “positioned,” “potential,” “predict,” “seek,” “should,” “target,” “will,” “would” and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology. The Company has based these forward-looking statements largely on its current expectations, estimates, forecasts and projections about future events and financial trends that it believes may affect its financial condition, results of operations, business strategy and financial needs. In light of the significant uncertainties in these forward-looking statements, you should not rely upon forward-looking statements as predictions of future events. These statements are subject to risks and uncertainties that could cause the actual results to vary materially, including, among others, the risks inherent in drug development such as those associated with the initiation, cost, timing, progress and results of the Company’s current and future research and development programs, preclinical and clinical trials, as well as economic, market, and social disruptions. For a detailed discussion of the risk factors that could affect the Company’s actual results, please refer to the risk factors identified in the Company’s Securities and Exchange Commission (SEC) reports, including but not limited to its Quarterly Report on Form 10-Q dated August 8, 2024. Except as required by law, the Company undertakes no obligation to update publicly any forward-looking statements for any reason.

 

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Investor Relations & Media:

Nicole Keith

investor.relations@sana.com

media@sana.com

 

 

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Sana Biotechnology, Inc.

Unaudited Selected Consolidated Balance Sheet Data

 

		June 30, 2024				December 31, 2023
		(in thousands)
Cash, cash equivalents, and marketable securities		$	251,643			$	205,195
Total assets			618,667				565,299
Contingent consideration			111,621				109,606
Success payment liabilities			20,847				12,799
Total liabilities			279,018				277,793
Total stockholders' equity			339,649				287,506

 

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Sana Biotechnology, Inc.

Unaudited Consolidated Statements of Operations

 

		Three Months Ended June 30,								Six Months Ended June 30,
		2024				2023				2024				2023
		(in thousands, except per share data)
Operating expenses:
Research and development		$	60,874			$	73,044			$	117,322			$	140,210
Research and development related success payments and contingent consideration			(27,944	)			26,679				10,063				26,799
General and administrative			16,442				16,566				32,711				33,332
Total operating expenses			49,372				116,289				160,096				200,341
Loss from operations			(49,372	)			(116,289	)			(160,096	)			(200,341	)
Interest income, net			3,202				2,374				6,236				4,350
Other expense, net			(4,121	)			(84	)			(3,906	)			(131	)
Net loss		$	(50,291	)		$	(113,999	)		$	(157,766	)		$	(196,122	)
Net loss per common share – basic and diluted		$	(0.21	)		$	(0.59	)		$	(0.70	)		$	(1.02	)
Weighted-average number of common shares – basic and diluted			234,440				192,540				225,872				191,888

 

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Sana Biotechnology, Inc.

Changes in the Estimated Fair Value of Success Payments and Contingent Consideration

 

		Success Payment Liability(1)				Contingent Consideration(2)				Total Success Payment Liability and Contingent Consideration
		(in thousands)
Liability balance as of December 31, 2023		$	12,799			$	109,606			$	122,405
Changes in fair value – expense			32,623				5,384				38,007
Liability balance as of March 31, 2024			45,422				114,990				160,412
Changes in fair value – gain			(24,575	)			(3,369	)			(27,944	)
Liability balance as of June 30, 2024		$	20,847			$	111,621			$	132,468
Total change in fair value for the six months ended June 30, 2024		$	8,048			$	2,015			$	10,063

 

 

Non-GAAP Financial Measures

To supplement the financial results presented in accordance with generally accepted accounting principles in the United States (GAAP), Sana uses certain non-GAAP financial measures to evaluate its business. Sana’s management believes that these non-GAAP financial measures are helpful in understanding Sana’s financial performance and potential future results, as well as providing comparability to peer companies and period over period. In particular, Sana’s management utilizes non-GAAP operating cash burn, non-GAAP research and development expense and non-GAAP net loss and net loss per share. Sana believes the presentation of these non-GAAP measures provides management and investors greater visibility into the company’s actual ongoing costs to operate its business, including actual research and development costs unaffected by non-cash valuation changes and certain one-time expenses for acquiring technology, as well as facilitating a more meaningful comparison of period-to-period activity. Sana excludes these items because they are highly variable from period to period and, in respect of the non-cash expenses, provides investors with insight into the actual cash investment in the development of its therapeutic programs and platform technologies.

These are not meant to be considered in isolation or as a substitute for comparable GAAP measures and should be read in conjunction with Sana’s financial statements prepared in accordance with GAAP. These non-GAAP measures differ from GAAP measures with the same captions, may be different from non-GAAP financial measures with the same or similar captions that are used by other companies, and do not reflect a comprehensive system of accounting. Sana’s management uses these supplemental non-GAAP financial measures internally to understand, manage, and evaluate Sana’s business and make operating decisions. In addition, Sana’s management believes that the presentation of these non-GAAP financial measures is useful to investors because they enhance the ability of investors to compare Sana’s results from period to period and allows for greater transparency with respect to key financial metrics Sana uses in making operating decisions. The following are reconciliations of GAAP to non-GAAP financial measures:

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Sana Biotechnology, Inc.

Unaudited Reconciliation of Change in Cash, Cash Equivalents, and Marketable Securities to

Non-GAAP Operating Cash Burn

 

		Six Months Ended June 30,
		2024				2023
		(in thousands)
Beginning cash, cash equivalents, and marketable securities		$	205,195			$	434,014
Ending cash, cash equivalents, and marketable securities			251,643				325,915
Change in cash, cash equivalents, and marketable securities			46,448				(108,099	)
Cash paid to purchase property and equipment			28,901				3,753
Change in cash, cash equivalents, and marketable securities, excluding capital expenditures			75,349				(104,346	)
Adjustments:
Net proceeds from issuance of common stock			(181,029	)			(27,014	)
Cash paid for personnel-related costs related to portfolio prioritizations			1,110				1,881
Cash received in connection with the Coronavirus Aid, Relief, and Economic Security Act			-				(7,063	)
Operating cash burn – Non-GAAP		$	(104,570	)		$	(136,542	)

 

 

 

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Sana Biotechnology, Inc.

Unaudited Reconciliation of GAAP to Non-GAAP Net Loss and Net Loss Per Share

		Three Months Ended June 30,								Six Months Ended June 30,
		2024				2023				2024				2023
		(in thousands, except per share data)
Net loss – GAAP		$	(50,291	)		$	(113,999	)		$	(157,766	)		$	(196,122	)
Adjustments:
Change in the estimated fair value of the success payment liabilities(1)			(24,575	)			20,784				8,048				15,444
Change in the estimated fair value of contingent consideration(2)			(3,369	)			5,895				2,015				11,355
Impairment of other asset			4,069				-				4,069				-
Net loss – Non-GAAP		$	(74,166	)		$	(87,320	)		$	(143,634	)		$	(169,323	)
Net loss per share – GAAP		$	(0.21	)		$	(0.59	)		$	(0.70	)		$	(1.02	)
Adjustments:
Change in the estimated fair value of the success payment liabilities(1)			(0.11	)			0.11				0.03				0.08
Change in the estimated fair value of contingent consideration(2)			(0.02	)			0.03				0.01				0.06
Impairment of other asset			0.02				-				0.02				-
Net loss per share – Non-GAAP		$	(0.32	)		$	(0.45	)		$	(0.64	)		$	(0.88	)
Weighted-average shares outstanding – basic and diluted			234,440				192,540				225,872				191,888

 

 

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v3.24.2.u1

Document and Entity Information	Aug. 08, 2024
Cover [Abstract]
Amendment Flag	false
Entity Central Index Key	0001770121
Document Type	8-K
Document Period End Date	Aug. 08, 2024
Entity Registrant Name	SANA BIOTECHNOLOGY, INC.
Entity Incorporation, State or Country Code	DE
Entity File Number	001-39941
Entity Tax Identification Number	83-1381173
Entity Address, Address Line One	188 East Blaine Street
Entity Address, Address Line Two	Suite 400
Entity Address, City or Town	Seattle
Entity Address, State or Province	WA
Entity Address, Postal Zip Code	98102
City Area Code	(206)
Local Phone Number	701-7914
Written Communications	false
Soliciting Material	false
Pre Commencement Tender Offer	false
Pre Commencement Issuer Tender Offer	false
Security 12b Title	Common Stock, $0.0001 par value per share
Trading Symbol	SANA
Security Exchange Name	NASDAQ
Entity Emerging Growth Company	true
Entity Ex Transition Period	false

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