UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported):
(Exact name of registrant as specified in its charter)
|
|
|
|
|
|
|
|||
(State or other jurisdiction of incorporation) |
|
(Commission File Number)
|
|
(IRS Employer Identification Number) |
(Address of principal executive offices, including Zip Code)
Registrant’s telephone number, including area code: (
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 |
|
|
The |
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.
Item 2.02 Results of Operations and Financial Condition.
On August 3, 2023, Sana Biotechnology, Inc. (the “Company”) issued a press release announcing its financial results for the quarter and year ended June 30, 2023. 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 3, 2023 |
104 |
|
Cover Page Interactive Data File (embedded within the Inline XBRL document) |
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 3, 2023 |
By: |
/s/ Nathan Hardy |
|
|
Nathan Hardy |
|
|
Executive Vice President and Chief Financial Officer |
Exhibit 99.1
Sana Biotechnology Reports Second Quarter 2023 Financial Results and Business Updates
Enrolling patients in ARDENT, the SC291 Phase 1 clinical trial in B-cell malignancies, with initial data expected this year
Expect data later this year from investigator-sponsored trial with hypoimmune-modified primary human islet cells
Goal to submit INDs this year for both SC262 and SG299 in hematologic cancers
Hosted R&D Day, showcasing broad portfolio across platforms, programs, and diseases
Announced plan to develop SC291 in autoimmune disorders
Shared preclinical data that transplanted allogeneic hypoimmune-modified islet cells evade rejection and control glucose without immunosuppression or insulin treatment in non-human primate diabetes study
Data published in Science Translational Medicine, Nature Communications, and Nature Biotechnology show that hypoimmune-modified allogeneic cells survive and escape immune detection while remaining fully functional across different cell types in several species and disease models, including non-human primates with normal immune systems
Presented multiple abstracts from hypoimmune and fusogen platforms at 2023 AACR, ASGCT, and ISSCR meetings
Strengthened R&D leadership with addition of Dr. Doug Williams as President of Research and Development and Dr. Gary Meininger as Chief Medical Officer
Cash position of $325.9 million expected to support activities through multiple data readouts and last into 2025
SEATTLE — August 3, 2023 — Sana Biotechnology, Inc. (NASDAQ: SANA), a company focused on changing the possible for patients through engineered cells, today reported financial results and business highlights for the second quarter 2023.
“We continue to execute on our plans to deliver clinical data using Sana’s hypoimmune (HIP) technology in two studies later in 2023, providing insight into how the promising preclinical HIP data translate into people,” said Steve Harr, Sana’s President and Chief Executive Officer. “If the HIP technology is effective in preventing rejection of allogeneic cells, we believe it can rapidly translate into important therapeutics for various blood cancers, B-cell mediated autoimmune diseases, and type 1 diabetes. We are on track to advance our emerging clinical pipeline and file multiple additional INDs this year, and we have the balance sheet to enable multiple clinical data readouts from our pipeline.”
Recent Corporate Highlights
Opportunity for clinical proof of concept for two different first-in-human studies, each with the potential for initial clinical data this year
Published preclinical data in Nature Communications describing immune evasion, persistence, and durable anti-tumor activity of Sana’s hypoimmune-modified CD19-directed CAR T cells
Published preclinical data in Science Translational Medicine demonstrating that Sana’s hypoimmune-modified pseudo-islets control type 1 diabetes
Published preclinical data in Nature Biotechnology demonstrating that Sana’s hypoimmune-modified cells survive allogeneic transplant across several species, including non-human primates (NHPs) with normal immune systems, and remain fully functional
Presented multiple abstracts at several medical conferences, including AACR, ASGCT, and ISSCR 2023, highlighting both the hypoimmune and fusogen platforms
Strengthened Research and Development leadership with the appointment of two seasoned drug developers
Second Quarter 2023 Financial Results
GAAP Results
Non-GAAP Measures
A discussion of non-GAAP measures, including a reconciliation of GAAP and non-GAAP measures, is presented below under “Non-GAAP Financial Measures.”
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, including the expected timing of IND filings and clinical trials for the Company’s product candidates and indications for which such INDs will be filed; expectations regarding the timing, substance, and impact of data from clinical trials of the Company’s product candidates and an investigator-sponsored trial utilizing hypoimmune-modified primary human islet cells in type 1 diabetes patients (the “IST”); expectations regarding the Company’s participation at scientific conferences; the potential ability of SC291 to serve as clinical proof-of-platform for the Company’s other hypoimmune-modified CAR T cell candidates; expectations with respect to the potential therapeutic benefits and impact of its development programs and platforms, including the potential ability of the hypoimmune platform to overcome immunologic rejection of allogeneic cells and the impact thereof, the potential for hypoimmune-modified islet cells to demonstrate allogeneic immune evasion, autoimmune evasion, and control of type 1 diabetes, and the potential ability to replace missing islet cells without immunosuppression in patients with type 1 diabetes; expectations regarding the IST, including the ability to initiate the IST and the potential of the IST to show cell survival and immune evasion without immunosuppression; the potential ability of preclinical data to provide insight for the Company’s development programs and platforms; and expectations regarding the Company’s capital position, resources, and balance sheet and the potential impact thereof on the Company’s development programs, including data readouts from such programs. 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 3, 2023. Except as required by law, the Company undertakes no obligation to update publicly any forward-looking statements for any reason.
###
Investor Relations & Media:
Nicole Keith
investor.relations@sana.com
media@sana.com
Sana Biotechnology, Inc.
Unaudited Selected Consolidated Balance Sheet Data
|
|
June 30, 2023 |
|
|
December 31, 2022 |
|
||
|
|
(in thousands) |
|
|||||
Cash, cash equivalents, and marketable securities |
|
$ |
325,915 |
|
|
$ |
434,014 |
|
Total assets |
|
|
707,147 |
|
|
|
822,720 |
|
Contingent consideration |
|
|
161,734 |
|
|
|
150,379 |
|
Success payment liabilities |
|
|
36,451 |
|
|
|
21,007 |
|
Total liabilities |
|
|
352,118 |
|
|
|
323,405 |
|
Total stockholders' equity |
|
|
355,029 |
|
|
|
499,315 |
|
Sana Biotechnology, Inc.
Unaudited Consolidated Statements of Operations
|
|
Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
||||||||||
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
||||
|
|
(in thousands, except per share data) |
|
|||||||||||||
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Research and development |
|
$ |
73,044 |
|
|
$ |
72,540 |
|
|
$ |
140,210 |
|
|
$ |
145,229 |
|
Research and development related success payments and contingent consideration |
|
|
26,679 |
|
|
|
(17,928 |
) |
|
|
26,799 |
|
|
|
(73,366 |
) |
General and administrative |
|
|
16,566 |
|
|
|
18,292 |
|
|
|
33,332 |
|
|
|
32,726 |
|
Total operating expenses |
|
|
116,289 |
|
|
|
72,904 |
|
|
|
200,341 |
|
|
|
104,589 |
|
Loss from operations |
|
|
(116,289 |
) |
|
|
(72,904 |
) |
|
|
(200,341 |
) |
|
|
(104,589 |
) |
Interest income, net |
|
|
2,374 |
|
|
|
637 |
|
|
|
4,350 |
|
|
|
976 |
|
Other expense, net |
|
|
(84 |
) |
|
|
(198 |
) |
|
|
(131 |
) |
|
|
(300 |
) |
Net loss |
|
$ |
(113,999 |
) |
|
$ |
(72,465 |
) |
|
$ |
(196,122 |
) |
|
$ |
(103,913 |
) |
Net loss per common share - basic and diluted |
|
$ |
(0.59 |
) |
|
$ |
(0.39 |
) |
|
$ |
(1.02 |
) |
|
$ |
(0.56 |
) |
Weighted-average number of common shares - basic and diluted |
|
|
192,540 |
|
|
|
187,626 |
|
|
|
191,888 |
|
|
|
186,801 |
|
Sana Biotechnology, Inc.
Changes in the Estimated Fair Value of Success Payments and Contingent Consideration
|
|
Success Payment |
|
|
Contingent |
|
|
Total Success Payment Liability and Contingent Consideration |
|
|||
|
|
(in thousands) |
|
|||||||||
Liability balance as of December 31, 2022 |
|
$ |
21,007 |
|
|
$ |
150,379 |
|
|
$ |
171,386 |
|
Changes in fair value - expense (gain) |
|
|
(5,340 |
) |
|
|
5,460 |
|
|
|
120 |
|
Liability balance as of March 31, 2023 |
|
|
15,667 |
|
|
|
155,839 |
|
|
|
171,506 |
|
Changes in fair value - expense |
|
|
20,784 |
|
|
|
5,895 |
|
|
|
26,679 |
|
Liability balance as of June 30, 2023 |
|
$ |
36,451 |
|
|
$ |
161,734 |
|
|
$ |
198,185 |
|
Total change in fair value for the six months ended June 30, 2023 |
|
$ |
15,444 |
|
|
$ |
11,355 |
|
|
$ |
26,799 |
|
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:
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, |
|
|||||
|
|
2023 |
|
|
2022 |
|
||
|
|
(in thousands) |
|
|||||
Beginning cash, cash equivalents, and marketable securities |
|
$ |
434,014 |
|
|
$ |
746,877 |
|
Ending cash, cash equivalents, and marketable securities |
|
|
325,915 |
|
|
|
579,566 |
|
Change in cash, cash equivalents, and marketable securities |
|
|
(108,099 |
) |
|
|
(167,311 |
) |
Cash paid to purchase property and equipment |
|
|
3,753 |
|
|
|
11,924 |
|
Change in cash, cash equivalents, and marketable securities, excluding capital expenditures |
|
|
(104,346 |
) |
|
|
(155,387 |
) |
Adjustments: |
|
|
|
|
|
|
||
Net proceeds from issuance of common stock(1) |
|
|
(27,014 |
) |
|
|
- |
|
Cash paid for restructuring(2) |
|
|
1,881 |
|
|
|
- |
|
Cash received in connection with the Coronavirus Aid, Relief, and Economic Security Act |
|
|
(7,063 |
) |
|
|
- |
|
Operating cash burn - Non-GAAP |
|
$ |
(136,542 |
) |
|
$ |
(155,387 |
) |
Sana Biotechnology, Inc.
Unaudited Reconciliation of GAAP to Non-GAAP General and Administrative Expense
|
|
Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
||||||||||
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
||||
|
|
(in thousands) |
|
|||||||||||||
General and administrative - GAAP |
|
$ |
16,566 |
|
|
$ |
18,292 |
|
|
$ |
33,332 |
|
|
$ |
32,726 |
|
Adjustments: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Write-off of construction in progress costs incurred in connection with the Fremont facility |
|
|
- |
|
|
|
(4,474 |
) |
|
|
- |
|
|
|
(4,474 |
) |
General and administrative - Non-GAAP |
|
$ |
16,566 |
|
|
$ |
13,818 |
|
|
$ |
33,332 |
|
|
$ |
28,252 |
|
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, |
|
||||||||||
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
||||
|
|
(in thousands, except per share data) |
|
|||||||||||||
Net loss - GAAP |
|
$ |
(113,999 |
) |
|
$ |
(72,465 |
) |
|
$ |
(196,122 |
) |
|
$ |
(103,913 |
) |
Adjustments: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Change in the estimated fair value of the success payment liabilities(1) |
|
|
20,784 |
|
|
|
(14,098 |
) |
|
|
15,444 |
|
|
|
(69,008 |
) |
Change in the estimated fair value of contingent consideration(2) |
|
|
5,895 |
|
|
|
(3,830 |
) |
|
|
11,355 |
|
|
|
(4,358 |
) |
Write-off of construction in progress costs incurred in connection with the Fremont facility |
|
|
- |
|
|
|
4,474 |
|
|
|
- |
|
|
|
4,474 |
|
Net loss - Non-GAAP |
|
$ |
(87,320 |
) |
|
$ |
(85,919 |
) |
|
$ |
(169,323 |
) |
|
$ |
(172,805 |
) |
Net loss per share - GAAP |
|
$ |
(0.59 |
) |
|
$ |
(0.39 |
) |
|
$ |
(1.02 |
) |
|
$ |
(0.56 |
) |
Adjustments: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Change in the estimated fair value of the success payment liabilities(1) |
|
|
0.11 |
|
|
|
(0.08 |
) |
|
|
0.08 |
|
|
|
(0.37 |
) |
Change in the estimated fair value of contingent consideration(2) |
|
|
0.03 |
|
|
|
(0.02 |
) |
|
|
0.06 |
|
|
|
(0.02 |
) |
Write-off of construction in progress costs incurred in connection with the Fremont facility |
|
|
- |
|
|
|
0.02 |
|
|
|
- |
|
|
|
0.02 |
|
Net loss per share - Non-GAAP |
|
$ |
(0.45 |
) |
|
$ |
(0.47 |
) |
|
$ |
(0.88 |
) |
|
$ |
(0.93 |
) |
Weighted-average shares outstanding - basic and diluted |
|
|
192,540 |
|
|
|
187,626 |
|
|
|
191,888 |
|
|
|
186,801 |
|