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 first
quarter of 2021.
“We continue to make progress across our platforms and pipeline,
targeting a broad set of diseases,” said Steve Harr, Sana’s
President and Chief Executive Officer. “In the first quarter, we
bolstered our balance sheet, continued to build our capabilities,
and moved forward our science. We recently presented scientific
data at a medical conference for the first time, highlighting the
potential of both our in vivo delivery platform and our ex vivo
hypoimmune platform to make innovative CAR T therapies for cancer
patients. We look forward to presenting more scientific data and
progress updates from our various pipeline programs at conferences
this year.”
Recent Corporate Scientific Highlights
- Presented proof of concept animal
studies from the in vivo fusogen T cell and ex vivo hypoimmune
allogeneic T cell programs at the American Association for Cancer
Research Annual Meeting 2021, highlighting the platforms’ ability
to make potentially differentiated CAR T cells.
- A single intravenous dose of targeted
fusosomes enables specific delivery of a CD19 CAR transgene to CD8+
T cells, creating CAR T cells in vivo, that show a dose-dependent
anti-tumor response regardless of prior T cell activation
status.
- Hypoimmunogenic CAR T cells show the
ability to functionally evade the innate and adaptive immune system
in allogeneic recipients and demonstrate tumor killing, potentially
leading to universal CAR T cells that can persist without
immunosuppression.
First Quarter 2021 Financial Results
GAAP Results
- Cash Position: Cash,
cash equivalents, and marketable securities as of March 31, 2021
were $981.9 million compared to $412.0 million as of December 31,
2020, an increase of $569.9 million. Sana successfully completed
its initial public offering in February 2021 and issued 27.0
million shares of common stock, including 3.5 million shares
pursuant to the full exercise of the underwriters’ option to
purchase additional shares, at a price of $25.00 per share, for net
proceeds of $626.4 million.
- Research and Development
Expenses: Research and development expenses for the three
months ended March 31, 2021, inclusive of non-cash expenses, were
$168.9 million compared to $27.3 million for the three months ended
March 31, 2020. The increase of $141.6 million was primarily due to
non-cash expenses for the increase in the estimated fair value of
the success payment liabilities in aggregate and contingent
consideration of $115.7 million and $11.4 million, respectively.
The increase was also due to personnel-related expenses related to
increased headcount to expand Sana’s research and development
capabilities, costs for preclinical studies, laboratory supplies,
and facility costs. Research and development expenses include
stock-based compensation of $2.5 million for the three months ended
March 31, 2021 and $0.6 million for the three months ended March
31, 2020.
- General and Administrative
Expenses: General and administrative expenses for the
three months ended March 31, 2021, inclusive of non-cash expenses,
were $11.8 million compared to $6.0 million for the three months
ended March 31, 2020. The increases of $5.8 million was primarily
due to increased personnel-related expenses attributable to an
increase in headcount to build our infrastructure, consulting and
legal fees, insurance associated with being a public company, and
facility costs. General and administrative expenses include
stock-based compensation of $1.5 million for the three months ended
March 31, 2021 and $0.1 million for the three months ended March
31, 2020.
- Net Loss: Net loss for
the three months ended March 31, 2021 was $180.6 million, or $1.52
per share, compared to $32.9 million, or $3.04 per share, for the
three months ended March 31, 2020.
Non-GAAP Measures
- Non-GAAP Operating Cash
Burn: Non-GAAP operating cash burn for the three months
ended March 31, 2021 was $48.9 million compared to $29.5 million
for the three months March 31, 2020. Non-GAAP operating cash burn
is the decrease in cash, cash equivalents, and marketable
securities excluding cash inflows from financing activities, cash
outflows from business development activities, and the purchase of
property and equipment.
- Non-GAAP Research and
Development Expenses: Non-GAAP research and development
expenses for the three months ended March 31, 2021 were $41.9
million compared to $26.0 million for the three months ended March
31, 2020. Non-GAAP research and development expenses excludes
one-time costs to acquire technology and non-cash expenses related
to the change in the estimated fair value of contingent
consideration and success payment liabilities.
- Non-GAAP Net Loss:
Non-GAAP net loss for the three months ended March 31, 2021 was
$53.6 million, or $0.45 per share, compared to $31.6 million, or
$2.92 per share, for the three months ended March 31, 2020.
Non-GAAP net loss excludes one-time costs to acquire technology and
non-cash expenses related to the change in the estimated fair value
of contingent consideration and success payment liabilities.
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 more than 280 people working together to create an enduring
company that changes how the world treats disease. Sana has
operations in Seattle, Cambridge, and South San Francisco.
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 pre-clinical development plans
and timing expectations; updates at scientific and medical
conferences; and the ability to make CAR T cells that evade the
innate and adaptive immune system or that persist without
immunosuppression. 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 the economic,
market and social disruptions due to the ongoing COVID-19 public
health crisis. 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 SEC reports, including but not
limited to its Annual Report on Form 10-K dated March 24, 2021 and
Quarterly Report on Form 10-Q dated May 5, 2021. Except as required
by law, the Company undertakes no obligation to update publicly any
forward-looking statements for any reason.
Investor Relations:Nicole
Keithinvestor.relations@sana.com
Media:Morgan Warners, Finsbury Glover
Heringmedia@sana.com
Sana Biotechnology,
Inc.Unaudited Selected Consolidated Balance Sheet
Data
|
March 31, 2021 |
|
December 31, 2020 |
|
|
|
|
|
(in thousands) |
Cash, cash equivalents, and marketable securities |
$ |
981,864 |
|
|
$ |
411,995 |
|
Total assets |
|
1,304,466 |
|
|
|
730,296 |
|
Contingent consideration |
|
133,294 |
|
|
|
121,901 |
|
Success payment
liabilities |
|
192,151 |
|
|
|
76,494 |
|
Total liabilities |
|
422,483 |
|
|
|
298,583 |
|
Convertible preferred
stock |
|
- |
|
|
|
852,897 |
|
Total stockholders' equity
(deficit) |
|
881,983 |
|
|
|
(421,184 |
) |
Sana Biotechnology,
Inc.Unaudited Consolidated Statements of
Operations
|
Three Months Ended March 31, |
|
2021 |
|
2020 |
|
|
|
|
|
(in thousands, except per share data) |
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
$ |
168,930 |
|
|
$ |
27,320 |
|
General and administrative |
|
11,821 |
|
|
|
5,955 |
|
Total operating expenses |
|
180,751 |
|
|
|
33,275 |
|
Loss from operations |
|
(180,751 |
) |
|
|
(33,275 |
) |
Interest income, net |
|
121 |
|
|
|
395 |
|
Other income, net |
|
13 |
|
|
|
5 |
|
Net loss |
$ |
(180,617 |
) |
|
$ |
(32,875 |
) |
Net loss per share, basic and
diluted |
$ |
(1.52 |
) |
|
$ |
(3.04 |
) |
Weighted-average shares
outstanding, basic and diluted |
|
119,131 |
|
|
|
10,820 |
|
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 ongoing actual costs to operate its
business, including actual research and development costs
unaffected by non-cash valuation changes and 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
|
Three Months Ended March 31, |
|
2021 |
|
2020 |
|
|
|
|
|
(in thousands) |
Beginning cash, cash equivalents, and marketable securities |
$ |
411,995 |
|
|
$ |
138,982 |
|
Ending cash, cash equivalents,
and marketable securities |
|
981,864 |
|
|
|
103,841 |
|
Change in cash, cash
equivalents, and marketable securities |
|
569,869 |
|
|
|
(35,141 |
) |
Cash paid to purchase property and equipment |
|
6,440 |
|
|
|
5,600 |
|
Change in cash, cash
equivalents, and marketable securities, excluding capital
expenditures |
|
576,309 |
|
|
|
(29,541 |
) |
Adjustments: |
|
|
|
|
|
|
|
Cash paid to acquire technology(1) |
|
1,246 |
|
|
|
- |
|
Net proceeds received from the initial public offering of common
stock |
|
(626,405 |
) |
|
|
- |
|
Operating cash burn -
Non-GAAP |
$ |
(48,850 |
) |
|
$ |
(29,541 |
) |
(1) |
The non-GAAP adjustment of $1.2 million for the three months ended
March 31, 2021 is the holdback payment in connection with the
acquisition of Cytocardia, Inc. in November 2019. |
Sana Biotechnology,
Inc.Unaudited Reconciliation of GAAP to Non-GAAP
Research and Development Expense
|
Three Months Ended March 31, |
|
2021 |
|
2020 |
|
|
|
|
|
(in thousands) |
Research and development expense - GAAP |
$ |
168,930 |
|
|
$ |
27,320 |
|
Adjustments: |
|
|
|
|
|
|
|
Change in the estimated fair value of the success payment
liabilities(1) |
|
(115,657 |
) |
|
|
(552 |
) |
Change in the estimated fair value of contingent
consideration(2) |
|
(11,393 |
) |
|
|
(362 |
) |
Change in the estimated fair value of contingent liability(3) |
|
- |
|
|
|
(373 |
) |
Research and development
expense - Non-GAAP |
$ |
41,880 |
|
|
$ |
26,033 |
|
Sana Biotechnology,
Inc.Unaudited Reconciliation of GAAP to Non-GAAP
Net Loss and Net Loss Per Share
|
Three Months Ended March 31, |
|
2021 |
|
2020 |
|
|
|
|
|
(in thousands, except per share data) |
Net loss - GAAP |
$ |
(180,617 |
) |
|
$ |
(32,875 |
) |
Adjustments: |
|
|
|
|
|
|
|
Change in the estimated fair value of the success payment
liabilities(1) |
|
115,657 |
|
|
|
552 |
|
Change in the estimated fair value of contingent
consideration(2) |
|
11,393 |
|
|
|
362 |
|
Change in the estimated fair value of contingent liability(3) |
|
- |
|
|
|
373 |
|
Net loss - Non-GAAP |
$ |
(53,567 |
) |
|
$ |
(31,588 |
) |
Net loss per share - GAAP |
$ |
(1.52 |
) |
|
$ |
(3.04 |
) |
Adjustments: |
|
|
|
|
|
|
|
Change in the estimated fair value of the success payment
liabilities(1) |
|
0.97 |
|
|
|
0.05 |
|
Change in the estimated fair value of contingent
consideration(2) |
|
0.10 |
|
|
|
0.03 |
|
Change in the estimated fair value of contingent liability(3) |
|
- |
|
|
|
0.03 |
|
Net loss per share -
Non-GAAP |
$ |
(0.45 |
) |
|
$ |
(2.93 |
) |
Weighted-average shares
outstanding, basic and diluted |
|
119,131 |
|
|
|
10,820 |
|
(1) |
For the three months ended March 31, 2021 and 2020, the expense
related to the Cobalt success payment liability was $91.8 million
and $0.3 million, respectively and the expense related to the
Harvard success payment liability was $23.9 million and $0.2
million, respectively. |
(2) |
The contingent consideration was recorded in connection with the
acquisition of Cobalt. |
(3) |
The contingent liability was recorded in connection with the
Harvard license agreement and paid in June 2020. |
|
|
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