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 2022.
“In the first quarter, we made significant progress in moving
toward clinical trials for programs across our multiple platforms
including the ex vivo hypoimmune allogeneic CAR T (SC291) and in
vivo fusogen CAR T (SG295) programs, and we remain on track to file
INDs for both of these programs this year,” said Steve Harr, Sana’s
President and Chief Executive Officer. “In addition to advancing
these programs, we continue to make progress across our earlier
pipeline, including SC451, our hypoimmune stem-cell derived
pancreatic islet cell therapy for patients with type 1 diabetes,
and multiple product candidates in our CAR T portfolio. Our people,
broad set of technologies, and strong balance sheet enable us to
pursue this ambitious pipeline.”
Continued progress in building Sana’s
hypoimmune ex vivo platform
and in vivo fusogen platform with
presentations at multiple conferences
- Hypoimmune ex vivo platform: Presented preclinical data
demonstrating that hypoimmune CAR T cells were able to evade both
the innate and adaptive arms of the immune system in animal models
while retaining their antitumor activity at the 2022 American
Association for Cancer Research Annual Meeting.
- In vivo fusogen platform: Scheduled to present preclinical data
regarding hypoimmune pancreatic islet cells, generation of
hypoimmune allogeneic regulatory T cells, retargeted fusosomes for
in vivo delivery to T cells, fusosome-targeted gene transfer to
human hepatocytes, and a novel vector copy number assay at the 2022
American Society of Gene & Cell Therapy meeting later in
May.
Expanded Sana’s CAR T capability to potentially develop
best-in-class, broadly accessible CAR T cell therapies
- Entered into an exclusive agreement with the National
Institutes of Health (NIH) for worldwide commercial rights to the
NIH’s CD22 chimeric antigen receptor with a fully-human binder.
This CAR construct has shown efficacy in several clinical studies,
including in CD19 CAR T cell therapy failures. Targeting both CD19
and CD22 with an “off-the-shelf” product, whether in combination
with Sana’s hypoimmune platform or fusogen platform, offers the
potential of higher and more durable complete response rates in
earlier-stage patients as well as in patients that have previously
failed an autologous CD19 CAR T cell therapy.
- Entered into a non-exclusive agreement with IASO
Biotherapeutics and Innovent Biologics for commercial rights to a
clinically validated fully-human B cell maturation antigen (BCMA)
CAR construct, which Sana intends to incorporate into both the
company’s ex vivo hypoimmune allogeneic and in vivo fusogen
platforms for the treatment of multiple myeloma.
First Quarter 2022 Financial Results
GAAP Results
- Cash Position: Cash, cash equivalents, and
marketable securities as of March 31, 2022 were $657.4 million
compared to $746.9 million as of December 31, 2021. The decrease of
$89.5 million was primarily driven by cash used in operations of
$77.7 million and cash used for the purchase of property and
equipment of $7.5 million. Cash used in operations includes $6.2
million of upfront license payments related to licensing CD22 and
BCMA as well as multiple cash payments that will not recur this
year.
- Research and Development Expenses: For the
three months ended March 31, 2022, research and development
expenses, inclusive of non-cash expenses, was $72.7 million
compared to $41.9 million for the same period in 2021. The increase
of $30.8 million was due to an increase in personnel expenses
related to increased headcount to expand Sana’s research and
development capabilities, increased costs for third-party
manufacturing, laboratory supplies, facility and other allocated
costs, and costs to acquire technology complementary to our own.
Research and development expenses include non-cash stock-based
compensation of $5.7 million and $2.7 million for the three months
ended March 31, 2022 and 2021, respectively.
- Research and Development Related Success Payments and
Contingent Consideration: For the three months ended March
31, 2022, we recognized a non-cash gain of $55.4 million in
connection with the change in the estimated fair value of the
success payment liabilities and contingent consideration in
aggregate, compared to expenses of $127.1 million for the same
period in 2021. The value of these potential liabilities can
fluctuate significantly with changes in our market capitalization
and stock price.
- General and Administrative Expenses: General
and administrative expenses for the three months ended March 31,
2022, inclusive of non-cash expenses, were $14.4 million compared
to $11.8 million for the same period in 2021. The increase of $2.6
million was primarily due to increased personnel-related expenses
attributable to an increase in headcount to support our continued
research and development activities. General and administrative
expenses include stock-based compensation of $2.0 million and $1.5
million for the three months ended March 31, 2022 and 2021,
respectively.
- Net Loss: Net loss for the three months ended
March 31, 2022 was $31.4 million, or $0.17 per share, compared to
$180.6 million, or $1.52 per share, for the same period in
2021.
Non-GAAP Measures
- Non-GAAP Operating Cash Burn: Non-GAAP
operating cash burn for the three months ended March 31, 2022 was
$82.0 million compared to $48.9 million for the same period in
2021. 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 Net Loss: Non-GAAP net loss for the
three months ended March 31, 2022 was $86.9 million, or $0.47 per
share, compared to $53.6 million, or $0.45 per share, for the same
period in 2021. Non-GAAP net loss excludes certain 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 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 pre-clinical, clinical and
regulatory development plans and timing expectations; the potential
ability to make hypoimmune CAR T cells that evade the immune system
while retaining their antitumor activity; the Company’s
participation in the 2022 American Society of Gene & Cell
Therapy meeting and the subject matter of the Company’s
presentation at that meeting; the potential use and utility of
licensed technologies for Sana’s programs; the potential efficacy
of the NIH’s CAR construct; and the potential benefits of targeting
both CD19 and CD22 with an “off-the-shelf” product, including in
combination with Sana’s hypoimmune or fusogen platform. 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 Quarterly Report on Form 10-Q dated May 10, 2022.
Except as required by law, the Company undertakes no obligation to
update publicly any forward-looking statements for any reason.
Investor Relations & Media:Nicole
Keithinvestor.relations@sana.commedia@sana.com
Sana Biotechnology,
Inc.Unaudited Selected Consolidated Balance Sheet
Data
|
|
March 31, 2022 |
|
|
December 31, 2021 |
|
|
|
(in thousands) |
|
Cash, cash equivalents, and marketable securities |
|
$ |
657,392 |
|
|
$ |
746,877 |
|
Total assets |
|
|
1,047,613 |
|
|
|
1,129,407 |
|
Contingent consideration |
|
|
153,215 |
|
|
|
153,743 |
|
Success payment liabilities |
|
|
47,615 |
|
|
|
102,525 |
|
Total liabilities |
|
|
345,958 |
|
|
|
400,905 |
|
Total stockholders' equity |
|
|
701,655 |
|
|
|
728,502 |
|
Sana Biotechnology,
Inc.Unaudited Consolidated Statements of
Operations
|
|
Three Months Ended March 31, |
|
|
|
2022 |
|
|
2021 |
|
|
(in thousands, except per share data) |
|
Operating expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
$ |
72,689 |
|
|
$ |
41,880 |
|
Research and development related success payments and contingent
consideration |
|
|
(55,438 |
) |
|
|
127,050 |
|
General and administrative |
|
|
14,434 |
|
|
|
11,821 |
|
Total operating expenses |
|
|
31,685 |
|
|
|
180,751 |
|
Loss from operations |
|
|
(31,685 |
) |
|
|
(180,751 |
) |
Interest income, net |
|
|
339 |
|
|
|
121 |
|
Other income (expense),
net |
|
|
(102 |
) |
|
|
13 |
|
Net loss |
|
$ |
(31,448 |
) |
|
$ |
(180,617 |
) |
Net loss per common share -
basic and diluted |
|
$ |
(0.17 |
) |
|
$ |
(1.52 |
) |
Weighted-average number of common
shares - basic and diluted |
|
|
185,955 |
|
|
|
119,131 |
|
Sana Biotechnology,
Inc.Changes in the Estimated Fair Value of Success
Payments and Contingent Consideration
|
|
Success
PaymentLiability(1) |
|
|
ContingentConsideration(2) |
|
|
Total SuccessPayment Liabilityand
ContingentConsideration |
|
|
|
(in thousands) |
|
Liability balance as of December 31, 2021 |
|
$ |
102,525 |
|
|
$ |
153,743 |
|
|
$ |
256,268 |
|
Changes in fair value - expense (gain) |
|
|
(54,910 |
) |
|
|
(528 |
) |
|
|
(55,438 |
) |
Liability balance as of March 31,
2022 |
|
|
47,615 |
|
|
|
153,215 |
|
|
|
200,830 |
|
Total change in fair value for
the three months ended March 31, 2022 |
|
$ |
(54,910 |
) |
|
$ |
(528 |
) |
|
$ |
(55,438 |
) |
(1) |
Cobalt
Biomedicine, Inc. (Cobalt) and the Presidents of Harvard College
(Harvard) are entitled to success payments pursuant to the terms
and conditions of their agreements. The success payments are
recorded at fair value and remeasured at each reporting period with
changes in the estimated fair value recorded in research and
development related success payments and contingent consideration
on the statement of operations. |
(2) |
Cobalt is entitled to contingent consideration upon the
achievement of certain milestones pursuant to the terms and
conditions of the agreement. Contingent consideration is recorded
at fair value and remeasured at each reporting period with changes
in the estimated fair value recorded in research and development
related success payments and contingent consideration on the
statement of operations. |
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 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
toNon-GAAP Operating Cash Burn
|
|
Three Months Ended March 31, |
|
|
|
2022 |
|
|
2021 |
|
|
|
(in thousands) |
|
Beginning cash, cash equivalents, and marketable securities |
|
$ |
746,877 |
|
|
$ |
411,995 |
|
Ending cash, cash equivalents,
and marketable securities |
|
|
657,392 |
|
|
|
981,864 |
|
Change in cash, cash
equivalents, and marketable securities |
|
|
(89,485 |
) |
|
|
569,869 |
|
Cash paid to purchase property and equipment |
|
|
7,533 |
|
|
|
6,440 |
|
Change in cash, cash
equivalents, and marketable securities, excluding capital
expenditures |
|
|
(81,952 |
) |
|
|
576,309 |
|
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 |
|
$ |
(81,952 |
) |
|
$ |
(48,850 |
) |
(1) |
The non-GAAP
adjustment of $1.2 million for the three months ended March 31,
2021 was the holdback payment related to the acquisition of
Cytocardia, Inc. in 2019. |
Sana Biotechnology,
Inc.Unaudited Reconciliation of GAAP to Non-GAAP
Net Loss and Net Loss Per Share
|
|
Three Months Ended March 31, |
|
|
|
2022 |
|
|
2021 |
|
|
|
(in thousands, except per share data) |
|
Net loss - GAAP |
|
$ |
(31,448 |
) |
|
$ |
(180,617 |
) |
Adjustments: |
|
|
|
|
|
|
|
|
Change in the estimated fair value of the success payment
liabilities(1) |
|
|
(54,910 |
) |
|
|
115,657 |
|
Change in the estimated fair value of contingent
consideration(2) |
|
|
(528 |
) |
|
|
11,393 |
|
Net loss - Non-GAAP |
|
$ |
(86,886 |
) |
|
$ |
(53,567 |
) |
Net loss per share - GAAP |
|
$ |
(0.17 |
) |
|
$ |
(1.52 |
) |
Adjustments: |
|
|
|
|
|
|
|
|
Change in the estimated fair value of the success payment
liabilities(1) |
|
|
(0.30 |
) |
|
|
0.97 |
|
Change in the estimated fair value of contingent
consideration(2) |
|
|
- |
|
|
|
0.10 |
|
Net loss per share -
Non-GAAP |
|
$ |
(0.47 |
) |
|
$ |
(0.45 |
) |
Weighted-average shares
outstanding - basic |
|
|
185,955 |
|
|
|
119,131 |
|
(1) |
For the three
months ended March 31, 2022, the gain related to the Cobalt and
Harvard success payment liabilities was $46.8 million and $8.1
million, respectively, compared to expense of $91.8 million and
$23.9 million, respectively, for the same period in 2021. |
(2) |
The contingent consideration was recorded in connection with
the acquisition of Cobalt. |
Sana Biotechnology (NASDAQ:SANA)
Historical Stock Chart
From Jun 2024 to Jul 2024
Sana Biotechnology (NASDAQ:SANA)
Historical Stock Chart
From Jul 2023 to Jul 2024