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 fourth
quarter and year ended December 31, 2022.
“2022 began our transformation from a research focused
organization to a clinical-stage company, setting the stage for
important clinical data in 2023 and 2024 to better define our
product candidates and platforms,” said Steve Harr, Sana’s
President and Chief Executive Officer. “The recent clearance of our
first IND – for SC291, a hypoimmune-modified, CD19-targeted
allogeneic CAR T therapy for patients with B-cell malignancies –
offers the first of several near-term opportunities to understand
our hypoimmune technology in patients and its potential to move
forward important medicines. We anticipate initial clinical data
with this program and hypoimmune islet cells in type 1 diabetic
patients in 2023. We also expect to file INDs in oncology for an
additional allogeneic CAR T program and our first in vivo fusogen
program targeting T cells. Our balance sheet gives us the financial
strength to build on our execution in 2022 and push our R&D
portfolio forward.”
Recent Corporate Highlights
Advancing to the clinic with two opportunities for
clinical proof of concept this year for the hypoimmune platform,
including ex vivo
hypoimmune-modified allogeneic CAR T cells and
hypoimmune-modified primary human islet cells:
- SC291 is a hypoimmune-modified
CD19-targeted allogeneic CAR T for patients with B cell
malignancies. The SC291 IND has been cleared, and Sana expects to
share initial clinical data later this year. Success unlocks
potential value of a broader hypoimmune-modified allogeneic CAR T
platform with clinically-validated CD22 and BCMA CAR
constructs.
- Sana expects an investigator sponsor
trial using primary human hypoimmune-modified islet cells
transplanted in type 1 diabetes patients to begin later this year.
Sana anticipates sharing initial clinical data later this year. The
goal is to understand pancreatic islet cell survival without
immunosuppression in these autoimmune patients, providing insight
into Sana’s ongoing hypoimmune-modified stem cell-derived
pancreatic islet cell program (SC451), which has a goal of filing
an IND in 2024.
Building pipeline with potential to deliver multiple
clinical data readouts over the next several years across three
platforms – ex vivo
hypoimmune-modified allogeneic CAR T cells, stem-cell
derived cell therapies, and the in vivo
fusogen platform:
- ex vivo
hypoimmune-modified allogeneic CAR T platform:
Sana has the opportunity to unlock a potentially best-in-class,
broadly accessible allogeneic CAR T franchise across multiple
patient populations using clinically-validated CAR constructs,
including SC291 (CD19), SC262 (CD22), SC255 (BCMA), and beyond.
- In 2022, entered into an agreement with
the National Institutes of Health (NIH) for worldwide exclusive
commercial rights to the NIH’s CD22 chimeric antigen receptor with
a fully-human binder for use in certain ex vivo allogeneic CAR T
applications. This CAR construct has shown a promising efficacy
profile in several clinical studies, including in autologous CD19
CAR T cell therapy failures. SC262 incorporates this
clinically-validated CAR with T cells manufactured using hypoimmune
technology with a goal of filing an IND in 2023.
- In 2022, 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. SC255 incorporates this
clinically-validated CAR with T cells manufactured using the
hypoimmune platform with a goal of filing an IND in 2024.
- stem-cell derived
platform: Sana has several programs using stem-cell
derived cell therapies, including SC451 and SC379.
- SC451 is a hypoimmune stem-cell derived
islet cell program for type 1 diabetes with a goal of a 2024
IND.
- SC379 is a stem-cell derived glial
progenitor cell therapy targeting multiple central nervous system
diseases with a goal of a 2024 IND.
- in vivo
fusogen platform: The fusogen platform focuses on
in vivo cell specific delivery of genetic material. Sana’s lead
program using this platform is SG299, previously called SG295, an
in vivo CAR T product candidate that utilizes a CD8-targeted
fusosome to deliver a CD19 CAR to generate a CD19-targeted CAR T
cell. The company continues to progress earlier programs focused on
cell-specific delivery of various payloads.
- SG299 has the potential to generate CAR
T cells in vivo (inside the patient), eliminating the need for
conditioning chemotherapy and complex CAR T cell manufacturing. The
company’s goal is to file an IND this year to study this drug
candidate in patients with B cell malignancies.
- In 2022, Sana transitioned to a new
manufacturing process for SG295 and renamed the product SG299 in
connection with that transition. SG299 has at least a 50X
improvement in product potency, which Sana believes has the
potential to translate into better efficacy, safety, and long-term
manufacturability. The company plans to use this second-generation
process for the first-in-human studies in patients with B cell
malignancies.
- Demonstrated that two additional
fusosome candidates eliminated tumors in preclinical models – a
CD4+ T cell targeting fusosome delivering a CD19 CAR and a CD8+ T
cell targeting fusosome delivering a CD22 CAR.
Advanced Sana’s hypoimmune ex
vivo platform and in
vivo fusogen platform with presentations at AACR,
ASGCT, ADA, ISSCR, and ASH:
- ex vivo hypoimmune platform: Sana’s
hypoimmune platform makes multiple genomic modifications to cells
with the goal of preventing allogeneic transplant rejection, and
importantly includes modifications to prevent both adaptive and
innate immune recognition and rejection. Sana’s pipeline includes
hypoimmune-modified cells to replace damaged or missing cells in
the body in a number of different diseases, including, among
others, cancer, type 1 diabetes, and various neurologic conditions.
- Presented preclinical data
demonstrating that hypoimmune-modified 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.
- Presented preclinical data showing
survival of transplanted allogeneic hypoimmune-modified cells of
several different types – including pancreatic islet cells,
cardiomyocytes, and retinal pigment epithelial cells – in a variety
of locations in non-human primates.
- Presented preclinical data showing that
hypoimmune-modified allogeneic regulatory T cells function and are
able to evade immune detection in preclinical models. These cells
have the potential to treat a variety of autoimmune disorders.
- Presented preclinical data outlining
the importance of CD47 overexpression as part of the hypoimmune
platform to evade adaptive and innate immune response, the use of
CRISPR/Cas12b in scaled hypoimmune-modified allogeneic CAR T
manufacturing, the development of assays to evaluate T cell quality
from healthy, allogeneic donors, and the generation of a
hypoimmune-modified BCMA-directed allogeneic CAR T cell.
- hypoimmune-modified pancreatic islet
cells: Type 1 diabetes is a disease in which a person’s immune
system destroys one’s own pancreatic beta cells, which are a key
component in pancreatic islets. Hypoimmune technology is
incorporated in SC451, Sana’s ongoing stem cell-derived pancreatic
islet cell program, for which Sana has a goal of filing an IND in
2024 for the treatment of type 1 diabetes.
- Presented preclinical data showing
that transplanted hypoimmune-modified pancreatic islet cells evade
allogeneic immune response and autoimmune response in a novel type
1 diabetes mouse model. These data build upon previous in vitro
data showing that hypoimmune-modified pancreatic islet cells are
not recognized by serum from type 1 diabetic patients, including no
T cell or antibody recognition.
- Presented preclinical data showing
that hypoimmune-modified islet cells transplanted intramuscularly
may be capable of persisting and functioning in diabetic patients
without immune suppression.
- in vivo fusogen platform: Presented
additional preclinical data utilizing retargeted fusosomes for in
vivo delivery of genetic payloads to various cells, including CD8+
T cells, CD4+ T cells, human hepatocytes, and initial data on our
work in hematopoietic stem cells. This technology is the backbone
of Sana’s in vivo delivery platform and is incorporated into
various product candidates, including SG299.
Announced expected cash runway into 2025 to enable
multiple data readouts across the platforms; largest part of cash
savings from plans to relocate manufacturing facility to Bothell,
Washington
- Expect cash runway into 2025 enabling
multiple data readouts across the platforms based on current
timelines for lead programs.
- Announced decision to move Sana’s
manufacturing plant from Fremont, CA to Bothell, WA, resulting in
approximately $100 million in expected cost savings compared to the
initial build-out plan. As part of this decision, Sana signed a
lease agreement to develop an approximately 80,000 square foot
manufacturing facility in Bothell, WA. The facility will be
designed to support the late-stage clinical and early commercial
manufacturing of multiple product candidates across the
portfolio.
Announced key corporate updates, building on the
company’s scientific excellence and operational
capabilities
- Announced a portfolio prioritization
and corporate restructuring designed to optimize the development of
programs at or nearing clinical development, continue investments
in the core research platforms and innovation, and maintain a
strong balance sheet.
- Named the top place to work on the
BioSpace 2023 Best Places to Work small employer list, based on
attributes including compensation, innovation, career growth
opportunities, leadership, culture, diversity, equity and
inclusion, reputation, and flexibility and remote work.
- Strengthened the leadership team with
the appointments of Snehal Patel to lead technical operations and
Julie Lepin to lead regulatory affairs.
Fourth Quarter 2022 Financial Results
GAAP Results
- Cash Position: Cash, cash equivalents, and
marketable securities as of December 31, 2022 were $434.0 million
compared to $746.9 million as of December 31 2021. The decrease of
$312.9 million was primarily driven by cash used in operations of
$289.9 million and cash used for the purchase of property and
equipment of $20.9 million. Cash used in operations includes $6.2
million of upfront payments related to licensing technology for the
company’s CD22 and BCMA programs, $4.3 million of one-time
restructuring costs related to the portfolio prioritization and
corporate restructuring in the fourth quarter of 2022, and $3.2
million of costs incurred related to the previously planned
manufacturing facility in Fremont, CA (the Fremont facility) which
will be replaced by the facility in Bothell, WA (the Bothell
facility). In addition, our cash balance will increase by $6.7
million in July 2023 as the letter of credit related to the Fremont
facility reduces from $6.7 million to $0.6 million in July
2023.
- Research and Development Expenses: For the
three and twelve months ended December 31, 2022, research and
development expenses, inclusive of non-cash expenses, were $63.9
million and $285.9 million, respectively, compared to $108.5
million and $248.6 million for the same periods in 2021. The
decrease of $44.6 million for the three months ended December 31,
2022 was primarily due to the one-time upfront payment to Beam
Therapeutics Inc. (Beam) in the fourth quarter of 2021 to license
its gene editing technology, partially offset by an increase in
research, development, and third-party manufacturing costs, and
facility and software expenses. The increase of $37.3 million for
the twelve months ended December 31, 2022 was largely due to
increases in personnel-related expenses, including increased
headcount to expand Sana’s research and development capabilities,
increased research, laboratory, and third-party manufacturing
costs, and allocated personnel costs, depreciation expense, and
facility and software costs. These increases were partially offset
by the one-time upfront payment to Beam in the fourth quarter of
2021 to license its gene editing technology. Research and
development expenses for the three and twelve months ended December
31, 2022 include non-cash stock-based compensation of $6.0 million
and $26.6 million, respectively, and $5.3 million and $15.2
million, respectively, for the same periods in 2021.
- Research and Development Related Success Payments and
Contingent Consideration: For the three and twelve months
ended December 31 2022, Sana recognized non-cash gains of $5.5
million and $84.9 million, respectively, in connection with the
change in the estimated fair value of the success payment
liabilities and contingent consideration in aggregate. Sana
recognized a non-cash gain of $9.9 million for the three months
ended December 31, 2021 and a non-cash expense of $57.9 million for
the twelve months ended December 31, 2021. The value of these
potential liabilities may fluctuate significantly with changes in
Sana’s market capitalization and stock price.
- General and Administrative Expenses: General
and administrative expenses for the three months ended December 31,
2022, inclusive of non-cash expenses, were $23.3 million compared
to $12.7 million for the same period in 2021. The increase of $10.6
million was primarily due to one-time restructuring costs of $8.7
million, including stock-based compensation of $1.9 million,
related to the portfolio prioritization and corporate restructuring
in the fourth quarter of 2022, operating costs associated with the
Fremont facility, business taxes, and legal fees. These increases
were offset by a decline in personnel-related expenses. General and
administrative expenses for the twelve months ended December 31,
2022 were $71.6 million compared to $50.4 million for the same
period in 2021. The increase of $21.2 million was primarily due to
one-time restructuring costs of $8.7 million, including stock-based
compensation of $1.9 million, related to the portfolio
prioritization and corporate restructuring in the fourth quarter of
2022, the write-off of construction in progress costs incurred in
connection with the Fremont facility, personnel-related expenses
attributable to an increase in headcount to support Sana’s
continued research and development activities, and operating costs
associated with the Fremont facility. General and administrative
expenses for the three and twelve months ended December 31, 2022
include stock-based compensation of $4.6 million and $11.8 million,
respectively, and $2.0 million and $7.1 million, respectively, for
the same periods in 2021.
- Net Loss: Net loss for the three and twelve
months ended December 31, 2022 was $80.4 million, or $0.42 per
share, and $269.5 million, or $1.43 per share, respectively,
compared to $110.7 million, or $0.60 per share, and $355.9 million,
or $2.14 per share, respectively, for the same periods in
2021.
Non-GAAP Measures
- Non-GAAP Operating Cash Burn: Non-GAAP
operating cash burn for the twelve months ended December 31, 2022
was $288.3 million compared to $209.6 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 and
non-recurring restructuring activities, and the purchase of
property and equipment.
- Non-GAAP General and Administrative Expense:
Non-GAAP general and administrative expense for the three and
twelve months ended December 31, 2022 was $14.6 million and $58.4
million, respectively, compared to $12.7 million and $50.4 million,
respectively, for the same periods in 2021. Non-GAAP general and
administrative expense excludes one-time restructuring costs,
including stock-based compensation, related to the portfolio
prioritization and corporate restructuring in the fourth quarter of
2022 and the write-off of construction in progress costs incurred
in connection with the Fremont facility.
- Non-GAAP Net Loss: Non-GAAP net loss for the
three and twelve months ended December 31, 2022 was $77.2 million,
or $0.40 per share, and $341.2 million, or $1.81 per share,
respectively, compared to $120.6 million, or $0.65 per share, and
$298.1 million, or $1.79 per share, respectively, for the same
periods in 2021. Non-GAAP net loss excludes non-cash expenses
related to the change in the estimated fair value of contingent
consideration and success payment liabilities, one-time
restructuring costs, including stock-based compensation, related to
the portfolio prioritization and corporate restructuring in the
fourth quarter of 2022, and the write-off of construction in
progress costs incurred in connection with the Fremont
facility.
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, including the
expected timing of IND filings for the Company’s product candidates
and indications for which such INDs will be filed, and expected
timing, substance, and impact of data from clinical trials of its
product candidates and an investigator-sponsored trial utilizing
hypoimmune-modified primary human islet cells in patients with type
1 diabetes (the IST); expectations regarding the IST, including the
Company’s ability to initiate the IST and the potential of the IST
to provide insight on the performance of the Company’s hypoimmune
technology and SC451 program, including in patients; the potential
to generate a pipeline of allogeneic CAR T therapies using
clinically-validated CAR constructs; expectations regarding the
Company’s expected use of a CD22 chimeric antigen receptor with a
fully-human binder in-licensed from the NIH; expectations with
respect to the potential therapeutic benefits and impact of its
development programs; the potential of the Company’s SG299 program
to generate CAR T cells in vivo and the potential impact thereof;
the potential advantages of the second-generation manufacturing
process for the Company’s SG299 program; the potential ability of
the hypoimmune platform to make genomic modifications to cells to
prevent allogeneic transplant rejection and the potential ability
of such modifications to prevent both adaptive and innate immune
recognition and rejection, and the potential benefits associated
therewith; the potential ability of the Company’s pipeline of
hypoimmune-modified cells to replace damaged or missing cells in
the body in various diseases, including cancer, type 1 diabetes,
and various neurologic conditions; the Company’s expected cash
runway and the potential impact thereof on the Company’s
development programs, including data readouts from such programs;
expectations regarding cost savings associated with its decision to
move the Company’s manufacturing plant from Fremont, California to
Bothell, Washington; expectations with respect to the design of the
Company’s manufacturing plant; the expected outcomes and benefits
associated with the Company’s portfolio prioritization;
expectations regarding the impact of a reduction in the amount of
the letter of credit for the Company’s Fremont, California facility
on the Company’s cash balance; and the potential impact of changes
in the Company’s market capitalization and stock price on its
potential success payment and contingent consideration liabilities.
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 Securities and Exchange
Commission (SEC) reports, including but not limited to its Annual
Report on Form 10-K dated March 16, 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
Keithinvestor.relations@sana.commedia@sana.com
Sana Biotechnology,
Inc.Unaudited Selected Consolidated Balance Sheet
Data
|
December 31, 2022 |
|
|
December 31, 2021 |
|
|
(in thousands) |
|
Cash, cash equivalents, and marketable securities |
$ |
434,014 |
|
|
$ |
746,877 |
|
Total assets |
|
822,720 |
|
|
|
1,129,407 |
|
Contingent consideration |
|
150,379 |
|
|
|
153,743 |
|
Success payment
liabilities |
|
21,007 |
|
|
|
102,525 |
|
Total liabilities |
|
323,405 |
|
|
|
400,905 |
|
Total stockholders'
equity |
|
499,315 |
|
|
|
728,502 |
|
Sana Biotechnology,
Inc.Unaudited Consolidated Statements of
Operations
|
Three Months Ended December 31, |
|
|
Twelve Months Ended December 31, |
|
|
2022 |
|
|
2021 |
|
|
2022 |
|
|
2021 |
|
|
(in thousands, except per share data) |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
$ |
63,921 |
|
|
$ |
108,505 |
|
|
$ |
285,885 |
|
|
$ |
248,626 |
|
Research and development related success payments and contingent
consideration |
|
(5,454 |
) |
|
|
(9,905 |
) |
|
|
(84,882 |
) |
|
|
57,873 |
|
General and administrative |
|
23,321 |
|
|
|
12,679 |
|
|
|
71,561 |
|
|
|
50,410 |
|
Total operating expenses |
|
81,788 |
|
|
|
111,279 |
|
|
|
272,564 |
|
|
|
356,909 |
|
Loss from operations |
|
(81,788 |
) |
|
|
(111,279 |
) |
|
|
(272,564 |
) |
|
|
(356,909 |
) |
Interest income, net |
|
1,613 |
|
|
|
267 |
|
|
|
3,762 |
|
|
|
676 |
|
Other income (expense),
net |
|
(268 |
) |
|
|
281 |
|
|
|
(674 |
) |
|
|
305 |
|
Net loss |
$ |
(80,443 |
) |
|
$ |
(110,731 |
) |
|
$ |
(269,476 |
) |
|
$ |
(355,928 |
) |
Net loss per common share -
basic and diluted |
$ |
(0.42 |
) |
|
$ |
(0.60 |
) |
|
$ |
(1.43 |
) |
|
$ |
(2.14 |
) |
Weighted-average number of
common shares - basic and diluted |
|
190,420 |
|
|
|
183,987 |
|
|
|
188,344 |
|
|
|
166,433 |
|
Sana Biotechnology,
Inc.Changes in the Estimated Fair Value of Success
Payments and Contingent Consideration
|
Success
PaymentLiability(1) |
|
|
ContingentConsideration(2) |
|
|
Total Success Payment Liability and Contingent
Consideration |
|
|
(in thousands) |
|
Liability balance as of December 31, 2021 |
$ |
102,525 |
|
|
$ |
153,743 |
|
|
$ |
256,268 |
|
Changes in fair value – gain |
|
(54,910 |
) |
|
|
(528 |
) |
|
|
(55,438 |
) |
Liability balance as of March
31, 2022 |
|
47,615 |
|
|
|
153,215 |
|
|
|
200,830 |
|
Changes in fair value – gain |
|
(14,098 |
) |
|
|
(3,830 |
) |
|
|
(17,928 |
) |
Liability balance as of June
30, 2022 |
|
33,517 |
|
|
|
149,385 |
|
|
|
182,902 |
|
Changes in fair value – expense (gain) |
|
2,193 |
|
|
|
(8,255 |
) |
|
|
(6,062 |
) |
Liability balance as of
September 30, 2022 |
|
35,710 |
|
|
|
141,130 |
|
|
|
176,840 |
|
Changes in fair value – expense (gain) |
|
(14,703 |
) |
|
|
9,249 |
|
|
|
(5,454 |
) |
Liability balance as of
December 31, 2022 |
$ |
21,007 |
|
|
$ |
150,379 |
|
|
$ |
171,386 |
|
Total change in fair value for
the twelve months ended December 31, 2022 |
$ |
(81,518 |
) |
|
$ |
(3,364 |
) |
|
$ |
(84,882 |
) |
(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 respective 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 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
toNon-GAAP Operating Cash Burn
|
Twelve Months Ended December 31, |
|
|
2022 |
|
|
2021 |
|
|
(in thousands) |
|
Beginning cash, cash equivalents, and marketable securities |
$ |
746,877 |
|
|
$ |
411,995 |
|
Ending cash, cash equivalents,
and marketable securities |
|
434,014 |
|
|
|
746,877 |
|
Change in cash, cash
equivalents, and marketable securities |
|
(312,863 |
) |
|
|
334,882 |
|
Cash paid to purchase property and equipment |
|
20,876 |
|
|
|
29,862 |
|
Change in cash, cash
equivalents, and marketable securities, excluding capital
expenditures |
|
(291,987 |
) |
|
|
364,744 |
|
Adjustments: |
|
|
|
|
|
|
|
Cash paid for restructuring(1) |
|
4,333 |
|
|
|
- |
|
Cash paid to acquire technology(2) |
|
- |
|
|
|
52,096 |
|
Net proceeds from issuance of common stock(3) |
|
(601 |
) |
|
|
(626,405 |
) |
Operating cash burn -
Non-GAAP |
$ |
(288,255 |
) |
|
$ |
(209,565 |
) |
(1) |
The non-GAAP adjustment of $4.3 million for the twelve months ended
December 31, 2022 consisted of cash payments related to the
portfolio prioritization and corporate restructuring in the fourth
quarter of 2022. |
(2) |
The non-GAAP adjustment of $52.1
million for the twelve months ended December 31, 2021 consisted of
the one-time upfront payment of $50.0 million to Beam to license
its gene editing technology and holdback payments of $2.1 million
related to the acquisitions of Cytocardia, Inc. and Oscine
Corp. |
(3) |
Net proceeds of $0.6 million were
received in connection with the at the market sales agreement in
the twelve months ended December 31, 2022. Net proceeds of $626.4
million were received in connection with the initial public
offering in the twelve months ended December 31, 2021. |
Sana Biotechnology,
Inc.Unaudited Reconciliation of GAAP to Non-GAAP
General and Administrative Expense
|
Three Months Ended December 31, |
|
Twelve Months Ended December 31, |
|
|
2022 |
|
2021 |
|
2022 |
|
2021 |
|
|
(in thousands) |
|
General and administrative - GAAP |
$ |
23,321 |
|
$ |
12,679 |
|
$ |
71,561 |
|
$ |
50,410 |
|
Adjustments: |
|
|
|
|
|
|
|
|
|
|
|
|
Write-off of construction in progress costs incurred in connection
with the previously planned Fremont facility(1) |
|
- |
|
|
- |
|
|
(4,474 |
) |
|
- |
|
Costs incurred in connection with restructuring(2) |
|
(8,704 |
) |
|
- |
|
|
(8,704 |
) |
|
- |
|
General and administrative -
Non-GAAP |
$ |
14,617 |
|
$ |
12,679 |
|
$ |
58,383 |
|
$ |
50,410 |
|
(1) |
The Fremont facility will be replaced with the Bothell
facility. |
(2) |
One-time restructuring costs,
including stock-based compensation of $1.9 million, related to the
portfolio prioritization and corporate restructuring in the fourth
quarter of 2022. |
Sana Biotechnology,
Inc.Unaudited Reconciliation of GAAP to Non-GAAP
Net Loss and Net Loss Per Share
|
Three Months Ended December 31, |
|
|
Twelve Months Ended December 31, |
|
|
2022 |
|
|
2021 |
|
|
2022 |
|
|
2021 |
|
|
(in thousands, except per share data) |
|
Net loss - GAAP |
$ |
(80,443 |
) |
|
$ |
(110,731 |
) |
|
$ |
(269,476 |
) |
|
$ |
(355,928 |
) |
Adjustments: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Change in the estimated fair value of the success payment
liabilities(1) |
|
(14,703 |
) |
|
|
(31,667 |
) |
|
|
(81,518 |
) |
|
|
26,031 |
|
Change in the estimated fair value of contingent
consideration(2) |
|
9,249 |
|
|
|
21,762 |
|
|
|
(3,364 |
) |
|
|
31,842 |
|
Write-off of construction in progress costs incurred in connection
with the previously planned Fremont facility3) |
|
- |
|
|
|
- |
|
|
|
4,474 |
|
|
|
- |
|
Costs incurred in connection with restructuring(4) |
|
8,704 |
|
|
|
- |
|
|
|
8,704 |
|
|
|
- |
|
Net loss - Non-GAAP |
$ |
(77,193 |
) |
|
$ |
(120,636 |
) |
|
$ |
(341,180 |
) |
|
$ |
(298,055 |
) |
Net loss per share - GAAP |
$ |
(0.42 |
) |
|
$ |
(0.60 |
) |
|
$ |
(1.43 |
) |
|
$ |
(2.14 |
) |
Adjustments: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Change in the estimated fair value of the success payment
liabilities(1) |
|
(0.08 |
) |
|
|
(0.17 |
) |
|
|
(0.43 |
) |
|
|
0.16 |
|
Change in the estimated fair value of contingent
consideration(2) |
|
0.05 |
|
|
|
0.12 |
|
|
|
(0.02 |
) |
|
|
0.19 |
|
Write-off of construction in progress costs incurred in connection
with the previously planned Fremont facility(3) |
|
- |
|
|
|
- |
|
|
|
0.02 |
|
|
|
- |
|
Costs incurred in connection with restructuring(4) |
|
0.05 |
|
|
|
- |
|
|
|
0.05 |
|
|
|
- |
|
Net loss per share -
Non-GAAP |
$ |
(0.40 |
) |
|
$ |
(0.65 |
) |
|
$ |
(1.81 |
) |
|
$ |
(1.79 |
) |
Weighted-average shares
outstanding - basic and diluted |
|
190,420 |
|
|
|
183,987 |
|
|
|
188,344 |
|
|
|
166,433 |
|
(1) |
For the three months and twelve ended December 31, 2022, the gains
related to the Cobalt success payment liability were $12.9 million
and $69.3 million, respectively, compared to a gain of $23.3
million and an expense of 23.6 million for the same periods in
2021. For the three months and twelve ended December 31, 2022, the
gains related to the Harvard success payment liability were $1.8
million and $12.2 million, respectively, compared to a gain of $8.4
million and an expense of $2.4 million for the same periods in
2021. |
(2) |
The contingent consideration was
recorded in connection with the acquisition of Cobalt. |
(3) |
The Fremont facility will be
replaced with the Bothell facility. |
(4) |
One-time restructuring costs,
including stock-based compensation of $1.9 million, related to the
portfolio prioritization and corporate restructuring in the fourth
quarter of 2022. |
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