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 third
quarter 2023.
“We continue to execute on our plans to develop our hypoimmune
technology, with the potential to deliver data from four different
clinical settings in 2023 and 2024,” said Steve Harr, Sana’s
President and Chief Executive Officer. “We have increased
confidence that this platform can prevent immune recognition of
allogeneic cells, unlocking the potential for important medicines
in blood cancers, B-cell-mediated autoimmune diseases, and type 1
diabetes, and we look forward to sharing data later this year and
next. With our recent strategic repositioning, we expect 2024
operating cash burn to be below $200 million, enabling multiple
clinical data readouts with our current balance sheet and a cash
runway into 2025.”
Recent Corporate Highlights
Human proof of concept data in multiple clinical
settings – including oncology, autoimmune diseases, and type 1
diabetes – expected in 2023 and 2024
- The ARDENT trial evaluates SC291, an ex
vivo HIP-modified CD19-directed allogeneic CAR T cell therapy, in
patients with B-cell malignancies. The goal of the hypoimmune
platform is to overcome the immunologic rejection of allogeneic
cells, which, if successful with SC291, may result in longer CAR T
cell persistence and a higher rate of durable complete responses
for these patients.
- Enrollment in the ARDENT Phase 1 study
continues, and initial clinical data are expected in 2023 and more
robust data expected in 2024.
- The CTA was submitted for an IST
evaluating an ex vivo HIP-modified primary human pancreatic islet
cell therapy in patients with type 1 diabetes patients. The goal of
the study is to show that transplantation of HIP-modified
pancreatic islets is safe, evades immune recognition, survives, and
functions without immunosuppression.
- Initial HIP proof of concept data are
expected in 2023 and 2024.
- Sana is developing SC451, a
hypoimmune-modified stem-cell derived pancreatic islet cell therapy
for patients with type 1 diabetes. Sana expects insights from the
IST to inform the development of SC451.
- The IND has been submitted for SC291
for the treatment of multiple B-cell-mediated autoimmune diseases,
and preliminary clinical data are expected in 2024.
- The IND is on track for submission in
4Q 2023 for SC262, an ex vivo HIP-modified CD22-directed allogeneic
CAR T cell therapy, for the treatment of B-cell lymphomas and
leukemias in patients who have failed CD19-directed CAR T
therapies. Preliminary clinical data are expected in 2024.
- Preclinical data are scheduled for
presentation at ASH in December regarding HIP-modified
CD22-directed and GPRC5D-directed allogeneic CAR T cells and topics
related to fusogen specificity, extracorporeal delivery, and
applications in targeting hematopoietic stem cells.
Third Quarter 2023 Financial Results
GAAP Results
- Cash Position: Cash,
cash equivalents, and marketable securities as of September 30,
2023 were $268.6 million compared to $434.0 million as of December
31, 2022. The decrease of $165.4 million was primarily driven by
cash used in operations of $201.6 million and cash used for the
purchase of property and equipment of $6.0 million. The decrease in
cash was offset by net proceeds of $27.0 million from at the market
equity offerings during the nine months ended September 30, 2023.
The lease for our previously planned manufacturing facility in
Fremont, California (the Fremont facility) was terminated during
the third quarter of 2023, and the letter of credit of $6.7 million
associated with this lease was returned to Sana and is included in
cash and cash equivalents as of September 30, 2023.
- Research and Development
Expenses: For the three and nine months ended September
30, 2023, research and development expenses, inclusive of non-cash
expenses, were $65.6 million and $205.8 million, respectively,
compared to $76.7 million and $222.0 million for the same periods
in 2022. The decrease of $11.1 million for the three months ended
September 30, 2023 compared to the same period in 2022 was
primarily due to decreased laboratory and research costs associated
with lower research and development headcount, personnel-related
costs, and third-party manufacturing costs at contract development
and manufacturing organizations (CDMOs). The decrease of $16.2
million for the nine months ended September 30, 2023 compared to
the same period in 2022 was primarily due to decreased laboratory
and research costs, personnel-related costs, including non-cash
stock-based compensation expense, third-party manufacturing costs
at CDMOs, costs to acquire technology, and costs related to the
Fremont facility that are now included in general and
administrative expense. These decreases were partially offset by
increased clinical development costs, non-cash lease costs for
Sana's planned manufacturing facility in Bothell, Washington (the
Bothell facility), and depreciation. Research and development
expenses include non-cash stock-based compensation of $5.7 million
and $18.4 million, respectively, for the three and nine months
ended September 30, 2023, and $7.4 million and $20.6 million, for
the same periods in 2022.
- Research and Development
Related Success Payments and Contingent Consideration: For
the three and nine months ended September 30, 2023, Sana recognized
gains of $82.6 million and $55.8 million, respectively, in
connection with the change in the estimated fair value of the
success payment liabilities and contingent consideration in
aggregate, compared to gains of $6.1 million and $79.4 million for
the same periods in 2022. 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 and nine months ended September 30, 2023, inclusive of
non-cash expenses, were $19.2 million and $52.5 million,
respectively, compared to $15.5 million and $48.2 million for the
same periods in 2022. The increase of $3.7 million for the three
months ended September 30, 2023 compared to the same period in 2022
was primarily due to a loss on termination of lease associated with
the Fremont facility (Fremont lease) and an increase in patent and
other legal fees. These increases were partially offset by a
decrease in insurance costs. The increase of $4.3 million for the
nine months ended September 30, 2023 compared to the same period in
2022 was primarily due to an increase in patent and other legal
fees, a loss on termination of the Fremont lease, non-cash
stock-based compensation, costs related to the Fremont facility,
which were formerly in research and development expense, and
consulting fees. These increases were partially offset by the
write-off of construction in progress costs in 2022 for the Fremont
facility, and a decrease in insurance costs.
- Net Loss: Net income
for the three months ended September 30, 2023 was $1.0 million, or
$0.00 per share, and net loss for the nine months ended September
30, 2023 was $195.1 million, or $1.01 per share. Net loss for the
three and nine months ended September 30, 2022 were $85.1 million,
or $0.45 per share, and $189.0, or $1.01 per share,
respectively.
Non-GAAP Measures
- Non-GAAP Operating Cash
Burn: Non-GAAP operating cash burn for the nine months
ended September 30, 2023 was $187.2 million compared to $219.8
million for the same period in 2022. 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, costs related to the early
termination of the Fremont lease, non-recurring items, and the
purchase of property and equipment.
- Non-GAAP General and
Administrative Expenses: Non-GAAP general and
administrative expenses for the three and nine months ended
September 30, 2023 was $16.5 million and $49.8 million,
respectively, compared to $15.5 million and $43.8 million for the
same periods in 2022. Non-GAAP general and administrative expense
excludes the loss on termination of the Fremont lease and the
write-off of construction in progress costs incurred in connection
with the Fremont facility in 2022.
- Non-GAAP Net Loss:
Non-GAAP net loss for the three and nine months ended September 30,
2023 was $79.0 million, or $0.41 per share, and $248.3 million, or
$1.28 per share, respectively, compared to $91.2 million, or $0.48
per share, and $264.0 million, or $1.42 per share for the same
periods in 2022. Non-GAAP net loss excludes non-cash expenses and
gains related to the change in the estimated fair value of
contingent consideration and success payment liabilities, the loss
on termination of the Fremont lease, and the write-off of
construction in progress costs incurred in connection with the
Fremont facility in 2022.
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,
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 patients;
expectations regarding the Company’s participation at ASH;
expectations regarding the Company’s 2024 operating cash burn and
cash runway, including the impact of the Company’s cash position on
its ability to obtain data readouts from the Company’s clinical
trials; potential indications for the Company’s product candidates;
the potential of the IST to serve as clinical proof-of-platform for
the Company’s 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,
and the potential ability to replace missing islet cells without
immunosuppression by evading allogeneic and autoimmune responses;
and the impact of data from the IST on the development of SC451.
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 November 8, 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.com media@sana.com
Sana Biotechnology,
Inc.Unaudited Selected Consolidated Balance Sheet
Data
|
|
September 30, 2023 |
|
|
December 31, 2022 |
|
|
|
(in thousands) |
|
Cash, cash equivalents, and marketable securities |
|
$ |
268,570 |
|
|
$ |
434,014 |
|
Total assets |
|
|
631,440 |
|
|
|
822,720 |
|
Contingent consideration |
|
|
103,156 |
|
|
|
150,379 |
|
Success payment liabilities |
|
|
12,414 |
|
|
|
21,007 |
|
Total liabilities |
|
|
265,588 |
|
|
|
323,405 |
|
Total stockholders' equity |
|
|
365,852 |
|
|
|
499,315 |
|
|
|
|
|
|
|
|
|
|
Sana Biotechnology,
Inc.Unaudited Consolidated Statements of
Operations
|
|
Three Months Ended September 30, |
|
|
Nine Months Ended September 30, |
|
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
|
|
(in thousands, except per share data) |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
65,613 |
|
|
$ |
76,735 |
|
|
$ |
205,823 |
|
|
$ |
221,964 |
|
Research and development related success payments and contingent
consideration |
|
|
(82,615 |
) |
|
|
(6,062 |
) |
|
|
(55,816 |
) |
|
|
(79,428 |
) |
General and administrative |
|
|
19,183 |
|
|
|
15,514 |
|
|
|
52,515 |
|
|
|
48,240 |
|
Total operating expenses |
|
|
2,181 |
|
|
|
86,187 |
|
|
|
202,522 |
|
|
|
190,776 |
|
Loss from operations |
|
|
(2,181 |
) |
|
|
(86,187 |
) |
|
|
(202,522 |
) |
|
|
(190,776 |
) |
Interest income, net |
|
|
2,862 |
|
|
|
1,173 |
|
|
|
7,212 |
|
|
|
2,149 |
|
Other income (expense),
net |
|
|
303 |
|
|
|
(106 |
) |
|
|
172 |
|
|
|
(406 |
) |
Net income (loss) |
|
$ |
984 |
|
|
$ |
(85,120 |
) |
|
$ |
(195,138 |
) |
|
$ |
(189,033 |
) |
Net income (loss) per common
share – basic |
|
$ |
0.00 |
|
|
$ |
(0.45 |
) |
|
$ |
(1.01 |
) |
|
$ |
(1.01 |
) |
Weighted-average number of
common shares – basic |
|
|
196,978 |
|
|
|
189,303 |
|
|
|
193,605 |
|
|
|
187,645 |
|
Net income (loss) per share –
diluted |
|
$ |
0.00 |
|
|
$ |
(0.45 |
) |
|
$ |
(1.01 |
) |
|
$ |
(1.01 |
) |
Weighted-average shares
outstanding – diluted |
|
|
200,473 |
|
|
|
189,303 |
|
|
|
193,605 |
|
|
|
187,645 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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, 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 |
|
Changes in fair value – gain |
|
|
(24,037 |
) |
|
|
(58,578 |
) |
|
|
(82,615 |
) |
Liability balance as of September
30, 2023 |
|
$ |
12,414 |
|
|
$ |
103,156 |
|
|
$ |
115,570 |
|
Total change in fair value for
the nine months ended September 30, 2023 |
|
$ |
(8,593 |
) |
|
$ |
(47,223 |
) |
|
$ |
(55,816 |
) |
(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
|
|
Nine Months Ended September 30, |
|
|
|
2023 |
|
|
2022 |
|
|
|
(in thousands) |
|
Beginning cash, cash equivalents, and marketable securities |
|
$ |
434,014 |
|
|
$ |
746,877 |
|
Ending cash, cash equivalents,
and marketable securities |
|
|
268,570 |
|
|
|
511,573 |
|
Change in cash, cash
equivalents, and marketable securities |
|
|
(165,444 |
) |
|
|
(235,304 |
) |
Cash paid to purchase property and equipment |
|
|
5,986 |
|
|
|
16,274 |
|
Change in cash, cash
equivalents, and marketable securities, excluding capital
expenditures |
|
|
(159,458 |
) |
|
|
(219,030 |
) |
Adjustments: |
|
|
|
|
|
|
Net proceeds from issuance of common stock(1) |
|
|
(27,009 |
) |
|
|
(724 |
) |
Cash paid for restructuring(2) |
|
|
1,881 |
|
|
|
- |
|
Cash received in connection with the Coronavirus Aid, Relief, and
Economic Security Act |
|
|
(7,063 |
) |
|
|
- |
|
Cash paid in connection with the early termination of the Fremont
lease |
|
|
4,423 |
|
|
|
- |
|
Operating cash burn -
Non-GAAP |
|
$ |
(187,226 |
) |
|
$ |
(219,754 |
) |
(1) Net proceeds of $27.0 million were received in connection
with at market equity offerings in the nine months ended September
30, 2023.(2) The non-GAAP adjustment of $1.9 million for the nine
months ended September 30, 2023 consisted of cash payments related
to the portfolio prioritization and corporate restructuring in the
fourth quarter of 2022.
Sana Biotechnology,
Inc.Unaudited Reconciliation of GAAP to Non-GAAP
General and Administrative Expense
|
|
Three Months Ended September 30, |
|
|
Nine Months Ended September 30, |
|
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
|
|
(in thousands) |
|
General and administrative – GAAP |
|
$ |
19,183 |
|
|
$ |
15,514 |
|
|
$ |
52,515 |
|
|
$ |
48,240 |
|
Adjustments: |
|
|
|
|
|
|
|
|
|
|
|
|
Loss on termination of lease associated with the Fremont
facility(1) |
|
|
(2,668 |
) |
|
|
- |
|
|
|
(2,668 |
) |
|
|
- |
|
Write-off of construction in progress costs incurred in connection
with the Fremont facility |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(4,474 |
) |
General and administrative -
Non-GAAP |
|
$ |
16,515 |
|
|
$ |
15,514 |
|
|
$ |
49,847 |
|
|
$ |
43,766 |
|
(1) For the three and nine months ended September 30, 2023, the
loss of $2.7 million included $4.4 million in fees incurred, offset
by a gain of $1.7 million recorded in connection with the
derecognition of the right-of use asset and lease liability.
Sana Biotechnology,
Inc.Unaudited Reconciliation of GAAP to Non-GAAP
Net Loss and Net Loss Per Share
|
|
Three Months Ended September 30, |
|
|
Nine Months Ended September 30, |
|
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
|
|
(in thousands, except per share data) |
|
Net income (loss) – GAAP |
|
$ |
984 |
|
|
$ |
(85,120 |
) |
|
$ |
(195,138 |
) |
|
$ |
(189,033 |
) |
Adjustments: |
|
|
|
|
|
|
|
|
|
|
|
|
Change in the estimated fair value of the success payment
liabilities(1) |
|
|
(24,037 |
) |
|
|
2,193 |
|
|
|
(8,593 |
) |
|
|
(66,815 |
) |
Change in the estimated fair value of contingent
consideration(2) |
|
|
(58,578 |
) |
|
|
(8,255 |
) |
|
|
(47,223 |
) |
|
|
(12,613 |
) |
Loss on termination of lease associated with the Fremont
facility(3) |
|
|
2,668 |
|
|
|
- |
|
|
|
2,668 |
|
|
|
- |
|
Write-off of construction in progress costs incurred in connection
with the Fremont facility |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
4,474 |
|
Net loss – Non-GAAP |
|
$ |
(78,963 |
) |
|
$ |
(91,182 |
) |
|
$ |
(248,286 |
) |
|
$ |
(263,987 |
) |
Net income (loss) per share –
GAAP |
|
$ |
- |
|
|
$ |
(0.45 |
) |
|
$ |
(1.01 |
) |
|
$ |
(1.01 |
) |
Adjustments: |
|
|
|
|
|
|
|
|
|
|
|
|
Change in the estimated fair value of the success payment
liabilities(1) |
|
|
(0.12 |
) |
|
|
0.01 |
|
|
|
(0.04 |
) |
|
|
(0.36 |
) |
Change in the estimated fair value of contingent
consideration(2) |
|
|
(0.30 |
) |
|
|
(0.04 |
) |
|
|
(0.24 |
) |
|
|
(0.07 |
) |
Loss on termination of lease associated with the Fremont
facility(3) |
|
|
0.01 |
|
|
|
- |
|
|
|
0.01 |
|
|
|
- |
|
Write-off of construction in progress costs incurred in connection
with the Fremont facility |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
0.02 |
|
Net loss per share –
Non-GAAP |
|
$ |
(0.41 |
) |
|
$ |
(0.48 |
) |
|
$ |
(1.28 |
) |
|
$ |
(1.42 |
) |
Weighted-average shares
outstanding – basic |
|
|
196,978 |
|
|
|
189,303 |
|
|
|
193,605 |
|
|
|
187,645 |
|
(1) For the three and nine months ended September 30, 2023, the
gains related to the Cobalt success payment liability were $22.0
million and $8.3 million, respectively, compared to an expense of
$2.4 million and a gain of $56.5 million, respectively, for the
same periods in 2022. For the three and nine months ended September
30, 2023, the gains related to the Harvard success payment
liability were $2.0 million and $0.3 million, respectively,
compared to gains of $0.2 million and 10.3 million, respectively,
for the same periods in 2022. (2) The contingent consideration is
in connection with the acquisition of Cobalt.(3) For the three and
nine months ended September 30, 2023, the loss of $2.7 million
included $4.4 million in fees incurred, offset by a gain of $1.7
million recorded in connection with the derecognition of the
right-of use asset and lease liability.
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