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, 2023.
“2023 was an important year for the company, setting a strong
foundation in three therapeutic areas with significant unmet needs
– blood cancers, B-cell mediated autoimmune diseases, and type 1
diabetes. With the ongoing trials in these areas – ARDENT, GLEAM,
VIVID, and the primary islet cell investigator-sponsored trial – we
expect to treat 40-60 patients across multiple indications in 2024
and report data from each study,” said Steve Harr, Sana’s President
and Chief Executive Officer. “By year-end 2024, our goal is to
demonstrate that we are able to transplant allogeneic cells in
patients in multiple settings without immune detection or
rejection, delivering potentially transformative therapies across
multiple therapeutic areas. With the recent financing, we were able
to strengthen the balance sheet, allowing us to continue to invest
appropriately in moving our clinical pipeline forward.”
Recent Corporate Highlights
Advancing four clinical programs across seven
indications, including an allogeneic CAR T program targeting CD19+
cancers, an allogeneic CAR T program for B-cell mediated autoimmune
diseases, an allogeneic CAR T program targeting CD22+ cancers, and
a primary islet cell therapy in type 1 diabetes:
- SC291 is a hypoimmune (HIP)-modified
CD19-directed allogeneic CAR T for patients with B-cell
malignancies and B-cell mediated autoimmune diseases.
- The ARDENT trial evaluates SC291 in
patients with B-cell malignancies. Early SC291 data from the
ongoing ARDENT trial suggest the ability to dose safely, the
desired immune evasion profile, and early clinical efficacy.
Enrollment in this dose escalation study continues, and Sana
expects to share more data in 2024.
- The GLEAM trial evaluates SC291 in
patients with B-cell mediated autoimmune diseases including lupus
nephritis, extrarenal lupus, and antineutrophil cytoplasmic
antibody (ANCA)-associated vasculitis. The Investigational New Drug
Application (IND) cleared in 4Q 2023, and Sana expects to share
initial data in 2024.
- The VIVID trial evaluates SC262, a
HIP-modified CD22-directed allogeneic CAR T, in patients with
relapsed or refractory B-cell malignancies. The VIVID trial
initially investigates SC262 in patients who have received prior
CD19-directed CAR T therapy. The IND cleared in early 2024, and
Sana expects to share initial data in 2024.
- UP421 is a primary human HIP-modified
islet cell therapy for patients with type 1 diabetes. The goal of
this investigator-sponsored trial is to understand islet cell
survival and immune evasion without immunosuppression in patients
with autoimmunity, along with function as measured by C-peptide
production. The Clinical Trial Application (CTA) cleared in 4Q
2023, and Sana expects initial data to be shared in the first half
of 2024.
Published preclinical data in Cell Stem
Cell demonstrating that HIP-modified islet cells
provided lasting endocrine function in a fully immunocompetent
non-human primate, enabling the achievement of exogenous insulin
independence without immunosuppression for six-month study
duration:
- Sana developed HIP-modified allogeneic
islet cells, which cluster into effective endocrine organoids
termed “pseudo islet grafts” (p-islets). HIP p-islets engrafted and
provided stable endocrine function, enabling insulin independence
in the absence of immunosuppression.
- The allogeneic HIP p-islet graft
survived for the six-month duration of the study with no indication
of immune recognition of the HIP p-islet engraftment at any
time.
- To demonstrate that there was no
regeneration or recovery of an endogenous islet cell population in
the diabetic NHP, HIP p-islets were eliminated using an anti-CD47
antibody, demonstrating proof of principle of CD47 overexpression
and a potential safety switch.
Published preclinical data in Nature
Communications, Science
Translational Medicine, and
Nature Biotechnology describing immune
evasion, persistence, and durable anti-tumor activity of
HIP-modified CD19-directed CAR T cells and HIP-modified
pseudo-islets control type 1 diabetes in preclinical
models:
- Sana developed HIP-modified
CD19-targeted allogeneic CAR T cells and compared them to
unmodified CD19-targeted allogeneic CAR T cells in a murine
leukemia model with a humanized immune system. Although both
HIP-modified and unmodified CAR T cells showed robust early tumor
killing, cell durability was much greater in humanized mice treated
with HIP-modified cells. HIP-modified allogeneic CAR T cells
persisted and removed all evidence of tumor for the duration of the
study. HIP-modified CAR T cells also cleared all evidence of tumor
after re-injection with cancer cells 90 days into the study.
- Preclinical data showed that p-islets
survive, persist, escape allogeneic and autoimmune rejection, and
normalize blood glucose in diabetic models with humanized immune
systems.
- Preclinical data demonstrated that
HIP-modified cells survive allogeneic transplant across several
species, including non-human primates with normal immune systems,
and remain fully functional.
Advanced Sana’s HIP ex vivo
platform with presentations at AACR, ADA, ISSCR, and
ASH:
- Presented preclinical data
demonstrating that HIP-modified CAR T cells provide lasting tumor
control in immunocompetent allogeneic humanized mice even with
tumor re-challenge.
- Presented preclinical data showing that
HIP-modified CD19-directed CAR T cells have the potential to serve
as a universal off-the-shelf therapy with long-term durability of
response without immunosuppression.
- Presented preclinical data showing
HIP-modified primary pancreatic islet cells alleviate type 1
diabetes in humanized mice and avoid immune rejection without
immunosuppression.
- Presented preclinical data showing that
intramuscular administration of islet cells in humanized mice does
not impact cell function and viability and may serve as a preferred
administration route for patients.
- Presented preclinical data supporting
HIP-modified CD22-directed and GPRC5D-directed allogeneic CAR T
cell programs.
- Presented preclinical data highlighting
the SC379 glial progenitor cell program.
Completed financing with gross proceeds of approximately
$189.8 million to further support activities to enable multiple
data readouts and announced key corporate updates:
- Closed on an upsized public offering in
February 2024 of 21.8 million shares of Sana’s common stock, which
includes the full exercise of the underwriter’s option, and
pre-funded warrants to purchase 12.7 million shares of Sana’s
common stock. The gross proceeds from this offering were
approximately $189.8 million before deducting underwriting
discounts and commissions and estimated offering expenses.
- Strengthened the Research and
Development leadership with the appointment of two seasoned drug
developers, Doug Williams, Ph.D., as President of Research and
Development, and Gary Meininger, M.D., as Chief Medical
Officer.
- Announced an increased focus on the ex
vivo cell therapy platform based on extensive preclinical and early
translational clinical data and a reduction in near-term investment
on the fusogen in vivo delivery platform, resulting in an expected
2024 operating burn below $200 million.
- Named on the BioSpace 2024 Best Places
to Work small employers list for the second year in a row.
Fourth Quarter 2023 Financial Results
GAAP Results
- Cash Position: Cash,
cash equivalents, and marketable securities as of December 31, 2023
were $205.2 million compared to $434.0 million as of December 31,
2022. The decrease of $228.8 million was primarily driven by cash
used in operations of $253.6 million and cash used for the purchase
of property and equipment of $20.0 million. The decrease in cash
was partially offset by net proceeds of $27.0 million from at the
market equity offerings during the year ended December 31,
2023.
- Research and Development
Expenses: For the three and twelve months ended December
31, 2023, research and development expenses, inclusive of non-cash
expenses, were $63.0 million and $268.8 million, respectively,
compared to $63.9 million and $285.9 million for the same periods
in 2022. The decrease of $0.9 million for the three months ended
December 31, 2023 compared to the same period in 2022 was primarily
due to decreased laboratory and research costs, partially due to
the portfolio prioritizations in 2022 and 2023, a decline in
personnel-related costs, including non-cash stock-based
compensation, and lower costs for third-party manufacturing at
CDMOs. These decreases were partially offset by costs incurred
related to the impairment of certain lab equipment and leasehold
improvements, primarily due to the portfolio prioritization in the
fourth quarter of 2023 and increased clinical development costs.
The decrease of $17.1 million for the twelve months ended December
31, 2023 compared to the same period in 2022 was primarily due to
decreased laboratory and research costs partially due to the
portfolio prioritizations in 2022 and 2023, lower costs for
third-party manufacturing at CDMOs, decreased costs to acquire
technology, and lower non-cash stock-based compensation expense.
These decreases were partially offset by increased clinical
development costs and costs incurred related to the impairment of
certain lab equipment and leasehold improvements, primarily due to
the portfolio prioritization in the fourth quarter of 2023.
Research and development expenses include non-cash stock-based
compensation of $4.9 million and $23.2 million, respectively, for
the three and twelve months ended December 31, 2023, and $6.0
million and $26.6 million, for the same periods in 2022.
- Research and Development
Related Success Payments and Contingent Consideration: For
the three and twelve months ended December 31, 2023, Sana
recognized a non-cash expense of $6.8 million and a non-cash gain
of $49.0 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 $5.5
million and $84.9 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 twelve months ended December 31, 2023, inclusive of
non-cash expenses, were $20.8 million and $73.3 million,
respectively, compared to $23.3 million and $71.6 million for the
same periods in 2022. The decrease of $2.5 million for the three
months ended December 31, 2023 compared to the same period in 2022
was primarily due lower personnel-related costs, including non-cash
stock-based compensation, a decrease in costs related to Sana’s
previously planned manufacturing facility in Fremont, California
(Fremont facility), which were formerly in research and development
expense, and lower insurance costs. These decreases were partially
offset by an increase in patent and other legal fees. The increase
of $1.7 million for the twelve months ended December 31, 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
lease associated with the Fremont facility (Fremont lease), and
increased facility costs. 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 loss for
the three and twelve months ended December 31, 2023 was $88.1
million, or $0.45 per share, and $283.3 million, or $1.46 per
share, respectively, compared to $80.4 million, or $0.42 per share,
and $269.5 million, or $1.43 per share for the same periods in
2022.
Non-GAAP Measures
- Non-GAAP Operating Cash
Burn: Non-GAAP operating cash burn for the twelve months
ended December 31, 2023 was $233.0 million compared to $288.3
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 Research and
Development Expenses: Non-GAAP research and development
expenses for the three and twelve months ended December 31, 2023
were $56.0 million and $261.8 million, respectively, compared to
$63.9 million and $285.9 million for the same periods in 2022.
Non-GAAP research and development expense in 2023 excludes an
expense related to the impairment of certain lab equipment and
leasehold improvements, primarily due to the portfolio
prioritization in the fourth quarter of 2023.
- Non-GAAP General and
Administrative Expenses: Non-GAAP general and
administrative expenses for the three and twelve months ended
December 31, 2023 were $15.6 million and $65.4 million,
respectively, compared to $14.6 million and $58.4 million for the
same periods in 2022. Non-GAAP general and administrative expense
excludes personnel-related costs related to the portfolio
prioritizations in the fourth quarters of 2023 and 2022, the net
expense recorded in connection with the early termination of the
Fremont lease and derecognition of the related right-of-use asset
and lease liability in 2023, 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 twelve months ended December
31, 2023 was $69.1 million, or $0.35 per share, and $317.4 million,
or $1.63 per share, respectively, compared to $77.2 million, or
$0.40 per share, and $341.2 million, or $1.81 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,
personnel-related costs related to portfolio prioritizations in the
fourth quarters of 2023 and 2022, an expense related to the
impairment of certain lab equipment and leasehold improvements,
primarily due to the portfolio prioritization in the fourth quarter
of 2023, the net expense recorded in connection with the early
termination of the Fremont lease and derecognition of the related
right-of-use asset and lease liability in 2023, 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 number of patients to be
treated and the indications to be evaluated in its clinical trials
in 2024; 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; the
potential ability to use hypoimmune technology to dose safely and
achieve efficacy in certain indications; expectations regarding the
Company’s 2024 operating cash burn; expectations regarding the
potential of the gross proceeds from the recent financing along
with the Company’s existing cash position to support activities
through multiple data readouts; and the ability to demonstrate by
year-end 2024 that the Company’s is able to transplant allogeneic
cells in patients in multiple settings without immune detection or
rejection. 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 Annual Report on Form 10-K dated February 29, 2024. 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, 2023 |
|
|
December 31, 2022 |
|
|
(in thousands) |
|
Cash, cash equivalents, and marketable securities |
$ |
205,195 |
|
|
$ |
434,014 |
|
Total assets |
|
565,299 |
|
|
|
822,720 |
|
Contingent consideration |
|
109,606 |
|
|
|
150,379 |
|
Success payment liabilities |
|
12,799 |
|
|
|
21,007 |
|
Total liabilities |
|
277,793 |
|
|
|
323,405 |
|
Total stockholders' equity |
|
287,506 |
|
|
|
499,315 |
|
Sana Biotechnology, Inc.Unaudited
Consolidated Statements of Operations |
|
|
Three Months Ended December 31, |
|
|
Twelve Months Ended December 31, |
|
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
|
(in thousands, except per share data) |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
Research and development |
$ |
63,000 |
|
|
$ |
63,921 |
|
|
$ |
268,823 |
|
|
$ |
285,885 |
|
Research and development related success payments and contingent
consideration |
|
6,835 |
|
|
|
(5,454 |
) |
|
|
(48,981 |
) |
|
|
(84,882 |
) |
General and administrative |
|
20,784 |
|
|
|
23,321 |
|
|
|
73,299 |
|
|
|
71,561 |
|
Total operating expenses |
|
90,619 |
|
|
|
81,788 |
|
|
|
293,141 |
|
|
|
272,564 |
|
Loss from operations |
|
(90,619 |
) |
|
|
(81,788 |
) |
|
|
(293,141 |
) |
|
|
(272,564 |
) |
Interest income, net |
|
2,726 |
|
|
|
1,613 |
|
|
|
9,938 |
|
|
|
3,762 |
|
Other expense, net |
|
(224 |
) |
|
|
(268 |
) |
|
|
(52 |
) |
|
|
(674 |
) |
Net loss |
$ |
(88,117 |
) |
|
$ |
(80,443 |
) |
|
$ |
(283,255 |
) |
|
$ |
(269,476 |
) |
Net loss per common share –
basic and diluted |
$ |
(0.45 |
) |
|
$ |
(0.42 |
) |
|
$ |
(1.46 |
) |
|
$ |
(1.43 |
) |
Weighted-average number of
common shares – basic and diluted |
|
197,317 |
|
|
|
190,420 |
|
|
|
194,541 |
|
|
|
188,344 |
|
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 |
|
Changes in fair value – expense |
|
385 |
|
|
|
6,450 |
|
|
|
6,835 |
|
Liability balance as of December
31, 2023 |
$ |
12,799 |
|
|
$ |
109,606 |
|
|
$ |
122,405 |
|
Total change in fair value for
the twelve months ended December 31, 2023 |
$ |
(8,208 |
) |
|
$ |
(40,773 |
) |
|
$ |
(48,981 |
) |
(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, |
|
|
|
2023 |
|
|
|
2022 |
|
|
(in thousands) |
|
Beginning cash, cash
equivalents, and marketable securities |
$ |
434,014 |
|
|
$ |
746,877 |
|
Ending cash, cash equivalents,
and marketable securities |
|
205,195 |
|
|
|
434,014 |
|
Change in cash, cash
equivalents, and marketable securities |
|
(228,819 |
) |
|
|
(312,863 |
) |
Cash paid to purchase property and equipment |
|
20,032 |
|
|
|
20,876 |
|
Change in cash, cash
equivalents, and marketable securities, excluding capital
expenditures |
|
(208,787 |
) |
|
|
(291,987 |
) |
Adjustments: |
|
|
|
|
|
Net proceeds from issuance of common stock(1) |
|
(27,020 |
) |
|
|
(601 |
) |
Cash paid in connection with the termination of the Fremont
lease |
|
4,423 |
|
|
|
- |
|
Cash paid for personnel-related costs related to portfolio
prioritizations |
|
5,454 |
|
|
|
4,333 |
|
Cash received in connection with the Coronavirus Aid, Relief, and
Economic Security Act |
|
(7,063 |
) |
|
|
- |
|
Operating cash burn –
Non-GAAP |
$ |
(232,993 |
) |
|
$ |
(288,255 |
) |
(1) Net proceeds of $27.0 million and $0.6 million were
received in connection with at market equity offerings in the
twelve months ended December 31, 2023 and 2022, respectively.
Sana Biotechnology, Inc.Unaudited
Reconciliation of GAAP to Non-GAAP Research and Development
Expense |
|
|
Three Months Ended December 31, |
|
|
Twelve Months Ended December 31, |
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
|
(in thousands) |
|
Research and development expense – GAAP |
$ |
63,000 |
|
|
$ |
63,921 |
|
|
$ |
268,823 |
|
|
$ |
285,885 |
|
Adjustments: |
|
|
|
|
|
|
|
|
|
|
|
Expense related to the impairment of certain lab equipment and
leasehold improvements(1) |
|
(7,014 |
) |
|
|
- |
|
|
|
(7,014 |
) |
|
|
- |
|
Research and development
expense – Non-GAAP |
$ |
55,986 |
|
|
$ |
63,921 |
|
|
$ |
261,809 |
|
|
$ |
285,885 |
|
(1) The impairment of $7.0 million recorded in the three
months ended December 31, 2023 was primarily related to the
portfolio prioritization that occurred during the quarter.
Sana Biotechnology, Inc.Unaudited
Reconciliation of GAAP to Non-GAAP General and Administrative
Expense |
|
|
Three Months Ended December 31, |
|
|
Twelve Months Ended December 31, |
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
|
(in thousands) |
|
General and administrative – GAAP |
$ |
20,784 |
|
|
$ |
23,321 |
|
|
$ |
73,299 |
|
|
$ |
71,561 |
|
Adjustments: |
|
|
|
|
|
|
|
|
|
|
|
Costs incurred in connection with portfolio prioritizations |
|
(5,203 |
) |
|
|
(8,704 |
) |
|
|
(5,203 |
) |
|
|
(8,704 |
) |
Loss on termination of Fremont lease(1) |
|
- |
|
|
|
- |
|
|
|
(2,668 |
) |
|
|
- |
|
Write-off of construction in progress costs incurred in connection
with the Fremont facility |
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(4,474 |
) |
General and administrative –
Non-GAAP |
$ |
15,581 |
|
|
$ |
14,617 |
|
|
$ |
65,428 |
|
|
$ |
58,383 |
|
(1) For the twelve months ended December 31, 2023, the net
expense 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 December 31, |
|
|
Twelve Months Ended December 31, |
|
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
|
(in thousands, except per share data) |
|
Net loss – GAAP |
$ |
(88,117 |
) |
|
$ |
(80,443 |
) |
|
$ |
(283,255 |
) |
|
$ |
(269,476 |
) |
Adjustments: |
|
|
|
|
|
|
|
|
|
|
|
Change in the estimated fair value of the success payment
liabilities(1) |
|
385 |
|
|
|
(14,703 |
) |
|
|
(8,208 |
) |
|
|
(81,518 |
) |
Change in the estimated fair value of contingent
consideration(2) |
|
6,450 |
|
|
|
9,249 |
|
|
|
(40,773 |
) |
|
|
(3,364 |
) |
Costs incurred in connection with portfolio prioritizations |
|
5,203 |
|
|
|
8,704 |
|
|
|
5,203 |
|
|
|
8,704 |
|
Loss on termination of Fremont lease(3) |
|
- |
|
|
|
- |
|
|
|
2,668 |
|
|
|
- |
|
Write-off of construction in progress costs incurred in connection
with the Fremont facility |
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
4,474 |
|
Expense related to the impairment of certain lab equipment and
leasehold improvements(4) |
|
7,014 |
|
|
|
- |
|
|
|
7,014 |
|
|
|
- |
|
Net loss – Non-GAAP |
$ |
(69,065 |
) |
|
$ |
(77,193 |
) |
|
$ |
(317,351 |
) |
|
$ |
(341,180 |
) |
Net loss per share – GAAP |
$ |
(0.45 |
) |
|
$ |
(0.42 |
) |
|
$ |
(1.46 |
) |
|
$ |
(1.43 |
) |
Adjustments: |
|
|
|
|
|
|
|
|
|
|
|
Change in the estimated fair value of the success payment
liabilities(1) |
|
- |
|
|
|
(0.08 |
) |
|
|
(0.04 |
) |
|
|
(0.43 |
) |
Change in the estimated fair value of contingent
consideration(2) |
|
0.03 |
|
|
|
0.05 |
|
|
|
(0.21 |
) |
|
|
(0.02 |
) |
Costs incurred in connection with portfolio prioritizations |
|
0.03 |
|
|
|
0.05 |
|
|
|
0.03 |
|
|
|
0.05 |
|
Loss on termination of Fremont lease(3) |
|
- |
|
|
|
- |
|
|
|
0.01 |
|
|
|
- |
|
Write-off of construction in progress costs incurred in connection
with the Fremont facility |
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
0.02 |
|
Expense related to the impairment of certain lab equipment and
leasehold improvements(4) |
|
0.04 |
|
|
|
- |
|
|
|
0.04 |
|
|
|
- |
|
Net loss per share –
Non-GAAP |
$ |
(0.35 |
) |
|
$ |
(0.40 |
) |
|
$ |
(1.63 |
) |
|
$ |
(1.81 |
) |
Weighted-average shares
outstanding – basic and diluted |
|
197,317 |
|
|
|
190,420 |
|
|
|
194,541 |
|
|
|
188,344 |
|
(1) For the three months ended December 31, 2023, the
expense related to the Cobalt success payment liability was $0.4
million compared to a gain of $7.9 million for the twelve months
ended December 31, 2023. For the three and twelve months ended
December 31, 2022, the gains related to the Cobalt success payment
liability were $12.9 million and $69.3 million, respectively. For
the three and twelve months ended December 31, 2023, the gains
related to the Harvard success payment liability were $12.0
thousand and $0.3 million, respectively, compared to gains of $1.8
million and 12.2 million, respectively, for the same periods in
2022. (2) The contingent consideration is in connection with
the acquisition of Cobalt.(3) For the twelve months ended
December 31, 2023, the net expense 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.(4) The impairment of $7.0 million recorded
in the three months ended December 31, 2023 was primarily related
to the portfolio prioritization that occurred during the
quarter.
Grafico Azioni Sana Biotechnology (NASDAQ:SANA)
Storico
Da Nov 2024 a Dic 2024
Grafico Azioni Sana Biotechnology (NASDAQ:SANA)
Storico
Da Dic 2023 a Dic 2024