On this page of StockholderLetter.com we present the latest annual shareholder letter from Sana Biotechnology, Inc. — ticker symbol SANA. Reading current and past SANA letters to shareholders can bring important insights into the investment thesis.

$Dear Fellow Stockholders, maniacal in controlling our spend. We have increased our cost discipline, made tough choices around our portfolio, DQG VLJQL FDQWO\ GHFUHDVHG RXU EXUQ UDWH 7KHVH VWHSV have been painful, and there are no guarantees that we are GRQH EXW E\ WDNLQJ WKHP ZH KDYH LQFUHDVHG RXU ORQJ WHUP probability of success given the current market. Not every HI FDFLRXV GUXJ ZLOO JHW GHYHORSHG JLYHQ WKH FXUUHQW macroeconomic conditions, but we will do everything we can to push forward our most promising candidates. Charles Dickens opening from $ Tale of Two Cities It was the best of times, it was the worst of times captures much of the current moment at Sana. Our science is unfolding in an incredibly exciting way. I am more optimistic than ever that we will make a disruptive and positive impact with one or many important medicines, translating into an important company. At the same time, our stock price remains under tremendous pressure. In this letter I will address that challenge as well as our path forward. We have made tremendous progress in proving our two platforms hiding allogeneic cells from rejection and the in vivo delivery of genetic material as well as translating them into impactful therapies. Before delving into our progress, though, I want to address some of the adversities we face. Cell and gene therapies are out of favor with investors, and to a lesser extent, with large companies that are potential partners. The capital needed for success is deemed too great, and even if success occurs, there are questions about the one and done curative business model. The upfront costs at treatment can strain patients, payers, government/employers, and even providers. Beyond that, macro factors such DV JHRSROLWLFDO WXUEXOHQFH XQFHUWDLQW\ DERXW LQ DWLRQ and prospects for economic growth, new tariffs, and a higher for longer interest rate environment have combined to put pressure on all risk assets. Despite PHDQLQJIXO VFLHQWL F GH ULVNLQJ ZH KDYH DFKLHYHG RYHU the past several years, the combined impact of these factors is a higher cost of capital for Sana. To survive and thrive in this environment, we need to make our balance sheet last longer, and over time, we need to show that we can deliver value to patients at a reasonable cost. In the near term, that means being Second, we need to strengthen our balance sheet, as the company will need more money to keep executing on our mission. There are multiple mechanisms for bringing capital into the company, including corporate partnerships, which typically both bring in cash and reduce burn; selling equity; raising debt; and some novel and alternative mechanisms we are working on. Like most biotech companies, we will almost certainly raise capital through issuing stock over time, which should FRPH DV QR VXUSULVH WR DQ\ LQYHVWRU LQ WKLV HOG 7KDW said, right now, we believe we have better options that will unlock meaningful shareholder value. Although there is no guarantee that we will be able to execute on these options, stay tuned, as our management team and board are focused here and understand how critical capital is to the company s future. Let me turn to why I am so optimistic about our future. :H QRZ KDYH DOO WKH FRPSRQHQWV WR EXLOG D RQH WLPH functionally curative therapy for type 1 diabetes, a disease that impacts almost 2 million people in the US and over 9 million people worldwide. We recently showed, in a human study, that we can overcome the most important limitation to making a safe and effective treatment with the potential for broad adoption by this patient population overcoming immune rejection of allogeneic (somebody else s) pancreatic beta cells without the need for immunosuppression. We need the time and capital to make this potential a reality, to watch vigilantly for any safety issues, and eventually to increase our manufacturing scale to meet the size of the XQPHW QHHG *LYHQ WKH SURJUHVV DW 6DQD DQG LQ WKH HOG ZH EHOLHYH WKDW D VLPSOH RQH WLPH WUHDWPHQW OHDGLQJ WR ORQJ WHUP QRUPDO EORRG JOXFRVH ZLWK QR QHHG IRU DQ\ further insulin therapy or immunosuppression is now inevitable. Our job is to make Sana the company that delivers this transformative therapeutic. Type 1 diabetes is a disease in which a person s immune system attacks and kills pancreatic beta cells, rendering the person incapable of making insulin and controlling blood glucose. The disease was a death sentence until the discovery of insulin therapy 100 years ago, and despite$
$many improvements over the past century, the unmet need remains substantial. People with type 1 diabetes OLYH \HDUV OHVV WKDQ WKRVH ZLWKRXW LW GXULQJ WKDW time they are at risk for side effects from blood sugar that is too low (coma or death) and too high (coma, amputation, blindness, kidney failure, heart attack, VWURNH DQG PRUH DQG WKH GD\ WR GD\ PRQLWRULQJ DQG treatment is taxing. Patients deserve a better answer. About 25 years ago, clinicians started transplanting primary pancreatic islets (islets are made of pancreatic alpha, beta, and delta cells) from recently deceased donors, and many patients who receive those transplants can remain off insulin therapy for well over a decade. Unfortunately, cadaveric sourcing is not predictable, KDV VLJQL FDQW YDULDELOLW\ EHWZHHQ GRQRUV DQG LV QRW VFDODEOH $GGLWLRQDOO\ SDWLHQWV QHHG WR PDLQWDLQ OLIH long immunosuppression, and because the toxicities from these medicines are substantial at present, there are not that many patients for whom this degree of immunosuppression is better than insulin. Over the past few years, several groups have shown that they can take pluripotent stem cells, differentiate them into pancreatic islets, and transplant them successfully into patients. This method appears to provide a more consistent product and offers a clearer path to scalability. +RZHYHU LW VWLOO UHTXLUHV VLJQL FDQW LPPXQRVXSSUHVVLRQ limiting its potential impact. Therefore, the key element standing between the current state and a functional cure for this disease a single treatment leading to normal blood sugar with no more insulin or immunosuppression is removing the immunosuppression. Since the advent of transplant medicine, the rejection of allogeneic cells has been a key limiting factor. We have proven in multiple preclinical models and now in humans that we can overcome this limitation using our hypoimmune, or HIP, technology. ,Q HDUO\ ZH UHSRUWHG WKH UVW LQ KXPDQ VWXG\ VKRZLQJ WKDW ZH FDQ WUDQVSODQW JHQH PRGL HG +,3 pancreatic islets into the arm of a person with type 1 GLDEHWHV DQG WKH FHOOV VXUYLYH DQG IXQFWLRQ 7KH UVW patient in this study is now out over 3 months, making KLV RZQ LQVXOLQ IRU WKH UVW WLPH LQ RYHU \HDUV DQG he is on NO immunosuppressive drugs. As far as we NQRZ WKLV LV WKH UVW VXFFHVVIXO H[DPSOH RI WUDQVSODQWLQJ allogeneic cells with no immunosuppression into a patient with normal immune function. In fact, this patient KDV D SUH H[LVWLQJ DXWRLPPXQH UHVSRQVH WR SDQFUHDWLF beta cells from his type 1 diabetes, and we still have seen no evidence of rejection. This outcome is truly transformative for diabetic patients, and its implications over time can extend to many other areas. I do not want to minimize the challenging work ahead of us. I also think it is important for all stakeholders patients with type 1 diabetes, their families, governments, payers, regulators, providers, and our shareholders to understand how transformative this drug, and the broader technology, can be. Millions of people are waiting for it, and we need to deliver. The next year will undoubtedly bring opportunities as ZHOO DV GLI FXOW FKRLFHV :H KDYH D QXPEHU RI DVVHWV LQ development, but no other has the potential upside of a drug for type 1 diabetes. Stay tuned, as we expect to have data in diseases ranging from lupus to refractory blood cancers in 2025 and 2026. We are optimistic about the progress we have made with our in vivo delivery capability, and in particular, recent progress in making in vivo CAR T cells. In a space that has been searching for differentiation, we believe our technology may offer something important and novel. We hope to move all of these assets forward, either on our own or with a partner. No matter what path we choose, we will protect our ability to prosecute the opportunity in diabetes. Charles Dickens was a realist with a slight bent toward optimism. Starting and running a biotech company in any environment, but particularly this one, requires a similar PLQGVHW :H UPO\ EHOLHYH LQ RXU DELOLW\ WR WUDQVIRUP WKH possible for patients with our medicines, which are the result of years of hard work from our team. We recognize that the path has not been easy, and the road ahead is not completely clear. Our mission is clear, however, and we have a team with the insight, resilience, curiosity, and humility to see it through. On behalf of our employees and board, I thank you, our shareholders, for your support and patience. It is a tough market, and we have faced some headwinds. Regardless, we need to deliver for you. Know that I wake up every day focused on this task. I expect to report a year of meaningful progress with next year s letter and look forward to brighter days for us all. Steve Harr, MD$
$FORWARD-LOOKING STATEMENTS 7KLV OHWWHU FRQWDLQV IRUZDUG ORRNLQJ VWDWHPHQWV DERXW 6DQD %LRWHFKQRORJ\ ,QF ZLWKLQ WKH PHDQLQJ RI WKH IHGHUDO securities laws, including those related to our vision, progress, and business plans and expectations for our development programs, product candidates, and technology platforms, including with respect to the potential timing DQG VLJQL FDQFH RI GDWD IURP RXU FOLQLFDO WULDOV WKH SRWHQWLDO EHQH WV RI RXU SURGXFW FDQGLGDWHV DQG WHFKQRORJLHV and our potential ability to progress our development programs, including in certain indications. All statements other than statements of historical facts contained in this letter, including, among others, statements regarding our VWUDWHJ\ H[SHFWDWLRQV DQG SURVSHFWV DUH IRUZDUG ORRNLQJ VWDWHPHQWV ,Q VRPH FDVHV \RX FDQ LGHQWLI\ IRUZDUG ORRNLQJ 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. We have based WKHVH IRUZDUG ORRNLQJ VWDWHPHQWV ODUJHO\ RQ RXU FXUUHQW H[SHFWDWLRQV HVWLPDWHV IRUHFDVWV DQG SURMHFWLRQV DERXW IXWXUH HYHQWV DQG QDQFLDO WUHQGV WKDW ZH EHOLHYH PD\ DIIHFW RXU QDQFLDO FRQGLWLRQ UHVXOWV RI RSHUDWLRQV EXVLQHVV VWUDWHJ\ DQG QDQFLDO QHHGV ,Q OLJKW RI WKH VLJQL FDQW XQFHUWDLQWLHV LQ WKHVH IRUZDUG ORRNLQJ VWDWHPHQWV \RX VKRXOG QRW UHO\ XSRQ IRUZDUG ORRNLQJ VWDWHPHQWV DV SUHGLFWLRQV RI IXWXUH HYHQWV 7KHVH VWDWHPHQWV DUH VXEMHFW WR ULVNV DQG 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 our 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 our actual results, please refer to the risk IDFWRUV LGHQWL HG LQ RXU UHSRUWV OHG ZLWK WKH 6HFXULWLHV DQG ([FKDQJH &RPPLVVLRQ LQFOXGLQJ EXW QRW OLPLWHG WR RXU $QQXDO 5HSRUW RQ )RUP . GDWHG 0DUFK ([FHSW DV UHTXLUHG E\ ODZ ZH XQGHUWDNH QR REOLJDWLRQ WR XSGDWH SXEOLFO\ DQ\ IRUZDUG ORRNLQJ VWDWHPHQWV IRU DQ\ UHDVRQ$

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4/25/2025 Letter Continued (Full PDF)
•

4/28/2023 SANA Stockholder Letter
•

4/26/2024 SANA Stockholder Letter
•

More "Biotechnology" Category Stockholder Letters
•

SANA Benford's Law Stock Score = 84

SANA Shareholder/Stockholder Letter Transcript:

Annual Report
2024

Dear Fellow Stockholders,
maniacal in controlling our spend. We have increased our
cost discipline, made tough choices around our portfolio,
DQG VLJQL FDQWO\ GHFUHDVHG RXU EXUQ UDWH 7KHVH VWHSV
have been painful, and there are no guarantees that we are
GRQH EXW E\ WDNLQJ WKHP ZH KDYH LQFUHDVHG RXU ORQJ WHUP
probability of success given the current market. Not every
HI FDFLRXV GUXJ ZLOO JHW GHYHORSHG JLYHQ WKH FXUUHQW
macroeconomic conditions, but we will do everything we
can to push forward our most promising candidates.
Charles Dickens opening from $ Tale of Two Cities
It was the best of times, it was the worst of times
captures much of the current moment at Sana. Our
science is unfolding in an incredibly exciting way. I am
more optimistic than ever that we will make a disruptive
and positive impact with one or many important
medicines, translating into an important company. At the
same time, our stock price remains under tremendous
pressure. In this letter I will address that challenge as
well as our path forward.
We have made tremendous progress in proving our two
platforms hiding allogeneic cells from rejection and
the in vivo delivery of genetic material as well as
translating them into impactful therapies. Before delving
into our progress, though, I want to address some of the
adversities we face. Cell and gene therapies are out of
favor with investors, and to a lesser extent, with large
companies that are potential partners. The capital needed
for success is deemed too great, and even if success
occurs, there are questions about the one and done
curative business model. The upfront costs at treatment
can strain patients, payers, government/employers,
and even providers. Beyond that, macro factors such
DV JHRSROLWLFDO WXUEXOHQFH XQFHUWDLQW\ DERXW LQ DWLRQ
and prospects for economic growth, new tariffs, and
a higher for longer interest rate environment have
combined to put pressure on all risk assets. Despite
PHDQLQJIXO VFLHQWL F GH ULVNLQJ ZH KDYH DFKLHYHG RYHU
the past several years, the combined impact of these
factors is a higher cost of capital for Sana.
To survive and thrive in this environment, we need to
make our balance sheet last longer, and over time, we
need to show that we can deliver value to patients at
a reasonable cost. In the near term, that means being
Second, we need to strengthen our balance sheet, as
the company will need more money to keep executing
on our mission. There are multiple mechanisms for
bringing capital into the company, including corporate
partnerships, which typically both bring in cash and
reduce burn; selling equity; raising debt; and some novel
and alternative mechanisms we are working on. Like
most biotech companies, we will almost certainly raise
capital through issuing stock over time, which should
FRPH DV QR VXUSULVH WR DQ\ LQYHVWRU LQ WKLV HOG 7KDW
said, right now, we believe we have better options that
will unlock meaningful shareholder value. Although
there is no guarantee that we will be able to execute
on these options, stay tuned, as our management team
and board are focused here and understand how critical
capital is to the company s future.
Let me turn to why I am so optimistic about our future.
:H QRZ KDYH DOO WKH FRPSRQHQWV WR EXLOG D RQH WLPH
functionally curative therapy for type 1 diabetes, a
disease that impacts almost 2 million people in the
US and over 9 million people worldwide. We recently
showed, in a human study, that we can overcome the
most important limitation to making a safe and effective
treatment with the potential for broad adoption by this
patient population overcoming immune rejection
of allogeneic (somebody else s) pancreatic beta cells
without the need for immunosuppression. We need
the time and capital to make this potential a reality, to
watch vigilantly for any safety issues, and eventually to
increase our manufacturing scale to meet the size of the
XQPHW QHHG *LYHQ WKH SURJUHVV DW 6DQD DQG LQ WKH HOG
ZH EHOLHYH WKDW D VLPSOH RQH WLPH WUHDWPHQW OHDGLQJ WR
ORQJ WHUP QRUPDO EORRG JOXFRVH ZLWK QR QHHG IRU DQ\
further insulin therapy or immunosuppression is now
inevitable. Our job is to make Sana the company that
delivers this transformative therapeutic.
Type 1 diabetes is a disease in which a person s immune
system attacks and kills pancreatic beta cells, rendering
the person incapable of making insulin and controlling
blood glucose. The disease was a death sentence until the
discovery of insulin therapy 100 years ago, and despite

many improvements over the past century, the unmet
need remains substantial. People with type 1 diabetes
OLYH \HDUV OHVV WKDQ WKRVH ZLWKRXW LW GXULQJ WKDW
time they are at risk for side effects from blood sugar
that is too low (coma or death) and too high (coma,
amputation, blindness, kidney failure, heart attack,
VWURNH DQG PRUH DQG WKH GD\ WR GD\ PRQLWRULQJ DQG
treatment is taxing. Patients deserve a better answer.
About 25 years ago, clinicians started transplanting
primary pancreatic islets (islets are made of pancreatic
alpha, beta, and delta cells) from recently deceased
donors, and many patients who receive those transplants
can remain off insulin therapy for well over a decade.
Unfortunately, cadaveric sourcing is not predictable,
KDV VLJQL FDQW YDULDELOLW\ EHWZHHQ GRQRUV DQG LV QRW
VFDODEOH $GGLWLRQDOO\ SDWLHQWV QHHG WR PDLQWDLQ OLIH
long immunosuppression, and because the toxicities
from these medicines are substantial at present, there
are not that many patients for whom this degree of
immunosuppression is better than insulin.
Over the past few years, several groups have shown that
they can take pluripotent stem cells, differentiate them
into pancreatic islets, and transplant them successfully
into patients. This method appears to provide a more
consistent product and offers a clearer path to scalability.
+RZHYHU LW VWLOO UHTXLUHV VLJQL FDQW LPPXQRVXSSUHVVLRQ
limiting its potential impact.
Therefore, the key element standing between the
current state and a functional cure for this disease a
single treatment leading to normal blood sugar with
no more insulin or immunosuppression is removing
the immunosuppression. Since the advent of transplant
medicine, the rejection of allogeneic cells has been a key
limiting factor. We have proven in multiple preclinical
models and now in humans that we can overcome this
limitation using our hypoimmune, or HIP, technology.
,Q HDUO\ ZH UHSRUWHG WKH UVW LQ KXPDQ VWXG\
VKRZLQJ WKDW ZH FDQ WUDQVSODQW JHQH PRGL HG +,3
pancreatic islets into the arm of a person with type 1
GLDEHWHV DQG WKH FHOOV VXUYLYH DQG IXQFWLRQ 7KH UVW
patient in this study is now out over 3 months, making
KLV RZQ LQVXOLQ IRU WKH UVW WLPH LQ RYHU \HDUV DQG
he is on NO immunosuppressive drugs. As far as we
NQRZ WKLV LV WKH UVW VXFFHVVIXO H[DPSOH RI WUDQVSODQWLQJ
allogeneic cells with no immunosuppression into a
patient with normal immune function. In fact, this patient
KDV D SUH H[LVWLQJ DXWRLPPXQH UHVSRQVH WR SDQFUHDWLF
beta cells from his type 1 diabetes, and we still have seen
no evidence of rejection.
This outcome is truly transformative for diabetic
patients, and its implications over time can extend
to many other areas. I do not want to minimize the
challenging work ahead of us. I also think it is important
for all stakeholders patients with type 1 diabetes, their
families, governments, payers, regulators, providers, and
our shareholders to understand how transformative this
drug, and the broader technology, can be. Millions of
people are waiting for it, and we need to deliver.
The next year will undoubtedly bring opportunities as
ZHOO DV GLI FXOW FKRLFHV :H KDYH D QXPEHU RI DVVHWV LQ
development, but no other has the potential upside of
a drug for type 1 diabetes. Stay tuned, as we expect to
have data in diseases ranging from lupus to refractory
blood cancers in 2025 and 2026. We are optimistic about
the progress we have made with our in vivo delivery
capability, and in particular, recent progress in making
in vivo CAR T cells. In a space that has been searching
for differentiation, we believe our technology may offer
something important and novel. We hope to move all of
these assets forward, either on our own or with a partner.
No matter what path we choose, we will protect our
ability to prosecute the opportunity in diabetes.
Charles Dickens was a realist with a slight bent toward
optimism. Starting and running a biotech company in any
environment, but particularly this one, requires a similar
PLQGVHW :H UPO\ EHOLHYH LQ RXU DELOLW\ WR WUDQVIRUP WKH
possible for patients with our medicines, which are the
result of years of hard work from our team. We recognize
that the path has not been easy, and the road ahead is not
completely clear. Our mission is clear, however, and we
have a team with the insight, resilience, curiosity, and
humility to see it through.
On behalf of our employees and board, I thank you, our
shareholders, for your support and patience. It is a tough
market, and we have faced some headwinds. Regardless,
we need to deliver for you. Know that I wake up every
day focused on this task. I expect to report a year of
meaningful progress with next year s letter and look
forward to brighter days for us all.
Steve Harr, MD

FORWARD-LOOKING STATEMENTS
7KLV OHWWHU FRQWDLQV IRUZDUG ORRNLQJ VWDWHPHQWV DERXW 6DQD %LRWHFKQRORJ\ ,QF ZLWKLQ WKH PHDQLQJ RI WKH IHGHUDO
securities laws, including those related to our vision, progress, and business plans and expectations for our
development programs, product candidates, and technology platforms, including with respect to the potential timing
DQG VLJQL FDQFH RI GDWD IURP RXU FOLQLFDO WULDOV WKH SRWHQWLDO EHQH WV RI RXU SURGXFW FDQGLGDWHV DQG WHFKQRORJLHV
and our potential ability to progress our development programs, including in certain indications. All statements
other than statements of historical facts contained in this letter, including, among others, statements regarding our
VWUDWHJ\ H[SHFWDWLRQV DQG SURVSHFWV DUH IRUZDUG ORRNLQJ VWDWHPHQWV ,Q VRPH FDVHV \RX FDQ LGHQWLI\ IRUZDUG ORRNLQJ
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. We have based
WKHVH IRUZDUG ORRNLQJ VWDWHPHQWV ODUJHO\ RQ RXU FXUUHQW H[SHFWDWLRQV HVWLPDWHV IRUHFDVWV DQG SURMHFWLRQV DERXW
IXWXUH HYHQWV DQG QDQFLDO WUHQGV WKDW ZH EHOLHYH PD\ DIIHFW RXU QDQFLDO FRQGLWLRQ UHVXOWV RI RSHUDWLRQV EXVLQHVV
VWUDWHJ\ DQG QDQFLDO QHHGV ,Q OLJKW RI WKH VLJQL FDQW XQFHUWDLQWLHV LQ WKHVH IRUZDUG ORRNLQJ VWDWHPHQWV \RX VKRXOG
QRW UHO\ XSRQ IRUZDUG ORRNLQJ VWDWHPHQWV DV SUHGLFWLRQV RI IXWXUH HYHQWV 7KHVH VWDWHPHQWV DUH VXEMHFW WR ULVNV DQG
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 our 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 our actual results, please refer to the risk
IDFWRUV LGHQWL HG LQ RXU UHSRUWV OHG ZLWK WKH 6HFXULWLHV DQG ([FKDQJH &RPPLVVLRQ LQFOXGLQJ EXW QRW OLPLWHG WR RXU
$QQXDO 5HSRUW RQ )RUP . GDWHG 0DUFK ([FHSW DV UHTXLUHG E\ ODZ ZH XQGHUWDNH QR REOLJDWLRQ WR XSGDWH
SXEOLFO\ DQ\ IRUZDUG ORRNLQJ VWDWHPHQWV IRU DQ\ UHDVRQ

4/25/2025 Letter Continued (Full PDF)

SANA Shareholder/Stockholder Letter Transcript:

SANA Stockholder/Shareholder Letter (Sana Biotechnology, Inc.) | www.StockholderLetter.com Copyright © 2023 - 2025, All Rights Reserved

SANA Stockholder/Shareholder Letter (Sana Biotechnology, Inc.) | www.StockholderLetter.com
Copyright © 2023 - 2025, All Rights Reserved