PowerPoint PresentationCORPORATE PRESENTATION
March 2021
Fortress Biotech
Forward Looking Statements This presentation may contain “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section
21E of the Securities Exchange Act of 1934, as amended. For such forward-looking statements, we claim the protection of the safe harbor for forward-
looking statements contained in the Private Securities Litigation Reform Act of 1995. As used below and throughout this presentation, the words “we”,
“us” and “our” may refer to Fortress individually or together with one or more partner companies, as dictated by context. Such statements include, but
are not limited to, any statements relating to our growth strategy, products and product development programs and any other statements that are not
descriptions of fact. Forward-looking statements are based on management’s current expectations and are subject to risks and uncertainties that
could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially
from those currently anticipated include: risks related to our growth strategy; risks relating to the results of research and development activities; our
ability to obtain, perform under and maintain financing and strategic agreements and relationships; uncertainties relating to preclinical and clinical
testing; our dependence on third party suppliers; our ability to attract, integrate, and retain key personnel; the early stage of products under
development; our need for and continued access to additional funds; government regulation; patent and intellectual property matters; competition; as
well as other risks described in our Securities and Exchange Commission filings. We expressly disclaim any obligation or undertaking to release
publicly any updates or revisions to any forward looking statements contained herein to reflect any change in our expectations or any changes in
events, conditions or circumstances on which any such statement is based, except as may be required by law. The information contained herein is
intended to be reviewed in its totality, and any stipulations, conditions or provisos that apply to a given piece of information in one part of this
presentation should be read as applying mutatis mutandis to every other instance of such information appearing herein. This presentation may
contain depictions of Fortress’ percentage ownership positions in several of its affiliated companies; while we endeavor to update such figures
regularly, these percentages are subject to periodic change for a variety of reasons, and updates may not occur more frequently than every calendar
month or quarter. Accordingly, you should understand that the percentage figures presented herein may only portray Fortress’ ownership positions as
of the most recent update, and not necessarily as of the date on which you are reviewing these materials.
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To build a pipeline of both development-stage / commercial-stage assets and leverage the most
efficient course to move products forward with our partners.
Strategy
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Exelderm® CAEL-101 MB-101 Anti-GITR
Luxamend® MB-107 MB-103 CK-103
Fortress Biotech Programs*
*Includes product candidates in development at Fortress, at its majority-owned and majority-controlled subsidiaries and at entities in which it holds minority ownership positions.
Dermatology Gene Therapy Oncology /
Hematology Pain Rare Diseases
Rheumatology
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Aim to meaningfully increase value and diversify the overall risk for Fortress shareholders
Fortress Process
market
Low acquisition cost
Get there first
« «
1. Includes employees and product candidates in development at Fortress, at its majority-owned and majority-controlled partners.
The Fortress Advantage: Our Model VS Others
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move quickly and go after many of the drug candidates
that we go after very successfully) and we are not
Most licensees and acquirers go through competitive
processes
We are not bound by disease type or modality type!
We focus on opportunism and diversification!
Finding drug candidates that are in the clinic that
appear to be effective (that are not being shopped or
are being poorly shopped)
Have to believe in the data, market opportunity, barriers
to entry
Oligonucleotides 2 3 0
Vaccines 2 0 4
PD-L1 2 1
EGFR 1 1
IL13Rα2 1 2
CD123 3 2
HER2 2 2
CS1 1 1
PSCA 1 1
CD20 2 1
Poised for multiple:
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Value
10
11
vivo lentiviral cell
interests in Mustang, incentivizing us to keep
building value in Mustang
NIH with very exciting
human data, and fully
Fortress
Biotech
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prescribing dermatologists
2016 2017 2018 2019 3Q 2020
$ in millions
331% GROWTH
51% GROWTH
49% GROWTH
29% GROWTH
OVER 3Q
Launching one new product in the first half of 2021
As of 1/29/2021, Fortress owns
93% of Journey on an outstanding
share basis and 62% on a fully-
diluted basis.
29% or eligible to receive up to ~$48M of
the distribution, net of fees • Potential additional payments pursuant to
Contingent Value Rights; CVR payout of 10-
20% of gross profits2
value of CVRs
Agreement with Sentynl
position in Caelum and provided $50M in
development funding, with an additional
$14M in funding due upon achievement of
a site enrollment milestone* • Up to $500M payable to non-Alexion
shareholders of Caelum in connection with
Alexion/acquirer exercise of option (timing
for decision accelerated if there is an
Alexion change of control) • $150M upfront • Up to $350M in contingent approval /
sales milestone payments • FBIO owns ~29% of Caelum and is eligible
to receive ~43% of upfront and
approval/sales milestone proceeds in event
of Alexion exercise of option
Contingent Exclusive Acquisition Option
Granted To Alexion (Jan. 2019)
1subject to conditions described in Avenue public filings 2Fortress to receive ~1/3 of CVR royalty if certain net sales thresholds are met 3Complete Response Letter received from the FDA in October 2020. Also in October 2020, InvaGen communicated to Avenue that it believes a Material Adverse Effect has occurred due to the impact of the COVID-19 pandemic on potential commercialization and projected sales of IV Tramadol, which means it is possible InvaGen could attempt to avoid its obligation to consummate the second stage closing under the Stock Purchase & Merger Agreement “SPMA”. Avenue disagrees with InvaGen’s assertion that a Material Adverse Effect has occurred and has advised InvaGen of this position. Additionally, in connection with the resubmission of Avenue’s New Drug Application in February 2021, InvaGen communicated to Avenue that it believes the proposed label under certain circumstances would constitute a Material Adverse Effect on the purported basis that the proposed label under certain circumstances would make the product commercially unviable. Avenue notified InvaGen that it disagrees with InvaGen’s assertion. Nevertheless, InvaGen may seek to avoid its obligation to consummate the second stage closing under the SPMA. *On 12/12/20 AZN announced the acquisition of ALXN. If/when this transaction closes, AZN has 6 months to exercise their option to acquire Caelum.
• Sentynl to acquire CUTX-101 for up to $20M
in upfront and regulatory milestone
payments through NDA approval • Cyprium eligible to receive sales milestones
totaling up to $255M • Royalties on CUTX-101 net sales are also
payable: • 6% due on portion of annual net sales
up to $75M • 17.5% due on portion of annual net
sales between $75M and $100M • 25% due on portion of annual net sales
over $100M. • Cyprium will retain 100% ownership over any
FDA PRV that may be issued at NDA approval
for CUTX-101. Data suggests PRVs may be
worth ~$75M to ~$110M, each • FBIO owns ~72% of Cyprium
Candidate* Indication Phase 1 Phase 2 Phase 3 Next Milestone Partnership % /
Royalty†
start in 3Q 2021, and be completed in
4Q 2021
72% Cyprium
more BLA filings
ongoing 43% Caelum***
(newly diagnosed) in 2Q 2021
20% Mustang
20% Mustang
resubmission of its NDA
21% Checkpoint
Phase 2 Data in Adults expected 2022
78% Cellvation;
Near-term Value Creating Pipeline
Registration-enabling† Estimated as of 3.1.2021
*Includes product candidates in development at Fortress, at its majority-owned and majority-controlled partners and at entities in which it holds minority ownership positions.
**FBIO is eligible to receive ~29% of the proceeds upon the second-stage closing of the InvaGen transaction net of fees, and currently owns 23% of Avenue’s issued and outstanding capital stock.
***FBIO is eligible to receive ~43% of the proceeds from an Alexion acquisition option exercise, and currently owns ~29% of Caelum’s issued and outstanding capital stock.
****FBIO receives ~1/3 of the CVR Royalty on gross profits based on certain net sales thresholds Based on most recent internal forecasts and assuming approval in all denoted indications
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Candidate* Indication Preclinical Phase 1 Phase 2 Phase 3 Next Milestone Partnership % /
Royalty†
expected 4Q2021
20% Mustang;
Preclinical POC data to support IND in
Refractory Epilepsy anticipated 1H2021
60% Baergic
4.5% Royalty
~$200M - $300M
(refractory epilepsy)
MB-101 Glioblastoma (GBM) COH expected to file IND for Phase 1
combination trial with MB-108 in 2021
20% Mustang;
20% Mustang;
expected in 2021
4.5% Royalty $400M - $500M
MB-108 Glioblastoma (GBM) COH expected to file IND for Phase 1
combination trial with MB-101 in 2021
20% Mustang;
4.5% Royalty
with MB-101)
MB-104 Multiple Myeloma (MM) First data disclosure from COH Phase 1 trial
expected 2021
20% Mustang;
prostate cancer trial expected 4Q2021
20% Mustang;
81% Helocyte;
Dotinurad Rheumatology Filing U.S. IND
Early Clinical Pipeline
*Includes product candidates in development at Fortress, at its majority-owned and majority-controlled partners and at entities in
which it holds minority ownership positions. ^ Based on most recent internal forecasts and assuming approval in all denoted indications
Potential Peak
Sales Revenue^
Candidate* Indication Preclinical Phase 1 Phase 2 Phase 3 Next Milestone Partnership % /
Royalty†
Non-human primate long-
61% Aevitas; 4.5%
2021
ConVax Cytomegalovirus
Prevention & Control
2021
ONCOlogues KRAS G12D Finalize KRAS G12D in-vivo
dataset
*Includes product candidates in development at Fortress, at its majority-owned and majority-controlled partners and at entities in
which it holds minority ownership positions. ^ Based on most recent internal forecasts and assuming approval in all denoted indications
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showing a nearly 80% reduction in the risk of death
(Hazard Ratio = 0.21, p<0.0001)
o FDA granted Rare Pediatric Disease, Orphan Drug,
Fast Track, and Breakthrough Therapy designations
o EMA COMP issued positive opinion on Orphan
Medicinal Product Designation in July 2020
o Would be the first FDA approved therapy in this
indication
Review Voucher (valuation range ~$75M to $110M)
CUTX-101
Pipeline Assets
Menkes Disease
Status Phase 3 complete
3Q 2021 and be completed in 4Q 2021
PRV Potentially eligible for PRV ~$75M to
~$110M
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o Potential therapy for cutaneous squamous cell carcinoma
and lung cancer, and other solid tumor indications
o Potentially differentiated vs marketed PD-(L)1s
o Interim P1 data showed efficacy in multiple tumor types w/
well tolerated safety profile; 51.4% objective response rate
and 13.5% complete response rate in half the planned
pivotal cohort of cosibelimab in metastatic cutaneous
squamous cell carcinoma
submissions
COSIBELIMAB*
Pipeline Assets
Status Registration-enabling Phase 1
2021
Potential initiation of pivotal trial in
NSCLC expected 2021
*Product candidate in development at Checkpoint Therapeutics, Inc., an entity which was founded by Fortress
and in which Fortress still maintains a large ownership position.
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o Granted Orphan Drug designations in the U.S. and EU
o No FDA, EMEA, or PMDA approved therapies in this
indication
o ~4.5k newly-diagnosed patients (U.S.) per year
o Potentially understated market size given AL Amyloidosis
often misdiagnosed
exercise their option to acquire Caelum
CAEL-101*
Pipeline Assets
AL Amyloidosis
*Product candidate in development at Caelum Biosciences, Inc., an entity which was founded by Fortress and in
which Fortress still maintains a large minority ownership position.
Est. Patient
Status Two Ongoing Phase 3 Trials
Next Steps
Phase 3 program with enrollment in both trials
expected to complete by 2022
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o ~1 in 225k newborns per year (U.S.)
o ~400 patients living with XSCID post-transplant in the US
and ~650 patients living with XSCID post-transplant in high
and mid-income ex-U.S. countries
Rare Pediatric Disease Designations for MB-107 & MB-207
granted by FDA 3Q2020; Orphan Drug Designations for
MB-107 & MB-207 granted by FDA 3Q2020
o Published clinical results demonstrate**:
o Multilineage engraftment of transduced cells
o Reconstitution of functional T cells and B cells
o Normalization of NK-cell counts
MB-107 & MB-207*
Pipeline Assets
diagnosed patients 2Q 2021 (MB-107)
File IND for Ph2 reg. trial in previously
transplanted patients, 2Q 2021 (MB-207)
PRVs Potential PRVs for each of the 2 patient
populations, ~$75M to ~$110M for each PRV
*Product candidates in development at Mustang Bio, Inc., an entity which was founded by Fortress and in which Fortress still maintains a large ownership
position.
**Mamcarz E et al. N Engl J Med. 2019; 380: 1525-1534; also, Mamcarz E et al. Blood. 2019;134(Suppl1): 2058.
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targeted autologous CAR-T cell therapy for treatment
of NHL & CLL
o Announced Initial MB-106 Phase 1 Data at the 2020
American Society of Hematology Annual Meeting
o Data presented showed an extremely favorable safety
profile and clinical activity with an 89% ORR and 44%
complete response rate over 4 dose levels in 9 patients
treated with our modified cell manufacturing process
MB-106*
Pipeline Assets
Est. Market Estimated Peak Sales in U.S. of $750M - $1,000M
Status Phase 1
Next Steps File IND for multicenter Phase 1 / pivotal Phase 2
clinical trial in NHL/CLL 1Q 2021
Data Expect additional data readout from Fred Hutch trial
2Q 2021
*Product candidates in development at Mustang Bio, Inc., an entity which was founded by Fortress and in which Fortress still maintains a large ownership
position.
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EGFR
susceptible mutations as a monotherapy or in
combination with anti-tumor immune potentiating
therapies
on Lung Cancer
TAGRISSO®
CK-101*
Pipeline Assets
*Product candidate in development at Checkpoint Therapeutics, Inc., an entity which was founded by Fortress
and in which Fortress still maintains a large ownership position.
Est. Market $6b+ / year
Est. Market Estimated Peak Sales of $790M**
Status Refiled the NDA for IV Tramadol on 2/12/21
Next Steps PDUFA goal date of 4/12/21 from the
resubmission of its NDA
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operative pain therapies amid opioid crisis
o Potential to replace conventional narcotics in wide
range of patients
minimizes dilution and provides substantial upside to
shareholders; First stage closed in February 2019****
o Strong IP position on proprietary dosing regimen
expected to protect exclusivity in the U.S. until 2036
IV Tramadol*
Pipeline Assets
Post-operative pain management
*Product candidate in development at Avenue Therapeutics, Inc., an entity which was founded by Fortress and in which Fortress still maintains a large minority ownership position **Based on internal forecasts ***Fortress to receive ~1/3 of CVR royalty if certain net sales thresholds are met ****In October 2020, InvaGen communicated to Avenue that it believes a Material Adverse Effect has occurred due to the impact of the COVID-19 pandemic on potential commercialization and projected sales of IV Tramadol, which means it is possible InvaGen could attempt to avoid its obligation to consummate the second stage closing under the SPMA. Avenue disagrees with InvaGen’s assertion that a Material Adverse Effect has occurred and has advised InvaGen of this position. Additionally, in connection with the resubmission of Avenue’s New Drug Application in February 2021, InvaGen communicated to Avenue that it believes the proposed label under certain circumstances would constitute a Material Adverse Effect on the purported basis that the proposed label under certain circumstances would make the product commercially unviable. Avenue notified InvaGen that it disagrees with InvaGen’s assertion. Nevertheless, InvaGen may seek to avoid its obligation to consummate the second stage closing under the SPMA.
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receptor system
GABAα2/3, minimizing adverse events that are
typically seen with benzodiazepines, which are non-
selective agonists
disorders, affecting ~1% of the world population
(~3M in the U.S.)
Pipeline Assets
CNS Disorders
Est. Patient
U.S.
Next Steps
Refractory Epilepsy anticipated 1H 2021
*Product candidates in development at Baergic Bio, Inc., an entity which was founded by Fortress and in which Fortress still maintains a large ownership
position.
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nucleus, displacing mutant DNA strand, preventing mutant
mRNA transcription
root of genetic disease
o KRAS G12D remains a complete unmet need and plays a heavy role in devastating cancers, including: ~35% of pancreatic, ~12% of colorectal, and ~5% of endometrial and NSCLC
o KRAS G12C for NSCLC is considered ~$4B market
opportunity with ~40K patients in the US/EU
o KRAS G12D has ~180K patients in the US/EU within
pancreatic, colorectal, endometrial and NSCLC
o Single Stranded RNA viruses, like COVID-19, are easily
targeted by ONCOlogues
Pipeline Assets
Est. Market Various Gene-Silencing Markets >$1B each
KRAS G12D estimated >$10B
POC in coronaviruses
Additional Oncogene targets
Finalize clinical formulation
*Product candidates in development at Oncogenuity, Inc., an entity which was founded by Fortress and in which Fortress still maintains a large ownership
position.
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Potential Near-term Value-Creating Events for FBIO Shareholders
1IV Tramadol, CAEL-101, Cosibelimab, CK-101, CUTX-101, MB-107 (newly diagnosed XSCID), MB-207 (previously transplanted XSCID) and ONCOlogues are product candidates in development at FBIO partner companies 2Fortress to receive ~1/3 of CVR royalty if certain net sales thresholds are met 3Received Complete Response Letter from the FDA in October 2020. Also in October 2020, InvaGen communicated to Avenue that it believes a Material Adverse Effect has occurred due to the impact of the COVID-19 pandemic on potential
commercialization and projected sales of IV Tramadol, which means it is possible InvaGen could attempt to avoid its obligation to consummate the second stage closing under the SPMA. Avenue disagrees with InvaGen’s assertion that a Material Adverse Effect has occurred and has advised InvaGen of this position. Additionally, in connection with the resubmission of Avenue’s New Drug Application in February 2021, InvaGen communicated to Avenue that it believes the proposed label under certain circumstances would constitute a Material Adverse Effect on the purported basis that the proposed label under certain circumstances would make the product commercially unviable. Avenue notified InvaGen that it disagrees with InvaGen’s assertion. Nevertheless, InvaGen may seek to avoid its obligation to consummate the second stage closing under the SPMA. The FDA has set a PDUFA goal date of April 12, 2021 for the resubmission of the IV Tramadol NDA.
IV Tramadol1,3 & Cipla
upfront in contingent acquisition of
Avenue
profits2
registration trial for newborns with XSCID
2Q 2021
previously transplanted patients,
expected 2Q 2021
Journey Medical
first 9 mos of 2020, a 29% increase over
the first 9 mos of 2019
o Launching one new product in the first
half of 2021
Cosibelimab and CK-1011
metastatic cSCC >80% enrolled, with full
top-line results anticipated 2H 2021
o Potential initiation of CK-101 global
registration study for treatment of lung
cancer
o Eligible to receive ~72% of up to $267M (in
regulatory and sales milestones)
o Cyprium will retain 100% ownership of a PRV
that may be issued at FDA approval of CUTX-
101
to ~$110M, each
(upfront and approval / sales milestones) in
event of Alexion exercise of contingent
option
CARES Phase 3 program with enrollment in
both trials expected to complete by 2022
Lindsay Rosenwald, MD
Eric K. Rowinsky, MD
Robyn Hunter
Revenue Growth
1Includes employees and product candidates in development at Fortress, at its majority-owned and majority-controlled partners.
NASDAQ FBIO
Market Cap as of 3/1/21: ~$367.0 million
Consolidated cash as of 9/30/20: $220.0 million1
FBIO standalone cash as of 9/30/20: $97.4 million2
Value of FBIO ownership of public partner
companies as of 3/1/21: ~$118.8 million3
1 Consolidated cash, cash equivalents, short-term investments (certificates of deposit) and restricted cash
2 Fortress’ cash, cash equivalents, short-term investments (certificates of deposit) and restricted cash (excludes public partner companies)
3 Approximate value of Fortress’ holdings in ATXI, CKPT and MBIO
FORTRESS BIOTECH
Financial Snapshot