F O R T R E S S B I O T E C H
CORPORATE
PRESENTATION
July 2025
2
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 partners and suppliers (including the capabilities of
partners who have acquired product candidates that we formerly owned or controlled); 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. Also, unless
otherwise indicated, all ownership positions are presented in terms of Fortress’ percentage ownership of the issued and outstanding (and not fully-diluted) shares in the applicable
subsidiary or partner company.
3
F O R T R E S S B I O T E C H
FORTRESS BIOTECH
OVERVIEW
4
Recent highlights
• NDA acceptance for priority review of CUTX-101 (copper histidinate) for treatment of
Menkes Disease with a target PDUFA action date of September 30, 2025.
• Cyprium will retain ownership over any Priority Review Voucher that may be issued at
NDA approval and eligible to receive tiered royalties (3.0% up to 12.5%) and up to $129
million in aggregate development and sales milestones from partner Sentynl.
• Fortress owns ~74% of Cyprium and entitled to a 2.5% annual equity dividend.
PDUFA (CUTX-101) – September 30, 2025
• Checkpoint Therapeutics announced BLA approval for UNLOXCYT (cosibelimab-ipdl) in
December 2024.
• First and only programmed death ligand-1 (“PD-L1”) blocking antibody to receive FDA
marketing approval for metastatic and locally advanced cSCC. Additionally, Unloxcyt has
demonstrated the ability to induce antibody-dependent cell-mediated cytotoxicity
(“ADCC”).
BLA approval (Unloxcyt) – December 2024
• Closed acquisition of Checkpoint by Sun Pharma on May 30, 2025.
• Fortress to receive ~$28 million plus up to an additional $4.8M upon achievement of the
CVR.
• Fortress also eligible to receive a 2.5% royalty on net sales.
Checkpoint Therapeutics Sale Closed – March 2025
• Journey Medical announced NDA approval for EMROSI (Minocycline Hydrochloride
Extended-Release Capsules, 40mg) on November 4, 2024 for treatment of inflammatory
lesions of rosacea in adults.
• Two Phase 3 clinical trials met all co-primary and secondary endpoints and Emrosi
demonstrated statistically significant superiority over both the current standard-of-care
treatment and placebo for Investigator’s Global treatment success as well as reduction in
total inflammatory lesion count in both studies.
• Fortress owns ~43% of Journey (Nasdaq: DERM).
NDA approval (Emrosi) – November 2024
Fortress Biotech Overview
5
Fortress Biotech is a revenue-
generating life sciences
company, focused on
commercial dermatology and
acquiring and developing
clinical-stage assets across
various therapeutic areas
Fortress Biotech Overview
STRATEGIC PORTFOLIO
Commercial dermatology portfolio
and mid-to-late-stage clinical
candidates across areas including rare
diseases, oncology, and dermatology
BUSINESS DEVELOPMENT
Focus on clinical stage candidates with
proof-of-concept in humans that
address areas of unmet medical need
and expanding marketed dermatology
portfolio
DIVERSIFICATION
/ UNIQUE MODEL
Large, highly inefficient market to
acquire validated human clinical
candidates efficiently on favorable
terms
Portfolio includes product candidates in development at Fortress, at Fortress’ private subsidiaries (referred to herein as “subsidiaries”), at Fortress’ public subsidiaries (referred to herein as “partner companies”) and at entities with
whom one of the foregoing parties has a significant business relationship, such as an exclusive license or an ongoing product-related payment obligation (such entities referred to herein as “partners”).
POISED FOR GROWTH
Current revenues plus multiple
pending approvals and large pipeline
plus 17,000 targets
REVENUE / SCALABILITY
Combined product diversification with
multiple sources of revenue and
potential cash-flow scalability
6
Portfolio overview
Fortress Biotech Overview
2
FDA approvals received in 2024
15
10 clinical and 5 preclinical candidates
across therapeutic areas including
oncology and rare disease
2.5% Equity Dividend
From 6 subsidiaries and partner
companies annually
9
Subsidiaries and partner companies
$100M - $2B
In potential annual peak sales by
clinical candidate*
4.5% Royalty
From multiple clinical candidates
across 20+ indications
8
FDA approved and marketed
dermatology products; $55M in 2024
product revenue
Portfolio includes product candidates in development at Fortress, at Fortress’ private subsidiaries (referred to herein as “subsidiaries”), at Fortress’ public subsidiaries (referred to herein as “partner companies”) and at entities with
whom one of the foregoing parties has a significant business relationship, such as an exclusive license or an ongoing product-related payment obligation (such entities referred to herein as “partners”).
* Contingent on FDA approval and other market factors.
1
FDA approval anticipated in 2025
7
Triplex
Triplex
IV tramadol
Dotinurad***
Immunotherapy / vaccine for CMV and HIV
Donor vaccine for CMV in recipients of HSCT
Post-operative acute pain management
URAT1 inhibitor for gout and hyperuricemic conditions
Phase 2 ongoing
Phase 2 ongoing
Potential Ph3 safety study
Phase 1b ongoing
Other
CUTX-101^
CAEL-101**
AJ201†
BAER-101
Menkes Diseases (copper metabolism disorder)
Light chain (AL) amyloidosis
Spinal and bulbar muscular atrophy (Kennedy’s Disease)
Rare epilepsies
PDUFA Sept. 30, 2025
BLA in 2025/2026
Phase 1b/2a ongoing
Phase 2 ready
Rare Diseases
Development pipeline and commercial portfolio
Therapeutic Area Asset Indication Pre-clinical Phase 1 Phase 2 Phase 3 Registration Marketed Status
Fortress Biotech Overview
Dermatology
Qbrexza
®
Accutane
®
Amzeeq
®
Zilxi
®
Exelderm
®
Targadox
®
Luxamend
®
Emrosi
Primary axillary hyperhidrosis (excessive sweating)
Severe recalcitrant nodular acne*
Inflammatory lesions of non-nodular acne
Inflammatory lesions of rosacea
Antifungal cream for common skin infections
Adjunctive therapy for severe acne
Water-based emulsion for wounds
Inflammatory lesions of rosacea
Marketed
Marketed
Marketed
Marketed
Marketed
Marketed
Marketed
Mktd / NDA approved Nov. 2024
Unloxcyt ^^
MB-106
MB-101
MB-108
MB-109
Metastatic and locally advanced cutaneous squamous cell carcinoma
CD20 CAR-T for autoimmune
IL13Rα2 CAR-T for recurrent glioblastoma (GBM)
HSV-1 oncolytic virus (OV) for recurrent GBM
Recurrent GBM and anaplastic astrocytoma (MB-101+MB-108)
BLA approved Dec. 2024
Phase 1 autoimmune planned
Phase 1 ongoing
Phase 1 ongoing
Phase 1 GBM planned
Oncology /
Hematology
Portfolio includes select product candidates in development at Fortress, at Fortress’ private
subsidiaries (referred to herein as “subsidiaries”), at Fortress’ public subsidiaries (referred to herein
as “partner companies”) and at entities with whom one of the foregoing parties has a significant
business relationship, such as an exclusive license or an ongoing product-related payment obligation
(such entities referred to herein as “partners”).
Please see additional important safety information for Accutane below and the medication guide
and full prescribing information here for Boxed Earning, Contradictions, other important Warnings
and Precautions, Drug Interactions, Use in Specific Populations, and other Adverse Reactions.
^ In development at partner Sentynl Therapeutics.
** In development at partner Caelum Biosciences.
^^ Acquired by Sun Pharma on May 30, 2025.
*** In development at partner Crystalys Therapeutics.
† License agreement terminated in April 2025 with future milestones and royalties owed to Avenue.
8
Urica
Dotinurad*** (URAT1 inhibitor for gout)
Checkpoint*
Unloxcyt (anti-PD-L1 mAb for cSCC)
Helocyte
Triplex (CMV vaccine/immunotherapy) Nine ongoing Phase 1 and Phase 2 clinical trials in various indications
Caelum**
CAEL-101 (mAb for AL amyloidosis)
$56.9M
Monetization
$125M in potential
milestones
Cyprium^
CUTX-101 (copper histidinate for Menkes)
$4.5M
Milestone
$8M
Milestone
Journey (DERM)
Current commercial dermatology portfolio
$63.1M
Product revenue
Emrosi (small molecule for rosacea)
Avenue (ATXI)
Potential Phase 2a initiation
Ongoing Phase 1b/2a clinical trial in SBMA
IV tramadol (small molecule for post-op pain)
BAER-101 (GABAA α2/3 PAM for epilepsy)
AJ201 (small molecule for SBMA)†
Fortress anticipates achieving several milestones in the near future
Portfolio includes select product candidates in development at Fortress, at Fortress’ private subsidiaries (referred to herein as
“subsidiaries”), at Fortress’ public subsidiaries (referred to herein as “partner companies”) and at entities with whom one of the
foregoing parties has a significant business relationship, such as an exclusive license or an ongoing product-related payment
obligation (such entities referred to herein as “partners”).
* Acquired by Sun Pharma on May 30, 2025. ^ In development at partner Sentynl Therapeutics. ** In development at partner
Caelum Biosciences. *** In development at partner Crystalys Therapeutics †In development at AnnJi Pharma with future
milestones and royalties due to Avenue.
Partner Company Asset
2021
Potential Peak
Sales (Global)
2022
2023
2024
2025
2026
2027
2028
2029
2030+
Anticipated product revenue/royalties Potential PRV/milestone/monetization proceeds Potential regulatory approval
< $500M $500M - $1B > $1B
Fortress Biotech Overview
Potential Phase 1 for autoimmune
IND accepted by the FDA for Phase 1 combination trial in GBM
Mustang (MBIO)
MB-106 (CD20 CAR-T for autoimmune)
MB-109 (CAR-T + oncolytic virus for GBM)
FDA approval
$71.0M
Product revenue
$59.7M
Product revenue
$55.1M
Product revenue
Acquired by
Crystalys
Acquired by Sun
9
Near-term Growth
Fortress Biotech Overview
Q4 2024: 1 NDA + 1 BLA approved
Journey / Emrosi for rosacea (NDA approved Nov. 2024)
Checkpoint / Unloxcyt for metastatic and locally advanced cutaneous
squamous cell carcinoma (BLA approved Dec. 2024)
CUTX-101 for Menkes disease (PDUFA Sep. 30, 2025) with potential
receipt of Priority Review Voucher
Checkpoint sold to Sun Pharma; FBIO to receive ~$28m upfront + up to
$4.8m upon achievement of CVR (closed in May 2025). Also eligible to
receive a 2.5% royalty on net sales
Q2 2025: 1 subsidiary acquisition closed
Q3 2025: 1 PDUFA target action date
10
CAEL-101
mAb 11-1F4
Light chain (AL) amyloidosis
Acquired by AstraZeneca in Oct 2021
Two ongoing global Phase 3 studies for AL
amyloidosis
42% of future proceeds to Caelum
from AstraZeneca**
$56.9M received by
FBIO**
Up to ~$125M
in future proceeds
Late-Stage Portfolio: multiple near-term value inflection points
Candidate Indication(s)
Potential Peak Sales*
(Global)
Phase 1
Phase 2
Pivotal / Phase 3
< $500M $500M - $1B > $1B
Fortress Biotech Overview
Status / Upcoming Anticipated Milestones FBIO Ownership % / Royalty
†
CUTX-101^^^
Copper Histidinate
Menkes Disease
NDA accepted and granted priority review by FDA;
target PDUFA action date of September 30, 2025
(potential PRV worth $100M+)^^
74% of Cyprium
3.0% - 12.5% royalty payable to
Cyprium from partner Sentynl^^
2.5% Annual Equity Dividend
Portfolio includes product candidates in development at Fortress, at its majority-owned and majority-controlled partners, and
partner companies that Fortress may otherwise have an economic interest in.
† Ownership estimated as of March 31, 2025, or sourced from public ownership filings.
* Potential peak sales are based on internal forecasts and/or market comps and assume approval in all denoted indications and
are subject to change.
^^ Acquired by Sun Pharma on May 30, 2025. ^^^ Refer to slide 16 and the footnotes thereto for further information, including
CUTX-101 royalties.
** Product candidate in development at partner Caelum Biosciences. *** Asset transfer of dotinurad to partner Crystalys
Therapeutics in July 2024; Urica received 35% outstanding equity of Crystalys and a 3% royalty on future net sales of dotinurad
Triplex
Immunotherapy
Cytomegalovirus (CMV)
HIV
Non-Hodgkin lymphoma
Nine ongoing clinical trials including HIV/CMV co-
infection Phase 2 trial; first patient dosed in
NIH/NIAID fully-funded ($20M+) Phase 2 liver
transplant trial for control of CMV in Q2 24; first
patient dosed in Phase 2 donor vaccination trial in
Q1 25
83% of Helocyte
4.5% royalty
2.5% Annual Equity Dividend
Dotinurad***
URAT1 inhibitor
Gout
Asset acquired by Crystalys in 2024
Pivotal trial expected to commence in 2025
70% of Urica
3% royalty to Urica
2.5% Annual Equity Dividend
Emrosi (DFD-29)
Oral Small Molecule
Rosacea
Approved by the FDA in Nov. 2024;
Commercial launch in Q1’25
43% of DERM
NDA approved, Nov. 2024
Unloxcyt
(Cosibelimab)^^
Anti-PD-L1 mAb
Recurrent or
metastatic cancers
Acquired by Sun Pharma in May 2025 2.5% royalty to Fortress
BLA approved, Dec. 2024
11
AJ201
Small Molecule**
Spinal and Bulbar Muscular
Atrophy
(SBMA
)
Phase 1b/2a in SBMA patients ongoing
10% of ATXI
4.5% Royalty
2.5% Annual Equity
Dividend
BAER-101
GABAA α2/3 PAM
Refractory Epilepsy &
Panic Disorder
Potential initiation of Phase 2a epilepsy study
10% of ATXI
4.5% Royalty
2.5% Annual Equity
Dividend
MB-101
IL13Rα2 CAR-T
Recurrent Glioblastoma
(GBM)
Received Orphan Drug Designation (ODD) in Q3
2025; IND accepted by FDA, potential MB-109 (MB-
101 + MB-108) Phase 1 trial initiation in GBM
8% of MBIO
4.5% Royalty
2.5% Equity
Dividend
MB-108
Oncolytic Virus (OV)
Recurrent GBM
Received Orphan Drug Designation (ODD) in Q4
2024; IND accepted by FDA, potential MB-109 (MB-
101 + MB-108) Phase 1 trial initiation in GBM
8% of MBIO
4.5% Royalty
2.5% Equity
Dividend
Early-to-Mid Stage Portfolio: impactful pipeline for high unmet need areas
Portfolio includes product candidates in development at Fortress, at its majority-owned and majority-controlled partners, and
partner companies that Fortress may otherwise have an economic interest in.
† Ownership estimated as of March 31, 2025 or sourced from public ownership filings.
*Potential peak sales are based on internal forecasts and/or market comps and assume approval in all denoted indications
and are subject to change.
** License agreement terminated in April 2025 with future milestones and royalties owed to Avenue.
< $500M $500M - $1B > $1B
Fortress Biotech Overview
Candidate Indication(s) Status / Upcoming Anticipated Milestones FBIO Ownership % / Royalty
†
Potential Peak
Sales* (Global)
Preclinical Phase 1 Phase 2 Phase 3
MB-109
IL13Rα2 CAR-T + OV
Recurrent GBM and
Anaplastic Astrocytoma
IND accepted by FDA, potential MB-109 (MB-101 +
MB-108) Phase 1 trial initiation in GBM
8% of MBIO
4.5% Royalty
2.5% Equity
Dividend
MB-106
CD20 CAR-T
Autoimmune
Potential Phase 1 for autoimmune
8% of MBIO
4.5% Royalty
2.5% Annual Equity
Dividend
CMV-HIV CAR-T
Bispecific CAR-T
Human Immunodeficiency
Virus (HIV-1)
Phase 1 trial enrolling
83% of Helocyte
4.5% Royalty
2.5% Annual Equity
Dividend
12
CEVA-102
Cell Therapy
TBI, GvHD, ARDS, CHF,
Crohn’s (Off-the-Shelf)
Potential IND filing
80% of Cellvation
4.5% Royalty
2.5% Annual Equity Dividend
AAV-ATP7A
AAV Gene Therapy
Menkes Disease $4M grant received for IND-enabling
74% of Cyprium
4.5% Royalty
2.5% Annual Equity Dividend
CEVA-D
Bioreactor Device
Mechano-transduction
Device for Cell
Therapies
Data published in Frontiers in Immunology
80% of Cellvation
4.5% Royalty
2.5% Annual Equity Dividend
Early-to-Mid Stage Portfolio: impactful pipeline for high unmet need areas
Portfolio includes product candidates in development at Fortress, at its majority-owned and majority-controlled partners, and
partner companies that Fortress may otherwise have an economic interest in.
† Ownership estimated as of March 31, 2025 or sourced from public ownership filings.
* Potential peak sales are based on internal forecasts and/or market comps and assume approval in all denoted indications and
are subject to change.
** 4D Molecular Therapeutics acquired Aevitas’ short-form human factor H asset in April 2023 for up to ~$140 million in potential
milestones and additional royalties on net sales.
< $500M $500M - $1B > $1B
Fortress Biotech Overview
Candidate Indication(s) Status / Upcoming Anticipated Milestones FBIO Ownership % / Royalty
†
Potential Peak
Sales* (Global)
Preclinical Phase 1 Phase 2 Phase 3
AAV.sFH
AAV Gene Therapy
Complement-mediated
diseases
Asset sold to 4DMT in April 2023
Up to ~$140M in future milestone
proceeds plus royalties**
IV tramadol
Small Molecule
Post-operative acute
pain management
Potential pivotal Phase 3 safety trial
10% of ATXI
4.5% Royalty
2.5% Annual Equity Dividend
13
F O R T R E S S B I O T E C H
SELECT PIPELINE
DETAILS
14
Fortress Biotech Model
Unloxcyt
Anti-PD-L1 mAb for treatment of metastatic
and locally advanced cSCC
CVR = Contingent Value Right
† Ownership based on recent public filings and in connection with announcement of merger. 6.9M shares inclusive of 0.7M Class A common stock.
FDA approved BLA in Dec. 2024
Acquisition of Checkpoint Therapeutics by Sun Pharma
closed on May 30, 2025
STATUS
Fortress to receive ~$28M and a 2.5% royalty on
future net sales of Unloxcyt.
CVR of up to an additional $4.8M upon approval in the
EU.
For additional details regarding the transaction, please
refer to 8-Ks filed with the SEC by both FBIO and CKPT.
FBIO OWNERSHIP
% & ROYALTY†
First and only programed death ligand-1 (“PD-L1”) blocking antibody to receive FDA marketing
approval for metastatic and locally advanced cSCC. Additionally, Unloxcyt (cosibelimab-ipdl) has
demonstrated the ability to induce antibody-dependent cell-mediated cytotoxicity (“ADCC”)
FDA approval granted based on clinically meaningful objective response rates and duration of
response data, as assessed by an independent central review committee, from Study CK-301-101
(NCT03212404), a multicenter, multicohort, open-label study of UNLOXCYT in adults with
advanced solid tumor cancers, including cSCC
ASSET OVERVIEW
15
Fortress Biotech Model
Emrosi
Minocycline Hydrochloride Extended-Release Capsule,
40mg for treatment of rosacea
Best-in-class oral therapy for inflammatory lesions of rosacea, based on head-to-head Phase 3
clinical trials against Oracea® (doxycycline, 40mg), the current standard of care
Two multicenter, active and placebo-controlled studies in 653 patients with moderate to
severe papulopustular rosacea
Statistically and clinically significant difference in Emrosi compared to placebo and existing
standard of care (Oracea) on all co-primary and secondary endpoints
Emrosi demonstrated IGA Treatment Success* of 62.7%, compared to 39% for Oracea and
28.2% for placebo at 16 weeks
Emrosi reduced lesion count by -19 lesions, compared to -14.8 for Oracea and -11.3 for
placebo at 16 weeks
No significant safety issues noted in trials
Patents include three U.S. Orange Book listed patents with exclusivity until 2039
ASSET OVERVIEW
Product candidate in development at Journey Medical Corporation, a Fortress Partner Company.
1 Wehausen, B., Hill, D. E, & Feldman, S. R. (2016). Most people with psoriasis or rosacea are not being
treated: a large population study. Dermatology Online Journal, 22(7).
2 Symphony, PHAST Prescription data. TRx sales defined as TRx$ = TRx x WAC Price.
^ Potential peak sales are based on internal forecasts and/or market comps and assume approval in all
denoted indications and are subject to change.
* Investigators Global Assessment (IGA) Treatment Success is based on the proportion of subjects with
IGA (modified scale without erythema) ‘treatment success’ – Grade 0 or 1 (clear or almost clear) at
Week 16 with at least a 2 grade reduction from Baseline to Week 16.
16.5M people in the U.S. alone suffer from Rosacea,
representing ~5% of the population
1
U.S. Rosacea Market: ~$1.0B/year
2
EST. MARKET
FDA approved New Drug Application (NDA), Nov. 2024
STATUS
Commercial launch ongoing, first prescriptions filled in
March 2025
NEXT STEPS
Best-in-class oral therapy FDA approved to treat
inflammatory lesions of rosacea in adults
NEAR-TERM
VALUE CREATION
43% of DERM
FBIO
OWNERSHIP %
>$300M
POTENTIAL PEAK
GLOBAL SALES^
16
Fortress Biotech Model
CUTX-101
Subcutaneous injectable formulation of Copper Histidinate for patients
with Menkes Disease
Cyprium eligible to receive sales milestones totaling up to $129M and tiered royalties (3.00% of
net sales up to $75M, 8.75% between $75M and $100M, 12.50% over $100M)
Cyprium will retain 100% ownership over any FDA PRV that may be issued at NDA approval for
CUTX-101*
MONETIZATION OVERVIEW
Product candidate in development at partner Sentynl Therapeutics. *Cyprium completed asset transfer of CUTX-101 in Dec. 2023.
1 Kaler SG, Ferreira CR, Yam LS. Estimated birth prevalence of Menkes disease and ATP7A-related disorders based on the Genome
Aggregation Database (gnomAD). Mol Genet Metab Rep. 2020;24:100602.
**In the event of a sale of a PRV by Cyprium, Cyprium would be obligated to make payments to the NIH and to holders of
Cyprium’s 9.375% Series A Cumulative Redeemable Perpetual Preferred (all as disclosed in Fortress’ public filings).
^ Potential peak sales are based on internal forecasts and/or market comps and assume approval in all denoted indications and
are subject to change.
Estimated 50-225+ patients per year with Menkes in the
US
1
alone, with anticipated PRV worth approximately
$100M-150M**
EST. MARKET
NDA accepted and granted priority review by FDA
STATUS
Target PDUFA date of September 30, 2025 and potential
PRV
NEXT STEPS
Received $4.5M asset transfer payment in 2023
Anticipated milestones, royalties, and PRV monetization
NEAR-TERM
VALUE CREATION
74% of Cyprium | 3.0-12.5% royalty to Cyprium, 2.5%
annual equity dividend and 4.5% royalty to Fortress
FBIO OWNERSHIP
% & ROYALTY
$500M - $1B
POTENTIAL PEAK
GLOBAL SALES^
Reported positive top-line clinical efficacy data, showing a nearly 80% reduction in the risk of
death (Hazard Ratio = 0.21, p<0.0001)
Observed median overall survival of Early Treatment cohort patients of 14.75 years for CUTX-
101 compared to 1.34 years for historical control with a hazard ratio of 0.208 (p<0.0001)
ASSET OVERVIEW
17
Fortress Biotech Model
CAEL-101*
Monoclonal antibody (mAb) for the treatment of patients with
amyloid light chain (“AL”) amyloidosis
*As Caelum was acquired by AstraZeneca in 2021, Fortress may not be apprised of ongoing developments pertaining to CAEL-101 to
the same degree that Fortress had been prior to such acquisition; accordingly, the information presented on this slide may not
reflect the latest disposition of the product candidate.
^ Potential peak sales are based on internal forecasts and/or market comps and assume approval in all denoted indications and are
subject to change. AstraZeneca’s Alexion acquired Caelum Biosciences on Oct 5, 2021 for up to $500 million. FBIO received ~$56.9
million upfront under such transaction and is eligible to receive ~42% of the proceeds from all future milestone payments.
Fortress received $56.9M upfront and is eligible to receive up to ~$125M in future milestones
including $19M on approval
MONETIZATION OVERVIEW
Granted Orphan Drug designations in the U.S. and EU
No FDA, EMEA, or PMDA approved therapies for indication
ASSET OVERVIEW
30K to 45K patients in U.S. and EU with ~4.5K newly-
diagnosed patients (U.S.) per year
EST. MARKET
Two ongoing global Phase 3 Trials run by AstraZeneca (AZ)*
STATUS
Enrollment completed in the CAELUM CARES Phase 3
program
NEXT STEPS
AstraZeneca anticipates Phase 3 trial readouts in 2H
2025
NEAR-TERM
VALUE CREATION
Caelum (developer of CAEL-101) was founded by
Fortress and acquired by AstraZeneca in 2021
FBIO OWNERSHIP
% & ROYALTY
Likely understated market size given AL Amyloidosis often misdiagnosed
18
Fortress Biotech Model
Dotinurad
URAT1 inhibitor for gout
Product candidate in development at Urica Therapeutics, Inc., a Fortress subsidiary.
^ Potential peak sales are based on internal forecasts and/or market comps and assume approval in all
denoted indications and are subject to change.
*Asset transfer of dotinurad to partner Crystalys Therapeutics in July 2024; Urica received 35%
outstanding equity of Crystalys and a 3% royalty on future net sales of dotinurad
FUJI YAKUHIN
Urica received 35% outstanding equity of Crystalys and a 3% secured royalty on future net sales
of dotinurad*
MONETIZATION OVERVIEW
Demonstrated to be an efficacious oral therapy for lowering serum uric acid levels (sUA) with
excellent safety profile from clinical trials in Japan involving over 1,000 patients
Dotinurad (URECE® tablet) was approved in Japan in 2020 as a once-daily 1st line oral therapy
for gout and hyperuricemia
ASSET OVERVIEW
U.S. initial addressable market of 2-3 million refractory
gout patients
EST. MARKET
Potential pivotal trial to commence in 2025
NEXT STEPS
Clinical development including first pivotal trial
potentially starting in 2025
NEAR-TERM
VALUE CREATION
70% of Urica Therapeutics,
2.5% annual equity dividend
FBIO OWNERSHIP
% & ROYALTY
$1B+
POTENTIAL PEAK
GLOBAL SALES^
Eisai Co., Ltd. announced approvals in China (Dec 2024) and Thailand (Oct 2024).
19
Fortress Biotech Model
Multiple ongoing studies*: Liver Transplant - Phase 2,
HSCT - Phase 2, NHL - Phase 1, HIV - Phase 2 & Phase 1
STATUS
Data readouts from nine ongoing studies
NEXT STEPS
Anticipated clinical progression and data readouts
NEAR-TERM
VALUE CREATION
83% of Helocyte,
4.5% royalty, 2.5% annual equity dividend
FBIO OWNERSHIP
% & ROYALTY
Multi-billion dollar opportunity across various
indications
POTENTIAL PEAK
GLOBAL SALES^
Triplex
Universal multi-antigen MVA-based immunotherapy for the treatment of
CMV in solid organ transplants and hemopoietic stem cell transplants,
Non-Hodgkin lymphoma and HIV
EST. MARKET
Solid Organ Transplant - ~59K pts/year, Hematopoietic
Stem Cell Transplant – ~30K pts/year, Non-Hodgkin's
lymphoma (NHL) – ~81K pts/year, HIV – 3.5M pts
Product candidate in development at Helocyte, a Fortress Partner Company.
^ Potential peak sales are based on internal forecasts and/or market comps and assume approval in all denoted indications and are subject to change.
* Ongoing study NCT codes include: NCT06075745, NCT03354728, NCT05432635, NCT05099965, NCT06252402, NCT05801913, NCT06735690,
NCT06059391
Triplex is a Modified Vaccinia Ankara (MVA), which generates rapid, robust, and durable CD4 &
CD8 T Cell Response to the target of pp65 + IE1 + IE2
Triplex may address patient unmet needs across multiple diseases:
Potential to be a leading treatment for CMV control in SOT and HSCT recipients
Potential to be a leading treatment for CMV control in patients with HIV
Potential to eliminate HIV-infected cells in patients when combined with a CAR-T cell therapy
Potential to improve the efficacy of CAR-T cell therapies by increasing expansion and durability
ASSET OVERVIEW
20
Fortress Biotech Model
MB-109
IL13Rα2 CAR-T + HSV-1 Oncolytic Virus for Glioblastoma
and High-Grade Astrocytoma
• IND accepted by the FDA to initiate Phase 1
combination trial for MB-109 (MB-101+ MB-108) for
recurrent GBM
• MB-101 (IL13Rα2 CAR-T) Phase 1 complete
• MB-108 (HSV-1 Oncolytic Virus) Phase 1 ongoing at
University of Alabama at Birmingham
STATUS
Potentially initiate Phase 1 in GBM
NEXT STEPS
8% of MBIO
4.5% royalty, 2.5% annual equity dividend
FBIO OWNERSHIP
% & ROYALTY
$1B+
POTENTIAL PEAK
GLOBAL SALES^
MB-101 + MB-108 combination is designed to turn the tumor microenvironment “hot”, which
may improve the efficacy of CAR-T cell therapy
MB-108 HSV-1 (herpes simplex virus 1) oncolytic virus infects tumor cells, which reshapes the tumor
microenvironment (TME) through cytokine release and recruitment of endogenous CD8-positive effector T
cells
“Hot” TME may enable MB-101 CAR-T cells to better infiltrate the tumor mass, undergo activation and effect
tumor cell killing
Received Orphan Drug Designation (ODD) in Q3 2025 for MB-101 for the treatment of
astrocytomas and glioblastoma and ODD in Q4 2024 for MB-108 for the treatment of malignant
glioma
ASSET OVERVIEW
U.S. incidence of 12K
EST. MARKET
Product candidate in development at Mustang Bio, Inc., a Fortress Partner Company.
^ Potential peak sales are based on internal forecasts and/or market comps and assume approval in all denoted indications and are subject to change.
21
Fortress Biotech Model
MB-106
CD20 Autologous CAR-T Cell Therapy for
autoimmune diseases
Potentially initiate proof-of-concept Phase 1 trial for
autoimmune diseases
NEXT STEPS
8% of MBIO
4.5% royalty, 2.5% annual equity dividend
FBIO OWNERSHIP
% & ROYALTY†
Peak sales potential in U.S. of >$1 billion
EST. MARKET
Planning proof-of-concept Phase 1 trial for
autoimmune diseases
STATUS
$500M - $1B
POTENTIAL PEAK
GLOBAL SALES^
Third generation fully-human CD20 targeted autologous CAR-T with Orphan Drug Designation
for Waldenstrom macroglobulinemia (WM)
Updated data from multi-center Phase 1/2 trial showed favorable safety profile and clinical
responses from all nine patients
Complete response (CR) and durability in the treatment of patients with relapsed or refractory indolent B-cell
Non-Hodgkin Lymphoma; no occurrence of CRS above grade 1 and no ICANS of any grade
Five patients with follicular lymphoma (FL) achieved a CR rate of 100%
CR observed in patients previously treated with CD19-targeted CAR T- cell therapy
Results from single-center Phase 1/2 trial at Fred Hutch:
FL final cohort data showed Overall Response Rate (ORR) of 95% and CR rate of 80% was observed
(n=20) across all dose levels
Higher dose levels had an ORR of 100% and CR of 91% and 10 patients in remission over 1 year, seven
of which over 2 years
Favorable safety profile with no grade 3+ CRS and no occurrence of ICANS
WM cohort showed 83% of patients (5/6) treated responded to treatment including 2 CRs, 1 very good
partial response, 1 partial response, 1 minor response and 1 stable disease
Favorable safety profile with no grade 3+ CRS and no grade 2+ ICANS
Exploring proof-of-concept Phase 1/2 for autoimmune diseases
ASSET OVERVIEW
Product candidate in development at Mustang Bio, Inc., a Fortress Partner Company.
^ Potential peak sales are based on internal forecasts and/or market comps and assume approval in all denoted indications and are subject to change.
22
F O R T R E S S B I O T E C H
BUSINESS MODEL
DETAIL
23
Strategic plan to
generate near-
term cash flow
and
long-term value
Fortress Biotech Overview
EQUITY
Generate 2.5% equity
dividend from majority of existing
subsidiary and partner companies
ROYALTIES
Generate 4.5% royalties
from majority of existing product
candidates*
ACQUISITIONS
Continue to expand portfolio by
acquiring, developing, and
commercializing new clinical
candidates
EXPANSION
Leverage growing team of
key opinion leaders to launch
NewCos
MONETIZATION
Generate revenue from
strategic transactions including
exits and licensing agreements
PRODUCT REVENUE
Generate cash-flow as
clinical candidates become
commercially available
01. 02. 03.
04. 05. 06.
* Fortress does not receive royalties from its partner company Journey Medical nor from certain assets that have been sold, including CAEL-101 and AAV.sFH Gene Therapy. In some
instances, royalties may vary for assets that been acquired, including a 2.5% royalty for Unloxcyt to Fortress and tiered royalties between 3% and 12.5% for CUTX-101 to Cyprium.
24
Market inefficiencies create opportunities
GLOBAL ARBITRAGE
Fortress acquires rights to drugs that are already approved in the EU and Japan and
obtains licenses to market these assets ex-EU or ex-Japan respectively
Fortress Biotech Model
* IQVIA Global Trends in R&D 2022, Congressional Budget Office
April 2021 – R&D in the Pharma Industry, Public filings.
** GlobalData. Phase I includes assets that have filed an IND /
CTA, but not yet started Phase I
^ FDA Novel Drug Approvals 2024.
*** GlobalData. Phase I includes assets that have filed an IND /
CTA, but not yet started Phase I; Phase III includes pre-
registration candidates.
^^ Clinical Development Success Rates and Contributing Factors
2011-2020.
FBIO Strategic Focus
Fortress partners with Key Opinion Leaders (KOLs) to acquire later-stage clinical product
candidates with existing proof-of-concept
Preclinical
$350bn+ industry spend on
life sciences R&D*
14,500 clinical candidates in
development globally**
50 novel drugs approved by
the FDA in 2024^
Clinical Success Rates by Phase^^
48% of candidates***
52% move to Phase 2
36% of candidates***
29% move to Phase 3
16% of candidates***
52% move to Approval
Phase 1 Phase 2
FDA
Approval
Phase 3
25
Fortress Biotech Model
Recent portfolio
milestones
1
NDA accepted and granted priority
review by FDA; target PDUFA action
date of September 30, 2025
1
BLA submission* potentially in 2025/26
LATE-STAGE AND REGULATORY
EXECUTION
Portfolio and pipeline includes product candidates in development at Fortress, at
its majority-owned and majority-controlled partners, and at partner companies
that Fortress may otherwise have an economic interest in
* BLA anticipated to be filed on behalf of partner Caelum Biosciences.
** Acquired by Sun Pharma on May 30, 2025.
Dec. 2024
Unloxcyt**: BLA approved for the treatment of metastatic and locally advanced cutaneous squamous cell
carcinoma (“cSCC”)
Jan. 2025
CUTX-101: NDA accepted and granted priority review by FDA; target PDUFA action date of September 30,
2025
Sep. 2024
Unloxcyt**: Longer-term data from pivotal trial in cSCC presented at ESMO with deepening of responses
over time and higher ORR and CR rates than observed in primary analyses
Nov. 2024 Emrosi: received FDA approval in Nov. 2024 for the treatment of inflammatory lesions from rosacea
Jul. 2024
Dotinurad: Asset sold by Urica Therapeutics to Crystalys Therapeutics for 35% ownership of Crystalys with
anti-dilution and 3% secured royalty
2
Approvals in Q4’24
May 2025 Checkpoint: Acquired by Sun Pharma; FBIO to receive $28M and a 2.5% royalty on net sales of Unloxcyt
EARLY-TO-MID-STAGE CLINICAL
PROGRESSION
19
ongoing clinical trials
26
Potential Trial
Initiations
Fortress believes shareholders will benefit from potential near-term catalysts
MB-106, MB-109, BAER-101, and IV Tramadol are product candidates in development at Fortress subsidiary/partner companies.
* Acquired by Sun Pharma on May 30, 2025.
^ Refer to Footnote regarding CUTX-101 on slide 16.
**Asset is currently fully controlled by AstraZeneca through the acquisition of Caelum; all estimates and dates related to CAEL-101
are based on public statements made by AstraZeneca. Fortress remains eligible to receive up to an additional ~$125 million in
milestone payments from the transaction; milestones expected during the timeframe above.
^^Asset transfer of dotinurad to partner Crystalys Therapeutics in July 2024.
Fortress Biotech Overview
Category Company Asset
Anticipated Milestone Anticipated Timing
Monetization
Events
Checkpoint* Corporate
o Acquired by Sun Pharma in May 2025 May 2025
Cyprium^
CUTX-101
o Potential approval and PRV issuance Q3 2025
o Eligible to receive 76% of up to $129M in remaining regulatory and sales milestones 2025+
Caelum**
CAEL-101
o Eligible to receive ~42% of additional payments to Caelum shareholders totaling up to $295M from
regulatory and commercial milestones
2025+
Regulatory
Decisions
Journey
Emrosi (DFD-29)
o NDA approved Nov. 2024 for the treatment of Rosacea Nov. 2024
Checkpoint*
Unloxcyt (Cosibelimab)
o BLA approved in Dec. 2024 for for metastatic and locally advanced cSCC Dec. 2024
Cyprium
CUTX-101^
o FDA Decision for Menkes Disease Q3 2025
Caelum*
CAEL-101
o FDA Decision for AL amyloidosis 2026+
Clinical Data
Helocyte
Triplex
o Readouts from various Phase 1/2 trials for CMV in transplant and HIV 2025
Caelum**
CAEL-101
o Readout of the Caelum CARES Phase 3 trials H2 2025
Urica^^
Dotinurad
o Initiation of pivotal trial(s) for treatment of gout 2025+
Mustang
MB-106
o Initiation of Phase 1 proof-of-concept study for autoimmune diseases
2025
MB-109
o Initiation of Phase 1 novel combination (CAR-T + oncolytic virus) trial for GBM 2025
Helocyte
Triplex
o Dosing of first patient in combination CMV-CD19 CAR-T + Triplex arm for NHL 2025
CMV-HIV CAR-T
o Enrollment of first patient in CMV-HIV CAR-T trial 2025
27
Fortress Biotech Model
Management Team
Previously, CEO of Arvinas, LLC, SVP and Executive Global Program Head of Cell & Gene Therapies Unit at Novartis
Mustang Bio
CEO
Manny
Litchman, MD
Previously, VP of Dermatology Sales at Medicis Pharmaceutical Corporation; executed 50+ product launches during
career
Journey Medical
CEO
Claude
Maraoui
Previously, General Partner at TVM Capital, Head of Licensing and BD at Imbrium Therapeutics, Medical Affairs and
BD at Purdue Pharma
Avenue
CEO
Alix MacLean,
MD
Co-founder of Cougar Biotechnology (acquired by JNJ), Chelsea Therapeutics (acquired by Lundbeck), Indevus Pharma
(acquired by Endo). Additionally co-founded Biocryst, Keryx, and CorMedix
Fortress
Chairman & CEO
Lindsay
Rosenwald, MD
Current CEO and President of TG Therapeutics. Founder of ACCESS Oncology (acquired by Keryx Biopharmaceuticals).
Began career as an attorney at Cravath, Swaine & Moore LLP
Fortress
Executive Vice Chair
Mike
Weiss, JD
Former Director at Barings, Director of Corp Dev at Sorrento Therapeutics, VP of Healthcare Investment Banking at FBR
& Co., management consulting at IQVIA
Fortress
CFO & Head of Corp
Dev
David
Jin
28
Partnerships with
leading academic
institutions, global
pharmaceuticals,
and research and
treatment centers
ACADEMIC INSTITUTIONS
Fortress Biotech Model
GLOBAL PHARMACEUTICALS
RESEARCH & TREATMENT CENTERS
FUJI YAKUHIN
29
Fortress supports and collaborates with subsidiary and partner
companies
Fortress Biotech Model
* Applicable to most Fortress subsidiaries, but not all.
Fortress provides all business development efforts including active identification of
synergistic portfolio assets
Fortress provides ongoing operational, strategic, administrative and finance support
Most subsidiary/partner companies provide Fortress an annual 2.5% equity dividend
and a 4.5% royalty on net sales*, which incentivizes Fortress to continue to build value
over time
Subsidiary/partner companies and Fortress can share resources, personnel, and
expertise
FORTRESS PORTFOLIO
Thank you!
F O R T R E S S B I O T E C H
