Corporate Presentation
October 2025
1
Shield Therapeutics
Fast Growing, Mission Driven, Specialty Pharmaceutical Company
Large global iron deficiency/iron deficiency anemia (ID/IDA)
market ripe for disruption
• +15 million iron deficient individuals in the US with and without anemia
40-60% of patients on traditional irons often lead to discontinuation due to intolerable GI side effects or insufficient efficacy
ACCRUFeR®/FeRACCRU® (ferric maltol) set to the be the oral iron treatment of choice
Approved by the FDA, EMA, TGA, Swiss Medic, and Health Canada as the only prescription oral iron indicated for the treatment of ID/IDA
Highly tolerable proprietary oral formulation that offers a low side effect profile,
distinguishing itself from conventional iron treatments
Poised to turn cash flow positive by end of 2025
A strengthened balance sheet with enough cash to get to turning cash flow positive by the end of 2025
Peak revenue potential of ACCRUFeR® of ~$450M2, Strong IP through 2035
3 1. Cancelo-Hidalgo MJ, et al. Curr Med Res Opin. 2013;29(4):291-303
2. Shield management estimate
Anders Lundstrom
CEO
Santosh Shanbhag
CFO
Lucy Huntington-Bailey
General Counsel
Andy Hurley
Chief Commercial Officer
David Childs
VP, Manufacturing and Strategic Alliance
Dr. Jackie Mitchell
VP, Quality, Clinical and Regulatory Affairs
4
Iron Deficiency with s without Anemia (ID/IDA)
Universal problem: HCP's are struggling to treat IDA because patients can't tolerate the GI side
effects of oral iron salts
Oral ferrous salts dissociate in the stomach. Unabsorbed iron (Fe+) generates reactive oxidative species (ROS), causing irritation and damage to the intestinal lining and gastrointestinal (GI) side effects
Up to 70% of patients can experience GI related side effects1,2 including bloating, dark
stool, nausea, distention
Up to 60% of patients will discontinue treatment with ferrous (iron) salts primarily due
to GI adverse events and lack of effectiveness3
5
1. DeLoughery TG. Safety of oral and intravenous iron. Acta Haematol. 2019;142(1):8-12. doi:10.1159/000496966; 2. Tolkien Z, Stecher L, Mander AP, Pereira DIA, Powell JJ. Ferrous sulfate
supplementation causes significant gastrointestinal side-e ects in adults: a systematic review and meta-analysis. PLoS One; 3. Cancelo-Hidalgo MJ, et al. Curr Med Res Opin. 2013;29(4):291-303
ACCRUFeR® designed for efficacy and tolerability
Unique MOA (mechanism of action) Shields and Delivers Elemental Iron to the Small Intestine 1, 2
Proprietary formulation
ACCRUFeR® is formulated in a maltol complex vs. traditional oral irons, provided in ferrous-based formulations
Low iron dose
60 mg of elemental iron is delivered by ACCRUFeR® daily
ACCRUFeR is dosed at 30mg BID, MOA = mechanism of action
ACCRUFeR® (ferric maltol) [Prescribing Information]. Austin, TX: Shield Therapeutics, 2019. Revised 02/22.
ACCRUFeR® remains tightly
bound in the stomach
The unique Maltol Shield protects iron from the stomach, remaining tightly bound as it passes through
Dissociates upon uptake in
the duodenum
Iron remains bioavailable, chelated, and ready to replenish iron stores.
Excess iron is excreted in the
stool
Shield graphic for illustrative purposes only
6
Significant window of opportunity exists for ACCRUFeR®
IV Iron
>G0% ferrous salts2
Iron replacement that patients will actually take
Oral Iron
A well tolerated oral iron that effectively normalizes and maintains Hb, ferritin, and TSAT levels1
7
Data from AEGIS 1 and 2 study
2023 IQVIA Xponent PlanTrak
ACCRUFeR®/FeRACCRU® (ferric maltol) portfolio - Global footprint
disease phase 1 phase 2 phase 3 regulatory marketed market opportunity Partner
ID/IDA
Prevalence in DE: ~3.3% of ID/IDA5, UK: ~8%/3% (women/men) IDA6
(adults)
ID/IDA
(pediatrics)
priority review; decision in 202c
15M Adults with ID/IDA3
6-7% of population have ID4
5.2M people with ID/IDA7
15% prevalence of ID/IDA8
~1.0M8 kids with ID/IDA9
co-promote
co-promote
decision in 202c
TBD
Pulmonary Arterial Hypertension (PAH)
$230M market in 202410
ID/IDA = Iron deficiency without and with anemia, 1. Norgine: EU, UK, Norway, Australia, New Zealand, other non-EU Countries, 2. ASK Pharma: China, Hong Kong, Macau, Taiwan 3. 2024 HCP and Patient Quant studies, 2025 Digital Online analysis, 4. The
8 Journal of Nutrition, Population Iron Status in Canada: Results from the Canadian Health Measures Survey 2012-2019 5. Manz, K.C., Murphy, D., Stavenow, F. et al. Epidemiology and treatment of patients with iron deficiency and iron deficiency anemia: a study on longitudinal German health claims data. BMC Public Health 25, 3053 (2025) 6. The Journal of Nutrition, Volume 155, Issue 3, March 2025, Pages 1005 7. Prevalence and risk factors for iron deficiency anemia in the Korean population: results of the
fifth Korea National Health and Nutrition Examination Survey 8. CSL Vifor 9.Compass Patient Claims with Pathways 2024 10.https://www.techsciresearch.com/report/japan-pulmonary-arterial-hypertension-drugs-market/24634.html
While ID/IDA is vast, reaching patients who have the urgency to treat is critical to the success of ACCRUFeR®
+15 MM
Adults with ID/IDA
Adults with ID/IDA in the U.S.
+5 MM
Actively Seeking Oral Iron
2.5 MM
Taking oral iron
500K
Taking oral iron
DTC Marketing
ID/IDA
Actively seeking oral iron treatment online
HCP s DTC Marketing
50K HCPs (Primary Care, Women's Health (WH),
Nephrology, Hematology/Oncology, Gastroenterology)
1.3M patients* have GI side effects from oral iron salt
HCP (field targets) s Marketing
10K HCP (Primary Care and WH)
250K patients* have GI side effects from oral iron salt
2024 HCP and Patient Quant studies, 2025 Digital Online analysis
9 *Patients taking Oral Iron Salts and have GI Side Effects estimated to be 40%-60% (Cancelo-Hidalgo MJ, et al. Curr Med Res Opin. 2013;29(4):291-303 and
HCP and patient quant 2024
Consumer related marketing efforts rapidly increasing ACCRUFeR® awareness
Social Media Influencers
GI side effects
Fitness 4%
9%
IBD 15%
Nutrition C Weight Loss 15%
CKD
12%
Cancer 12%
Beauty Pregnancy,
10% Perimenopause,
Menorrhagia 13%
Reached +1M patients
Top Social Media Channels and
Patient Communities
Digital Advertising
Reached +3.3M patients
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Physician focused marketing efforts has expanded reach into specialists
Sales Efforts
2025
Other, 3%
GI, 0%
Hem/Onc, 0%
Neph, 0%
WH, 39%
Primary Care,
58%
Marketing Efforts
YTD (Aug)
WH
20%
GI
10%
HEM
4%
NEPH
15%
Primary care
22%
Oncology
17%
PED
1%
Others
11%
WH = Women's Health; HEM = Hematology; GI = Gastroenterology; NEPH = Nephrology; ONC = Oncology
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Early indicators show positive impact of digital strategy on Rx by new writers
New Writer - New Rx With and Without Field Interactions
New TRX w/ Field R3M New TRX w/o Field R3M
600
R3M ACCRUFeR® NRx
500
400
300
200
100
0
Jan-25 Feb-25 Mar-25 Apr-25 May-25 Jun-25 Jul-25 Aug-25 Sep-25
12 Internal data, data on file
Key ACCRUFeR® initiatives building ACCRUFeR® momentum
Increase awareness of ACCRUFeR®
Patients and HCPs via digital marketing/initiatives
Endemic Ads and Rollout of Influencers within patient-focused social media channels
Significant increase in EMR banner marketing to providers
Enhance Sales Force Output
Redesign of sales territories has resulted in strong prescription growth
Continue to Drive Demand in Top 6 States (NY, CA, TX, FL, GA, NC)
Increase Prior Authorization (PA) submissions, PA approval rate s Covered Rx Fill rate
Focus on more PA's submissions
Contract with additional pharmacies that have robust PA approval process support for offices
Leverage Case Managers to contact patients to pick up unfilled prescriptions
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#1 branded prescription oral iron in the US ID/IDA* market
Source: IQVIA Xponent PlanTrak
*ID/IDA: Iron Deficiency with & without Anemia
2025 Business Priorities
Grow ACCRUFeR® Net Revenues
Turn Cash Flow Positive by End of 2025
Launch in Canada, and execute regulatory process in Korea, China, and the Pediatric Population
Q3 25 Q3 25 Q3 25
#1 branded prescription oral iron in the US ID/IDA market
~$13.1M ACCRUFeR® Net Revenues
~54K TRx with ~22% consignment1
~:237 Net Selling Price in Ǫ2 25
$8.6M cash and cash equivalents
Net burn of :3M excluding :2.0M placing
~$2.0M placing
@7.5p/share, 5% premium to 30D VWAP
On track to turn cash flow positive in Q4 2025
Priority Review by FDA for ACCRUFeR®
children with iron deficiency anemia (IDA)
Positive efficacy and safety results for ACCRUFeR® in Heart Failure (HF) and Iron Deficiency Anemia (IDA)
15
1. Consignment business represents prescriptions that were dispensed at no cost or at a significantly subsidized price to patients and were not reimbursed by payors
Note: Unaudited 2025 financials
ACCRUFeR® prescriptions demonstrating significant uptake since launch
5,000
4,500
4,000
3,500
3,000
2,500
2,000
1,500
1,000
500
-
16 Internal data, data on file
Jul-21 Aug-21 Sep-21 Oct-21 Nov-21 Dec-21 Jan-22
Feb-22 Mar-22 Apr-22 May-22 Jun-22 Jul-22
Fully staffed Shield and
Viatris sales team in the US
Aug-22 Sep-22 Oct-22 Nov-22 Dec-22 Jan-23
ACCRUFeR® Weekly US TRx
Feb-23 Mar-23 Apr-23 May-23 Jun-23 Jul-23
•
•
New consignment strategy Sales force optimization
Aug-23 Sep-23 Oct-23 Nov-23 Dec-23 Jan-24 Feb-24 Mar-24 Apr-24 May-24 Jun-24 Jul-24 Aug-24 Sep-24 Oct-24 Nov-24 Dec-24 Jan-25
Feb-25 Mar-25 Apr-25 May-25 Jun-25 Jul-25
Aug-25 Sep-25
HCP and Patient discuss ACCRUFeR®
HCP sends Rx to Specialty Pharmacy
HCP
Patient
ACCRUFeR® Distribution in the US
ACCRUFeR®
Order Placed
ACCRUFeR®
Order Placed
ACCRUFeR®
Order Placed
Rx Dispenses Q3 '25
>54K
Net Revenue Q3 '25
c.$13.1M
3rd Party Logistics (inventory)
Title Model Provider (inventory)
Distributor
(inventory)
Pharmacies
Prescription
Patient
(inventory)
17
Continued growth in ACCRUFeR® in the US in Q3 2025
ACCRUFeR® Net Revenues
Net Price Per Script
Total Prescriptions
Quarterly
Quarterly
Quarterly
$13.1M
$237
$187
$171
$167
$139
$231
$237
c.36
c.44
c.41
c.37
c.47
c.54
$12.8M
$11.2M
$6.9M $7.2M
$6.4M
$4.1M
21
16
27
10
28
16
31
10
37
11
43
12
c.2G
16
13
Q1 24 Q2 24 Q3 24 Q4 24 Q1 25 Q2 25 Q3 25
Q1 24 Q2 24 Q3 24 Q4 24 Q1 25 Q2 25 Q3 25
Q1 24 Q2 24 Q3 24 Q4 24 Q1 25 Q2 25 Q3 25
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Note: Consignment business represents prescriptions that were dispensed at no cost or at a significantly subsidized price to patients and were not reimbursed by payors
Prescription data based on IQVIA NPA + BlinkRx consignment Unaudited 2025 financials
On track to turn cash flow positive in Q4 2025 driven by continued ACCRUFeR® growth in the US and effective working capital management
$10
Quarterly Cash Burn (Net of New Financing) in millions
Impact of one-
time milestone payments
$0
($10)
($20)
Q2 23
Q3 23
Q4 23
Q1 24
Q2 24
Q3 24
Q4 24
Q1 25
Q2 25
Q325
Q4 25
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Note: Unaudited 2025 financials
Shield Therapeutics
Fast Growing, Mission Driven, Specialty Pharmaceutical Company
Vast market opportunity with significant revenue potential
Shield-Viatris US partnership driving growth in ACCRUFeR® prescriptions, net revenue and net selling price
Global partnerships continue to progress at a steady pace with anticipated milestones and double-digit royalties
Goal to be cash flow positive by end of 2025
Looking for partnership opportunities to expand the portfolio
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Delivering on the brand promise
Thank You!
Anders Lundstrom - Chief Executive Officer
Santosh Shanbhag - Chief Financial Officer
https://www.shieldtherapeutics.com
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