8-K
iBio, Inc. (IBIO)
8-K
2025-06-24
For: 2025-06-24
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April 07, 2026
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (date of earliest event reported): June 24, 2025
iBio, Inc.
(Exact name of registrant as specified in charter)
Delaware
(State or other jurisdiction of incorporation)
| | |
|---|---|
| 001-35023 | 26-2797813 |
| (Commission File Number) | (IRS Employer Identification No.) |
11750 Sorrento Valley Road, Suite 200
San Diego , California **** 92121 ****
(Address of principal executive offices and zip code)
( 979 ) 446-0027
(Registrant’s telephone number including area code)
N/A
(Former Name and Former Address)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of registrant under any of the following provisions:
☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐ Soliciting material pursuant to Rule 14a-12(b) under the Exchange Act (17 CFR 240.14a-12)
☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b) of the Act:
| | | |
|---|---|---|
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered |
| Common Stock, $0.001 par value per share | IBIO | The Nasdaq Stock Market LLC |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by checkmark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
Item 7.01. Regulation FD Disclosure.
iBio, Inc. (the “Company”) has updated its corporate presentation. A copy of the updated corporate presentation is filed as Exhibit 99.1 to this Current Report on Form 8-K.
The corporate presentation attached as Exhibit 99.1 to this Current Report on Form 8-K includes “safe harbor” language pursuant to the Private Securities Litigation Reform Act of 1995, as amended, indicating that certain statements contained therein are “forward-looking” rather than historical.
The Company undertakes no duty or obligation to update or revise the information contained in this Current Report on Form 8-K, although it may do so from time to time if its management believes it is appropriate. Any such updating may be made through the filing of other reports or documents with the Securities and Exchange Commission, through press releases or through other public disclosures.
Item 8.01. Other Events.
The Company has updated its corporate presentation for use in meetings with investors, analysts and others. A copy of the updated corporate presentation is filed as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated by reference herein.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
| Exhibit No. | Description | |
|---|---|---|
| | | |
| 99.1 | | Corporate Presentation of iBio, Inc., dated June 2025 |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Date: June 24, 2025 | IBIO, INC. | |
|---|---|---|
| By: | /s/ Marc A. Banjak | |
| Name: Marc A. Banjak | ||
| Title: Chief Legal Officer |
Exhibit 99.1
| Breakthrough Antibodies<br>for Obesity and<br>Cardiometabolic Diseases<br>Corporate Presentation<br>June 2025 | ||
|---|---|---|
| Certain statements in this presentation constitute "forward-looking statements" within the<br>meaning of the Private Securities Litigation Reform Act of 1995, as amended. Words such as<br>"may," "might," "will," "should," "believe," "expect," "anticipate," "estimate," "continue,"<br>"predict," "forecast," "project," "plan," "intend" or similar expressions, or statements regarding<br>intent, belief, or current expectations, are forward-looking statements. These forward-looking statements are based upon current estimates and includes statements regarding<br>near term catalysts. While iBio, Inc., a Delaware corporation (including its consolidated<br>subsidiaries, “iBio,” the “Company,” “we,” “us” or “our”) believes these forward-looking<br>statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to us on the date of this<br>presentation. These forward-looking statements are subject to various risks and<br>uncertainties, many of which are difficult to predict that could cause actual results to differ<br>materially from current expectations and assumptions from those set forth or implied by any<br>forward-looking statements. Important factors that could cause actual results to differ<br>materially from current expectations include, among others, the Company’s ability to<br>obtain regulatory approvals for commercialization of its product candidates, or to comply<br>with ongoing regulatory requirements, regulatory limitations relating to its ability to promote<br>or commercialize its product candidates for specific indications, acceptance of its product<br>candidates in the marketplace and the successful development, marketing or sale of<br>products, its ability to attain license agreements, the continued maintenance and growth<br>of its patent estate, its ability to establish and maintain collaborations, its ability to obtain or<br>maintain the capital or grants necessary to fund its research and development activities,<br>competition, its ability to retain its key employees or maintain its Nasdaq Stock Market<br>listing, and the other factors discussed in the Company’s most recent Annual Report on<br>Form 10-K and the Company’s subsequent filings with the SEC, including subsequent<br>periodic reports on Forms 10-Q and 8-K. The information in this presentation is provided only<br>as of today, and we undertake no obligation to update any forward-looking statements<br>contained in this presentation on account of new information, future events, or otherwise,<br>except as required by law.<br>Forward looking statements<br>2 | ||
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| Revolution Sparked a New Era<br>in Obesity Treatment<br>Evolution Will Define Its Future<br>Incretin Class Agonists Have<br>Revolutionized Obesity Treatment<br>>10% of American adults have taken a GLP-11<br>Interventional weight loss previously only<br>achievable via surgery<br>Attention is Shifting to Therapies<br>That Build on That Foundation<br>Durability of weight loss<br>Lean mass preservation and fat-specific<br>weight loss<br>Improved tolerability and convenience<br>1. https://www.kff.org/health-costs/poll-finding/kff-health-tracking-poll-may-2024-the-publics-use-and-views-of-glp-1-drugs/ | ||
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| “For every 1 kg weight lost… 0.32 kg<br>lean tissue was lost and for every 1 kg<br>weight regained…, only 0.08 kg lean<br>tissue was regained”1<br>1. Beavers et al (2011), Am J Clin Nutr. 94:767-74, 2. Johnson et al (2017), J Bone Miner Res. 32(11):2278-2287 4<br>The GLP-1 Revolution Unlocked Possibility — We Aim to Drive the Evolution<br>GLP-1<br>Treatment<br>start<br>GLP-1<br>Treatment<br>stop<br>Follow up<br>Obesity + Cardiovascular<br>Complication Risk<br>“Compared to (control) group, the<br>[weight loss/regain] group had a<br>statistically significant 39% increased<br>risk of a frailty fracture”2<br>Healthy Weight | ||
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| 5<br>iBio’s Strategy to Redefine Obesity Care with Next-Generation Antibody<br>Therapies<br>Address Challenges With<br>Current GLP-1 Drugs<br>• Muscle mass loss<br>• Side effects leading to<br>discontinuation<br>• Inconvenient dosing<br>frequency<br>• Room for high quality<br>weight loss<br>Focus on Highly<br>Validated Targets<br>• Preserve and build<br>muscle mass<br>• Fat-specific weight<br>reduction<br>• Targeting both sides of<br>the equation, calorie<br>intake and energy<br>expenditure<br>iBio’s Platform Fuels a<br>High-Value Pipeline<br>• Tackling complex, hard<br>to drug targets<br>• Optimizing function and<br>developability<br>simultaneously<br>• Rapidly optimizing<br>multi-specifics | ||
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| Next Generation<br>Antibodies for Obesity<br>Targeting Key Gaps in<br>Current Care<br>Corporate Highlights<br>Lead Programs<br>ƒ IBIO-600: Long-acting<br>myostatin antibody<br>ƒ IBIO-610: First-in-class<br>Activin E antibody<br>Pipeline Expansion<br>ƒ 3 early-stage high novelty<br>programs and 2 partnered<br>programs<br>ƒ Discovery to development<br>candidate in as little as 7<br>months<br>ƒ AI engine delivers precisely<br>targeted antibodies with<br>exceptional developability<br>Near Term Catalyst<br>6<br>IBIO-600 IND/IND<br>equivalent filing by<br>1Q2026*<br>IBIO-600 Phase 1<br>initiated 2Q2026*<br>IBIO-610 IND/IND<br>equivalent filing by<br>end of 2026*<br>* Financing Dependent | ||
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| * Financing Dependent<br>7<br>iBio’s Strategy in Motion: Rapidly Advancing Next-Gen Treatments Beyond<br>First-Gen Obesity Drugs<br>Program Early<br>Discovery<br>Late<br>Discovery<br>Lead<br>Optimization<br>IND-Enabling Phase 1<br>IBIO-600<br>Myostatin<br>IBIO-610<br>Activin-E<br>Myostatin x Activin A<br>(obesity/ potentially PH-HFpEF)<br>Amylin Receptor<br>Target 4<br>Partnered with<br>Anticipated Milestones*<br>IND Filing Q1 2026<br>PH 1 Trial Start Q2 2026<br>Anticipated Milestone*<br>IND Filing 2H 2026 | ||
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| Transition slide –<br>IBIO-600<br>Long-Acting Anti-Myostatin<br>Antibody | ||
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| 1. Schuelke M. (2004). New England Journal of Medicine 350(2682–2688).<br>2. Deng, B. (2017). Nutrition and Metabolism, 14(29). 9<br>Strengthening the Weight Loss Journey: Myostatin Inhibition to Preserve<br>Muscle Mass<br>We are developing Myostatin inhibitors to preserve and increase muscle mass, complementary to current<br>treatments<br>Why We Target Myostatin<br>• Incretin drugs reduce caloric intake,<br>causing weight loss in both fat and muscle<br>• Myostatin is a highly validated key<br>negative regulator of muscle mass1<br>• Inhibition of Myostatin function drives<br>significant muscle growth without<br>apparent adverse health effects<br>• Beyond its effects on muscle, Myostatin<br>plays a role in the regulation of total body<br>fat mass2<br>Binding of<br>Myostatin to cells<br>leads to muscle<br>atrophy<br>Blocking of<br>Myostatin leads to<br>muscle growth | ||
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| 10<br>IBIO-600: A Differentiated Long Acting Anti-Myostatin Program<br>Potential best-in-class PK based on allometric scaling and dosing<br>regimen suggests 2-4x improved PK over competitors<br>Improved<br>Pharmacokinetics<br>Dual myostatin and GDF11 blockade has potential for improved<br>lean mass preservation and fat mass reduction Dual Mechanism<br>Optimized for high expression and stability to enable efficient<br>manufacturing process<br>Enhanced<br>Manufacturability<br>High formulation concentration to lower injection volume Coformulation Optionality<br>Convenience Administration as infrequent as twice a year | ||
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| Data on file 11<br>IBIO-600 Enhances Muscle Differentiation in Human Myoblasts by Targeting<br>the Two Growth Suppressors Myostatin and GDF11<br>IBIO-600 Increases Myoblast<br>Differentiation<br>Baseline human myoblast<br>differentiation (untreated)<br>Myostatin inhibits human<br>myoblast differentiation<br>IBIO-600 blocks Myostatin<br>and increases human<br>myoblast differentiation<br>The human Myoblast differentiation model is highly<br>predictive of muscle growth in humans<br>0.1 1 10 100 1000<br>IBIO-600 (nM)<br>Fusion index<br>Myostatin only<br>IBIO-600<br>0.1 1 10 100 1000<br>IBIO-600 (nM)<br>Fusion index<br>GDF11 only<br>IBIO-600<br>Myostatin<br>GDF11 | ||
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| 1. Linear elimination phase used to estimate half-life with simple linear model<br>Data on file 12<br>IBIO-600 Fc Engineering Drives Extended Half-Life in Obese NHPs<br>Dose t1/2 (days)<br>5 mg/kg, I.V. 52.4<br>IBIO-600 Fc Engineering Results in<br>Enhanced FcRn Binding<br>Clone Fc Fold increase over standard IgG<br>IBIO-600 FAB Standard IgG4 1.0<br>IBIO-600 Engineered IgG4 16.5<br>IBIO-600 Demonstrates Extended<br>Half-Life in NHPs<br>12 Week Pharmacokinetics Data1<br>0 20 40 60 80<br>10<br>100<br>1000<br>Days<br>Serum mAb<br>(ug/mL)<br>IBIO-600<br>Study<br>Details:<br>• Obese, aged NHPs<br>• Monthly DEXA scan for body composition<br>• Periodic PK sampling<br>Study<br>Design:<br>• N=3 per group<br>• 5mg/kg single I.V. dose<br>t1/2 = 52.4 | ||
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| 13<br>IBIO-600 Dose Modeling From Human Muscle Cells and Monkey PK Predicts<br>Low Dose Requirements to Block Myostatin for Extended Durations<br>IBIO-600 Blocks the Effect of Myostatin<br>on Human Muscle Cells<br>IC90 (90% inhibition level) = 1.2 ug/mL (7.97 nM)<br>0 20 40 60 80<br>10<br>100<br>1000<br>Days<br>Serum mAb<br>(ug/mL)<br>IBIO-600<br>30 μg/mL<br>At 5 mg/kg Dose, IBIO-600 Achieves<br>>90% Myostatin Inhibition for 8 Weeks<br>IC90 in muscle (1.2 ug/mL) translates to 30 ug/ml plasma levels assuming<br>mAb Muscle/Plasma Ratio ~4%<br>Data on file | ||
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| . 1 https://pmc.ncbi.nlm.nih.gov/articles/PMC9709760/#CR37<br>2 https://www.jstage.jst.go.jp/article/bpb/43/5/43_b19-01042/_html/-char/en<br>Data on File<br>14<br>Allometric Scaling Predicts Potentially Extended Half-Life for IBIO-600,<br>Enabling Infrequent Dosing and Prolonged Myostatin Inhibition<br>Y=2.49x+17<br>0 10 20 30<br>0<br>20<br>40<br>60<br>80<br>100<br>Allometric scaling<br>YTE and LS mAb only<br>NHP t1/2 (days)<br>Human t1/2 (days) Dose NHP t1/2 (actual) Human t1/2 (predicted)1,2 5 mg/kg, I.V. 52.4 74-130 days<br>Measured NHP and Predicted<br>Human Half-Life of IBIO-600<br>Allometric Scaling Model for Half-Life<br>Extended Antibodies1<br>Generic allometric scaling model for antibodies2<br>T1/2Human= T1/2NHP x Human Body Weight NHP Body Weight<br>0.15 | ||
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| Data on file 15<br>PK Modeling Suggests IBIO-600 Can Be Dosed Twice-Yearly, Quarterly, or<br>Co-Formulated With Weekly GLP-1s<br>Twice Per Year Dosing<br>(4 x 2 mL s.c.)<br>0 200 400 600 800<br>0<br>50<br>100<br>150<br>200<br>Day after first dose<br>Serum (ug/mL)<br>Single Dose<br>Twice a Year Dosing<br>IC90 in muscle<br>0 200 400 600 800<br>0<br>50<br>100<br>Day after first dose<br>Serum (ug/mL)<br>Single Dose<br>Weekly Dosing<br>IC90 in muscle<br>Weekly + 2mL Load<br>Modeling Assumptions: 150 mg/mL formulation<br>T1/2 = 90 days Bioavailability = 70%<br>Quarterly Dosing<br>(2 x 2 mL s.c. or 1 x 2 mL s.c. + 2 mL loading dose)<br>0 200 400 600 800<br>0<br>50<br>100<br>150<br>Day after first dose<br>Serum (ug/mL)<br>Single Dose<br>Q3M (4 mL)<br>IC90 in muscle<br>Q3M (2mL + 2mL load)<br>Co-Dosing With Weekly GLP-1<br>(1 x 0.167 mL s.c. injections) | ||
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| ROI (gluteal and thigh region) DEXA<br>Data on file 16<br>Single Clinically Relevant Low Dose of IBIO-600 Drives Sustained Muscle<br>Gain and Fat Loss in Aged, Obese Non-Human Primates<br>Percent Increase in Lean Mass<br>Weeks post dose<br>0<br>5<br>10<br>15<br>Change in lean mass<br>(%, from baseline)<br>4 8 12<br>-20<br>-10<br>0<br>10<br>Change in fat mass<br>(%, from baseline)<br>4 8 12<br>Weeks post dose<br>Percent Decrease in Fat Mass<br>Single 5 mg/kg Dose Single 5 mg/kg Dose | ||
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| * Financing Dependent 17<br>IBIO-600 Summary and Next Steps<br>9 NHP studies show potential best-in-class<br>half-life, may enable dosing as infrequent<br>as twice a year<br>9 Differentiated profile (myostatin and<br>GDF11 blockade) drives robust lean mass<br>growth and fat loss in NHPs<br>9 High expression titers and stability at high<br>concentrations expect to enable<br>efficient, scalable manufacturing<br>IBIO-600 Highlights<br>o IND-enabling studies (CMC manufacturing<br>and GLP toxicology) ongoing<br>o Initial regulatory filing (IND or equivalent)<br>planned for Q1 2026*<br>o First patient dosed anticipated in 2Q 2026*<br>Status and Planned Development | ||
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| IBIO-610<br>Anti-Activin E Antibody | ||
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| Type 2 Diabetes (T2D) 19<br>IBIO-610 Targets Activin E to Drive Targeted Fat Loss and Maintains Weight<br>Reduction After GLP-1 Discontinuation<br>Why We Target Activin E<br>ƒ Activin E is a Hepatokine, produced in the<br>liver and a member of the TGF<br>E family<br>ƒ Activin E and its receptor are highly<br>genetically validated<br>ƒ Genetic loss of function decreases adiposity<br>and risk for Diabetes / Cardiovascular<br>Disease (CVD)<br>ƒ 2 RNA targeting molecules provide<br>preclinical pharmacological validation<br>ƒ Challenge to produce active recombinant<br>Activin E until recently has proven to be<br>extremely difficult for antibody discovery | ||
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| 20<br>IBIO-610 Breaks New Ground as the Known First-in-Class Antibody<br>Targeting Activin E<br>Antagonist antibody offers potential for greater Activin E inhibition<br>than siRNA-based knockdown approaches<br>Class-Leading Pathway<br>Targeting<br>Pre-clinical studies demonstrate weight loss with no impact on<br>lean mass Dual Mechanism<br>Synergistic weight loss with appetite reducing drugs like GLP-1<br>or Amylin<br>Synergistic to GLP-1<br>Receptor Agonists<br>Stand-alone weight loss intervention and weight loss maintenance<br>post GLP-1 or Amylin treatment<br>Weight Lowering and<br>Maintenance Therapy | ||
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| Target Protein Binding Assay Reporter Cell Line Functional Assay Primary Human Adipocyte Assay<br>Data on file 21<br>IBIO-610 Exhibits High-Affinity Binding and Potent Inhibition of Activin E<br>Signaling in Engineered and Primary Human Fat Cells<br>0.001 0.01 0.1 1 10 100<br>0<br>2000<br>4000<br>6000<br>mAb (nM)<br>RLU<br>Isotype Cnt<br>IBIO-610<br>No treatment<br>IC50 = 158 pM<br>1 10 100 1000<br>0<br>10<br>20<br>30<br>40<br>IBIO-610 (nM)<br>% pSmad2+ cells<br>No treatment<br>Activin E only<br>Activin E + IBIO-610<br>IC50 = 44 nM | ||
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| *Non-responder outlier mice removed, IBIO-610 mouse surrogate used. 10 mg/kg, BIW dosing. DIO mice<br>Data on file 22<br>IBIO-610 Induces Fat-Selective Weight Loss in Diet-Induced Obese Mice<br>0 7 14 21 28<br>-15<br>-10<br>-5<br>0<br>5<br>Day<br>Body Weight % Change<br>Baseline and Vehicle Corrected PBS IBIO-610 -8.9% *** *** *** *** ****<br>p<0.0001<br>p<0.005 ***<br>****<br>Baseline Week 4<br>0<br>5<br>10<br>15<br>20<br>Fat Mass (g)<br>* p<0.05<br>*<br>+0.4%<br>-26%<br>PBS<br>IBIO-610<br>Weight Loss = 8.9% Fat Loss = 26% No Lean Mass Loss<br>Baseline Week 4<br>0<br>5<br>10<br>15<br>20<br>25<br>Lean Mass (g)<br>* p<0.05<br>+3.0% +3.5%<br>PBS<br>IBIO-610<br>Study<br>Design<br>Week -16<br>High-fat diet<br>induction<br>Week -7<br>DEXA<br>Day 1<br>DEXA<br>Day 14<br>DEXA<br>Day 28<br>Randomization<br>and baseline 4 weeks treatment | Semaglutide daily | Antibodies 2x week |
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| Data on file 23<br>IBIO-610 Synergizes with GLP-1 Through a Distinct, Non-Appetite-Based<br>Mechanism<br>Synergistic Weight Loss No Additional Appetite Suppression Visceral Fat Reduction<br>Study<br>Design<br>Week -16<br>High-fat diet<br>induction<br>Week -7<br>DEXA<br>Day 1<br>DEXA<br>Day 14<br>DEXA<br>Day 28<br>Randomization<br>and baseline 4 weeks treatment | Semaglutide daily | Antibodies 2x week<br>0 7 14 21 28<br>-50<br>-40<br>-30<br>-20<br>-10<br>0<br>Day<br>Body Weight % Change<br>Baseline and Vehicle Corrected PBS Sema IBIO-610+Sema -27.8% -35.3%<br>p<0.0001 vs. PBS<br>p<0.005 vs. PBS<br>p<0.01 vs. Sema<br>****<br>***<br>**<br>****<br>**<br>****<br>** **** **** **<br>**** **<br>**** **<br>**<br>****<br>**<br>****<br>**** **** ****<br>****<br>****<br>****<br>PBS<br>Sema<br>IBIO-610+Sema<br>0<br>1<br>2<br>3<br>Food Intake (g)<br>Average, per mouse, weeks 1-4<br>PBS<br>Sema<br>IBIO-610+Sema<br>0<br>500<br>1000<br>1500<br>2000<br>Visceral Fat (mg)<br>Epididymal -58%<br>-69% |
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| Data on file 24<br>IBIO-610 Prevents Weight Regain Following GLP-1 Treatment in Obese Mice<br>Significant Prevention of Weight Regain Fat-Specific Effect<br>Study<br>Design<br>0 5 10 15 20 25 30 35<br>75<br>80<br>85<br>90<br>95<br>100<br>105<br>Day of Treatment<br>Body Weight (%)<br>Baseline and Vehicle Corrected PBS Sema=>PBS<br>Sema=>IBIO-610<br>IBIO-610<br>Initiation<br>ns<br>**<br>*<br>**<br>* p<0.05 compared to Sema=>PBS<br>p<0.005 compared to PBS<br>PBS<br>Sema => PBS<br>Sema => IBIO-610<br>0<br>2<br>4<br>6<br>8<br>Combined Fat<br>mWAT+iWAT+eWAT<br>mass (g)<br>✱✱✱<br>✱✱✱<br>PBS<br>Sema => PBS<br>Sema => IBIO-610<br>0.00<br>0.05<br>0.10<br>0.15<br>0.20<br>0.25<br>Quadriceps (Muscle)<br>mass (g)<br>PBS<br>Sema => PBS<br>Sema => IBIO-610<br>0<br>1<br>2<br>3<br>4<br>Liver<br>mass (g)<br>Vehicle<br>Semaglutide<br>Semaglutide<br>30 DIO mice<br>PBS only<br>Sema => PBS<br>Sema => IBIO-610<br>Day 1<br>Sema cessation<br>Day 14<br>IBIO-610<br>Start day 11<br>Day 14<br>Vehicle<br>Vehicle<br>IBIO-610<br>Day 15 Day 35<br>Necropsy<br>(adipose, muscle,<br>liver assessment) | ||
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| 25<br>The Next Wave of iBio<br>Innovation<br>Early Pre-Clinical Programs | ||
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| *Dual Amylin and Calcitonin Receptor Agonists<br>**Selective Amylin Receptor Agonist 26<br>Harnessing Amylin Biology with Precision Targeting: iBio’s Engineered<br>Antibody Agonist Approach<br>Why We Target Amylin Selective amylin receptor agonists (rather than DACRAs*) have potential as a more precisely targeted obesity<br>intervention<br>• Validated metabolic hormone that<br>promotes satiety, slows gastric<br>emptying, and reduces postprandial<br>glucose excursions<br>• Clinical studies with amylin analogs<br>confirm efficacy in weight loss, but<br>peptide-based approaches may be<br>sub-optimal (dosing, tolerability,<br>manufacturability)<br>• Amylin receptor-selective antibody<br>agonists could provide a differentiated<br>profile, with potential for longer<br>duration of action and reduced side<br>effects alone or in combination therapy<br>Calcitonin<br>Receptor<br>Amylin<br>Receptor 1<br>Amylin<br>Receptor 2<br>Amylin<br>Receptor 3<br>DACRA*<br>1. J Gingell, J. et al. An allosteric role for receptor activity-modifying proteins in defining GPCR<br>pharmacology. Cell Discov 2, 16012 (2016).<br>SARA** | ||
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| 27<br>Combined Myostatin and Activin A Antagonism<br>Synergistic Effect on Muscle Growth and Potential Treatment for Pulmonary Hypertension (PH) in Heart Failure With Preserved Ejection Fraction (HFpEF)<br>We are developing bispecific co-inhibitors of Myostatin and Activin A to enhance muscle growth and<br>improve quality of weight loss during and after treatment with incretin drugs<br>Why Myostatin & Activin A<br>ƒ Myostatin and Activin A are key negative<br>regulators of muscle mass<br>ƒ Both are members of the TGF<br>β superfamily<br>ƒ Activin A mechanism is pharmacologically<br>validated1, 2<br>ƒ Combined Activin A and Myostatin inhibition,<br>causes more pronounced muscle growth3<br>ƒ Myostatin and Activin A inhibition are key<br>features for treating PH-HFpEF<br>1.Villanueva, J. et al. Am J Cardiovasc Drugs (2024).<br>2.US20220119514A1, Regeneron corporate slides<br>3.Latres, E. et al. Nat Commun 8, 15153 (2017).<br>Binding of<br>Myostatin and<br>Activin A to cells<br>leads to muscle<br>atrophy<br>Simultaneous<br>blocking of<br>Myostatin and<br>Activin A leads to<br>muscle growth | ||
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| Data on file 28<br>iBio’s Myostatin and Activin A Bi-Specific Targets Both Key Negative Muscle<br>Regulators, Synergistically Increasing Muscle Mass<br>Increased muscle fusion index in human muscle stem cells is a<br>surrogate of muscle growth<br>Negative control (Myostatin + Activin A) without antibody<br>Myostatin + Activin A with Activin A Antibody<br>Myostatin + Activin A with Myostatin Antibody<br>Myostatin + Activin A with Myostatin x Activin A Bi-Specific<br>Only a Myostatin x Activin<br>A bi-specific antibody fully<br>blocks both muscle<br>growth suppressors,<br>enabling optimal growth,<br>while single-target<br>antibodies fall short<br>In Vitro Data | ||
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| 29<br>Technology Stack | ||
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| Any Epitope on Any Drug Target<br>AI Epitope Engineering and Antibody Optimization Engines unlock challenging target classes<br>• Multi-layer technology<br>platform addresses multiple<br>challenges in Ab discovery<br>• Patented Epitope Steering<br>technology<br>• Single-step Ab StableHu x<br>Mammalian Display<br>• Masked (ShieldTx®) Antibodies<br>• T-cell engager panel<br>(EngageTx<br>gag<br>e<br>T<br>x )<br>iBio’s Discovery Engine<br>iBio’s Proprietary AI<br>Technology Platform<br>We use our Tech Stack to generate new IP against hard-to-drug targets<br>–<br>from idea to Development Candidate in 7 months<br>• Selectively targets functional<br>epitopes<br>• Epitopes with complex modes of<br>action<br>• Unlocks novel target classes<br>• Accelerates discovery of Ab<br>against validated targets<br>AI-guided precision hits that<br>are epitope class agnostic<br>• Gen AI creates mammalian display<br>libraries with phage-like diversity<br>• Single-shot multidimensional lead<br>optimization<br>• Compatible with multi-specific antibody<br>formats<br>• Antibody format agnostic<br>Generative AI meets mammalian<br>display: Ab optimization in 3 weeks<br>30 | ||
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| Any Epitope on Any Drug Target<br>AI Epitope Engineering and Antibody Optimization Engines unlock challenging target classes<br>• Multi-layer technology<br>platform addresses multiple<br>challenges in Ab discovery<br>• Patented Epitope Steering<br>technology<br>• Single-step Ab StableHu x<br>Mammalian Display<br>• Masked (ShieldTx) Antibodies<br>• T-cell engager panel<br>(EngageTx)<br>iBio’s Discovery Engine<br>iBio’s Proprietary AI<br>Technology Platform<br>We use our Tech Stack to generate new IP against hard-to-drug targets<br>–<br>from idea to Development Candidate in 7 months<br>• Selectively targets functional<br>epitopes<br>• Epitopes with complex modes of<br>action<br>• Unlocks novel target classes<br>• Accelerates discovery of Ab<br>against validated targets<br>AI-guided precision hits that<br>are epitope class agnostic<br>• Gen AI creates mammalian display<br>libraries with phage-like diversity<br>• Single-shot multidimensional lead<br>optimization<br>• Compatible with multi-specific antibody<br>formats<br>• Antibody format agnostic<br>Generative AI meets mammalian<br>display: Ab optimization in 3 weeks<br>31 | ||
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| 32<br>Mammalian Display Enables Rapid Whole Molecule Optimization<br>Input library of<br>diverse<br>sequences,<br>formats, masks,<br>and linkers<br>Multi-dimensional<br>cell sorting selects<br>for high expression,<br>positive on target<br>binding, and<br>negative off-target<br>binding | ||
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| Corporate Summary | ||
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| 34<br>A Leadership Team with Deep Industry Experience<br>Deep expertise in cardiometabolic<br>disorders<br>Marc Banjak<br>CLO<br>Martin Brenner, DVM, Ph.D.<br>CEO & CSO<br>Kristi Sarno<br>Senior VP BD<br>Felipe Duran<br>CFO | ||
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| Executive Summary Corporate Highlights<br>Differentiated Pipeline Solving for the<br>Challenges of today’s GLP1’s<br>¾ Quality weight loss (IBIO-600, IBIO-610)<br>¾ Developability (IBIO-600, IBIO-610)<br>Patented AI-Driven Discovery Tech Stack<br>¾ Rapidly advance a highly<br>developable pre-clinical pipeline<br>¾ Solve hard-to-drug problems<br>Financial Highlights<br>¾ $10.5M in cash and<br>restricted cash and<br>cash equivalents as of<br>May 1, 2025<br>¾ ~16.22M shares<br>outstanding as of June<br>13, 2025<br>35 | ||
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| Appendix | ||
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| 37<br>Pre-Clinical<br>Immuno-Oncology<br>Pipeline | ||
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| *Tumor Micro Environment 38<br>Beyond Cardiometabolic – Driving Value Within Our Oncology Pipeline<br>Program MoA Potential<br>Indications<br>Early<br>Discovery<br>Late<br>Discovery<br>Lead<br>Optimization<br>IND-Enabling Highlights<br>IBIO-101 Treg depletion, IL-2 sparing<br>Solid tumors,<br>orphan<br>indications<br>Synergistic efficacy with<br>checkpoint inhibitors<br>CCR8<br>Tumor-infiltrating Treg<br>depletion<br>Solid tumors Highly selective vs. closely<br>related GPCRs<br>Trop-2 x CD3<br>Tumor-protease<br>activated T<br>cell engager<br>Solid tumors<br>ShieldTx technology enables<br>masking; delivery as pro-drug<br>activated in TME*<br>MUC16 x CD3<br>Tumor-protease<br>activated T<br>cell engager<br>Ovarian and<br>pancreatic<br>cancer<br>Binds membrane-proximal<br>epitope, distinct from<br>Regeneron MUC16xCD3<br>EGFRvIII ADCC- enhanced Fc Glioblastoma Highly selective for EGFRvIII over EGFR<br>Latent TGF<br>β<br>Protein<br>Complex<br>Stabilization<br>Solid tumors<br>Innovative mechanism of<br>action locking protein complex<br>in inactive form<br>ShieldTx<br>EngageTx<br>ShieldTx<br>EngageTx | ||
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| 39<br>Technology<br>Stack | ||
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| 40<br>iBio’s Tech Stack Aims to Solve Major Challenges in Antibody Discovery &<br>Development<br>Epitope<br>Steering<br>StableHu<br>&<br>Mammalian Display<br>Unlocking Novel<br>Biology<br>Reduced Lead-Optimization Time<br>Optimization in less than 4 weeks<br>Minimized Developability Risk<br>Mammalian Display in<br>Manufacturing Cell Line<br>Potential for Improved Safety<br>Selective “on-tissue” action of<br>masked antibodies<br>First in Class Antibodies and / or<br>Best in Class Antibodies<br>Pursuit of Elusive<br>Targets<br>GPCRs, Ion Channels,<br>Protein Complexes<br>Complex modalities<br>Agonistic Antibodies,<br>Cell Activators,<br>Protein Complex<br>Stabilizers<br>Fully human Ab<br>Reduced immunogenicity<br>risk by clinically validated<br>Ab frameworks<br>Speed<br>Rapid hit ID vs immunization<br>campaigns<br>Improved Developability<br>Known sequence liabilities<br>eliminated<br>Optimized<br>Antibody Leads<br>Proprietary Naïve<br>mAb Library<br>Library Diversity<br>ML tools create focused<br>diversity with smaller library<br>size<br>Speed<br>Simultaneous, Multi-Dimensional Optimization<br>Improved Developability<br>Mammalian Display with<br>production cell lines<br>exclusively yields expressible<br>clones<br>Improved Speed and Developability | ||
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| 41<br>iBio’s Tech Stack Addresses Immuno-oncology Discovery and<br>Development Challenges<br>ShieldTx<br>2nd Gen T-cell<br>Engager Panel<br>Finely tuned T-cell engagement<br>Adjustable T-cell engagement to fit<br>any tumor target engager<br>Improved safety prediction<br>Cyno cross reactivity allows for<br>better preclinical safety<br>assessment<br>Improved Safety Profile<br>Tissue selective action through<br>“smart”, conditionally activated,<br>antibodies<br>Sequence Diversity<br>Increased humanness and broad<br>CD3 activity for optimized pairing<br>with antigen arms<br>Hu-Cyno Cross Reactivity<br>Risk reduction via cyno monkey<br>toxicity study compatibility<br>Range of Cytokine Release<br>Tailored cytokine release for<br>expanded therapeutic window<br>Enhanced Efficacy<br>and Safety of I/O<br>Antibody Leads<br>EngageTx<br>Greater Safety With<br>Tissue Specificity<br>Seamlessly Integrated Ab<br>Masking<br>Engineered epitopes serve<br>dual purpose for raising and<br>masking of Abs<br>Flexibility in Candidate<br>Selection<br>Simultaneous co-optimization<br>of Ab, mask and linker<br>provides maximized flexibility<br>in candidate selection | ||
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| Input<br>Antibody<br>StableHu<br>AI-Engine<br>Mammalian<br>Display<br>Output<br>Antibody<br>Template<br>CDR<br>Predict library of<br>human CDR variants<br>Single-cell screen<br>mammalian display CDR<br>library<br>Optimized antibody<br>with fully human CDRs<br>42<br>Accelerate Success: StableHu Antibody Optimization & Mammalian Display<br>Screening Propel Faster, Cost-Effective Antibody Development | ||
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| 43<br>“Smart” Antibodies: ShieldTx Conditionally Activated Antibodies Strive to<br>Improve Safety by Selectively Targeting Diseased but not Healthy Tissue<br>H+<br>Diseased Tissue<br>“On-epitope,<br>off-tissue”<br>therapy<br>Healthy Tissue<br>“On-epitope,<br>on-tissue”<br>therapy<br>DME<br>activation<br>Diseased Tissue<br>“On epitope,<br>on tissue”<br>therapy<br>Healthy Tissue<br>“On epitope,<br>off tissue”<br>therapy | ||
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| 44<br>EngageTx, a CD3-Based T-Cell Engager Panel, Addresses 3 Key Challenges:<br>Cytokine Release, NHP Cross-Reactivity and Immunogenicity Risk<br>Numerous<br>tumor<br>antigen arms<br>Diverse<br>CD3<br>engager arms<br>1 Sequence Diversity<br>2 Hu-Cyno Cross-Reactivity Range of Cytokine Release 3<br>Increased humanness and broad CD3<br>activity for optimized<br>paring with tumor antigen arms<br>Risk reduction via cyno monkey<br>toxicity study compatibility<br>Tailored cytokine release for expanded<br>therapeutic window<br>Release of<br>cytokines<br>TNFα, IFNγ,<br>IL-2, (IL6)<br>Increased<br>cytotoxicity<br>Reduced<br>cytokine<br>release<br>Release of<br>cytotoxic granules<br>Granzyme,<br>Perforin<br>Cascade of<br>immune activation<br>Tumor<br>cell<br>death<br>Activated<br>T cell<br>Tumor cell | ||
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| Epitope<br>Engineering<br>Engine*<br>Proprietary<br>Antibody<br>Library<br>AI-powered mammalian-display<br>co-optimization of mono/multi-specific antibody and<br>conditionally activated mask<br>Engineered<br>Epitope<br>Steering<br>AI-powered<br>engineering of<br>conformational<br>epitopes<br>Epitope-specific<br>antigens that steer<br>discovery to<br>intended epitopes<br>1 2 3 4<br>Naïve human<br>sequence<br>antibody library,<br>free of liabilities<br>Optimized<br>Antibody<br>Leads<br>5<br>Evaluated &<br>ranked in<br>translational<br>disease models<br>* U.S. Patent No. 11,545,238 (issued January 3, 2023) 45<br>iBio's Platform Tackles Discovery Challenges for the Next Era of Antibodies<br>EngageTx ShieldTx<br>StableHu Antibody<br>Optimizer<br>On-epitope,<br>On-tissue<br>Clinical Candidate | ||
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