RegeneRx 2018 Annual Meeting

June 13, 2018

2OTCQB: RGRX

Forward-Looking Statements

This investor presentation contains certain forward-looking statements that involve risks and uncertainties that could

cause actual results to be materially different from historical results or from any future results expressed or implied by

such forward-looking statements. Examples of such forward-looking statements include statements concerning the target

dates for completing the company’s or its partners’ ongoing clinical trials for ophthalmic and orphan indications, the

potential size of addressable markets, including the market for eye drops and parenteral delivery products, the company’s

ability to enter into any collaborations with respect to the development or commercialization of its product candidates, and

the therapeutic potential of Tβ4 for ophthalmic, cardiovascular and neurovascular disorders. Factors that may cause

actual results to differ materially from any future results expressed or implied by any forward-looking statements include

the risk that although Tβ4 has demonstrated potential therapeutic benefit for dermal, ophthalmic, cardiovascular and

neurovascular disorders, the company’s product candidates may not demonstrate safety and/or efficacy in clinical trials,

the risk that encouraging results from early research, preclinical studies, compassionate use or clinical trials may not be

confirmed upon further analysis of the detailed results, the risk that additional information relating to the safety, efficacy or

tolerability of our product candidates may be required by regulatory agencies, the risk that the company or its licensees

will not obtain approval to market the company’s product candidates in the U.S. or abroad, the risks associated with

reliance on outside financing to meet capital requirements, the risks associated with reliance on licensees for the funding

or conduct of further development and commercialization activities relating to the company’s product candidates, the risks

that the company’s patents will not be enforceable or expire prior to commercial marketing, and such other risks

described in the company’s latest Annual Report on Form 10-K, and other filings the company makes with the SEC. Any

forward-looking statements are made pursuant to Section 27A of the Securities Act of 1933, as amended, and Section

21E of the Securities Exchange Act of 1934, as amended, and, as such, speak only as of the date made. The Company

undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future

events or otherwise.

3OTCQB: RGRX

Overview

RegeneRx (RGRX) is a clinical-stage, biopharmaceutical company

engaged in the design, research and development of novel peptides

targeted at diseases with unmet medical needs. The Company conducts its

research and clinical trials through an outsourced partnership business

model.

Market Data

Ticker (OTCQB) RGRX

Price (6/11/18) $0.20

52 Week Range $0.14 - $0.38

Market Cap ~$23.9 mil

Average Daily Trading (3 mos) ~54,000

Common Shares Outstanding 119.6 mil

Insider/Affiliate Ownership ~48%

3

4OTCQB: RGRX

Investment Highlights

▪ Developing Thymosin beta 4 (Tβ4), a novel therapeutic peptide for tissue and organ

protection, repair, and regeneration.

− Potential new paradigm for treatment of ophthalmic, cardiac, central nervous system (CNS), peripheral nervous system

(PNS), and dermal disorders

− Supported by deep intellectual property portfolio

▪ Focused on RGN-259 preservative-free eye drops in late-stage clinical development

for dry eye syndrome and neurotrophic keratitis (NK)

− Approaching commercialization with recently completed Phase 3 clinical trials

− ARISE-3 trial targeted for initiation in Q3-Q4 2018

− $4.4 billion global annual dry eye market; $500 million global annual NK market

▪ New targets identified for RGN-352 injectable

− Grant by collaborator for cardiac development in Asia to be submitted this year

− Link between Tβ4 and patients with severe septic shock

▪ Low-cost outsourced business model

− 3 active global strategic partnerships via out-licensing and JV agreements

− Royalties, regulatory and commercial milestone payments + equity in JV

− No financial obligations for RGRX pursuant to strategic partnerships

− Low burn rate, late clinical stage product candidates

5OTCQB: RGRX

Utilize Outsourced/Partnership Business Model

▪ Objectives:

− Demonstrate proof-of-concept with R&D and early clinical trials

− Partner with companies with clinical development and/or commercialization

strengths

• Strategy enables multiple paths to commercialization

• Mitigates risks and facilitates efficiency

− Obtain royalties and development and commercial milestone payments from

licensees

− Retain significant equity position and royalties through joint ventures

− Leverage R&D through Material Transfer Agreements (MTAs) with major

research institutions

− Minimum fixed costs and funding obligations will provide strong operating

leverage

6OTCQB: RGRX

International Partners Aligned with RegeneRx

▪ 3 active strategic partnerships and a U.S. joint venture in place

− ReGenTree Joint Venture

• Exclusive U.S. and Canadian ophthalmic license to RGN-259 from RegeneRx

• GtreeBNT, as majority partner in JV, is funding all clinical development

• RGRX retains equity and royalty and has veto power on all material financial transactions

− GtreeBNT

• Licensed RGN-259 for ophthalmology in Pan Asia territory (excluding countries licensed by

Lee’s)

• Licensed dermal wound healing drug candidate, RGN-137, in the U.S., Canada, EU, S. Korea,

Japan and Australia

− Lee’s Pharmaceuticals

• Licensed Tβ4 product candidates for China, HK, Taiwan and Macau

• Initially developing RGN-259 for dry eye syndrome

▪ RegeneRx retains significant rights to existing product candidates

− EU rights to RGN-259 retained by RegeneRx

− World-wide rights to RGN-352 (except China), retained by RegeneRx

7OTCQB: RGRX

Market Opportunities

1 The estimated U.S. treatable population, the estimated annual U.S. market value and the estimated annual world-wide market value for each disease described herein have been derived from market data reports, scientific and medical publications, and other sources of information thought to be reliable. RGRX has extrapolated certain prevalence numbers based on reported demographic populations in specific territories. RGRX has not utilized pricing data estimations for its products to determine the potential value of the markets described herein. RGRX does not warrant the accuracy of the information and undertakes no obligation to publicly update any information contained herein, whether as a result of new information, future events or otherwise.

2 Stage 2 & 3

3 Epidemiology of severe sepsis, Virulence, 2014 Jan 1; 5(1): 4-11. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3916382/. Approximate 25% annual U.S. mortality rate for

patients with severe sepsis (280,000)

4 GlobalData Healthcare, Sept 1, 2017 https://www.globaldata.com/sepsis-septic-shock-market-worth-5-9-billion-2026/. Sepsis space among the seven major pharmaceutical

markets set to grow from $2.8 billion in 2016 to $5.9 billion by 2026.

5 All stages of EB

6 RnRMarketResearch 2014

Product Disease/applicationEst. US Treatable

Pop./year1

Est. Annual US

Market Value1

Est. Annual Global

Market Value1

(excl. US)

RGN-259 Dry Eye Syndrome 20M $2.8B $1.6B

(Tβ4 eye drop) Neurotrophic Keratopathy (NK) (orphan)2 10K $100M $400M

Recurrent Corneal Erosions 2.8M - -

Corneal Surgeries 1.3M - -

RGN-352 Severe Sepsis 1.13M3

$2.8B (including US)4

(Tβ4 Inj. Solution) Acute Myocardial Infarction 650K $10.8B $7.2B

Peripheral Neuropathy 3M $1.2B $1.2B

Stroke 800K $4.8B $3.2B

Traumatic Brain Injury 500K $800M $1.2B

RGN-137 Epidermolysis Bullosa (EB) (orphan)5 <50K >$500K >$1B

(Tβ4 dermal gel) Other Dermal Wounds ~$17B (including US)6

8OTCQB: RGRX

Robust Late Stage Clinical Programs

RGN-259 Preservative-Free Eye Drops

RGN-137 Dermal Gel

Clinical Trials with 3 Partners

Dry Eye - U.S.

Phase 3, ARISE-2

Completed 2017

ReGenTree J.V.

Dry Eye - China

Phase 2

Start Unknown

Lee’s Pharma

NK - U.S.

Phase 3, SEER-1

Enrolling Pts

ReGenTree J.V.

Multiple Partners Create Multiple Paths to Commercialization

Dry Eye - S. Korea

Waiting for U.S.

NDA Submission1

GtreeBNT

EB

Open Trial

Initiate 2018

GtreeBNT

1 U.S. NDA would likely allow commercial marketing in S. Korea w/o clinical trials

9OTCQB: RGRX

Efficacy Results from 2nd Phase 3 Dry Eye Trial (ARISE-2)

▪ RGN-259 demonstrated statistically significant improvement in both signs

and symptoms of dry eye

− 601 patient, double-masked, placebo-controlled U.S. dry eye trial in controlled adverse

environment (CAE) model

− Patients had a statistically significant reduction in ocular discomfort at Day 15

• An approvable endpoint

− Improved ocular staining at Day 15 and Day 29 in patient subgroup

• An approvable endpoint

− Exhibited fast-acting and global treatment effect in adverse environment

− Safe and well-tolerated

▪ Basis for ARISE-3 trial endpoints

10OTCQB: RGRX

U.S. Dry Eye Market

▪ Restasis® and Lifitegrast (Xiidra™) are only Rx products in U.S. for dry eye

− >$1 billion annual Restasis® sales(1)

− Patients experience burning & stinging with Restasis®

− Efficacy typically not seen for 6 months

− Package insert states Restasis® is only 15% effective vs. 5% for placebo

▪ Xiidra™ recently launched in U.S.

− Estimated $400 million 1st year sales

− Patients report irritation, reduced visual acuity, and dysgeusia (foul taste in mouth)

▪ Clinical data for RGN-259 shows effects are within days, with no burning or

stinging or dysgeusia reported

▪ RGN-259 demonstrated higher efficacy than Restasis® when compared side

by side in animal model of dry eye

RGN-259 Compares Favorably to Approved Drugs for Dry Eye

(1) Source: Drugs.com Statistics, 2013 (http://www.drugs.com/stats/top100/sales).

11OTCQB: RGRX

U.S. Neurotrophic Keratopathy Clinical Trial

▪ Neurotrophic Keratopathy (NK)

− Chronic degenerative disease characterized by decreased corneal sensitivity and

limited or no corneal healing

− Approximately 50,000 cases of NK in EU and U.S.(1)

• Estimated 10,000 stage 2 and 3 cases

− No effective drugs currently available

▪ Orphan drug designation received on December 31, 2013

▪ ReGenTree Phase 3 trial completion expected in 2018-2019

− RGRX will have access for use in other territories, i.e., EU

▪ Preliminary masked data indicated that 7 of 17 patients enrolled had

complete healing although it is not known if the patients were in active,

placebo, or both groups.

(1) Clinical Ophthalmology 2014; 8: 571–579.

12OTCQB: RGRX

New Opportunities

▪ We are collaborating with a medical consortium in Singapore interested in

exploring the development of RGN-352 to treat myocardial infarction. They are

submitting a major grant to study RGN-352 in large animals to evaluate safety,

efficacy, and determine a dose response for MI. Data gained from this study

should be directly applicable to humans and allow us, or a partner, to more

readily move into Phase 2 human trials in Asia and/or U.S.

▪ A group of physicians and researchers at major U.S. medical institutions are

evaluating the relationship between Tβ4 and F-actin in patients with septic

shock. As recently reported in “Expert Opinion,” there appears to be a

correlation between patients that develop severe septic shock, with a historical

40% mortality rate, with high levels of F-actin and low levels of Tβ4. Since time

is of the essence in septic shock cases, should this correlation prove to be an

accurate prognostic we believe it would offer an opportunity utilize RGN-352 for

treatment of this critical subgroup of sepsis patients. Work is currently ongoing

in establishing this correlation and results should be available this year.

13OTCQB: RGRX

Key Milestones Over Next 18 Months

✓ Q2 2018 – Positive FDA response on ARISE-3 dry eye protocol

▪ Q3-Q4 2018 – ReGenTree to initiate ARISE-3 in U.S.

▪ Q4 2018 – Gtree to begin U.S. EB Trial

▪ 2019 – Upon receipt of grant, collaborators to initiate RGN-352 cardiac

study in large animals in Singapore

▪ 2019 – If data are confirmed, design RGN-352 septic shock protocol

and seek collaboration with major medical research institutions

in U.S. phase 2 clinical trial

▪ 2019 – Complete and Report ARISE-3 trial

▪ 2019 – Meet with FDA re: NDA, assuming ARISE-3

is successful

14OTCQB: RGRX

Financial Highlights and Capitalization

Financial Highlights and Capitalization

(1) Majority of notes held by insiders (Management, Board, and Affiliates).

(2) Cash on hand will fund planned operations into the first quarter of 2019.

($/000s) March 31, 2018

Cash $ 924

Total Current Assets 955

Current Liabilities 776

Convertible Notes, Net of Derivative Liability(1) 439

Total Liabilities and Stockholder's Deficit (1,948)

Full time Equivalent Employees 4

Monthly Cash Burn ~100

Projected Cash Runway(2) Early 2019

Common Shares Outstanding 119,637

Fully Diluted Shares Outstanding 139,850

Insider and Closely Held Shares ~48%

15OTCQB: RGRX

Common Stockholder Questions

1. Explain the ARISE-3 Trial Protocol and will it use CAE?

• The ARISE-3 trial protocol is designed to build on the results of ARISE-2. That is to say

that it will utilize the efficacy results seen in ARISE-2 as primary endpoints in ARISE-3 in the

same CAE model. FDA has approved the trial protocol.

• Primary endpoint 1 = Day 15 symptom evaluation compared to baseline

• Primary endpoint 2 = Day 15 sign evaluation in patients in lower 50 percentile (more

severe patients) compared to baseline

16OTCQB: RGRX

Common Stockholder Questions

2. What is the status of the NK trial, why were some data released to the public, and what are

the future plans for the study?

• The NK trial was designed to enroll 46 patients and is ongoing. However, as with many

orphan diseases, recruiting patients has been very slow. Our partners at Gtree observed

that 7 out of 17 patients had completely healed, which is the endpoint of the treatment,

although it is not known what group(s) the patients were in since the study has not been

unmasked. The ReGenTree team will have to decide whether to try to complete the trial

with 46 patients or unmask it after 17 to see where the responses were. That decision

has not been made as yet.

17OTCQB: RGRX

Common Stockholder Questions

3. Why does clinical trial information seem slow in reaching stockholders?

• Our partner, GtreeBNT, controls the outflow of information emanating from the dry eye

and NK clinical trials. They are very thorough in evaluating data and do not release it

prematurely. Gtree and RegeneRx try to coordinated the simultaneous release of

material information. Occasionally, we see information released in Korea that has not

been released in the U.S. In those cases, we have to confirm the information, and when

confirmed, we release it in the U.S. This can take awhile. Coordination between

companies and countries with sometimes different agendas, regulations, and control of

information can be complicated. Moreover, legal liability requires us to be as certain as

possible of information before we disseminate it.

18OTCQB: RGRX

Common Stockholder Questions

5. Why does it take so long to upload information on clinicaltrials.gov?

• ReGenTree is operated by GtreeBNT and is the sponsor of the dry eye and NK trials. It

is, therefore, responsible for uploading clinical trial information. ReGenTree is aware of

its obligations and time lines related to reporting information to clinicaltrials.gov.

19OTCQB: RGRX

Common Stockholder Questions

6. Explain the terms of the ReGenTree joint venture. Who operates and controls the JV?

• The ReGenTree JV is a U.S. joint venture owned by RegeneRx and GtreeBNT. Its terms

are flexible depending on sales milestones and future commercialization efforts.

• The JV started out 51% owned by GtreeBNT and 49% by RegeneRx

• The equity percentage has changed based on clinical milestones obtained by the JV. The current equity

percentage by RGRX is 38.5%. The minimum equity percentage by RGRX would be 25% if the JV obtains

an NDA.

• Separate from the equity ownership, RGRX retains a royalty on future commercial sales between mid-

single digits and low double digits, depending on the type or continuing combination of commercialization

efforts.

• In the event the JV is sold to a third party such as a multi-national pharmaceutical company, which would

unlikely accept a continued royalty obligation, RGRX would receive no less than 40% of the value of the

sale.

• GtreeBNT is required under the JV to fund 100% of the clinical development through NDA approval. It is

estimated Gtree has spent over $50 million to date to sponsor the clinical trials and conduct all the non-

clinical and CMC work necessary for production and a future NDA. RGRX has no funding responsibility at

any time.

• By contract, RGRX has 1 of 3 board seats on the JV. Importantly, unanimous board approval is required

for any major financial or strategic transaction, essentially giving RGRX veto power over all major

transactions and giving RGRX a significant amount of control on the future of the JV.

• RegeneRx retains all rights to RGN-259 in the EU.

20OTCQB: RGRX

Common Stockholder Questions

7. Can RGRX partners/licensees separately patent inventions related to the Licensed Product to

the detriment of RGRX? Why is patent status sometimes available online before being

released by RGRX? Is there only a single patent for a specific medical use or do patents

overlap in coverage.

• RGRX partners or licensees may separately patent inventions related to our Licensed Products.

However, if they do so RegeneRx will receive an exclusive, royalty-free license to practice such

inventions in all non-licensed territories, and even within the licensed territory for a non-licensed field.

Therefore, any such inventions could potentially be of significant benefit to RGRX.

• Patent application status is often published online without any head’s up to the inventors, the assignee, or

the legal firm, as, too, are sometimes FDA actions. RGRX finds out at the same time the public may find

out. However, unlike the public, we do not comment on such things until we receive official notifications

as we have to be certain and accurate with our public disclosures. Also, sometimes there are

uncertainties associated with the online publications and we cannot comment because we do not know

the final answer. The public, of course, can comment anytime without any obligation for accuracy.

• Most people do not fully understand patents. Patents typically serve two purposes: (1) to offer exclusivity

to the inventor(s) for a certain period of time and/or (2) to enable the practice of the invention. We strive

to maximize both of these strategies. Patents often overlap, with one being broad and another being

specific, or one covering a medical indication and another covering a composition or manufacturing

process. The expiries often cover different time periods so that when one expires on a certain aspect of

an invention another is still in effect continuing the exclusivity of an invention. Therefore, a patent

portfolio may have many patents with many claims that complement and overlap each other and

designed to create as much protection as possible over as long a period as possible.