33
Planet MicroCap Showcase April 27, 2017 NYSE MKT: ISR

Planet MicroCap Showcase April 27, 2017 - IsoRay...Apr 27, 2017  · IsoRay’s filings with the Securities and Exchange Commission (in particular, it’s most recently filed Form

  • Upload
    others

  • View
    0

  • Download
    0

Embed Size (px)

Citation preview

Page 1: Planet MicroCap Showcase April 27, 2017 - IsoRay...Apr 27, 2017  · IsoRay’s filings with the Securities and Exchange Commission (in particular, it’s most recently filed Form

Planet MicroCap Showcase

April 27, 2017

NYSE MKT: ISR

Page 2: Planet MicroCap Showcase April 27, 2017 - IsoRay...Apr 27, 2017  · IsoRay’s filings with the Securities and Exchange Commission (in particular, it’s most recently filed Form

Safe Harbor Statement Statements in this presentation about IsoRay's future expectations, including: the advantages of our products and their delivery systems, whether interest in and use, awareness and adoption of our products will increase or continue, whether opportunities will be available to expand the market for our products, whether changes to IsoRay's management and sales team and strategy will result in growth, whether investments in sales and marketing, production and research and development will result in growth, whether our technical assistance in the brain and gynecological applications will result in a viable commercial product for sale, whether studies and protocols will produce favorable results or lead to publications, whether peer-reviewed publications of treatment results using our products will report favorable results, whether our intellectual property will adequately protect our proprietary technologies, and all other statements in this presentation, other than historical facts, are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 ("PSLRA"). This statement is included for the express purpose of availing IsoRay, Inc. of the protections of the safe harbor provisions of the PSLRA. It is important to note that actual results and ultimate corporate actions could differ materially from those in such forward-looking statements based on such factors as physician acceptance, training and use of our products, our ability to successfully manufacture, market and sell our products, our ability to manufacture our products in sufficient quantities to meet demand within required delivery time periods while meeting our quality control standards, our ability to enforce our intellectual property rights, whether additional studies are released and support the conclusions of past studies, whether ongoing patient results with our products are favorable and in line with the conclusions of clinical studies and initial patient results, patient results achieved when our products are used for the treatment of cancers and malignant diseases beyond prostate, successful completion of future research and development activities, whether we, our distributors and our customers will successfully obtain and maintain all required regulatory approvals and licenses to market, sell and use our products in its various forms, continued compliance with ISO standards as audited by BSI, the success of our sales and marketing efforts, changes in reimbursement rates, changes in laws and regulations applicable to our products, and other risks detailed from time to time in IsoRay's reports filed with the SEC. Unless required to do so by law, the Company undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

For more information regarding risks and uncertainties that could affect IsoRay’s results of operations or financial condition review IsoRay’s filings with the Securities and Exchange Commission (in particular, it’s most recently filed Form 10-K and Form 10-Qs). IsoRay undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. This presentation shall not constitute an offer to sell or the solicitation of an offer to sell or the solicitation of an offer to buy any securities of IsoRay nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction.

2

NYSE MKT: ISR

Page 3: Planet MicroCap Showcase April 27, 2017 - IsoRay...Apr 27, 2017  · IsoRay’s filings with the Securities and Exchange Commission (in particular, it’s most recently filed Form

Overview

Isoray Medical passionately designs and develops innovative and personalized

permanent implant brachytherapy products that effectively treat many forms of

cancer. We believe in pioneering solutions for life beyond your cancer.

Isoray’s Cesium-131 isotope, with a shorter half-life and higher energy than other

commonly used radioisotopes for low dose-rate (LDR) brachytherapy, has been

shown to be a highly effective cancer treatment with less side effects and quicker

recovery time.

3

Market Data

Ticker (NYSE MKT) ISR

Price (4/24/2017) $0.57

52 Week Range $0.48 - $1.20

Market Cap $32.0 M

Average Daily Trading (3 mos) ~130,000

Common Shares Outstanding 55.0 M

Cash, Cash Equivalents & CD’s* $11.9 M

Trailing 12 Month Revenue $4.4 M

NYSE MKT: ISR

* As of December 31, 2016

Page 4: Planet MicroCap Showcase April 27, 2017 - IsoRay...Apr 27, 2017  · IsoRay’s filings with the Securities and Exchange Commission (in particular, it’s most recently filed Form

Investment Highlights

• Only manufacturer in the world of Cesium-131 LDR*

brachytherapy seeds, a radioisotope which represents a

significant advancement in cancer therapy with fast resolution

of side effects and at lower cost than alternative treatments • More than 10,000 patients have been implanted with patent protected

Cesium-131 seeds

• Making significant investments in market development of prostate and other

body parts to support assumption of leadership

• Intense focus on 2-pronged growth strategy • Renewed commitment on establishing market leadership in LDR brachytherapy treatment of prostate cancer

- Launched new sales strategies in Fall 2016 with more experienced leadership and sales team

- Current LDR brachytherapy market void of leadership

- Opportunities to leverage growth segments in Prostate Cancer Market

• Growing clinical evidence for multiple cancer indications in difficult to treat recurrent patients - GammaTile collaboration for Brain cancer

- Gynecology, Head & Neck, Lung cancers

• Strong balance sheet to support growth strategy • $11.9 million cash** and no debt as of December 31, 2016

• Programs in place for ongoing cost and process improvements

4

* LDR – low dose rate; ** Includes cash, cash equivalents and certificates of deposit

NYSE MKT: ISR

Page 5: Planet MicroCap Showcase April 27, 2017 - IsoRay...Apr 27, 2017  · IsoRay’s filings with the Securities and Exchange Commission (in particular, it’s most recently filed Form

Management Team & Advisory Board

Page 6: Planet MicroCap Showcase April 27, 2017 - IsoRay...Apr 27, 2017  · IsoRay’s filings with the Securities and Exchange Commission (in particular, it’s most recently filed Form

Tom LaVoy Chairman of the Board and Chief Executive Officer

• Director, IsoRay since 2005 before appointment as Chairman and Chief Executive Officer in early 2016. • Over 35 years experience leading and building successful, publicly traded businesses. • Previously Deputy Chief Operating Officer, President of Corporate Services and Chief Financial Officer, SuperShuttle

International, transportation industry leader, 1997-2015. Instrumental in developing strategic growth plans including: growing revenue from $35 million to >$340 million; acquiring 30+ businesses; expanding operations to 50+ locations; spearheading sale to large international partner, Veolia Transportation Inc., in 2006.

• Prior CFO, Photocomm, Inc., leader in solar electric manufacturing, engineering and distribution, 1987 - 1997.

William A. Cavanagh Chief Operating Officer and

Chief Scientific Officer

• Appointed Chief Operating Officer, March 2016; previously Vice-President R&D, 2010 – 2016. • Over 20 year career in cancer treatment technologies beginning in early 1990s, including research and

development of a therapy involving insertion of radioactive sources directly into prostate for treatment of prostate cancer.

• Designed several cancer treatment-related studies; listed as author on 34 peer-reviewed publications; listed as inventor on U.S. patent application detailing a novel treatment for cancer.

• Previously Director, Haakon Ragde Foundation for Advanced Cancer Studies, Seattle, WA.

Michael L. Krachon Vice President, Sales and Marketing

• Over 20 years’ experience of progressive growth in sales and marketing in the medical industry. • Previously leader of brachytherapy commercial team, C.R. Bard Inc., 2001-2016, global brachytherapy market

leader. • Chairman of Coalition for Advancement of Brachytherapy, 2009 – 2016. • Recognized national speaker for brachytherapy; instrumental in successfully supporting the industry through

congressional lobbying efforts to re-establish reimbursement codes for brachytherapy.

Experienced Management Team

6

NYSE MKT: ISR

Page 7: Planet MicroCap Showcase April 27, 2017 - IsoRay...Apr 27, 2017  · IsoRay’s filings with the Securities and Exchange Commission (in particular, it’s most recently filed Form

Collaboration with Key Brachytherapy Thought Leaders

• Dr. Steven Kurtzman, El Camino Hospital Center, Mountain View, CA

• Dr. Brian Moran, Chicago Prostate Center

• Dr. Bradley Prestidge, Bon Secours, Westchester, NY

• Dr. John Sylvester, Riverside, FL

• Dr. Mark Randall / Dr. Jonathan Feddock, University of Kentucky

7

NYSE MKT: ISR

Page 8: Planet MicroCap Showcase April 27, 2017 - IsoRay...Apr 27, 2017  · IsoRay’s filings with the Securities and Exchange Commission (in particular, it’s most recently filed Form

Cesium-131 Technology

Page 9: Planet MicroCap Showcase April 27, 2017 - IsoRay...Apr 27, 2017  · IsoRay’s filings with the Securities and Exchange Commission (in particular, it’s most recently filed Form

Cesium-131 is the Fastest Acting LDR* Isotope for Treating Aggressive Cancers

9

* LDR – low dose rate; Source: “Table of Radioactive Isotopes. V.S. Shirley, ed. Lawrence Berkeley Laboratory, University of California. John Wiley & Sons, 1986.

• Higher Energy • Shorter Half-Life (Faster Dose Delivery) • Improved Efficiency of Dose Coverage

NYSE MKT: ISR

• Rapid Resolution of Side Effects • Higher Biologically Effective Dose • Demonstrated Disease Control

Page 10: Planet MicroCap Showcase April 27, 2017 - IsoRay...Apr 27, 2017  · IsoRay’s filings with the Securities and Exchange Commission (in particular, it’s most recently filed Form

Cesium-131 from Isoray Medical is Most Significant Radio-Isotope Advancement in Over 30 Years

• Targeted therapy delivers high dose of radiation to only a few millimeters of tissue beyond

the intended treatment site, allowing for precise treatment and preservation of critical

structures

• Shorter Half Life, Higher Energy, Low Dose Rate (LDR) isotope

aggressively attacks cancer • Low impact on critical tissues surrounding a treatment site

• Faster radiation deposition for fast growing cancers

• Delivered through multiple 510(k) cleared products • Sutured seeds, Seed sutured mesh, Implantable strands,

Single seed applicators

• Most cost-effective and life preserving cancer radiation treatment • Single treatment session done at time of surgery or instead of surgery

• Demonstrated enhanced quality of life resulting from low side effect profile

• Strong IP portfolio includes proprietary chemical separation

methods and construction of device • Patents issued in U.S., Canada and EU

• Trademark strategy for updated branding

10

NYSE MKT: ISR

Page 11: Planet MicroCap Showcase April 27, 2017 - IsoRay...Apr 27, 2017  · IsoRay’s filings with the Securities and Exchange Commission (in particular, it’s most recently filed Form

Significant Cesium-131 Experience

11

• Over 10,000 patients treated • Includes ~500 patients over last 4 years in more

aggressive cancers of Brain, Head & Neck, Gyn

• Cleared for use in U.S. for all types of cancer

and tumors • FDA clearance received in 2003

• CE Mark/ISO certified for EU sales in 2012

• Increasing number of peer reviewed articles

have been published • 6+ years of prostate data available

• Multiple cancer sites under current study

• Published studies facilitate increased

utilization and commercialization • Management expects this to lead to multi-

institutional reporting and more general

adoption

NYSE MKT: ISR

Page 12: Planet MicroCap Showcase April 27, 2017 - IsoRay...Apr 27, 2017  · IsoRay’s filings with the Securities and Exchange Commission (in particular, it’s most recently filed Form

Growth Opportunities: Prostate Cancer

Page 13: Planet MicroCap Showcase April 27, 2017 - IsoRay...Apr 27, 2017  · IsoRay’s filings with the Securities and Exchange Commission (in particular, it’s most recently filed Form

Prostate - Most Immediate Opportunity

• Current market estimated at $90 - $120 million annually • ~30,000 procedures / year @ $3-4,000 / procedure

• IsoRay has 3% market share; room to gain share with new sales and marketing focus

• Cesium-131 compares favorably to Palladium-103, which is used for ~35% of procedures

• UPMC recent publication in Red Journal highlights improved side affect profile for Cesium 131 use versus other Isotopes

• Prostate brachytherapy market now stabilizing after 8 years of decline • Decline due to competing therapies with newer technologies and better financial reimbursement

• Competing therapies have not performed as well as expected

- Recurrences have occurred at higher rates than brachytherapy

• Brachytherapy continues to deliver consistent disease control

• ASCEND RT- Results for High Risk patients using triple therapy show significantly improved long-term outcomes

• No clear industry leader • Small number of Brachytherapy competitors left, all with reduced sales forces

• Consolidation of market is continuing and companies continue to tighten expenses

• Making significant investments in market development to support leadership role

• IsoRay has production capacity to support growth • Minimal additional investment necessary for production expansion

• Evaluating / developing delivery systems to support differing physician techniques

• Manufacturing automation project in place to reduce costs of products

13

NYSE MKT: ISR

Page 14: Planet MicroCap Showcase April 27, 2017 - IsoRay...Apr 27, 2017  · IsoRay’s filings with the Securities and Exchange Commission (in particular, it’s most recently filed Form

• Short-half life of Cesium-131 delivers treatment quickly to the patient, allowing the patient to recover quickly.

• Initial studies have shown that the patient IPSS will return to baseline faster than brachytherapy with Iodine-125.

• Recent UPMC Data in Red Journal5 . shows return to clinical base line in 3 months

and statistical baseline in 6 months versus 12 to 18 months for Iodine 125.

Cesium-131 Patient Advantages

14

1. Benoit, R.M., et al. Clin Oncol (R Coll Radiol), 2014. 26(12): p. 776-80. 3. Keyes, M., et al. Int J Radiat Oncol Biol Phys, 2009. 73(4): p. 1023-32. 4. Ash, D., et al. Radiother Oncol, 2007. 84(2): p. 135-9. 5. Glaser SM, et al. Int J Radiat Oncol Biol Phys 2017.

NYSE MKT: ISR

Page 15: Planet MicroCap Showcase April 27, 2017 - IsoRay...Apr 27, 2017  · IsoRay’s filings with the Securities and Exchange Commission (in particular, it’s most recently filed Form

Encouraging Outcomes for Prostate Cancer

Study Results

• 485 patients, 99.5% disease specific survival rate 5 years after treatment1

• Decreased duration of urinary and bowel morbidity, a major problem with other isotopes

• Results on par with Iodine and Palladium

reports at a similar time-frame

• With availability of interim long-term data,

The American College of Radiology

recognized Cesium-131 as an established

brachytherapy isotope

15

NYSE MKT: ISR

“… these intermediate-term outcomes show that there is no reason at this time to suspect that 131Cs will not provide oncological outcomes at least on par with

those of 125I and 103Pd.” … Ronald Benoit, M.D. University of Pittsburgh Medical Center

Bice, W., et al. Presented at the 2008 Cesium Advisory Group Meeting, November 2008. Tucson, Arizona, U.S.A., 2005

Page 16: Planet MicroCap Showcase April 27, 2017 - IsoRay...Apr 27, 2017  · IsoRay’s filings with the Securities and Exchange Commission (in particular, it’s most recently filed Form

Combo Therapy Delivers Superior Results

• Numbers refer to study references

Grimm, P, BJUI, 109(S) 22-29, Feb 2012 9

Meta analysis of the literature

suggests a higher rate of control for

high risk prostate cancers with

“triple therapy” - external beam

radiation, brachytherapy and

hormone therapy - compared to

other treatment approaches.

Range of results was fairly compact,

suggesting high reproducibility of

outcomes (light blue oval).

“The superiority of triple therapy

is now supported by the results

of a randomized trial” ASCENDE Trial J Clin Oncol 33, 2015 (suppl 7; abstr 3)

www.pctrf.org

NYSE MKT: ISR

16

Page 17: Planet MicroCap Showcase April 27, 2017 - IsoRay...Apr 27, 2017  · IsoRay’s filings with the Securities and Exchange Commission (in particular, it’s most recently filed Form

Dose Comparison of Radiation Treatments

Representative Dose Distributions for a Selected Patient for 5 Treatment Radiation Techniques After Radiobiological Conversion

Source: Dietmar G, et al, Int J Radiation Oncol Biol Phys, Vol. 88, No. 3, pp. 715e722, 2014 0360-3016

The controlled dose delivered by interstitial Brachytherapy Techniques resulted in less radiation to the Bladder, Rectum, and Normal Tissue when

compared to external techniques.

17

NYSE MKT: ISR

Page 18: Planet MicroCap Showcase April 27, 2017 - IsoRay...Apr 27, 2017  · IsoRay’s filings with the Securities and Exchange Commission (in particular, it’s most recently filed Form

• Higher Risk Patients • More advanced prostate cancers being

diagnosed due to the discouragement

of PSA screening

• ASCENDE-RT trial - Randomized data show

benefits of brachytherapy combined with

external radiation treatment

• Targeted, or Focal, Treatments • MRI diagnosing individual lesions

• Patients want to preserve quality of life - Primarily Sexual and Urinary side effects

• Urologists want to future options - Exploring HIFU, Cryo, Lasers

• Salvage Treatments • 20 - 40% of external radiation patients will need additional treatment

- No tolerance for additional radiation to surrounding tissues

• Benefits from highly targeted nature of Cs-131

Increasing Growth in Multiple Prostate Patient Segments

NYSE MKT: ISR

18

ASCENDE-RT Outcomes

Growth Potential for all Segments - 25,000 - 75,000 Patients

Randomized study between combination therapy and external radiation for high

risk localized prostate cancer

Page 19: Planet MicroCap Showcase April 27, 2017 - IsoRay...Apr 27, 2017  · IsoRay’s filings with the Securities and Exchange Commission (in particular, it’s most recently filed Form

Growth Opportunities: Other Aggressive Cancers

Page 20: Planet MicroCap Showcase April 27, 2017 - IsoRay...Apr 27, 2017  · IsoRay’s filings with the Securities and Exchange Commission (in particular, it’s most recently filed Form

Growing Body of Literature Demonstrating Success in Other Aggressive Cancers

• Growing experience for recurrent and primary Brain tumors

• Barrow Neurological Institute’s experience with a proprietary delivery system, GammaTile

- Aggressive nature of Cesium-131 delivers targeted treatment to the surgical bed

• Series from Weill Cornell Medical College demonstrate high rates of brain cancer control when Cesium-131 brachytherapy is combined with surgery

• Strategic collaboration in Gynecological cancer treatment

• University of Kentucky, leading facility for treatment of cervical and uterine cancers

- Initial data presentations at World Congress of Brachytherapy, June 2016

- Recurrent and primary gynecological tumors

• Expanding experience in Head and Neck cancers

• Strategic collaborations with Thomas Jefferson University and Case Western

• Additional sites for expanded protocols

20

NYSE MKT: ISR

Page 21: Planet MicroCap Showcase April 27, 2017 - IsoRay...Apr 27, 2017  · IsoRay’s filings with the Securities and Exchange Commission (in particular, it’s most recently filed Form

High Rates of Local Control Have Been Demonstrated with Other Aggressive Cancers

Patient Population

% Local Control

# of Ongoing Studies

Centers Current Duration

(YRS)

Current Treatment Standard

Brain Recurrent 95% 2 BNI, Cornell 5 Palliative

Gynecological Recurrent 80% 2 U. Kentucky 5 Surgery

Head & Neck Recurrent 56% 3 Case Western 6 Surgery

Lung High Risk 100% 2 Cornell 6 Surgery

21

Surgical Research Typically Conducted on Most Difficult Cases with Few Remaining Options

NYSE MKT: ISR

Page 22: Planet MicroCap Showcase April 27, 2017 - IsoRay...Apr 27, 2017  · IsoRay’s filings with the Securities and Exchange Commission (in particular, it’s most recently filed Form

Potential Benefits for Large Numbers of Patients

22

Disease State Annual Diagnosis* Potential LDR Patients*

Prostate cancer 200,000 140,000

Recurrent Brain Tumors 200,000 50,000

Recurrent Gynecological Tumors

7,000 3,500

Head & Neck Tumors 61,000 15,000

Lung Cancer 180,000 10,000

Total Opportunity 648,000 218,500 Patients

* IsoRay estimates

Page 23: Planet MicroCap Showcase April 27, 2017 - IsoRay...Apr 27, 2017  · IsoRay’s filings with the Securities and Exchange Commission (in particular, it’s most recently filed Form

On-Going Collaboration with GammaTile, LLC

• Novel system to deliver brain brachytherapy treatment at time of surgery

• Developed by team of neurosurgeons, radiation oncologists and other medical professionals from the prestigious Barrow Neurological Institute, Phoenix, AZ

- World's largest neurological disease treatment and research institution, consistently ranked as one of the best neurosurgical training centers in U.S.

• Device is a combination of Cesium-131 seeds embedded into collagen “tiles” that are placed onto the resection margin during surgery

- Process adds less than 10 minutes to brain surgery

• GammaTile LLC has made significant investment

- Holds six issued U.S. patents; 15 additional applications filed

• FDA approval and Reimbursement code assignment in process

• NTAP application for reimbursement submitted in October 2016, decision expected mid-2017

• 510(k) application submitted March, 2017

NYSE MKT: ISR

23

Page 24: Planet MicroCap Showcase April 27, 2017 - IsoRay...Apr 27, 2017  · IsoRay’s filings with the Securities and Exchange Commission (in particular, it’s most recently filed Form

GammaTile, LLC Patient Experience

• Over 80 patients have been treated with the system over the past five years

• Pre-commercialization evaluation

- Recurrent and primary tumors

- Metastatic brain cancers which affect ~15% of all cancer patients

• 2 Clinical series reported in 2016 at Society for Neuro-Oncology1

• Extended median time to recurrence and very low rate of side effects

• 20 tumors in 16 patients with very aggressive recurrent malignant meningioma

- 95% tumor local control, despite multiple failures of previous surgery + radiation

• 18 patients who had recurrences of high-grade glioma following standard-of-care therapy

- 84% experienced no tumor re-growth at surgical site at median time of analysis of ~six months

1Brachman, D., Prospective trial of surgery and permanent intraoperative brachytherapy (S+BT) using a modular, biocompatible radiation implant for recurrent aggressive meningiomas., Society of Neuro-Oncology Conference on Meningioma, Toronto, Canada, June 17-18, 2016. 2N Shonka, et al. http://www.cancernetwork.com/cancer-management/primary-and-metastatic-brain-tumors. November 1, 2015.

NYSE MKT: ISR

24

Page 25: Planet MicroCap Showcase April 27, 2017 - IsoRay...Apr 27, 2017  · IsoRay’s filings with the Securities and Exchange Commission (in particular, it’s most recently filed Form

Comparison of Radiation Distribution and Intensity: GammaTile™ vs External Beam

Distribution and intensity of radiation using “Conformal 3D” treatment

Distribution and intensity of radiation using “IMRT” treatment

Distribution and intensity using GammaTile™ treatment

IMRT = (Intensity Modulated Radiation Therapy) and 3D Conformation Radiation Therapy are the most sophisticated means of delivering external beam radiation to a target

without exposing untargeted tissue

25

NYSE MKT: ISR

Page 26: Planet MicroCap Showcase April 27, 2017 - IsoRay...Apr 27, 2017  · IsoRay’s filings with the Securities and Exchange Commission (in particular, it’s most recently filed Form

Collaboration with University of Kentucky for Primary and Recurrent GYN Cancers

• Leading facility for the treatment of women whose cervical and uterine

cancers had recurred after surgery and radiation therapy

• Previously utilized brachytherapy with Gold-198 placed in and around the tumor

• Alternative is surgical exoneration of the pelvis, where all pelvic organs are removed

• Switched to Cesium-131 after seeing results of evaluation cases

• Two series presented at 2016 World Congress of Brachytherapy

- First study: 21 patients with recurrent GYN cancers – 81% successful control

- Second study: 22 patients with newly diagnosed GYN cancers – 100% early control

• Very low rate of complication rates in both series

• Collaborating to develop training and awareness programs to support

treatment techniques

• Potential treatment alternative for 13,000 cervix / 60,000 uterus cases

annually in U.S.1

NYSE MKT: ISR

26

12016 estimates, American Cancer Society

Page 27: Planet MicroCap Showcase April 27, 2017 - IsoRay...Apr 27, 2017  · IsoRay’s filings with the Securities and Exchange Commission (in particular, it’s most recently filed Form

Promise in Multiple Aggressive Cancer Surgical Markets

"Use of the Cesium-131 tiles, which were able to

be implanted very quickly at the time of

surgery, and starting radiation therapy at the

time of resection as opposed to weeks after

resection when using external beam radiation,

were advantages of our novel approach. We are

seeing 95% local control of the treated tumors in

our study using surgery and Cesium-131

implants. In addition, we observed a very low

rate of radiation injury, which has been a major

concern in the past, for patients who have

undergone multiple treatments for their brain

tumors."

Dr. David Brachman, Director of Radiation Oncology, Barrow Neurological Institute,

Clinical Professor of Radiation Oncology, University of Arizona

College of Medicine-Phoenix

“These women were facing very radical surgery to

address their recurrent cancers and it turned out

that Cesium-131 therapy offered a much better

solution for them. This is the first study utilizing

Cesium-131 therapy for these gynecologic

cancers and we have followed these women

closely in order to evaluate the effectiveness of

this treatment. We are very pleased with the

results.”

Dr. Jonathan Feddock Assistant Professor of Radiation Medicine

University of Kentucky College of Medicine

“Cesium-131 is a very appealing new isotope for

radiation oncologists and head and neck cancer

patients. I would recommend Cesium-131 to other

physicians… it is a great and safe option to re-

irradiate patients with recurrent resectable

head and neck cancer.”

Dr. Voichita Bar Ad Associate Professor

Thomas Jefferson University - Philadelphia

NYSE MKT: ISR

27

Page 28: Planet MicroCap Showcase April 27, 2017 - IsoRay...Apr 27, 2017  · IsoRay’s filings with the Securities and Exchange Commission (in particular, it’s most recently filed Form

Summary

Page 29: Planet MicroCap Showcase April 27, 2017 - IsoRay...Apr 27, 2017  · IsoRay’s filings with the Securities and Exchange Commission (in particular, it’s most recently filed Form

Focused Growth Strategy

• Renewed Commitment to the Community through Marketing, Awareness,

Training and Communication • New sales and marketing team with deep experience

• New website, branding and marketing materials focused on providing resources to patients, their

friends, family and the community

- Launched in September 2016

• Increased training and education resources for physicians

- Urology awareness programs

- Physician training opportunities “on-demand” at leading LDR facilities

• Collaborating with the Prostate Cancer Treatment Research Foundation

- Bringing resources directly to patients to help guide them through the process from diagnosis to post-

treatment follow up

• Re-instituted Medical Advisory Board

- Top 4-5 medical leaders in prostate brachytherapy

• Creating Centers of Excellence • Displays of IsoRay's commitment to brachytherapy best practices for medical professionals through

awareness, training, and publishing

• Programs in place for ongoing cost and process improvements

29

NYSE MKT: ISR

Page 30: Planet MicroCap Showcase April 27, 2017 - IsoRay...Apr 27, 2017  · IsoRay’s filings with the Securities and Exchange Commission (in particular, it’s most recently filed Form

Balance Sheet Highlights

($/000s) Dec 31, 2016 June 30, 2016

Cash, Cash Equivalents & CD’s $11,947 $15,359

Total Current Assets 13,179 13,629

Current Liabilities 871 1,094

Long Term Debt* 0 0

Stockholder's Equity 13,567 16,401

Total Liabilities and Stockholder's Equity $14,985 $18,102

Basic & Diluted Common Shares Outstanding 55,017 55,011

Working capital $12,373 $12,356

Current ratio 16.35 12.47

Strong Balance Sheet to Support Growth * Long-term debt excludes amounts that are not related to cash borrowings or operational debt

30

Page 31: Planet MicroCap Showcase April 27, 2017 - IsoRay...Apr 27, 2017  · IsoRay’s filings with the Securities and Exchange Commission (in particular, it’s most recently filed Form

Key Takeaways

• Only manufacturer in the world of Cesium-131 LDR*

brachytherapy seeds, a radioisotope which represents a

significant advancement in cancer therapy with fast resolution

of side effects and at lower cost than alternative treatments • More than 10,000 patients have been implanted with patent protected

Cesium-131 seeds

• Making significant investments in market development of prostate and other

body parts to support assumption of leadership

• Intense focus on 2-pronged growth strategy • Renewed commitment on establishing market leadership in LDR brachytherapy treatment of prostate cancer

- Launched new sales strategies in Fall 2016 with more experienced leadership and sales team

- Current LDR brachytherapy market void of leadership

- Opportunities to leverage growth segments in Prostate Cancer Market

• Growing clinical evidence for multiple cancer indications in difficult to treat recurrent patients - GammaTile collaboration for Brain cancer

- Gynecology, Head & Neck, Lung cancers

• Strong balance sheet to support growth strategy • $11.9 million cash** and no debt as of December 31, 2016

• Programs in place for ongoing cost and process improvements

31

* LDR – low dose rate; ** Includes cash, cash equivalents and certificates of deposit

NYSE MKT: ISR

Page 32: Planet MicroCap Showcase April 27, 2017 - IsoRay...Apr 27, 2017  · IsoRay’s filings with the Securities and Exchange Commission (in particular, it’s most recently filed Form

Thank You!

For Further Information: Tom LaVoy

Chairman and CEO (509) 375-1202

[email protected]

32

Page 33: Planet MicroCap Showcase April 27, 2017 - IsoRay...Apr 27, 2017  · IsoRay’s filings with the Securities and Exchange Commission (in particular, it’s most recently filed Form

End Notes

1. Mendez, MH, et al (June 2015) Current trends and new frontiers in focal therapy for localized prostate cancer. Current Urology Report 16:35

2. Barocas, DA, et al Effect of USPSTF Grade D Recommendation against Screening for Prostate Cancer on Incident Prostate Cancer Diagnosis in the United States. J Urol 194(6) The Journal of Urology, 2015

3. Grimm, et al., British Journal of Urology International, Vol. 109 (Suppl 1), 2012; Merrick, et al., Techniques in Urology,Vol 7, 2001; Potters, et al., Journal of Urology, May 2005; Sharkey, et al., Current Urology Reports, 2002

4. Feddock, J., et al., Permanent interstitial re-irradiation with cesium-131: a highly successful second chance for cure in recurrent pelvic malignancies. Brachytherapy 15(S1): p. S78-9, 2016

5. Feddock, J., et al., Outpatient interstitial implants – integrating cesium-131 permanent interstitial brachytherapy into definitive treatment for gynecological malignancies. Brachytherapy 15(S1): p. S93-4, 2016

6. Pham, A., et al., Neurocognitive function and quality of life in patients with newly diagnosed brain metastasis after treatment with intra-operative cesiumWernicke, A.G., et al., Surgical technique and clinically relevant resection cavity dynamics following implantation of cesium-131 brachytherapy in patients with brain metastases. Operative Neurosurgery, 2016. 12(1): p. 49-60, 2016.-131 brachytherapy: a prospective trial. J Neuro-Oncology 127(1): p. 63-71, 2016.

7. Wernicke, A.G., et al., Surgical technique and clinically relevant resection cavity dynamics following implantation of cesium-131 brachytherapy in patients with brain metastases. Operative Neurosurgery, 2016. 12(1): p. 49-60, 2016.

8. Wernicke, A.G., et al., Cesium-131 brachytherapy for recurrent brain metastases: durable salvage treatment for previously irradiated metastatic disease. J Neurosurg: Published online June 3, 2016; DOI: 10.3171/2016.3.JNS152836.

9. Wernicke, A.G., et al., The cost-effectiveness of surgical resection and cesium-131 intraoperative brachytherapy versus surgical resection and stereotactic radiosurgery in the treatment of metastatic brain tumors. J Neuro-Oncology, 127(1): p. 145-53, 2016.

10. Pham, A., et al., Cesium-131 brachytherapy in high risk and recurrent head and neck cancers: first report of long-term outcomes. J Contemporary Brachytherapy 7(6): p. 445-52, 2015.

11. Brachman, D., Prospective trial of surgery and permanent intraoperative brachytherapy (S+BT) using a modular, biocompatible radiation implant for recurrent aggressive meningiomas., Society of Neuro-Oncology Conference on Meningioma, Toronto, Canada, June 18th, 2016.

12. Parashar, B., et al., Analysis of stereotactic radiation vs. wedge resection vs. wedge resection plus Cesium-131 brachytherapy in early stage lung cancer. Brachytherapy 14(5): p. 648-54, 2015.

33

NYSE MKT: ISR