Category: Health

 

Lineage Cell Therapeutics Proudly Supports Patients’ Access To Innovative Cell Therapy Treatments And Research Through Passage Of Proposition 14

 

Voters Authorize California Institute for Regenerative Medicine to Fund $5.5 Billion in Grants for Stem Cell Research and Development

CARLSBAD, Calif.–(BUSINESS WIRE)–Nov. 13, 2020– Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs, strongly endorses the recent passing of Proposition 14 in California. This bill will enhance patients’ access to groundbreaking stem cell therapy treatments by authorizing the California Institute for Regenerative Medicine (CIRM) the ability to fund up to $5.5 billion in grants to support therapeutic development, medical research, and facilities based on stem cell technologies. This initiative builds upon the success of Proposition 71, which issued approximately $3 billion for the funding of stem cell research and led to important medical advances, including functional cures in some patients receiving cell therapy treatments. The development of Lineage’s OPC1 oligodendrocyte progenitor cell therapy for the treatment of acute spinal cord injury (SCI), was one of the first clinical trials supported by CIRM and has showed durable and encouraging results in some patients.

“At Lineage, the patients and their families inspire us to advance cell therapy products and this recent approval of Proposition 14 ensures that access to cutting edge cell-based therapies can continue from companies like ours,” stated Brian M. Culley, Lineage CEO. “Cell therapy has the ability to make a profound impact on millions of lives and the passage of Proposition 14 reflects California’s serious commitment to supporting innovative local companies through the expensive and time-consuming process required to discover and test new cell-based therapies and will drive further innovation in stem cell development and research. Of note, our clinical study of OPC1 for the treatment of acute spinal cord injury was one of the first cell therapy clinical trials supported by CIRM under Prop 71. It was tremendously meaningful for some of our patients’ success stories to be featured in the Prop 14 campaign this year, along with others who have experienced life-changing benefits from stem cell therapy innovation in California. We are extremely thankful to CIRM for their partnership and valuable contributions, not only to Lineage, but also for other companies working in this exciting and rapidly growing field. We believe that all three of our clinical-stage programs could be considered for future grant funding under this new initiative.”

About OPC1

OPC1 is an oligodendrocyte progenitor cell (OPC) transplant therapy designed to provide clinically meaningful improvements to motor recovery in individuals with acute spinal cord injuries (SCI). OPCs are naturally occurring precursors to the cells which provide electrical insulation for nerve axons in the form of a myelin sheath. SCI occurs when the spinal cord is subjected to a severe crush or contusion injury and typically results in severe functional impairment, including limb paralysis, aberrant pain signaling, and loss of bladder control and other body functions. There are approximately 18,000 new spinal cord injuries annually in the U.S. and there currently are no FDA-approved drugs specifically for the treatment of SCI. The OPC1 program has been partially funded by a $14.3 million grant from the California Institute for Regenerative Medicine. OPC1 has received Regenerative Medicine Advanced Therapy (RMAT) designation and Orphan Drug designation from the U.S. Food and Drug Administration (FDA).

About the OPC1 Clinical Study

The SCiStar Study of OPC1 is an open-label, 25-patient, single-arm trial testing three sequential escalating doses of OPC1 which was administered 21 to 42 days post-injury, at up to 20 million OPC1 cells in patients with subacute motor complete (AIS-A or AIS-B) cervical (C-4 to C-7) acute spinal cord injuries (SCI). These individuals had experienced severe paralysis of the upper and lower limbs. The primary endpoint in the SCiStar study was safety as assessed by the frequency and severity of adverse events related to OPC1, the injection procedure, and immunosuppression with short-term, low-dose tacrolimus. Secondary outcome measures included neurological functions measured by upper extremity motor scores (UEMS) and motor level on International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) examinations through 365 days post-treatment. Enrollment is complete in this study; patients will continue to be evaluated on a long-term basis.

About Lineage Cell Therapeutics, Inc.

Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineage’s programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineage’s clinical programs are in markets with billion dollar opportunities and include three allogeneic (“off-the-shelf”) product candidates: (i) OpRegen®, a retinal pigment epithelium transplant therapy in Phase 1/2a development for the treatment of dry age-related macular degeneration, a leading cause of blindness in the developed world; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; and (iii) VAC, an allogeneic dendritic cell therapy platform for immuno-oncology and infectious disease, currently in clinical development for the treatment of non-small cell lung cancer. For more information, please visit www.lineagecell.com or follow the Company on Twitter @LineageCell.

Forward-Looking Statements

Lineage cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “design,” “intend,” “expect,” “could,” “plan,” “potential,” “predict,” “seek,” “should,” “would,” “contemplate,” project,” “target,” “tend to,” or the negative version of these words and similar expressions. Such statements include, but are not limited to, statements relating to Lineage’s expected eligibility for grants. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Lineage’s actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including risks and uncertainties inherent in Lineage’s business and other risks in Lineage’s filings with the Securities and Exchange Commission (the SEC). Lineage’s forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. Further information regarding these and other risks is included under the heading “Risk Factors” in Lineage’s periodic reports with the SEC, including Lineage’s Annual Report on Form 10-K filed with the SEC on March 12, 2020 and its other reports, which are available from the SEC’s website. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Lineage undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(ir@lineagecell.com)
(442) 287-8963

Solebury Trout IR
Gitanjali Jain Ogawa
(Gogawa@troutgroup.com)
(646) 378-2949

Russo Partners – Media Relations
Nic Johnson or David Schull
Nic.johnson@russopartnersllc.com
David.schull@russopartnersllc.com
(212) 845-4242

Source: Lineage Cell Therapeutics, Inc.

 

Lineage Cell Therapeutics Completes Patient Enrollment In Phase 1/2a Clinical Study Of Opregen® Cell Therapy For The Treatment Of Dry Age-Related Macular Degeneration

 

• OpRegen Data Update to be Featured in Presentation by Principal Investigator Christopher D. Riemann, M.D., at 2020 AAO Annual Meeting on November 15, 2020
• Therapeutic Expert Call to Discuss Results Scheduled for November 17, 2020 @ 4pm ET/1pm PT

CARLSBAD, Calif.–(BUSINESS WIRE)–Nov. 11, 2020– Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing three novel cell therapies for serious conditions, today announced the successful completion of enrollment in its 24-patient Phase 1/2a study of its lead product candidate, OpRegen®. OpRegen is an investigational cell therapy consisting of retinal pigment epithelium (RPE) cells administered to the subretinal space for the treatment of dry age-related macular degeneration (AMD) with geographic atrophy (GA). Updated interim results from the ongoing Phase 1/2a study will be presented at the 2020 American Academy of Ophthalmology Annual Meeting (AAO 2020) during the OP02V Retina, Vitreous Original Papers Session on November 15, 2020 at 10:40am Eastern Time / 7:40 am Pacific Time by Christopher D. Riemann, M.D., Vitreoretinal Surgeon and Fellowship Director, Cincinnati Eye Institute and University of Cincinnati School of Medicine. Dr. Riemann also will participate in a call to discuss the interim results on November 17, 2020 at 4:00 pm Eastern Time / 1:00 pm Pacific Time. Interested parties can access the event on the Events and Presentations section of Lineage’s website.

“Completion of patient enrollment in our OpRegen study is a significant achievement for our team and reflects the focused commitment we have made to advancing our three cell therapy product candidates. We believe the potential for transplanted cells to safely and durably treat serious diseases and conditions, particularly where traditional molecular approaches have failed, will usher in a new treatment paradigm for modern medicine. Demonstrating this potential in clinical trials is a vital step in that process and we are thankful to have reached this important milestone,” stated Brian Culley, CEO. “As a result of increased awareness of our study and promising data we reported recently, including the first known demonstration of retinal tissue restoration in a clinical setting, we were able to enroll and treat the final five patients in cohort 4 in just five weeks. We also surpassed our original goal by utilizing the Gyroscope Orbit SDS in 7 of the last 9 patients. We extend our gratitude to the participating patients, their families, and the study investigators and coordinators in both the US and Israel. With this milestone reached, our focus turns toward collecting safety and efficacy data on the most recently treated patients, evaluating options for later-stage clinical development, including with potential partners, and approaching the FDA to discuss our next steps. Our objective is to position the OpRegen program as a front-runner in the race to address an unmet need in what is widely expected to be a multi-billion-dollar dry AMD therapeutic market.”

About OpRegen

OpRegen is currently being evaluated in a Phase 1/2a open-label, dose escalation safety and efficacy study of a single injection of human retinal pigment epithelium cells derived from an established pluripotent cell line and transplanted subretinally in patients with advanced dry AMD with GA. The study enrolled 24 patients into 4 cohorts. The first 3 cohorts enrolled only legally blind patients with best corrected visual acuity (BCVA) of 20/200 or worse. The fourth cohort enrolled patients with vision as high as 20/64. Cohort 4 also included patients treated with a new “thaw-and-inject” formulation of OpRegen, which can be shipped directly to sites and used immediately upon thawing, removing the complications and logistics of having to use a dose preparation facility. The primary objective of the study is to evaluate the safety and tolerability of OpRegen as assessed by the incidence and frequency of treatment emergent adverse events. Secondary objectives are to evaluate the preliminary efficacy of OpRegen treatment by assessing the changes in ophthalmological parameters measured by various methods of primary clinical relevance. Additionally, for the patients in Cohort 4 that receive subretinal delivery of OpRegen utilizing the Gyroscope Orbit Subretinal Delivery System (Gyroscope Orbit SDS), objectives will include the evaluation of the safety of delivery of OpRegen using the Gyroscope Orbit SDS.

Recently, Lineage reported the first known finding of retinal tissue regeneration in a patient receiving OpRegen for the treatment of atrophic dry AMD. This unprecedented finding supports the view that dry AMD is not an irreversible, degenerative condition and that some portion of diseased retinal tissue may be recoverable in atrophic end-stage disease patients. These findings were initially observed by an independent external advisor using multiple imaging technologies and were subsequently confirmed by the reading center and additional experts in the field of retinal imaging. The Company also has observed evidence of benefit in other patients, including increases in Best Corrected Visual Acuity (BCVA), reduction in the growth of GA, and increases in reading speed.

OpRegen is a registered trademark of Cell Cure Neurosciences Ltd., a majority-owned subsidiary of Lineage Cell Therapeutics, Inc.

About Dry AMD

Dry age-related macular degeneration (AMD) is a leading cause of adult blindness in the developed world. There are two forms of AMD: wet AMD and dry AMD. Dry AMD is the more common of the two types, accounting for approximately 85-90% of cases. Wet AMD is the less common of the two types, accounting for approximately 10-15% of cases. Global sales of the two leading wet AMD therapies were in excess of $10 billion in 2019. Nearly all cases of wet AMD begin as dry AMD. Dry AMD typically affects both eyes. There are currently no U.S. Food and Drug Administration (FDA) or European Medicines Agency (EMA) approved treatment options available for patients with dry AMD.

About Lineage Cell Therapeutics, Inc.

Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineage’s programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineage’s clinical programs are in markets with billion dollar opportunities and include three allogeneic (“off-the-shelf”) product candidates: (i) OpRegen®, a retinal pigment epithelium transplant therapy in Phase 1/2a development for the treatment of dry age-related macular degeneration, a leading cause of blindness in the developed world; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; and (iii) VAC, an allogeneic dendritic cell therapy platform for immuno-oncology and infectious disease, currently in clinical development for the treatment of non-small cell lung cancer. For more information, please visit www.lineagecell.com or follow the Company on Twitter @LineageCell.

Forward-Looking Statements

Lineage cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “design,” “intend,” “expect,” “could,” “plan,” “potential,” “predict,” “seek,” “should,” “would,” “contemplate,” project,” “target,” “tend to,” or the negative version of these words and similar expressions. Such statements include, but are not limited to, statements relating to the potential for cell therapy generally and the expected addressable market for OpRegen. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Lineage’s actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including risks and uncertainties inherent in Lineage’s business and other risks in Lineage’s filings with the Securities and Exchange Commission (the SEC). Lineage’s forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. Further information regarding these and other risks is included under the heading “Risk Factors” in Lineage’s periodic reports with the SEC, including Lineage’s Annual Report on Form 10-K filed with the SEC on March 12, 2020 and its other reports, which are available from the SEC’s website. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Lineage undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(ir@lineagecell.com)
(442) 287-8963

Solebury Trout IR
Gitanjali Jain Ogawa
(Gogawa@troutgroup.com)
(646) 378-2949

Russo Partners – Media Relations
Nic Johnson or David Schull
Nic.johnson@russopartnersllc.com
David.schull@russopartnersllc.com
(212) 845-4242

Source: Lineage Cell Therapeutics, Inc.

 

Utilizing pluripotent stem cells in cell therapy

 

In this episode of Conversations in Healthcare, Mike Ward, Global Head of Thought Leadership at DRG, speaks with Brian Culley, CEO of Lineage Cell Therapeutics. Brian and Mike discuss the company’s cell therapy program, utilizing pluripotent stem cells, initially targeting dry age-related macular degeneration, acute spinal cord injuries, and non-small cell lung cancer. Brian shares about the status of their Phase 1/2a clinical trials, and how COVID-19 has affected the company’s operations. Learn more in the full episode.

 

 

Cocrystal Pharma Selected to Present at the World Antiviral Conference

 

BOTHELL, WA, Nov. 10, 2020 (GLOBE NEWSWIRE) — Cocrystal Pharma, Inc. (NASDAQ: COCP), (“Cocrystal” or the “Company”), a clinical stage biotechnology company discovering and developing novel antiviral therapeutics, today announced that Dr. Gary Wilcox and Dr. Sam Lee, have been selected to present at the World Antiviral Conference on Thursday, November 12, 2020 at 1:20 PM EST. The Company’s presentation titled, “Antivirals against coronavirus and the A strains of the influenza virus,” will be accessible to those registered to attend the virtual event.

As part of the presentation, Dr. Wilcox will discuss Cocrystal’s novel, broad spectrum influenza antivirals and novel antiviral compounds for the treatment of coronavirus infections that are currently in development. In addition to the presentation, Dr. Lee and Dr. Wilcox will participate in a Q&A session.

Cocrystal is applying its proprietary platform technology to develop novel, broad spectrum influenza antivirals that are specifically designed to be effective against all significant A strains of the influenza virus and to have a high barrier to resistance due to the mechanism used to target the virus’ replication machinery. Additionally, Cocrystal is developing novel antiviral compounds for the treatment of coronavirus infections, which to-date, have demonstrated in vitro anti-SARS-CoV-2 activity, the virus responsible for the COVID-19 pandemic, and in vivo efficacy in MERS-CoV-infected animal models. The Company initiated its preclinical studies of COVID-19 inhibitors during the second quarter of 2020 and anticipates the selection of its lead preclinical molecule by year end.

About the World Antiviral Conference

Evident with every viral pandemic including COVID-19, rapid deployment of compatible antiviral therapies is of paramount importance, particularly before a long-term strategy of a vaccine is possible. Antivirals can prevent or control viral diseases from emerging diseases, respiratory infections, and chronic diseases to virus-associated tumors.

Brought to you by the World Vaccines Congress Series team, this virtual congress is designed to get up to speed and help accelerate your antiviral research from bench to patient. For more information about the event, visit the conference website: here.

About Cocrystal Pharma, Inc.

Cocrystal Pharma, Inc. is a clinical stage biotechnology company discovering and developing novel antiviral therapeutics that target the replication process of influenza viruses, SARS-CoV-2 virus, hepatitis C viruses, and norovirus. Cocrystal employs unique, proprietary, structure-based technologies and Nobel Prize winning expertise to create first- and best-in-class antiviral drugs. For further information about Cocrystal, please visit www.cocrystalpharma.com.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements related to our ability to show CC-42344 drug superiority when seeking FDA approval and our plans regarding the completion of the IND-enabling studies and the beginning of clinical trials. We have based these forward-looking statements largely on our current expectations and projections about future events. Some or all of the events anticipated by these forward-looking statements may not occur. Important factors that could cause actual results to differ from those in the forward-looking statements include, but are not limited to, the impact of the COVID -19 pandemic, the availability of products manufactured by third parties, and the future results of preclinical and clinical studies. Further information on our risk factors is contained in our filings with the Securities and Exchange Commission, including our Annual Report on Form 10-K for the year ended December 31, 2019 and our Quarterly Report on Form 10-Q for the quarter ended June 30, 2020. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.

Investor and Media Contact:

JTC Team, LLC
(833) 475-8247
COCP@jtcir.com

Source: Cocrystal Pharma, Inc.

 

OptimizeRx Third Quarter 2020 Revenue Up 110% to Record $10.5 Million, Driving Non-GAAP Net Income of $1.1 million or $0.07 Per Share

 

ROCHESTER, Mich., Nov. 09, 2020 (GLOBE NEWSWIRE) — OptimizeRx Corp. (Nasdaq: OPRX), a leading provider of digital health solutions for life science companies, reported results for the three and nine months ended September 30, 2020. Quarterly and nine months comparisons are to the same year-ago period.

Financial Highlights

• Revenue in the third quarter of 2020 increased 110% to a record $10.5 million, with the first nine months of 2020 up 56% to a record $26.9 million.
• Gross profit in the third quarter of 2020 increased 99% to $6.0 million.
• GAAP net loss totaled $0.3 million or $(0.02) per share in the third quarter, with non-GAAP net income at $1.1 million or $0.07 per share (see definition of this non-GAAP measure and reconciliation to GAAP, below).
• Cash and cash equivalents totaled $12.0 million at September 30, 2020.
• Closed additional enterprise deals, bringing total value of enterprise-level engagements to $21 million in annualized revenue.

Q3 2020 Operational Highlights

• Expanded direct-to-patient reach via partnership with Epion Health, a leader in digital patient engagement solutions, allowing patients at health systems and medical groups across the nation access to the OptimizeRx digital health and communications platform.
• Partnered with Higi, a consumer healthcare technology and engagement company, to provide healthcare consumers with financial assistance and treatment support programs at point-of-dispense. Higi provides OptimizeRx access to more than 10,000 self-service health stations nationwide that allow consumers to measure, track and act on their health data.
• Expanded digital health communication network in collaboration with Change Healthcare to enable providers in the Change Healthcare network to digitally receive important information from the life sciences industry via OptimizeRx.
• Secured two SaaS-based enterprise-level engagements with a combined annual contract value of $3.6 million.
• Enhanced corporate governance with the addition of Greg Wasson, former president and CEO of Walgreens Boots Alliance, to the board of directors.
• Continued webinar series featuring industry thought leaders discussing innovative ideas for improving medication launches.

Q3 2020 Financial Summary

Total revenue in the third quarter of 2020 increased 110% to a record $10.5 million versus $5.0 million in the same year-ago quarter. The quarterly increase was due to increases in sales in the company’s messaging products and patient engagement products, including from its acquisition of RMDY Health in 2019.

Gross margin decreased to 57.1% in the third quarter of 2020 as compared to 60.4% in the year-ago quarter. The decrease was related to a change in mix of services provided. The company expects gross margin to improve in the fourth quarter with a target of 60% for the year.

Operating expenses totaled $6.2 million, up from $5.0 million in the same year-ago quarter. The increase was due to the company’s efforts to expand its product line and build out its organization for future growth.

Net loss on a GAAP basis in the third quarter of 2020 was $0.3 million or $(0.02) per share, as compared to a net loss of $1.6 million or $(0.11) per share in the third quarter of 2019.

Non-GAAP net income for the third quarter of 2020 was $1.1 million or $0.07 per share, compared to non-GAAP net loss of $0.9 million or $(0.07) per diluted share in the same year-ago period (see definition of these non-GAAP measures and reconciliation to GAAP, below).

While the company expects to return to GAAP profitability as its revenue grows, expenses related to investments in growth initiatives or non-cash charges could result in a GAAP loss in any given quarter. Given the opportunity at hand as discussed below, the company continues to be focused on top-line growth while maintaining a strong balance sheet.

Cash and cash equivalents totaled $12.0 million at September 30, 2020, as compared to $14.1 million at June 30, 2020. The decrease was due to an increased investment in working capital. The company has continued to operate debt-free and expects to be cash-flow positive for the remainder of the year.

Management Commentary

“In Q3, we realized triple digit revenue growth, mostly organic, which drove strong non-GAAP net income,” stated OptimizeRx CEO, William Febbo. “It reflects how our pharma clients are increasingly seeing the point-of-care as essential to their marketing spend.”

“We also continued to see a growing proportion of enterprise-level recurring revenue and growing interest from our customer base for our new solutions, such as patient engagement, hub enrollment and TelaRep™. We finalized our integration and go-forward plan for patient engagement, which provides additional scale for driving growth in recurring revenue. It also opens up access to additional budgets within our client base and supports improved gross margins over time.

“We expanded our platform reach during the quarter via our Higi and Epion partnerships that connect us digitally to millions of new patients. We see ourselves at just the beginning of a broad expansion into retail or point-of-dispense as another channel to enable affordability and adherence. Both of these partnerships are very timely, as we are all looking for ways to connect digitally at more points in the healthcare workflow and maximize access to care.

“We are seeing more rapid adoption of digital tools for doctors to combat the COVID disruption. Macro trends are in our favor as highlighted by the rapid adoption of telehealth and other digital tools. A clear theme forming is the need for the appropriate digital tools for doctors to maintain their practices with under such drastic disruptions occurring with the pandemic. This allows for our solutions to be highlighted as an effective tool set to help deliver care to patients.

“Looking ahead, we are on track for a strong annual growth rate, non-GAAP income and positive cash flow from operational activities. Our pipeline is better than it has ever been, currently sitting at $140 million, nearly double versus this time last year. We continue to anticipate a close rate in the range of 35 percent to 50 percent, with these prospects keeping us on pace for another year of record growth in an expanding addressable market.”

Conference Call

OptimizeRx management will host the presentation, followed by a question and answer period.

Date: Monday, November 9, 2020
Time: 4:30 p.m. Eastern time (1:30 p.m. Pacific time)
Toll-free dial-in number: 1-800-430-8332
International dial-in number: 1-323-347-3277
Conference ID: 9818386

Please call the conference telephone number five minutes prior to the start time. An operator will register your name and organization. If you have any difficulty connecting with the conference call, please contact CMA at 1-949-432-7566.

A replay of the call will be available after 7:30 p.m. Eastern time on the same day through November 30, 2020, as well as available for replay via the Investors section of the OptimizeRx website at optimizerx.com/investors.

Toll-free replay number: 1-844-512-2921
International replay number: 1-412-317-6671
Replay ID: 9818386

Definition and Use of Non-GAAP Financial Measures

This earnings release includes a presentation of non-GAAP net income (loss) and non-GAAP earnings (loss) per share or non-GAAP EPS, both of which are non-GAAP financial measures.

The company defines non-GAAP net income (loss) as GAAP net income (loss) with an adjustment to add back depreciation, amortization, non-cash lease expense, stock-based compensation, acquisition expenses, income or loss related to the fair value of contingent consideration, and deferred income taxes. Non-GAAP EPS is defined as non-GAAP net income (loss) divided by the number of weighted average shares outstanding on a basic and diluted basis. The company has provided non-GAAP financial measures to aid investors in better understanding its performance. Management believes that these non-GAAP financial measures provide additional insight into the operations and cashflow of the company.

Because of varying available valuation methodologies, subjective assumptions and the variety of equity instruments that can impact a company’s non-cash operating expenses, management believes that providing non-GAAP financial measures that excludes non-cash expenses allows for meaningful comparisons between the company’s core business operating results and those of other companies, as well as provides an important tool for financial and operational decision making and for evaluating the company’s own core business operating results over different periods of time.

The company’s non-GAAP net income (loss) and non-GAAP EPS measures may not provide information that is directly comparable to that provided by other companies in the company’s industry, as other companies in the industry may calculate such non-GAAP financial results differently. The company’s non-GAAP net income (loss) and non-GAAP EPS are not measurements of financial performance under GAAP and should not be considered as an alternative to operating income or as an indication of operating performance or any other measure of performance derived in accordance with GAAP. The company does not consider these non-GAAP measures to be substitutes for or superior to the information provided by its GAAP financial results.

The table, “Reconciliation of non-GAAP to GAAP Financial Measures,” included below, provides a reconciliation of non-GAAP net income (loss) and non-GAAP EPS for the three months and nine months ended September 30, 2020 and 2019.

About OptimizeRx

OptimizeRx Corporation (NASDAQ: OPRX) is a digital health company that facilitates communication at the point-of-care among all stakeholders in healthcare. Primarily focused on life science and payer clients, its suite of digital and mobile SaaS-based solutions enables affordability, patient adherence and care management. OptimizeRx’s network reaches more than 60% of U.S. ambulatory providers, delivering therapeutic support on specialty medications and patient financial assistance directly within a provider’s workflow through leading electronic health platforms. OptimizeRx’s fully integrated platform supports the real-time exchange of information, improving provider knowledge and patient engagement, and ultimately leading to healthier outcomes.

For more information, follow the company on Twitter, LinkedIn or visit www.optimizerx.com.

Important Cautions Regarding Forward Looking Statements

This press release contains forward-looking statements within the definition of Section 27A of the Securities Act of 1933, as amended, and such as in section 21E of the Securities Act of 1934, as amended. These forward-looking statements should not be used to make an investment decision. The words ‘estimate,’ ‘possible’ and ‘seeking’ and similar expressions identify forward-looking statements, which speak only as to the date the statement was made. The company undertakes no obligation to publicly update or revise any forward-looking statements, whether because of new information, future events, or otherwise. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted, or quantified. Future events and actual results could differ materially from those set forth in, contemplated by, or underlying the forward-looking statements. The risks and uncertainties to which forward-looking statements are subject include, but are not limited to, the effect of government regulation, competition, and other material risks.

Company Contact
Doug Baker, CFO
Tel (248) 651-6568 x807
dbaker@optimizerx.com

Media Contact
Maira Alejandra, Media Relations Manager
Tel (754) 245-7070
malejandra@optimizerx.com

Investor Relations Contact
Ron Both or Grant Stude
CMA Investor Relations
Tel (949) 432-7557
oprx@cma.team

See Optimizerx Corporation Condensed Consolidated Balance Sheets (Unaudited)

Source: OptimizeRx