Study of Non-Invasive Vagus Nerve Stimulation (nVNS) Shows Improvement in PTSD Symptoms and Decreased Inflammatory Response to Stress

 

ROCKAWAY, NJ, 
Aug. 10, 2021 (GLOBE NEWSWIRE) — 
electroCore, Inc. (Nasdaq: ECOR), a commercial-stage bioelectronic medicine company, today announced the publication of a peer reviewed manuscript, “Transcutaneous Cervical Vagal Nerve Stimulation (tcVNS/nVNS) in Patients with Posttraumatic Stress Disorder (PTSD): A Pilot Study of Effects on PTSD Symptoms and Interleukin-6 Response to Stress” in the Journal of Affective Disorders Reports. The manuscript reports the results of a randomized, double-blind, sham-controlled study conducted at 
Georgia Institute of Technology and 
Emory University that resulted from work funded in part by the 
Defense Advanced Research Projects Agency (DARPA) Biological Technologies Office (BTO) Targeted Neuroplasticity Training (TNT) program through the 
Naval Information Warfare Center.

PTSD is a psychiatric disorder that may occur in people who have experienced or witnessed a traumatic event such as a natural disaster, serious accident, terrorist act, war, combat, or who have been threatened with death, sexual violence or serious injury.   Eight million American adults experience PTSD annually, and with limited FDA approved therapies, there is a large unmet medical need. The disorder is more prominent in women, with about 10% of women and 4% of men developing PTSD at some point in their lives.

The study enrolled twenty patients suffering from PTSD. Study participants were exposed to personalized traumatic scripts followed by an immediate stimulation by an active or sham non-invasive vagus nerve stimulator (nVNS). The results show that three-months of treatment with nVNS lead to a 31% reduction (p<0.013) in PTSD symptoms compared to sham on the PTSD Checklist (PCL), as well as a significant decrease in hyperarousal symptoms (p=0.008) and a decrease in overall and somatic (gastric) anxiety. At the conclusion of the study, patients who continued to use nVNS for a further 3 month open-label period showed a significant improvement in their overall symptoms reported by the Clinical Global Index (p=0.003). Furthermore, nVNS effectively blocked the increase in the levels of the inflammatory cytokine IL-6 that is overexpressed in patients with PTSD who are exposed to a traumatic script (p<0.05).

Dr.  Douglas Bremner, Professor of Psychiatry and Radiology at 
Emory University School of Medicine and the primary investigator for the study commented, “PTSD is a devastating condition that can strike at almost any time after physical or mental trauma. Current treatments do not address the breadth of what a person with PTSD experiences. Dr.  Omer Inan, the Linda J. and  Mark C. Smith Chair in Bioscience and Bioengineering, Associate Professor of Electrical and Computer Engineering at 
Georgia Institute of Technology, and co-investigator on the study added, “the results from this study, while still preliminary, suggest a role for nVNS as a practical and safe novel treatment for PTSD.”

“We congratulate and thank   Dr. Bremner,  Dr. Inan, and their clinical and research teams at 
Georgia Tech, 
Emory University and the 
University of Utah, as well as the patients and families that participated in this study,” commented Eric Liebler, Senior Vice President of Neurology at electroCore. “PTSD strikes both our veterans who serve at home and across the globe, as well friends and family members who can suffer from the repercussions of a trauma at any time. We are pleased to be able to support the team’s on-going efforts to further define the possible use of nVNS in people with PTSD.”

The full publication is available at: https://www.sciencedirect.com/science/article/pii/S2666915321001165?via%3Dihub

About electroCore, Inc.
electroCore, Inc. is a commercial stage bioelectronic medicine company dedicated to improving patient outcomes through its non-invasive vagus nerve stimulation therapy platform, initially focused on the treatment of multiple conditions in neurology. The company’s current indications are the preventive treatment of cluster headache and migraine and the acute treatment of migraine and episodic cluster headache.
For more information, visit www.electrocore.com.

About gammaCore^TM
gammaCore^TM (nVNS) is the first non-invasive, hand-held medical therapy applied at the neck as an adjunctive therapy to treat migraine and cluster headache through the utilization of a mild electrical stimulation to the vagus nerve that passes through the skin. Designed as a portable, easy-to-use technology, gammaCore can be self-administered by patients, as needed, without the potential side effects associated with commonly prescribed drugs. When placed on a patient’s neck over the vagus nerve, gammaCore stimulates the nerve’s afferent fibers, which may lead to a reduction of pain in patients.

gammaCore (nVNS) is FDA cleared in 
the United States for adjunctive use for the preventive treatment of cluster headache in adult patients, the acute treatment of pain associated with episodic cluster headache in adult patients, and the acute and preventive treatment of migraine in adolescent (ages 12 and older) and adult patients. gammaCore is CE-marked in the 
European Union for the acute and/or prophylactic treatment of primary headache (Migraine, Cluster Headache, Trigeminal Autonomic Cephalalgias and Hemicrania Continua) and Medication Overuse Headache in adults.

gammaCore is contraindicated for patients if they:

• Have an active implantable medical device, such as a pacemaker, hearing aid implant, or any implanted electronic device
• Have a metallic device, such as a stent, bone plate, or bone screw, implanted at or near the neck
• Are using another device at the same time (e.g., TENS Unit, muscle stimulator) or any portable electronic device (e.g., mobile phone)
  
  

Safety and efficacy of gammaCore have not been evaluated in the following patients:

• Patients diagnosed with narrowing of the arteries (carotid atherosclerosis)
• Patients who have had surgery to cut the vagus nerve in the neck (cervical vagotomy)
• Pediatric patients (less than 12 years)
• Pregnant women
• Patients with clinically significant hypertension, hypotension, bradycardia, or tachycardia
  
  

Please refer to the gammaCore Instructions for Use for all of the important warnings and precautions before using or prescribing this product.

Forward-Looking Statements

This press release and other written and oral statements made by representatives of electroCore may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, but are not limited to, statements about electroCore’s business prospects and clinical and product development plans; its pipeline or potential markets for its technologies; the timing, outcome and impact of regulatory, clinical and commercial developments; the availability and impact of payer coverage, the potential of nVNS generally and gammaCore in particular to treat PTSD symptoms and related disorders and other statements that are not historical in nature, particularly those that utilize terminology such as “anticipates,” “will,” “expects,” “believes,” “intends,” other words of similar meaning, derivations of such words and the use of future dates. Actual results could differ from those projected in any forward-looking statements due to numerous factors. Such factors include, among others, the ability to raise the additional funding needed to continue to pursue electroCore’s business and product development plans, the inherent uncertainties associated with developing new products or technologies, the ability to commercialize gammaCore™, the potential impact and effects of COVID-19 on the business of electroCore, electroCore’s results of operations and financial performance, and any measures electroCore has and may take in response to COVID-19 and any expectations electroCore may have with respect thereto, competition in the industry in which electroCore operates and overall market conditions. Any forward-looking statements are made as of the date of this press release, and electroCore assumes no obligation to update the forward-looking statements or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law. Investors should consult all of the information set forth herein and should also refer to the risk factor disclosure set forth in the reports and other documents electroCore files with the 
SEC available at www.sec.gov.

Investors:
Rich CockrellCG Capital
404-736-3838
ecor@cg.capital

or

Media Contact:
Jackie Dorsky
electroCore
908-313-6331
Jackie.dorsky@electrocore.com

Monday, August 09, 2021

Ocugen (OCGN)
Making Progress With Covaxin and Gene Therapy

Ocugen Inc is a clinical stage biopharmaceutical company. It is focused on discovering, developing and commercializing a pipeline of innovative therapies that address rare and underserved eye diseases. Ocugen offers a diversified ophthalmology portfolio that includes novel gene therapies, biologics, and small molecules and targets a broad range of high-need retinal and ocular surface diseases.

Robert LeBoyer, Senior Research Analyst, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

Ocugen reported 2Q21 loss of $26.0 million or $(0.13) per share, compared with our estimate of $7.7 million or $(0.04) per share. The difference was mostly due to a $15 licensing fee paid to Bharat Biotech for an amendment to expand Covaxin rights in Canada. Excluding this one-time payment, the loss would have been $11.0 million or $(0.06) per share. The company ended 2Q21 with $115.8 in total cash.


Covaxin Continues To Make Progress Toward The Market.  Ocugen reported that the review process for regulatory approval in Canada is underway. Bharat Biotech has selected Jubilant HollisterStier as its Covaxin manufacturing partner and has begun the technology transfer. The company is continuing discussions with the FDA regarding the requirements for BLA submission, although no new details were …

This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary.  Proper due diligence is required before making any investment decision. 

Monday, August 09, 2021

PsyBio Therapeutics Corp. (PSYBF)(PSYB:CA)
Initiating Coverage

PsyBio Therapeutics is developing biosynthetic psychoactive compounds which offer a new paradigm of treatment to reverse the course of mental health issues. Psychoactive medications treat the illness by rewiring the brain through contemplation and a change of perception in combination with psychotherapy vs. Standard of care (SSRI’s, SNRI’s, MAOI’s, NDRI’s, etc…) which just chemically treat symptoms. Working in partnership with Miami University utilizing a proprietary platform technology to biologically synthesize psilocybin and other targeted next generation active compounds in Psilocybe Cubensis and other fungi and plants.

Robert LeBoyer, Senior Research Analyst, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

PsyBio Therapeutics Is Developing Psychedelic Drugs For Therapeutic Use.  PsyBio is developing drugs to treat psychiatric disorders.  Its has a proprietary manufacturing process for making psilocybin, the active component in “magic mushrooms” as well as related psychedelic analogues. These compounds include norbaeocystin, baeocystine, aeruginocin, and DMT. PsyBio is developing these compounds as both monotherapies and combinations that could increase efficacy at lower doses.


Biosynthetic Manufacturing Is A Strength. PsyBio has developed proprietary biosynthesis processes for producing psychedelic compounds.  The company can produce large quantities of these compounds at pharmaceutical specifications for potency, stability, and purity. This reduces the variability and cost compared with other methods. Its patent portfolio covers its biological manufacturing processes and …

This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary.  Proper due diligence is required before making any investment decision. 

Ocugen Provides Business Update and Second Quarter 2021 Financial Results

 

Conference Call and Webcast Today at 8:30 a.m. ET

• Rolling regulatory submission to Health Canada completed and review process initiated; U.S. FDA talks continue
• Multiple milestones achieved across regulatory and supply chain to support potential commercialization of pipeline assets
• The Company experienced organizational growth to reflect new business requirements in clinical development, manufacturing, and commercialization
  

MALVERN, Pa., Aug. 06, 2021 (GLOBE NEWSWIRE) — Ocugen, Inc. (“Ocugen” or the “Company”) (NASDAQ: OCGN), a biopharmaceutical company focused on discovering, developing, and commercializing gene therapies to cure blindness diseases and developing a vaccine to save lives from COVID-19, today reported second quarter 2021 financial results along with a general business update.

“The second quarter has proven how dynamic the life sciences sector is during this time of global crisis, and we are undeterred in our efforts to contribute to the public health agenda. Our regulatory submission to Health Canada and our ongoing discussions with the U.S. Food and Drug Administration continue to provide us direction in potentially obtaining regulatory approvals for COVAXIN™ in North America. We are also continuing our forward momentum to take on blindness diseases and are on track to initiate our first gene therapy clinical trial for OCU400 in the latter part of 2021. Overall, I’m very pleased with our growth and efforts to date,” said Dr. Shankar Musunuri, Chairman, Chief Executive Officer, and Co-Founder of Ocugen.

Business Highlights

FORWARD MOMENTUM FOR COVAXIN™ AND OPHTHALMIC PIPELINE

• The Company’s partner, Bharat Biotech of India, completed and posted its Phase 3 clinical trial results for COVAXIN™ demonstrating 77.8% efficacy against overall COVID-19 disease, 93.4% efficacy against severe COVID-19 disease, 63.6% efficacy against asymptomatic COVID-19 disease, and 65.2% efficacy against the Delta variant, B.1.617.2. Adverse events in the COVAXIN™ and control arms of the Phase 3 clinical trial were observed in 12.4% of subjects, with less than 0.5% of subjects experiencing serious adverse side effects. This data was submitted to a peer-reviewed journal for future potential publication.
• In June, an amendment to the agreement with Bharat Biotech was finalized which expanded the Company’s rights to develop, manufacture, and commercialize COVAXIN™ into Canada (in addition to the United States). Soon after in July, the Company announced the completion of its regulatory submission to Health Canada for COVAXIN™, which was accepted under the Minister of Health’s Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19 and transitioned to a New Drug Submission for COVID-19. The submission was conducted through the Company’s new affiliate, Vaccigen, Ltd., and the review process has begun in Canada.
• Discussions with the U.S. Food and Drug Administration are ongoing, and the Company is still proceeding with a strategy focused on the agency’s requested Biologics License Application pathway and determining what data requirements and U.S.-based clinical trials will be required to support such submission.
• Technology transfer activities are ongoing between Bharat Biotech and Jubilant HollisterStier, which the Company has selected to be its contract manufacturing partner with respect to COVAXIN™.
• The Company’s development activities targeting retinal diseases based on its breakthrough modifier gene therapy platform continue to progress. Its first candidate therapy, OCU400, is anticipated to move into two parallel Phase 1/2a clinical trials in the United States later this year. The Company is currently also evaluating options to commence OCU400 clinical trials in Europe in 2022.
  

COMPANY POSITIONING FOR FUTURE GROWTH

• New management team member, Mike Shine, joined the Company in early June as Senior Vice President, Commercial, bringing nearly 35 years of industry experience. Mr. Shine will lead commercial efforts for the Company’s portfolio including COVAXIN™’s launch in Canada and the United States, if authorized or approved.
• Employee count has grown as the Company establishes enhanced capabilities in Research and Development, Clinical Development, Commercial, Supply Chain, and Communications.
• The Company entered the Russell 2000 and 3000 Indices in June, which reflects the organization’s performance, growth, and value.
  

Second Quarter 2021 Financial Results

• Ocugen’s cash, cash equivalents, and restricted cash totaled $115.8 million as of June 30, 2021, compared to $24.2 million as of December 31, 2020. Ocugen had 198.7 million shares of common stock outstanding as of June 30, 2021.
• Research and development expenses for the three months ended June 30, 2021 were $18.9 million compared to $1.6 million for the three months ended June 30, 2020. Research and development expenses for the three months ended June 30, 2021 included a $15.0 million up-front payment to Bharat Biotech for the right and license to COVAXIN™ development, manufacturing, and commercialization in Canada. General and administrative expenses for the three months ended June 30, 2021 were $6.8 million compared to $1.8 million for the three months ended June 30, 2020. Ocugen reported a $0.13 net loss per share for the three months ended June 30, 2021 compared to a $0.19 net loss per share for the three months ended June 30, 2020.

Conference Call and Webcast Details

Ocugen has scheduled a conference call and webcast for 8:30 a.m. eastern time today to discuss the financial results and recent business highlights. Ocugen’s senior management team will host the call, which will be open to all listeners. There will also be a question-and-answer session following the prepared remarks.

The call can be accessed by dialing (844) 873-7330 (U.S.) or (602) 563-8473 (international) and providing the conference ID 6663619. To access a live audio webcast of the call on the “Investors” section of the Ocugen website, please click here. A replay of the webcast will be archived on Ocugen’s website for approximately 45 days following the call.

About Ocugen, Inc.
Ocugen, Inc. is a biopharmaceutical company focused on discovering, developing, and commercializing gene therapies to cure blindness diseases and developing?a vaccine to?save lives from COVID-19. Our breakthrough modifier gene therapy platform has the potential to treat multiple retinal diseases with one drug – “one to many” and our novel biologic product candidate aims to offer better therapy to patients with underserved diseases such as wet age-related macular degeneration, diabetic macular edema, and diabetic retinopathy.?We are co-developing Bharat Biotech’s COVAXIN™ vaccine candidate for COVID-19 in the U.S. and Canadian markets.?For more information, please visit www.ocugen.com.

Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such forward-looking statements include information about qualitative assessments of available data, potential benefits, expectations for clinical trials, and anticipated timing of clinical trial readouts and regulatory submissions. This information involves risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, including the risk that such dates are not met due to impacts from the ongoing COVID-19 pandemic, as well as risks associated with preliminary and interim data, including the possibility of unfavorable new clinical trial data and further analyses of existing clinical trial data; the risk that the results of in-vitro studies will not be duplicated in human clinical trials; the risk that clinical trial data are subject to differing interpretations and assessments, including during the peer review/publication process, in the scientific community generally, and by regulatory authorities; whether and when data from Bharat Biotech’s clinical trials will be published in scientific journal publications and, if so, when and with what modifications; whether we will be able to provide the U.S. Food and Drug Administration (“FDA”) with sufficient additional information regarding the design of and results from preclinical and clinical studies of COVAXIN™, which have been conducted by Bharat Biotech in India in order for those trials to support a Biologics License Application (“BLA”); the size, scope, timing and outcome of any additional trials or studies that we may be required to conduct to support a BLA; any additional chemistry, manufacturing, and controls information that we may be required to submit; the timing of our BLA filing; whether and when a BLA for COVAXIN™ will be submitted to the FDA; whether and when a BLA may be approved by the FDA, an application for authorization under the Interim Order for emergency use may be approved by Health Canada, or a New Drug Submission application may be approved by Health Canada, which authorizations or approvals will depend on myriad factors, including making a determination as to whether the vaccine candidate’s benefits outweigh its known risks and determination of the vaccine candidate’s efficacy and, if authorized or approved, whether it will be commercially successful; whether developments with respect to the COVID-19 pandemic will affect the regulatory pathway available for vaccines in the United States, Canada, or other jurisdictions; manufacturing capabilities, manufacturing capacity, and supply restrictions, including whether sufficient doses of COVAXIN™ can be manufactured or supplied within our projected time periods; market demand for COVAXIN™ in the United States or Canada; decisions by the FDA or Health Canada impacting labeling, manufacturing processes, safety, and/or other matters that could affect the availability or commercial potential of COVAXIN™ in the United States or Canada, including development of products or therapies by other companies. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (“SEC”), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events, or otherwise, after the date of this press release.

Ocugen Contact:
Ken Inchausti
Head, Investor Relations & Communications
+1 484 237 3398
ken.inchausti@ocugen.com

Please submit investor-related inquiries to: IR@ocugen.com

(tables to follow)

OCUGEN, INC.

CONSOLIDATED BALANCE SHEETS

(in thousands)

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OCUGEN, INC.

CONSOLIDATED STATEMENTS OF OPERATIONS

(in thousands, except share and per share amounts)

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	Image Credit: NHGRI (Flickr)

Machine Learning Plus Insights from Genetic Research Shows the Workings of Cells – and May Help Develop New Drugs for COVID-19 and Other Diseases

 

We combined a machine learning algorithm with knowledge gleaned from hundreds of biological experiments to develop a technique that allows biomedical researchers to figure out the functions of the proteins that turn genes on and off in cells, called transcription factors. This knowledge could make it easier to develop drugs for a wide range of diseases.

Early on during the COVID-19 pandemic, scientists who worked out the genetic code of the RNA molecules of cells in the lungs and intestines found that only a small group of cells in these organs were most vulnerable to being infected by the SARS-CoV-2 virus. That allowed researchers to focus on blocking the virus’s ability to enter these cells. Our technique could make it easier for researchers to find this kind of information.

 

This article was republished with permission from The Conversation, a news site dedicated to sharing ideas from academic experts. It represents the research-based findings and opinions  Shang Gao, Doctoral student in Bioinformatics, University of Illinois at Chicago and Jalees Rehman, Professor of Medicine, Pharmacology and Biomedical Engineering, University of Illinois at Chicago

 

The biological knowledge we work with comes from this kind of RNA sequencing, which gives researchers a snapshot of the hundreds of thousands of RNA molecules in a cell as they are being translated into proteins. A widely praised machine learning tool, the Seurat analysis platform, has helped researchers all across the world discover new cell populations in healthy and diseased organs. This machine learning tool processes data from single-cell RNA sequencing without any information ahead of time about how these genes function and relate to each other.

Our technique takes a different approach by adding knowledge about certain genes and cell types to find clues about the distinct roles of cells. There has been more than a decade of research identifying all the potential targets of transcription factors.

Armed with this knowledge, we used a mathematical approach called Bayesian inference. In this technique, prior knowledge is converted into probabilities that can be calculated on a computer. In our case it’s the probability of a gene being regulated by a given transcription factor. We then used a machine-learning algorithm to figure out the function of the transcription factors in each one of the thousands of cells we analyzed.

We published our technique, called Bayesian Inference Transcription Factor Activity Model, in the journal Genome Research and also made the software freely available so that other researchers can test and use it.

 

Why It Matters

Our approach works across a broad range of cell types and organs and could be used to develop treatments for diseases like COVID-19 or Alzheimer’s. Drugs for these difficult-to-treat diseases work best if they target cells that cause the disease and avoid collateral damage to other cells. Our technique makes it easier for researchers to home in on these targets.

 

 

A human cell (greenish blob) is heavily infected with SARS-CoV-2 (orange dots), the virus that causes COVID-19, in this colorized microscope image.  – National Institute of Allergy and Infectious Diseases

 

What Other Research is Being Done?

Single-cell RNA-sequencing has revealed how each organ can have 10, 20 or even more subtypes of specialized cells, each with distinct functions. A very exciting new development is the emergence of spatial transcriptomics, in which RNA sequencing is performed in a spatial grid that allows researchers to study the RNA of cells at specific locations in an organ.

A recent paper used a Bayesian statistics approach similar to ours to figure out distinct roles of cells while taking into account their proximity to one another. Another research group combined spatial data with single-cell RNA-sequencing data and studied the distinct functions of neighboring cells.

 

What’s Next

We plan to work with colleagues to use our new technique to study complex diseases such as Alzheimer’s disease and COVID-19, work that could lead to new drugs for these diseases. We also want to work with colleagues to better understand the complexity of interactions among cells. 

 

Suggested Reading:

Emerging Biotech Opportunities from an Emerging Health Problem

Advancing Research Into Alzheimer’s with Stem Cells

Scientists Now Better Understand Viral Mutations

Diabetes Type 1 – Close to a Cure Panel Discussion (Video)

 

Stay up to date. Follow us:

Ocugen Provides Business Update and Second Quarter 2021 Financial Results

 

Conference Call and Webcast Today at 8:30 a.m. ET

• Rolling regulatory submission to Health Canada completed and review process initiated; U.S. FDA talks continue
• Multiple milestones achieved across regulatory and supply chain to support potential commercialization of pipeline assets
• The Company experienced organizational growth to reflect new business requirements in clinical development, manufacturing, and commercialization
  

MALVERN, Pa., Aug. 06, 2021 (GLOBE NEWSWIRE) — Ocugen, Inc. (“Ocugen” or the “Company”) (NASDAQ: OCGN), a biopharmaceutical company focused on discovering, developing, and commercializing gene therapies to cure blindness diseases and developing a vaccine to save lives from COVID-19, today reported second quarter 2021 financial results along with a general business update.

“The second quarter has proven how dynamic the life sciences sector is during this time of global crisis, and we are undeterred in our efforts to contribute to the public health agenda. Our regulatory submission to Health Canada and our ongoing discussions with the U.S. Food and Drug Administration continue to provide us direction in potentially obtaining regulatory approvals for COVAXIN™ in North America. We are also continuing our forward momentum to take on blindness diseases and are on track to initiate our first gene therapy clinical trial for OCU400 in the latter part of 2021. Overall, I’m very pleased with our growth and efforts to date,” said Dr. Shankar Musunuri, Chairman, Chief Executive Officer, and Co-Founder of Ocugen.

Business Highlights

FORWARD MOMENTUM FOR COVAXIN™ AND OPHTHALMIC PIPELINE

• The Company’s partner, Bharat Biotech of India, completed and posted its Phase 3 clinical trial results for COVAXIN™ demonstrating 77.8% efficacy against overall COVID-19 disease, 93.4% efficacy against severe COVID-19 disease, 63.6% efficacy against asymptomatic COVID-19 disease, and 65.2% efficacy against the Delta variant, B.1.617.2. Adverse events in the COVAXIN™ and control arms of the Phase 3 clinical trial were observed in 12.4% of subjects, with less than 0.5% of subjects experiencing serious adverse side effects. This data was submitted to a peer-reviewed journal for future potential publication.
• In June, an amendment to the agreement with Bharat Biotech was finalized which expanded the Company’s rights to develop, manufacture, and commercialize COVAXIN™ into Canada (in addition to the United States). Soon after in July, the Company announced the completion of its regulatory submission to Health Canada for COVAXIN™, which was accepted under the Minister of Health’s Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19 and transitioned to a New Drug Submission for COVID-19. The submission was conducted through the Company’s new affiliate, Vaccigen, Ltd., and the review process has begun in Canada.
• Discussions with the U.S. Food and Drug Administration are ongoing, and the Company is still proceeding with a strategy focused on the agency’s requested Biologics License Application pathway and determining what data requirements and U.S.-based clinical trials will be required to support such submission.
• Technology transfer activities are ongoing between Bharat Biotech and Jubilant HollisterStier, which the Company has selected to be its contract manufacturing partner with respect to COVAXIN™.
• The Company’s development activities targeting retinal diseases based on its breakthrough modifier gene therapy platform continue to progress. Its first candidate therapy, OCU400, is anticipated to move into two parallel Phase 1/2a clinical trials in the United States later this year. The Company is currently also evaluating options to commence OCU400 clinical trials in Europe in 2022.
  

COMPANY POSITIONING FOR FUTURE GROWTH

• New management team member, Mike Shine, joined the Company in early June as Senior Vice President, Commercial, bringing nearly 35 years of industry experience. Mr. Shine will lead commercial efforts for the Company’s portfolio including COVAXIN™’s launch in Canada and the United States, if authorized or approved.
• Employee count has grown as the Company establishes enhanced capabilities in Research and Development, Clinical Development, Commercial, Supply Chain, and Communications.
• The Company entered the Russell 2000 and 3000 Indices in June, which reflects the organization’s performance, growth, and value.
  

Second Quarter 2021 Financial Results

• Ocugen’s cash, cash equivalents, and restricted cash totaled $115.8 million as of June 30, 2021, compared to $24.2 million as of December 31, 2020. Ocugen had 198.7 million shares of common stock outstanding as of June 30, 2021.
• Research and development expenses for the three months ended June 30, 2021 were $18.9 million compared to $1.6 million for the three months ended June 30, 2020. Research and development expenses for the three months ended June 30, 2021 included a $15.0 million up-front payment to Bharat Biotech for the right and license to COVAXIN™ development, manufacturing, and commercialization in Canada. General and administrative expenses for the three months ended June 30, 2021 were $6.8 million compared to $1.8 million for the three months ended June 30, 2020. Ocugen reported a $0.13 net loss per share for the three months ended June 30, 2021 compared to a $0.19 net loss per share for the three months ended June 30, 2020.

Conference Call and Webcast Details

Ocugen has scheduled a conference call and webcast for 8:30 a.m. eastern time today to discuss the financial results and recent business highlights. Ocugen’s senior management team will host the call, which will be open to all listeners. There will also be a question-and-answer session following the prepared remarks.

The call can be accessed by dialing (844) 873-7330 (U.S.) or (602) 563-8473 (international) and providing the conference ID 6663619. To access a live audio webcast of the call on the “Investors” section of the Ocugen website, please click here. A replay of the webcast will be archived on Ocugen’s website for approximately 45 days following the call.

About Ocugen, Inc.
Ocugen, Inc. is a biopharmaceutical company focused on discovering, developing, and commercializing gene therapies to cure blindness diseases and developing?a vaccine to?save lives from COVID-19. Our breakthrough modifier gene therapy platform has the potential to treat multiple retinal diseases with one drug – “one to many” and our novel biologic product candidate aims to offer better therapy to patients with underserved diseases such as wet age-related macular degeneration, diabetic macular edema, and diabetic retinopathy.?We are co-developing Bharat Biotech’s COVAXIN™ vaccine candidate for COVID-19 in the U.S. and Canadian markets.?For more information, please visit www.ocugen.com.

Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such forward-looking statements include information about qualitative assessments of available data, potential benefits, expectations for clinical trials, and anticipated timing of clinical trial readouts and regulatory submissions. This information involves risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, including the risk that such dates are not met due to impacts from the ongoing COVID-19 pandemic, as well as risks associated with preliminary and interim data, including the possibility of unfavorable new clinical trial data and further analyses of existing clinical trial data; the risk that the results of in-vitro studies will not be duplicated in human clinical trials; the risk that clinical trial data are subject to differing interpretations and assessments, including during the peer review/publication process, in the scientific community generally, and by regulatory authorities; whether and when data from Bharat Biotech’s clinical trials will be published in scientific journal publications and, if so, when and with what modifications; whether we will be able to provide the U.S. Food and Drug Administration (“FDA”) with sufficient additional information regarding the design of and results from preclinical and clinical studies of COVAXIN™, which have been conducted by Bharat Biotech in India in order for those trials to support a Biologics License Application (“BLA”); the size, scope, timing and outcome of any additional trials or studies that we may be required to conduct to support a BLA; any additional chemistry, manufacturing, and controls information that we may be required to submit; the timing of our BLA filing; whether and when a BLA for COVAXIN™ will be submitted to the FDA; whether and when a BLA may be approved by the FDA, an application for authorization under the Interim Order for emergency use may be approved by Health Canada, or a New Drug Submission application may be approved by Health Canada, which authorizations or approvals will depend on myriad factors, including making a determination as to whether the vaccine candidate’s benefits outweigh its known risks and determination of the vaccine candidate’s efficacy and, if authorized or approved, whether it will be commercially successful; whether developments with respect to the COVID-19 pandemic will affect the regulatory pathway available for vaccines in the United States, Canada, or other jurisdictions; manufacturing capabilities, manufacturing capacity, and supply restrictions, including whether sufficient doses of COVAXIN™ can be manufactured or supplied within our projected time periods; market demand for COVAXIN™ in the United States or Canada; decisions by the FDA or Health Canada impacting labeling, manufacturing processes, safety, and/or other matters that could affect the availability or commercial potential of COVAXIN™ in the United States or Canada, including development of products or therapies by other companies. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (“SEC”), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events, or otherwise, after the date of this press release.

Ocugen Contact:
Ken Inchausti
Head, Investor Relations & Communications
+1 484 237 3398
ken.inchausti@ocugen.com

Please submit investor-related inquiries to: IR@ocugen.com

(tables to follow)

OCUGEN, INC.

CONSOLIDATED BALANCE SHEETS

(in thousands)

(Unaudited)

OCUGEN, INC.

CONSOLIDATED STATEMENTS OF OPERATIONS

(in thousands, except share and per share amounts)

(Unaudited)

 

Lineage Cell Therapeutics to Report Second Quarter 2021 Financial Results and Provide Business Update on August 12, 2021

 

CARLSBAD, Calif.–(BUSINESS WIRE)–Aug. 5, 2021– 

Lineage Cell Therapeutics, Inc.
 (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, today announced that it will report its second quarter 2021 financial and operating results on 
Thursday, August 12, 2021, following the close of the 
U.S. financial markets. Lineage management will also host a conference call and webcast on 
Thursday, August 12, 2021, at 
4:30 p.m. Eastern Time/
1:30 p.m. Pacific Time to discuss its second quarter 2021 financial and operating results and to provide a business update.

Interested parties may access the conference call by dialing (866) 888-8633 from the 
U.S. and 
Canada and (636) 812-6629 from elsewhere outside the 
U.S. and 
Canada and should request the “Lineage Cell Therapeutics Call”. A live webcast of the conference call will be available online in the Investors section of Lineage’s website. A replay of the webcast will be available on Lineage’s website for 30 days and a telephone replay will be available through 
August 22, 2021, by dialing (855) 859-2056 from the 
U.S. and 
Canada and (404) 537-3406 from elsewhere outside the 
U.S. and 
Canada and entering conference ID number 4876810. 

About Lineage Cell Therapeutics, Inc.

Lineage Cell Therapeutics is a clinical-stage biotechnology company developing allogeneic 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 subacute spinal cord injuries; and (iii) VAC2, an allogeneic dendritic cell therapy produced from Lineage’s VAC technology platform for immuno-oncology and infectious disease, currently in Phase 1 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.

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

Solebury Trout IR
Gitanjali Jain Ogawa
(Gogawa@soleburytrout.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 to Report Second Quarter 2021 Financial Results and Provide Business Update on August 12, 2021

 

CARLSBAD, Calif.–(BUSINESS WIRE)–Aug. 5, 2021– 

Lineage Cell Therapeutics, Inc.
 (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, today announced that it will report its second quarter 2021 financial and operating results on 
Thursday, August 12, 2021, following the close of the 
U.S. financial markets. Lineage management will also host a conference call and webcast on 
Thursday, August 12, 2021, at 
4:30 p.m. Eastern Time/
1:30 p.m. Pacific Time to discuss its second quarter 2021 financial and operating results and to provide a business update.

Interested parties may access the conference call by dialing (866) 888-8633 from the 
U.S. and 
Canada and (636) 812-6629 from elsewhere outside the 
U.S. and 
Canada and should request the “Lineage Cell Therapeutics Call”. A live webcast of the conference call will be available online in the Investors section of Lineage’s website. A replay of the webcast will be available on Lineage’s website for 30 days and a telephone replay will be available through 
August 22, 2021, by dialing (855) 859-2056 from the 
U.S. and 
Canada and (404) 537-3406 from elsewhere outside the 
U.S. and 
Canada and entering conference ID number 4876810. 

About Lineage Cell Therapeutics, Inc.

Lineage Cell Therapeutics is a clinical-stage biotechnology company developing allogeneic 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 subacute spinal cord injuries; and (iii) VAC2, an allogeneic dendritic cell therapy produced from Lineage’s VAC technology platform for immuno-oncology and infectious disease, currently in Phase 1 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.

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

Solebury Trout IR
Gitanjali Jain Ogawa
(Gogawa@soleburytrout.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.

TherapeuticsMD Announces Second Quarter 2021 Financial Results

 

– 2Q21 total net product revenue increased by 17% over 1Q21 to 
$23 million –

– ANNOVERA^® prescription growth supported by improved access to providers and increased telemedicine options for patients –

– Prescriptions for IMVEXXY® grew by 8% over 1Q21, outpacing the VVA market –

– 
Centers for Medicare and Medicaid Services recommended that ANNOVERA receive its own unique national J-Code that could be live as early as Q421 –

– vitaCare signed new customer and pipeline continues to grow –

– Conference call scheduled for 
8:30 a.m. ET today –

BOCA RATON, Fla.–(BUSINESS WIRE)–Aug. 4, 2021– 
TherapeuticsMD, Inc. (“TXMD” or the “Company”) (NASDAQ: TXMD), an innovative, leading women’s healthcare company, today reported financial results for the second quarter ended 
June 30, 2021.

“We continue to make steady progress in line with our expectations related to ANNOVERA and IMVEXXY driving prescription growth, net margins and broader patient access. Importantly, we are seeing improved access to health care providers for our sales force and expansion of our relationships in the telemedicine channel and believe we are well positioned to grow our products across all channels. Our overall volumes and net revenues were very healthy, and vitaCare prescription services is building the foundation for growth in the future. vitaCare recently signed its third customer contract and has a strong pipeline of more than 30 potential customers. In addition, we continue to evaluate investment into vitaCare, including potentially selling a minority stake, which could provide a non-dilutive source of capital for TXMD shareholders,” said  Robert G. Finizio, Chief Executive Officer of 
TherapeuticsMD.

Second Quarter 2021 Financial Results and Business Highlights

Net Product Revenue

		Three Months Ended
		June 30,						March 31,
		2021			2020			2021
ANNOVERA		$	9,555		$	1,835		$	8,750
IMVEXXY			9,838			5,086			7,012
BIJUVA			2,156			1,352			2,445
Prescription vitamin			1,452			2,428			1,425
Product revenue, net			23,001			10,701			19,632
License revenue			—			—			234
Total revenue, net		$	23,001		$	10,701		$	19,866

ANNOVERA (segesterone acetate and ethinyl estradiol vaginal system)

• ANNOVERA net product revenue of 
  $9.6 million for the second quarter of 2021 increased by 
  $7.7 million compared to 
  $1.8 million for the second quarter of 2020 and 
  $0.8 million compared to 
  $8.8 million for the first quarter of 2021.
• Net revenue per unit, calculated from sales to wholesalers and pharmacies, was 
  $1,157 for the second quarter of 2021.
• Approximately 7,299 ANNOVERA prescriptions were dispensed to patients during the second quarter of 2021. Prescriptions increased 202% compared to the second quarter of 2020 and 17% compared to the first quarter of 2021. Refill rates remained strong at approximately 50% for eligible patients.

IMVEXXY (estradiol vaginal inserts)

• IMVEXXY net product revenue of 
  $9.8 million for the second quarter of 2021 increased by 
  $4.8 million compared to 
  $5.1 million for the second quarter of 2020 and 
  $2.8 million compared to 
  $7.0 million for the first quarter of 2021.
• Net revenue per unit, calculated from sales to wholesalers and pharmacies, was 
  $64 for the second quarter of 2021, reflecting a 56% improvement in net price compared to the second quarter of 2020. This is the fourth consecutive quarter that IMVEXXY has achieved a record net revenue per unit.
• Approximately 117,000 IMVEXXY prescriptions were dispensed to patients during the second quarter of 2021. Total prescriptions increased by 8% from the first quarter of 2021. IMVEXXY fill rates remained above category averages at approximately 4.4 fills per year with over 20% of patients filling a 90-day supply.
• New telemedicine relationship with UpScript is designed to provide increased patient access to IMVEXXY with the potential to improve conversion to prescription in the online channel.
• The recently launched direct-to-consumer campaign for IMVEXXY, Long  May She Reign, has had a positive impact on both interest and engagement.

BIJUVA (estradiol and progesterone)

• BIJUVA net product revenue of 
  $2.2 million for the second quarter of 2021 increased by 
  $0.8 million compared to 
  $1.4 million for the second quarter of 2020 but decreased by 
  $0.3 million compared to 
  $2.4 million for the first quarter of 2021.
• Net revenue per unit, calculated from sales to wholesalers and pharmacies, was approximately 
  $68 for the second quarter of 2021.
• Approximately 31,900 BIJUVA prescriptions were dispensed to patients in the second quarter of 2021. Total prescriptions increased by 3.5% from the first quarter of 2021.
• BIJUVA received approval in seven European countries.
• BIJUVA 0.5/100 received a PDUFA date of 
  March 21, 2022.

Cost of Goods Sold and Gross Margin

• Cost of goods was 
  $4.1 million with gross margin of 82% for the second quarter of 2021 compared to 
  $4.4 million with gross margin of 59% for the second quarter of 2020 and 
  $4.7 million with gross margin of 76% for the first quarter of 2021. The improvement in the Company’s gross margin for the second quarter of 2021 from the second quarter of 2020 and first quarter of 2021 was mainly attributable to an inventory obsolescence charge in the second quarter of 2020 and the first quarter of 2021.

Operating Expense, Net Loss and Related Information

• Total operating expense of 
  $54.0 million for the second quarter of 2021 increased by 
  $2.7 million compared to 
  $51.3 million for the second quarter of 2020 and 
  $9.6 million compared to 
  $44.5 million for the first quarter of 2021.
• Net loss for the second quarter of 2021 was 
  $42.7 million, or 
  $0.11 per basic and diluted share, compared to net loss for the second quarter of 2020 of 
  $52.0 million, or 
  $0.19 per basic and diluted share, and net loss for the first quarter of 2021 of 
  $39.4 million, or 
  $0.11 per basic and diluted share.

Balance Sheet

• As of 
  June 30, 2021, the Company’s cash on hand totaled 
  $111.4 million, compared with 
  $80.5 million as of 
  December 31, 2020.
• For the first six months of 2021, the Company received 
  $151.1 million in net proceeds from its at-the-market and underwritten equity offerings. Subsequent to quarter-end, in 
  July 2021, the Company received an additional 
  $31.8 million in net proceeds from its at-the-market offering.
• As of 
  June 30, 2021, the remaining outstanding principal amount under the Company’s Financing Agreement was 
  $200.0 million, which reflects a repayment of 
  $50.0 million of principal during the first six months of 2021.

Conference Call and Webcast Details

TherapeuticsMD will host a conference call and live audio webcast today at 
8:30 a.m. ET to discuss these financial results and provide a business update.

Date:					Wednesday, August 4, 2021
Time:					8:30 a.m. ET
Telephone Access (US):					866-665-9531
Telephone Access (International):					724-987-6977
Access Code for All Callers:					7736027

A live webcast and audio archive for the event may be accessed on the home page or from the “Investors & Media” section of the 
TherapeuticsMD website at www.therapeuticsmd.com. Please connect to the website prior to the start of the presentation to ensure adequate time for any software downloads that may be necessary to listen to the webcast. A replay of the webcast will be archived on the website for at least 30 days. In addition, a digital recording of the conference call will be available for replay beginning two hours after the call’s completion and for at least 30 days with the dial-in 855-859-2056 or international 404-537-3406 and Conference ID: 7736027.

Please see the Full Prescribing Information, including indication and Boxed WARNING, for each 
TherapeuticsMD product as follows:

• IMVEXXY (estradiol vaginal inserts) at https://imvexxy.com/pi.pdf
• BIJUVA (estradiol and progesterone) capsules at https://www.bijuva.com/pi.pdf
• ANNOVERA (segesterone acetate and ethinyl estradiol vaginal system) at www.annovera.com/pi.pdf

Forward-Looking Statements

This press release by 
TherapeuticsMD, Inc. may contain forward-looking statements. Forward-looking statements may include, but are not limited to, statements relating to TherapeuticsMD’s objectives, plans and strategies as well as statements, other than historical facts, that address activities, events or developments that the company intends, expects, projects, believes or anticipates will or may occur in the future. These statements are often characterized by terminology such as “believes,” “hopes,” “may,” “anticipates,” “should,” “intends,” “plans,” “will,” “expects,” “estimates,” “projects,” “positioned,” “strategy” and similar expressions and are based on assumptions and assessments made in light of management’s experience and perception of historical trends, current conditions, expected future developments and other factors believed to be appropriate. Forward-looking statements in this press release are made as of the date of this press release, and the company undertakes no duty to update or revise any such statements, whether as a result of new information, future events or otherwise. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties, many of which are outside of the company’s control. Important factors that could cause actual results, developments and business decisions to differ materially from forward-looking statements are described in the sections titled “Risk Factors” in the company’s filings with the 
Securities and Exchange Commission, including its most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, as well as reports on Form 8-K, and include the following: the effects of the COVID-19 pandemic; the company’s ability to maintain or increase sales of its products; the company’s ability to develop and commercialize IMVEXXY®, ANNOVERA®, and BIJUVA® and obtain additional financing necessary therefor; whether the company will be able to comply with the covenants and conditions under its term loan facility; whether the company will be able to successfully divest, or obtain an investment in, its vitaCare business and how the proceeds that may be generated by any such divestiture or investment will be utilized; the potential of adverse side effects or other safety risks that could adversely affect the commercialization of the company’s current or future approved products or preclude the approval of the company’s future drug candidates; whether the FDA will approve the lower dose of BIJUVA; the company’s ability to protect its intellectual property, including with respect to the Paragraph IV notice letters the company received regarding IMVEXXY and BIJUVA; the length, cost and uncertain results of future clinical trials; the company’s reliance on third parties to conduct its manufacturing, research and development and clinical trials; the ability of the company’s licensees to commercialize and distribute the company’s products; the ability of the company’s marketing contractors to market ANNOVERA; the availability of reimbursement from government authorities and health insurance companies for the company’s products; the impact of product liability lawsuits; the influence of extensive and costly government regulation; the volatility of the trading price of the company’s common stock and the concentration of power in its stock ownership.

– Financial Statements to Follow –

TherapeuticsMD, Inc. and Subsidiaries
Consolidated Balance Sheets
(In thousands, except per share data)
		June 30, 2021				December 31, 2020
		(Unaudited)
Assets:
Current assets:
Cash		$	111,424			$	80,486
Accounts receivable, net of allowance for credit losses of  $1,273 and  $1,118 as of  June 30, 2021 and  December 31, 2020, respectively			33,481				32,382
Inventory			7,574				7,993
Prepaid and other current assets			7,178				7,543
Total current assets			159,657				128,404
Fixed assets, net			1,647				1,942
License rights and other intangible assets, net			40,206				41,445
Right of use assets			8,838				9,566
Other non-current assets			253				253
Total assets		$	210,601			$	181,610
Liabilities and stockholders’ equity (deficit):
Current liabilities:
Current maturities of long-term debt		$	10,000			$	—
Accounts payable			14,565				21,068
Accrued expenses and other current liabilities			51,110				38,170
Total current liabilities			75,675				59,238
Long-term debt, net			175,261				237,698
Operating lease liabilities			8,381				8,675
Other non-current liabilities			358				—
Total liabilities			259,675				305,611
Commitments and contingencies
Stockholders’ equity (deficit):
Preferred stock, par value  $0.001; 10,000 shares authorized, none issued			—				—
Common stock, par value  $0.001; 600,000 shares authorized, 395,048 and 299,765 issued and outstanding as of  June 30, 2021 and  December 31, 2020, respectively			395				300
Additional paid-in capital			911,511				754,644
Accumulated deficit			(960,980	)			(878,945	)
Total stockholders’ deficit			(49,074	)			(124,001	)
Total liabilities and stockholders’ equity (deficit)		$	210,601			$	181,610

TherapeuticsMD, Inc. and Subsidiaries
Consolidated Statements of Operations
(Unaudited – in thousands, except per share data)
		Three Months Ended												Six Months Ended
		June 30,								March 31,				June 30,
		2021				2020				2021				2021				2020
Product revenue, net		$	23,001			$	10,701			$	19,632			$	42,633			$	22,952
License revenue			—				—				234				234				—
Total revenue, net			23,001				10,701				19,866				42,867				22,952
Cost of goods sold			4,132				4,400				4,687				8,819				7,115
Gross profit			18,869				6,301				15,179				34,048				15,837
Operating expenses:															—
Selling and marketing			32,164				29,887				24,024				56,188				68,683
General and administrative			19,873				18,710				18,383				38,256				37,103
Research and development			2,011				2,742				2,050				4,061				6,011
Total operating expenses			54,048				51,339				44,457				98,505				111,797
Loss from operations			(35,179	)			(45,038	)			(29,278	)			(64,457	)			(95,960	)
Other (expense) income:
Interest expense and other financing costs			(7,596	)			(7,027	)			(10,227	)			(17,823	)			(13,289	)
Other income, net			123				89				122				245				424
Total other (expense), net			(7,473	)			(6,938	)			(10,105	)			(17,578	)			(12,865	)
Loss before income taxes			(42,652	)			(51,976	)			(39,383	)			(82,035	)			(108,825	)
Provision for income taxes			—				—				—				—				—
Net loss		$	(42,652	)		$	(51,976	)		$	(39,383	)		$	(82,035	)		$	(108,825	)
Loss per common share, basic and diluted		$	(0.11	)		$	(0.19	)		$	(0.11	)		$	(0.22	)		$	(0.40	)
Weighted average common shares, basic and diluted			394,074				271,876				347,219				370,776				271,668

TherapeuticsMD, Inc. and Subsidiaries
Consolidated Statements of Cash Flows
(Unaudited – in thousands)
		Six Months Ended  June 30,
		2021				2020
Cash flows from operating activities:
Net loss		$	(82,035	)		$	(108,825	)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization			2,061				2,019
Charges (credits) to provision for doubtful accounts			445				(182	)
Inventory charge			502				5,965
Debt financing fees			2,681				692
Non-cash operating lease expense, including impairment of  $81 for the six months ended  June 30, 2020			434				770
Share-based compensation			5,467				5,369
Changes in operating assets and liabilities:
Accounts receivable			(1,544	)			6,287
Inventory			(83	)			(4,277	)
Prepaid and other current assets			365				4,448
Accounts payable			(6,503	)			(1,911	)
Accrued expenses and other current liabilities			12,940				(5,420	)
Other non-current liabilities			358				—
Total adjustments			17,123				13,760
Net cash used in operating activities			(64,912	)			(95,065	)
Cash flows from investing activities:
Payment of patent related costs			(423	)			(816	)
Purchase of fixed assets			(104	)			(26	)
Net cash used in investing activities			(527	)			(842	)
Cash flows from financing activities:
Proceeds from sale of common stock, net of costs			151,062				—
Proceeds from exercise of options and warrants			299				166
Proceeds from sale of common stock related to employee stock purchase plan			134				—
Repayments of debt			(50,000	)			—
Borrowings of debt			—				50,000
Payment of debt financing fees			(5,118	)			(1,250	)
Net cash provided by financing activities			96,377				48,916
Net increase in cash			30,938				(46,991	)
Cash, beginning of period			80,486				160,830
Cash, end of period		$	111,424			$	113,839
Supplemental disclosure of cash flow information:
Interest paid		$	14,284			$	12,032

 

Edward J. Borkowski
Executive Vice President
561-961-1900

Lisa M. Wilson

In-Site Communications, Inc.
212-452-2793
lwilson@insitecony.com

Source: 
TherapeuticsMD, Inc.

TherapeuticsMD Announces Second Quarter 2021 Financial Results

 

– 2Q21 total net product revenue increased by 17% over 1Q21 to 
$23 million –

– ANNOVERA^® prescription growth supported by improved access to providers and increased telemedicine options for patients –

– Prescriptions for IMVEXXY® grew by 8% over 1Q21, outpacing the VVA market –

– 
Centers for Medicare and Medicaid Services recommended that ANNOVERA receive its own unique national J-Code that could be live as early as Q421 –

– vitaCare signed new customer and pipeline continues to grow –

– Conference call scheduled for 
8:30 a.m. ET today –

BOCA RATON, Fla.–(BUSINESS WIRE)–Aug. 4, 2021– 
TherapeuticsMD, Inc. (“TXMD” or the “Company”) (NASDAQ: TXMD), an innovative, leading women’s healthcare company, today reported financial results for the second quarter ended 
June 30, 2021.

“We continue to make steady progress in line with our expectations related to ANNOVERA and IMVEXXY driving prescription growth, net margins and broader patient access. Importantly, we are seeing improved access to health care providers for our sales force and expansion of our relationships in the telemedicine channel and believe we are well positioned to grow our products across all channels. Our overall volumes and net revenues were very healthy, and vitaCare prescription services is building the foundation for growth in the future. vitaCare recently signed its third customer contract and has a strong pipeline of more than 30 potential customers. In addition, we continue to evaluate investment into vitaCare, including potentially selling a minority stake, which could provide a non-dilutive source of capital for TXMD shareholders,” said  Robert G. Finizio, Chief Executive Officer of 
TherapeuticsMD.

Second Quarter 2021 Financial Results and Business Highlights

Net Product Revenue

		Three Months Ended
		June 30,						March 31,
		2021			2020			2021
ANNOVERA		$	9,555		$	1,835		$	8,750
IMVEXXY			9,838			5,086			7,012
BIJUVA			2,156			1,352			2,445
Prescription vitamin			1,452			2,428			1,425
Product revenue, net			23,001			10,701			19,632
License revenue			—			—			234
Total revenue, net		$	23,001		$	10,701		$	19,866

ANNOVERA (segesterone acetate and ethinyl estradiol vaginal system)

• ANNOVERA net product revenue of 
  $9.6 million for the second quarter of 2021 increased by 
  $7.7 million compared to 
  $1.8 million for the second quarter of 2020 and 
  $0.8 million compared to 
  $8.8 million for the first quarter of 2021.
• Net revenue per unit, calculated from sales to wholesalers and pharmacies, was 
  $1,157 for the second quarter of 2021.
• Approximately 7,299 ANNOVERA prescriptions were dispensed to patients during the second quarter of 2021. Prescriptions increased 202% compared to the second quarter of 2020 and 17% compared to the first quarter of 2021. Refill rates remained strong at approximately 50% for eligible patients.

IMVEXXY (estradiol vaginal inserts)

• IMVEXXY net product revenue of 
  $9.8 million for the second quarter of 2021 increased by 
  $4.8 million compared to 
  $5.1 million for the second quarter of 2020 and 
  $2.8 million compared to 
  $7.0 million for the first quarter of 2021.
• Net revenue per unit, calculated from sales to wholesalers and pharmacies, was 
  $64 for the second quarter of 2021, reflecting a 56% improvement in net price compared to the second quarter of 2020. This is the fourth consecutive quarter that IMVEXXY has achieved a record net revenue per unit.
• Approximately 117,000 IMVEXXY prescriptions were dispensed to patients during the second quarter of 2021. Total prescriptions increased by 8% from the first quarter of 2021. IMVEXXY fill rates remained above category averages at approximately 4.4 fills per year with over 20% of patients filling a 90-day supply.
• New telemedicine relationship with UpScript is designed to provide increased patient access to IMVEXXY with the potential to improve conversion to prescription in the online channel.
• The recently launched direct-to-consumer campaign for IMVEXXY, Long  May She Reign, has had a positive impact on both interest and engagement.

BIJUVA (estradiol and progesterone)

• BIJUVA net product revenue of 
  $2.2 million for the second quarter of 2021 increased by 
  $0.8 million compared to 
  $1.4 million for the second quarter of 2020 but decreased by 
  $0.3 million compared to 
  $2.4 million for the first quarter of 2021.
• Net revenue per unit, calculated from sales to wholesalers and pharmacies, was approximately 
  $68 for the second quarter of 2021.
• Approximately 31,900 BIJUVA prescriptions were dispensed to patients in the second quarter of 2021. Total prescriptions increased by 3.5% from the first quarter of 2021.
• BIJUVA received approval in seven European countries.
• BIJUVA 0.5/100 received a PDUFA date of 
  March 21, 2022.

Cost of Goods Sold and Gross Margin

• Cost of goods was 
  $4.1 million with gross margin of 82% for the second quarter of 2021 compared to 
  $4.4 million with gross margin of 59% for the second quarter of 2020 and 
  $4.7 million with gross margin of 76% for the first quarter of 2021. The improvement in the Company’s gross margin for the second quarter of 2021 from the second quarter of 2020 and first quarter of 2021 was mainly attributable to an inventory obsolescence charge in the second quarter of 2020 and the first quarter of 2021.

Operating Expense, Net Loss and Related Information

• Total operating expense of 
  $54.0 million for the second quarter of 2021 increased by 
  $2.7 million compared to 
  $51.3 million for the second quarter of 2020 and 
  $9.6 million compared to 
  $44.5 million for the first quarter of 2021.
• Net loss for the second quarter of 2021 was 
  $42.7 million, or 
  $0.11 per basic and diluted share, compared to net loss for the second quarter of 2020 of 
  $52.0 million, or 
  $0.19 per basic and diluted share, and net loss for the first quarter of 2021 of 
  $39.4 million, or 
  $0.11 per basic and diluted share.

Balance Sheet

• As of 
  June 30, 2021, the Company’s cash on hand totaled 
  $111.4 million, compared with 
  $80.5 million as of 
  December 31, 2020.
• For the first six months of 2021, the Company received 
  $151.1 million in net proceeds from its at-the-market and underwritten equity offerings. Subsequent to quarter-end, in 
  July 2021, the Company received an additional 
  $31.8 million in net proceeds from its at-the-market offering.
• As of 
  June 30, 2021, the remaining outstanding principal amount under the Company’s Financing Agreement was 
  $200.0 million, which reflects a repayment of 
  $50.0 million of principal during the first six months of 2021.

Conference Call and Webcast Details

TherapeuticsMD will host a conference call and live audio webcast today at 
8:30 a.m. ET to discuss these financial results and provide a business update.

Date:					Wednesday, August 4, 2021
Time:					8:30 a.m. ET
Telephone Access (US):					866-665-9531
Telephone Access (International):					724-987-6977
Access Code for All Callers:					7736027

A live webcast and audio archive for the event may be accessed on the home page or from the “Investors & Media” section of the 
TherapeuticsMD website at www.therapeuticsmd.com. Please connect to the website prior to the start of the presentation to ensure adequate time for any software downloads that may be necessary to listen to the webcast. A replay of the webcast will be archived on the website for at least 30 days. In addition, a digital recording of the conference call will be available for replay beginning two hours after the call’s completion and for at least 30 days with the dial-in 855-859-2056 or international 404-537-3406 and Conference ID: 7736027.

Please see the Full Prescribing Information, including indication and Boxed WARNING, for each 
TherapeuticsMD product as follows:

• IMVEXXY (estradiol vaginal inserts) at https://imvexxy.com/pi.pdf
• BIJUVA (estradiol and progesterone) capsules at https://www.bijuva.com/pi.pdf
• ANNOVERA (segesterone acetate and ethinyl estradiol vaginal system) at www.annovera.com/pi.pdf

Forward-Looking Statements

This press release by 
TherapeuticsMD, Inc. may contain forward-looking statements. Forward-looking statements may include, but are not limited to, statements relating to TherapeuticsMD’s objectives, plans and strategies as well as statements, other than historical facts, that address activities, events or developments that the company intends, expects, projects, believes or anticipates will or may occur in the future. These statements are often characterized by terminology such as “believes,” “hopes,” “may,” “anticipates,” “should,” “intends,” “plans,” “will,” “expects,” “estimates,” “projects,” “positioned,” “strategy” and similar expressions and are based on assumptions and assessments made in light of management’s experience and perception of historical trends, current conditions, expected future developments and other factors believed to be appropriate. Forward-looking statements in this press release are made as of the date of this press release, and the company undertakes no duty to update or revise any such statements, whether as a result of new information, future events or otherwise. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties, many of which are outside of the company’s control. Important factors that could cause actual results, developments and business decisions to differ materially from forward-looking statements are described in the sections titled “Risk Factors” in the company’s filings with the 
Securities and Exchange Commission, including its most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, as well as reports on Form 8-K, and include the following: the effects of the COVID-19 pandemic; the company’s ability to maintain or increase sales of its products; the company’s ability to develop and commercialize IMVEXXY®, ANNOVERA®, and BIJUVA® and obtain additional financing necessary therefor; whether the company will be able to comply with the covenants and conditions under its term loan facility; whether the company will be able to successfully divest, or obtain an investment in, its vitaCare business and how the proceeds that may be generated by any such divestiture or investment will be utilized; the potential of adverse side effects or other safety risks that could adversely affect the commercialization of the company’s current or future approved products or preclude the approval of the company’s future drug candidates; whether the FDA will approve the lower dose of BIJUVA; the company’s ability to protect its intellectual property, including with respect to the Paragraph IV notice letters the company received regarding IMVEXXY and BIJUVA; the length, cost and uncertain results of future clinical trials; the company’s reliance on third parties to conduct its manufacturing, research and development and clinical trials; the ability of the company’s licensees to commercialize and distribute the company’s products; the ability of the company’s marketing contractors to market ANNOVERA; the availability of reimbursement from government authorities and health insurance companies for the company’s products; the impact of product liability lawsuits; the influence of extensive and costly government regulation; the volatility of the trading price of the company’s common stock and the concentration of power in its stock ownership.

– Financial Statements to Follow –

TherapeuticsMD, Inc. and Subsidiaries
Consolidated Balance Sheets
(In thousands, except per share data)
		June 30, 2021				December 31, 2020
		(Unaudited)
Assets:
Current assets:
Cash		$	111,424			$	80,486
Accounts receivable, net of allowance for credit losses of  $1,273 and  $1,118 as of  June 30, 2021 and  December 31, 2020, respectively			33,481				32,382
Inventory			7,574				7,993
Prepaid and other current assets			7,178				7,543
Total current assets			159,657				128,404
Fixed assets, net			1,647				1,942
License rights and other intangible assets, net			40,206				41,445
Right of use assets			8,838				9,566
Other non-current assets			253				253
Total assets		$	210,601			$	181,610
Liabilities and stockholders’ equity (deficit):
Current liabilities:
Current maturities of long-term debt		$	10,000			$	—
Accounts payable			14,565				21,068
Accrued expenses and other current liabilities			51,110				38,170
Total current liabilities			75,675				59,238
Long-term debt, net			175,261				237,698
Operating lease liabilities			8,381				8,675
Other non-current liabilities			358				—
Total liabilities			259,675				305,611
Commitments and contingencies
Stockholders’ equity (deficit):
Preferred stock, par value  $0.001; 10,000 shares authorized, none issued			—				—
Common stock, par value  $0.001; 600,000 shares authorized, 395,048 and 299,765 issued and outstanding as of  June 30, 2021 and  December 31, 2020, respectively			395				300
Additional paid-in capital			911,511				754,644
Accumulated deficit			(960,980	)			(878,945	)
Total stockholders’ deficit			(49,074	)			(124,001	)
Total liabilities and stockholders’ equity (deficit)		$	210,601			$	181,610

TherapeuticsMD, Inc. and Subsidiaries
Consolidated Statements of Operations
(Unaudited – in thousands, except per share data)
		Three Months Ended												Six Months Ended
		June 30,								March 31,				June 30,
		2021				2020				2021				2021				2020
Product revenue, net		$	23,001			$	10,701			$	19,632			$	42,633			$	22,952
License revenue			—				—				234				234				—
Total revenue, net			23,001				10,701				19,866				42,867				22,952
Cost of goods sold			4,132				4,400				4,687				8,819				7,115
Gross profit			18,869				6,301				15,179				34,048				15,837
Operating expenses:															—
Selling and marketing			32,164				29,887				24,024				56,188				68,683
General and administrative			19,873				18,710				18,383				38,256				37,103
Research and development			2,011				2,742				2,050				4,061				6,011
Total operating expenses			54,048				51,339				44,457				98,505				111,797
Loss from operations			(35,179	)			(45,038	)			(29,278	)			(64,457	)			(95,960	)
Other (expense) income:
Interest expense and other financing costs			(7,596	)			(7,027	)			(10,227	)			(17,823	)			(13,289	)
Other income, net			123				89				122				245				424
Total other (expense), net			(7,473	)			(6,938	)			(10,105	)			(17,578	)			(12,865	)
Loss before income taxes			(42,652	)			(51,976	)			(39,383	)			(82,035	)			(108,825	)
Provision for income taxes			—				—				—				—				—
Net loss		$	(42,652	)		$	(51,976	)		$	(39,383	)		$	(82,035	)		$	(108,825	)
Loss per common share, basic and diluted		$	(0.11	)		$	(0.19	)		$	(0.11	)		$	(0.22	)		$	(0.40	)
Weighted average common shares, basic and diluted			394,074				271,876				347,219				370,776				271,668

TherapeuticsMD, Inc. and Subsidiaries
Consolidated Statements of Cash Flows
(Unaudited – in thousands)
		Six Months Ended  June 30,
		2021				2020
Cash flows from operating activities:
Net loss		$	(82,035	)		$	(108,825	)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization			2,061				2,019
Charges (credits) to provision for doubtful accounts			445				(182	)
Inventory charge			502				5,965
Debt financing fees			2,681				692
Non-cash operating lease expense, including impairment of  $81 for the six months ended  June 30, 2020			434				770
Share-based compensation			5,467				5,369
Changes in operating assets and liabilities:
Accounts receivable			(1,544	)			6,287
Inventory			(83	)			(4,277	)
Prepaid and other current assets			365				4,448
Accounts payable			(6,503	)			(1,911	)
Accrued expenses and other current liabilities			12,940				(5,420	)
Other non-current liabilities			358				—
Total adjustments			17,123				13,760
Net cash used in operating activities			(64,912	)			(95,065	)
Cash flows from investing activities:
Payment of patent related costs			(423	)			(816	)
Purchase of fixed assets			(104	)			(26	)
Net cash used in investing activities			(527	)			(842	)
Cash flows from financing activities:
Proceeds from sale of common stock, net of costs			151,062				—
Proceeds from exercise of options and warrants			299				166
Proceeds from sale of common stock related to employee stock purchase plan			134				—
Repayments of debt			(50,000	)			—
Borrowings of debt			—				50,000
Payment of debt financing fees			(5,118	)			(1,250	)
Net cash provided by financing activities			96,377				48,916
Net increase in cash			30,938				(46,991	)
Cash, beginning of period			80,486				160,830
Cash, end of period		$	111,424			$	113,839
Supplemental disclosure of cash flow information:
Interest paid		$	14,284			$	12,032

 

Edward J. Borkowski
Executive Vice President
561-961-1900

Lisa M. Wilson

In-Site Communications, Inc.
212-452-2793
lwilson@insitecony.com

Source: 
TherapeuticsMD, Inc.

electroCore to Present at the Canaccord Genuity Growth Conference

 

ROCKAWAY, NJ, 
Aug. 02, 2021 (GLOBE NEWSWIRE) — 
electroCore, Inc. (the “Company”), (NASDAQ: ECOR), a commercial-stage bioelectronic medicine company, today announced that its management team will give a corporate presentation and be available for virtual one-on-one meetings at the 
Canaccord Genuity Growth Conference. The conference is taking place virtually from 
August 10 – 12, 2021. Details for the presentation are as follows:

Canaccord Genuity Growth Conference:
Date: 
Thursday, August 12, 2021
Time: 
8:30 am EDT
Investors can register for the conference HERE.

Following the conference a webcast replay of the presentation will be available on the Investor section of the company’s website, www.electrocore.com.

About electroCore, Inc.
electroCore, Inc. is a commercial stage bioelectronic medicine company dedicated to improving patient outcomes through its non-invasive vagus nerve stimulation therapy platform, initially focused on the treatment of multiple conditions in neurology. The company’s current indications are the preventive treatment of cluster headache and migraine and the acute treatment of migraine and episodic cluster headache.

For more information, visit www.electrocore.com.

Investors:
Rich CockrellCG Capital
404-736-3838
ecor@cg.capital

or

Media Contact:
Jackie Dorsky
electroCore
908-313-6331
Jackie.dorsky@electrocore.com

electroCore to Present at the Canaccord Genuity Growth Conference

 

ROCKAWAY, NJ, 
Aug. 02, 2021 (GLOBE NEWSWIRE) — 
electroCore, Inc. (the “Company”), (NASDAQ: ECOR), a commercial-stage bioelectronic medicine company, today announced that its management team will give a corporate presentation and be available for virtual one-on-one meetings at the 
Canaccord Genuity Growth Conference. The conference is taking place virtually from 
August 10 – 12, 2021. Details for the presentation are as follows:

Canaccord Genuity Growth Conference:
Date: 
Thursday, August 12, 2021
Time: 
8:30 am EDT
Investors can register for the conference HERE.

Following the conference a webcast replay of the presentation will be available on the Investor section of the company’s website, www.electrocore.com.

About electroCore, Inc.
electroCore, Inc. is a commercial stage bioelectronic medicine company dedicated to improving patient outcomes through its non-invasive vagus nerve stimulation therapy platform, initially focused on the treatment of multiple conditions in neurology. The company’s current indications are the preventive treatment of cluster headache and migraine and the acute treatment of migraine and episodic cluster headache.

For more information, visit www.electrocore.com.

Investors:
Rich CockrellCG Capital
404-736-3838
ecor@cg.capital

or

Media Contact:
Jackie Dorsky
electroCore
908-313-6331
Jackie.dorsky@electrocore.com

Ocugen to Host Conference Call on Friday, August 6 at 8:30 a.m. ET to Discuss Second Quarter 2021 Financial Results and Provide Business Update

 

MALVERN, Pa., July 30, 2021 (GLOBE NEWSWIRE) — Ocugen, Inc. (NASDAQ: OCGN), a biopharmaceutical company focused on discovering, developing, and commercializing gene therapies to cure blindness diseases and developing a vaccine to save lives from COVID-19, today announced that it will host a conference call to discuss its second quarter 2021 financial results and provide a business update at 8:30 a.m. ET on Friday, August 6, 2021.

Ocugen will issue a pre-market earnings announcement on the same day. Investors are invited to participate on the call using the following details:

• Dial-In Number: (844) 873-7330 (U.S.) or (602) 563-8473 (international)
• Conference ID: 6663619
• Webcast: Available in the “Investors” section of the Ocugen website and archived for approximately 45 days following the call
  

About?Ocugen, Inc.
Ocugen, Inc. is a biopharmaceutical company focused on discovering, developing, and commercializing gene therapies to cure blindness diseases and developing?a vaccine to?save lives from COVID-19. Our breakthrough modifier gene therapy platform has the potential to treat multiple retinal diseases with one drug – “one to many” and our novel biologic product candidate aims to offer better therapy to patients with underserved diseases such as wet age-related macular degeneration, diabetic macular edema, and diabetic retinopathy.?We are co-developing Bharat Biotech’s COVAXIN™ vaccine candidate for COVID-19 in the U.S. and Canadian markets.?For more information, please visit www.ocugen.com.

Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties. Such forward-looking statements within this press release include, without limitation, the intended use of net proceeds from the registered direct offering. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from our current expectations, such as market and other conditions. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (the “SEC”), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events or otherwise, after the date of this press release.

Ocugen Contact: 
Ken Inchausti
Head, Investor Relations & Communications
IR@Ocugen.com 

Please submit investor-related inquiries to: IR@ocugen.com