electroCore Announces New Patent Expanding Claims Related to Delivery of Non-Invasive Vagus Nerve Stimulation Therapy Using Mobile Devices

ROCKAWAY, NJ, 
Sept. 15, 2021 (GLOBE NEWSWIRE) —  
electroCore, Inc. (Nasdaq: ECOR), a commercial-stage bioelectronic medicine company, today announced that the United States Patent and Trademark Office has issued US Patent No. 11,097,102 to electroCore, relating to devices, systems and methods integrated with, or coupled to, smartphones that allow patients to self-treat medical conditions, such as migraine headache, by electrical non-invasive stimulation of nerves. The ‘102 patent is the 8^th US patent issued to ECOR in the company’s mobile connectivity platform, with additional US and International matters pending.

electroCore is building a portfolio of Intellectual Property (IP) around smartphone-integrated and smartphone connected non-invasive therapy. This IP may provide a foundation for combining the company’s clinically proven non-invasive Vagus Nerve Stimulation (nVNS) with application-based digital health platforms that could enable health care providers to use Remote Patient Monitoring or Remote Therapeutic Monitoring reimbursement codes. That combination, in turn, may enable future business models and revenue streams for the company’s products.

“This latest patent supports our IP portfolio focused on using mobile phone systems and methods to deliver non-invasive therapy,” said JP Errico, founder, board member and investor of electroCore, and co-inventor of the new patent. “By merging smartphones and medical devices, we hope to change how external neuromodulation devices are configured to deliver therapy, creating the potential for connected devices and/or smartphones that can not only monitor biomarkers like EKGs and EEGs, but can actually deliver therapy, thereby expanding the potential reach of our platform non-invasive vagus nerve therapy to millions of patients across the globe.”

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, the acute treatment of migraine and episodic cluster headache, and paroxysmal hemicrania and hemicrania continua in adults.

For more information, visit www.electrocore.com.

About gammaCore™
gammaCore™ (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, the treatment of paroxysmal hemicrania and hemicrania continua in adults, 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 issuance of US and international patents providing expanded IP coverage; the possibility of future business models and revenue streams from the company’s potential combining of nVNS and smartphone or application-based technologies; the availability and impact of payer coverage, the potential of nVNS generally and gammaCore in particular 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

Data From Ongoing Clinical Trial Continues to Demonstrate a Single Administration of OpRegen® Can Provide Anatomical and Functional Improvements in Patients With Dry AMD With Geographic Atrophy

• First Reported Case of Retinal Tissue Restoration Showed Zero Growth of Atrophy at 33 Months
• Second Case of Retinal Tissue Restoration Exhibited a 10% Reduction in Atrophy Size at 8 Months
• Third Case of Retinal Restoration is 18 Letters Above Baseline at Last Available Time Point
• Average Difference in BCVA Between Treated and Untreated Eyes Was More Than Two ETDRS Lines (10.8 Letters Read) in Cohort 4 Patients at 9-12 Months Post-Treatment

CARLSBAD, Calif.–(BUSINESS WIRE)–Sep. 15, 2021– 

Lineage Cell Therapeutics, Inc.
 (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, today reported updated interim results from its ongoing, 24-patient Phase 1/2a clinical study of its lead product candidate, OpRegen. OpRegen is an investigational cell therapy consisting of allogeneic retinal pigment epithelium (RPE) cells, administered in a single surgery to the subretinal space, for the treatment of dry age-related macular degeneration (AMD) with geographic atrophy (GA). These updated results include a minimum of 9 months of follow-up in all 12 patients treated in Cohort 4, which as a group had better baseline vision and smaller areas of GA at baseline than earlier cohorts. Overall, in the study (N=24), OpRegen has been well tolerated to date and there have been no new, unexpected ocular or systemic adverse events or serious adverse events not previously reported.

“I am particularly encouraged by the OCT findings in the second retinal restoration patient. Based on historical growth patterns, we knew this patient was a slower progressor than many other patients enrolled, and therefore less likely to benefit from treatment. Despite this, we have been able to demonstrate a reduction in the atrophic area as quickly as 2 months post-treatment and a marked slowing of disease progression,” stated Jordi Monés, M.D., Ph.D., Director of the Institut de la Màcula and 
Barcelona Macula Foundation. “Further, even in patients with an incomplete coverage of OpRegen over the primary area of atrophy, we have observed resolution of not only lesions of iRORA (incomplete retinal pigment epithelial and outer retinal atrophy), but also resolution of areas with features of cRORA, which is a state of complete loss of the RPE and outer retinal tissue. Additionally, the structural benefits may help explain the improvement in visual acuity. I eagerly look forward to new data as they are collected.”

“While competing efforts are focused on reducing the growth rate of geographic atrophy, Lineage has reported several patients whose areas of atrophy have stabilized or reduced in size. These observations, which are present across clinically-meaningful periods, indicate a reversal of the degeneration of critical retinal tissue layers which support vision, consistent with the proposed mechanism of an RPE cell transplant. Importantly, all three of the patients exhibiting restoration had confirmed historic growth rate in these areas and these data have been collected using multiple imaging modalities. The durability of the improvements to visual acuity, when coupled with the clear structural improvements we’ve seen in patients which received fuller coverage of OpRegen across their GA, strongly suggest that cell therapy may be able to achieve therapeutic benefits that are beyond the reach of targeted drugs or antibodies,” added  Brian M. Culley, Lineage CEO. “We are extremely pleased that our data is moving in a positive direction with each interim update we provide. We will continue to collect follow up data and work towards a meeting with FDA to discuss key aspects of our program. Our objective with OpRegen is to demonstrate the potential for allogeneic cell therapy to deliver the best available clinical outcomes and apply our technology to additional areas such as cancer, spinal cord injury, and other attractive opportunities.”

OpRegen Phase 1/2a Interim Clinical Results

• Overall, 8/12 (67%) of the Cohort 4 patients’ treated eyes were at or above baseline visual acuity at their last assessment, based on per protocol scheduled visits ranging from 9 months to over 3 years post-transplant. Conversely, 9/12 (75%) of the patients’ untreated eyes were below baseline visual acuity at that assessment.
• Improvement in best corrected visual acuity (BCVA) reached up to +24 letters on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart for a Cohort 4 patient.
• Comparing all treated eyes to all fellow (untreated) eyes showed an average difference of 10.8 letters read in Cohort 4 patients at their last assessment.
• In those Cohort 4 patients with a benefit in treated as compared with fellow eye (10/12), the average difference between treated and untreated eyes was 13.6 letters read at the last assessment, which exceeded 3 years post-transplant for some patients.
• Among the six Cohort 4 patients treated between September and 
  November 2020, three (50%) continue to exhibit marked improvements in BCVA, ranging from +5 to +18 to +24 letters read at the patient’s last scheduled assessment, which was at least 9 months post-transplant.
• Among the other three Cohort 4 patients treated in the Fall of 2020, one patient showed a gain of +1 letter read and two patients measured -2 and -6 letters below baseline at their last assessment.
• Across the study, in patients with previously reported structural improvements in the retina, decreases in drusen density, and a trend toward slower GA progression in treated compared to untreated eyes have continued to be present.
• Evidence of durable engraftment of OpRegen RPE cells has extended to more than 5 years in the earliest treated patients, supporting the potential for OpRegen to be a one-time treatment.

Retinal Tissue Restoration Update

• Three patients with evidence of retinal restoration and confirmed history of GA growth continue to demonstrate areas of retinal restoration as of their last per protocol assessments, ranging from 9 months to 33 months following treatment.
• The first Cohort 4 patient with evidence of retinal restoration and confirmed history of GA growth, demonstrated zero growth in atrophy (GA) 33 months following treatment with OpRegen.
• The second patient with evidence of restoration of critical retinal structures showed a 10% reduction at approximately 8 months after treatment, as assessed by square root transformation (SQRT).
  • Based on historical images of the patient’s treated eye taken ~2 years prior to treatment, the area of GA had increased from approximately 2.39 mm to approximately 2.81 mm at baseline.
  • Following OpRegen transplantation, the atrophic lesion measured approximately 2.28 mm at the patient’s month 2 per protocol assessment visit, which was smaller than the historical size of 2.39 mm from the image taken ~2 years prior to treatment.
  • Additional follow-up showed the lesion size calculated as approximately 2.53 mm at the patient’s month 8 per protocol assessment visit, which continued to be smaller than baseline.
• The third case of restoration demonstrated clinically meaningful improvements in visual acuity, having gained +18 letters on the ETDRS chart since OpRegen transplantation, supporting the view that the changes in retinal structure observable on Optical Coherence Tomography (OCT) can result in functional benefit.

As previously described, outer retinal layer restoration was observed using clinical high-resolution OCT. To be considered as suggestive of retinal restoration, new areas of RPE monolayer with overlying ellipsoid zone, external limiting membrane, and outer nuclear layer, which were not present at the time of baseline assessment, had to be present post-treatment with OpRegen. These findings, observed in 3 Cohort 4 patients, suggest integration of the new RPE cells with functional photoreceptors in areas that previously showed no presence of these cells. These effects were most prominent in the transitional areas around the primary area of atrophy. The use of OCT allows for a more precise determination of changes in retinal thickness, organization, and overall health of the retina in areas of potential atrophy, benefits which are possible with cell transplant therapy.

The loss of RPE cells over time creates progressively larger areas of atrophy in the adult retina, leading to impaired vision or complete blindness, a condition known as atrophic AMD. Humans lack the innate ability to regenerate retinal tissue and replace lost retina cells, which led to a presumption that progression of GA may someday be slowed or halted but could not be reversed. The unique findings from the ongoing OpRegen clinical study support a different view, in which an RPE cell transplant can potentially replace or rescue retinal cells in patients who suffer from retinal lesions or degeneration. The totality of these findings supports the view that atrophic AMD is not an irreversible, degenerative condition and that some portion of diseased retinal tissue may be recoverable.

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 BCVA of 20/200 or worse. The fourth cohort enrolled 12 better vision patients (BCVA from 20/65 to 20/250 with smaller mean areas of GA). 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. OpRegen has been well tolerated to date and there have been no new, unexpected ocular or systemic adverse events or serious adverse events that have not been previously reported. OpRegen is a registered trademark of 
Cell Cure Neurosciences Ltd., a majority-owned subsidiary of 
Lineage Cell Therapeutics, Inc.

About Age-Related Macular Degeneration
Age-related macular degeneration (AMD) is an eye disease that can blur the sharp, central vision in patients and is the leading cause of vision loss in people over the age of 60. There are two forms of AMD: dry (atrophic) AMD and wet (neovascular) AMD. Dry (atrophic) AMD is the more common of the two forms, accounting for approximately 85-90% of all cases. In atrophic AMD, parts of the macula get thinner with age and accumulations of extracellular material between Bruch’s membrane and the RPE, known as drusen, increase in number and volume, leading to a progressive loss of central vision, typically in both eyes. Global sales of the two leading wet AMD therapies were in excess of 
$10 billion in 2019. Nearly all cases of wet AMD eventually will develop the underlying atrophic AMD if the newly formed blood vessels are treated correctly. There are currently no 
U.S. Food and Drug Administration (FDA), or 
European Medicines Agency, approved treatment options available for patients with atrophic 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) 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.

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,” “can,” “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 benefits of treatment with OpRegen in dry AMD patients with GA, the significance of clinical data reported to date from the ongoing Phase 1/2a study of OpRegen, including the findings of retinal tissue restoration, Lineage plans to meet with the FDA to discuss OpRegen’s clinical development, the potential utilization of OCT imaging to measure efficacy in a pivotal clinical trial of OpRegen for the treatment of dry AMD with GA, and the potential for Lineage’s investigational allogeneic cell therapies to provide safe and effective treatment for multiple, diverse serious or life threatening conditions. 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 (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 most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q filed with the 
SEC 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@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.

electroCore Announces New Patent Expanding Claims Related to Delivery of Non-Invasive Vagus Nerve Stimulation Therapy Using Mobile Devices

ROCKAWAY, NJ, 
Sept. 15, 2021 (GLOBE NEWSWIRE) —  
electroCore, Inc. (Nasdaq: ECOR), a commercial-stage bioelectronic medicine company, today announced that the United States Patent and Trademark Office has issued US Patent No. 11,097,102 to electroCore, relating to devices, systems and methods integrated with, or coupled to, smartphones that allow patients to self-treat medical conditions, such as migraine headache, by electrical non-invasive stimulation of nerves. The ‘102 patent is the 8^th US patent issued to ECOR in the company’s mobile connectivity platform, with additional US and International matters pending.

electroCore is building a portfolio of Intellectual Property (IP) around smartphone-integrated and smartphone connected non-invasive therapy. This IP may provide a foundation for combining the company’s clinically proven non-invasive Vagus Nerve Stimulation (nVNS) with application-based digital health platforms that could enable health care providers to use Remote Patient Monitoring or Remote Therapeutic Monitoring reimbursement codes. That combination, in turn, may enable future business models and revenue streams for the company’s products.

“This latest patent supports our IP portfolio focused on using mobile phone systems and methods to deliver non-invasive therapy,” said JP Errico, founder, board member and investor of electroCore, and co-inventor of the new patent. “By merging smartphones and medical devices, we hope to change how external neuromodulation devices are configured to deliver therapy, creating the potential for connected devices and/or smartphones that can not only monitor biomarkers like EKGs and EEGs, but can actually deliver therapy, thereby expanding the potential reach of our platform non-invasive vagus nerve therapy to millions of patients across the globe.”

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, the acute treatment of migraine and episodic cluster headache, and paroxysmal hemicrania and hemicrania continua in adults.

For more information, visit www.electrocore.com.

About gammaCore™
gammaCore™ (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, the treatment of paroxysmal hemicrania and hemicrania continua in adults, 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 issuance of US and international patents providing expanded IP coverage; the possibility of future business models and revenue streams from the company’s potential combining of nVNS and smartphone or application-based technologies; the availability and impact of payer coverage, the potential of nVNS generally and gammaCore in particular 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

PDS Biotech Reports An Inducement Grant Under NASDAQ Listing Rule 5635(c)(4)

FLORHAM PARK, N.J., Sept. 15, 2021 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing novel cancer therapies based on the Company’s proprietary Versamune® T-cell activating technology, today announced that the compensation committee of the board of directors of the Company approved, on September 13, 2021, an equity award to Gregory Reid, the Company’s new VP of Program Development, as a material inducement to Mr. Reid entering into employment with PDS Biotech.

Prior to joining PDS Biotech, Mr. Reid amassed more than 30 years of experience in the pharmaceutical industry, primarily in drug development. Mr. Reid has worked extensively with biotech firms, successfully bringing several novel molecules targeting oncology and anti-fungal therapies from the bench through development. Internationally, Mr. Reid led many drug development programs in North America, Europe and Asia. Mr. Reid holds a M.Sc. in immunology from McGill University and an MBA from the John Molson School of Business at Concordia University, and is the author of more than 20 peer-reviewed manuscripts and abstracts.

“Greg brings a breadth of experience to PDS Biotech to support the advancement of the company’s innovative pipeline,” said PDS Biotech CEO, Frank Bedu-Addo. “He is an expert in oncology product development.”

An inducement grant of 63,800 shares of PDS Biotech’s common stock, in accordance with Nasdaq Listing Rule 5635(c)(4), was awarded as part of Mr. Reid’s compensation. The awards were granted under PDS Biotech’s 2019 Inducement Plan, as amended, in accordance with Nasdaq Listing Rule 5635(c)(4) and provides for the granting of equity awards to new employees of PDS Biotech. The option award has an exercise price of $14.99, the closing price of PDS Biotech’s common stock on September 13, 2021. The option award vests over a four-year period, with one-quarter of the shares vesting on the first anniversary of the grant date (September 13, 2022) and then monthly over the following 36 months, subject to continued employment with the company through the applicable vesting dates.

About PDS Biotechnology

PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of cancer immunotherapies based on the Company’s proprietary Versamune® T-cell activating technology platform. Our Versamune®-based products have demonstrated the potential to overcome the limitations of current immunotherapy by inducing in vivo, large quantities of high-quality, highly potent polyfunctional tumor specific CD4+ helper and CD8+ killer T-cells. PDS Biotech has developed multiple therapies, based on combinations of Versamune® and disease-specific antigens, designed to train the immune system to better recognize diseased cells and effectively attack and destroy them.  The company’s pipeline products address various cancers including breast, colon, lung, prostate and ovarian cancers.  To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.

Forward Looking Statements

This communication contains forward-looking statements (including within the meaning of Section 21E of the United States Securities Exchange Act of 1934, as amended, and Section 27A of the United States Securities Act of 1933, as amended) concerning PDS Biotechnology Corporation (the “Company”) and other matters. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the Company’s management, as well as assumptions made by, and information currently available to, management. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” “forecast,” “guidance”, “outlook” and other similar expressions among others. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the Company’s ability to protect its intellectual property rights; the Company’s anticipated capital requirements, including the Company’s anticipated cash runway and the Company’s current expectations regarding its plans for future equity financings; the Company’s dependence on additional financing to fund its operations and complete the development and commercialization of its product candidates, and the risks that raising such additional capital may restrict the Company’s operations or require the Company to relinquish rights to the Company’s technologies or product candidates; the Company’s limited operating history in the Company’s current line of business, which makes it difficult to evaluate the Company’s prospects, the Company’s business plan or the likelihood of the Company’s successful implementation of such business plan; the timing for the Company or its partners to initiate the planned clinical trials for PDS0101, PDS0203 and other Versamune® based products; the future success of such trials; the successful implementation of the Company’s research and development programs and collaborations, including any collaboration studies concerning PDS0101, PDS0203 and other Versamune® based products and the Company’s interpretation of the results and findings of such programs and collaborations and whether such results are sufficient to support the future success of the Company’s product candidates; the success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including our ability to fully fund our disclosed clinical trials, which assumes no material changes to our currently projected expenses), futility analyses, presentations at conferences and data reported in an abstract, and receipt of interim results, which are not necessarily indicative of the final results of the Company’s ongoing clinical trials;  any Company statements about its understanding of product candidates mechanisms of action and interpretation of preclinical and early clinical  results from its clinical development programs and any collaboration studies; the acceptance by the market of the Company’s product candidates, if approved; the timing of and the Company’s ability to obtain and maintain U.S. Food and Drug Administration or other regulatory authority approval of, or other action with respect to, the Company’s product candidates; and other factors, including legislative, regulatory, political and economic developments not within the Company’s control, including unforeseen circumstances or other disruptions to normal business operations arising from or related to COVID-19. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the risk factors included in the Company’s annual and periodic reports filed with the SEC. The forward-looking statements are made only as of the date of this press release and, except as required by applicable law, the Company undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise.

Media & Investor Relations Contact:

Deanne Randolph

PDS Biotech

Phone: +1 (908) 517-3613

Email: drandolph@pdsbiotech.com

Rich Cockrell

CG Capital

Phone: +1 (404) 736-3838

Email: rich@cg.capital