electroCore Completes Sale of New Jersey Tax Benefits

News and Market Data on electroCore

ROCKAWAY, N.J., 
April 26, 2022 (GLOBE NEWSWIRE) — 
electroCore, Inc. (Nasdaq: ECOR), a commercial-stage bioelectronic medicine company, today announced that it has completed the sale of its available tax benefits through the New Jersey Economic Development Authority’s Technology Business Tax Certificate Transfer program for fiscal year 2021. As a result, the Company has received approximately 
$445,000 in non-dilutive cash from the sale of these net operating loss (NOL) tax benefits.

“We are pleased to have received 
$445,000 from the New Jersey NOL program,” commented  Brian Posner, Chief Financial Officer of electroCore. “This is the third consecutive year that we have benefited from this program which provides us non-dilutive funding that will be beneficial to us as we continue to invest in our sales channels and marketing initiatives to expand consumer awareness of gammaCore.”

The New Jersey Technology Business Tax Certificate Transfer program enables qualified, unprofitable NJ-based technology or biotechnology companies with fewer than 225 US employees (including parent company and all subsidiaries) to sell a percentage of their NOL and research and development tax credits to unrelated profitable corporations. NOLs may be sold for at least 80 percent of their value, up to a maximum lifetime benefit of 
$20 million per business. This allows qualifying technology and biotechnology companies with NOLs to turn tax losses and credits into cash proceeds to fund their growth and operations, including research and development or other allowable expenditures.

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, the acute and preventive treatment of migraines in adolescents, 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 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 is 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, and paroxysmal hemicrania and hemicrania continua in 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:

• Adolescent patients with congenital cardiac issues
• 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

For more information, please visit gammaCore.com

Forward-Looking Statements
This press release 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 regarding electroCore’s business prospects, its sales and marketing and product development plans, future cash flow projections, anticipated costs, its product portfolio or potential markets for its technologies, the availability and impact of payor coverage, the potential of nVNS generally and gammaCore in particular to treat COVID-19, and other statements that are not historical in nature, particularly those using terminology such as “anticipates,” “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 obtain additional financing necessary to continue electroCore’s business, sales and marketing and product development plans, the uncertainties inherent in the development of new products or technologies, the ability to successfully commercialize gammaCore™, competition in the industry in which electroCore operates and general market conditions. All forward-looking statements are made as of the date of this press release, and electroCore undertakes no obligation to update 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 refer to all information set forth in this document and should also refer to the disclosure of risk factors set forth in the reports and other documents electroCore files with the
SEC, available at www.sec.gov.

Contact:
Rich Cockrell

CG Capital
404-736-3838
ecor@cg.capital

Image Credit: Peter Murphy (Flickr)

Latest Trials Confirm the Benefits of MDMA – the Drug in Ecstasy – for Treating PTSD

For people with post-traumatic stress disorder, recalling memories of physical or sexual assault, combat or disaster-related events can induce intense anxiety or panic attacks as well as debilitating flashbacks.

In the U.S., about 7% of people suffer from PTSD and lose an average of about four working days each month as a result. Trauma-specific psychotherapy, like cognitive processing or “talk” therapy, is the cornerstone of treatment for PTSD. But for approximately half of people, these traditional approaches are ineffective at fully addressing PTSD symptoms over the long term. Antidepressant drugs are frequently used if psychotherapy fails, or in combination with it, but the effects are usually modest.

MDMA (3,4-methylenedioxymethamphetamine) is an active ingredient in the illicit street drug known as ecstasy or molly. People in dance clubs and raves use illicit MDMA because it elevates mood and energy levels, induces a feeling of bonding with others and produces a surreal psychedelic effect. These same effects have been hypothesized to support people with PTSD during psychotherapy sessions, since they can make people more willing and able to share and explore their traumatic experiences. Our new meta-analysis of clinical trials confirms the benefits of MDMA-assisted psychotherapy in the treatment of PTSD.

We are a pharmacist and physician team who investigate the benefits and harms associated with substances of abuse like bath salts, phenibut, cannabis and synthetic marijuana. Through this work we have become intrigued about the therapeutic potential for some psychedelic drugs in the treatment of myriad psychiatric disorders, from PTSD to major depression, especially MDMA and psilocybin (hallucinogenic mushrooms).

It is important to state that using ecstasy or molly products from the street would not help PTSD symptoms because the MDMA needs be used along with carefully crafted psychotherapy in a safe, controlled environment. Ecstasy or molly products purchased illicitly never specify the exact amount of MDMA they contain, so it is impossible to dose it properly for PTSD. Taking too much MDMA or exercising while taking MDMA can cause heart attacks, strokes, seizures and arrhythmias and can damage muscles and kidneys.

What is MDMA-Assisted Psychotherapy?

In an MDMA-assisted psychotherapy session, patients take MDMA as a pill upon entering a psychiatrist’s office and then work with a team of therapists who help them divulge traumatic events or discuss aspects of those events over the course of several hours. They usually have non-MDMA sessions before the first MDMA session so they know what to expect. And they have at least one non-MDMA session after each MDMA one to work through the traumatic memories that were revealed and to learn coping strategies. A standard treatment course includes two or three multi-hour MDMA-assisted psychotherapy sessions and several non-MDMA sessions.

The MDMA products used in these sessions are pharmaceutical grade. This means that, unlike illicitly obtained street products, they do not contain other substances of abuse, such as methamphetamine, or contaminants like heavy metals, bacteria or mold. People with hypertension or those at high risk of heart attacks, strokes or arrhythmias should not participate, because they can have unsafe elevations in blood pressure and heart rate. In addition, patients are not allowed to leave for eight hours, until the effects of MDMA have fully worn off.

Assessing the Effectiveness of MDMA-Assisted Psychotherapy

In 2014, we reviewed the available animal data and the few preliminary human studies of MDMA-assisted psychotherapy, but at the time, higher-quality clinical trials had not yet been completed. But in the past few years, larger and higher-quality trials have been published, warranting an in-depth assessment.

So we recently reviewed the data comparing antidepressant use to placebos for patients with PTSD and performed a meta-analysis study of the six different clinical trials that assessed the usefulness of MDMA-assisted psychotherapy versus psychotherapy alone. All of the trials we analyzed included both men and women who had experienced a multitude of traumatic events that led to PTSD. The studies used the same points scale to determine the effectiveness of therapy, making it easier to compare data across studies. Scores above approximately 50 points mean a patient has severe PTSD, and scores reduced by more than 10 points from baseline are clinically meaningful.

We found that daily antidepressant therapy reduced PTSD by 6 to 14 points compared with the placebo, but a range of 27% to 47% of patients across the studies withdrew before the end of the trials. In contrast, MDMA-assisted psychotherapy reduced the scores by 22 points compared with those receiving psychotherapy with placebo, and patients were twice as likely to no longer meet the criteria for PTSD diagnosis by the end of the trials. In addition, only 8% of patients withdrew from MDMA-assisted psychotherapy trials. The main adverse effects included teeth grinding, jitteriness, headache and nausea. One of these MDMA trials found that participants’ blood pressure and heart rate were elevated in the course of MDMA therapy, but not to a concerning extent.

For several of the trials in our meta-analysis, investigators sent a questionnaire to participants 12 months after their last MDMA session to assess the long-term impact. Overall, 86% of participants said they received substantial benefits from the combined MDMA-assisted psychotherapy. Eighty-four percent of participants reported having improved feelings of well-being, 71% had fewer nightmares, 69% had less anxiety and 66% had improved sleep. The results from across all of the studies suggested that MDMA-assisted therapy was helping to alleviate the PTSD itself, not simply suppressing symptoms.

Looking Ahead

The U.S. Drug Enforcement Administration identifies MDMA and psilocybin as Schedule I controlled substances. According to the DEA, these substances have no currently accepted medical use in the U.S. and come with high abuse potential.

However, it’s worth noting an important exception. Cannabadiol, or CBD, a chemical that comes from the plant Cannabis sativa, is classified as a Schedule I drug. But the Food and Drug Administration approved its use in 2018 for the treatment of two rare and severe childhood seizure disorders. That doesn’t mean that the CBD in your lotion or seltzer has proof of benefit for most of the ills people are using it for, but its full therapeutic potential is still being explored. Given the strong consistent beneficial effects and manageable adverse events in the newer trials designed with FDA input, we suspect that MDMA-assisted psychotherapy will become an FDA-approved option for PTSD by the end of 2023. Psilocybin – commonly known as hallucinogenic mushrooms – also shows promise for treating major depression, but further research is needed.

The DEA’s stringent policies made it exceptionally hard for scientists to conduct research on Schedule I drugs for decades by criminalizing the possession of the products, even in research settings. But in 2018, the agency streamlined the application process for securing a waiver for research purposes. This made it easier for researchers to conduct trials into the pharmaceutical value of psychedelic drugs. Within the next decade, this shift will almost certainly accelerate the discovery of new treatments for patients suffering from mental illness.

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