electroCore Announces Exclusive License Agreement with Teijin for Japan Territory

News and Market Data on electroCore

 

ROCKAWAY, N.J., 
April 05, 2022 (GLOBE NEWSWIRE) — 
electroCore, Inc. (the “Company”), (NASDAQ: ECOR), a commercial-stage bioelectronic medicine company, today announced it has entered into an agreement with Teijin Limited (Teijin), a global conglomerate based in 
Japan offering advanced solutions in the fields including healthcare, material and information technology, to license certain exclusive rights to its non-invasive vagus nerve stimulation (nVNS) technology for commercialization in 
Japan for a range of primary headache disorders. 

Under the agreement, the Company will receive a non-refundable, upfront payment for the licenses and rights granted to Teijin. The financial terms contain milestone payments, payable upon the decision by Teijin to commercialize the licensed product for specific indications. The Company also will receive an annual license fee commencing on the first anniversary of the agreement and payable annually until the first commercial sale on any approved indication. Upon favorable regulatory and payor coverage decisions in 
Japan, the parties will enter into an exclusive commercial supply agreement for gammaCore nVNS. 

“We are delighted to enter into this exclusive license agreement with Teijin, a multinational life sciences company,” mentioned  Joshua Lev, Chief Strategy Officer of the Company. “Teijin is an ideal partner to drive commercialization of nVNS in 
Japan, and this agreement provides another global milestone for our nVNS platform technology, supporting a combined goal of improving the health and lives of primary headache sufferers across the globe.” 

The agreement contains customary terms and conditions, including renewal and termination provisions, as well as minimum purchase commitments once a commercial supply agreement is in place. Furthermore, Teijin is responsible for all costs associated with regulatory approval by the 
Pharmaceuticals and Medical Devices Agency (PMDA), the Japanese FDA equivalent. As part of the agreement, Teijin will have the right of first negotiation for a license to additional indications in Japan. 

About the Teijin Group
Teijin (TSE: 3401) is a technology-driven global group offering advanced solutions in the areas of environmental value; safety, security and disaster mitigation; and demographic change and increased health consciousness. Its main fields of operation are high-performance fibers such as aramid, 
carbon fibers & composites, healthcare, films, resin & plastic processing, polyester fibers, products converting and IT. The group has over 170 companies and around 20,000 employees spread out over 20 countries worldwide. It posted consolidated sales of 
JPY836.5 billion (
USD 6.8 billion) and total assets of 
JPY 1036.4 billion (
USD 8.4 billion) in the fiscal year ending 
March 31, 2021. 

For more information, please visit https://www.teijin.com/www.teijin.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, 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 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 (including with respect to enrollment in ongoing studies); its pipeline or potential markets for its technologies; the timing, outcome and impact of regulatory, clinical and commercial developments including online, e-commerce, direct-to-consumer channels, telehealth portal, and cash pay initiatives including 
Japan and its license agreement with Teijin; the issuance of 
U.S. and international patents providing expanded IP coverage; the possibility of future business models and revenue streams from the company’s potential use of nVNS for the acute treatment of PTSD, stroke and hemorrhagic brain injury, 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.

Contact:
Rich Cockrell

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

Monday, April 04, 2022

GABY Inc. (GABLF)
GABY Inc.: Focused on California Cannabis Consolidation

Gaby Inc is a wellness company that is engaged in the marketing of a variety of cannabis products, including flowers, concentrates, pre-rolls, edibles, topicals, tinctures, and other products. Some of its brands are Mankind, Sonoma Pacific, 2Rise, Lulu’s, and the Kind Republic. The company operates in two segments, namely licensed and unlicensed channels, both of which are in the manufacturing, distribution, and marketing of wellness products to address a variety of dietary and health concerns. All of its revenue comes from the United States.

Joe Gomes, Senior Research Analyst, Noble Capital Markets, Inc.

Joshua Zoepfel, Research Associate, Noble Capital Markets, Inc.

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

Initiating Coverage. We are initiating research coverage on GABY Inc. GABY Inc. is a California-focused cannabis retail consolidator and the owner of San Diego-based Mankind Dispensary, one of the oldest and largest licensed dispensaries in the state. With significant organic and inorganic growth opportunities, we believe GABLF shares present an attractive risk/reward situation.

Focus on California Consolidation.  GABY’s overarching strategy is to consolidate dispensaries in California. The Company’s first step was the April 2021 acquisition of Mankind Dispensary. The California market remains highly fragmented. No brand owns more than 2.5% of the retail dispensary locations and 4% of overall market share. Ripe for consolidation, in our view …

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, April 04, 2022

Baudax Bio (BXRX)
Chairman Announces Resignation

Baudax Bio is a biopharmaceutical company focused on developing therapies for post-operative pain, peri-operative pain, and anesthesia. The company currently has one approved therapy in ANJESO for post-operative pain. Proprietary ANJESO (meloxicam) injection is the first and only once-daily IV analgesic. The company also has a pipeline of early-stage candidates with two novel neuromuscular blocking agents (NMBAs), a proprietary related reversal agent to their NMBAs, and Dex-IN, an intranasal formulation of dexmedetomidine (Dex) that has sedative, analgesic, and anti-anxiety properties.

Gregory Aurand, Senior Research Analyst, Healthcare Services & Medical Devices, Noble Capital Markets, Inc.

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

Resignation announced.  Chairman of the Board of Directors Alfred Altomari announced March 30, 2022, that he was intending to resign. Mr. Altomari has been a director at Baudax Bio since 2019, and was a prior member of the Recro Pharma Board (Recro spun out Baudax Bio to shareholders in 2019). Mr. Altomari has extensive pharmaceutical experience and is currently Chairman and CEO at Agile Therapeutics, and serves on the board of Insmed, Inc.

Resignation effective with shareholder meeting.  Mr. Altomari announced that his resignation would be immediately following the Annual Meeting of Shareholders to be held May 4, 2022 …

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, April 04, 2022

Filament Health (FLHLF)
FY2021 Reported With A Review Of Clinical Pipeline Progress

Filament Health Corp is a natural psychedelic drug discovery and extraction technology company. Its mission is to see safe, approved, natural psychedelics in the hands of everyone who needs them as soon as possible. Filament engages in natural extraction technology commercialization, utilizing its intellectual property portfolio, in-house GMP facility, and Health Canada psilocybin Dealer’s License.

Robert LeBoyer, Vice President, Research Analyst, Life Sciences, Noble Capital Markets, Inc.

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

Filament Made Substantial Progress During 4Q21.  Filament Health reported a full year loss of $9.3 million or $(0.06) per share. During the quarter, Filament advanced its clinical pipeline, made licensing agreements, and strengthened its intellectual property. The cash balance at December 31, 2021 was $4.6 million.

Clinical Trials Have Begun.  During 4Q, Filament announced regulatory clearance for its first clinical trial. This trial began patient treatment in March 2022, testing its naturally-derived psilocybin and its bioactive form, psilocin. The trial has three arms to compare the standard doses of oral psilocybin (PEX010), oral psilocin (PEX020), and sublingual psilocin (PEX030) …

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, April 04, 2022

Ocugen (OCGN)
Gene Therapy Trial Reaches Progress Milestone

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, Vice President, Research Analyst, Life Sciences, Noble Capital Markets, Inc.

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

Ocugen Meets A Pipeline Milestone Ocugen announced treatment of the first patient in its Phase 1/2 trial for OCU400, the first product from its gene therapy platform to reach clinical trials.  OCU400 delivers genes to correct the genetic mutations that lead to retinitis pigmentosa, an ophthalmic condition that leads to vision loss and blindness. Patient screening began in 1Q22, meeting our expected timeframe for the trial. We see this milestone as good news for the product and the development pipeline.

Phase 1/2 Trial Is Designed To Show Safety and Efficacy.  The OCU400 Phase 1/2 trial is designed with three cohorts at increasing dose levels. After establishing basic safety at the low dose, two additional cohorts will receive higher doses. The treatment delivers functional copies of the NR2E3 and RHO genes, regulatory genes that affect expression of other genes in the disease pathway. Preliminary …

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, April 04, 2022

Onconova Therapeutics (ONTX)
Narazaciclib Data Presented At Scientific Industry Conference

Onconova Therapeutics Inc is a clinical-stage biopharmaceutical company operating in the US. It focuses on discovering and developing novel small molecule product candidates primarily to treat cancer. The company has created a library of targeted agents designed to work against cellular pathways important to cancer cells. Its product candidates are Single-agent IV rigosertib, Oral rigosertib + azacitidine, IV Briciclib, Recilisib, and ON 123300. The key product candidate Rigosertib is a small molecule which blocks cellular signaling by targeting RAS effector pathways.

Robert LeBoyer, Vice President, Research Analyst, Life Sciences, Noble Capital Markets, Inc.

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

Onconova Presented Data At The Next Generation Kinase Inhibitors Summit.  Onconova presented data from narazaciclib studies at an industry meeting attended by academic and corporate scientists. New data is not presented at this type of meeting, but speakers are able to present more information in greater detail than a medical meeting would typically allow. The communication with other scientists in the field also helps to establish a company’s expertise, and can lead to future collaborations, clinical site participation, and corporate partnerships.

Data Gave An Overview and Summary of Narazaciclib.  Data was presented by Onconova’s Director of Corporate Development, and a session was chaired by Onconova’s CEO. These presentations gave data on narazaciclib’s activity against CDK4, CDK6, and other intermediaries in a pathway that leads to cancer cell growth, proliferation, and metastasis. The data showed potent inhibition consistent with the …

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. 

 

Baudax Bio President & CEO Gerri Henwood provides a preview of their upcoming presentation at NobleCon18 NobleCon18 – Noble Capital Markets 18th Annual Small and Microcap Investor Conference – April 19-21, 2022 – Hard Rock, Hollywood, FL 100+ Public Company Presentations | Scheduled Breakouts | Panel Presentations | High-Profile Keynotes | Educational Sessions | Receptions & Networking Events Free Registration Available – More Info Research News and Advanced Market Data on BXRX NobleCon18 Presenting Companies About Baudax Bio Baudax Bio is a pharmaceutical company focused on commercializing and developing innovative products for acute care settings. ANJESO is the first and only 24-hour, intravenous (IV) COX-2 preferential non-steroidal anti-inflammatory (NSAID) for the management of moderate to severe pain. In addition to ANJESO, Baudax Bio has a pipeline of other innovative pharmaceutical assets including two novel neuromuscular blocking agents (NMBs) and a proprietary chemical reversal agent specific to these NMBs. For more information, please visit www.baudaxbio.com.

Image Credit: Hector Picard/ Marie LaFauci

Restoring Touch Through Electrodes Implanted in the Human Brain will Require Engineering Around a Sensory Lag

 

More than 5 million people in the United States are affected by limb loss or paralysis. Technological devices that directly interact with the brain, known as brain-computer interfaces, offer the potential to decode an individual’s thoughts and translate them into action using a robotic arm or a cursor on a screen. These neuroprosthetics can take the place of an amputated or paralyzed arm, for instance, helping the user take an action.

Much research in this field to date has focused on decoding brain signals – what is it that the person wants to do?

But there’s another equally important part of any real-world prosthetic system. It needs to be able to convey information in the other direction, too, back to the brain to provide feedback from the external world. Think about how challenging it would be to interact with the world in the absence of touch. Tasks such as lighting a match, picking up an egg and grasping a coffee cup become tremendously difficult.

 

This article was republished with permission from The Conversation, a news site dedicated to sharing ideas from academic experts. It was written by and represents the research-based opinions of David Caldwell Neurological Surgery Resident, University of California, San Francisco. Rajesh P. N. Rao Professor of Computer Science and Engineering and Director of the Center for Sensorimotor Neural Engineering, University of Washington.

 

At the University of Washington’s Center for Neurotechnology, our team is working out how best to engineer stimulation to the brain to restore tactile sensations that allow people to perform useful tasks. To this end, we are studying how people respond to sensation triggered by electrical stimulation of the brain. Our goal is to help devise a system that someday will allow someone who has lost the sense of touch to feel a loved one’s hand again.

Speed of Natural Touch Versus Brain Stimulation

To help localize the origin of a patient’s seizures prior to removing brain tissue to potentially help their epilepsy, Ojemann and Ko temporarily implant small, metal electrodes on top of and within the patient’s brain. These electrodes monitor the brain’s epileptic seizures so the neurosurgeons know where – and where not – to operate.

Our experiments use those same electrodes in two ways. We can record the electrical activity of the brain’s neurons. And we are also able to inject small amounts of electric current into specific parts of the brain. When we send a small burst of electricity to the touch-processing areas of the brain, the person experiences tactile sensations. In other words, when we activate particular neurons with electricity, the volunteer experiences it as if we were touching a particular part of their body.

In one study, we wanted to understand which tactile sensation an individual would perceive faster – artificial stimulation due to direct electrical stimulation of the brain via electrode, or natural tactile sensation due to a real touch on the patient’s hand?

We asked our subjects to press a button as quickly as possible using the hand opposite to where they felt the sensation. They were blindfolded to eliminate the potential for visual feedback that might confound our results.

 

Response times to direct stimulation of neurons in the brain were slower than response times to natural touch. Caldwell and Rao, CC BY-ND

 

What we discovered was surprising. Individuals responded more slowly to direct stimulation of their brain’s primary somatosensory cortex compared to a natural touch to their fingers. Even though an electric signal directly from the electrode in the brain bypassed all the peripheral nerves between the hand and head, the signal that traveled the longer journey up the ascending sensory nerves registered first.

This result held up even when we tested subjects again after a short break, suggesting that it cannot be explained solely as a novel sensation that the subjects needed time to learn.

Previous studies in nonhuman primates have found similar delays in reaction time relative to natural touch when researchers delivered electrical stimulation to a single location within somatosensory cortex. On the other hand, more recent research using multiple electrodes to stimulate somatosensory cortex in nonhuman primates found that such electrical stimulation could elicit response times slightly faster than natural touch.

Together, these studies demonstrate the complexities of stimulating the brain to replace natural tactile feedback. Future technologies and engineering strategies will need to take into account variability in touch sensation depending on how electrical stimulation is targeted in the brain.

 

Engineering Around a Sensory Lag

By discovering a delay in how people respond to direct electrical stimulation of their brains, we have revealed potential limitations in how current engineered solutions perform. The delay might limit how well future sensory neuroprosthetic devices using these clinical electrodes can work.

Fine motor movements – like picking up an egg without crushing it – rely on calibrating the effort based on what your sense of touch tells you.

Designers may need to account for a significant lag in artificial sensation relative to natural touch. For instance, if a user doesn’t receive feedback from touch sensors on a robotic hand quickly enough, and the overall system does not account for this delay in perception, someone attempting to pick up an egg with a robotic hand could apply too much pressure and crush it.

To improve reaction times and more broadly to enhance the utility of direct brain stimulation, we will need to take into account ongoing brain activity and tailor the electrical stimulation patterns for each person’s brain and the task at hand.

To achieve this goal, we have recently proposed a new type of brain-computer interface called a brain co-processor, which uses artificial intelligence to compute the best stimulation patterns for a task given current brain activity. Such an approach allows multiple electrodes to be used, possibly targeting multiple regions, and relies on co-adaptation with the brain to better approximate natural sensations.

Can electrical stimulation meaningfully substitute for natural touch during a complex task in the real world? We believe so. It will require both understanding the intricacies of information processing in the brain and incorporating this knowledge into future brain co-processors and neuroprosthetic devices for restoring touch.

 

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Elon Musk Talks About Tesla Bots, Birth Rates, and Federal Incentives

 

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Monday, April 04, 2022

GABY Inc. (GABLF)
GABY Inc.: Focused on California Cannabis Consolidation

Gaby Inc is a wellness company that is engaged in the marketing of a variety of cannabis products, including flowers, concentrates, pre-rolls, edibles, topicals, tinctures, and other products. Some of its brands are Mankind, Sonoma Pacific, 2Rise, Lulu’s, and the Kind Republic. The company operates in two segments, namely licensed and unlicensed channels, both of which are in the manufacturing, distribution, and marketing of wellness products to address a variety of dietary and health concerns. All of its revenue comes from the United States.

Joe Gomes, Senior Research Analyst, Noble Capital Markets, Inc.

Joshua Zoepfel, Research Associate, Noble Capital Markets, Inc.

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

Initiating Coverage. We are initiating research coverage on GABY Inc. GABY Inc. is a California-focused cannabis retail consolidator and the owner of San Diego-based Mankind Dispensary, one of the oldest and largest licensed dispensaries in the state. With significant organic and inorganic growth opportunities, we believe GABLF shares present an attractive risk/reward situation.

Focus on California Consolidation.  GABY’s overarching strategy is to consolidate dispensaries in California. The Company’s first step was the April 2021 acquisition of Mankind Dispensary. The California market remains highly fragmented. No brand owns more than 2.5% of the retail dispensary locations and 4% of overall market share. Ripe for consolidation, in our view …

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.