Wednesday, April 13, 2022

Cocrystal Pharma Inc. (COCP)
First Results From Influenza Program Announced

Cocrystal Pharma Inc is a clinical stage biotechnology company discovering and developing novel antiviral therapeutics that target the replication machinery of influenza viruses, hepatitis C viruses, and noroviruses. The company employs structure-based technologies and Nobel Prize-winning expertise to create first-and best-in-class antiviral drugs. It is developing CC-31244, an investigational, oral, broad-spectrum replication inhibitor called a non-nucleoside inhibitor (NNI). CC-31244 is currently being evaluated in a Phase 2a study for the treatment of hepatitis C as part of a cocktail for ultra-short therapy of 4 to 6 weeks.

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.

First Data From Influenza Program Reported.  Cocrystal reported preliminary data from the Phase 1 clinical trial testing CC-42344, its oral antiviral for pandemic and seasonal influenza A. This is an orally administered drug that targets viral polymerase, blocking an early step in the viral lifecycle. The first two cohorts receiving single ascending doses of CC-42344 showed favorable safety and pharmacokinetic profiles.

The Phase 1 Trial Continues.  The announcement was based on the first two cohorts treated with single doses of 100mg and 200mg and demonstrated safety with a favorable pharmacokinetic profile. To date, CC-42344 has shown strong bioavailablity, plasma levels that correlated with doses given, and a half-life that supports oral daily dosing. The trial has a target enrollment of 56 healthy adults and is …

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. 

 

Ceapro Inc. Reports Fourth Quarter and Full Year 2021 Financial Results and Operational Highlights

Research, News, and Market Data on Ceapro

 

– FY 2021 record sales of $17,200,000 compared to $15,100,000 for FY 2020, representing a 14% increase year over year; Ceapro’s best sales performance in Company history

– Net profit of $2,842,000 for the full year of 2021 compared to a net profit of 1,856,000 in 2020, a year over year increase of 53%

– R&D activities focused on the development of avenanthramide pills for a Phase 1 study, on advancing the development of innovative delivery systems with new chemical complexes and on processing yeast beta glucan from various sources for the development of an immune booster and as a potential inhalable therapeutic for COVID-19

– Achieved record production levels despite COVID-19 pandemic situation, supply chain and transportation logistic challenges

EDMONTON, Alberta, April 13, 2022 (GLOBE NEWSWIRE) — Ceapro Inc. (TSX-V: CZO, OTCQX: CRPOF) (“Ceapro” or the “Company”), a growth-stage biotechnology company focused on the development and commercialization of active ingredients for healthcare and cosmetic industries, today announced operational highlights and financial results for the fourth quarter and full year ended December 31, 2021.

“We are thrilled with achievements made in 2021 on all fronts from production operations to research and development, allowing us to expand our pipeline to build a high value life sciences Company focused on immune and inflammation-based diseases. A 14% year over year increase in sales for our base business is absolutely remarkable especially during such a year marked by a continued COVID-19 pandemic, inflationary pressure, issues related to availability of inputs, persistently high logistical transportation costs and labour scarcity. Despite these challenges, our team worked tirelessly to meet strong demand for our products and deliver one of the best ever performances in the Company’s history. I thank everyone wholeheartedly for their resilience and dedication,” stated Gilles Gagnon, M.Sc., MBA, President and CEO, of Ceapro. “In addition to excellent financial and operational results, we had many key highlights over the course of the year and are committed to building on these achievements.”

2021 Corporate and Operational Highlights

Pipeline Development

Avenanthramides:

• Announced expanded collaboration with Montreal Heart Institute (MHI) with new clinical study evaluating flagship product, avenanthramides, as a new potential pharmaceutical product. This Phase 1 safety and tolerability study will be led by renowned Dr. Jean-Claude Tardif. Published positive results from Ceapro’s previously conducted study evaluating anti-inflammatory properties of low doses of avenanthramides in exercise-induced inflammation paved the way for this clinical trial.

• Agreement signed with Corealis to formulate 30mg and 240mg dosage pills to be used in Phase 1 study with MHI.

• Completed physical characterization of avenanthramides and continued to monitor stability studies with new powder formulations.

• Completed the Phase 1 study protocol which expects to enroll approximately 72 patients.
  

Oat Beta Glucan:

• Completed pilot clinical trial evaluating oat beta glucan in patients with high cholesterol levels. While there were positive signals that beta glucan nutraceutical formulation may offer appreciable health benefits as indicated with approved Health Canada’s beta glucan monograph (Natural Product Division), the study did not achieve in a statistically significant manner the expected primary endpoint related to a decrease of low-density lipoproteins cholesterol when using Ceapro’s pill dosage form.

• Announced research agreement with Boston-based Angiogenesis Foundation to assess in vivo bioefficacy of oat beta glucan and avenanthramides in angiogenesis, blood vessel repairs, and wounds to assess healing and tissue regeneration in various inflammation-based diseases and conditions like COVID-19 presenting damages of the lung blood vessels.
  

Yeast Beta Glucan (YBG)

• Analyzed and screened YBG feedstock from numerous global suppliers to select ideal sources for best possible product.

• Identified process conditions for YBG improving morphology of YBG processed using PGX Technology (PGX-YBG) to boost immunomodulating activity.

• Further developed custom-shape formulations of PGX-YBG for oral administration.

• Obtained further evidence confirming that PGX-YBG is suitable for lung inhalation.

• Demonstrated, in vitro, that PGX processed YBG can prevent the activation of macrophages toward a pro-fibrotic phenotype which, according to experts in the field, is seen as a viable therapeutic strategy toward fibrotic disease.
  
  
  • PGX-YBG binds to specific receptors (Dectin 1) located on macrophages responsible for the cascade of immunomodulating events when activated.
  • McMaster’s research team discovered a new mechanism of action as per PGX-YBG’s ability to reprogram macrophages on its own.
    
• Continuing PGX-YBG project with McMaster University to assess preclinical animal models to determine posology.

• Initiated studies with a medical device manufacturer to assess aerosol/nebulizer device for inhalation of YBG.

• Proved, using an in vitro study, that the Company’s PGX Technology maintains the integrity of the YBG molecular structure and enhances its microscopic morphology which leads to a boost in its immunomodulatory activity without generating proinflammatory reaction. Based on these attributes PGX-YBG is poised to become a key strategic asset for the Company.
  

New Chemical Complexes / Delivery Systems:

• Announced the successful completion of a long-term research program conducted with University of Alberta. This screening program allowed Ceapro to retain the most promising products, such as PGX-alginate, and expand the PGX-processed products pipeline. Combination of alginate and YBG, leading to tunable PGX composites, are now viewed as the most promising products developed from this research program.

• Pursued bioavailability studies with University of Alberta for new chemical complexes YBG-CoQ10, alginate-CoQ10 and the newly formed alginate-YBG-CoQ10. Results are expected in Q3 2022.
  

Technology:

• Continued significant technical improvements of the existing PGX plant in Edmonton to develop equipment for the production of PGX-YBG for the purpose of generating material suitable for nutraceutical and lung delivery.

• Ongoing engineering design in collaboration with experts in the field for designing and building a PGX processing commercial unit. Alginate and yeast beta glucan would be the first products to be processed at large scale level. Given regulatory requirements and to accelerate market entry, yeast beta glucan as a standalone and/or in combination with alginate will be developed at first as a nutraceutical/immune booster.

• Pursued installment in Edmonton of a commercial scale unit for loading of bioactives onto PGX-processed biopolymers. This system allows loading of active pharmaceutical ingredients, like ibuprofen, onto thin soluble PGX alginate strips for wound healing or oral applications.

• Continued projects with University of Alberta and McMaster University for the development of potential delivery systems for multiple applications in healthcare.
  

Bioprocessing Operations

• Ceapro’s dedicated production team successfully responded to the growing market demand for the cosmeceutical base business by producing over 290 metric tons of active ingredients in 2021, a 20% increase over the previous year.

• Received renewal of the Site License from the Health Canada Natural Product Directorate. This License enables the Company to manufacture, package, label, release and distribute final products.

Corporate

• Fully repaid loan with Canadian Agricultural Adaptation Program (CAAP).
• Effective December 31, 2021, the Company wound up Ceapro Technology Inc., Ceapro Active Ingredients Inc. and Ceapro BioEnergy Inc. into the Company and dissolved Ceapro USA Inc. JuventeDC Inc. remains the only active fully owned subsidiary of Ceapro Inc.

• Announced expansion of a grant from National Research Council of Canada Industrial Research Assistance Program (NRC-IRAP) to further develop the patented PGX Technology to increase its innovation capacity by designing the first pharmaceutical PGX processing unit along with bioactive impregnation and loading units.

• Pursued out-licensing discussions for PGX-processed new chemical complexes.
  

Subsequent to Year End

• Signed a Supply and Distribution Agreement with Symrise securing the long-term sustainability of Ceapro’s base business.

• Appointed Mr. Ronnie Miller, former President & CEO of Roche Canada for the last 22 years, to the Company’s Board of Directors.
  

Financial Highlights for the Fourth Quarter and the Full Year 2021 Ended December 31, 2021

• Total sales of $3,562,000 for the fourth quarter of 2021 and $17,200,000 for the full year of 2021 compared to $2,706,000 and $15,100,000 for the comparative periods in 2020. These respective increases of 32% for Q4, 2021 and 14% for the full year 2021 were driven by volume sales increases in all of the Company’s primary products. The increase in revenue occurred despite being offset by a lower U.S. dollar relative to the Canadian dollar compared to the prior year, which negatively impacted revenue by approximately $1,358,000 for the full year 2021.

• Net profit of $776,000 for the fourth quarter of 2021 and a net profit of $2,842,000 for the full year of 2021 compared to a net loss of $539,000 and a net profit of 1,856,000 for the comparative periods in 2020, a year over year increase of 53.1% for the full year 2021. These results reflect a full year of operations in one production site only as compared to year 2020 that was marked by the completion of the decommissioning of Leduc manufacturing site and the final integration of production operations in the Edmonton facility. Margins improved on an annual basis from 50% in 2020 to 56% in 2021.

• Cash generated from operations of $3,510,000, for the full year 2021.

• Positive working capital balance of $10,755,000 as of December 31, 2021.
  

“While the Company’s business has not been significantly impacted by the COVID-19 pandemic, management remains very vigilant in ensuring the highest level of safety for Ceapro’s employees. Depending on the evolution of this pandemic situation and assuming minimal supply chain disruptions, I strongly believe the prospects for the Company remain very strong for the upcoming year. We expect Ceapro’s cosmeceuticals base business to continue growing and provide positive cash flows to support the expansion to a new business model to a high value life science/biopharmaceutical company involved in nutraceuticals and pharmaceuticals. We then expect to further invest into R&D to initiate an early clinical trial with our newly developed pill of avenanthramide, to continue the development of new chemical complexes as potential delivery systems for bioactives and to emphasize our current efforts for the development and assessment of yeast beta glucan as immune booster and as potential inhalable therapeutics for lung fibrotic diseases including COVID 19 conditions,” added Mr. Gagnon.

“Additionally, results from bioavailability studies with new chemical complexes and results with yeast beta glucan as an immune booster will drive decisions for the magnitude of capital expenditures to be incurred for the building of a commercial scale unit for PGX Technology. Based on a very solid foundation, a highly competent team, a healthy balance sheet and a very strong technology and product portfolio with the potential to access key large markets, we have all the key components for success,” concluded Mr. Gagnon.

CEAPRO INC.
Consolidated Balance Sheets
	December 31,		December 31,
	2021		2020
	$		$
ASSETS
Current Assets
Cash and cash equivalents	7,780,989		5,369,029
Trade receivables	2,092,842		2,019,723
Other receivables	45,850		102,224
Inventories (note 3)	1,644,893		1,210,079
Prepaid expenses and deposits	162,919		348,845
Total Current Assets	11,727,493		9,049,900
Non-Current Assets
Investment tax credits receivable	766,629		607,700
Deposits	79,539		82,124
Licences (note 4)	15,551		18,514
Property and equipment (note 5)	17,499,774		18,591,189
Deferred tax assets (note 13 (b))	439,063		874,304
Total Non-Current Assets	18,800,556		20,173,831
TOTAL ASSETS	30,528,049		29,223,731
LIABILITIES AND EQUITY
Current Liabilities
Accounts payable and accrued liabilities	682,057		1,067,622
Current portion of lease liabilities (note 6)	290,055		250,658
Current portion of CAAP loan (note 8)	–		72,263
Total Current Liabilities	972,112		1,390,543
Non-Current Liabilities
Long-term lease liabilities (note 6)	2,358,862		2,648,917
Deferred tax liabilities (note 13 (b))	–		874,304
Total Non-Current Liabilities	2,358,862		3,523,221
TOTAL LIABILITIES	3,330,974		4,913,764
Equity
Share capital (note 7 (b))	16,557,401		16,511,067
Contributed surplus (note 7 (e))	4,680,690		4,682,393
Retained earnings	5,958,984		3,116,507
Total Equity	27,197,075		24,309,967
TOTAL LIABILITIES AND EQUITY	30,528,049		29,223,731

CEAPRO INC.
Consolidated Statements of Net Income and Comprehensive Income
	2021		2020
Years Ended December 31,	$		$
Revenue (note 15)	17,195,329		15,121,282
Cost of goods sold	7,506,036		7,498,996
Gross margin	9,689,293		7,622,286
Research and product development	3,779,102		1,881,883
General and administration	3,239,672		3,282,754
Sales and marketing	47,119		111,044
Finance costs (note 11)	206,891		231,271
Income from operations	2,416,509		2,115,334
Other income (expense) (note 10)	202,281		(259,234	)
Income before tax	2,618,790		1,856,100
Income taxes
Current tax expense (note 13 (a))	215,376		–
Deferred tax benefit (note 13 (a))	(439,063	)	–
Income tax benefit	(223,687	)	–
Total net income and comprehensive income for the year	2,842,477		1,856,100
Net income per common share (note 20):
Basic	0.04		0.02
Diluted	0.04		0.02
Weighted average number of common shares outstanding (note 20):
Basic	77,673,804		77,594,629
Diluted	78,590,706		78,143,033

CEAPRO INC.
Consolidated Statements of Cash Flows
	2021		2020
Years Ended December 31,	$		$
OPERATING ACTIVITIES
Net income for the year	2,842,477		1,856,100
Adjustments for items not involving cash
Finance costs	140,270		153,538
Transaction costs	–		1,108
Depreciation and amortization	1,880,748		1,841,033
Gain on disposal of equipment	(5,000	)	–
Accretion	11,621		21,625
Income tax benefit	(439,063	)	–
Share-based payments	17,906		136,796
	4,448,959		4,010,200
CHANGES IN NON-CASH WORKING CAPITAL ITEMS
Trade receivables	(73,119	)	1,639,818
Other receivables	56,374		(55,412	)
Investment tax credits receivable	(158,929	)	–
Inventories	(434,814	)	(541,074	)
Prepaid expenses and deposits	111,044		(88,839	)
Accounts payable and accrued liabilities relating to operating activities	(298,765	)	(358,136	)
	(798,209	)	596,357
Net income for the year adjusted for non-cash and working capital items	3,650,750		4,606,557
Interest paid	(140,270	)	(153,538	)
CASH GENERATED FROM OPERATIONS	3,510,480		4,453,019
INVESTING ACTIVITIES
Purchase of property and equipment	(689,431	)	(528,707	)
Purchase of leasehold improvements	(19,472	)	(12,870	)
Proceeds from sale of equipment	5,000		353
Deposits relating to the purchase of equipment	–		(77,467	)
Accounts payable and accrued liabilities relating to investing activities	(86,800	)	134,554
CASH USED IN INVESTING ACTIVITIES	(790,703	)	(484,137	)
FINANCING ACTIVITIES
Stock options exercised	26,725		4,897
Repayment of long-term debt	–		(112,973	)
Repayment of CAAP loan	(83,884	)	(83,884	)
Repayment of lease liabilities	(250,658	)	(265,088	)
CASH USED IN FINANCING ACTIVITIES	(307,817	)	(457,048	)
Increase in cash and cash equivalents	2,411,960		3,511,834
Cash and cash equivalents at beginning of the year	5,369,029		1,857,195
Cash and cash equivalents at end of the year	7,780,989		5,369,029

The complete financial statements are available for review on SEDAR at https://sedar.com/Ceapro and on the Company’s website at www.ceapro.com.

About Ceapro Inc.

Ceapro Inc. is a Canadian biotechnology company involved in the development of proprietary extraction technology and the application of this technology to the production of extracts and “active ingredients” from oats and other renewable plant resources. Ceapro adds further value to its extracts by supporting their use in cosmeceutical, nutraceutical, and therapeutics products for humans and animals. The Company has a broad range of expertise in natural product chemistry, microbiology, biochemistry, immunology and process engineering. These skills merge in the fields of active ingredients, biopharmaceuticals and drug-delivery solutions. For more information on Ceapro, please visit the Company’s website at www.ceapro.com.

For more information contact:

Jenene Thomas
JTC Team, LLC
Investor Relations and Corporate Communications Advisor
T (US): +1 (833) 475-8247
E: czo@jtcir.com

Issuer:
Gilles R. Gagnon, M.Sc., MBA
President & CEO
T: 780-421-4555

Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release 

Source: Ceapro Inc.

Engineered Bacteria Could Help Protect “Good” Gut Microbes from Antibiotics

 

Anne Trafton | MIT
News Office

Antibiotics are life-saving drugs, but they can also harm the beneficial microbes that live in the human gut. Following antibiotic treatment, some patients are at risk of developing inflammation or opportunistic infections such as Clostridiodes difficile. Indiscriminate use of antibiotics on gut microbes can also contribute to the spread of resistance to the drugs.

In an effort to reduce those risks, MIT engineers have developed a new way to help protect the natural flora of the human digestive tract. They took a strain of bacteria that is safe for human consumption and engineered it to safely produce an enzyme that breaks down a class of antibiotics called beta-lactams. These include ampicillin, amoxicillin, and other commonly used drugs.

When this “living biotherapeutic” is given along with antibiotics, it protects the microbiota in the gut but allows the levels of antibiotics circulating in the bloodstream to remain high, the researchers found in a study of mice.

“This work shows that synthetic biology can be harnessed to create a new class of engineered therapeutics for reducing the adverse effects of antibiotics,” says James Collins, the Termeer Professor of Medical Engineering and Science in MIT’s Institute for Medical Engineering and Science (IMES) and Department of Biological Engineering, and the senior author of the new study.

Andres Cubillos-Ruiz PhD ’15, a research scientist at IMES and the Wyss Institute for Biologically Inspired Engineering at Harvard University, is the lead author of the paper, which appears today in Nature Biomedical Engineering. Other authors include MIT graduate students Miguel Alcantar and Pablo Cardenas, Wyss Institute staff scientist Nina Donghia, and Broad Institute research scientist Julian Avila-Pacheco.

Protecting the Gut

Over the past two decades, research has revealed that the microbes in the human gut play important roles in not only metabolism but also immune function and nervous system function.

“Throughout your life, these gut microbes assemble into a highly diverse community that accomplishes important functions in your body,” Cubillos-Ruiz says. “The problem comes when interventions such as medications or particular kinds of diets affect the composition of the microbiota and create an altered state, called dysbiosis. Some microbial groups disappear, and the metabolic activity of others increases. This unbalance can lead to various health issues.”

 

One major complication that can occur is infection of C. difficile, a microbe that commonly lives in the gut but doesn’t usually cause harm. When antibiotics kill off the strains that compete with C. difficile, however, these bacteria can take over and cause diarrhea and colitis. C. difficile infects about 500,000 people every year in the United States, and causes around 15,000 deaths.

Doctors sometimes prescribe probiotics (mixtures of beneficial bacteria) to people taking antibiotics, but those probiotics are usually also susceptible to antibiotics, and they don’t fully replicate the native microbiota found in the gut.

“Standard probiotics cannot compare to the diversity that the native microbes have,” Cubillos-Ruiz says. “They cannot accomplish the same functions as the native microbes that you have nurtured throughout your life.”

To protect the microbiota from antibiotics, the researchers decided to use modified bacteria. They engineered a strain of bacteria called Lactococcus lactis, which is normally used in cheese production, to deliver an enzyme that breaks down beta-lactam antibiotics. These drugs make up about 60 percent of the antibiotics prescribed in the United States.

When these bacteria are delivered orally, they transiently populate the intestines, where they secrete the enzyme, which is called beta-lactamase. This enzyme then breaks down antibiotics that reach the intestinal tract. When antibiotics are given orally, the drugs enter the bloodstream primarily from the stomach, so the drugs can still circulate in the body at high levels. This approach could also be used along with antibiotics that are injected, which also end up reaching the intestine. After their job is finished, the engineered bacteria are excreted through the digestive tract.

Using engineered bacteria that degrade antibiotics poses unique safety requirements: Beta-lactamase enzymes confer antibiotic resistance to harboring cells and their genes can readily spread between different bacteria. To address this, the researchers used a synthetic biology approach to recode the way the bacterium synthetizes the enzyme. They broke up the gene for beta-lactamase into two pieces, each of which encodes a fragment of the enzyme. These gene segments are located on different pieces of DNA, making it very unlikely that both gene segments would be transferred to another bacterial cell.

These beta-lactamase fragments are exported outside the cell where they reassemble, restoring the enzymatic function. Since the beta-lactamase is now free to diffuse in the surrounding environment, its activity becomes a “public good” for the gut bacterial communities. This prevents the engineered cells from gaining an advantage over the native gut microbes. 

“Our biocontainment strategy enables the delivery of antibiotic-degrading enzymes to the gut without the risk of horizontal gene transfer to other bacteria or the acquisition of an added competitive advantage by the live biotherapeutic,” Cubillos-Ruiz says.

Maintaining Microbial Diversity

To test their approach, the researchers gave the mice two oral doses of the engineered bacteria for every injection of ampicillin. The engineered bacteria made their way to the intestine and began releasing beta-lactamase. In those mice, the researchers found that the amount of ampicillin circulating the bloodstream was as high as that in mice who did not receive the engineered bacteria.

In the gut, mice that received engineered bacteria maintained a much higher level of microbial diversity compared to mice that received only antibiotics. In those mice, microbial diversity levels dropped dramatically after they received ampicillin. Furthermore, none of the mice that received the engineered bacteria developed opportunistic C. difficile infections, while all of the mice who received only antibiotics showed high levels of C. difficile in the gut.

“This is a strong demonstration that this approach can protect the gut microbiota, while preserving the efficacy of the antibiotic, as you’re not modifying the levels in the bloodstream,” Cubillos-Ruiz says.

The researchers also found that eliminating the evolutionary pressure of antibiotic treatment made it much less likely for the microbes of the gut to develop antibiotic resistance after treatment. In contrast, they did find many genes for antibiotic resistance in the microbes that survived in mice who received antibiotics but not the engineered bacteria. Those genes can be passed to harmful bacteria, worsening the problem of antibiotic resistance.

The researchers now plan to begin developing a version of the treatment that could be tested in people at high risk of developing acute diseases that stem from antibiotic-induced gut dysbiosis, and they hope that eventually, it could be used to protect anyone who needs to take antibiotics for infections outside the gut.

“If the antibiotic action is not needed in the gut, then you need to protect the microbiota. This is similar to when you get an X-ray, you wear a lead apron to protect the rest of your body from the ionizing radiation,” Cubillos-Ruiz says. “No previous intervention could offer this level of protection. With our new technology we can make antibiotics safer by preserving beneficial gut microbes and by reducing the chances of emergence of new antibiotic resistant variants.”

 

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electroCore Provides Business Update and Select First Quarter 2022 Financial Guidance

News and Market Data on electroCore

April 12, 2022 at 8:00 AM EDT

• Record revenue
  from product sales will be approximately $1.9M;
  approximately 60% growth over first quarter 2021
• March 31, 2022,
  cash balance of approximately $29.9M

ROCKAWAY, N.J.
, 
April 12, 2022 (GLOBE NEWSWIRE) — 
electroCore, Inc.
 (the “Company”) (Nasdaq: ECOR), a commercial-stage bioelectronic medicine company, today provided an operating and business update as well as select unaudited preliminary financial guidance for the first quarter of 2022.

“We are pleased to announce preliminary first quarter results, recording approximately 60% growth over same period last year, and approximately 27% growth over the fourth quarter of 2021,” stated  Dan Goldberger , Chief Executive Officer of electroCore. “Revenue from product sales in the quarter ended 
March 31, 2022, will be approximately 
$1.9 million
. This is the second consecutive quarter where our total revenue growth over the prior year quarter was approximately 60% indicating that our continued investment in our sales channels and marketing initiatives are expanding consumer awareness and building momentum into the remainder of 2022.” 

Government
Channels: During the first quarter of 2022, the Company expects to recognize revenue of approximately 
$1,260,000 pursuant to the 
Department of Veterans Affairs (“VA”) and 
Department of Defense (“DoD”) originating prescriptions, compared to 
$858,000 or 47% growth from the fourth quarter of 2021 and 
$679,000 or 86% growth over the first quarter of 2021. 105 
VA and 
DoD military treatment facilities have purchased gammaCore products through 
March 31, 2022, as compared to 100 through the fourth quarter of 2021 and 79 through the first quarter of 2021.

Commercial: During the first quarter of 2022, the Company expects to recognize revenue of approximately 
$300,000 from our commercial channels, dominated by our cash pay initiatives and representing approximately an 11% increase over Q4 2021 and a 107% increase from Q1 2021.

Outside
of the U.S.: The Company expects to recognize revenue of approximately 
$300,000 outside of the 
U.S. for the first quarter ended 
March 31, 2022
, representing approximately 15% decrease from Q4 2021 and 20% decrease from Q1 2021. Our international business was impacted by COVID in January and February of this year, but the channel started to rebound in 
March 2022
.

Financial
Guidance
Preliminary unaudited financial guidance for the first quarter of 2022:

Revenue: The Company anticipates first quarter 2021 revenue from product sales will be approximately 
$1.9 million. This represents an approximately 27% increase over fourth quarter 2021 revenue of 
$1.5 million and approximately 60% growth over first quarter 2021 revenue of 
$1.2 million
.

Cash
Position: The Company ended the first quarter of 2022 with approximately 
$29.9 million
 of cash, cash equivalents, and marketable securities, compared to 
$34.7 million as of the end of 2021. 

Mr. Goldberger  further commented, “Our business grew robustly in the first quarter, despite the headwinds faced overseas as a result of COVID. With our strong balance sheet and discipline around targeted investment in sales and marketing, we will be able to educate and improve physician and patient awareness, which will ultimately lead to the successful adoption of gammaCore globally.”

The Company intends to provide a detailed operational and financial update during its first quarter of 2022 earnings call in 
May 2022
.

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 about electroCore’s expectations for revenue and cash used in operations during the first quarter 2022, growth through acquisitions, its expectations for future performance, as well as electroCore’s business prospects (including its e-commerce initiative, and gConcierge and gCDirect programs) and clinical and product development plans for 2022 and beyond, its pipeline or potential markets (including cash pay programs) for its technologies, additional indications for gammaCore, the timing, outcome and impact of regulatory, clinical and commercial developments (including human trials for the study of headache, PTH, mTBI, Parkinson’s diseases and sleep deprivation stress and the business, operating or financial impact of such studies), further international expansion, and statements about anticipated distribution arrangements, government and payor funding arrangements (including those relating to 
Canada, 
Western Europe
, 
Qatar, 
Taiwan, and 
China) 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™, 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

 

Cocrystal Pharma Reports Favorable Preliminary Data from Phase 1 Initial Cohorts with CC-42344, a Novel, Broad-Spectrum Influenza A antiviral

Research, News, and Market Data on Cocrystal Pharma

CC-42344 administered
orally as a single 100 mg or 200 mg dose in healthy adults showed a
favorable safety and pharmacokinetic profile

BOTHELL, Wash., April
12, 2022 (GLOBE NEWSWIRE) — Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”) reported preliminary results of a Phase 1 study with CC-42344, demonstrating a favorable safety and pharmacokinetic profile. CC-42344 is a broad-spectrum oral antiviral for the treatment of pandemic and seasonal influenza A with a novel mechanism of action.

The ongoing Phase 1 clinical trial plans to enroll 56 healthy adults. Results from the first two single-ascending dose 100 mg and 200 mg cohorts showed a favorable pharmacokinetic profile of CC-42344. To date, CC-42344, has demonstrated excellent oral bioavailability, dose-dependent plasma exposures, and a half-life supportive of oral daily dosing. The Phase 1 study is designed to evaluate CC-42344 administered in single-ascending and multiple-ascending doses. Cocrystal expects to report full results from the study in 2022.

“Today’s update reinforces Cocrystal’s progress in developing best-in-class antiviral medicines. Influenza is one of the most serious worldwide public health threats. Important concerns remain about the emergence of pandemic strains and resistance to available drugs. We are encouraged by the safety and pharmacokinetic profile observed to date with single oral doses of CC-42344 and look forward to initiating the next portion of the trial,” said Sam Lee, Ph.D., Cocrystal’s President and co-interim CEO. “Based on a novel mechanism of action and high barrier to resistance, we believe CC-42344 could provide a potentially best-in-class oral candidate for the treatment of pandemic and seasonal influenza infection.”

About CC-42344
CC-42344 is an oral PB2 inhibitor that blocks an essential step of viral replication and was discovered using Cocrystal’s proprietary structure-based drug discovery platform technology. It is specifically designed to be effective against all significant pandemic and seasonal influenza A strains and to have a high barrier to resistance due to the way the virus’ replication machinery is targeted. CC-42344 targets the influenza polymerase, an essential replication enzyme with several highly essential regions common to multiple influenza strains, including pandemic strains. In vitro testing showed CC-42344’s excellent antiviral activity against influenza A strains, including pandemic and seasonal strains, as well as against strains resistant to Tamiflu^® and Xofluza^™, while also demonstrating favorable pharmacokinetic and safety profiles.

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

Cautionary Note
Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding our plans to enroll 56 new subjects for the Company’s influenza A Phase 1 study, expectations of reporting full results of the study later in 2022, and the potential of CC-42344 to be a best-in-class candidate for the treatment of seasonal and pandemic influenza. The words “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events. Some or all of the events anticipated by these forward-looking statements may not occur. Important factors that could cause actual results to differ from those in the forward-looking statements include, but are not limited to, the risks and uncertainties arising from any future impact of the COVID-19 pandemic and the Russian invasion of Ukraine on the Australian and global economy and on our Company, including supply chain disruptions and our continued ability to proceed with our programs, including our influenza A program, the ability of the contract research organization to recruit patients into clinical trials, the results of future preclinical and clinical studies, and general risks arising from clinical trials. Further information on our risk factors is contained in our filings with the SEC, including our Annual Report on Form 10-K for the year ended December 31, 2021. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.

Investor Contact:
LHA Investor Relations
Jody Cain
310-691-7100

jcain@lhai.com

Media Contact:
JQA Partners
Jules Abraham
917-885-7378

Jabraham@jqapartners.com

Source: Cocrystal Pharma, Inc.