Onconova Therapeutics Reports Second Quarter 2021 Financial Results And Provides Business Update

 

Conference call and live webcast at 4:30 p.m. ET today

NEWTOWN, Pa., Aug. 12, 2021 (GLOBE NEWSWIRE) — Onconova Therapeutics, Inc. (NASDAQ: ONTX) (“Onconova”), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, today announced financial results for the three months ended June 30, 2021 and provided a business update.

Highlights for the second quarter of 2021 and subsequent weeks include:

• Enrollment in the first cohort of the Phase 1 solid tumor study of ON 123300 in the United States is complete with no dose limiting toxicities (DLT’s) observed. The second cohort is currently open for enrollment.
• The Phase 1 solid tumor study of ON 123300 in China is ongoing with no DLT’s observed to date. The study is currently enrolling the third dose cohort.
• The investigator-initiated Phase 1/2 study evaluating rigosertib in combination with the checkpoint inhibitor nivolumab in KRAS mutated non-small cell lung cancer (NSCLC) continues to progress. Initial data from the trial provide preliminary evidence of the anti-cancer activity of rigosertib-nivolumab combination therapy in patients who had previously failed all standard of care treatment, including checkpoint inhibition, and show that the maximum tolerated dose of rigosertib in combination with nivolumab was not yet determined in the three cohorts of the trial’s dose-escalation phase.
• The first patient was dosed in an investigator-initiated Phase 2 study designed to assess the efficacy and safety of rigosertib in patients with recessive dystrophic epidermolysis bullosa (RDEB)-associated locally advanced/metastatic squamous cell carcinoma (SCC), an ultra-rare and invariably fatal condition.
• The Company strengthened its management team with the appointment of Mark Gelder, M.D., as Chief Medical Officer.
• Preclinical data published in the peer-reviewed journal Molecular Cancer show that rigosertib synergistically enhanced the efficacy of immune checkpoint blockade in a murine melanoma model via the induction of immune-mediated cancer cell death, supporting the continued clinical evaluation of rigosertib in combination with checkpoint inhibitors.

Management Commentary

“During the second quarter we achieved key clinical and corporate milestones,” said Steven M. Fruchtman, M.D., President and Chief Executive Officer of Onconova. “In our lead ON 123300 program, we initiated our U.S. Phase 1 study and recently opened enrollment to the second cohort, and our partner, HanX Biopharmaceuticals, is currently enrolling to the third dose cohort of the complementary Phase 1 study underway in China. Through these trials, which are evaluating different dosing administration regimens, we aim to inform the design of a future Phase 2 basket trial evaluating ON 123300 in multiple high unmet need indications, including CDK 4/6 inhibitor refractory HR+ HER2- metastatic breast cancer. Given ON 123300’s ability in preclinical studies to overcome resistance to the most widely prescribed CDK 4/6 inhibitor, we believe this novel multi-kinase inhibitor has the potential to be a best-in-class therapy for this and other cancers.”

Dr. Fruchtman continued, “Beyond our lead program, we also reported very encouraging preliminary results from the investigator-initiated study evaluating rigosertib plus nivolumab in advanced KRAS-mutated NSCLC. These results highlighted the doublet’s favorable safety profile and provided preliminary evidence of efficacy in an extremely challenging patient population. Additional preliminary data from the trial is expected to be presented at a RAS-focused medical meeting in September. Looking forward, we will continue to leverage investigator-initiated programs to further rigosertib’s clinical development, while maintaining our primary focus and resources on ON 123300. Milestones ahead for the remainder of the year include continued progress of our ON 123300 clinical trials, expansion of rigosertib investigator-initiated studies program, and potentially acquiring new assets to augment our pipeline. With a strong financial position and a talented management team that was recently bolstered by the appointment of Dr. Mark Gelder as CMO, we believe we are well positioned to take advantage of the product development opportunities presented.”

Second Quarter Financial Results

Cash and cash equivalents as of June 30, 2021 were $43.7 million, compared with $19.0 million as of December 31, 2020. The Company believes that its cash and cash equivalents will be sufficient to fund ongoing clinical trials and business operations for more than eighteen months.

Research and development expenses were $1.9 million for the second quarter of 2021, compared with $4.8 million for the second quarter of 2020. The decrease was primarily related to higher clinical trial and consulting expenses in the 2020 period due to the INSPIRE study.

General and administrative expenses were $2.9 million for the second quarter of 2021, compared with $2.6 million for the second quarter of 2020. The increase was primarily due to expenses related to special meetings by proxy in the 2021 period.

Net loss for the second quarter of 2021 was $4.2 million, or $0.27 per share on 15.8 million weighted average shares outstanding, compared with a net loss for the second quarter of 2020 of $7.4 million, or $0.65 per share on 11.3 million weighted average shares outstanding.

Conference Call and Webcast

Onconova will host an investment community conference call today beginning at 4:30 p.m. Eastern Time, during which management will discuss financial results for the second quarter of 2021, provide a business update and answer questions. Interested parties can participate by dialing (855) 428-5741 (domestic callers) or (210) 229-8823 (international callers) and using conference ID 3876025.

A live webcast of the conference call will be available in the Investors & Media section of the Company’s website at www.onconova.com. A replay of the webcast will be available on the Onconova website for 90 days following the call.

About Onconova Therapeutics, Inc.
Onconova Therapeutics is a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer. The Company has proprietary targeted anti-cancer agents designed to disrupt specific cellular pathways that are important for cancer cell proliferation.

Onconova’s novel, proprietary multi-kinase inhibitor ON 123300 is being evaluated in two separate and complementary Phase 1 dose-escalation and expansion studies. These trials are currently underway in the United States and China.

Onconova’s product candidate rigosertib is being studied in an investigator-initiated study program, including in a dose-escalation and expansion Phase 1/2a investigator-initiated study targeting patients with KRAS+ non-small cell lung cancer with oral rigosertib in combination with nivolumab.

For more information, please visit www.onconova.com.

Forward-Looking Statements
Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, and involve risks and uncertainties. These statements relate to Onconova’s expectations regarding the timing of Onconova’s and investigator-initiated clinical development and data presentation plans, and the mechanisms and indications for Onconova’s product candidates. Onconova has attempted to identify forward-looking statements by terminology including “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “preliminary,” “approximately” or other words that convey uncertainty of future events or outcomes. Although Onconova believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including the success and timing of Onconova’s clinical trials, investigator-initiated trials and regulatory agency and institutional review board approvals of protocols, Onconova’s collaborations, the timing of the Company’s annual stockholder meeting, market conditions and those discussed under the heading “Risk Factors” in Onconova’s most recent Annual Report on Form 10-K and quarterly reports on Form 10-Q. Any forward-looking statements contained in this release speak only as of its date. Onconova undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

Company Contact:
Avi Oler
Onconova Therapeutics, Inc.
267-759-3680
ir@onconova.us
https://www.onconova.com/contact/

Investor Contact:
Bruce Mackle
LifeSci Advisors, LLC
646-889-1200
bmackle@lifesciadvisors.com

(Tables to follow)

ONCONOVA THERAPEUTICS, INC.
Condensed Consolidated Balance Sheets
(in thousands)
	June 30,				December 31,
		2021				2020
Assets	(unaudited)
Current assets:
Cash and cash equivalents	$	43,709			$	19,025
Receivables		27				37
Prepaid expenses and other current assets		457				722
Total current assets		44,193				19,784
Property and equipment, net		45				52
Other non-current assets		140				150
Total assets	$	44,378			$	19,986
Liabilities and stockholders’ equity
Current liabilities:
Accounts payable	$	4,290			$	4,833
Accrued expenses and other current liabilities		2,983				4,962
Deferred revenue		226				226
Total current liabilities		7,499				10,021
Warrant liability		530				321
Deferred revenue, non-current		3,356				3,469
Total liabilities		11,385				13,811
Stockholders’ equity:
Preferred stock		–				–
Common stock		158				124
Additional paid in capital		470,335				434,593
Accumulated other comprehensive income		2				14
Accumulated deficit		(437,502	)			(428,556	)
Total stockholders’ equity		32,993				6,175
Total liabilities and stockholders’ equity	$	44,378			$	19,986

ONCONOVA THERAPEUTICS, INC.
Condensed Consolidated Statements of Operations (unaudited)
(in thousands, except share and per share amounts)
	Three Months Ended June 30,								Six months months ended June 30,
		2021				2020				2021				2020
Revenue	$	57			$	56			$	113			$	108
Operating expenses:
General and administrative		2,850				2,594				5,067				4,401
Research and development		1,852				4,801				3,789				8,171
Total operating expenses		4,702				7,395				8,856				12,572
Loss from operations		(4,645	)			(7,339	)			(8,743	)			(12,464	)
Change in fair value of warrant liability		427				(56	)			(209	)			(119	)
Other (loss) income, net		(13	)			–				6				96
Net loss		(4,231	)			(7,395	)			(8,946	)			(12,487	)
Net loss per share of common stock, basic and diluted	$	(0.27	)		$	(0.65	)		$	(0.59	)		$	(1.14	)
Basic and diluted weighted average shares outstanding		15,780,863				11,303,508				15,201,719				10,996,624

Friday, August 13, 2021

PDS Biotechnology Corp (PDSB)
Moving Forward With Clinical Milestones On The Horizon

PDS Biotechnology Corp operates as a clinical stage biotechnology company, principally involved in drug discovery in the United States. It is primarily engaged in the treatment of various early-stage and late-stage cancers, including head and neck cancer, prostate cancer, breast cancer, cervical cancer, anal cancer, and other cancers. Its products are based on the proprietary Versamune platform technology, which activates and directs the human immune system to unleash a powerful and targeted attack against cancer cells.

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

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

Significant Data Was Presented In 2Q21.  PDS Biotechnology reported 2Q21 loss of $0.6 million or $(0.03) per share. Importantly, interim Phase 2 data from the lead trial for PDS0101 presented at the ASCO conference showed strong indications of efficacy. Additional data from this PDS0101 trial and two other Phase 2 trials are expected to be announced around 4Q/1H22.


Increased Cash Allows Clinical Trials To Move Forward.  During 2Q21, the company completed an offering that raised about $52 million in gross proceeds. Cash on hand at June 30, 2021 was $74.7 million. This gives the company sufficient operating cash to continue current operations and new clinical trials. Two additional Versamune platform products, PDS102 and PDS103, are expected to move to clinical …

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. 

Friday, August 13, 2021

Onconova Therapeutics Inc. (ONTX)
2Q21 Reported With Updates To Clinical Trials

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, Senior Research Analyst, Noble Capital Markets, Inc.

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

Onconova Reported 2Q21 and Updated Its Clinical Trial Progress Onconova reported a net loss of $4.2 million or $(0.27) per share for 2Q21, ended June 30. Cash on hand was $43.7 million, which we project to be sufficient for operations through 2023. The company gave updates on the clinical progress for several clinical trials of its two lead products, ON123300 and rigosertib.


The ON123300 Phase 1 solid tumor study has opened enrollment of its second cohort.  The first cohort has completed enrollment without dose-limiting toxicities. The ON123300 study in China is enrolling its third cohort in solid tumors, and has also not had dose-limiting toxicities. The company plans to use the data from these two trials to design the Phase 2 trial in 1H22 …

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. 

Neovasc Announces Second Quarter 2021 Financial Results

 

VANCOUVER and MINNEAPOLIS – (NewMediaWire) – August 10, 2021 – Neovasc, Inc. (“Neovasc” or the “Company”) (NASDAQ, TSX: NVCN), today reported financial results for the second quarter ended June 30, 2021.

Second Quarter Highlights

• Generated revenue of approximately $633,000 in the quarter, up 123% from the same period in 2020, and a sequential 40% increase from Q1 2021.
• Streamlined strategic focus to pursue three value-creation strategies around Reducer and Tiara TA, suspending Tiara TF activity and reducing headcount by 40%.  These moves are expected to extend the Company’s cash runway into 2024.
• Continued to execute a strategic focus of additional reimbursement agreements, announcing in June that Reducer had been granted the first national reimbursement from the National Health Service England.
• Continued to pursue clinical studies supporting Reducer:
  • Advanced preparations for COSIRA II, the pivotal US trial for Reducer.  The Company expects to file an Investigational Device Exemption (IDE) Supplement with the FDA in the third quarter.
  • Announced the first enrollment in the COSIMA trial in Germany, studying Reducer as a treatment for microvascular angina.

“Neovasc enjoyed a strong second quarter and continued to make good progress on its value creation strategies.  During the quarter we made a strategic decision to streamline our focus on three value creation strategies, coupled with a significant corporate headcount reduction, which is expected to extend our cash runway for three years.  We followed up on these moves in July, adding a new VP of Clinical Affairs and a VP of Regulatory Affairs, Global Angina Therapies to strengthen our expertise in these important areas.  We are placing a heavy emphasis on expanding the market penetration of our CE-marked Reducer device in Europe, working directly with hospitals, cardiologists, and medical associations to raise awareness of the Reducer’s safety, efficacy, and ease of use,” said Fred Colen, President and Chief Executive Officer of Neovasc. Mr. Colen continued, “Our team is also working diligently to expand reimbursement for the Reducer device.  Those efforts were rewarded when Reducer was granted full reimbursement by the National Health Service (NHS) England, and we look forward to sharing news of more reimbursement decisions in the second half of the year. In the United States, we continue to prepare for our pivotal U.S. trial for Reducer and expect to file an IDE Supplement in the third quarter.  With respect to Tiara, we are working with our notified body in Europe to understand all specific requirements and leverage of work already performed, to pursue a CE mark decision for the Tiara TA device under MDR.  There is much more work to do, but we are confident that we now have the team in place and the financial security to successfully execute on our value creation strategies.”

Financial results for the second quarter ended June 30, 2021

Revenues increased 123% to approximately $633,000 for the quarter ended June 30, 2021, compared to revenues of approximately $284,000 for the same period in 2020. 

The cost of goods sold for the three months ended June 30, 2021, was approximately $109,000, compared to $75,000 for the same period in 2020. The overall gross margin for the quarter ended June 30, 2021, was 83%, compared to 74% gross margin for the same period in 2020.

Total expenses for the quarter ended June 30, 2021, were $9.6 million compared to $8.9 million for the same period in 2020, representing an increase of approximately $748,000 or 8%.  The increase in total expenses can be substantially explained by the following non-cash charges; a $1.0 million increase in non-cash share-based payments and an approximate $903,000 charge related to the decision to pause the development of the Tiara TF device ($594,000 impairment charge due to fixed assets obsolescence, and $309,000 charge for employee termination expenses).  This increase in non-cash charges was offset by a $1.1 million decrease in cash-based employee expenses due to the Company’s reductions in force in December 2020 and June 2021.

Operating losses and comprehensive losses for the quarter ended June 30, 2021, were $9.1 million and $9.3 million, respectively, or $0.13 basic and diluted loss per share, as compared with $8.7 million operating losses and $12.2 million comprehensive losses, or $0.81 basic and diluted loss per share, for the same period in 2020.

Conference Call and Webcast information

Neovasc will be hosting a conference call and audio webcast today at 4:30 pm ET to discuss these results.

Domestic:                  1-877-407-9208
International:            1-201-493-6784
Reference ID Code: 13721306

Parties wishing to access the call via webcast should use the link in the Investors section of the Neovasc website at https://www.neovasc.com/investors/.  A replay of the webcast will be available in the Investors sections of the website approximately 30 minutes after the conclusion of the call.

About Neovasc Inc.

Neovasc is a specialty medical device company that develops, manufactures, and markets products for the rapidly growing cardiovascular marketplace. The Company is a leader in the development of minimally invasive transcatheter mitral valve replacement technologies, and minimally invasive devices for the treatment of refractory angina. Its products include the Neovasc Reducer™, for the treatment of refractory angina, which is not currently commercially available in the United States (6 U.S. patients have been treated under Compassionate Use) and has been commercially available in Europe since 2015, and Tiara™, for the transcatheter treatment of mitral valve disease, which is currently under clinical investigation in the United States, Canada, Israel, and Europe. For more information, visit: www.neovasc.com.

NEOVASC INC.

Condensed Interim Consolidated Statements of Financial Position

(Expressed in U.S. dollars) (Unaudited)                                                                 

NEOVASC INC.

Condensed Interim Consolidated Statements of Loss and Comprehensive Loss

For the three and six months ended June 30, 2021 and 2020
(Expressed in U.S. dollars) (Unaudited)                                                                             

 

Investors
Mike Cavanaugh
Westwicke/ICR
Phone: +1.617.877.9641
Mike.Cavanaugh@westwicke.com

Media
Sean Leous
Westwicke/ICR
Phone: +1.646.677.1839
Sean.Leous@icrinc.com

Forward-Looking Statement Disclaimer

Certain statements in this news release contain forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and applicable Canadian securities laws that may not be based on historical fact. When used herein, the words “expect”, “anticipate”, “estimate”, “may”, “will”, “should”, “intend,” “believe”, and similar expressions, are intended to identify forward-looking statements. Forward-looking statements may involve, but are not limited to, expectations as to the future growth of the Company, the expansion of reimbursement for the Reducer, the continued preparation for the US trial of the Reducer, the expectation to file an IDE Supplement in the third quarter, the pursual of a CE mark decision for the Tiara TA device under MDR and the growing cardiovascular marketplace. Many factors and assumptions could cause the Company’s actual results, performance or achievements to differ materially from those expressed or implied by the forward-looking statements, including, without limitation, the doubt about the Company’s ability to continue as a going concern; risks related to the recent COVID-19 coronavirus outbreak or other health epidemics, which could significantly impact the Company’s operations, sales or ability to raise capital or enroll patients in clinical trials and complete certain Tiara development milestones on the Company’s expected schedule; risks relating to the Company’s need for significant additional future capital and the Company’s ability to raise additional funding; risks relating to the sale of a significant number of Common Shares; risks relating to the possibility that the Company’s common shares (the “Common Shares”) may be delisted from the Nasdaq or the TSX, which could affect their market price and liquidity; risks relating to the Company’s conclusion that it did have effective internal control over financial reporting as of December 31, 2020 but not at December 31, 2019 and 2018; risks relating to the Common Share price being volatile; risks relating to the possibility that the Common Shares may be delisted from the Nasdaq or the TSX, which could affect their market price and liquidity; risks relating to the Company’s significant indebtedness, and its effect on the Company’s financial condition; risks relating to lawsuits that the Company is subject to, which could divert the Company’s resources and result in the payment of significant damages and other remedies; risks relating to claims by third-parties alleging infringement of their intellectual property rights; risks relating to the Company’s ability to establish, maintain and defend intellectual property rights in the Company’s products; risks relating to results from clinical trials of the Company’s products, which may be unfavorable or perceived as unfavorable; the Company’s history of losses and significant accumulated deficit; risks associated with product liability claims, insurance and recalls; risks relating to use of the Company’s products in unapproved circumstances, which could expose the Company to liabilities; risks relating to competition in the medical device industry, including the risk that one or more competitors may develop more effective or more affordable products; risks relating to the Company’s ability to achieve or maintain expected levels of market acceptance for the Company’s products, as well as the Company’s ability to successfully build its in-house sales capabilities or secure third-party marketing or distribution partners; risks relating to the Company’s ability to convince public payors and hospitals to include the Company’s products on their approved products lists; risks relating to new legislation, new regulatory requirements and the efforts of governmental and third-party payors to contain or reduce the costs of healthcare; risks relating to increased regulation, enforcement and inspections of participants in the medical device industry, including frequent government investigations into marketing and other business practices; risks relating to the extensive regulation of the Company’s products and trials by governmental authorities, as well as the cost and time delays associated therewith; risks relating to post-market regulation of the Company’s products; risks relating to health and safety concerns associated with the Company’s products and industry; risks relating to the Company’s manufacturing operations, including the regulation of the Company’s manufacturing processes by governmental authorities and the availability of two critical components of the Reducer; risks relating to the possibility of animal disease associated with the use of the Company’s products; risks relating to the manufacturing capacity of third-party manufacturers for the Company’s products, including risks of supply interruptions impacting the Company’s ability to manufacture its own products; risks relating to the Company’s dependence on limited products for substantially all of the Company’s current revenues; risks relating to the Company’s exposure to adverse movements in foreign currency exchange rates; risks relating to the possibility that the Company could lose its foreign private issuer status under U.S. federal securities laws; risks relating to the possibility that the Company could be treated as a “passive foreign investment company”; risks relating to breaches of anti-bribery laws by the Company’s employees or agents; risks relating to future changes in financial accounting standards and new accounting pronouncements; risks relating to the Company’s dependence upon key personnel to achieve its business objectives; risks relating to the Company’s ability to maintain strong relationships with physicians; risks relating to the sufficiency of the Company’s management systems and resources in periods of significant growth; risks relating to consolidation in the health care industry, including the downward pressure on product pricing and the growing need to be selected by larger customers in order to make sales to their members or participants; risks relating to the Company’s ability to successfully identify and complete corporate transactions on favorable terms or achieve anticipated synergies relating to any acquisitions or alliances; risks relating to conflicts of interests among the Company’s officers and directors as a result of their involvement with other issuers; and risks relating to anti­takeover provisions in the Company’s constating documents which could discourage a third-party from making a takeover bid beneficial to the Company’s shareholders. These risk factors and others relating to the Company are discussed in greater detail in the “Risk Factors” section of the Company’s Annual Information Form and in the Management’s Discussion and Analysis for the three and six months ended June 30, 2021 (copies of which may be obtained at www.sedar.com or www.sec.gov). The Company has no intention and undertakes no obligation to update or revise any forward-looking statements beyond required periodic filings with securities regulators, whether as a result of new information, future events or otherwise, except as required by law.

Ceapro Inc. Expands Collaboration with Montreal Heart Institute (MHI) with New Clinical Study Evaluating Flagship Product, Avenanthramide

 

– Second human trial to be conducted as part of a long-term Master Service Agreement with MHI

– Phase 1 study with Ceapro’s pharmaceutical grade avenanthramide to be coordinated by MHI’s Montreal Health Innovations Coordinating Center (MHICC) and led by Dr. Jean-Claude Tardif

EDMONTON, Alberta, Aug. 11, 2021 (GLOBE NEWSWIRE) — Ceapro Inc. (TSX-V: CZO; OTCQX: CRPOF), a growth-stage biotechnology company focused on the development and commercialization of active ingredients for healthcare and cosmetic industries, announced today that it has entered into a research agreement for a Phase 1 safety and pharmacokinetic study with its flagship product avenanthramide. This clinical study is part of the long-term formal collaboration signed in 2018 with the prestigious Montreal Heart Institute (MHI) and will be led by Jean-Claude Tardif, CM, MD, Director of the Montreal Heart Institute Research Center.

“As we are entering into the last phase of our trial with MHI for our beta-glucan as a potential cholesterol lowering agent, we are honoured to expand our work with the expert team from MHI to conduct a Phase 1 clinical trial to assess the safety and tolerability of our flagship product, avenanthramide, which is well known for its anti-histaminic and anti-inflammatory properties. While some studies have been conducted with various formulations of avenanthramides, to our knowledge none have been done with such a pure pharmaceutical grade formulation. The expertise of the team at MHI, one of the best research Institute specializing in cardiovascular disease in Canada and beyond, is exactly in line with Ceapro’s strategic sector of activities in lifestyle, inflammation and immune-based diseases. This agreement is another step in the expansion of Ceapro’s business model from a contract manufacturer to a life science company,” commented Gilles R. Gagnon, M.Sc., MBA, President and CEO of Ceapro.

Dr. Tardif added, “We are pleased to enter into this new clinical study with Ceapro to evaluate their flagship product, avenanthramide. Because many cardiovascular diseases are inflammation-based, we are quite excited to initiate, hopefully very soon, a clinical trial aimed at evaluating Ceapro’s avenanthramide as a potential therapeutic and/or as a preventive natural product to manage and potentially decrease the risk of cardiovascular diseases. Due to their favorable safety profile, active ingredients from natural products such as avenanthramide generate significant interest in preventing and managing chronic lifestyle diseases.’’

This safety and tolerability study will assess six escalating doses of avenanthramide given orally to healthy volunteers. A unique formulation of Ceapro’s avenanthramide is also under development through a partnership with Montreal-based COREALIS Pharma Inc., a specialty drug design company.

About the Montreal Heart Institute

Founded in 1954 by Dr. Paul David, the Montreal Heart Institute constantly aims for the highest standards of excellence in the cardiovascular field through its leadership in clinical and basic research, ultra-specialized care, professional training, and prevention. It houses the largest cardiology research center in Canada, the largest cardiovascular prevention center in the country, and the largest cardiovascular genetics center in Canada. The Institute is affiliated with the Université de Montréal and has more than 2000 employees, including 245 physicians and more than 85 researchers. For more information, please visit https://www.icm-mhi.org/en. The Montreal Health Innovations Coordinating Center (MHICC) is a leading full-service academic clinical research organization and an integral part of the Montreal Heart Institute (MHI). The MHICC possesses an established network of collaborators in over 4500 clinical sites in more than 35 countries. It has specific expertise in precision medicine, low-cost high-quality clinical trials, and drug repurposing (https:/www.mhicc.org).

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
Jenene Thomas Communications, 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.

Ceapro Inc. Expands Collaboration with Montreal Heart Institute (MHI) with New Clinical Study Evaluating Flagship Product, Avenanthramide

 

– Second human trial to be conducted as part of a long-term Master Service Agreement with MHI

– Phase 1 study with Ceapro’s pharmaceutical grade avenanthramide to be coordinated by MHI’s Montreal Health Innovations Coordinating Center (MHICC) and led by Dr. Jean-Claude Tardif

EDMONTON, Alberta, Aug. 11, 2021 (GLOBE NEWSWIRE) — Ceapro Inc. (TSX-V: CZO; OTCQX: CRPOF), a growth-stage biotechnology company focused on the development and commercialization of active ingredients for healthcare and cosmetic industries, announced today that it has entered into a research agreement for a Phase 1 safety and pharmacokinetic study with its flagship product avenanthramide. This clinical study is part of the long-term formal collaboration signed in 2018 with the prestigious Montreal Heart Institute (MHI) and will be led by Jean-Claude Tardif, CM, MD, Director of the Montreal Heart Institute Research Center.

“As we are entering into the last phase of our trial with MHI for our beta-glucan as a potential cholesterol lowering agent, we are honoured to expand our work with the expert team from MHI to conduct a Phase 1 clinical trial to assess the safety and tolerability of our flagship product, avenanthramide, which is well known for its anti-histaminic and anti-inflammatory properties. While some studies have been conducted with various formulations of avenanthramides, to our knowledge none have been done with such a pure pharmaceutical grade formulation. The expertise of the team at MHI, one of the best research Institute specializing in cardiovascular disease in Canada and beyond, is exactly in line with Ceapro’s strategic sector of activities in lifestyle, inflammation and immune-based diseases. This agreement is another step in the expansion of Ceapro’s business model from a contract manufacturer to a life science company,” commented Gilles R. Gagnon, M.Sc., MBA, President and CEO of Ceapro.

Dr. Tardif added, “We are pleased to enter into this new clinical study with Ceapro to evaluate their flagship product, avenanthramide. Because many cardiovascular diseases are inflammation-based, we are quite excited to initiate, hopefully very soon, a clinical trial aimed at evaluating Ceapro’s avenanthramide as a potential therapeutic and/or as a preventive natural product to manage and potentially decrease the risk of cardiovascular diseases. Due to their favorable safety profile, active ingredients from natural products such as avenanthramide generate significant interest in preventing and managing chronic lifestyle diseases.’’

This safety and tolerability study will assess six escalating doses of avenanthramide given orally to healthy volunteers. A unique formulation of Ceapro’s avenanthramide is also under development through a partnership with Montreal-based COREALIS Pharma Inc., a specialty drug design company.

About the Montreal Heart Institute

Founded in 1954 by Dr. Paul David, the Montreal Heart Institute constantly aims for the highest standards of excellence in the cardiovascular field through its leadership in clinical and basic research, ultra-specialized care, professional training, and prevention. It houses the largest cardiology research center in Canada, the largest cardiovascular prevention center in the country, and the largest cardiovascular genetics center in Canada. The Institute is affiliated with the Université de Montréal and has more than 2000 employees, including 245 physicians and more than 85 researchers. For more information, please visit https://www.icm-mhi.org/en. The Montreal Health Innovations Coordinating Center (MHICC) is a leading full-service academic clinical research organization and an integral part of the Montreal Heart Institute (MHI). The MHICC possesses an established network of collaborators in over 4500 clinical sites in more than 35 countries. It has specific expertise in precision medicine, low-cost high-quality clinical trials, and drug repurposing (https:/www.mhicc.org).

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
Jenene Thomas Communications, 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.

Neovasc Announces Second Quarter 2021 Financial Results

 

VANCOUVER and MINNEAPOLIS – (NewMediaWire) – August 10, 2021 – Neovasc, Inc. (“Neovasc” or the “Company”) (NASDAQ, TSX: NVCN), today reported financial results for the second quarter ended June 30, 2021.

Second Quarter Highlights

• Generated revenue of approximately $633,000 in the quarter, up 123% from the same period in 2020, and a sequential 40% increase from Q1 2021.
• Streamlined strategic focus to pursue three value-creation strategies around Reducer and Tiara TA, suspending Tiara TF activity and reducing headcount by 40%.  These moves are expected to extend the Company’s cash runway into 2024.
• Continued to execute a strategic focus of additional reimbursement agreements, announcing in June that Reducer had been granted the first national reimbursement from the National Health Service England.
• Continued to pursue clinical studies supporting Reducer:
  • Advanced preparations for COSIRA II, the pivotal US trial for Reducer.  The Company expects to file an Investigational Device Exemption (IDE) Supplement with the FDA in the third quarter.
  • Announced the first enrollment in the COSIMA trial in Germany, studying Reducer as a treatment for microvascular angina.

“Neovasc enjoyed a strong second quarter and continued to make good progress on its value creation strategies.  During the quarter we made a strategic decision to streamline our focus on three value creation strategies, coupled with a significant corporate headcount reduction, which is expected to extend our cash runway for three years.  We followed up on these moves in July, adding a new VP of Clinical Affairs and a VP of Regulatory Affairs, Global Angina Therapies to strengthen our expertise in these important areas.  We are placing a heavy emphasis on expanding the market penetration of our CE-marked Reducer device in Europe, working directly with hospitals, cardiologists, and medical associations to raise awareness of the Reducer’s safety, efficacy, and ease of use,” said Fred Colen, President and Chief Executive Officer of Neovasc. Mr. Colen continued, “Our team is also working diligently to expand reimbursement for the Reducer device.  Those efforts were rewarded when Reducer was granted full reimbursement by the National Health Service (NHS) England, and we look forward to sharing news of more reimbursement decisions in the second half of the year. In the United States, we continue to prepare for our pivotal U.S. trial for Reducer and expect to file an IDE Supplement in the third quarter.  With respect to Tiara, we are working with our notified body in Europe to understand all specific requirements and leverage of work already performed, to pursue a CE mark decision for the Tiara TA device under MDR.  There is much more work to do, but we are confident that we now have the team in place and the financial security to successfully execute on our value creation strategies.”

Financial results for the second quarter ended June 30, 2021

Revenues increased 123% to approximately $633,000 for the quarter ended June 30, 2021, compared to revenues of approximately $284,000 for the same period in 2020. 

The cost of goods sold for the three months ended June 30, 2021, was approximately $109,000, compared to $75,000 for the same period in 2020. The overall gross margin for the quarter ended June 30, 2021, was 83%, compared to 74% gross margin for the same period in 2020.

Total expenses for the quarter ended June 30, 2021, were $9.6 million compared to $8.9 million for the same period in 2020, representing an increase of approximately $748,000 or 8%.  The increase in total expenses can be substantially explained by the following non-cash charges; a $1.0 million increase in non-cash share-based payments and an approximate $903,000 charge related to the decision to pause the development of the Tiara TF device ($594,000 impairment charge due to fixed assets obsolescence, and $309,000 charge for employee termination expenses).  This increase in non-cash charges was offset by a $1.1 million decrease in cash-based employee expenses due to the Company’s reductions in force in December 2020 and June 2021.

Operating losses and comprehensive losses for the quarter ended June 30, 2021, were $9.1 million and $9.3 million, respectively, or $0.13 basic and diluted loss per share, as compared with $8.7 million operating losses and $12.2 million comprehensive losses, or $0.81 basic and diluted loss per share, for the same period in 2020.

Conference Call and Webcast information

Neovasc will be hosting a conference call and audio webcast today at 4:30 pm ET to discuss these results.

Domestic:                  1-877-407-9208
International:            1-201-493-6784
Reference ID Code: 13721306

Parties wishing to access the call via webcast should use the link in the Investors section of the Neovasc website at https://www.neovasc.com/investors/.  A replay of the webcast will be available in the Investors sections of the website approximately 30 minutes after the conclusion of the call.

About Neovasc Inc.

Neovasc is a specialty medical device company that develops, manufactures, and markets products for the rapidly growing cardiovascular marketplace. The Company is a leader in the development of minimally invasive transcatheter mitral valve replacement technologies, and minimally invasive devices for the treatment of refractory angina. Its products include the Neovasc Reducer™, for the treatment of refractory angina, which is not currently commercially available in the United States (6 U.S. patients have been treated under Compassionate Use) and has been commercially available in Europe since 2015, and Tiara™, for the transcatheter treatment of mitral valve disease, which is currently under clinical investigation in the United States, Canada, Israel, and Europe. For more information, visit: www.neovasc.com.

NEOVASC INC.

Condensed Interim Consolidated Statements of Financial Position

(Expressed in U.S. dollars) (Unaudited)                                                                 

NEOVASC INC.

Condensed Interim Consolidated Statements of Loss and Comprehensive Loss

For the three and six months ended June 30, 2021 and 2020
(Expressed in U.S. dollars) (Unaudited)                                                                             

 

Investors
Mike Cavanaugh
Westwicke/ICR
Phone: +1.617.877.9641
Mike.Cavanaugh@westwicke.com

Media
Sean Leous
Westwicke/ICR
Phone: +1.646.677.1839
Sean.Leous@icrinc.com

Forward-Looking Statement Disclaimer

Certain statements in this news release contain forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and applicable Canadian securities laws that may not be based on historical fact. When used herein, the words “expect”, “anticipate”, “estimate”, “may”, “will”, “should”, “intend,” “believe”, and similar expressions, are intended to identify forward-looking statements. Forward-looking statements may involve, but are not limited to, expectations as to the future growth of the Company, the expansion of reimbursement for the Reducer, the continued preparation for the US trial of the Reducer, the expectation to file an IDE Supplement in the third quarter, the pursual of a CE mark decision for the Tiara TA device under MDR and the growing cardiovascular marketplace. Many factors and assumptions could cause the Company’s actual results, performance or achievements to differ materially from those expressed or implied by the forward-looking statements, including, without limitation, the doubt about the Company’s ability to continue as a going concern; risks related to the recent COVID-19 coronavirus outbreak or other health epidemics, which could significantly impact the Company’s operations, sales or ability to raise capital or enroll patients in clinical trials and complete certain Tiara development milestones on the Company’s expected schedule; risks relating to the Company’s need for significant additional future capital and the Company’s ability to raise additional funding; risks relating to the sale of a significant number of Common Shares; risks relating to the possibility that the Company’s common shares (the “Common Shares”) may be delisted from the Nasdaq or the TSX, which could affect their market price and liquidity; risks relating to the Company’s conclusion that it did have effective internal control over financial reporting as of December 31, 2020 but not at December 31, 2019 and 2018; risks relating to the Common Share price being volatile; risks relating to the possibility that the Common Shares may be delisted from the Nasdaq or the TSX, which could affect their market price and liquidity; risks relating to the Company’s significant indebtedness, and its effect on the Company’s financial condition; risks relating to lawsuits that the Company is subject to, which could divert the Company’s resources and result in the payment of significant damages and other remedies; risks relating to claims by third-parties alleging infringement of their intellectual property rights; risks relating to the Company’s ability to establish, maintain and defend intellectual property rights in the Company’s products; risks relating to results from clinical trials of the Company’s products, which may be unfavorable or perceived as unfavorable; the Company’s history of losses and significant accumulated deficit; risks associated with product liability claims, insurance and recalls; risks relating to use of the Company’s products in unapproved circumstances, which could expose the Company to liabilities; risks relating to competition in the medical device industry, including the risk that one or more competitors may develop more effective or more affordable products; risks relating to the Company’s ability to achieve or maintain expected levels of market acceptance for the Company’s products, as well as the Company’s ability to successfully build its in-house sales capabilities or secure third-party marketing or distribution partners; risks relating to the Company’s ability to convince public payors and hospitals to include the Company’s products on their approved products lists; risks relating to new legislation, new regulatory requirements and the efforts of governmental and third-party payors to contain or reduce the costs of healthcare; risks relating to increased regulation, enforcement and inspections of participants in the medical device industry, including frequent government investigations into marketing and other business practices; risks relating to the extensive regulation of the Company’s products and trials by governmental authorities, as well as the cost and time delays associated therewith; risks relating to post-market regulation of the Company’s products; risks relating to health and safety concerns associated with the Company’s products and industry; risks relating to the Company’s manufacturing operations, including the regulation of the Company’s manufacturing processes by governmental authorities and the availability of two critical components of the Reducer; risks relating to the possibility of animal disease associated with the use of the Company’s products; risks relating to the manufacturing capacity of third-party manufacturers for the Company’s products, including risks of supply interruptions impacting the Company’s ability to manufacture its own products; risks relating to the Company’s dependence on limited products for substantially all of the Company’s current revenues; risks relating to the Company’s exposure to adverse movements in foreign currency exchange rates; risks relating to the possibility that the Company could lose its foreign private issuer status under U.S. federal securities laws; risks relating to the possibility that the Company could be treated as a “passive foreign investment company”; risks relating to breaches of anti-bribery laws by the Company’s employees or agents; risks relating to future changes in financial accounting standards and new accounting pronouncements; risks relating to the Company’s dependence upon key personnel to achieve its business objectives; risks relating to the Company’s ability to maintain strong relationships with physicians; risks relating to the sufficiency of the Company’s management systems and resources in periods of significant growth; risks relating to consolidation in the health care industry, including the downward pressure on product pricing and the growing need to be selected by larger customers in order to make sales to their members or participants; risks relating to the Company’s ability to successfully identify and complete corporate transactions on favorable terms or achieve anticipated synergies relating to any acquisitions or alliances; risks relating to conflicts of interests among the Company’s officers and directors as a result of their involvement with other issuers; and risks relating to anti­takeover provisions in the Company’s constating documents which could discourage a third-party from making a takeover bid beneficial to the Company’s shareholders. These risk factors and others relating to the Company are discussed in greater detail in the “Risk Factors” section of the Company’s Annual Information Form and in the Management’s Discussion and Analysis for the three and six months ended June 30, 2021 (copies of which may be obtained at www.sedar.com or www.sec.gov). The Company has no intention and undertakes no obligation to update or revise any forward-looking statements beyond required periodic filings with securities regulators, whether as a result of new information, future events or otherwise, except as required by law.

	Image Credit: Jessica Na (Flickr)

From CRISPR to Glowing Proteins to Optogenetics – Scientists’ Most Powerful Technologies Have Been Borrowed from Nature

 

Watson and Crick, Schrödinger and Einstein all made theoretical breakthroughs that have changed the world’s understanding of science.

Today big, game-changing ideas are less common. New and improved techniques are the driving force behind modern scientific research and discoveries. They allow scientists – including chemists like me – to do our experiments faster than before, and they shine light on areas of science hidden to our predecessors.

Three cutting-edge techniques – the gene-editing tool CRISPR, fluorescent proteins and optogenetics – were all inspired by nature. Biomolecular tools that have worked for bacteria, jellyfish and algae for millions of years are now being used in medicine and biological research. Directly or indirectly, they will change the lives of everyday people.

 

Bacterial Defense Systems
as Genetic Editors

Bacteria and viruses battle themselves and one another. They are at constant biochemical war, competing for scarce resources.

One of the weapons that bacteria have in their arsenal is the CRISPR-Cas system. It is a genetic library consisting of short repeats of DNA gathered over time from hostile viruses, paired with a protein called Cas that can cut viral DNA as if with scissors. In the natural world, when bacteria are attacked by viruses whose DNA has been stored in the CRISPR archive, the CRISPR-Cas system hunts down, cuts and destroys the viral DNA.

Scientists have repurposed these weapons for their own use, with groundbreaking effect. Jennifer Doudna, a biochemist based at the University of California, Berkeley, and French microbiologist Emmanuelle Charpentier shared the 2020 Nobel Prize in chemistry for the development of CRISPR-Cas as a gene-editing technique.

The Human Genome Project has provided a nearly complete genetic sequence for humans and given scientists a template to sequence all other organisms. However, before CRISPR-Cas, we researchers didn’t have the tools to easily access and edit the genes in living organisms. Today, thanks to CRISPR-Cas, lab work that used to take months and years and cost hundreds of thousands of dollars can be done in less than a week for just a few hundred dollars.

There are more than 10,000 genetic disorders caused by mutations that occur on only one gene, the so-called single-gene disorders. They affect millions of people. Sickle cell anemia, cystic fibrosis and Huntington’s disease are among the most well-known of these disorders. These are all obvious targets for CRISPR therapy because it is much simpler to fix or replace just one defective gene rather than needing to correct errors on multiple genes.

For example, in preclinical studies, researchers injected an encapsuled CRISPR system into patients born with a rare genetic disease, transthyretin amyloidosis, that causes fatal nerve and heart conditions. Preliminary results from the study demonstrated that CRISPR-Cas can be injected directly into patients in such a way that it can find and edit the faulty genes associated with a disease. In the six patients included in this landmark work, the encapsuled CRISPR-Cas minimissiles reached their target genes and did their job, causing a significant drop in a misfolded protein associated with the disease.

 

 

Jellyfish Light up the Microscopic
World

The crystal jellyfish, Aequorea Victoria, which drifts aimlessly in the northern Pacific, has no brain, no anus and no poisonous stingers. It is an unlikely candidate to ignite a revolution in biotechnology. Yet on the periphery of its umbrella, it has about 300 photo-organs that give off pinpricks of green light that have changed the way science is conducted.

This bioluminescent light in the jellyfish stems from a luminescent protein called aequorin and a fluorescent molecule called green fluorescent protein, or GFP. In modern biotechnology GFP acts as a molecular lightbulb that can be fused to other proteins, allowing researchers to track them and to see when and where proteins are being made in the cells of living organisms. Fluorescent protein technology is used in thousands of labs every day and has resulted in the awarding of two Nobel Prizes, one in 2008 and the other in 2014. And fluorescent proteins have now been found in many more species.

This technology proved its utility once again when researchers created genetically modified COVID-19 viruses that express GFP. The resulting fluorescence makes it possible to follow the path of the viruses as they enter the respiratory system and bind to surface cells with hairlike structures.

 

Algae Let us Play the Brain
Neuron by Neuron

When algae, which depend on sunlight for growth, are placed in a large aquarium in a darkened room, they swim around aimlessly. But if a lamp is turned on, the algae will swim toward the light. The single-celled flagellates – so named for the whiplike appendages they use to move around – don’t have eyes. Instead, they have a structure called an eyespot that distinguishes between light and darkness. The eyespot is studded with light-sensitive proteins called channelrhodopsins.

In the early 2000s, researchers discovered that when they genetically inserted these channelrhodopsins into the nerve cells of any organism, illuminating the channelrhodopsins with blue light caused neurons to fire. This technique, known as optogenetics, involves inserting the algae gene that makes channelrhodopsin into neurons. When a pinpoint beam of blue light is shined on these neurons, the channelrhodopsins open up, calcium ions flood through the neurons and the neurons fire.

Using this tool, scientists can stimulate groups of neurons selectively and repeatedly, thereby gaining a more precise understanding of which neurons to target to treat specific disorders and diseases. Optogenetics might hold the key to treating debilitating and deadly brain diseases, such as Alzheimer’s and Parkinson’s.

But optogenetics isn’t only useful for understanding the brain. Researchers have used optogenetic techniques to partially reverse blindness and have found promising results in clinical trials using optogenetics on patients with retinitis pigmentosa, a group of genetic disorders that break down retinal cells. And in mouse studies, the technique has been used to manipulate heartbeat and regulate bowel movements of constipated mice.

 

What Else Lies Within Nature’s
Toolbox?

What undiscovered techniques does nature still hold for us?

According to a 2018 study, people represent just 0.01% of all living things by mass but have caused the loss of 83% of all wild mammals and half of all plants in our brief time on Earth. By annihilating nature, humankind might be losing out on new, powerful and life-altering techniques without having even imagined them.

This article was republished with permission from The
Conversation, a news site dedicated to sharing ideas from academic
experts. It represents the research-based findings and
opinions  of Marc
Zimmer Professor of Chemistry, Connecticut College.

 

Suggested Reading:

Cells That Can Be Produced from Stem Cells

Advancing Research Into Alzheimer’s and Stem Cells

Preventing the Immune System from rejecting Gene Therapy

Stem Cell-Derived Retinal Pigment Epithelium Cells – Vision for the Future

 

Stay up to date. Follow us:

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

 

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

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

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

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

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

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

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

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

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

gammaCore is contraindicated for patients if they:

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

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

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

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

Forward-Looking Statements

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

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

or

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

Lineage to Present at the H.C. Wainwright Ophthalmology Conference on August 17, 2021

 

CARLSBAD, Calif.–(BUSINESS WIRE)–Aug. 10, 2021– 

Lineage Cell Therapeutics, Inc.
 (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, today announced that  Brian M. Culley, the Company’s Chief Executive Officer, will be participating in and presenting at the 

H.C. Wainwright & Co. Inc. 
Virtual Ophthalmology Conference
. Mr. Culley’s presentation will be available on-demand starting on 
August 17^th, 2021 at 
7am ET / 
4am PT.  Mr. Culley will also participate in an industry panel, Addressing Unmet Medical Needs in Macular Degeneration – Dry AMD and Stargardt Disease, hosted by Yi Chen, Ph.D., CFA, Managing Director, 
Senior Healthcare Analyst, 
H.C. Wainwright & Co., Inc., on 
August 17^th, 2021 at 
11am ET / 
8am PT.

Interested parties can register to view both the on-demand and live industry panel presentations on the Events and Presentations section of Lineage’s website. Additional videos are available on the Media page of the Lineage website.

About Lineage Cell Therapeutics, Inc. 

Lineage Cell Therapeutics is a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs. Lineage’s programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineage’s clinical programs are in markets with billion dollar opportunities and include three allogeneic (“off-the-shelf”) product candidates: (i) OpRegen^®, a retinal pigment epithelium transplant therapy in Phase 1/2a development for the treatment of dry age-related macular degeneration, a leading cause of blindness in the developed world; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of subacute spinal cord injuries; and (iii) VAC2, an allogeneic dendritic cell therapy produced from Lineage’s VAC technology platform for immuno-oncology and infectious disease, currently in Phase 1 clinical development for the treatment of non-small cell lung cancer. For more information, please visit www.lineagecell.com or follow the Company on Twitter @LineageCell.

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

Solebury Trout IR
Gitanjali Jain Ogawa
(Gogawa@soleburytrout.com)
(646) 378-2949

Russo Partners – Media Relations
Nic Johnson or  David Schull
Nic.johnson@russopartnersllc.com
David.schull@russopartnersllc.com
(212) 845-4242

Source: 
Lineage Cell Therapeutics, Inc.

Lineage to Present at the H.C. Wainwright Ophthalmology Conference on August 17, 2021

 

CARLSBAD, Calif.–(BUSINESS WIRE)–Aug. 10, 2021– 

Lineage Cell Therapeutics, Inc.
 (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, today announced that  Brian M. Culley, the Company’s Chief Executive Officer, will be participating in and presenting at the 

H.C. Wainwright & Co. Inc. 
Virtual Ophthalmology Conference
. Mr. Culley’s presentation will be available on-demand starting on 
August 17^th, 2021 at 
7am ET / 
4am PT.  Mr. Culley will also participate in an industry panel, Addressing Unmet Medical Needs in Macular Degeneration – Dry AMD and Stargardt Disease, hosted by Yi Chen, Ph.D., CFA, Managing Director, 
Senior Healthcare Analyst, 
H.C. Wainwright & Co., Inc., on 
August 17^th, 2021 at 
11am ET / 
8am PT.

Interested parties can register to view both the on-demand and live industry panel presentations on the Events and Presentations section of Lineage’s website. Additional videos are available on the Media page of the Lineage website.

About Lineage Cell Therapeutics, Inc. 

Lineage Cell Therapeutics is a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs. Lineage’s programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineage’s clinical programs are in markets with billion dollar opportunities and include three allogeneic (“off-the-shelf”) product candidates: (i) OpRegen^®, a retinal pigment epithelium transplant therapy in Phase 1/2a development for the treatment of dry age-related macular degeneration, a leading cause of blindness in the developed world; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of subacute spinal cord injuries; and (iii) VAC2, an allogeneic dendritic cell therapy produced from Lineage’s VAC technology platform for immuno-oncology and infectious disease, currently in Phase 1 clinical development for the treatment of non-small cell lung cancer. For more information, please visit www.lineagecell.com or follow the Company on Twitter @LineageCell.

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

Solebury Trout IR
Gitanjali Jain Ogawa
(Gogawa@soleburytrout.com)
(646) 378-2949

Russo Partners – Media Relations
Nic Johnson or  David Schull
Nic.johnson@russopartnersllc.com
David.schull@russopartnersllc.com
(212) 845-4242

Source: 
Lineage Cell Therapeutics, Inc.