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Results of Dermatitis Clinical Trial Due This Summer

Enrollment is now done for VYNE Therapeutics Inc.’s Phase 2a trial following encouraging Phase 1b efficacy data, noted an H.C. Wainwright & Co. report.

VYNE Therapeutics Inc. (VYNE:NASDAQ) finished enrolling patients, on schedule, in the Phase 2a trial evaluating FMX114 in mild to moderate atopic dermatitis, and topline results are expected in late July-early August of this year, reported H.C. Wainwright & Co. analyst Joseph Pantginis in a June 17 research note.

Also of note, H.C. Wainwright’s target price on VYNE of $7 per share indicates a significant potential return for investors given the biopharma company’s current share price is around $0.50.

In Phase 2a, a double-blinded study, the 25 enrolled patients are to receive FMX114 and vehicle treatment four times a day for four weeks, Pantginis relayed. The objective is to further assess the safety, pharmacokinetics, and efficacy of the company’s proprietary tofacitinib and fingolimod combination gel formulation.

Pantginis highlighted that results from the Phase 1b portion of the Phase 1b/2a trial are encouraging. Patients showed a significant reduction in atopic dermatitis signs and symptoms after two weeks of FMX114 treatment. The therapeutic was shown to be safe, too.

In the report, Pantginis also provided updates on VYNE’s two immunomodulatory assets, VYN201 and VYN202. These are BET inhibitors derived from the InhiBET platform.

“BET proteins are key regulators of inflammation and oncogenesis via mechanisms of transcriptional modulation,” the analyst explained.

As for VYN201, a locally administered pan-bromodomain inhibitor, it “demonstrated robust preclinical efficacy in a number of inflammatory indications,” noted Pantginis. Newly released data on VYN201 show it safely provides immunosuppression.

VYNE intends to pursue VYN201 in vitiligo first, given the market potential, “impressive preliminary data” and significant unmet need, Pantginis wrote. “Current therapies for vitiligo are limited in their ability to generate a rapid response, are typically cumbersome for patients, and have limited durability.”

As such, the company is targeting H2/22 for the launch of a Phase 1a/b clinical trial of VYN201 in vitiligo.

“This is an important step forward for VYNE and its InhiBET platform, and we look forward to updates in the upcoming months,” Pantginis added.

Regarding VYNE’s later-stage, orally administered VYN202, the biopharma has yet to decide which systemic hyperinflammatory indication to pursue it in first, but the choices include rheumatoid arthritis, and systemic lupus erythematosus, ulcerative colitis/Crohn’s disease, and multiple sclerosis. VYNE is looking to commence, later this year, a Phase 1 trial of VYN202 in the indication it chooses.

H.C. Wainwright & Co. has a Buy rating on VYNE.

Disclosures

1) Doresa Banning wrote this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. She or members of her household own securities of the following companies mentioned in the article: None. She or members of her household are paid by the following companies mentioned in this article: None.

2) The following companies mentioned in this article are billboard sponsors of Streetwise Reports: None. Click here for important disclosures about sponsor fees.

3) Comments and opinions expressed are those of the specific experts and not of Streetwise Reports or its officers. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.

4) The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional, and any action a reader takes as a result of the information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Streetwise Reports’ terms of use and full legal disclaimer. This article is not a solicitation for investment. Streetwise Reports does not render general or specific investment advice, and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Streetwise Reports does not endorse or recommend the business, products, services, or securities of any company mentioned on Streetwise Reports.

5) From time to time, Streetwise Reports LLC and its directors, officers, employees, or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in the securities mentioned. Directors, officers, employees, or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the decision to publish an article until three business days after the publication of the article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases.-

6) This article does not constitute medical advice. Officers, employees, and contributors to Streetwise Reports are not licensed, medical professionals. Readers should always contact their healthcare professionals for medical advice.

Disclosures for H.C.Wainwright & Co., VYNE Therapeutics, Inc., June 17, 2022

H.C. Wainwright & Co, LLC (the “Firm”) is a member of FINRA and SIPC and a registered U.S. Broker-Dealer.

I, Joseph Pantginis, Ph.D. and Emanuela Branchetti, Ph.D. , certify that 1) all of the views expressed in this report accurately reflect my personal views about any and all subject securities or issuers discussed; and 2) no part of my compensation was, is, or will be directly or indirectly related to the specific recommendation or views expressed in this research report; and 3) neither myself nor any members of my household is an officer, director or advisory board member of these companies.

None of the research analysts or the research analyst’s household has a financial interest in the securities of VYNE Therapeutics, Inc. (including, without limitation, any option, right, warrant, future, long or short position). As of May 31, 2022 neither the Firm nor its affiliates beneficially own 1% or more of any class of common equity securities of VYNE Therapeutics, Inc.. Neither the research analyst nor the Firm knows or has reason to know of any other material conflict of interest at the time of publication of this research report.

The research analyst principally responsible for preparation of the report does not receive compensation that is based upon any specific investment banking services or transaction but is compensated based on factors including total revenue and profitability of the Firm, a substantial portion of which is derived from investment banking services. The firm or its affiliates received compensation from VYNE Therapeutics, Inc. for non-investment banking services in the previous 12 months. The Firm or its affiliates did not receive compensation from VYNE Therapeutics, Inc. for investment banking services within twelve months before, but will seek compensation from the companies mentioned in this report for investment banking services within three months following publication of the research report. The Firm does not make a market in VYNE Therapeutics, Inc. as of the date of this research report.

The securities of the company discussed in this report may be unsuitable for investors depending on their specific investment objectives and financial position. Past performance is no guarantee of future results. This report is offered for informational purposes only, and does not constitute an offer or solicitation to buy or sell any securities discussed herein in any jurisdiction where such would be prohibited. This research report is not intended to provide tax advice or to be used to provide tax advice to any person. Electronic versions of H.C. Wainwright & Co., LLC research reports are made available to all clients simultaneously. No part of this report may be reproduced in any form without the expressed permission of H.C. Wainwright & Co., LLC. Additional information available upon request.

H.C. Wainwright & Co., LLC does not provide individually tailored investment advice in research reports. This research report is not intended to provide personal investment advice and it does not take into account the specific investment objectives, financial situation and the particular needs of any specific person. Investors should seek financial advice regarding the appropriateness of investing in financial instruments and implementing investment strategies discussed or recommended in this research report. H.C. Wainwright & Co., LLC’s and its affiliates’ salespeople, traders, and other professionals may provide oral or written market commentary or trading strategies that reflect opinions that are contrary to the opinions expressed in this research report.

H.C. Wainwright & Co., LLC and its affiliates, officers, directors, and employees, excluding its analysts, will from time to time have long or short positions in, act as principal in, and buy or sell, the securities or derivatives (including options and warrants) thereof of covered companies referred to in this research report.

The information contained herein is based on sources which we believe to be reliable but is not guaranteed by us as being accurate and does not purport to be a complete statement or summary of the available data on the company, industry or security discussed in the report. All opinions and estimates included in this report constitute the analyst’s judgment as of the date of this report and are subject to change without notice. Securities and other financial instruments discussed in this research report: may lose value; are not insured by the Federal Deposit Insurance Corporation; and are subject to investment risks, including possible loss of the principal amount invested.

New Positive Data Seem to Support Drug Label Expansion

Checkpoint Therapeutics Inc., the biopharma behind this late-stage monoclonal antibody for metastatic cutaneous squamous cell carcinoma, could use the new trial results to seek approval in the locally advanced presentation of this cancer, too, noted a Ladenburg Thalmann report.

clinical trial

Checkpoint Therapeutics Inc. (CKPT:NASDAQ) reported positive interim data from its pivotal trial of cosibelimab, an anti-PD-L1 antibody, in locally advanced cutaneous squamous cell carcinoma, reported Ladenburg Thalmann analyst Matthew Kaplan in a June 17 research note.

“We are impressed with the initial robust results and believe there is a possibility they could be included in the planned metastatic cutaneous squamous cell carcinoma biologics license application filing and potentially serve as the basis for label expansion to include locally advanced cutaneous squamous cell carcinoma,” Kaplan wrote.

Kaplan noted Ladenburg Thalmann’s target price on Buy-rated Checkpoint Therapeutics is $26 per share, which, when compared to its current $1.07 share price, implies significant return potential for investors.

The Massachusetts-headquartered biopharma is on track to file, later this year, the biologics license application with the U.S. Food and Drug Administration (FDA) for cosibelimab in another form of cutaneous squamous cell carcinoma, metastatic.

Checkpoint presented positive data in this indication at the recent American Society of Clinical Oncology 2022 conference. Of the pivotal trial’s 78 patients with metastatic cutaneous squamous cell carcinoma, 47.4% achieved the primary endpoint of objective response rate; the 95% confidence interval range is 36–59.1. In terms of safety, most treatment-related adverse events were grade 1 or 2; less than 10% were grade 3.

“Pivotal efficacy data reinforce our view cosibelimab has a potential best-in-class efficacy and safety profile in cutaneous squamous cell carcinoma,” Kaplan wrote. “We see strong potential for cosibelimab to grab significant market share in [this] $1 billion-plus market.”

In locally advanced cutaneous squamous cell carcinoma, Checkpoint’s just-released interim cosibelimab data demonstrate a 54.8% objective response rate among the first 31 patients of a planned 80. Kaplan explained these results “significantly exceeded the lower bound of the 95% confidence interval of 25%, which is deemed clinically meaningful by the FDA.”

Further, according to Kaplan, the finding compares well to that of Libtayo’s PD-1 antibody, cemiplimab, in the same indication. The objective response rate with cemiplimab in 78 patients was 44%; the 95% confidence interval range is 32–55.

“These initial [cosibelimab] results bode well for the success of the cosibelimab full locally advanced cutaneous squamous cell carcinoma study results,” Kaplan commented.

 

Disclosures

1) Doresa Banning wrote this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. She or members of her household own securities of the following companies mentioned in the article: None. She or members of her household are paid by the following companies mentioned in this article: None.

2) The following companies mentioned in this article are billboard sponsors of Streetwise Reports: None. Click here for important disclosures about sponsor fees.

3) Comments and opinions expressed are those of the specific experts and not of Streetwise Reports or its officers. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.

4) The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional, and any action a reader takes as a result of the information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Streetwise Reports’ terms of use and full legal disclaimer. This article is not a solicitation for investment. Streetwise Reports does not render general or specific investment advice, and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Streetwise Reports does not endorse or recommend the business, products, services, or securities of any company mentioned on Streetwise Reports.

5) From time to time, Streetwise Reports LLC and its directors, officers, employees, or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in the securities mentioned. Directors, officers, employees, or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the decision to publish an article until three business days after the publication of the article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases.

6) This article does not constitute medical advice. Officers, employees, and contributors to Streetwise Reports are not licensed, medical professionals. Readers should always contact their healthcare professionals for medical advice.

Disclosures for Ladenburg Thalmann & Co., Checkpoint Therapeutics, Inc., June 17, 2022

Analyst Certification: I, Matthew L. Kaplan, attest that the views expressed in this research report accurately reflect my personal views about the subject security and issuer. Furthermore, no part of my compensation was, is, or will be directly or indirectly related to the specific recommendation or views expressed in this research report, provided, however, that: The research analyst primarily responsible for the preparation of this research report has or will receive compensation based upon various factors, including the volume of trading at the firm in the subject security, as well as the firm’s total revenues, a portion of which is generated by investment banking activities.

General Disclosures: Ladenburg Thalmann & Co. Inc. makes a market in Checkpoint Therapeutics, Inc.. Ladenburg Thalmann & Co. Inc. intends to seek compensation for investment banking and/or advisory services from Checkpoint Therapeutics, Inc. within the next 3 months. Ladenburg Thalmann & Co. Inc had an investment banking relationship with Checkpoint Therapeutics, Inc. within the last 12 months.

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New Drug for Heart Failure on Path to Approval, Analyst Says

The U.S. Food and Drug Administration will likely approve Cytokinetics Inc.’s small molecule in Q1/23, during which its PDUFA date is scheduled, noted an H.C. Wainwright & Co. report.

The original PDUFA date for Cytokinetics Inc.’s (CYTK:NASDAQ) omecamtiv mecarbil was just extended three months until Feb. 28, 2023, by the U.S. Food and Drug Administration (FDA) for review of the additional data it requested relative to the new drug application (NDA), reported H.C. Wainwright & Co. analyst Joseph Pantginis in a June 17 research note.

“Our confidence in omecamtiv’s approval remains unaltered, and we expect the drug to launch in Q1/23,” Pantginis wrote.

Omecamtiv mecarbil is the California-based biopharma’s lead drug candidate, awaiting approval in heart failure. Whereas the PDUFA date delay is not ideal for patients with this medical condition, it allows Cytokinetics more time to prepare for the commercial launch, noted Pantginis.

Also positive for the California-based biopharma, Pantginis wrote, “conversations around potential partnering for the drug (European Union and Japan) continue and should further bolster the company’s nondilutive funding.”

Pantginis highlighted that the further pharmacokinetic data Cytokinetics submitted to the FDA on request is consistent with and does not change any of the conclusions the company already made about omecamtiv mecarbil based on its analyses of all of the available information. As such, H.C. Wainwright’s thesis on the biopharma company remains the same.

What’s next regarding the NDA for omecamtiv is two meetings. One, yet to be scheduled, will be for the FDA and its Advisory Committee.

The second is a late-cycle meeting, likely to take place later this year, between the FDA and Cytokinetics. This event, Pantginis noted, is an opportunity for the biopharma to reiterate omecamtiv’s benefits and, as asserted by key opinion leaders, the likelihood of physician uptake.

In other news, Pantginis reported that Cytokinetics presented, at the American Society of Echocardiography’s 2022 conference, affirming trial results of aficamtem, which the company is developing as a treatment for obstructive and nonobstructive hypertrophic cardiomyopathy as well as heart failure with preserved ejection fraction.

These data pertaining to aficamtem and obstructive hypertrophic cardiomyopathy, according to Pantginis, show the drug quickly provides effective and safe clinical benefits. They “add to and corroborate the previously reported evidence of improvement in cardiac function (resting and provoked left ventricular outflow tract obstruction), patients’ symptoms (New York Heart Association class improved in the majority of treated patients), and remodeling (reduction in plasma N terminal pro hormone BNP).”

Different data, which Cytokinetics presented at the European Society of Cardiology’s 2022 Heart Failure Congress, showed the benefits of aficamtem continued long term, 12 and 24 weeks, without left ventricular ejection fraction drops below 50% and without dosing being interrupted or the drug stopped.

The biopharma has aficamtem trials underway and is planning others.

“Further analysis could contribute to highlighting aficamten’s properties, its potential position in the hypertrophic cardiomyopathy landscape as well as to accelerating its development in nonobstructive hypertrophic cardiomyopathy,” Pantginis wrote.

H.C. Wainwright has a Buy rating and a $75 per share price target on Cytokinetics, the current share price of which is around $40.58.

 

Disclosures

1) Doresa Banning wrote this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. She or members of her household own securities of the following companies mentioned in the article: None. She or members of her household are paid by the following companies mentioned in this article: None.

2) The following companies mentioned in this article are billboard sponsors of Streetwise Reports: None. Click here for important disclosures about sponsor fees.

3) Comments and opinions expressed are those of the specific experts and not of Streetwise Reports or its officers. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.

4) The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional, and any action a reader takes as a result of the information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Streetwise Reports’ terms of use and full legal disclaimer. This article is not a solicitation for investment. Streetwise Reports does not render general or specific investment advice, and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Streetwise Reports does not endorse or recommend the business, products, services, or securities of any company mentioned on Streetwise Reports.

5) From time to time, Streetwise Reports LLC and its directors, officers, employees, or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in the securities mentioned. Directors, officers, employees, or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the decision to publish an article until three business days after the publication of the article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases.

6) This article does not constitute medical advice. Officers, employees, and contributors to Streetwise Reports are not licensed, medical professionals. Readers should always contact their healthcare professionals for medical advice.

Disclosures for H.C.Wainwright & Co., CytokineticsInc., June 17, 2022

H.C. Wainwright & Co, LLC (the “Firm”) is a member of FINRA and SIPC and a registered U.S. Broker-Dealer.

I, Joseph Pantginis, Ph.D. and Emanuela Branchetti, Ph.D. , certify that 1) all of the views expressed in this report accurately reflect my personal views about any and all subject securities or issuers discussed; and 2) no part of my compensation was, is, or will be directly or indirectly related to the specific recommendation or views expressed in this research report; and 3) neither myself nor any members of my household is an officer, director or advisory board member of these companies.

None of the research analysts or the research analyst’s household has a financial interest in the securities of Cytokinetics, Inc. (including, without limitation, any option, right, warrant, future, long or short position). As of May 31, 2022 neither the Firm nor its affiliates beneficially own 1% or more of any class of common equity securities of Cytokinetics, Inc. Neither the research analyst nor the Firm knows or has reason to know of any other material conflict of interest at the time of publication of this research report.

The research analyst principally responsible for preparation of the report does not receive compensation that is based upon any specific investment banking services or transaction but is compensated based on factors including total revenue and profitability of the Firm, a substantial portion of which is derived from investment banking services. The firm or its affiliates received compensation from Cytokinetics, Inc. for non-investment banking services in the previous 12 months.

The Firm or its affiliates did receive compensation from Cytokinetics, Inc. for investment banking services within twelve months before, and will seek compensation from the companies mentioned in this report for investment banking services within three months following publication of the research report. H.C. Wainwright & Co., LLC managed or co-managed a public offering of securities for Cytokinetics, Inc. during the past 12 months. The Firm does not make a market in Cytokinetics, Inc. as of the date of this research report.

The securities of the company discussed in this report may be unsuitable for investors depending on their specific investment objectives and financial position. Past performance is no guarantee of future results. This report is offered for informational purposes only, and does not constitute an offer or solicitation to buy or sell any securities discussed herein in any jurisdiction where such would be prohibited. This research report is not intended to provide tax advice or to be used to provide tax advice to any person. Electronic versions of H.C. Wainwright & Co., LLC research reports are made available to all clients simultaneously.

No part of this report may be reproduced in any form without the expressed permission of H.C. Wainwright & Co., LLC. Additional information available upon request. H.C. Wainwright & Co., LLC does not provide individually tailored investment advice in research reports. This research report is not intended to provide personal investment advice and it does not take into account the specific investment objectives, financial situation and the particular needs of any specific person. Investors should seek financial advice regarding the appropriateness of investing in financial instruments and implementing investment strategies discussed or recommended in this research report.

H.C. Wainwright & Co., LLC’s and its affiliates’ salespeople, traders, and other professionals may provide oral or written market commentary or trading strategies that reflect opinions that are contrary to the opinions expressed in this research report. H.C. Wainwright & Co., LLC and its affiliates, officers, directors, and employees, excluding its analysts, will from time to time have long or short positions in, act as principal in, and buy or sell, the securities or derivatives (including options and warrants) thereof of covered companies referred to in this research report. The information contained herein is based on sources which we believe to be reliable but is not guaranteed by us as being accurate and does not purport to be a complete statement or summary of the available data on the company, industry or security discussed in the report. All opinions and estimates included in this report constitute the analyst’s judgment as of the date of this report and are subject to change without notice. Securities and other financial instruments discussed in this research report: may lose value; are not insured by the Federal Deposit Insurance Corporation; and are subject to investment risks, including possible loss of the principal amount invested.

Dispute Between Biopharma Cos. To Be Resolved by Sept. 30

The arbitration court extended the original deadline for a decision in this case of an alleged breach of contract between TRACON Pharmaceuticals Inc. and I-Mab Biopharma, noted an H.C. Wainwright & Co. report.

Doctor

TRACON Pharmaceuticals Inc. (TCON:NASDAQ) just received word that the deadline for a decision in its ongoing arbitration with I-Mab Biopharma was pushed back to Sept. 30, 2022, reported H.C. Wainwright & Co. analyst Edward White in a June 15 research note.

“A win for TRACON could mean an inflow of nondilutive capital, which is not included in our models,” White noted.

TRACON is a California-based clinical-stage biopharmaceutical company focused on developing and commercializing targeted drugs to treat cancer. I-Mab, headquartered in China, is developing biologics for immuno-oncology.

The arbitration hearing between TRACON and I-Mab ended on Feb. 28, 2022. Subsequently, in May, the two companies submitted post-hearing briefs to the arbitration tribunal.

The basis of the arbitration, White explained, is TRACON’s contention that I-Mab breached its contractual obligations outlined in two collaboration and clinical trial agreements signed in 2018.

Those trial agreements relate to the development of TJ004309, a CD73 antibody, by TRACON. They also relate to five of I-Mab’s proprietary bispecific antibody product candidates to be selected, by I-Mab within five years, for development and commercialization in North America.

The court stayed the initial lawsuit filed by I-Mab, followed by a counterclaim on the part of TRACON, in favor of arbitration, White added.

The analyst pointed out that this arbitration with the extended decision date differs from the arbitration concerning I-Mab’s potential $9 million payment to TRACON with respect to the option for TJ004309.

H.C. Wainwright & Co. has a Buy rating and a $12 per share target price on TRACON, the current share price of which is around $1.30.

 

Disclosures

1) Doresa Banning wrote this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. She or members of her household own securities of the following companies mentioned in the article: None. She or members of her household are paid by the following companies mentioned in this article: None.

2) The following companies mentioned in this article are billboard sponsors of Streetwise Reports: None. Click here for important disclosures about sponsor fees.

3) Comments and opinions expressed are those of the specific experts and not of Streetwise Reports or its officers. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.

4) The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional, and any action a reader takes as a result of the information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Streetwise Reports’ terms of use and full legal disclaimer. This article is not a solicitation for investment. Streetwise Reports does not render general or specific investment advice, and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Streetwise Reports does not endorse or recommend the business, products, services, or securities of any company mentioned on Streetwise Reports.

5) From time to time, Streetwise Reports LLC and its directors, officers, employees, or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in the securities mentioned. Directors, officers, employees, or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the decision to publish an article until three business days after the publication of the article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases.

6) This article does not constitute medical advice. Officers, employees, and contributors to Streetwise Reports are not licensed, medical professionals. Readers should always contact their healthcare professionals for medical advice.

Disclosures for H.C. Wainwright & Co., TRACON Pharmaceuticals Inc. , June 15, 2022

H.C. Wainwright & Co, LLC (the “Firm”) is a member of FINRA and SIPC and a registered U.S. Broker-Dealer.

I, Edward White, certify that 1) all of the views expressed in this report accurately reflect my personal views about any and all subject securities or issuers discussed; and 2) no part of my compensation was, is, or will be directly or indirectly related to the specific recommendation or views expressed in this research report; and 3) neither myself nor any members of my household is an officer, director or advisory board member of these companies.

None of the research analysts or the research analyst’s household has a financial interest in the securities of TRACON Pharmaceuticals, Inc. and I-Mab (including, without limitation, any option, right, warrant, future, long or short position). As of May 31, 2022 neither the Firm nor its affiliates beneficially own 1% or more of any class of common equity securities of TRACON Pharmaceuticals, Inc. and I-Mab.

Neither the research analyst nor the Firm knows or has reason to know of any other material conflict of interest at the time of publication of this research report. The research analyst principally responsible for preparation of the report does not receive compensation that is based upon any specific investment banking services or transaction but is compensated based on factors including total revenue and profitability of the Firm, a substantial portion of which is derived from investment banking services.

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Biotech Co. Advances 3 New Clinical Stage Assets

Ocugen Inc.’s new diverse product candidates include a COVID vaccine, a gene therapeutic for retinitis pigmentosa, and a cell therapy to prevent osteoarthritis, noted a ROTH Capital Partners report.

Running

Ocugen Inc.’s (OCGN:NASDAQ) initial valuation will be driven by its gene therapeutic, OCU400, and the COVID vaccine, COVAXIN, purported ROTH Capital Partners analyst Jonathan Aschoff in a June 15 research note.

ROTH recently resumed analyst coverage of Ocugen with Aschoff taking it over. With that, the investment bank developed fresh financial projections and established a new target price on the biotech, of $8 per share. Ocugen’s current share price, in comparison, is around $1.90.

ROTH based its target price on future commercial success of and projected revenue from COVAXIN in the U.S. and from OCU400 in the U.S. and the EU5 countries.

“As such, we believe that there is substantial room for potential upside to these projections,” Aschoff wrote.

Ocugen, based in Pennsylvania, U.S.A., is focused on discovering, developing, and commercializing novel gene therapies, biologicals, and vaccines in the therapeutic areas of eye, infectious and orthopedic diseases.

Regarding OCU400, Aschoff relayed, that enrollment is underway for a Phase 1/2 dose escalation and safety trial of this modifier gene therapeutic in retinitis pigmentosa that results from mutations in the NR2E3 and RHO genes.

Because OCU400 targets a nuclear hormone receptor that regulates multiple functions in the retina, it potentially could treat retinal diseases caused by several gene mutations, noted Aschoff.

“The program could potentially be expanded to include additional genetic mutations in Phase 3 to evaluate OCU400 in both retinitis pigmentosa and Leber congenital amaurosis,” the analyst added.

As for COVAXIN, Ocugen has the complete North American rights to it, where the vaccine is currently authorized for emergency use in adults and is under review for the same in children, wrote Aschoff.

The biotech plans to resume its Phase 2/3 immuno-bridging and broadening trial of COVAXIN in the U.S. It also intends to finalize, with input from the U.S. Food and Drug Administration (FDA), additional studies needed to file, with the agency, a biologics license application for the vaccine.

Ocugen is also in discussions with Health Canada about funding to acquire Liminal BioScience’s manufacturing facility in Ontario, Aschoff indicated. Ocugen envisions using this plant for research and for manufacturing COVAXIN, its gene therapies, and the other product candidates in its existing and future pipelines.

Finally, Ocugen is advancing its autologous neocartilage cell therapy platform, NeoCart, currently designing a Phase 3 program for it. NeoCart is designed to repair full-thickness lesions in adult knee cartilage to prevent osteoarthritis. For this indication, NeoCart currently has the FDA’s regenerative medicine advanced therapy designation.

“NeoCart has the potential to accelerate healing and reduce pain by rebuilding damaged knee cartilage back to how it was before the injury,” Aschoff commented.

Regarding Ocugen’s financial status, the analyst highlighted that the biotech has sufficient cash, $129.9 million as of the end of Q1/22, to fund operations past the readouts of the COVAXIN immuno-bridging trial and the OCU400 safety study, into 2023.

Disclosures

1) Doresa Banning wrote this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. She or members of her household own securities of the following companies mentioned in the article: None. She or members of her household are paid by the following companies mentioned in this article: None.

2) The following companies mentioned in this article are billboard sponsors of Streetwise Reports: None. Click here for important disclosures about sponsor fees.

3) Comments and opinions expressed are those of the specific experts and not of Streetwise Reports or its officers. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.

4) The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional, and any action a reader takes as a result of the information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Streetwise Reports’ terms of use and full legal disclaimer. This article is not a solicitation for investment. Streetwise Reports does not render general or specific investment advice, and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Streetwise Reports does not endorse or recommend the business, products, services, or securities of any company mentioned on Streetwise Reports.

5) From time to time, Streetwise Reports LLC and its directors, officers, employees, or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in the securities mentioned. Directors, officers, employees, or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the decision to publish an article until three business days after the publication of the article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases.

6) This article does not constitute medical advice. Officers, employees, and contributors to Streetwise Reports are not licensed, medical professionals. Readers should always contact their healthcare professionals for medical advice.

Disclosures for Roth Capital Partners, Ocugen Inc., June 15, 2022

Regulation Analyst Certification (“Reg AC”): The research analyst primarily responsible for the content of this report certifies the following under Reg AC: I hereby certify that all views expressed in this report accurately reflect my personal views about the subject company or companies and its or their securities. I also certify that no part of my compensation was, is or will be, directly or indirectly, related to the specific recommendations or views expressed in this report.

General Disclosures: ROTH makes a market in shares of Ocugen, Inc. and as such, buys and sells from customers on a principal basis. Shares of Ocugen Inc. may be subject to the Securities and Exchange Commission’s Penny Stock Rules, which may set forth sales practice requirements for certain low-priced securities.

ROTH Capital Partners, LLC expects to receive or intends to seek compensation for investment banking or other business relationships with the covered companies mentioned in this report in the next three months. The material, information and facts discussed in this report other than the information regarding ROTH Capital Partners, LLC and its affiliates, are from sources believed to be reliable, but are in no way guaranteed to be complete or accurate. This report should not be used as a complete analysis of the company, industry or security discussed in the report. Additional information is available upon request. This is not, however, an offer or solicitation of the securities discussed. Any opinions or estimates in this report are subject to change without notice. An investment in the stock may involve risks and uncertainties that could cause actual results to differ materially from the forward-looking statements. Additionally, an investment in the stock may involve a high degree of risk and may not be suitable for all investors. No part of this report may be reproduced in any form without the express written permission of ROTH.

NFL Player Teams With Biopharma Co. to Help SCD Patients

Source: Streetwise Reports   06/17/2022

Shares of Global Blood Therapeutics Inc. traded 12% higher after the company reported it has teamed up with New York Jets running back Tevin Coleman and his family to promote education and to offer hope and support to families affected by sickle cell disease.

Biopharmaceutical company Global Blood Therapeutics Inc. (GBT:NASDAQ), which is focused on the development of potentially life-changing medicines for sickle cell anemia and other diseases, yesterday announced “a new partnership with New York Jets running back Tevin Coleman and his wife, Akilah, whose 4-year-old daughter lives with sickle cell disease (SCD), with the goal of educating, inspiring, and raising awareness about SCD – especially among other parents and caregivers.”

The firm noted that the campaign is kicking off ahead of World Sickle Cell Day which this year happens to fall on Father’s Day, June 19, 2022. Global Blood Therapeutics advised that the Coleman family has offered to share their own personal story as part of the company’s Sickle Cell Speaks education program. The company stated that the program was established to present the opportunity for afflicted individuals and family members to share their own authentic stories and experiences of living with sickle cell in order to increase awareness and dispel any misconceptions about the disease.

Tevin Coleman, who is an NFL running back with the New York Jets and sickle cell dad, remarked, “As a dad and husband, there’s nothing more important than the health of my family. This World Sickle Cell Day and Father’s Day, I am especially grateful for my daughter, Nazaneen, who lives and thrives with sickle cell disease.”

Coleman added, “Too many children and adults with sickle cell go untreated, don’t have regular checkups, and only get care when they suffer from symptoms. By sharing our family’s story, we hope to inspire other families and warriors through their journeys to learn all they can and get the early and proactive care that’s best for them.”

The company stated that as part of its Sickle Cell Speaks campaign both Tevin and Akilah will be sharing what they refer to as their “playbook” for those families who are directly impacted by sickle cell disease. The couple is expected to actively participate in numerous appearances both in person and across social media with the goal of lending support and boosting engagement with the sickle cell community.

Global Blood Therapeutics’ EVP and Head of R&D Kim Smith-Whitley, M.D., a pediatric hematologist with over 30 years of experience in caring for SCD patients, commented, “We are excited to partner with Tevin Coleman and his wonderful family to shine the light on their story as we join the sickle cell community in recognizing World Sickle Cell Day…The Colemans have taken important steps to build a foundation of healthy habits and support for their daughter that we hope will help other families create their own playbook for tackling sickle cell, along with the resources available on Sickle Cell Speaks.”

Sickle Cell Disease (SCD) is a lifelong inherited blood disorder that is caused by a genetic mutation in the beta-chain of hemoglobin, which leads to the formation of abnormal hemoglobin known as sickle hemoglobin (HbS). Starting in early childhood, SCD patients typically experience unpredictable and recurrent episodes or crises of severe pain that is attributed to blocked blood flow to organs. The suffering undergone by these children often leads to psychosocial and physical disabilities.

The firm pointed out that Sickle cell disease (SCD) affects over 150,000 people combined in the U.S. and Europe and millions of others worldwide. Though it is most prevalent among those with ancestral roots in sub-Saharan Africa, it also is common in those with Hispanic, Middle Eastern, South Asian and Southern European origins. The company advised that of the roughly 100,000 people in the U.S. who have SCD, about 16,000 are children between the ages of 4 and 11 years old. The company stated that “early intervention and treatment of SCD have shown potential to modify the course of this disease, reduce symptoms and events, prevent long-term organ damage and extend life expectancy.”

Global Blood Therapeutics is a biopharmaceutical company headquartered in South San Francisco, Calif. that is engaged in discovering, developing and providing life-changing medical treatments to patients in underserved communities. The firm is highly focused on the area of sickle cell disease (SCD). The company endeavors to transform the treatment of SCD, an area which the fundamental cause has been understood for decades, but that has lacked innovation in new therapeutics and access to care.

The company mentioned that it has developed the first FDA approved medicine called Oxbryta® (voxelotor) to address the underlying cause of SCD. GBT indicated that Oxbryta works by directly inhibiting sickle hemoglobin (HbS) polymerization, which it explained is the root cause of red blood cell sickling in individuals afflicted with SCD.

In addition, the firm’s drug development pipeline includes several other compounds including a P-selectin inhibitor called inclacumab, which is presently being evaluated in a Phase 3 trial as a potential treatment to reduce the frequency of vaso-occlusive crises (VOCs) and reduce hospital re-admissions post-VOC. VOCs are the most commonly reported occurring complications associated with SCD that result in intense pain and potential irreversible organ damage.

Global Blood Therapeutics started the day with a market cap of around $1.5 billion with approximately 10.82 million shares outstanding. GBT shares opened slightly higher today at $24.16 (+$0.35, +1.47%) over yesterday’s $23.81 closing price. The stock has traded today between $23.91 and $27.765 per share and is currently trading at $26.70 (+$2.89, +12.14%).

 

Disclosure

1) Stephen Hytha compiled this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. He or members of his household own securities of the following companies mentioned in the article: None. He or members of his household are paid by the following companies mentioned in this article: None.
2) The following companies mentioned in this article are billboard sponsors of Streetwise Reports: None. Click here for important disclosures about sponsor fees.
3) Comments and opinions expressed are those of the specific experts and not of Streetwise Reports or its officers. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.
4) The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Streetwise Reports’ terms of use and full legal disclaimer. This article is not a solicitation for investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company mentioned on Streetwise Reports.
5) From time to time, Streetwise Reports LLC and its directors, officers, employees or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in securities mentioned. Directors, officers, employees or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the decision to publish an article until three business days after the publication of the article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases.
6) This article does not constitute medical advice. Officers, employees and contributors to Streetwise Reports are not licensed medical professionals. Readers should always contact their healthcare professionals for medical advice.

Healthcare Tech Firm Improves Earnings and Cash Flow in Q3/22

These changes earned Reliq Health Technologies Inc. an upgrade in overall rating by independent investment research and advisory firm, Jefferson Research.

Reliq Health Technologies Inc. (RHT:TSX.V; RQHTF:OTCQB; A2AJTB:WKN) bolstered its cash flow and earnings during Q3/22, leading Jefferson Research to uprate the telemedicine company to Hold from Sell, as reported in a June 10 research note.

Jefferson rates companies on five metrics—cash flow quality, earnings quality, operating efficiency, balance sheet, and valuation—to derive an overall rating.

During Q3/22, Reliq achieved a better quarter-over-quarter (QOQ) rating in two categories: earnings quality and cash flow quality.

In earnings quality, the area in which it performed the best, the company moved to Strongest from Strong.

“With a reported net income of -$800,000 in the last quarter that was equal to the adjusted number, Reliq’s quality of net income earnings is extremely high,” Jefferson Research noted.

In terms of cash flow quality, Reliq also shone. Having increased cash flow to -$1.5 million from -$2.8 million QOQ, the company garnered a Strong rating, improved from Weak.

Also positive for Reliq is its Low-Risk valuation rating.

“A favorable valuation (a Least Risk or Low-Risk rating) implies lower potential downward price risk that is evidenced by a company price multiple that is lower than the corresponding sector average,” Jefferson Research explained.

Areas in which Reliq could improve are operating efficiency and balance sheet, Jefferson Research noted.

In the operating efficiency category, Reliq showed no change, again earning a rating of Weak. This is because the life sciences company’s gross margin and asset turnover worsened during Q3/22. Gross margin dropped to 65.1% from 74%.

“The lower margin indicates that Reliq’s competitive position has worsened and the company may not be able to derive higher prices for their goods or services,” according to Jefferson Research.

On a positive note regarding operating efficiency, however, during the quarter, Reliq strengthened its earnings before interest and tax margin (to -29.7% from -93%), net margin, return on investment capital, sales, and general administrative costs, and equity turnover.

As for the balance sheet, Reliq fared worse QOQ, moving to a rating of Weakest from Weak because of worsening quick and current ratios. The lower current ratio, having dropped to 4.6 times from 7.3 times, indicates Reliq decreased its amount of current assets relative to current liabilities. The decreased quick ratio, down to 4.4 times from 6.7 times, shows the company lowered its total liquid assets relative to current liabilities.

“The balance sheet shows the ability of Reliq to pay its bills and fund future growth,” Jefferson Research wrote.

 

Disclosures

1) Doresa Banning wrote this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. She or members of her household own securities of the following companies mentioned in the article: None. She or members of her household are paid by the following companies mentioned in this article: None.

2) The following companies mentioned in this article are billboard sponsors of Streetwise Reports: Reliq Health Technologies Inc. Click here for important disclosures about sponsor fees.

3) Comments and opinions expressed are those of the specific experts and not of Streetwise Reports or its officers. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.

4) The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional, and any action a reader takes as a result of the information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Streetwise Reports’ terms of use and full legal disclaimer. This article is not a solicitation for investment. Streetwise Reports does not render general or specific investment advice, and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Streetwise Reports does not endorse or recommend the business, products, services, or securities of any company mentioned on Streetwise Reports.

5) From time to time, Streetwise Reports LLC and its directors, officers, employees, or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in the securities mentioned. Directors, officers, employees, or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the decision to publish an article until three business days after the publication of the article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases.

As of the date of this article, officers and/or employees of Streetwise Reports LLC (including members of their household) own securities of Reliq Health Technologies Inc., a company mentioned in this article.

Disclosures for Jefferson Research, Reliq Health Technologies Inc., June 10, 2022

This report is for information purposes only for clients of Jefferson Research & Management and in no way should be interpreted as a complete investment recommendation. This report has been prepared exclusively by Jefferson Research & Management. Information contained in this report is obtained from sources believed to be reliable, but no guarantee is made to its accuracy and no representation is made that it is complete, or that errors, if discovered, will be corrected.

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2) No employee of Jefferson Research & Management is on the board of any covered company and no outsiders are members of Jefferson Research & Management’s board.

3) Jefferson Research & Management employees trading stock in rated companies are subject to trading restrictions prior to release (once identified) and for a one day period subsequent to rating changes but do not individually or collectively own more than 1 percent of the outstanding stock of a covered company. No part of this report can be reprinted or transmitted electronically without the prior written authorization of Jefferson Research & Management.

Reproduction of any information, data or material, including ratings (“Content”) in any form is prohibited except with the prior written permission of the relevant party. Such party, its affiliates and suppliers (“Content Providers”) do not guarantee the accuracy, adequacy, completeness, timeliness or availability of any Content and are not responsible for any errors or omissions (negligent or otherwise), regardless of the cause, or for the results obtained from the use of such Content. In no event shall Content Providers be liable for any damages, costs, expenses, legal fees, or losses (including lost income or lost profit and opportunity costs) in connection with any use of the Content. A reference to a particular investment or security, a rating or any observation concerning an investment that is part of the Content is not a recommendation to buy, sell or hold such investment or security, does not address the suitability of an investment or security and should not be relied on as investment advice. Credit ratings are statements of opinions and are not statements of fact. 

Investors Gain a Breath of Fresh Air From Ph. 3 CS Trial Results

Source: Streetwise Reports   06/13/2022

Optinose Inc. shares traded 40% higher after the company reported positive top-line data from its Phase 3 ReOpen2 Trial of XHANCE for use in treating chronic sinusitis without nasal polyps.

Optinose Inc.

Specialty pharmaceutical company Optinose Inc. (OPTN:NASDAQ), which is engaged in the development of therapeutics and medical products utilized in caring for patients treated by allergy specialists and ear, nose, and throat (ENT) doctors, today announced “the statistically significant benefits of XHANCE in the ReOpen2 trial for both the symptoms co-primary endpoint and the CT scan co-primary endpoint.”

Optinose stated that in the global Phase 3 ReOpen2 XHANCE trial, patients who had been diagnosed with chronic sinusitis (CS) but did not have nasal polyps, demonstrated significant improvement when treated with both doses of XHANCE® (fluticasone propionate) nasal spray together with the company’s Bi-Directional™ Exhalation Delivery System™ versus patients in the controlled (placebo) group. The firm highlighted that the study represents the first Phase 3 initiative to ever show improvement in both symptoms and inflammation inside the sinuses with a nasal therapy for CS patients.

Optinose’s President Ramy Mahmoud, M.D., M.P.H. commented, “ReOpen2 is a large, international, controlled trial, studying 222 patients with chronic sinusitis who did not also have nasal polyps. Currently there are no FDA-approved drug treatments for this large patient population…With top-line results showing that patients with chronic sinusitis experienced significant improvement in both symptoms and inflammation inside the sinuses, ReOpen2 confirms and builds on the positive results from ReOpen1 and, importantly, provides evidence supporting the effectiveness of XHANCE in the very large chronic sinusitis population without nasal polyps.”

“Our team is working to quickly complete the analyses of both ReOpen1 and ReOpen2 and has begun the work necessary to seek a new indication that expands access to XHANCE for this broader group of patients,” Dr. Mahmoud added.

Rick Chandra, M.D., Professor of Otolaryngology, Chief of Rhinology, Sinus & Skull Base Surgery at Vanderbilt University, remarked, “I see patients every day who suffer greatly from the symptoms of chronic sinusitis, despite availability of current nasal treatments. I am excited to see this important confirmatory data showing the benefits of XHANCE in this challenging population. This evidence has potential to change the treatment paradigm for chronic sinusitis patients.”

The firm mentioned that the Phase 3 ReOpen2 trial is a randomized, double-blind study designed to evaluate the safety and efficacy of XHANCE (OPN-375) in patients with chronic sinusitis (CS) without nasal polyps. CS patients in the study were treated over a period of 24 weeks and were administered either one or two sprays of XHANCE in each nostril twice daily.

The company listed that the two predetermined primary endpoints in the trial were “change from baseline in symptoms, as measured by a composite score of patient-reported symptoms (including nasal congestion, facial pain or pressure sensation, and nasal discharge) at the end of week 4, and objective change in inflammation inside the sinus cavities, as measured by the change in average of percentages of volume occupied by disease across the ethmoid and maxillary sinuses as measured by CT scan.”

The company explained it is estimated that that up to thirty million adults in the U.S. are affected by CS. The firm advised that CS is a chronic and serious inflammatory disease affecting the paranasal sinuses and the nasal cavity at the point where healthy sinus openings ventilate and drain. Patients diagnosed with CS typically exhibit prolonged symptoms that persist for a period of at least 12 weeks, with most experiencing symptoms lasting for many years. In some patients, the condition can be accompanied by nasal polyposis, polyps that have developed in the nasal cavities. The company stated that at present there are not any FDA-approved drug treatments for CS; however, there are certain medicines such as XHANCE that have received FDA approval for treatment of nasal polyps.

Optinose is a specialty pharmaceutical firm based in Yardley, Pa. that concentrates its efforts on developing and commercializing innovative products and medicines for individuals who are afflicted with diseases that are treated by allergists and ear, nose and throat (ENT) specialists. Optinose stated that “XHANCE is a drug-device combination product that uses the Exhalation Delivery System™ (also referred to as the EDS®) designed to deliver a topical anti-inflammatory corticosteroid to the high and deep regions of the nasal cavity where sinuses ventilate and drain.” In addition, the company licenses its Onzetra® Xsail®, a sumatriptan nasal powder indicated for acute treatment of migraine with or without aura in adults, to Currax Pharmaceuticals for sale in the U.S. Canada and Mexico.

Optinose Inc. started the day with a market cap of around $153.0 million with approximately 82.7 million shares outstanding and a short interest of about 2.4%. OPTN shares opened 16% higher today at $2.15 (+$0.30, +16.22%) over Friday’s $1.85 closing price. The stock has traded today between $2.00 and $2.83 per share and is currently trading at $2.59 (+$0.74, +40.00%).

Disclosure

1) Stephen Hytha compiled this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. He or members of his household own securities of the following companies mentioned in the article: None. He or members of his household are paid by the following companies mentioned in this article: None.

2) The following companies mentioned in this article are billboard sponsors of Streetwise Reports: None. Click here for important disclosures about sponsor fees.

3) Comments and opinions expressed are those of the specific experts and not of Streetwise Reports or its officers. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.

4) The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Streetwise Reports’ terms of use and full legal disclaimer. This article is not a solicitation for investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company mentioned on Streetwise Reports.

5) From time to time, Streetwise Reports LLC and its directors, officers, employees or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in securities mentioned. Directors, officers, employees or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the decision to publish an article until three business days after the publication of the article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases.

6) This article does not constitute medical advice. Officers, employees and contributors to Streetwise Reports are not licensed medical professionals. Readers should always contact their healthcare professionals for medical advice.

Biopharma Co. Meets Primary Endpoints in ARDS Trial

Source: Streetwise Reports   06/08/2022

MediciNova Inc. shares traded 9% higher after the company released top-line data from its Phase 2 study of MN-166 (ibudilast) in hospitalized COVID-19 patients deemed to be at elevated risk for acute respiratory distress syndrome. In the study, MN-166 demonstrated significant decreases in respiratory failure.

Reliq Health technologies

Clinical-stage biopharmaceutical company MediciNova Inc. (MNOV:NASDAQ), which is engaged in the development of several novel small molecule therapies for use in treatment of fibrotic, inflammatory and neurodegenerative diseases, today announced “positive top-line results from MediciNova’s Phase 2 clinical trial of MN-166 (ibudilast) in hospitalized COVID-19 patients at risk for developing acute respiratory distress syndrome (ARDS).”

MediciNova advised that over the course of the study MN-166 (ibudilast) was shown to provide large improvements in each of the four predetermined clinical endpoints versus the control group. The company highlighted that MN-166 (ibudilast) had significantly achieved one of the trial’s co-primary endpoints which was identified as the percentage of patients who remained free of respiratory failure. The firm stated that it also successfully achieved another key objective endpoint in the study based upon the proportion of subjects who were discharged from the hospital.

The company advised that the multi-center, randomized, double-blind study enrolled a total of 36 hospitalized male and female patient subjects with an average (mean) age of 60. Each of the hospitalized patients were confirmed to be infected with SARS-CoV-2 and were identified as at risk for developing ARDS and were receiving standard of care, including anticoagulation therapy.

Of the 36 participants, half (17) were treated with MN-166 (ibudilast) 100 mg/day for a period of 7 days and the other half (17) were administered a daily placebo. The groups included equal numbers of men and women.

The firm noted that the top-line results announced pertain to analysis of results related to two pre-established endpoints and two other secondary endpoints. MediciNova reported that after seven days of treatment with MN-166 (ibudilast), 71% of subjects in the treated group remained free from respiratory failure, compared to 35% of subjects in the control group.

The firm added that 71% of subjects in the group that had been treated with MN-166 (ibudilast) also successfully met the study’s co-primary endpoint of clinical status which was measured based upon improvement on the NIAID scale at Day 7, which once again was a higher improvement than that recorded in the placebo group of 47%.

The company provided the data for two other key secondary endpoints and mentioned that 65% of subjects in the MN-166 (ibudilast) group were able to be discharged from the hospital after seven days versus 29% of subjects in the control group.

The firm indicated that that the clinical status (condition), 7% of subjects in the MN-166 (ibudilast) group and 24% of subjects in the placebo group had deteriorated at Day 7 with no deaths in the MN-166 (ibudilast) group but two registered deaths in the placebo group.

The company’s Chief Medical Officer Kazuko Matsuda, M.D., Ph.D., M.P.H. stated, “We are pleased to report the positive top-line results from this study. We believe MN-166 has potential for efficacy in all patients with risk for ARDS and acute lung injury caused by COVID-19 or other infections or causes. There is a large unmet medical need for better treatments as the current rate of death in the hospital is approximately 40% for ARDS patients. We plan to discuss the results of this study with the FDA and get their feedback to determine next steps.”

The firm mentioned that “ARDS is a frequently lethal lung condition caused by excessive inflammation for which there are no effective therapies beyond supportive care.”

The company explained that “MN-166 (ibudilast) is a small molecule compound that inhibits phosphodiesterase type-4 (PDE4) and inflammatory cytokines, including macrophage migration inhibitory factor (MIF).” The firm advised that in addition to the above ARDS study, MN-166 (ibudilast) is currently being evaluated in other late-stage clinical trials as a potential treatment for neurodegenerative diseases including amyotrophic lateral sclerosis (ALS), multiple sclerosis (MS), degenerative cervical myelopathy (DCM) and several other indications.

MediciNova is biopharma firm headquartered in La Jolla, Calif. The company focuses on discovering and developing novel, small-molecule therapeutics for the treatment of diseases with unmet medical needs in several key areas including neurology, respiratory and liver diseases. The company noted that at present it has 11 active programs in various stages of clinical development. The firm indicated that the two leading compounds in its development pipeline are MN-166 (ibudilast) for neurological disorders and MN-001 (tipelukast) for fibrotic diseases. The company is also developing another compound called MN-221 for treating respiratory diseases such as asthma and COPD.

MediciNova began the day Wednesday with a market cap of around $115.3 million with approximately 49.0 million shares outstanding and a short interest of about 2.5%. MNOV shares opened almost 15% higher Wednesday at $2.70 (+$0.35, +14.89%) over Tuesday’s $2.35 closing price. The stock traded Wednesday between $2.51 and $2.7699 per share and closed for trading at $2.56 (+$0.21, +8.94%).

 

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1) Stephen Hytha compiled this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. He or members of his household own securities of the following companies mentioned in the article: None. He or members of his household are paid by the following companies mentioned in this article: None.

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New Drug for Peanut Allergy in Toddlers Shown Safe and Effective

The response rate to DBV Technologies SA’s drug patch in the recent Phase 3 clinical trial was statistically significant, which bodes well for the company as there is currently no approved therapy for children with this condition.

DBV Technologies SA’s (DBVT:NASDAQ) Viaskin patch for peanut allergy in one to three-year-olds was shown to be effective and safe in a Phase 3 clinical trial, reported H.C. Wainwright & Co. analyst Andrew Fein in a June 8 research note. This is significant because no approved therapy exists for youngsters with this condition.

Generally, the EPITOPE trial demonstrated that 250 micrograms of Viaskin epicutaneous immunotherapy, after one year, achieved the primary endpoint of difference between the percentage of treatment responders in the active versus placebo cohorts.

Specifically, after one year, 67% of treated patients versus 33.5% of placebo patients met responder criteria, Fein relayed. This translates to a statistically significant response rate of 33.4% (p<0.001).

“We highlight that the lower bound of the 95% confidence interval was 22.4%, comfortably exceeding the prespecified 15% threshold,” the analyst added.

The EPITOPE trial also showed the safety profile of Viaskin 250 micrograms in one to three-year-olds is consistent with that in children aged four years and older. Mild to moderate skin reactions at the patch site were the most common adverse events.

Fein pointed out that the safety profile of Viaskin is better than that of Palforzia, an approved oral peanut allergy drug for four to 17-year-olds. In EPITOPE, of the patients who received Viaskin, 1.6% had an anaphylactic reaction, from or not from the drug, which did not require epinephrine. This compares to 9.4% of patients with oral Palforzia, which occurred in trials not related to Viaskin.

Based on these positive EPITOPE data, DBV Technologies will continue advancing Viaskin toward approval in this early age group.

Fein highlighted that the French biopharma has a second shot on goal with Viaskin, and that is with a modified Viaskin patch for children ages four to 11 years. DBV Technologies has a Type C meeting with the U.S. Food and Drug Administration scheduled this quarter to discuss and finalize the protocol of the next planned trial in this regard, Phase 3 VITESSE.

“The main difference between the patches is the size and shape of the overlay itself, with the same occlusion chamber design, intended to satisfy optimized delivery,” Fein explained.

H.C. Wainwright has a Buy rating and a $10 per share price target on DBV Technologies, the stock of which is currently trading around $2.85 per share.

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1) Doresa Banning compiled this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. She or members of her household own securities of the following companies mentioned in the article: None. She or members of her household are paid by the following companies mentioned in this article: None.

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3) Comments and opinions expressed are those of the specific experts and not of Streetwise Reports or its officers. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.

4) The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional, and any action a reader takes as a result of the information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Streetwise Reports’ terms of use and full legal disclaimer. This article is not a solicitation for investment. Streetwise Reports does not render general or specific investment advice, and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Streetwise Reports does not endorse or recommend the business, products, services, or securities of any company mentioned on Streetwise Reports.

5) From time to time, Streetwise Reports LLC and its directors, officers, employees, or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in the securities mentioned. Directors, officers, employees, or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the decision to publish an article until three business days after the publication of the article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases.

6) This article does not constitute medical advice. Officers, employees, and contributors to Streetwise Reports are not licensed, medical professionals. Readers should always contact their healthcare professionals for medical advice.

Disclosures for H.C. Wainwright & Co., DBV Technologies S.A., June 8, 2022

H.C. Wainwright & Co, LLC (the “Firm”) is a member of FINRA and SIPC and a registered U.S. Broker-Dealer.

I, Andrew S. Fein, Matthew Caufield, Andres Y. Maldonado, PhD and Ananda Ghosh, PhD , certify that 1) all of the views expressed in this report accurately reflect my personal views about any and all subject securities or issuers discussed; and 2) no part of my compensation was, is, or will be directly or indirectly related to the specific recommendation or views expressed in this research report; and 3) neither myself nor any members of my household is an officer, director or advisory board member of these companies.

None of the research analysts or the research analyst’s household has a financial interest in the securities of DBV Technologies S.A. (including, without limitation, any option, right, warrant, future, long or short position).

As of May 31, 2022 neither the Firm nor its affiliates beneficially own 1% or more of any class of common equity securities of DBV Technologies S.A. Neither the research analyst nor the Firm knows or has reason to know of any other material conflict of interest at the time of publication of this research report.

The research analyst principally responsible for preparation of the report does not receive compensation that is based upon any specific investment banking services or transaction but is compensated based on factors including total revenue and profitability of the Firm, a substantial portion of which is derived from investment banking services.

The firm or its affiliates received compensation from DBV Technologies S.A. for non-investment banking services in the previous 12 months. The Firm or its affiliates did not receive compensation from DBV Technologies S.A. for investment banking services within twelve months before, but will seek compensation from the companies mentioned in this report for investment banking services within three months following publication of the research report.

The Firm does not make a market in DBV Technologies S.A. as of the date of this research report. The securities of the company discussed in this report may be unsuitable for investors depending on their specific investment objectives and financial position. Past performance is no guarantee of future results. This report is offered for informational purposes only, and does not constitute an offer or solicitation to buy or sell any securities discussed herein in any jurisdiction where such would be prohibited. This research report is not intended to provide tax advice or to be used to provide tax advice to any person. Electronic versions of H.C. Wainwright & Co., LLC research reports are made available to all clients simultaneously.

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