Tag: Biotechnology

Release – Ocugen Announces Publication of a Comprehensive Review of BBV152 in Frontiers in Immunology

Posted on by aweinsoff@channelchek.com

Research, News, and Market Data on OCGN

September 14, 2022

  • Data include the persistence of immune responses and protection against variants of concern, especially Delta and Omicron
  • Ocugen has North American commercialization rights for BBV152, commercialized as COVAXIN™

MALVERN, Pa., Sept. 14, 2022 (GLOBE NEWSWIRE) — Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines, today announced the publication “A comprehensive review of BBV152 vaccine development, effectiveness, safety, challenges, and prospects” appeared in Frontiers in Immunology. BBV152, commercialized as COVAXIN™, is developed and manufactured by Ocugen’s partner Bharat Biotech, a global leader in vaccine innovation based in Hyderabad, India. BBV152 is currently authorized by the World Health Organization, authorized under Emergency Use Authorization in 28 countries, and accepted as a COVID-19 vaccine to travel into over 85 countries. It is under clinical investigation by Ocugen in the United States for use in adults aged 18 years and older.

This review by Dotiwala and Upadhyay provides a detailed analysis of the immunogenicity, safety, and efficacy of BBV152—a whole virus inactivated vaccine and an important tool in the fight to control the COVID-19 pandemic. Additionally, BBV152 has a broader impact on public health, as it induces high neutralization efficacy against different SARS-CoV-2 variants of concern.

“Unfortunately, the COVID-19 pandemic is not yet over, despite the introduction of effective vaccines and a greater understanding of COVID-19 pathogenesis and transmission dynamics,” said David Fajgenbaum, MD, MBA, MSc, Assistant Professor of Medicine, Translational Medicine & Human Genetics, University of Pennsylvania, and Ocugen Vaccine Scientific Advisory Board member. “This study demonstrates durability through immune memory and a broader immune response with BBV152 and provides further evidence that additional vaccine options—including those built on a traditional vaccine platform—are needed.”

Findings include:

  • 77.8% and 93.4% protection from symptomatic COVID-19 disease and severe symptomatic COVID-19 disease respectively.
  • Studies in pediatric populations show superior immunogenicity (geometric mean titer ratio of 1.76 compared to an adult) with a seroconversion rate of >95%.
  • Reactogenicity and safety profiles were comparable across all pediatric age groups between 2-18 yrs.

The study concludes that BBV152 is a suitable alternative to mRNA vaccines.

About Ocugen, Inc.
Ocugen, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines that improve health and offer hope for patients across the globe. We are making an impact on patient’s lives through courageous innovation—forging new scientific paths that harness our unique intellectual and human capital. Our breakthrough modifier gene therapy platform has the potential to treat multiple retinal diseases with a single product, and we are advancing research in infectious diseases to support public health and orthopedic diseases to address unmet medical needs. 
Discover more at www.ocugen.com and follow us on Twitter and LinkedIn.

Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks, and uncertainties that may cause actual events or results to differ materially from our current expectations. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (SEC), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events, or otherwise, after the date of this press release.

Contact:

Tiffany Hamilton
Head of Communications
IR@ocugen.com

Why Biotech May Finish out 2022 Very Strong

Posted on by cpatches
Image Credit: Jason Mrachina (Flickr)

The Reasons Biotech is Gaining Ground on the Field

Similar to their watching a horse race, with a sense that their horse is starting to come from behind and may even be moving toward the front of the pack, biotech investors are leaning over the rail, watching their sector’s increased pace. This week biotechs, as measured by the ETF $XBI, crossed above its 200-day moving average – only last week the biotech sector’s momentum took it above its 50-day moving average. Does this technical indicator demonstrate the growing strength will continue, or does this indicate that it may be approaching overbought?

Technical analysis is not usually clear on this; below, we look for clues in the sector’s fundamentals to better handicap its chances.

Source: Koyfin

Pace of Deals

In 2021, the overall healthcare sector experienced record merger and acquisition activity. The first half of 2022 also had significant activity; however, at $92.4 billion in value and 481 deals announced, the pace of activity was down 51% from the same period in 2021. This may feel slow but is well ahead of the pre-pandemic pace for these companies.  For example, it’s a 37% increase from the first half of 2020. This could be seen as fundamentally positive for a sector that is trading below its 2021 levels and even below the second half of 2020. 

One catalyst for this continued high pace of deals which may even help accelerate it, is that big pharmacies are flush with cash. This cash serves them best if invested in the next generation of medicine or valuable patent. Fortunately for big pharma, small and mid-sized biotech companies are more likely now to form financial partnerships, agree to merger arrangements, or be outright purchased in order to help with their need for cash to continue operations.

This dynamic is easy to understand; there is less money flowing into the smaller incubator-type companies than the big pharmaceutical companies that have had money pouring in from generous pandemic-related government contracts. These small companies, many working on what may be life-changing science, rarely have sizeable sales. Sales and revenue come after the final phase of testing, FDA approval, and marketing. A small biotech company that sees its research and development possibly making a difference a few years from now, but is currently burning through capital at a pace where it may only last another 12 months, might welcome partnership or acquisition talks with a cash-rich suitor.

News of any injection of cash or capital in these smaller biotechs is usually an event that pushes the price up by percentage points in a short period of time. A full buyout can do much more.

XBI provides exposure to US biotech stocks, as defined by GICS, from a universe that invests across the market-cap spectrum. The fund equal-weights its portfolio, which in turn emphasizes small- and micro-caps and greatly reduces single-name risk. Thus, the weighted-average market-cap is much smaller than some competitors. Unlike other funds in this segment, XBI is a pure biotech play, with relatively small pharma overlap. The index is rebalanced quarterly.  – FactSet

Put yourself in the position of big pharma in 2022 into 2023. Your firm may now be sitting on a huge war chest thanks to the pandemic. This is now being eroded by high inflation. Management’s role is to use resources to provide value to shareholders. In the meantime, biotech is well-priced and motivated to talk.

And then the clock is always ticking on patent cliffs for big pharma. They may be very amenable to shop for acquisition targets as they look out at the expiration of patent rights and the exclusive protection those patents provide. Analysts estimate the top-ten pharmaceutical manufacturers have more than 46 percent of their revenues at risk between 2022 and 2030. Behemoths like Bristol Myers Squibb, Pfizer and Merck will be among the most exposed over the next decade.

Take Away

Watching a thoroughbred that was lagging behind the pack find an opening and begin to gain ground on those around it is exciting. When you have money on the horse, it’s even more enjoyable. The performance of the biotech sector was far behind other industries for much of this year. Moving into fall it has been outperforming its own average and many other investment areas.

There are fundamentals in play that could keep this strength going. What’s more is that these factors have little to do with the overall market, which many now fear

This challenge may catalyze M&A in the industry as large firms look to recoup lost revenue streams and invest in patents.

Paul Hoffman

Managing Editor, Channelchek

Sources

https://www.nasdaq.com/articles/consolidation-case-for-biotech-etf-bbh

https://www.jdsupra.com/legalnews/big-pharma-firms-return-to-the-deal-6580128/

Release – Axcella Therapeutics to Participate in the H.C. Wainwright Global Investment Conference

Posted on by aweinsoff@channelchek.com

Research, News, and Market Data on AXLA

September 12, 2022 at 8:00 AM EDT

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Sep. 12, 2022– Axcella Therapeutics (Nasdaq: AXLA), a clinical-stage biotechnology company pioneering a new approach to treat complex diseases using multi-targeted endogenous metabolic modulator (EMM) compositions, today announced that management will participate in a fireside chat and one-on-one meetings at the H.C. Wainwright Global Investment Conference taking place September 12 – 14, 2022 both virtually and in-person in New York City.

Details for the fireside chat are as follows:

Date:Tuesday, September 13, 2022
Time:10:30 am Eastern Time
Webcast:https://journey.ct.events/view/6604fa89-69be-476a-b518-b615e1ac7fb6

The conference call webcast will be accessible in the Investors & News section on the company’s website at www.axcellatx.com. An archive of the webcast replay will be available on the Company’s website for up to 90 days.

To request a one-on-one in-person or virtual meeting, please register here.

Internet Posting of Information

Axcella uses the “Investors and News” section of its website, www.axcellatx.com, as a means of disclosing material nonpublic information, to communicate with investors and the public, and for complying with its disclosure obligations under Regulation FD. Such disclosures include, but may not be limited to, investor presentations and FAQs, Securities and Exchange Commission filings, press releases, and public conference calls and webcasts. The information that we post on our website could be deemed to be material information. As a result, we encourage investors, the media and others interested to review the information that we post there on a regular basis. The contents of our website shall not be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended.

About Axcella Therapeutics (Nasdaq: AXLA)

Axcella is a clinical-stage biotechnology company pioneering a new approach to treat complex diseases using compositions of endogenous metabolic modulators (EMMs). The company’s product candidates are comprised of EMMs and derivatives that are engineered in distinct combinations and ratios to reset multiple biological pathways, improve cellular energetics, and restore homeostasis. Axcella’s pipeline includes lead therapeutic candidates in Phase 2 development for the treatment of Long COVID and NASH. The company’s unique model allows for the evaluation of its EMM compositions through non-IND clinical studies or IND clinical trials. For more information, please visit www.axcellatx.com.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220912005400/en/

Ashley Robinson
arr@lifesciadvisors.com
(617) 430-7577

Source: Axcella Therapeutics

Cocrystal Pharma (COCP) – Influenza Program Update

Posted on by cpatches


Monday, September 12, 2022

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

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

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

Cocrystal Has Reported Progress In Its Influenza Program.  Cocrystal has reported Phase 1 data and plans for a Phase 2a  trial for CC-42344, its oral drug for seasonal and pandemic influenza.  The drug is an inhibitor of the enzyme PB2 (polymerase basic 2), a subunit of the RNA polymerase required for the replication cycle of the virus.  This early point of action could make it effective against all strains of influenza.

Phase 1 Data Confirmed Once-Daily Dosing.  In July 2022, Cocrystal announced pharmacokinetic data from its Phase 1 trial. The single ascending-dose stage met its goals, confirming administration on a once-daily basis.  Patient enrollment continues in the multiple ascending dose portion.  The company plans to present the study data at a medical meeting later in the year.


Get the Full Report

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. 

Release – Baudax Bio to Present at the 24th Annual H.C. Wainwright Healthcare Conference

Posted on by aweinsoff@channelchek.com

Research, News, and Market Data on BXRX

September 08, 2022 4:05pm EDT

MALVERN, Pa., Sept. 08, 2022 (GLOBE NEWSWIRE) — Baudax Bio, Inc. (NASDAQ:BXRX), a pharmaceutical company focused on innovative products for acute care settings, today announced that Gerri Henwood, the Company’s President and Chief Executive Officer, will present at the 24th Annual H.C. Wainwright Healthcare Conference, taking place in New York, New York on Wednesday, September 14, 2022 at 3:00 p.m. Eastern Time.

A webcast of the presentation will be available on the “Events” page within the investors section of the Baudax Bio website at https://www.baudaxbio.com/news-and-investors. The webcast will be archived on the company’s website for 90 days following the event.

About Baudax Bio

Baudax Bio is a pharmaceutical company focused on innovative products for acute care settings. Baudax Bio markets ANJESO®, the first and only 24-hour, non-opioid, intravenous (IV) COX-2 preferential non-steroidal anti-inflammatory (NSAID) for the management of moderate to severe pain. In addition to ANJESO, Baudax Bio has a pipeline of other innovative pharmaceutical assets including two clinical-stage, novel neuromuscular blocking agents (NMBs) and a proprietary chemical reversal agent specific to these NMBs. For more information, please visit www.baudaxbio.com.

CONTACT:

Investor Relations Contact:

Argot Partners
Sam Martin / Kaela Ilami
(212) 600-1902
baudaxbio@argotpartners.com

Media Contact:

Argot Partners
David Rosen
(212) 600-1902
david.rosen@argotpartners.com

Source: Baudax Bio, Inc.

Released September 8, 2022

Release – Ocugen CSO to Participate in 3rd Annual Gene Therapy for Ophthalmic Disorders Conference

Posted on by cpatches

Research, News, and Market Data on OCGN

MALVERN, Pa., Sept. 08, 2022 (GLOBE NEWSWIRE) — Ocugen, Inc. (“Ocugen” or the “Company”) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines, today announced that the Company’s Chief Scientific Officer, Arun Upadhyay, PhD, will be among the featured speakers at the 3rd Annual Gene Therapy for Ophthalmic Disorders conference, which is being held Sept. 13-16 in Danvers, Massachusetts.

Details regarding Dr. Upadhyay’s presentation are as follows:

Event:3rd Annual Gene Therapy for Ophthalmic Disorders Conference
Topic:Highlighting the Modifier Gene Therapy Approach for the Treatment of Retinitis Pigmentosa
Date:September 14, 2022
Time:9:15 a.m. ET
Location:DoubleTree by Hilton Boston North Shore, Danvers, Mass.

About Ocugen, Inc.
Ocugen, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines that improve health and offer hope for patients across the globe. We are making an impact on patient’s lives through courageous innovation—forging new scientific paths that harness our unique intellectual and human capital. Our breakthrough modifier gene therapy platform has the potential to treat multiple retinal diseases with a single product, and we are advancing research in infectious diseases to support public health and orthopedic diseases to address unmet medical needs. Discover more at www.ocugen.com and follow us on Twitter and LinkedIn.

Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks, and uncertainties that may cause actual events or results to differ materially from our current expectations. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (SEC), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events, or otherwise, after the date of this press release.

Contact:
Tiffany Hamilton
Head of Communications
IR@ocugen.com

Release – Avivagen Announces Publication of Peer-Reviewed Article in Food and Chemical Toxicology Journal

Posted on by cpatches

Research, New, and Market Data on VIVXF

Publication of this Scientific Paper on the Safety of Oxidized Beta Carotene  is a milestone on the path to broader regulatory clearance to market and sell OxC-beta™ Products in the U.S. and supports wide-spread adoption of the technology around the world

Ottawa, ON /Business Wire/ September 7, 2022 /– Avivagen Inc.  (TSXV:VIV, OTCQB:VIVXF) (“Avivagen”), a life sciences corporation focused on developing and commercializing products for livestock, companion animal and human applications that safely enhances feed intake and supports immune function, thereby supporting general health and performance, is pleased to announce that its scientific paper entitled “Safety and uptake of fully Oxidized Beta Carotene” (the active ingredient in the company’s OxC-beta™ product line) has been published in the Journal of Food and Chemical Toxicology. A link to the article is provided below.

“With any innovative product, adoption and uptake require a robust understanding of the benefits and safety of that product and necessitate significant scrutiny. Avivagen has been working tirelessly to showcase the multiple, compelling use cases of OxC-beta and concurrent proven safety. This new peer reviewed publication, one of now ten such publications on OxC-beta, represents the cumulative work on the attractive safety profile of our product. This pioneering work by Dr. Graham Burton, co-founder of Avivagen, and his team lays important groundwork to seek further regulatory approvals for OxC-beta in the U.S. and around the world, for multiple use cases and with strong, proven scientific underpinnings expected by our end market customers.”, said Kym Anthony, Avivagen CEO.  “We look forward to sharing these results with existing and new customers and providing this to regulatory bodies around the world as we look to further expand our access to large markets.”

Please refer to the full content of the peer-reviewed publication on the “Safety and uptake of fully oxidized Beta Carotene” by following the link below: https://www.sciencedirect.com/science/article/pii/S0278691522005853

About OxC-beta™ Technology
β-carotene has been primarily recognized for the health benefits it provides when it is transformed into vitamin A by biochemical reaction with oxygen in the body. Avivagen discovered that spontaneous oxidation of β-carotene produces a mixture of oxidation compounds other than vitamin A that also provide important health benefits. The mixture of β-carotene oxidation compounds, OxC-beta, a product developed by Avivagen, contains neither β-carotene or vitamin A, indicating its health benefits stem uniquely from the oxidation compounds themselves. Incorporation of OxC-beta into products for livestock, companion animal and humans show a range of practical benefits. A peer reviewed paper just published in the prestigious Food and Chemical Toxicology journal (https://doi.org/10.1016/j.fct.2022.113387) has reported that OxC-beta has a very high margin of safety and the discovery that the natural counterpart of OxC-beta is present at significant levels in mouse tissues and blood. A standard toxicology study conducted in rats established a No Observed Adverse Effect Level that is several thousand-fold higher than the level of supplementation with OxC-beta used in livestock, companion animals and humans. These findings are highly significant in establishing the safety of OxC-beta with respect to regulatory approvals of the product in various major jurisdictions.

About Avivagen
Avivagen is a life sciences corporation focused on developing and commercializing products for livestock, companion animal and human applications that, by safely supporting immune function, promote general health and performance.  It is a public corporation traded on the TSX Venture Exchange under the symbol VIV and is headquartered in Ottawa, Canada, based in partnership facilities of the National Research Council of Canada. For more information, visit www.avivagen.com. The contents of the website are expressly not incorporated by reference in this press release.

About OxC-beta™ Livestock
Avivagen’s OxC-beta™ technology is derived from Avivagen discoveries about β-carotene and other carotenoids, compounds that give certain fruits and vegetables their bright colours. Through support of immune function the technology provides a non-antibiotic means of promoting health and growth. OxC-beta™ Livestock is a proprietary product shown to be an effective and economic alternative to the antibiotics commonly added to livestock feeds. The product is currently available for sale in the United States, Philippines, Mexico, Taiwan, New Zealand, Thailand, Brazil, Australia, Vietnam and Malaysia.

Avivagen’s OxC-beta™ Livestock product is safe, effective and could fulfill the global mandate to remove all in-feed antibiotics as growth promoters. Numerous international livestock trials with poultry and swine using OxC-beta™ Livestock have proven that the product performs as well as, and, sometimes, in some aspects, better than in-feed antibiotics.

Forward Looking Statements
This news release includes certain forward-looking statements that are based upon the current expectations of management. Forward-looking statements involve risks and uncertainties associated with the business of Avivagen Inc. and the environment in which the business operates. Any statements contained herein that are not statements of historical facts may be deemed to be forward-looking, including those identified by the expressions “aim”, “anticipate”, “appear”, “believe”, “consider”, “could”, “estimate”, “expect”, “if”, “intend”, “goal”, “hope”, “likely”, “may”, “plan”, “possibly”, “potentially”, “pursue”, “seem”, “should”, “whether”, “will”, “would” and similar expressions.

Statements set out in this news release relating to the potential positive impacts expected to arise from the publication of the above referenced article, the possibility for further regulatory approvals and expanded use cases for Avivagen’s products, the future growth and prospects for Avivagen and the possibility for OxC-beta™ Livestock to replace antibiotics in livestock feeds as growth promoters are forward-looking statements. These forward-looking statements are subject to a number of risks and uncertainties that could cause actual results or events to differ materially from current expectations. For instance, Avivagen’s products may not gain market acceptance or regulatory approval in new jurisdictions or for new applications and may not be widely accepted as a replacement for antibiotics as growth promoters in livestock feeds due to many factors, many of which are outside of Avivagen’s control.  Readers are referred to the risk factors associated with the business of Avivagen set out in Avivagen’s most recent management’s discussion and analysis of financial condition available at www.SEDAR.com. Except as required by law, Avivagen assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those reflected in the forward-looking statements.

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.

For more information:
Avivagen Inc.
Drew Basek
Director of Investor Relations
100 Sussex Drive, Ottawa, Ontario, Canada K1A 0R6 Phone: 416-540-0733
E-mail: d.basek@avivagen.com

Kym Anthony
Chief Executive Officer
100 Sussex Drive, Ottawa, Ontario, Canada K1A 0R6 Head Office Phone: 613-949-8164
Website: www.avivagen.com
Copyright © 2022 Avivagen Inc. OxC-beta™ is a trademark of Avivagen Inc.

Release – Cocrystal Pharma to Participate in the H.C. Wainwright Global Investment Conference

Posted on by cpatches

Research, News, and Market Data on COCP

BOTHELL, Wash., Sept. 06, 2022 (GLOBE NEWSWIRE) — Cocrystal Pharma, Inc. (Nasdaq: COCP) announces that management will participate virtually in the hybrid in-person and virtual H.C. Wainwright 24th Annual Global Investment Conference being held September 12-14, 2022.

An on-demand presentation by James Martin, CFO and interim co-CEO, will be available to conference attendees on the H.C. Wainwright platform beginning Monday, September 12 at 7:00 a.m. Eastern time. Management is available throughout the conference for virtual one-on-one meetings. Institutional investors and industry professionals can register to attend the conference virtually or in-person at the Lotte New York Palace. The Cocrystal presentation will be posted to the Company’s website beginning September 12.

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

Investor Contact:
LHA Investor Relations
Jody Cain
310-691-7100
jcain@lhai.com

Media Contact:
JQA Partners
Jules Abraham
917-885-7378
Jabraham@jqapartners.com

Source: Cocrystal Pharma, Inc.

Released September 6, 2022

Release – Ocugen, Inc. to Present at H.C. Wainwright 24th Annual Global Investment Conference

Posted on by cpatches

Research, News, and Market Data on OCGN

MALVERN, Pa., Sept. 06, 2022 (GLOBE NEWSWIRE) — Ocugen, Inc. (“Ocugen” or the “Company”) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines, announced that Dr. Shankar Musunuri, Chairman, Chief Executive Officer and Co-Founder of Ocugen, will participate in an in-person fireside chat at the H.C. Wainwright 24th Annual Global Investment Conference being held September 12-14, 2022 in New York, NY.

Details regarding Dr. Musunuri’s fireside chat are as follows:

Event:H.C. Wainwright 24th Annual Global Investment Conference
Date:September 12, 2022
Time:3:30 – 4:00 p.m. ET
Location:Lotte New York Palace Hotel
Webcast:Live Fireside Chat

A live video webcast beginning at 3:30 p.m. ET on the day of the presentation will be available on the events page of the Ocugen investor site. The webcast replay will be archived for 90 days following the event.

About Ocugen, Inc.
Ocugen, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines that improve health and offer hope for patients across the globe. We are making an impact on patient’s lives through courageous innovation—forging new scientific paths that harness our unique intellectual and human capital. Our breakthrough modifier gene therapy platform has the potential to treat multiple retinal diseases with a single product, and we are advancing research in infectious diseases to support public health and orthopedic diseases to address unmet medical needs. Discover more at www.ocugen.com and follow us on Twitter and LinkedIn.

Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks, and uncertainties that may cause actual events or results to differ materially from our current expectations. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (SEC), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events, or otherwise, after the date of this press release.

Contact:
Tiffany Hamilton
Head of Communications
IR@ocugen.com

Biotech and Pharmaceutical Companies How they are Different

Posted on by cpatches
Image Credit: Pixabay (Pexels)

The Differences Investors Should Know Between Biotech Companies and Pharmaceutical Manufacturers

In mid-June of this year, the stock market seemed to have changed. The oil sector that had been up for most of the year began trending down, and most other industries that had been hard hit began moving up in a mid-year “V” shape. The new leader replacing oil was biotech, which had been one of the hardest hit at the beginning of the year. It makes sense that biotech trades with its own cycles – it’s a very different sector. There is reason to believe that fundamentals favor the biotech sector now, below we discuss the nuances of these very interesting companies, and explain how they are different than other drug companies..

With biotech stocks, regulators, financiers, the highly educated, geniuses, technology, and investors all come together to help people in the most important way – life and health. For investors, it provides its own set of challenges, and at least two possible rewards. If an investor uncovers the stock that has the right mix of science, money and regulatory approval, they may not only cash in like few other sectors, but also be part of improving the health of generations to come.

Above, I did use the word “possible”. This is true of all stocks in all sectors, but the volatility in the biotech sector is a demonstration of the adage that for bigger potential rewards, one would have to increase their risk. Companies in this industry, often startups with great patents, burn through millions of dollars, often with zero earnings, and with any potential for earnings years off and contingent on being right about their science and the products it can provide. This means stock selection in biotech requires a deeper understanding of the company and potential for its work than in other sectors.


What’s included in the Biotechnology Sector?

Biotechnology focuses on novel drug development and clinical research aimed at treating diseases and medical conditions.

They are almost always unprofitable, and many have no revenue at all. In fact, some stock analysts would suggest that the main distinction between a biotech and a pharmaceutical company lies in profitability. Biotechnology is often characterized as being more research and development than manufacturing. They serve as incubators for the ideas that lead to the next “miracle” cures. But, drug development has a long development timeline. A successful candidate can take a decade or more to go from idea to available medicine. That’s if it is among the roughly 10% of prospective candidates that reaches approval for use.

Why would anyone invest in a company that is developing a pipeline of potential products that each have about a 10% chance of approval? Because breakthrough drugs, and the potential for breakthroughs, each step forward on the path toward approval often provides a huge upward move in the stock price. Even if not eventually approved. Conversely failure to move forward often comes with a rapid decline from disappointment.


Differences Between Biotech and Pharmaceuticals

There is a lot of overlap and a gray area between what is biotech and what is pharmaceutical. Here are some guidelines of where the differences often lay.

Biotechnology ventures tend to be more entrepreneurial pursuits with a lot on the line for the success of an idea, while pharmaceutical companies have an ongoing business and can better gauge and manage business risk. One reason is pharmaceutical companies often have a large diversified portfolio of approved drugs they market. They may also have drugs in various stages of research and development, but these costs are usually investments in future products using current revenue.

A biotechnology firm is often based on “new” science and driven to develop a useful and profitable application for the science. An example of a growing segment of biotech is biopharma which develops drugs originating living organisms.

Large pharmaceutical companies often pay stable dividends to shareholders, this is rare in companies that fall under the biotech umbrella, if there are earnings it may be reinvested in moving forward the study of drugs in development. Many biotechs’ strength is to explore and develop, not to market the successful result. Large pharmaceutical companies, like Johnson and Johnson (JNJ)or Eli Lilly (LLY) are marketing machines, they look to smaller biotech to be an incubator to keep their portfolio of products fresh.

The two industries also stand apart when it comes to valuation and business evaluation. Models and valuation derived from cash flow are quite relevant in assessing pharmaceutical stocks. While many analysts gamely attempt to construct discounted cash flow models for early-stage biotechs, the reality is that success is often thumbs-up or thumbs-down (“drug works” or “drug doesn’t work”).


The FDA Has Final Say

As the regulatory body that approves new drugs for the U.S. market, as well as issues permits for human clinical trials, the Food and Drug Administration (FDA) is the gatekeeper for every biotech firm. Investors should have some understanding of the FDA process and requirements or follow an analyst covering the sector that does. In order to get FDA approval, biotechs must establish a sufficient body of information that the drug is safe and effective. This is generally done through a series of at least three clinical trials.

If the trials meet the goals for safety and efficacy, the company files a request for approval called a New Drug Application (NDA). If the NDA is approved, the FDA sets the date a decision will be made by on the application.


Product Pipeline

A biotech’s pipeline is the future of the company. Investors focus a great deal on the number of entrants in the pipeline, the stages of study they are at, and the overall science, and competing products (if any). It’s critical to establish valuation forecasts.

Different biotech companies tend to operate in different stages of a product’s development. The stages are, most commonly, preclinical testing, enabling studies, clinical trials, and biologics licensing. A company that is focused on the early stage of research and development will conduct preliminary research to determine whether an idea may successfully be used against a disease or ailment. It attempts to answer, “can this technology become a product?”. This step requires translating the technology into a product. Preclinical testing is the phase of product development when a company must show that its proposed product is safe. They must also determine what the pharmacokinetics (PK) pharmacodynamics (PD) are. PK shows what happens to a drug once it enters the body, ie: how quickly its absorbed, distributed, metabolized, and excreted. Studies done for the express purpose of convincing the FDA to approve the start of clinical trials in humans are called Investigational New Drug (IND)-enabling.

Once a startup has received approval from the FDA to begin clinical trials for their product, they progress through a series of phases depending on how their product fares. These phases are:

Phase 1 This first trial’s main purpose is to determine that the product is safe for use in humans. The number of participants is kept as small as possible, and may be limited to patients who are farther along in a disease state or who have exhausted other options for treatment.

Phase 2 The second phase continues to confirm that the product is safe, but increases the number of participants and tries to determine the optimum dose and regimen.

Phase 3 Typically the last clinical trial phase and is designed to determine whether the treatment is truly effective, and is expanded to include enough people so the potential side effects are more likely to be captured in the data.

The biologics license application (BLA) is the process by which a biologic that has successfully completed clinical trials applies to the FDA to be sold to the public. A new drug application (NDA) is the same process, but for pharmaceuticals.


Take Away

Biotech investing can be very rewarding. Investors need to understand the company and the risks, and also the stage in the pipeline and the success of recent trials. Failed attempts by companies in this sector at devising the next wonder drug outnumber successes. One success may easily make up for some failures for investors.   With research into the company and even reliance on trusted analysts that specialize in biotechs, an investor can increase their chances of uncovering oversized profits. We encourage you, if you are not signed up for Channelchek and the research by Noble Capital Markets equity analysts delivered to your inbox each morning, to take the time and register with us now.


Paul Hoffman

Managing Editor, Channelchek

Sources

https://www.universitylabpartners.org/blog/product-development-in-life-science

https://biotechhealth.com/biotech-vs-pharma/

https://www.qualio.com/blog/biotech-vs-pharma