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 [email protected]
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.
Gregory Aurand, Senior Research Analyst, Healthcare Services & Medical Devices, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
What’s in a name? The rebranding identifies the Company’s CHITOSAN based regenerative medicine technology while expanding the scope of the technology beyone orthopedics. While the near term pipeline is focused on the repair of orthopedic soft tissue (rotator cuff and meniscus) as initial markets with great need, the Company’s proprietary platform has much broader potential regenerative applications, including in cardiovascular, dermatology, wound healing, oncology and neurology.
Tickers will change. The corporate rebranding was approved at the last Annual General and Special Meeting of Shareholders held July 21, 2022, following the passing of a special resolution authorizing a name change. Effective on or around September 12th, shares will begin trading on the CSE as CHGX. Subject to change, it is expected that the OTCQB ticker will also be updated to CHGX.
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.
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.”
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: [email protected]
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.
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
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.
CHATHAM, N.J., Sept. 06, 2022 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced three oral presentations by academic collaborators at the 29th International Congress of The Transplantation Society (TTS 2022) being held September 10-14, 2022 in Buenos Aires, Argentina, and virtually. Copies of the presentations will be available under the Scientific Presentations tab of the Tonix website at www.tonixpharma.com following the conference.
Oral Presentation Details
Title:
Long-term rejection free renal allograft survival with Fc-modified anti-CD154 antibody monotherapy in nonhuman primates
Date:
Monday, September 12, 2022
Time:
4:35 p.m. EDT (17:35 ART)
Session:
Campfire Session: Models, mechanisms & therapies
Presenter
Grace Lassiter, M.D., Research Fellow of the Kawai Lab
Title:
Monotherapy with TNX-1500, a Fc-modified anti-CD154mAb, prolongs cardiac allograft survival in cynomolgus monkeys
Date:
Tuesday, September 13, 2022
Time:
3:25 p.m. EDT (16:25 ART)
Session:
Mini-Oral Abstracts Session: Snap-shots of thoracic transplantation
Presenter
Kohei Kinoshita, M.D., Research Fellow of the Pierson Lab
Title:
Long-term (>1 year) rejection/TMA free survival of kidney xenografts with triple xenoantigen knockout and multiple human transgenes in nonhuman primates
Date:
Wednesday, September 14, 2022
Time:
10:00 a.m EDT (11:00 ART)
Session:
Mini-Oral Abstracts Session: Xenotransplantation
Presenter
Grace Lassiter, M.D., Research Fellow of the Kawai Lab
Tonix Pharmaceuticals Holding Corp.*
Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing therapeutics to treat and prevent human disease and alleviate suffering. Tonix’s portfolio is composed of central nervous system (CNS), rare disease, immunology and infectious disease product candidates. Tonix’s CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix’s lead CNS candidate, TNX-102 SL (cyclobenzaprine HCl sublingual tablet), is in mid-Phase 3 development for the management of fibromyalgia with a new Phase 3 study launched in the second quarter of 2022 and interim data expected in the second quarter of 2023. TNX-102 SL is also being developed to treat Long COVID, a chronic post-acute COVID-19 condition. Tonix initiated a Phase 2 study in Long COVID in the third quarter of 2022 and expects interim data in the first half of 2023. TNX-1300 (cocaine esterase) is a biologic designed to treat cocaine intoxication and has been granted Breakthrough Therapy designation by the FDA. A Phase 2 study of TNX-1300 is expected to be initiated in the first quarter of 2023. TNX-1900 (intranasal potentiated oxytocin), a small molecule in development for chronic migraine, is expected to enter the clinic with a Phase 2 study in the fourth quarter of 2022. Tonix’s rare disease portfolio includes TNX-2900 (intranasal potentiated oxytocin) for the treatment of Prader-Willi syndrome. TNX-2900 has been granted Orphan Drug designation by the FDA. Tonix’s immunology portfolio includes biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft and xenograft rejection and for the treatment of autoimmune diseases. A Phase 1 study of TNX-1500 is expected to be initiated in the first half of 2023. Tonix’s infectious disease pipeline consists of a vaccine in development to prevent smallpox and monkeypox, next-generation vaccines to prevent COVID-19, and a platform to make fully human monoclonal antibodies to treat COVID-19. TNX-801, Tonix’s vaccine in development to prevent smallpox and monkeypox, also serves as the live virus vaccine platform or recombinant pox vaccine (RPV) platform for other infectious diseases. A Phase 1 study of TNX-801 is expected to be initiated in Kenya in the first half of 2023. Tonix’s lead vaccine candidate for COVID-19 is TNX-1850, a live virus vaccines based on Tonix’s recombinant pox live virus vector vaccine platform. A Phase 1 study of the COVID-19 vaccine is expected to be initiated in the second half of 2023.
*All of Tonix’s product candidates are investigational new drugs or biologics and have not been approved for any indication.
This press release and further information about Tonix can be found at www.tonixpharma.com.
Forward Looking Statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; delays and uncertainties caused by the global COVID-19 pandemic; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2021, as filed with the Securities and Exchange Commission (the “SEC”) on March 14, 2022, and periodic reports filed with the SEC on or after the date thereof. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.
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.
MALVERN, Pa., Sept. 01, 2022 (GLOBE NEWSWIRE) — Baudax Bio, Inc. (the “Company” or “Baudax Bio”) (NASDAQ: BXRX), a pharmaceutical company focused on therapeutics for acute care settings, today announced the closing of its previously announced public offering of an aggregate of 11,819,172 shares of its common stock (or pre-funded warrants in lieu thereof), together with accompanying common stock purchase warrants, at a public offering price of $0.525 per share (or pre-funded warrant) and accompanying warrants. Each share of common stock (or pre-funded warrant) was sold in the offering together with a Series A-1 warrant to purchase one share of common stock at an exercise price of $0.525 per share and a Series A-2 warrant to purchase one share of common stock at an exercise price of $0.525 per share. The Series A-1 warrants are exercisable immediately and will expire five years from the date of issuance, and the Series A-2 warrants are exercisable immediately and will expire thirteen months from the date of issuance.
H.C. Wainwright & Co. acted as the exclusive placement agent for the offering.
The gross proceeds from the offering, before deducting the placement agent’s fees and other offering expenses, were approximately $6.2 million. The Company intends to use the net proceeds from this offering for pipeline development activities and general corporate purposes.
The securities described above were offered pursuant to a registration statement on Form S-1 (File No. 333-266499), which was declared effective by the Securities and Exchange Commission (the “SEC”) on August 29, 2022. The offering was made only by means of a prospectus which is a part of the effective registration statement. A final prospectus relating to the offering has been filed with the SEC. Electronic copies of the final prospectus may be obtained on the SEC’s website at http://www.sec.gov and may also be obtained by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (212) 856-5711 or e-mail at [email protected].
This press release shall not constitute an offer to sell or a solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.
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®, the Company has a pipeline of other innovative pharmaceutical assets including two clinical-stage, novel neuromuscular blocking (NMBs) agents and a proprietary chemical reversal agent specific to these NMBs.
Forward Looking
Statements
This press release contains forward-looking statements that involve risks and uncertainties. Such forward-looking statements reflect Baudax Bio’s expectations about its future performance and opportunities that involve substantial risks and uncertainties. When used herein, the words “anticipate,” “believe,” “estimate,” “may,” “upcoming,” “plan,” “target,” “goal,” “intend” and “expect” and similar expressions, as they relate to Baudax Bio or its management, are intended to identify such forward-looking statements. Forward-looking statements may include, without limitation, statements regarding market conditions and the use of net proceeds from the offering. These forward-looking statements are based on information available to Baudax Bio as of the date of publication on this internet site and are subject to a number of risks, uncertainties, and other factors that could cause Baudax Bio’s performance to differ materially from those expressed in, or implied by, these forward-looking statements. These risks and uncertainties include, among other things, risks related to market and other conditions, the ongoing economic and social consequences of the COVID-19 pandemic, Baudax Bio’s ability to advance its current product candidate pipeline through pre-clinical studies and clinical trials, Baudax Bio’s ability to raise future financing for continued development of its product candidates such as BX1000, BX2000 and BX3000, Baudax Bio’s ability to pay its debt and satisfy conditions necessary to access future tranches of debt, Baudax Bio’s ability to comply with the financial and other covenants under its credit facility, Baudax Bio’s ability to manage costs and execute on its operational and budget plans, Baudax Bio’s ability to achieve its financial goals; and Baudax Bio’s ability to obtain, maintain and successfully enforce adequate patent and other intellectual property protection. These forward-looking statements should be considered together with the risks and uncertainties that may affect Baudax Bio’s business and future results included in Baudax Bio’s filings with the Securities and Exchange Commission at www.sec.gov. These forward-looking statements are based on information currently available to Baudax Bio, and Baudax Bio assumes no obligation to update any forward-looking statements except as required by applicable law.
Investor Relations
Contact: Argot Partners Sam Martin / Kaela Ilami (212) 600-1902 [email protected]
Media Contact: Argot Partners David Rosen (212) 600-1902 [email protected]
NEWTOWN, Pa., Sept. 01, 2022 (GLOBE NEWSWIRE) — Onconova Therapeutics, Inc. (NASDAQ: ONTX), (“Onconova”), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, today announced that the Company will be participating virtually in the H.C. Wainwright 24th Annual Global Investment Conference, which is taking place in a hybrid format at the Lotte New York Palace Hotel.
A corporate overview presented by Steven Fruchtman, M.D., President & CEO of Onconova, will be available on-demand beginning on Monday, September 12, 2022, at 7:00 a.m. ET. The presentation can be viewed here or on the “Corporate Events and
Presentations” section of the Onconova website and will be archived for 90 days. Dr. Fruchtman and other members of the Onconova management team will also be available for virtual one-on-one meetings through the conference from September 12 – 16, 2022. Those interested in requesting a meeting should contact their H.C. Wainwright representative.
About
Onconova Therapeutics, Inc.
Onconova Therapeutics is a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer. The Company has proprietary targeted anti-cancer agents designed to disrupt specific cellular pathways that are important for cancer cell proliferation.
Onconova’s novel, proprietary multi-kinase inhibitor narazaciclib (formerly ON 123300) is being evaluated in two separate and complementary Phase 1 dose-escalation and expansion studies. These trials are currently underway in the United States and China.
Onconova’s product candidate rigosertib is being studied in an investigator-sponsored study program, including in a dose-escalation and expansion Phase 1/2a investigator-sponsored study with oral rigosertib in combination with nivolumab for patients with KRAS+ non-small cell lung cancer.
MALVERN, Pa., Sept. 01, 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 appointment of Robert J. Hopkins, MD, MPH & TM, FACP, FIDSA, as Chief Medical Officer. Arun Upadhyay, PhD, previously Senior Vice President, Research & Development, will now serve as the Company’s Chief Scientific Officer, overseeing the development and manufacturing of Ocugen’s clinical and commercial product portfolio and evaluating new technologies.
“We are extremely pleased to have Dr. Hopkins driving our clinical programs as his expertise across the industry along with his work at the U.S. Food and Drug Administration, and the Biomedical Advanced Research and Development Authority will provide us with tremendous insights in bringing innovative solutions to patients,” said Dr. Shankar Musunuri, Chairman, Chief Executive Officer, and Co-Founder of Ocugen.
“Dr. Upadhyay has been invaluable in establishing Ocugen’s unique modifier gene delivery platform and collaborating with our partner Bharat Biotech in the development of COVAXIN™,” said Dr. Musunuri. “It’s truly been a pleasure working alongside him for the past several years, and we look to his scientific leadership to deliver new breakthroughs in medicine.”
Dr. Hopkins has more than 25 years’ experience as a physician and clinical researcher. In addition to his work in government organizations, he has held senior level positions at Merck Research Labs, DynPort Vaccine Company, Emergent BioSolutions, and Aeras. He has developed and commercialized multiple vaccine and therapeutic products, Phases 1 through 4. Prior to joining Ocugen, he was the Chief Medical Officer at Adaptive Phage Therapeutics where he oversaw regulatory affairs, clinical development, and clinical operations.
“I look forward to bringing my vaccines and therapeutics experience to Ocugen,” said Dr. Hopkins. “It’s imperative that we provide additional options in the fight against COVID-19, as well as deliver new gene and cell therapies to address unmet medical need.”
Dr. Upadhyay has spent more than 20 years in discovery research and innovation developing novel therapeutic modalities and drug-delivery technologies. He has been leading nonclinical, early-to-late-stage global product development and manufacturing, bioanalyses, and clinical trial supply management. Dr. Upadhyay has led multiple successful regulatory submissions in the U.S. He has worked extensively in drug development—ranging from small molecules to biologics, and advanced cell and gene therapy modalities. Prior to joining Ocugen, he led ophthalmic drug development and delivery research at the University of Colorado Denver in the Department of Pharmaceutical Sciences. There, Dr. Upadhyay was instrumental in developing novel approaches for sustained and targeted drug delivery of peptides, proteins, RNA, and DNA to cells and tissues. Dr. Upadhyay also led engineering of polymeric micro and nano carriers’ system of vaccine antigens to enhance immunogenicity and protective immunity.
“I’m excited to expand my role at Ocugen and lead our R&D and manufacturing teams to advance our product pipeline and evolve the Company in gene therapy and regenerative medicine,” said Dr. Upadhyay.
Dr. Hopkins and Dr. Upadhyay are part of Ocugen’s leadership team, reporting directly to the Chief Executive Officer.
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.
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This is Catalyst – a new short-form video series that asks senior executives the questions investors want answered. Exclusively on Channelchek. Brian Culley, CEO of Lineage Cell Therapeutics provides an update on the company’s OpRegen program for the treatment of dry age-related macular degeneration and answers questions regarding the latest developments with Lineage’s OPC1 program for spinal cord injury, and how they are managing in the current challenging biotech environment. All in less than three minutes.
Baudax Bio (BXRX) Priced Common Offering; Reducing Price Target
Baudax Bio is a pharmaceutical company focused on innovative products for acute care settings. ANJESO is the first and only 24-hour, intravenous (IV) COX-2 preferential non-steroidal anti-inflammatory (NSAID) for the management of moderate to severe pain. In addition to ANJESO, Baudax Bio has a pipeline of other innovative pharmaceutical assets including two novel neuromuscular blocking agents (NMBs) and a proprietary chemical reversal agent specific to these NMBs. For more information, please visit www.baudaxbio.com.
Gregory Aurand, Senior Research Analyst, Healthcare Services & Medical Devices, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
Priced $6.2 million offering. Late Monday, Baudax announced the pricing of its public offering. The offering of 11.819 million shares of common or pre-funded warrants at a public offering price of $0.525 per share were sold as a unit. Each share or warrant unit included a Series A-1 warrant to purchase one share at $0.525, and a Series A-2 warrant to purchase one share at $0.525. The Series A-1 warrant is exercisable immediately with a 5 year expiration, while the Series A-2 warrant expires 13 months from date of issuance. The gross proceeds of the offering, expected to close on or about September 1st, are around $6.2 million. Baudax intends to use the net proceeds from the offering for pipeline development activities and general corporate purposes.
Pricing is at depressed levels. While funding needs were anticipated, the Baudax offering of common shares and warrants are coming near all-time lows. The common stock price, at the $0.525 offering level, has declined 31% since the Q2 financials were released August 11th. …
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.
