Tag: Biotechnology

Baudax Bio (BXRX) – Full Top Line BX1000 Phase II Results Presented

Posted on by cpereira@noblefcm.com


Wednesday, April 26, 2023

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 Vice President, Equity Research Analyst, Healthcare Services & Medical Devices, Noble Capital Markets, Inc.

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

Key Opinion Leader Webinar.  In conjunction with the full top line data release, yesterday Baudax Bio held a key opinion leader webinar to discuss the results in greater detail.  Led by Gerri Henwood, President and CEO, and Stuart McCallum, Chief Medical Officer, the webinar featured Dr. Todd Bertoch, CEO of JBR Clinical Research, and Dr. Harold Minkowitz, Associate Director at MD Anderson Cancer Center Dept. of Anesthesiology and Perioperative Medicine.

BX1000 patient data was “spectacular”.  Similar to the prior two interim analyses, the full 79-patient (of the four 20-patient cohorts one patient in the rocuronium arm was not evaluated due to issues with the endotracheal tube) trial showed that all BX1000 patients met Good or Excellent intubating conditions at 60 seconds. From a safety perspective, treatment emergent side effects like nausea were comparable to rocuronium (current standard) in all BX1000 cohorts. There will be 28-day patient safety follow-up and this data could be available in around four weeks.


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Release – PDS Biotech Receives $1.4 Million After Selling Its Net Operating Loss Tax Benefits Through The New Jersey Economic Development Program

Posted on by aweinsoff@channelchek.com

Research News and Market Data on PDSB

FLORHAM PARK, N.J., April 24, 2023 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing a growing pipeline of targeted immunotherapies for cancer and infectious disease announced the Company received $1.4 million from the net sale of tax benefits to an unrelated, profitable New Jersey corporation pursuant to the Company’s participation in the New Jersey Technology Business Tax Certificate Transfer Net Operating Loss (NOL) program for State Fiscal Year 2021.

“We are pleased to receive funds from the New Jersey NOL program,” said Matthew Hill, Chief Financial Officer of PDS Biotech. “The funding will be beneficial to us as we transition our lead asset, PDS0101, into a registrational trial for the treatment of HPV16-positive metastatic or recurrent head and neck cancer.”

The New Jersey Technology Business Tax Certificate Transfer program enables qualified, unprofitable NJ-based technology or biotechnology companies with fewer than 225 US employees (including parent company and all subsidiaries) to sell a percentage of their NOL and research and development tax credits to unrelated profitable corporations. This allows qualifying technology and biotechnology companies with NOLs to turn tax losses and credits into cash proceeds to fund their growth and operations, including research and development or other allowable expenditures.

About PDS Biotechnology 

PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of targeted cancer and infectious disease immunotherapies based on our proprietary Versamune®, Versamune® plus PDS0301, and Infectimune™ T cell-activating platforms. We believe our targeted immunotherapies have the potential to overcome the limitations of current immunotherapy approaches through the activation of the right type, quantity and potency of T cells. To date, our lead Versamune® clinical candidate, PDS0101, has demonstrated the ability to reduce tumors and stabilize disease in combination with approved and investigational therapeutics in patients with a broad range of HPV16-associated cancers in multiple Phase 2 clinical trials. and will be advancing into a Phase 3 clinical trial in combination with KEYTRUDA® for the treatment of recurrent/metastatic HPV16-positive head and neck cancer in 2023.   Our Infectimune™ based vaccines have also demonstrated the potential to induce not only robust and durable neutralizing antibody responses, but also powerful T cell responses, including long-lasting memory T cell responses in pre-clinical studies to date. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech. 

Forward Looking Statements 

This communication contains forward-looking statements (including within the meaning of Section 21E of the United States Securities Exchange Act of 1934, as amended, and Section 27A of the United States Securities Act of 1933, as amended) concerning PDS Biotechnology Corporation (the “Company”) and other matters. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the Company’s management, as well as assumptions made by, and information currently available to, management. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” “forecast,” “guidance”, “outlook” and other similar expressions among others. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the Company’s ability to protect its intellectual property rights; the Company’s anticipated capital requirements, including the Company’s anticipated cash runway and the Company’s current expectations regarding its plans for future equity financings; the Company’s dependence on additional financing to fund its operations and complete the development and commercialization of its product candidates, and the risks that raising such additional capital may restrict the Company’s operations or require the Company to relinquish rights to the Company’s technologies or product candidates; the Company’s limited operating history in the Company’s current line of business, which makes it difficult to evaluate the Company’s prospects, the Company’s business plan or the likelihood of the Company’s successful implementation of such business plan; the timing for the Company or its partners to initiate the planned clinical trials for PDS0101, PDS0203 and other Versamune® and Infectimune™ based product candidates; the future success of such trials; the successful implementation of the Company’s research and development programs and collaborations, including any collaboration studies concerning PDS0101, PDS0203 and other Versamune® and Infectimune™ based product candidates and the Company’s interpretation of the results and findings of such programs and collaborations and whether such results are sufficient to support the future success of the Company’s product candidates; the success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including the Company’s ability to fully fund its disclosed clinical trials, which assumes no material changes to the Company’s currently projected expenses), futility analyses, presentations at conferences and data reported in an abstract, and receipt of interim or preliminary results (including, without limitation, any preclinical results or data), which are not necessarily indicative of the final results of the Company’s ongoing clinical trials; any Company statements about its understanding of product candidates mechanisms of action and interpretation of preclinical and early clinical results from its clinical development programs and any collaboration studies; to aid in the development of the Versamune® platform;  and other factors, including legislative, regulatory, political and economic developments not within the Company’s control. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the risk factors included in the Company’s annual, quarterly and periodic reports filed with the SEC. The forward-looking statements are made only as of the date of this press release and, except as required by applicable law, the Company undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise.   

Versamune® is a registered trademark and Infectimune™ is a trademark of PDS Biotechnology. KEYTRUDA® is a registered trademark of Merck Sharp and Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, N.J., USA.

Investor Contacts:
Deanne Randolph
PDS Biotech
Phone: +1 (908) 517-3613
Email: drandolph@pdsbiotech.com

Rich Cockrell
CG Capital
Phone: +1 (404) 736-3838
Email: pdsb@cg.capital

Media Contacts: 
Tiberend Strategic Advisors, Inc.
Dave Schemelia 
Phone: +1 (609) 468-9325 
dschemelia@tiberend.com  
Bill Borden 
Phone: +1 (732) 910-1620 
bborden@tiberend.com

Release – Cocrystal Pharma Appoints Pharma Industry Veteran Fred Hassan to its Board of Directors

Posted on by aweinsoff@channelchek.com

Research News and Market Data on COCP

APRIL 24, 2023

BOTHELL, Wash., April 24, 2023 (GLOBE NEWSWIRE) — Cocrystal Pharma, Inc. (Nasdaq: COCP) (Cocrystal or the Company) announces the appointment of Fred Hassan to its Board of Directors, increasing its Board membership to six. Mr. Hassan’s distinguished 40-year career includes serving in senior executive and director positions at global pharmaceutical companies and leading investment firms. Earlier this month, Cocrystal announced Mr. Hassan’s $2 million investment in the Company through an at-the-market private placement.

“It’s an honor to attract such a highly accomplished industry veteran to our Board,” said Roger Kornberg, PhD, Cocrystal Chairman, Chief Scientist and Chairman of the Scientific Advisory Board. “We expect that Fred’s significant experience will strengthen our corporate governance and his guidance will be instrumental in advancing our antiviral pipeline. On behalf of my fellow Directors, I welcome Fred and look forward to working together.”

“I appreciate Cocrystal’s tremendous potential in developing safe and effective antiviral therapies in priority indications of global concern,” said Mr. Hassan. “I’m impressed with the ability of the company’s structure-based discovery platform technology to efficiently discover and develop novel drug candidates. I look forward to working closely with Cocrystal’s Board and executive leadership to advance our pipeline toward commercialization.”

Mr. Hassan is Chairman of the investment firm Caret Group and a Director of Warburg Pincus LLC, a global private equity firm. From 2003 to 2009 Mr. Hassan served as Chairman and Chief Executive Officer of Schering-Plough and from 2001 to 2003 he was Chairman and Chief Executive Officer of Pharmacia Corporation, a company via the merger of Monsanto Company and Pharmacia & Upjohn, Inc. He joined Pharmacia & Upjohn, Inc. as Chief Executive Officer in 1997. Earlier in his career Mr. Hassan held leadership positions with Wyeth, including serving as Executive Vice President and as a Director from 1995 to 1997, and with Sandoz Pharmaceuticals, including leading its U.S. pharmaceuticals business.

Mr. Hassan is a Director of Precigen, Inc., BridgeBio Pharma and Prometheus Biosciences, Inc., which earlier this month announced a definitive agreement to be acquired by Merck for approximately $10.8 billion. Previously he was a Director of Amgen, Inc. and Time Warner Inc. (now Warner Media, LLC). Over the course of his career, he has served on various other Boards including at Avon Products, Inc. and Bausch & Lomb, which was acquired by Valeant Pharmaceuticals International, Inc.

Mr. Hassan has chaired several prominent pharmaceutical industry organizations including The Pharmaceutical Research and Manufacturers of America (PhRMA) and The International Federation of Pharmaceutical Manufacturers Associations (IFPMA). He received a BS in chemical engineering from the Imperial College of Science and Technology at the University of London and an MBA from Harvard Business School.

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. For further information about Cocrystal, please visit www.cocrystalpharma.com.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the advancement of the Company’s pipeline toward commercialization and the Company’s potential for developing safe and effective antiviral therapies in priority indications of global concern. The words “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events. Some or all of the events anticipated by these forward-looking statements may not occur. Important factors that could cause actual results to differ from those in the forward-looking statements include, but are not limited to, the risks and uncertainties arising from inflation, interest rate increases, the current banking crisis and the Ukraine war on our Company, our collaboration partners, and on the U.S., U.K., Australia and global economies, including manufacturing and research delays arising from raw materials and labor shortages, supply chain disruptions and other business interruptions including any adverse impacts on our ability to obtain raw materials and test animals as well as similar problems with our vendors and our current Contract Research Organization (CRO) and any future CROs and Contract Manufacturing Organizations, the results of the studies for CC-42344 and CDI-988, the ability of our CROs to recruit volunteers for, and to proceed with, clinical studies, our and our collaboration partners’ technology and software performing as expected, financial difficulties experienced by certain partners, the results of future preclinical and clinical trials, the impact of COVID-19 (including long-term and pervasive effects of the virus), general risks arising from clinical trials, receipt of regulatory approvals, regulatory changes, development of effective treatments and/or vaccines by competitors, including as part of the programs financed by the U.S. government. Further information on our risk factors is contained in our filings with the SEC, including our Annual Report on Form 10-K for the year ended December 31, 2022. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.

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

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

Release – Ocugen To Present at Association For Research In Vision And Ophthalmology 2023 Annual Meeting

Posted on by aweinsoff@channelchek.com

Research News and Market Data on OCGN

April 20, 2023

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MALVERN, Pa., April 20, 2023 (GLOBE NEWSWIRE) — Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologics, and vaccines, today announced that the Company will present on its innovative modifier gene therapy platform, including OCU400 for the treatment of retinitis pigmentosa and Leber congenital amaurosis, OCU410 for the treatment of dry age-related macular degeneration (dry AMD), and OCU410ST for the treatment of Stargardt disease; along with OCU200, a novel biologic candidate to treat diabetic macular edema (DME), at The Association for Research in Vision and Ophthalmology (ARVO) 2023 Annual Meeting in New Orleans from April 23-27, 2023.

“We are thrilled to share more detail on our unique modifier gene therapy platform, as well as our novel biologics ophthalmic product pipeline with the professional community at ARVO,” commented Arun Upadhyay, PhD, Chief Scientific Officer and Head of Research, Development and Medical at Ocugen. “It is especially exciting to be at ARVO just following positive preliminary safety and efficacy results from the Phase 1/2 trial of OCU400 for the treatment of retinitis pigmentosa. We look forward to highlighting this most recent news along with the work we are doing across our ophthalmology portfolio to combat hard-to-treat blindness diseases affecting millions of patients globally,” Dr. Upadhyay concluded.

Poster Presentation:

Title: Modifier Gene Approach Using OCU410 for Dry AMD Therapy: One Gene—Multiple Targets 
Authors: Dinesh Singh, Mohamed Nsaibia, Sree Kattala, Subechhya Neupane, Matthew Ritts, Arun Upadhyay
Presenter: Dinesh Singh, Associate Director, Discovery, Ocugen
Presentation Type/Number: Poster Session, 755-C0356
Location: Exhibit Hall
Date: Sunday, April 23, 2023
Time: Noon – 1:45 p.m. CDT

Exhibitor Presentations (Exhibitor Education Lounge):

Title: Ocugen—OCU400—Modifier Gene Therapy for Treatment of Inherited Retinal Diseases: Retinitis Pigmentosa & Leber Congenital Amaurosis
Presenter: Arun Upadhyay, PhD, CSO and Head of Research, Development and Medical, Ocugen
Date: Monday, April 24, 2023
Time: 2 p.m. CDT

Title: Ocugen—OCU410 & OCU410ST—Nuclear Receptor Gene RORA as a Potential Therapeutic for Dry AMD and Stargardt disease
Presenter: Dinesh Singh, Associate Director, Discovery, Ocugen
Date: Tuesday, April 25, 2023
Time: 2 p.m. CDT

Title: Ocugen—OCU200—A Novel Biologic for the Treatment of DME, DR, and Wet AMD
Presenter: Pushpendra Singh, Director, Cell and Gene Therapy, Ocugen
Date: Wednesday, April 26, 2023
Time: 2 p.m. CDT

About OCU400
OCU400 is the Company’s gene-agnostic modifier gene therapy product based on NHR gene, NR2E3. NR2E3 regulates diverse physiological functions within the retina—such as photoreceptor development and maintenance, metabolism, phototransduction, inflammation and cell survival networks. Through its drive functionality, OCU400 resets altered/affected cellular gene-networks and establishes homeostasis—a state of balance, which has potential to improve retinal health and function in patients with inherited retinal diseases. These diseases, combined, account for approximately 125,000 cases in the U.S.

About OCU410 and OCU410ST
OCU410 is a modifier gene therapy product candidate being developed for the treatment of dry AMD. OCU410 utilizes an AAV delivery platform for the retinal delivery of the RORA (RAR Related Orphan Receptor A) gene. Various genes associated with AMD are regulated by RORA. The RORA protein plays an important role in lipid metabolism and demonstrates an anti-inflammatory role, which we believe could be a potential therapeutic candidate for dry AMD based on in-vitro and in-vivo (animal model) studies. Using the same technology as OCU410, Ocugen plans to submit an IND for Stargardt disease, an orphan eye disease, in Q2 2023.

About OCU200
OCU200 is a novel fusion protein consisting of human transferrin linked to human tumstatin. It exerts anti-proliferative, anti-inflammatory, and anti-oxidative effects by selective targeting to the retinal and choroidal tissues. OCU200 potentially showcases better bioavailability and tissue penetrance than tumstatin alone due to transferrin and provides distinct MOA binding through αVβ3 integrin pathways that can potentially reduce the number of injections for patients. OCU200 can potentially be used for the treatment of DME, diabetic retinopathy, and wet age-related macular degeneration. These diseases, combined, account for approximately 10 million cases in the U.S.

About Ocugen, Inc.
Ocugen, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologics, 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
Tiffany.Hamilton@ocugen.com

Release – Cocrystal Pharma to Present New Data from its CC-42344 Phase 1 Influenza A Study at the 7th Annual ISIRV Antiviral Group Conference

Posted on by aweinsoff@channelchek.com

APRIL 18, 2023

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BOTHELL, Wash., April 18, 2023 (GLOBE NEWSWIRE) — Cocrystal Pharma, Inc. (Nasdaq: COCP) (Cocrystal or the Company) announces the acceptance of an oral presentation containing new data from the Company’s CC-42344 Phase 1 influenza A study at the 7th Annual International Society for Influenza and Other Respiratory Virus Diseases’ (ISIRV) Antiviral Group Conference. Sam Lee, Ph.D., President and co-CEO, will present “First-in-Human Study of CC-42344, a Novel Broad-Spectrum Influenza A Polymerase PB2 Inhibitor” on May 4, 2023 at 11:05 a.m. Pacific time. The conference theme is “Advancing Respiratory Virus Therapeutics: Lessons Learned from COVID-19” and the event is being held May 3-5 in Seattle.

“We are excited to share additional data from our Phase 1 study with CC-42344 in influenza A and to outline next steps for our compound at this well-respected conference,” said Dr. Lee. “We plan to file a regulatory submission for a Phase 2a influenza A human challenge study that we expect to initiate in the second half of 2023.”

Cocrystal intends to issue a press release summarizing the new data presented at the conference and to post the conference slides to the Company’s website following Dr. Lee’s presentation.

About CC-42344
CC-42344 is a novel PB2 inhibitor discovered using Cocrystal’s proprietary structure-based drug discovery platform technology. CC-42344 targets the influenza polymerase complex, an essential enzyme required for the viral replication. In vitro testing showed CC-42344’s potent antiviral activity against influenza A strains, including pandemic and seasonal strains, as well as against strains resistant to Tamiflu® and Xofluza®.

About ISIRV
The International Society for Influenza and other Respiratory Virus Diseases (ISIRV) is an independent and international scientific professional society promoting the prevention, detection, treatment and control of influenza and other respiratory virus diseases. ISIRV was founded in 2005 as the first scientific society with a fully worldwide remit focused on influenza and respiratory virus disease. As a global scientific society, ISIRV fulfils this mission through promoting the exchange and dissemination of information, facilitating the interaction of scientists and of public health specialists and the promotion of international collaborative efforts against these diseases. More information is available here.

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

Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the Company’s plans and anticipated timelines to begin its Phase 2a human challenge study with its oral PB2 inhibitor CC-42344 in the second half of 2023. The words “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events. Some or all of the events anticipated by these forward-looking statements may not occur. Important factors that could cause actual results to differ from those in the forward-looking statements include, but are not limited to, the risks and uncertainties arising from inflation, interest rate increases, the current banking crisis and the Ukraine war on our Company, our collaboration partners, and on the U.S. and U.K. and global economies, including manufacturing and research delays arising from raw materials and labor shortages, supply chain disruptions and other business interruptions including any adverse impacts on our ability to obtain raw materials and other supplies as well as similar problems with our vendors and our current Contract Research Organization (CRO) and any future CROs and Contract Manufacturing Organizations, the results of the studies for CC-42344 , the ability of our CROs to recruit volunteers for, and to proceed with, clinical studies, our and our collaboration partners’ technology and software performing as expected, financial difficulties experienced by certain partners, the results of future preclinical and clinical trials, the impact of COVID-19 (including long-term and pervasive effects of the virus), general risks arising from clinical trials, receipt of regulatory approvals, regulatory changes, and the potential development of effective treatments by competitors. Further information on our risk factors is contained in our filings with the SEC, including our Annual Report on Form 10-K for the year ended December 31, 2022. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.

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

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

# # #

Source: Cocrystal Pharma, Inc.

Released April 18, 2023

Release – Ocugen Announces Positive Preliminary Safety and Efficacy Results from the Phase 1/2 Trial of OCU400, a Modifier Gene Therapy Product Candidate, for the Treatment of Retinitis Pigmentosa and Leber Congenital Amaurosis

Posted on by cpatches

Research News and Market Data on OCGN

  • Favorable safety and tolerability profile related to OCU400 investigational product candidate
  • Initial clinical data from low and medium dose cohorts indicates positive trend in Multi-luminance mobility testing and Best-Corrected Visual Acuity scores for OCU400 treated eyes
  • 71.4% (5/7) of OCU400 treated eyes in low and medium dose cohorts experienced at least 1 Lux luminance level improvement in mobility test from baseline
  • 66.7% (2/3) of OCU400 treated eyes in low dose cohorts at 9-month follow-up experienced at least 2 Lux luminance level improvement in mobility test from baseline
  • Ocugen believes these preliminary data supports potential of modifier gene therapy platform in gene-agnostic treatment of complex and heterogenous inherited genetic diseases

MALVERN, Pa., April 14, 2023 (GLOBE NEWSWIRE) —  Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologics, and vaccines, today announced positive preliminary data among retinitis pigmentosa (RP) participants treated in the first two cohorts of the Phase 1/2 trial to assess the safety and efficacy of OCU400 for RP associated with NR2E3 and Rhodopsin (RHO) mutations and Leber Congenital Amaurosis (LCA) with mutation(s) in the CEP290 gene. These preliminary results provide support that OCU400, Ocugen’s first-in-class therapeutic approach utilizing a proprietary modifier gene therapy platform, has the potential to be a gene-agnostic therapeutic for RP and LCA patients with inherited retinal degeneration.

“It is very gratifying to see these positive preliminary results from our novel modifier gene therapy approach,” said Dr. Shankar Musunuri, Chairman, Chief Executive Officer, and Co-Founder of Ocugen. “This is the first clinical validation of the platform where patient responses across various genetic mutations support that OCU400 has the potential to transform the lives of many patients who are struggling with debilitating blindness diseases.”

This Phase 1/2 trial is a multicenter, open-label, dose ranging study. A total of 18 RP subjects have been enrolled in this study—10 subjects in the dose escalation and 8 subjects in the expansion phase, respectively. The age of subjects enrolled to date ranges from 18-77 years across RHO and NR2E3 gene mutations. We further expanded this Phase1/2 trial to enroll LCA patients with CEP290 gene mutation and pediatric patients with NR2E3, RHO and CEP290 mutations.

In Cohort 1 and 2 of the clinical trial, 7 participants with severe vision impairment due to RP associated with RHO and NR2E3 gene mutations received a unilateral subretinal injection of either a low dose (1.66 x 1010 vg/mL) or medium dose (3.33 x 1010 vg/mL) OCU400, respectively. In the preliminary data analysis, 9-month follow-up data for 3 subjects [Cohort 1], and 6-month follow-up data for 4 subjects [N=1 from Cohort 1 and N=3 from Cohort 2] were evaluated.

Results showed a favorable safety profile and visual improvements after treatment with OCU400 as measured by multi-luminance mobility testing (MLMT) and best corrected visual acuity assessment (BCVA).

Key efficacy outcomes from 7 subjects demonstrated:

  • 100% of treated eyes showed a stable or improved MLMT score trend;
  • 5 of 7 (71.4%) OCU400 treated eyes demonstrated a 1 or more Lux level improvement in MLMT score compared to 28.6 % of untreated eyes;
  • 66.7% (2 of 3) of OCU400 treated eyes in Cohort 1 with 9-month follow-up demonstrated a 2 or more Lux level improvement in MLMT score compared to none of the untreated eyes; and
  • 3 of 7 (42.9%) OCU400 treated eyes demonstrated 8-11 letters of improvement in BCVA score compared to none of the untreated eyes.

“I was not expecting such substantial improvements in visual function among the trial participants I have been working with because of the advanced stage of their retinal disease,” said David Birch, PhD, Scientific Director, Retina Foundation of the Southwest, principal investigator of the study. “I am very pleased by the outcomes I have seen in my own clinic and am hopeful that OCU400 could provide a therapeutic solution for RP patients who are not only facing loss of vision, but also challenged with the psychological burden of losing their independence.”

“The early results from patients treated in the Phase 1/2 clinical trial are encouraging and support the paradigm-changing potential of modifier gene therapy technology to address unmet medical needs for patients with RP and LCA,” said Arun Upadhyay, PhD, Chief Scientific Officer and Head of Research, Development and Medical at Ocugen. “With this favorable safety profile and positive trend in efficacy signals, we are very eager to see longer-term data, and to potentially initiate Phase 3 trials in the U.S. and EU.”

Ocugen will continue to monitor long-term safety and efficacy data from the treated patients, and advance development of OCU400 to bring a potential treatment option to RP and LCA patients.

CanSinoBIO, Ocugen’s strategic partner, provided all CMC development and clinical supplies for the Phase 1/2 trial of OCU400.

A webcast and conference call will take place today at 8 a.m. ET:
Dial-in Numbers: (800) 715-9871 for U.S. callers and (646) 307-1963 for international callers
Conference ID: 4898155
Webcast: Available on the events section of the Ocugen investor site

About Modifier Gene Therapy
Modifier gene therapy is designed to fulfill unmet medical needs related to retinal diseases, including IRDs, such as RP, LCA, and Stargardt disease, as well as dry AMD. Our modifier gene therapy platform is based on the use of NHRs, master gene regulators, which have the potential to restore homeostasis — the basic biological processes in the retina. Unlike single-gene replacement therapies, which only target one genetic mutation, we believe that our modifier gene therapy platform, through its use of NHRs, represents a novel approach that has the potential to address multiple retinal diseases caused by mutations in multiple genes with one product, and to address complex diseases that are potentially caused by imbalances in multiple gene networks. Currently Ocugen has three modifier gene therapy programs OCU400 (RP, LCA), OCU410 (dry AMD), OCU410ST (Stargardt disease).

About OCU400
OCU400 is the Company’s gene-agnostic modifier gene therapy product based on NHR gene, NR2E3. NR2E3 regulates diverse physiological functions within the retina—such as photoreceptor development and maintenance, metabolism, phototransduction, inflammation and cell survival networks. Through its drive functionality, OCU400 resets altered/affected cellular gene-networks and establishes homeostasis—a state of balance, which has potential to improve retinal health and function in patients with inherited retinal diseases.

About Ocugen, Inc.
Ocugen, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologics, and vaccines that improve health and offer hope for patients across the globe. We are making an impact on patients’ 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, including, but not limited to, statements regarding the development of OCU400 and the interpretation of preliminary clinical trial results. 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, including, but not limited to, the risk that preliminary clinical data may not be indicative of final clinical data or data in later stage clinical trials. 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

Baudax Bio (BXRX) – ANJESO Asset Transfer and S-1 Filing

Posted on by cpereira@noblefcm.com


Friday, April 14, 2023

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.

ANJESO rights go back to Alkermes. In a late March 8K filing, Baudax Bio entered into an agreement with Alkermes Pharma Ireland Limited (Alkermes), transferring the rights to certain patents, trademarks, equipment, data and other rights related to ANJESO to Alkermes. Baudax Bio is also withdrawing the New Drug Application (NDA) related to ANJESO and agreed, if Alkermes elects later, to transfer the withdrawn NDA to Alkermes. The Company also granted Alkermes a non-exclusive, irrevocable, royalty-free and paid up worldwide license to additional intellectual property owned by Baudax Bio necessary to exploit ANJESO going forward.

Transfer agreement terminates payments due to Alkermes.  Alkermes and Baudax Bio agreed the transfer agreement terminates the ANJESO Purchase and Sale Agreement, the Asset Transfer and License Agreement, and the Development, Manufacturing and Supply Agreement. With the terminations, no further payments will be owed or payable by Baudax Bio to Alkermes.


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*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 – PDS Biotech to Host Interleukin 12 (IL-12) Immunocytokine-Focused KOL Roundtable on April 21, 2023

Posted on by aweinsoff@channelchek.com

Research News and Market Data on PDSB

FLORHAM PARK, N.J., April 12, 2023 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing a growing pipeline of targeted immunotherapies for cancer and infectious disease, announced it will host a Key Opinion Leader (KOL) Roundtable on Interleukin-12 (IL-12) for analysts, investors and the scientific community from 8:00 to 9:00 AM, ET on April 21, 2023.

This PDS Biotech-sponsored event will focus on the potential of an IL-12 immunocytokine in oncology and the clinical results and promise demonstrated to date with PDS0301, the company’s novel investigational tumor-targeting IL-12 fusion protein. The novel investigational antibody targeted IL-12 enhances the proliferation, potency and longevity of T cells in the tumor microenvironment while also limiting its presence in the blood, which appears to promote tolerability and safety. The event will be moderated by PDS Biotech’s Chief Medical Officer, Dr. Lauren Wood, and will feature presentations from the following cancer research experts:

  • James Gulley, M.D., Ph.D., Co-Director of the Center for Immuno-Oncology, Deputy Director of the Center for Cancer Research, and Acting Clinical Director of the National Cancer Institute
  • Jeffrey Schlom, Ph.D., Co-Director of the Center for Immuno-Oncology at the Center for Cancer Research of the National Cancer Institute

Registration for PDS Biotech’s IL-12 Focused KOL Roundtable is now open, and a live webcast of the event will be available online in the investor relations section of the company’s website at PDS Biotech – Investor Relations. A replay will be available on the company website for 90 days following the webcast.

About PDS Biotechnology 

PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of targeted cancer and infectious disease immunotherapies based on our proprietary Versamune®, Versamune® plus PDS0301, and Infectimune™ T cell-activating platforms. We believe our targeted immunotherapies have the potential to overcome the limitations of current immunotherapy approaches through the activation of the right type, quantity and potency of T cells. To date, our lead Versamune® clinical candidate, PDS0101, has demonstrated the ability to reduce tumors and stabilize disease in combination with approved and investigational therapeutics in patients with a broad range of HPV16-associated cancers in multiple Phase 2 clinical trials and will be advancing into a Phase 3 clinical trial in combination with KEYTRUDA® for the treatment of recurrent/metastatic HPV16-positive head and neck cancer in 2023.   Our Infectimune™ based vaccines have also demonstrated the potential to induce not only robust and durable neutralizing antibody responses, but also powerful T cell responses, including long-lasting memory T cell responses in pre-clinical studies to date. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech. 

About PDS0301 

PDS0301 is a novel investigational fusion protein of a tumor-targeting antibody and Interleukin 12 (IL-12) that enhances the proliferation, potency and longevity of T cells in the tumor microenvironment. Together with Versamune® based immunotherapies PDS0301 may work synergistically to promote a targeted T cell attack against cancers. PDS0301 is given by a simple subcutaneous injection. Clinical data suggest the addition of PDS0301 to Versamune® based immunotherapies, such as PDS0101, can demonstrate significant disease control by shrinking tumors and/or prolonging survival in patients with recurrent/metastatic cancers with poor survival prognosis.  

Forward Looking Statements

This communication contains forward-looking statements (including within the meaning of Section 21E of the United States Securities Exchange Act of 1934, as amended, and Section 27A of the United States Securities Act of 1933, as amended) concerning PDS Biotechnology Corporation (the “Company”) and other matters. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the Company’s management, as well as assumptions made by, and information currently available to, management. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” “forecast,” “guidance”, “outlook” and other similar expressions among others. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the Company’s ability to protect its intellectual property rights; the Company’s anticipated capital requirements, including the Company’s anticipated cash runway and the Company’s current expectations regarding its plans for future equity financings; the Company’s dependence on additional financing to fund its operations and complete the development and commercialization of its product candidates, and the risks that raising such additional capital may restrict the Company’s operations or require the Company to relinquish rights to the Company’s technologies or product candidates; the Company’s limited operating history in the Company’s current line of business, which makes it difficult to evaluate the Company’s prospects, the Company’s business plan or the likelihood of the Company’s successful implementation of such business plan; the timing for the Company or its partners to initiate the planned clinical trials for PDS0101, PDS0203 and other Versamune® and Infectimune™ based product candidates; the future success of such trials; the successful implementation of the Company’s research and development programs and collaborations, including any collaboration studies concerning PDS0101, PDS0203 and other Versamune® and Infectimune™ based product candidates and the Company’s interpretation of the results and findings of such programs and collaborations and whether such results are sufficient to support the future success of the Company’s product candidates; the success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including the Company’s ability to fully fund its disclosed clinical trials, which assumes no material changes to the Company’s currently projected expenses), futility analyses, presentations at conferences and data reported in an abstract, and receipt of interim or preliminary results (including, without limitation, any preclinical results or data), which are not necessarily indicative of the final results of the Company’s ongoing clinical trials; any Company statements about its understanding of product candidates mechanisms of action and interpretation of preclinical and early clinical results from its clinical development programs and any collaboration studies; to aid in the development of the Versamune® platform;  and other factors, including legislative, regulatory, political and economic developments not within the Company’s control. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the risk factors included in the Company’s annual, quarterly and periodic reports filed with the SEC. The forward-looking statements are made only as of the date of this press release and, except as required by applicable law, the Company undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise.    

Versamune® is a registered trademark and Infectimune™ is a trademark of PDS Biotechnology.

Investor Contacts:
Deanne Randolph
PDS Biotech
Phone: +1 (908) 517-3613
Email: drandolph@pdsbiotech.com

Rich Cockrell
CG Capital
Phone: +1 (404) 736-3838
Email: pdsb@cg.capital

Media Contacts: 
Tiberend Strategic Advisors, Inc.
Dave Schemelia 
Phone: +1 (609) 468-9325 
dschemelia@tiberend.com  

Bill Borden 
Phone: +1 (732) 910-1620 
bborden@tiberend.com

Release – Ocugen To Host Virtual Investor & Analyst Event On April 14, 2023

Posted on by aweinsoff@channelchek.com

Research News and Market Data on OCGN

April 11, 2023

COMPANY TO SHARE PRELIMINARY SAFETY AND EFFICACY DATA FROM ONGOING PHASE 1/2 TRIAL OF OCU400 FOR THE TREATMENT OF RETINITIS PIGMENTOSA AND LEBER CONGENITAL AMAUROSIS

MALVERN, Pa., April 11, 2023 (GLOBE NEWSWIRE) — Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologics, and vaccines, today announced that it will host an Investor and Analyst Event on April 14, 2023, at 8 a.m. ET. During the webcast and conference call, members of the Ocugen leadership team and key opinion leaders will review preliminary safety and efficacy results from the Phase 1/2 trial of OCU400 for the treatment of retinitis pigmentosa (RP) and Leber congenital amaurosis (LCA).

The event will feature:

Shankar Musunuri, PhD, MBA, Chairman, CEO and Co-founder, Ocugen

Arun Upadhyay, PhD, Chief Scientific Officer, Head of Research, Development & Medical, Ocugen

Huma Qamar, MD, MPH, Head of Clinical Development and Medical Affairs, Ocugen

David Birch, PhD, Scientific Director, Retina Foundation of the Southwest, primary investigator of the study

Neena B. Haider, PhD, Fellow of ARVO and inventor of modifier gene therapy

Webcast and Conference Call Details

Dial-in Numbers: (800) 715-9871 for U.S. callers and (646) 307-1963 for international callers
Conference ID: 4898155
Webcast: Available on the events section of the Ocugen investor site

A replay of the call and archived webcast will be available for approximately 45 days following the event on the Ocugen investor site.

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

ChitogenX Inc. (CHNXF) – New Private Placement Offering Announced

Posted on by cpereira@noblefcm.com


Thursday, April 06, 2023

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.

Replaces terminated original placement. The original best efforts private placement expected to close near the end of February for gross proceeds up to $4.35 million (currencies in Canadian $), subject to a $3 million minimum, under a listed issuer exemption prospectus, was terminated. The new offering is a non-brokered $2.5 million gross proceeds private placement.  Of the original two parts in the February offering, the non-brokered $1.75 million gross proceeds private placement at $0.225/unit portion has closed.

Offering terms revised slightly. The smaller new offering carries slightly different terms than the originally announced listed issuer exemption offering.  The new offering units are now priced at $0.20/unit (vs. $0.225/unit), with 12.5 million units being offered. Each unit consists of one Class A share of common and one purchase warrant exercisable at $0.35 with a 5 year expiration. After 6 months, if the volume weighted average trading price exceeds $0.50 for 10 consecutive trading days, ChitogenX can accelerate the expiration date. This new offering is expected to close around April 14, 2023.


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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 – Ocugen Chief Scientific Officer to Present At 2023 World Vaccine Congress

Posted on by aweinsoff@channelchek.com

Research News and Market Data on OCGN

March 31, 2023

PDF Version

MALVERN, Pa., March 31, 2023 (GLOBE NEWSWIRE) — Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologics, and vaccines, today announced that the Company’s Chief Scientific Officer, Arun Upadhyay, PhD, will present at the World Vaccine Congress being held April 3 – 6 in Washington D.C.

“Current COVID-19 vaccines are limited by a lack of durability and inability to stop infection and transmission,” said Dr. Upadhyay. “Inhaled vaccines have the potential to generate rapid mucosal immunity in respiratory pathways, limiting infection and transmission. I look forward to discussing Ocugen’s inhaled vaccine technology—to address COVID-19 and flu—during the World Vaccine Congress.”

Ocugen is currently developing a novel mucosal vaccine platform that includes OCU500, a bivalent COVID-19 inhaled vaccine; OCU510, a seasonal quadrivalent flu inhaled vaccine; and OCU520, a combination quadrivalent seasonal flu and bivalent COVID-19 inhaled vaccine. The OCU500 series grants Ocugen a distinct product candidate profile status that could significantly impact major global health obstacles and maximize the Company’s opportunity to serve broader patient markets. For the 2022 to 2023 flu season, in the United States alone, more than 50% of the population above six months of age received a seasonal flu shot, representing a market size of more than 170 million doses.

Details on Dr. Upadhyay’s participation are as follows:

Presentation Title: “A next generation inhalation-based mucosal vaccine for COVID-19 and Flu: Potential approach to reduce infection and transmission”
Date: Wednesday, April 5, 2023
Time: 5:40 p.m. ET
Location: Walter E. Washington Convention Center, Washington D.C. – Level 2, Room 203AB

Roundtable Discussion Title: “Going beyond existing limitations – Why mucosal vaccines are essential for respiratory diseases”
Date: Tuesday, April 4, 2023
Time: 11:40 – 12:20 p.m. ET (rotation 1); 12:30 – 1:10 p.m. ET (rotation 2)
Location: Walter E. Washington Convention Center, Washington D.C. – Room 203B

About Ocugen, Inc.
Ocugen, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologics, 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

MAIA Biotechnology (MAIA) – Clinical Progress Continues With 4Q22 Report

Posted on by cpereira@noblefcm.com


Friday, March 31, 2023

MAIA is a targeted therapy, immuno-oncology company focused on the development and commercialization of potential first-in-class drugs with novel mechanisms of action that are intended to meaningfully improve and extend the lives of people with cancer. Our lead program is THIO, a potential first-in-class cancer telomere targeting agent in clinical development for the treatment of NSCLC patients with telomerase-positive cancer cells. For more information, please visit www.maiabiotech.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.

Financial Results. Maia Biotechnology reported a 4Q22 loss of $5.1 million or $(0.47) per share and a FY2022 loss of $15.7 million or $(1.75) per share. The Phase 2 THIO-101 trial continues to enroll and treat patients at its clinical sites, with several clinical milestone ahead during FY2023. The company ended FY2022 with $10.9 million in cash.

THIO-101 Reached Expected Milestones During 4Q22.  MAIA began patient treatment in the THIO-101 trial in NSCLC (non-small cell lung cancer) in July 2022. The first patients were treated in Australia, with European country approvals announced in December 2022. These approvals allow opening clinical sites in Hungary, Poland, and Bulgaria to support European approval. MAIA reported that two European patients have been begun treatment.


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*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. 

Axcella Therapeutics (AXLA) – FY2022 Reported With AXA1125 “Phase 2b/3 Ready”

Posted on by cpereira@noblefcm.com


Friday, March 31, 2023

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 restore cellular homeostasis in multiple key biological pathways and improve cellular energetic efficiency. Axcella’s pipeline includes lead therapeutic candidates in Phase 2 development for the treatment of Long COVID and non-alcoholic steatohepatitis (NASH), and the reduction in risk of overt hepatic encephalopathy (OHE) recurrence. 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.

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.

4Q22 Reported.  Axcella Health reported a 4Q22 loss of $23.0 million or $(0.33) per share and a FY2022 loss of $81.2 million or $(1.49) per share. The 4Q loss included restructuring and impairment charges of $4.2 million. Since the restructuring, Axcella has made significant progress transforming AXA1125 from Phase 2a data into an approved IND for a Phase 2b/3 clinical trial.  The company ended FY2023 with $17.1 million in cash.

Long COVID Trial Is “Phase 2b/3 Ready”. In February 2023, Axcella announced the FDA accepted its IND for a Phase 2b/3 pivotal study testing AXA1125 in Long COVID. The design of the study was based on the results of its Phase 2a placebo-controlled trial in Long COVID announced in August 2022. The Phase 2a data showed statistically significant results in mental and physical fatigue scores. Although an experimental biomarker endpoint in muscle recovery was not met, the FDA accepted the IND for a Phase 2b/3 trial.


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Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.

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.