Tag: Health

Tonix Pharmaceuticals (TNXP) – Looking Forward To Late-Stage Data Presentations

Posted on by cpereira@noblefcm.com


Tuesday, May 09, 2023

Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing therapeutics and diagnostics to treat and prevent human disease and alleviate suffering. Tonix’s portfolio is composed of immunology, rare disease, infectious disease, and central nervous system (CNS) product candidates. Tonix’s immunology portfolio includes biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-15001 which is a humanized monoclonal antibody targeting CD40-ligand 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 second half of 2022. Tonix’s rare disease portfolio includes TNX-29002 for the treatment of Prader-Willi syndrome. TNX-2900 has been granted Orphan-Drug Designation by the FDA. Tonix’s infectious disease pipeline includes a vaccine in development to prevent smallpox and monkeypox called TNX-8013, next-generation vaccines to prevent COVID-19, and an antiviral to treat COVID-19. Tonix’s lead vaccine candidates for COVID-19 are TNX-1840 and TNX-18504, which are live virus vaccines based on Tonix’s recombinant pox vaccine (RPV) platform. TNX-35005 (sangivamycin, i.v. solution) is a small molecule antiviral drug to treat acute COVID-19 and is in the pre-IND stage of development. TNX-102 SL6, (cyclobenzaprine HCl sublingual tablets), is a small molecule drug being developed to treat Long COVID, a chronic post-acute COVID-19 condition. Tonix expects to initiate a Phase 2 study in Long COVID in the second quarter of 2022. The Company’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, is in mid-Phase 3 development for the management of fibromyalgia with a new Phase 3 study launched in the second quarter of 2022. Finally, TNX-13007 is a biologic designed to treat cocaine intoxication that is expected to start a Phase 2 trial in the second quarter of 2022. TNX-1300 has been granted Breakthrough Therapy Designation by the FDA.

Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.

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

1Q23 Reported Within Expectations. Tonix reported a 1Q23 loss of $33.0 million or $(0.52) per share, consistent with our expectations of a loss of $34.8 million or $(0.57) per share. During the quarter, the company reported a shift in pipeline priorities toward its CNS programs and discontinuation of some early-stage programs. There are several clinical data presentations expected during 2H23 that we see as potential drivers of the stock in 2H23. The company ended the quarter with $72.0 million in cash.

Looking Forward To Phase 3 Results In Fibromyalgia. Data was presented for the completed RELIEF Phase 3, the first of the two studies needed for an NDA. The interim analysis for the Phase 3 RESILIANT trial has been cancelled, avoiding the “statistical penalty” for the early analysis as well as saving time and money. The RESILIANT data announcement is expected in 4Q23.


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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. 

MAIA Biotechnology (MAIA) – 1Q23 Reported As Trial Progress Continues

Posted on by cpereira@noblefcm.com


Tuesday, May 09, 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, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.

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

1Q23 Loss Reported With Progress Review. Maia Biotechnology announced a 1Q23 loss of $4.1 million or $(0.38) per share. Progress during the quarter included announcement of preliminary safety data from its lead trial in non-small cell lung cancer, THIO-101, and patient enrollment in Part B. Preclinical data was presented on THIO in liver cancer, an indication planned for the THIO-102 trial later in 2H23. Cash on March 31 was $7.6 million, excluding $5.75 million raised in a public offering completed in late April.

THIO-101 Part A Safety Results Were Presented. THIO-101 is the first trial testing THIO in combination with Libtayo, an anti-PD-1 checkpoint inhibitor from Regeneron. The data was from the Part A safety lead-in stage that tested a dose of 360 mg in 6 patients with advanced non-small cell lung cancer. There were no dose-limiting toxicities or safety issues reported. As of April 2023, the first two patients enrolled in Part A were still alive and reached survival endpoints of 10 and 9 months. Both patients have advanced Stage IV metastatic disease and had failed third and fourth line of therapy, with life expectancy of about 6 months.


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Ocugen (OCGN) – Moving Past Covaxin, Focusing On Gene Therapy and Pipeline Products

Posted on by cpereira@noblefcm.com


Monday, May 08, 2023

Ocugen, Inc. is a biotechnology company focused on developing and commercializing novel gene therapies, biologicals, and vaccines. The lead product, Covaxin, is a killed-virus vaccine for COVID-19 in-licensed from Bharat Biotech (India). The lead product in its gene therapy program, OCU400, is in Phase 1/2 clinical trials for retinitis pigmentosa.

Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.

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

Financial Report Includes Discontinuation Of Covaxin. Ocugen reported 1Q23 financial results of a loss of $16.5 million or $(0.07) per share, beating our estimate of a loss of $23.9 million or $(0.11) per share.  The difference was largely due to lower Research and Development spending at $9.6 million compared to our estimate of $15.9 million, attributed to the discontinuation of Covaxin development. Cash on hand at March 31 was $76.7 million, with the reduction in R&D expected to extend the cash runway into 1Q24.

Moving Beyond Covaxin. In view of recent changes in FDA guidance for monovalent COVID-19 vaccines, Ocugen has determined that Covaxin is no longer commercially viable and has discontinued development. We see this as a neutral to mild positive since the company had already announced that it would not continue development without outside funding. This should complete the shift to the gene therapy platform, NeoCart, and the inhaled vaccines.


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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. 

GeoVax Labs, Inc. (GOVX) – Initiating Coverage With $6 Price Target

Posted on by cpereira@noblefcm.com


Monday, May 08, 2023

GeoVax Labs, Inc., a clinical-stage biotechnology company, develops human vaccines for infectious diseases and cancer in the United States and internationally. The company through its patented Modified Vaccinia Ankara-Virus Like Particle vaccine platform develops various vaccines. It is developing various vaccines that are in human clinical trials, and preclinical research and development phases, including vaccines against human immunodeficiency virus (HIV); Zika virus; malaria; and hemorrhagic fever viruses, such as Ebola, Sudan, Marburg, and Lassa, as well as therapeutic vaccines for chronic Hepatitis B infections and cancers. The company has collaboration and partnership agreements with the National Institute of Allergy and Infectious Diseases of the National Institutes of Health; the HIV Vaccines Trial Network; Centers for Disease Control and Prevention; United States Army Research Institute of Infectious Disease; U.S. Naval Research Laboratory; Emory University; University of Pittsburgh; Georgia State University Research Foundation; Peking University; University of Texas Medical Branch; the Institute of Human Virology at the University of Maryland; the Scripps Research Institute; the Burnet Institute; American Gene Technologies, Inc.; Viamune, Inc.; Vaxeal Holding SA; CaroGen Corporation; Virometix AG; and Leidos, Inc. GeoVax Labs, Inc. was founded in 2001 and is based in Smyrna, Georgia.

Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.

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

Initiating Coverage of GOVX. GeoVax Labs is developing gene therapies, immunotherapies, and vaccines for cancer and infectious diseases. Gedeptin, its lead cancer product, is a gene-directed therapy for cancer.  The treatment delivers a gene to the cancer cells that converts an inactive prodrug into an active cytotoxic drug within the tumor cells. 

Gedeptin Uses A Proprietary Gene Delivery Technology. Gedeptin uses an adenovirus vector to deliver a gene to cancer cells that converts an inactive prodrug into an active cytotoxic drug within the tumor cells. This increases the drug’s potency inside the cancer cells while avoiding healthy tissue. Gedeptin is currently in a Phase 1/2 trial for advanced head and neck cancers, and has been granted Orphan Drug Designation for oral and pharyngeal cancers.


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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. 

ChitogenX Inc. (CHNXF) – Third Time’s the Charm? Non-Brokered Private Placement Terms Amended Again

Posted on by cpereira@noblefcm.com


Wednesday, May 03, 2023

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.

Offering increased to $5 million from $2.5 million. The new amended offering terms adjust the number of share units for a lower price and increased shares being offered for gross proceeds of $5 million (currencies in Canadian $). The original terms were priced at $0.225/unit.  The 1st amendment from early April was priced at $0.20/unit, consisting of a share of common and a purchase warrant excercisable at $0.35 with a 5 year expiration, for expected gross proceeds of $2.5 million.

New terms increase share count.  The new 2nd amended offering prices the share units at $0.15/unit, consisting of one share of common stock and a purchase warrant exercisable at $0.35. The warrants terminate 36 months from the closing date (now expected May 3, 2023). For the maximum $5 million in gross proceeds, the new amended offering consists of 33,333,333 units.


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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. 

Baudax Bio (BXRX) – Offering Closed; Adjusting Estimates for Expected Higher R&D Expenses

Posted on by cpereira@noblefcm.com


Tuesday, May 02, 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.

$4 million gross proceeds.   Baudax Bio closed its public offering of 3,478,262 common shares (or pre-funded warrants) at $1.15 per share. Each share was accompanied by a Series A-5 warrant to purchase one share and a Series A-6 warrant to purchase one share, both exercisable at $1.15.  The Series A-5 warrant is exercisable immediately and expires five years from issuance.  The Series A-6 warrant is also exercisable immediately and expires 18 months from issuance. The offering was pursuant to an S-1 filing effective April 26, 2023.

Funding needs.  As part of the restructured credit agreement, the Company needed capital for upcoming debt payments and related minimum liquidity requirements. The proceeds will also be used for advancing the NMB pipeline. We expect continued funding needs and have incorporated a higher share count into our outlook.


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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. 

MustGrow Biologics Corp. (c) – Reports 4Q22 and FY22 Results

Posted on by cpereira@noblefcm.com


Monday, May 01, 2023

Joe Gomes, Managing Director, Equity Research Analyst, Generalist , Noble Capital Markets, Inc.

Joshua Zoepfel, Research Associate, Noble Capital Markets, Inc.

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

4Q22 Operational Update. MustGrow released 4Q22 and full year 2022 operating results at the end of last week. As we have just provided an update on the Company following management’s webinar presentation, we will just highlight key elements of the results here.

Financial Results. Zero revenue and a loss of $1.0 million, or a loss of $0.02/sh for the fourth quarter., similar to the 4Q21 loss, although EPS loss last year was $0.03 due to fewer outstanding shares. The 4Q22 loss was about 1/2 of the 3Q22 loss due to lower stock comp expense and professional fees expense. For the full year, MustGrow reported revenue of $6,479 and a net loss of $5.6 million, or a loss of $0.11/sh, compared to a loss of $3.1 million, or a loss of $0.07/sh in 2021.


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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. 

MustGrow Biologics Corp. (MGROF) – Corporate Presentation

Posted on by cpereira@noblefcm.com


Friday, April 28, 2023

Joe Gomes, Managing Director, Equity Research Analyst, Generalist , Noble Capital Markets, Inc.

Joshua Zoepfel, Research Associate, Noble Capital Markets, Inc.

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

Webinar. We had the opportunity to participate in MustGrow’s webinar presentation on recent corporate progress, biological industry developments, and upcoming catalysts. The key takeaways, in our view: MustGrow and its partners continue to make progress toward commercialization of the Company’s unique technology; revenues could begin within 12 months; the TAM is large and growing; and stricter governmental regulations across the world highlight the need for sustainable products like MustGrow’s products.

TAM. The global pesticide market grows at a 3.5% CAGR and should hit $82 billion by 2030, with the fertilizer market growing at a 2.5% CAGR to $242 billion by 2030. But with an ever increasing movement to limit or outright ban certain pesticide and fertilizer products, the TAM for MustGrow grows even faster.


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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. 

Schwazze (SHWZ) – Growing to Everest Heights

Posted on by cpereira@noblefcm.com


Wednesday, April 26, 2023

Schwazze (OTCQX:SHWZ, NEO:SHWZ) is building a premier vertically integrated regional cannabis company with assets in Colorado and New Mexico and will continue to take its operating system to other states where it can develop a differentiated regional leadership position. Schwazze is the parent company of a portfolio of leading cannabis businesses and brands spanning seed to sale. The Company is committed to unlocking the full potential of the cannabis plant to improve the human condition. Schwazze is anchored by a high-performance culture that combines customer-centric thinking and data science to test, measure, and drive decisions and outcomes. The Company’s leadership team has deep expertise in retailing, wholesaling, and building consumer brands at Fortune 500 companies as well as in the cannabis sector. Schwazze is passionate about making a difference in our communities, promoting diversity and inclusion, and doing our part to incorporate climate-conscious best practices.

Joe Gomes, Managing Director, Equity Research Analyst, Generalist , Noble Capital Markets, Inc.

Joshua Zoepfel, Research Associate, Noble Capital Markets, Inc.

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

Another Acquisition. Schwazze announced the Company signed definitive documents to acquire certain assets of Sucellus, LLC. In the proposed acquisition, the Company will manage Everest Apothecary, Inc. and will be for $38 million in a combination of cash, a four-year seller note, and Company stock. It is expected to close in 2Q23.

Who is Everest? Everest is a not-for-profit company established in 2016 consisting of 14 dispensaries located in Albuquerque, Santa Fe, Las Cruces, Los Lunas, Sunland Park, Belen, and Texico, and also consists of approximately 16,000 square feet of cultivation and a 8,500 square foot manufacturing facility. The acquisition is similar to the R. Greenleaf acquisition done by Schwazze in 2022, where 10 dispensaries, four cultivation facilities, and a manufacturing facility were acquired for $42 million.


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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. 

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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*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. 

PDS Biotechnology Corp. (PDSB) – Roundtable on IL-12 Highlights PDS0301

Posted on by cpereira@noblefcm.com


Monday, April 24, 2023

PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of molecularly targeted cancer and infectious disease immunotherapies based on the Company’s proprietary Versamune® and Infectimune™ T-cell activating technology platforms. Our Versamune®-based products have demonstrated the potential to overcome the limitations of current immunotherapy by inducing in vivo, large quantities of high-quality, highly potent polyfunctional tumor specific CD4+ helper and CD8+ killer T-cells. PDS Biotech has developed multiple therapies, based on combinations of Versamune® and disease-specific antigens, designed to train the immune system to better recognize diseased cells and effectively attack and destroy them. The Company’s pipeline products address various cancers including HPV16-associated cancers (anal, cervical, head and neck, penile, vaginal, vulvar) and breast, colon, lung, prostate and ovarian cancers.

Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.

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

KOL Discussion Of IL-12. PDL Biotechnology held a Roundtable Discussion on cancer therapy with IL-12 and its proprietary, tumor-seeking version, PDS0301. The panel was moderated by Dr. Lauren Wood, Chief Medical Officer, and featured two distinguished scientists from the National Cancer Institute. The presentations highlighted the distinctions between PDL0301 and recombinant IL-12, with clinical data from trials testing both drugs.

Comparisons Between IL-12 and PDS0301. The presentations pointed out the differences between IL-12 and PDS0301, the proprietary version developed by the NCI and licensed by PDS. One of the key points is that PDS0301 is an antibody linked to IL-12. The antibody domain targets and binds to cancer cell DNA that has been released from dead or dying cancer cells. This concentrates PDS0301 in the tumor, then the IL-12 portion stimulates an immune response. This differs from other trials that have used recombinant IL-12 to stimulate an immune response. In comparison, systemic rIL-12 delivery or targeting technologies have resulted in lack of efficacy, systemic side effects, or both.


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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 – 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

PDF Version

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

Onconova Therapeutics (ONTX) – Data Presented on Narazaciclib Targets and Mechanisms

Posted on by cpereira@noblefcm.com


Thursday, April 20, 2023

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 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.

Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.

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Data Presented At AACR Annual Meeting. Onconova presented two posters at the American Association of Cancer Research annual meeting, held April 14 to April 19. These posters from preclinical studies gave additional details on the activity, targets, and mechanism of action for narazaciclib, its CDK4/6 inhibitor, and comparisons with other approved CDK4/6 inhibitors.

Study On Naraciclib Targets. The first poster showed that narazaciclib inhibits CDK4/6 as well as additional kinases in cancer progression and metastasis. Data included the BUB1 kinase that is overexpressed in breast and uterine cancers, showing correlations between BUB1 expression and poor survival. BUB1 was inhibited by narazaciclib, but not palbociclib (Ibrance, from Pfizer) or abemaciclib (Verzenio, from Lilly). The poster also presented data showing that narazaciclib may lead to the expression of immune modulators in tumor cells that lead to anti-tumor immunity, an important mechanism for preventing recurrence.


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