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
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.
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.
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 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.
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.
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
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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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:
PresentationTitle: “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 DiscussionTitle: “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 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 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.
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.
Cocrystal Pharma, Inc. is a clinical-stage biotechnology company discovering and developing novel antiviral therapeutics that target the replication process of influenza viruses, coronaviruses (including SARS-CoV-2), hepatitis C viruses and noroviruses. Cocrystal employs unique structure-based technologies and Nobel Prize-winning expertise to create first- and best-in-class antiviral drugs. For further information about Cocrystal, please visit www.cocrystalpharma.com.
Robert LeBoyer, Vice President, Research Analyst, Life Sciences , Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
Financial Results. Cocrystal reported a 4Q loss of $4.5 million or $(0.55) per share and a FY2022 loss of $38.8 million or $(4.77) per share. The full-year results included a non-cash charge of $19.1 million for the impairment of goodwill in 2Q22. Excluding the charge, expenses levels for Research and Development and General and Administrative expense were close to expectations. The company ended FY2022 with $37.1 million in cash.
Influenza Clinical Trial Expected To Begin In 2H2023. In December 2022, Cocrystal reported preliminary safety and tolerability results from its dose-ranging Phase 1 study for orally administered CC-42344 for influenza. A Phase 2a study has been designed to challenge healthy human volunteers with pharmaceutically-produced influenza A virus, then treat with CC-42344. An application to start trials in the UK is planned for 1H2023, with enrollment beginning in 2H23. Preclinical development of an inhaled formulation of CC-42344 continues.
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.
BOTHELL, Wash., March 29, 2023 (GLOBE NEWSWIRE) — Cocrystal Pharma, Inc. (Nasdaq: COCP) reports financial results for the 12 months ended December 31, 2022, and provides updates on its antiviral pipeline, upcoming milestones and business activities.
“This is an eventful time for Cocrystal with multiple near-term milestones with our highly promising antiviral programs,” said Sam Lee, Ph.D., President and co-CEO of Cocrystal. “Preparations are ongoing with a UK regulatory filing to begin an influenza A Phase 2a human challenge study with our novel oral PB2 inhibitor CC-42344. Pending regulatory clearance, we expect patient enrollment to begin in the second half of this year.
“We are also preparing to file with the Australian regulatory agency to begin a first-in-human trial in our oral COVID-19 program with our novel, broad-spectrum protease inhibitor CDI-988. This trial is also slated to begin in the first half of 2023, subject to regulatory clearance,” he added. “In our norovirus program, preclinical development activities are ongoing and we plan to select a lead oral candidate by mid-2023.”
“We made significant progress over the past year that put us on pace to initiate two clinical trials during 2023,” said James Martin, CFO and co-CEO. “We expect our cash will be sufficient to fund operating activities for the coming year as we tightly manage our financial resources under our cost-efficient operating model. We also intend to pursue non-dilutive funding to further support development of our promising antiviral programs.”
Antiviral Product Pipeline Overview
We are developing antiviral therapeutics that inhibit the essential viral replication function of RNA viruses that cause acute and chronic viral diseases. Our drug discovery process focuses on the highly conserved regions of the viral enzymes and inhibitor-enzyme interactions at the atomic level. It differs from traditional, empirical medicinal chemistry approaches that often require iterative high-throughput compound screening and lengthy hit-to-lead processes. In designing drug candidates, we seek to anticipate and avert potential viral mutations leading to resistance. By designing and selecting drug candidates that interrupt the viral replication process and have specific binding characteristics, we seek to develop drugs that not only are effective against both the virus and possible mutants of the virus, but also have reduced off-target interactions that may cause undesirable clinical side effects. We will continue developing preclinical and clinical drug candidates using our proprietary drug discovery technology.
Influenza Programs
Influenza is a severe respiratory illness caused by either the influenza A or B virus that results in disease outbreaks mainly during the winter months. The global seasonal influenza market was valued at $6.5 billion in 2021 and is projected to reach up to $27.95 billion by 2029, according to Data Bridge Market Research.
Pandemic and Seasonal Influenza A
Our novel oral PB2 inhibitor, CC-42344, has shown excellent antiviral activity against influenza A strains including pandemic and seasonal strains, as well as strains resistant to Tamiflu® and Xofluza®.
In March 2022 we initiated enrollment in our randomized, double-controlled, dose-escalating Phase 1 study to evaluate the safety, tolerability and pharmacokinetics of orally administered CC-42344 in healthy adults.
In April 2022 we announced preliminary Phase 1 study data demonstrating a favorable safety and pharmacokinetic (PK) profile in the first two cohorts in the single-ascending dose portion of the study.
In July 2022 we reported PK results from the single-ascending dose of the study supporting once-daily dosing.
In December 2022 we reported favorable safety and tolerability results from the Phase 1 study with CC-42344 for influenza A.
We entered into an agreement with a UK-based clinical research organization to conduct a Phase 2a human challenge study evaluating safety, viral and clinical measures of orally administered CC-42344 in influenza A-infected subjects. Under the human challenge model, healthy adults will be infected with the influenza A virus under carefully controlled conditions, which we believe will hasten trial enrollment.
We expect to submit an application with the United Kingdom Medicines and Healthcare Products Regulatory Agency in the first half of 2023 to conduct this study. Pending clearance by the agency, we expect to initiate the study in the second half of 2023.
Preclinical development is underway with an inhaled formulation of CC-42344 as a treatment and prophylaxis for influenza A.
Pandemic and Seasonal Influenza A/B Program
Merck recently notified the Company that they continue development activities with the compounds discovered under this agreement and that they have filed on behalf of both companies multiple U.S. and international patent applications associated with these compounds. Merck continues to be responsible for managing the patents.
In January 2019 we entered into an Exclusive License and Research Collaboration Agreement with Merck Sharp & Dohme Corp. (Merck) to discover and develop certain proprietary influenza antiviral agents that are effective against both influenza A and B strains. This agreement includes milestone payments of up to $156 million plus royalties on sales of products discovered under the agreement.
In January 2021 we announced completion of all research obligations under the agreement. Merck is now solely responsible for further preclinical and clinical development of compounds discovered under this agreement.
COVID-19 and Other Coronavirus Programs
By targeting viral replication enzymes and protease, we believe it is possible to develop an effective treatment for all coronavirus diseases including COVID-19, Severe Acute Respiratory Syndrome (SARS) and Middle East Respiratory Syndrome (MERS). Our main SARS-CoV-2 protease inhibitors showed potent in vitro pan-viral activity against common human coronaviruses, rhinoviruses and respiratory enteroviruses that cause the common cold, as well as against noroviruses that can cause symptoms of acute gastroenteritis.
Oral Protease Inhibitor CDI-988
We selected CDI-988 as our lead candidate for development as a potential oral treatment for SARS-CoV-2. CDI-988, which was designed and developed using our proprietary structure-based drug discovery platform technology, targets a highly conserved region in the active site of SARS-CoV-2 3CL (main) protease required for viral RNA replication.
CDI-988 exhibited superior in vitro potency against SARS-CoV-2 with activity maintained against current variants of concern, and demonstrated a safety profile and PK properties that are supportive of daily dosing.
We are currently conducting good laboratory practice (GLP) toxicology studies in preparation for a Phase 1 study.
Preparations are underway to submit an application to the Australian regulatory authority for a planned randomized, double-blind, placebo-controlled Phase 1 study. Pending regulatory clearance, we expect to initiate the study in the first half of 2023. We believe the FDA’s guidance for further development of our antiviral candidate CDI-45205 (described below) also provides us with a clearer pathway for our planned Phase 1 study with CDI-988, as well as directives for designing a subsequent Phase 2 study.
Intranasal/Pulmonary Protease Inhibitor CDI-45205
An IND-enabling study is ongoing with CDI-45205, our novel SARS-CoV-2 3CL (main) protease inhibitor being developed as a potential treatment for SARS-CoV-2 and its variants.
We received guidance from the FDA regarding further preclinical and clinical development of CDI-45205 that provides a clearer pathway for future clinical development.
CDI-45205 and several analogs showed potent in vitro activity against the main SARS-CoV-2 variants to date including the Omicron variant, surpassing the activity observed with the original Wuhan strain.
CDI-45205 demonstrated good bioavailability in mouse and rat PK studies via intraperitoneal injection, and no cytotoxicity against a variety of human cell lines. CDI-45205 also demonstrated a strong synergistic effect with the FDA-approved COVID-19 medicine remdesivir.
CDI-45205 was among the broad-spectrum viral protease inhibitors we obtained from Kansas State University Research Foundation (KSURF) under an exclusive license agreement announced in April 2020. We believe the protease inhibitors obtained from KSURF have the ability to inhibit the inactive SARS-CoV-2 polymerase replication enzymes into an active form.
Replication Inhibitors
We are using our proprietary structure-based drug discovery platform technology to discover replication inhibitors for orally administered therapeutic and prophylactic treatments for SARS-CoV-2. Replication inhibitors hold potential to work with protease inhibitors in a combination therapy regimen.
Norovirus Program
We are developing certain proprietary broad-spectrum, non-nucleoside polymerases for the treatment of human norovirus infections using our proprietary structure-based drug design technology platform. We also hold exclusive rights to norovirus protease inhibitors for use in humans under the KSURF license.
We are targeting the selection of an oral preclinical lead in the first half of 2023.
Norovirus is a global public health problem responsible for nearly 90% of epidemic, non-bacterial outbreaks of gastroenteritis around the world.
Hepatitis C Program
We are seeking a partner to advance the development of CC-31244 following the successful completion of a Phase 2a study. This compound has shown favorable safety and preliminary efficacy in a triple-regimen Phase 2a study in combination with Epclusa (sofosbuvir/velpatasvir) for the ultra-short duration treatment of individuals infected with the hepatitis C virus (HCV).
HCV is a viral infection of the liver that causes both acute and chronic infection. In June 2022 the World Health Organization estimates that 58 million people worldwide have chronic HCV infection.
2022Financial Results
Research and development expenses for 2022 were $12.4 million compared with $8.8 million for 2021, with the increase primarily due to advancing our influenza lead candidate CC-42344 through a Phase 1 trial and preparation for a Phase 2a clinical trial planned for 2023, as well as advancing our lead COVID-19 clinical oral candidate CDI-988 in preparation for a Phase 1 clinical trial planned for 2023. General and administrative expenses for 2022 were $5.7 million compared with $5.4 million for 2021, with the increase primarily due to professional fees and litigation expenses.
The Company’s litigation with an insurer resulted in the insurance company obtaining a summary judgment during the second quarter of 2022 and accounted for a potential $1.6 million adverse award. The Company filed an appeal in July 2022. Pending the outcome of the appeal, the Company paid $1.6 million into the registry of the court, which stayed execution of the judgment. The United States Court of Appeals for the Third Circuit held oral argument on the appeal on March 8, 2023, and the parties are still awaiting a ruling on the appeal.
The net loss for 2022 was $38.8 million, or $4.77 per share, compared with the net loss for 2021 of $14.2 million, or $0.16 per share. This increase was primarily due to a $19.1 million non-cash impairment-loss of goodwill and an increase in R&D expenses as we continue to advance CC-42344, CDI-988 and other product candidates.
Cocrystal reported unrestricted cash of $37.1 million as of December 31, 2022 compared with $58.7 million as of December 31, 2021. Net cash used in operating activities for 2022 was $21.4 million. The Company reported working capital of $39.0 million and 8.1 million common shares outstanding as of December 31, 2022.
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.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding our plans for the future development of preclinical and clinical drug candidates, our expectations regarding future characteristics of the product candidates we develop, the expected time of achieving certain value driving milestones in our programs, including, preparation, commencement and advancement of clinical studies for certain product candidates in 2023, the viability and efficacy of potential treatments for coronavirus and other diseases, expectations for the markets for certain therapeutics, our ability to execute our clinical and regulatory goals and deploy regulatory guidance towards future studies, the expected sufficiency of our cash balance to fund our planned operations, our liquidity and planned cost-efficient management of our financial resources, and our continued pursuit of non-dilutive funding. 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 the impact of COVID-19 (including long-term and pervasive effects of the virus), inflation, interest rate increases 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 reliance on Merck for further development in the influenza A/B program under the license and collaboration agreement, 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, 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, potential mutations in a virus we are targeting which may result in variants that are resistant to a product candidate we develop, and the outcome of our appeal of the summary judgment. 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.
FLORHAM PARK, N.J., March 29, 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, today announced that Dr. Frank Bedu-Addo, President and Chief Executive Officer, will participate in Cantor’s Future of Oncology Virtual Symposium being held on April 3-5, 2023.
Cantor Symposium Presentation Date: Tuesday, April 4, 2023 Time: 3:00 PM ET
For more information about the conference, please contact your Cantor representative directly.
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 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. 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.
