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, Vice President, Research Analyst, Life Sciences , Noble Capital Markets, Inc.
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Data To Be Presented At SITC. PDS Biotechnology released two PDS0101 abstracts to be presented at the SITC (Society for Immunotherapy of Cancer) meeting later this week. Data will be from the Phase 2 IMMUNOCERV trial in cervical cancer in combination with chemotherapy and radiation and the trial known as the Triple Combination Study or NCI Study, testing PDS0101 in combination with two immunomodulating agents. We believe both studies show positive results that are consistent with our expectations.
IMMUNOCERV Trial Highlights. The Phase 2 IMMUNOCERV trial is testing PDS0101 in combination with standard-of-care chemotherapy in advanced cervical cancer. Out of 17 patients enrolled in the study, 8 had been reached the 170-day status evaluation for by PET CT. Complete responses (CR) were seen in 7 out of 8 (87.5%) of the patients. One year survival was all 8 out of 8 (100%), with 7 out of 8 disease free (87.5%). One patient who only received 3 out of 5 doses showed signs of residual disease. The study is still ongoing.
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.
Patients with high-risk, locally advanced cervical cancer on IMMUNOCERV demonstrated increased tumor-infiltrating polyfunctional CD8+ (killer) T cells, and 1-year overall survival of 100%
Data from study across several checkpoint inhibitor refractory HPV-positive cancers demonstrate an increase in HPV-specific T cells following treatment with PDS0101-based triple combination
FLORHAM PARK, N.J., Nov. 07, 2022 (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 upcoming poster presentations of clinical data from two Phase 2 clinical trials of PDS0101 at the 37th Annual Meeting for the Society for Immunotherapy of Cancer (SITC 2022) being held November 8-12, 2022 in Boston. PDS0101 is PDS Biotech’s lead candidate being developed as a potential treatment for HPV-positive cancers.
The first abstract accepted for presentation, titled, “IMMUNOCERV, an ongoing Phase II trial combining PDS0101, an HPV-specific T cell immunotherapy, with chemotherapy and radiation for treatment of locally advanced cervical cancers,” highlights data from The University of Texas MD Anderson Cancer Center-led IMMUNOCERV Phase 2 clinical trial (NCT04580771). The study is investigating PDS0101 in combination with standard-of-care chemoradiotherapy (CRT) for the potential treatment of cervical cancer in patients with large tumors over 5cm in size and/or cancer that has spread to the lymph nodes (lymph node metastasis). Highlights from the study being presented at SITC 2022 include:
17 patients have been enrolled in the trial.
8 of the 17 patients had completed a Day 170 post-treatment Positron Emission Tomography, Computed Tomography (PET CT) scan to assess the status of the cancer.
87.5% (7/8) of patients treated with the combination of PDS0101 and CRT demonstrated a complete response (CR) on Day 170 by PET CT. One patient who received 3 of the 5 scheduled doses of PDS0101 showed signs of residual disease.
In comparison, 74.1% (40/54) of locally advanced patients who received CRT alone and were monitored at The University of Texas MD Anderson Cancer Center on a prospective protocol independent of IMMUNOCERV had a CR on PET CT at Day 170.
The 1-year overall survival is 100% (8/8) in patients treated with the combination of PDS0101 and CRT.
The observed 1-year disease-free survival rate for IMMUNOCERV patients is 87.5% (7/8).
Patients treated with the combination of PDS0101 and CRT had a 71% increase in multi-cytokine-inducing (polyfunctional) killer (CD8+) T cells within the tumors from baseline to end of treatment (38% to 65%). This increase in activated T cells was not seen in patients receiving standard-of-care CRT.
Toxicity of PDS0101 was limited to low-grade local injection site reactions.
The second abstract, titled “Immune Correlates Associated with Clinical Benefit in Patients with Checkpoint Refractory HPV-Associated Malignancies Treated with Triple Combination Immunotherapy,” reports data from the Phase 2 triple combination trial (NCT04287868), which is being led by the Center for Cancer Research at the National Cancer Institute (NCI), part of the National Institutes of Health. The study is investigating PDS0101 in combination with two investigational immune-modulating agents: M9241, a tumor-targeting IL-12 (immunocytokine), and bintrafusp alfa, a bifunctional checkpoint inhibitor (PD-L1/ TGF-β). The triple combination is being studied in checkpoint inhibitor (CPI)-naïve and -refractory patients with advanced HPV-positive anal, cervical, head and neck, vaginal, and vulvar cancers who have failed prior therapy. For most patients who are CPI refractory, there is no effective therapy. The immune correlates before and after treatment in the CPI refractory patient population were studied. Highlights from the study being presented at SITC 2022 include:
A more than two-fold increase in HPV16-specific T cells in the blood of 79% (11/14 tested) of the evaluated patients.
Immune responses were associated with increases in natural killer cells, soluble granzyme B (associated with active killer T cells), IFN-γ, TNF-α, etc., two weeks after the first treatment cycle thus signaling a pro-inflammatory response.
These immunogenicity findings highlight the potential role of the combination in altering immune suppressive forces, and support previously announced results documenting promising clinical outcomes in the CPI-refractory population receiving the triple combination.
“We are very pleased that research describing PDS0101’s therapeutic potential will be highlighted in two poster presentations at SITC 2022, including encouraging preliminary efficacy results from the ongoing IMMUNOCERV Phase 2 clinical trial,” said Dr. Frank Bedu-Addo, CEO of PDS Biotech. “Taken together, the data being presented at SITC 2022 demonstrate the potential ability of PDS0101 to elicit in patients the right type and quality of therapeutic immune response. This seems to allow PDS0101 to work in combination with a variety of therapeutic agents to generate clinical responses that appear to exceed current standards of care and allow for improved outcomes in patients with HPV-positive cancers. We look forward to continued progression of our Phase 2 clinical trials evaluating the efficacy, safety and tolerability of PDS0101 in combination with other therapies.”
Details of the posters being presented at SITC 2022 are as follows:
Abstract Number: 674 Abstract Title: IMMUNOCERV, an ongoing Phase II trial combining PDS0101, an HPV-specific T cell immunotherapy, with chemotherapy and radiation for treatment of locally advanced cervical cancers Presenting Author: Dr. Ann Klopp, The University of Texas MD Anderson Cancer Center Session Date: Friday, Nov. 11
Abstract Number: 695 Abstract Title: Immune correlates associated with clinical benefit in patients with checkpoint refractory HPV-associated malignancies treated with triple combination immunotherapy Presenting Author: Dr. Meg Goswami, National Cancer Institute Session Date: Thursday, Nov. 10
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® and Infectimune™ T cell-activating technology platforms. We believe our targeted Versamune® based candidates have the potential to overcome the limitations of current immunotherapy by inducing large quantities of high-quality, potent polyfunctional tumor specific CD4+ helper and CD8+ killer T cells. To date, our lead Versamune® clinical candidate, PDS0101, has demonstrated the potential to reduce tumors and stabilize disease in combination with approved and investigational therapeutics in patients with a broad range of HPV-expressing cancers in multiple Phase 2 clinical trials. 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 PDS0101
PDS Biotech’s lead candidate, PDS0101, combines the utility of the Versamune® platform with targeted antigens in HPV-expressing cancers. In partnership with Merck & Co., PDS Biotech is evaluating a combination of PDS0101 and KEYTRUDA® in a Phase 2 study in first-line treatment of recurrent or metastatic head and neck cancer, and also in second line treatment of recurrent or metastatic head and neck cancer in patients who have failed prior checkpoint inhibitor therapy. A National Cancer Institute-supported Phase 2 clinical study of PDS0101 in a triple combination therapy is also being conducted in checkpoint inhibitor refractory patients with multiple advanced HPV-associated cancers. A third Phase 2 clinical trial in first line treatment of locally advanced cervical cancer is being led by The University of Texas MD Anderson Cancer Center. A final Phase 2 clinical trial of PDS0101 monotherapy in first line treatment of newly diagnosed patients HPV16+ head and neck cancer patients is being conducted at the Mayo Clinic.
KEYTRUDA® is a registered trademark of Merck Sharp and Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
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 our 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; and other factors, including legislative, regulatory, political and economic developments not within the Company’s control, including unforeseen circumstances or other disruptions to normal business operations arising from or related to COVID-19. 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 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.
CARLSBAD, Calif.–(BUSINESS WIRE)–Nov. 3, 2022– Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, today announced that it will report its third quarter 2022 financial and operating results on Thursday, November 10, 2022, following the close of the U.S. financial markets. Lineage management will also host a conference call and webcast on Thursday, November 10, 2022, at 4:30 p.m. Eastern Time/1:30 p.m. Pacific Time to discuss its third quarter 2022 financial and operating results and to provide a business update.
Interested parties may access the conference call by dialing (800) 715-9871 from the U.S. and Canada and should request the “Lineage Cell Therapeutics Call” or provide conference ID number5262180. A live webcast of the conference call will be available online in the Investors section of Lineage’s website. A replay of the webcast will be available on Lineage’s website for 30 days and a telephone replay will be available through November 17, 2022, by dialing (800) 770-2030 from the U.S. and Canada and entering conference ID number 5262180.
About Lineage Cell Therapeutics, Inc.
Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineage’s programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineage’s clinical and preclinical programs are in markets with billion dollar opportunities and include five allogeneic (“off-the-shelf”) product candidates: (i) OpRegen, a retinal pigment epithelial cell therapy in development for the treatment of geographic atrophy secondary to age-related macular degeneration, is being developed under a worldwide collaboration with Roche and Genentech, a member of the Roche Group; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; (iii) VAC2, a dendritic cell therapy produced from Lineage’s VAC technology platform for immuno-oncology and infectious disease, currently in Phase 1 clinical development for the treatment of non-small cell lung cancer; (iv) ANP1, an auditory neuronal progenitor cell therapy for the potential treatment of auditory neuropathy; and (v) PNC1, a photoreceptor neural cell therapy for the potential treatment of vision loss due to photoreceptor dysfunction or damage. For more information, please visit www.lineagecell.com or follow the company on Twitter @LineageCell.
BOTHELL, Wash., Nov. 02, 2022 (GLOBE NEWSWIRE) — Cocrystal Pharma, Inc. (Nasdaq: COCP) announces that management will participate in two upcoming investor conferences as follows:
2022 BioFlorida Annual Conference: James Martin, CFO and interim co-CEO, will participate in a panel titled “BioTrends: Learning from the Pandemic: The Fight Against Infectious Diseases” on Thursday, November 3 at 2:05 p.m. Eastern time. The conference is being held at Hyatt Regency Miami. More information about the conference is available here.
Q4 Investor Summit: Mr. Martin will present a company overview on Monday, November 14 at 11:30 a.m. Eastern time. The conference is sponsored by the Investor Summit Group and is being held at the Sheraton New York Time Square Hotel. More information about the conference is available here.
A webcast of the Q4 Investor Summit presentation will be posted to the IR Calendar page of the company website.
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.
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, Vice President, Research Analyst, Life Sciences , Noble Capital Markets, Inc.
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Gene Therapy In The Spotlight. Ocugen held an R&D Day to highlight its programs in gene therapy and COVID-19. The presentations discussed the novel mechanisms behind its gene therapy products and the nature of the ophthalmic disease indications in development. While the company has been best known for COVAXIN and COVID-19, we have always seen the gene therapy indications as highly promising and underappreciated.
Modifier Gene Therapy Platform. The first presentations discussed the company’s novel approach to gene therapy. In contrast to other approaches that seek to transfer a functional copy of a gene to replace a gene that has mutated or become dysfunctional, Ocugen’s Modifier Gene Therapy targets a “master control gene” that controls the expression of multiple gene pathways, allowing products to be developed for diseases caused by downstream gene pathways and combinations of genetic mutations.
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.
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.
Financial Results. Axcella reported a 3Q22 loss of $17.8 million or $(0.34) per share, compared with our estimate of a loss of $21.7 million or $(0.43) per share. The company sold convertible notes raising $6.0 million to end the quarter with $25.4 million in cash and equivalents. After the quarter ended, it added $28.2 million in cash through a direct offering of common stock. Based on our 4Q22 estimate of a loss of $18.1 million, we project the cash balance at YE22 to be around $35.5 million.
Long COVID Study Results Were Encouraging. Results from a Phase 2a study testing AXA1125 in Long COVID were announced in early August, as discussed in our note from August 3. The data showed statistically significant improvements in both physical and mental fatigue symptoms. We believe this is clinically relevant for an estimated 20% to 30% of the people who have been infected with COVID-19. Axcella is in currently in discussions with regulatory authorities to design the next study, planned to begin in 2023.
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., Nov. 01, 2022 (GLOBE NEWSWIRE) — Cocrystal Pharma, Inc. (Nasdaq: COCP) announces it has been granted European patent EP3866778 titled “Combinations Of Inhibitors of Influenza Virus Replication,” which covers the Company’s broad-spectrum oral PB2 inhibitor CC-42344 in combination with approved influenza antiviral drugs including Tamiflu®, Xofluza® or Favipiravir. Cocrystal recently announced the completion of enrollment in a Phase 1 study with CC-42344 for the treatment of pandemic and seasonal influenza A, with topline study results expected later this year.
“This new patent provides meaningful protection for our PB2 clinical program in the European Union and is the first to be granted as we pursue a similar patent strategy in other jurisdictions,” said James Martin, Cocrystal’s CFO and interim Co-CEO. “The granting of this patent is an important step in our efforts to expand protection of our novel, best-in-class antiviral candidates both in the U.S. and internationally.”
About CC-42344 and Influenza CC-42344 is an oral PB2 inhibitor discovered using Cocrystal’s proprietary structure-based drug discovery platform technology. It is specifically designed to be effective against all significant pandemic and seasonal influenza A strains and to have a high barrier to resistance due to the way the virus’ replication machinery is targeted. CC-42344 targets the influenza polymerase, an essential replication enzyme with several highly essential regions common to multiple influenza strains. In vitro testing showed CC-42344’s excellent antiviral activity against influenza A strains, including pandemic and seasonal strains, as well as against strains resistant to Tamiflu® and Xofluza®, while also demonstrating favorable PK and safety profiles.
According to a June 2022 report by Precision Reports, the global influenza therapeutics market is projected to reach $9.5 billion by 2027, up from $6.6 billion in 2020 and growing at a 4.8% CAGR between 2021 and 2027.
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.
Cocrystal Pharma 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 the potential design and efficacy of CC-42344, and the demand and potential market size for products designed to treat influenza. 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 possibility that assumptions underlying market projections prove to be incorrect, the availability of federal government funding and budgetary issues that may arise, the risks and uncertainties arising from any future impact of the Russian invasion of Ukraine, and/or inflation and interest rate increases on the global economy, the U.K. and on our Company and collaboration partners, including supply chain disruptions and our continued ability to proceed with our programs such as obtaining the requisite regulatory approvals including from the United Kingdom Medicines and Healthcare Products Regulatory Agency, the ability of the CRO to recruit patients into clinical trials, and the results of the studies for CC-42344. 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, 2021. 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.
Promising Results from Phase 2a Placebo Controlled Clinical Trial for Long COVID
Positive Interim Data from Phase 2b EMMPACT Study of AXA1125 in Nonalcoholic Steatohepatitis (NASH)
$34.2 Million Registered Direct Offering of Common Stock Priced At The Market
Appointment of Two New Board Members
CAMBRIDGE, Mass.–(BUSINESS WIRE)–Nov. 1, 2022– Axcella Therapeutics (Nasdaq: AXLA), a clinical-stage biotechnology company pioneering a new approach to treat complex diseases using multi-targeted endogenous metabolic modulator (EMM) compositions, today announced financial results for the third quarter ended September 30, 2022 and provided a business update.
“This has been an extremely exciting period for Axcella,” said Bill Hinshaw President and Chief Executive Officer of Axcella. “Through the third quarter, we made important progress in our clinical development of AXA1125 and strengthened our balance sheet with a new financing. Specifically, we reported positive data from both our Phase 2 study of Long COVID and our Phase 2b EMMPACT study in non-alcoholic steatohepatitis (NASH). In addition, we completed a financing worth $34.2 million that will allow us to advance the Long COVID program and our EMMPACT Phase 2b clinical trial in NASH.”
Mr. Hinshaw continued, “As the company advances toward late-stage clinical trials, we are pleased to have the additions of Mr. Rosiello and Mr. Straight Nissen to our Board, whose extensive leadership experience will help guide Axcella as we focus on taking steps toward delivering these treatments to patients.”
Clinical Results in the Quarter:
The quarter saw progress in the clinical development of AXA1125, an orally delivered potent and safe compound addressing two very large markets: Long-COVID and NASH. This included the release of top-line results in Long COVID and an interim analysis of the Phase 2b EMMPACT trial in NASH.
Long COVID is a persistent and growing challenge of the pandemic, affecting an estimated one hundred million patients worldwide, with fatigue as the most common symptom. In a release of top-line results, subjects who received AXA1125 had improvements in measures of mental and physical fatigue that were both highly statistically significant and clinically relevant compared to those who received placebo. Mean changes in total, physical and mental scores in the CFQ-11 versus placebo were -4.30 (p=0.0039), -2.94 (p=0.0097) and -1.32 (p=0.0097), respectively.
NASH affects an estimated 40 million people in the U.S., including approximately 10% of U.S. children. The complex pathogenesis of NASH includes dysregulation of metabolism, inflammation and fibrosis. In this interim analysis, at 24-weeks there were statistically significant improvements in the liver stiffness measurement (LSM) using vibration-controlled transient elastography compared to placebo in the high dose arm for all subjects. Absolute changes in LSM were 0.13, -2.01, and -4.07 kilopascals (kPa) in the placebo, low dose and high dose arms, respectively (p= 0.0992 and 0.0096 for the low and high dose, respectively, compared to placebo). These results were supported by statistically significant improvements in other non-invasive measures of liver fibrosis: ELF and FIB-4. Statistically significant improvements in alanine aminotransferase (ALT) were seen at both weeks 12 and 24 in all subjects (placebo-adjusted difference of -28.61% (p=0.0183) and -36.3% (p=0.0017) for the low and high doses, respectively). All subjects experienced significantly greater changes from baseline in MRI-PDFF at 12-weeks compared to the change from baseline in the placebo group (placebo adjusted difference of -18.98% (p=0.0082) and -21.24% (p=0.0014) for the low and high doses, respectively).
Financing and Board:
In September 2022, the Company received $6.0 million from the issuance of convertible notes to funds associated with Flagship Pioneering. In October 2022, the Company secured an additional $28.2 million in gross proceeds through a registered direct offering of common stock, which also resulted in the conversion of the convertible notes into common stock. In total, the Company sold 20,847,888 shares of common stock at a purchase price of $1.64 per share. Since this offering was made without an underwriter or a placement agent, Axcella did not pay any underwriting or placement agent commissions. Simultaneous with the financing, the company appointed Robert Rosiello and Torben Straight Nissen to its Board of Directors, and Mr. Rosiello also became Chairman of the Board. After five years of service, David Epstein stepped off the Board, and will continue to support the Company as a consultant.
Financial Results:
Cash Position: As of September 30, 2022, cash, cash equivalents, and marketable securities totaled $25.4 million, compared to $55.0 million as of December 31, 2021. In September 2022, the Company received $6.0 million from the issuance of convertible notes to funds associated with Flagship Pioneering and, in October 2022, the Company secured an additional $28.2 million in gross proceeds through a registered direct offering of common stock. As part of the registered direct offering, the $6.0 million convertible notes automatically converted into the Company’s common stock. Axcella expects that its current cash balance will be sufficient to meet its operating needs into the second quarter of 2023, provided that, if the Company is unable to satisfy the cash covenants contained in its loan and security agreement with SLR Investment Corp., and SLR Investment Corp. seeks immediate repayment of the loan in full, the Company believes that its cash and cash equivalents will be sufficient to fund its operations into the late first quarter of 2023.
R&D Expenses: Research and development expenses for the quarter and nine months ended September 30, 2022 were $13.3 million and $43.7 million, respectively. Research and development expenses for the same periods ended September 30, 2021 were $10.1 million and $30.7 million, respectively. These increases are the result of the Company’s EMMPACT and Long COVID Phase 2 clinical trials, as well as closure costs for its EMMPOWER Phase 2 clinical trial.
G&A Expenses: General and administrative expenses for the quarter and nine months ended September 30, 2022 were $3.8 million and $12.3 million, respectively. General and administrative expenses for the same periods ended September 30, 2021 were $4.8 million and $14.0 million. These decreases are primarily the result of lower non-cash stock-based compensation expenses.
Net Loss: Net loss for the quarter and nine months ended September 30, 2022 was $17.8 million, or $0.34 per basic and diluted share, and $58.2 million, or $1.19 per basic and diluted share, respectively. This compares with a net loss of $15.6 million, or $0.41 per basic and diluted share, and $46.7 million, or $1.23 per basic and diluted share, for the quarter and nine months ended September 30, 2021.
Internet Posting of Information
Axcella uses the “Investors and News” section of its website, www.axcellatx.com, as a means of disclosing material nonpublic information, to communicate with investors and the public, and for complying with its disclosure obligations under Regulation FD. Such disclosures include, but may not be limited to, investor presentations and FAQs, Securities and Exchange Commission filings, press releases, and public conference calls and webcasts. The information that we post on our website could be deemed to be material information. As a result, we encourage investors, the media and others interested to review the information that we post there on a regular basis. The contents of our website shall not be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended.
About Axcella Therapeutics (Nasdaq: AXLA)
Axcella is a clinical-stage biotechnology company pioneering a new approach to treat complex diseases using compositions of endogenous metabolic modulators (EMMs). The company’s product candidates are comprised of EMMs and derivatives that are engineered in distinct combinations and ratios to restore cellular homeostasis in multiple biological pathways, improve cellular energetics and restore homeostasis. Axcella’s pipeline includes lead therapeutic candidates in Phase 2 development for the treatment of Long COVID, and NASH. The company’s unique model allows for the evaluation of its EMM compositions through non-IND clinical studies or IND clinical trials. For more information, please visit www.axcellatx.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements regarding the timing of the company’s clinical trial data readouts, its expected cash runway and the expected benefits of Mr. Rosiello’s and Mr. Straight Nissen’s service on the Board of Directors of Axcella. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, those related to the potential impact of COVID-19 on the company’s ability to conduct and complete its ongoing or planned clinical studies and clinical trials in a timely manner or at all due to patient or principal investigator recruitment or availability challenges, clinical trial site shutdowns or other interruptions and potential limitations on the quality, completeness and interpretability of data the company is able to collect in its clinical trials of AXA1125, other potential impacts of COVID-19 on the company’s business and financial results, including with respect to its ability to raise additional capital and operational disruptions or delays, changes in law, regulations, or interpretations and enforcement of regulatory guidance, whether data readouts support the company’s clinical trial plans and timing, clinical trial design and target indications for AXA1125, the clinical development and safety profile of AXA1125 and its therapeutic potential, whether and when, if at all, the company’s product candidates will receive approval from the FDA or other comparable regulatory authorities, potential competition from other biopharma companies in the company’s target indications, and other risks identified in the company’s SEC filings, including Axcella’s Annual Report on Form 10-K, Quarterly Report on Form 10-Q and subsequent filings with the SEC. The company cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. Axcella disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent the company’s views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. The company explicitly disclaims any obligation to update any forward-looking statements.
FLORHAM PARK, N.J., Oct. 31, 2022 (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 the Company will release financial results for the third quarter of 2022 on Monday, November 14, 2022, before the market opens. Following the release, management will host a conference call to review the financial results and provide a business update.
After the live webcast, the event will be archived on PDS Biotech’s website for six months.
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® and Infectimune™ T cell-activating technology platforms. We believe our targeted Versamune® based candidates have the potential to overcome the limitations of current immunotherapy by inducing large quantities of high-quality, potent polyfunctional tumor specific CD4+ helper and CD8+ killer T cells. To date, our lead Versamune® clinical candidate, PDS0101, has demonstrated the potential to reduce tumors and stabilize disease in combination with approved and investigational therapeutics in patients with a broad range of HPV-positive cancers in multiple Phase 2 clinical trials. 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.
Versamune® is a registered trademark and Infectimune™ is a trademark of PDS Biotechnology.
CARLSBAD, Calif.–(BUSINESS WIRE)–Oct. 31, 2022– Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, announced today that Jill Howe will join as the Company’s Chief Financial Officer, effective November 14, 2022. Ms. Howe brings more than 20 years of significant strategic, financial, and operational experience to Lineage, with an emphasis on capital strategy, corporate finance, treasury management, global infrastructure, and operational excellence. Ms. Howe has successfully built biotechnology organizations and implemented operational infrastructures alongside the execution of over $1.66 billion of capital raising transactions and will bring extensive strategic experience to the role. Most recently, Ms. Howe was Chief Financial Officer of DTx Pharma, and prior to that, was Vice President of Finance and Treasurer at Gossamer Bio, Inc., serving an integral role in the company’s initial public offering (IPO) and concurrent listing on the Nasdaq Global Select Market, various follow-on and debt deals, and overseeing all aspects of finance and accounting operations globally.
“Jill is a wonderful addition to our executive team as we work to establish Lineage as a leader in cell therapy and cell transplant medicine,” stated Brian M. Culley, Lineage CEO. “She is a successful executive with an extensive track record of execution in capital raising, strategic financial management, global expansion, and support, as well as mergers & acquisitions, and reflects the newest expansion of our team. Our continued growth will allow Lineage to exhibit greater productivity and increase the breadth of what we are able to accomplish in the months and years ahead.”
Ms. Howe most recently served as Chief Financial Officer of DTx Pharma, a biotechnology company creating novel RNA-based therapeutics to treat the genetic drivers of disease. From 2018 to 2021, she served as Vice President of Finance and Treasurer for Gossamer Bio, Inc. (NASDAQ: GOSS), a clinical-stage biopharmaceutical company focused on discovering, acquiring, developing and commercializing therapeutics in the disease areas of immunology, inflammation and oncology, where she managed all aspects of finance operations, accounting, and global IT and real estate efforts, including the building-out of world-class labs and office space. She also served as a Board member of all Irish and Luxembourg subsidiaries of Gossamer Bio. From 2016 through 2017 she served as Controller & Director of Finance at Amplyx Pharmaceuticals, Inc., a company dedicated to the development of therapies for debilitating and life-threatening diseases that affect people with compromised immune systems, which was subsequently acquired by Pfizer, Inc. From 2013 to 2016 she served as Controller & Director of Finance at Receptos, Inc. (NASDAQ: RCPT), which was subsequently acquired by Celgene, Inc. for more than $7 billion. Prior to that, from 2006 to 2013 she worked in various accounting roles, leading up to Director of Finance, at Somaxon Pharmaceuticals, Inc. (NASDAQ: SOMX), which was acquired by Pernix in 2012. Ms. Howe earned her Bachelor of Arts in Accounting from San Diego State University and serves on the Board of Directors of various nonprofit, private and public biotechnology companies. In 2022, Ms. Howe won the 2022 CFO of the Year Award in the small business category from the San Diego Business Journal and was specifically recognized for her leadership in building and managing successful financial teams, laying the groundwork for success, and as a San Diegan, for contributions to the community through her local charity work.
About Lineage Cell Therapeutics, Inc.
Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineage’s programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineage’s clinical programs are in markets with billion dollar opportunities and include five allogeneic (“off-the-shelf”) product candidates: (i) OpRegen, a retinal pigment epithelial cell therapy in development for the treatment of geographic atrophy secondary to age-related macular degeneration, is being developed under a worldwide collaboration with Roche and Genentech, a member of the Roche Group; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; (iii) VAC2, a dendritic cell therapy produced from Lineage’s VAC technology platform for immuno-oncology and infectious disease, currently in Phase 1 clinical development for the treatment of non-small cell lung cancer; (iv) ANP1, an auditory neuronal progenitor cell therapy for the potential treatment of auditory neuropathy; and (v) PNC1, a photoreceptor neural cell therapy for the treatment of vision loss due to photoreceptor dysfunction or damage. For more information, please visit www.lineagecell.com or follow the company on Twitter @LineageCell.
Forward-Looking Statements
Lineage cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as “believe,” “aim,” “may,” “will,” “estimate,” “continue,” “anticipate,” “design,” “intend,” “expect,” “could,” “can,” “plan,” “potential,” “predict,” “seek,” “should,” “would,” “contemplate,” “project,” “target,” “tend to,” or the negative version of these words and similar expressions. Such statements include, but are not limited to, statements relating to: Ms. Howe’s employment with Lineage and the anticipated or implied benefits thereof to Lineage and Lineage’s continued growth and ability to exhibit greater productivity in the future. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Lineage’s actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including, but not limited to, the risks and uncertainties inherent in Lineage’s business and other risks discussed in Lineage’s filings with the Securities and Exchange Commission (SEC). Lineage’s forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. Further information regarding these and other risks is included under the heading “Risk Factors” in Lineage’s periodic reports with the SEC, including Lineage’s most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q filed with the SEC and its other reports, which are available from the SEC’s website. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Lineage undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.
CAMBRIDGE, Mass.–(BUSINESS WIRE)–Oct. 27, 2022– Axcella Therapeutics (Nasdaq: AXLA), a clinical-stage biotechnology company pioneering a new approach to treat complex diseases using multi-targeted endogenous metabolic modulator (EMM) compositions, today announced that it plans to report its third quarter 2022 financial results and other business updates on November 1, 2022. The company will host a conference call at 8:30am ET that morning.
An archive of the webcast will be accessible in the Investors & News section on the company’s website at www.axcellatx.com.
Internet Posting of Information
Axcella uses the “Investors and News” section of its website, www.axcellatx.com, as a means of disclosing material nonpublic information, to communicate with investors and the public, and for complying with its disclosure obligations under Regulation FD. Such disclosures include, but may not be limited to, investor presentations and FAQs, Securities and Exchange Commission filings, press releases, and public conference calls and webcasts. The information that we post on our website could be deemed to be material information. As a result, we encourage investors, the media and others interested to review the information that we post there on a regular basis. The contents of our website shall not be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended.
About Axcella Therapeutics (Nasdaq: AXLA)
Axcella is a clinical-stage biotechnology company pioneering a new approach to treat complex diseases using compositions of endogenous metabolic modulators (EMMs). The company’s product candidates are comprised of EMMs and derivatives that are engineered in distinct combinations and ratios to reset multiple biological pathways, improve cellular energetics, and restore homeostasis. Axcella’s pipeline includes lead therapeutic candidates in Phase 2 development for the treatment of Long COVID and NASH. The company’s unique model allows for the evaluation of its EMM compositions through non-IND clinical studies or IND clinical trials. For more information, please visit www.axcellatx.com.
MALVERN, Pa., Oct. 27, 2022 (GLOBE NEWSWIRE) — Ocugen, Inc. (“Ocugen” or the “Company”) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines, today announced that it will host a conference call and live webcast to discuss the Company’s third quarter 2022 financial results and provide a business update at 8:30 a.m. ET on Tuesday, November 8, 2022.
Ocugen will issue a pre-market earnings announcement on the same day. Attendees are invited to participate in the call using the following details:
Dial-in Numbers: (800) 715-9871 for U.S. callers and (646) 307-1963 for international callers Conference ID: 3481499 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
BOTHELL, Wash., Oct. 26, 2022 (GLOBE NEWSWIRE) — Cocrystal Pharma, Inc. (Nasdaq: COCP) announces the completion of enrollment in a Phase 1 healthy volunteer study to assess the safety, tolerability and pharmacokinetics (PK) of its orally administered, novel, broad-spectrum antiviral candidate CC-42344 for the treatment of pandemic and seasonal influenza A. CC-42344 represents a new class of antiviral treatment designed to block an essential step in the viral replication and transcription of pandemic and seasonal influenza A.
In March 2022 enrollment was initiated in the randomized, double-blind, placebo-controlled Phase 1 study, which is being conducted in Australia. In July 2022 the company announced PK results from the single-ascending-dose portion of the study, which support once-daily dosing. Enrollment is now complete with the highest dose of the multiple-ascending-dose portion of the study.
To continue advancing the development of CC-42344, Cocrystal engaged a U.K.-based clinical research organization in August 2022 to conduct a human challenge Phase 2a study evaluating the antiviral activity safety and PK of CC-42344 in subjects infected with influenza A. This study will expose healthy volunteers to the virus in a controlled setting, which will significantly shorten the timeline for generating results.
“Completing enrollment in our Phase 1 study keeps us on track to announce topline results this year,” said Sam Lee, Ph.D., Cocrystal’s President and co-interim CEO. “Results from this study will be incorporated into a regulatory submission to the United Kingdom Medicines and Healthcare Products Regulatory Agency to conduct the human challenge Phase 2a study. Pending approval by the Agency, we expect initiation of the Phase 2a study in the second half of 2023.”
About CC-42344 and Influenza CC-42344 is an oral PB2 inhibitor discovered using Cocrystal’s proprietary structure-based drug discovery platform technology. It is specifically designed to be effective against all significant pandemic and seasonal influenza A strains and to have a high barrier to resistance due to the way the virus’ replication machinery is targeted. CC-42344 targets the influenza polymerase, an essential replication enzyme with several highly essential regions common to multiple influenza strains. In vitro testing showed CC-42344’s excellent antiviral activity against influenza A strains, including pandemic and seasonal strains, as well as against strains resistant to Tamiflu® and Xofluza®, while also demonstrating favorable PK and safety profiles.
According to a June 2022 report by Precision Reports, the global influenza therapeutics market is projected to reach $9.5 billion by 2027, up from $6.6 billion in 2020 and growing at a 4.8% CAGR between 2021 and 2027.
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.
Cocrystal Pharma 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 expected completion and submission of our Phase 1 results to the United Kingdom Medicines and Healthcare Products Regulatory Agency, our collaboration with a U.K.-based clinical research organization to conduct a Phase 2a clinical trial and the characteristics and anticipated resulting shortened timeline for the study including the anticipated initiation of the study in the second half of 2023, the potential design and efficacy of CC-42344, and the demand for products designed to treat influenza and opportunities presented thereby. 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 availability of federal government funding and budgetary issues that may arise, the risks and uncertainties arising from any future impact of the Russian invasion of Ukraine, and/or inflation and interest rate increases on the global economy, the U.K. and on our Company and collaboration partners, including supply chain disruptions and our continued ability to proceed with our programs such as obtaining the requisite regulatory approvals including from the United Kingdom Medicines and Healthcare Products Regulatory Agency, the ability of the CRO to recruit patients into clinical trials, and the results of the studies for CC-42344. 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, 2021. 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.
