Market Newsdesk

– Dose Escalation Portion of Phase 1 Trial of PRT543 Complete; Additional Expansion Cohorts Set to Initiate Early in the Second Quarter –

– Clinical Data Readouts Expected in 2H21 for Lead PRMT5 Inhibitors PRT543 and PRT811 –

– Phase 1 Dose-Escalation Study of Oral PRT1419 Ongoing –

– Preclinical Data from Multiple Programs to be Presented at the Upcoming 2021 AACR Annual Meeting –

WILMINGTON, Del., March 16, 2021 (GLOBE NEWSWIRE) — Prelude Therapeutics Inc. (“Prelude”, “the Company”, “we”, “our”) (Nasdaq: PRLD), a clinical-stage precision oncology company, today announced its financial results for the fourth quarter and full year ended December 31, 2020 and provided an update on recent developments.

“2020 marked a highly transformational year for Prelude with the successful completion of an initial public offering and progress across our three clinical-stage programs,” said Kris Vaddi, PhD, Chief Executive Officer of Prelude Therapeutics. “We are firmly committed to bringing novel therapies to patients in areas of high unmet need, and we have entered 2021 with both the momentum and resources that we believe will carry us through several key milestones. Notably, we are pleased to announce the completion of dose escalation activities in our ongoing Phase 1 trial of PRT543, our lead PRMT5 inhibitor, in patients with advanced solid tumors and hematologic malignancies, and that we will soon begin initiating additional expansion cohorts. We look forward to sharing clinical data for this program, as well as for our second PRMT5 inhibitor, PRT811, in the second half of this year.”

Dr. Vaddi added, “The ongoing Phase 1 trial of our third clinical candidate, PRT1419, an MCL1 inhibitor, also continues to progress, with the addition of dose expansion cohorts expected in the second half of the year. Finally, the continued advancement of our preclinical programs remains a high priority for us in 2021, with the anticipated submission of an IND application for PRT2527, our CDK9 inhibitor, in the second half of this year.”

Recent Highlights and Upcoming Milestones

PRT543

• Phase 1 Dose Escalation Complete; Additional Expansion Cohorts to Open in the Second Quarter. The Company today announced that the dose escalation portion of the Phase 1 trial of its lead product candidate, PRT543, is now complete, and that a recommended expansion dose with adequate safety, pharmacokinetics, and target engagement profile has been established. PRT543 is designed to be a potent, selective, and oral inhibitor of PRMT5. The dose expansion portion of the Phase 1 trial is currently open for the patient cohort with adenoid cystic carcinoma, and will be open for additional patient cohorts with solid tumor and hematologic malignancies early in the second quarter. As previously announced, preliminary data from the dose escalation portion of the trial demonstrated early signs of clinical activity and tolerability. The Company anticipates presenting initial clinical data from the Phase 1 trial at medical meetings in the second half of 2021.

• Preclinical Data to be Featured at the 2021 AACR Annual Meeting. Three preclinical presentations on PRT543 will be featured at the upcoming American Association for Cancer Research (AACR) Annual Meeting being held April 10-15, 2021 in a virtual setting. A copy of the posters, titled “PRMT5 inhibition downregulates MYB and NOTCH1 signaling, key molecular drivers of adenoid cystic carcinoma” (abstract 1138), “PRMT5 inhibition epigenetically regulates DNA damage response pathways in cancer cells and sensitizes to chemotherapy and PARP inhibition” (abstract 1185), and “PRMT5 inhibition regulates alternative splicing and DNA damage repair pathways in SF3B1 R625C expressing uveal melanoma cells” (abstract 1137), will be available in the Publications section of the Prelude Therapeutics website following the conclusion of the meeting.

PRT811

• Phase 1 Dose Expansion Cohorts Expected to Commence in Mid-2021. The dose escalation portion of the Company’s Phase 1 trial of its second clinical product candidate, PRT811, which is designed to be a potent, selective, and brain penetrant PRMT5 inhibitor, in patients with advanced solid tumors, including glioblastoma multiforme (GBM), remains ongoing. As previously reported, the trial has demonstrated early signs of clinical activity and tolerability. Prelude remains on track to establish the recommended expansion dose and commence the dose expansion portion of the trial in mid-2021 in patients with central nervous system cancers including GBM, with initial clinical data expected by the end of 2021.

PRT1419

• Oral Formulation: Dose Expansion and Combination Cohorts Expected to be Added to Ongoing Phase 1 Trial in the Second Half of 2021. The dose escalation portion of the Company’s first-in-human Phase 1 open-label, multicenter, dose-escalation study of oral PRT1419 in patients with relapsed/refractory hematologic malignancies, including acute myeloid leukemia and high-risk myelodysplastic syndromes, remains ongoing. PRT1419, which is the Company’s third clinical candidate, is designed to be an orally available, potent, and selective MCL1 inhibitor. The Company expects to add dose expansion and combination cohorts to the Phase 1 clinical trial in the second half of 2021.

• IV Formulation: IND Application Cleared. Prelude today announced the recent U.S. Food and Drug Administration (FDA) clearance of the Company’s Investigational New Drug (IND) application for an intravenous (IV) formulation of PRT1419. A Phase 1 trial of the IV formulation, which leverages the optimized physicochemical properties of PRT1419, is expected to commence in the first half of 2021 in patients with solid tumors.

• Data on Preclinical Characterization to be Featured at the 2021 AACR Annual Meeting. Data on the preclinical characterization of PRT1419 will be featured during a poster session at the 2021 AACR Annual Meeting. A copy of the poster, titled “Preclinical characterization of PRT1419, a potent, selective and orally available inhibitor of MCL1” (abstract 983), will be available in the Publication section of the Prelude Therapeutics website following the conclusion of the meeting.

Discovery Programs

• Advancement of Earlier-Stage Candidates Expected in 2021. Prelude remains on track to submit an IND application for PRT2527, which is designed to be a potent and selective CDK9 inhibitor, in 2021. The Company also continues to expect to initiate IND-enabling studies for PRT-SCA2, which is designed to be a SMARCA2 protein degrader, in 2021.

• Preclinical Data on SMARCA2 Protein Degradation to be Featured at the 2021 AACR Annual Meeting. A poster presentation on Prelude’s SMARCA2 protein degradation program, titled “Potent SMARCA2 targeted degraders induce genetic synthetic lethality in SMARCA4 deleted cancer” (abstract 1139), will be presented at the 2021 AACR Annual Meeting. A copy of the poster will be available in the Publications section of the Prelude Therapeutics website following the conclusion of the meeting.

Corporate

• Completed Successful Upsized Public Offering of $172.5 Million. In January 2021, the Company announced the closing of its upsized public offering of 2,583,334 shares of its voting common stock and 291,666 shares of its non-voting common stock, each at a public offering price of $60.00 per share, which includes the exercise in full of the underwriters’ option to purchase an additional 375,000 shares of its voting common stock. The aggregate gross proceeds from this offering were $172.5 million, before deducting underwriting discounts and commissions and estimated offering expenses payable by Prelude.

Fourth Quarter and Full Year 2020 Financial Results

• Cash and Cash Equivalents: Cash and cash equivalents as of December 31, 2020 were $218.3 million.

• Research and Development (R&D) Expenses: For the fourth quarter of 2020, R&D expense increased to $14.6 million from $8.8 million for the prior year period, and for the full year increased to $48.2 million compared to $24.3 million for 2019. The fourth quarter and full year increases were primarily due to increased clinical research costs for the PRT543 and PRT811 clinical trials and increased costs associated with the initiation of the clinical trial for PRT1419, which began in the third quarter of 2020. The Company also incurred an increase in chemistry, manufacturing, and other costs for those trials.

• General and Administrative (G&A) Expenses: G&A expenses for the fourth quarter of 2020 increased to $4.9 million from $1.2 million for the prior year period, and for the full year increased to $10.6 million compared to $3.8 million for 2019. The fourth quarter and full year increases were primarily due to an increase in personnel related expense due to increased employee headcount and an increase in professional fees as the Company expanded its operations to support R&D efforts and incurred additional costs associated with operating as a public company.

• Net Loss: For the fourth quarter of 2020, net loss was $19.3 million, or $0.45 per share, compared with a net loss of $10.0 million, or $5.56 per share, for the same period in 2019. Net loss for the year ended December 31, 2020 was $56.9 million, or $4.56 per share, compared with a net loss of $27.6 million, or $16.52 per share, for the year ended December 31, 2019.

• Financial Guidance: The Company believes that its current cash and cash equivalents will be sufficient to fund operating expenses and capital expenditure requirements into 2023.

About Prelude Therapeutics

Prelude Therapeutics is a clinical-stage precision oncology company developing innovative drug candidates targeting critical cancer cell pathways. The Company’s lead product candidates are designed to be oral, potent, and selective inhibitors of PRMT5. Prelude’s first clinical candidate, PRT543, is in Phase 1 development for advanced solid tumors and select myeloid malignancies. Prelude is also advancing PRT811, a second PRMT5 inhibitor optimized for high brain exposure, in a Phase 1 clinical trial including glioblastoma multiforme (GBM). The Company’s pipeline also includes its third clinical candidate, PRT1419, an orally available MCL1 inhibitor in Phase 1 development for patients with relapsed/refractory hematologic malignancies, and its two most advanced preclinical candidates, PRT2527, a CDK9 inhibitor, and PRT-SCA2, a SMARCA2 protein degrader.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, anticipated discovery, preclinical and clinical development activities, timing of availability and announcements of clinical results, the timing of the expansion portion for its Phase 1 clinical trial for PRT543, PRT811 and PRT1419, the timing of IND-related activities for PRT2527 and PRT-SCA2 and the potential benefits of the Company’s product candidates and platform. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. Although the Company believes that the expectations reflected in such forward-looking statements are reasonable, the Company cannot guarantee future events, results, actions, levels of activity, performance or achievements, and the timing and results of biotechnology development and potential regulatory approval is inherently uncertain. Forward-looking statements are subject to risks and uncertainties that may cause the Company’s actual activities or results to differ significantly from those expressed in any forward-looking statement, including risks and uncertainties related to the Company’s ability to advance its product candidates, the receipt and timing of potential regulatory designations, approvals and commercialization of product candidates, the impact of the COVID-19 pandemic on the Company’s business, clinical trial sites, supply chain and manufacturing facilities, the Company’s ability to maintain and recognize the benefits of certain designations received by product candidates, the timing and results of preclinical and clinical trials, the Company’s ability to fund development activities and achieve development goals, the Company’s ability to protect intellectual property, and other risks and uncertainties described under the heading “Risk Factors” in documents the Company files from time to time with the Securities and Exchange Commission. These forward-looking statements speak only as of the date of this press release, and the Company undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date hereof.

Contact

Investors: Melissa Forst
Media: Deborah Elson
Argot Partners
212.600.1902
[email protected] 

SAN MATEO, Calif., March 16, 2021 (GLOBE NEWSWIRE) — Acepodia, a biotechnology company developing next generation solid tumor and hematologic cancer cell therapies, today announced the closing of its $47 million Series B financing. The funding will be used to advance the company’s lead off-the-shelf natural killer (NK) cell therapy candidate, ACE1702, through clinical development in solid tumors, and to advance its preclinical NK and gamma delta T cell therapy pipeline into the clinic. Acepodia anticipates completing IND-enabling studies for two additional pipeline products in 2021.

The funding round was supported by new U.S. institutional investors, including Ridgeback Capital Investments, 8VC, and DEFTA Partners, and the Taiwan-based institutional investor-CDIB Capital Healthcare. Acepodia’s Series A investors also participated.

“This second capital raise for Acepodia represents a strong vote of confidence by our investors in our highly differentiated approach to cell therapy, particularly with NK cells, and in the Company’s potential to provide superior treatment options for patients with cancer,” said Sonny Hsiao, Ph.D., founder and chief executive officer of Acepodia. “Accessible and effective allogeneic, off-the-shelf cell therapies will be an important part of next generation cancer therapy. With our discipline and capital efficiency, we are well-positioned to execute on our corporate objectives, including the continued clinical development of these therapies, including our lead candidate, ACE1702 for the treatment of solid tumors, and execution of future clinical trial initiations for our promising preclinical portfolio of NK and NK-like gamma delta T cell therapy candidates.”

Wayne Holman, M.D., Chief Executive Officer and Founder of Ridgeback Capital, added, “We are excited to participate in this financing for Acepodia as we are believers in the foundational evidence suggesting cell therapies should play a significant role in the future of cancer therapy. We believe the prior success of Acepodia’s leadership group in cell therapies, and the unique Antibody-Cell Conjugation (ACC) technology when applied to allogeneic off-the-shelf cryopreserved NK cells could lead to enhanced and differentiated results.”

Acepodia’s technology enables development of cell therapies with improved tumor engagement and targeting through optimized cell receptor selection, and seamless conjugation with antibody therapies. Utilizing its proprietary, patent-protected Antibody-Cell Conjugation (ACC) technology, Acepodia is able to directly conjugate and arm NK or gamma delta T cells with validated anti-tumor antibodies for cell therapies, a design which has demonstrated the ability to overcome traditionally resilient tumor defenses in preclinical trials. The company is currently conducting an ongoing Phase 1 clinical trial of ACE1702, the first antibody-conjugated NK cell therapy in clinical development for the treatment of HER2-expressing solid tumors.

About Acepodia

Acepodia is a privately held biotechnology company focused on eradicating cancers of all types with potent and targeted first-in-class cell therapies. The company’s next generation allogeneic natural killer (NK) cell therapies are based on a proprietary NK cell line (oNK) that has been selected for its potent anti-tumor activity. This cell line is further enhanced by the company’s proprietary ACC (Antibody-Cell Conjugation) technology that links tumor-targeting antibodies to the surface proteins of oNK cells to direct and maximize tumor cell killing. The company’s lead product candidate, ACE1702, is an antibody-conjugated NK cell therapy in clinical development at multiple U.S. cancer centers for the treatment of HER2-expressing solid tumors. For more information, visit https://www.acepodia.com.

Acepodia Contact

Spike Lo, Senior Director of Business Development
Acepodia
886 (2) 2697-6100
[email protected]

Investor Contact

Sylvia Wheeler
Wheelhouse Life Science Advisors
[email protected]

Media Contact
Michael Tattory 
LifeSci Communications
1 (646) 751-4362
[email protected]

TORONTO, March 16, 2021 (GLOBE NEWSWIRE) — Worksport Ltd (OTC: WKSP) (or the “Company”) is excited to report to its investors, shareholders, and supporters that as of March 8, 2021, it has expanded its Private Label business segment, adding yet another major brand. Worksport’s Sales team has been effective in negotiations and successfully closed on their second major Private Label agreement in the US, bringing with it a multinational, very high value brand. As was previously stated, under the terms of the supply partnership, the identity of this party must remain private.

“Worksport continues to drive forward with charismatic representation and is expanding its Private Label business with high value, reputable brands. Our traction and respective attention are undeniable, and we will continue to take full advantage of this momentum while we finalize terms with an immediate third in the queue as more potential customers & partners alike knock on our door,” says Worksport CEO Steven Rossi. “I will emphasize, again, that although this Private Label brand’s identity must remain private due to contract terms, we are extremely excited to cooperate with them as their ecosystem includes large, nationally recognized companies, both in the USA and globally.”

As is Worksport’s standard practice, it will create bespoke tonneau cover designs exclusively for these multinational companies, from its original, non-solar, patented product lines. Assuredly, these products will not compete with Worksport’s branded product offerings, and are accretive to company income as the technology, designs, and manufacturing processes are already in place.

“Over the past decade, we have created the Gold standard for tonneau covers, building up a robust supply chain and continually refining operational processes. The impactful practices of this winning combination are beginning to be acknowledged by some of the biggest players in our target markets,” states Rossi, adding, “Indeed, we will continue to enhance and optimize our methods, ensuring our competitive moat to account for new alternative participants that may enter this space.”

Subsequent discussions have already hit on future agreement amendments for private label implementations of Worksport’s highly anticipated and forthcoming TerraVis Solar Tonneau Cover and COR Battery Systems. Accounting for the upper echelon of the U.S. economy’s revenue, the aforementioned brand earns upwards of $60 Billion annually, making them a very high value, long term client for Worksport.

To stay up-to-date on all the latest Worksport news… investors, shareholders, and supporters are encouraged to follow the company’s social media accounts on Twitter, Facebook, LinkedIn, and Instagram, as well as sign up for the company’s newsletters at www.worksport.com and www.goterravis.com. Worksport will continue to update investors, shareholders, and supporters to maintain the highest level of disclosure and information dissemination as Worksport continues to grow and develop at a very rapid pace.

About Worksport Ltd.

Worksport Ltd. (currently OTCQB: WKSP) develops and manufactures high quality, modular, attractively priced tonneau covers and solar-powered systems for light-duty trucks such as the Sierra, Silverado, Canyon, RAM, Ford F-Series, et al. and consumer adventures & emergency/ disaster-recovery purposes, where portable energy is a necessity. The modular, redefining Worksport TerraVis^™ tonneau cover system is being mindfully designed for the jobsite contractor and off-road, light-duty trucker – for work and play – to sustainably supply extra energy for those additional miles. Its allied TerraVis COR^™ mobile energy storage system (ESS), expected to launch by end of 2021, will be another redefining product targeted for vacationers, second-home owners, and campers. Plans are also being constructed to address the dire adoption & scaling needs of the EV markets with grid micro-charging stations to provide convenience and efficiency in recharging to smaller form-factor EVs. For more information, please visit www.worksport.com and www.goterravis.com.

Connect with Worksport:

LinkedIn

Facebook

Twitter

Instagram

For further information please contact:

Mr. Steven Rossi
CEO & Director
LinkedIn
Twitter
Worksport Ltd
T: 1-888-554-8789
E: [email protected]

Forward-Looking Statements

This document may contain forward-looking statements, relating to Worksport^™ operations or to the environment in which it operates, which are based on Worksport^™ operations, estimates, forecasts and projections. These statements are not guarantees of future Company performance and may involve risks and uncertainties that are difficult to predict, and/or are beyond Worksport’s control. A number of important factors could cause actual outcomes and results to differ materially from those expressed in these forward-looking statements. Consequently, readers should not place any undue reliance on such forward-looking statements. Worksport^™ disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. No Stock Exchange or Regulation Services Provider accepts responsibility for the adequacy or accuracy of this release. 

Attachments

• Figure 1
• Figure 2

SAN FRANCISCO, March 16, 2021 (GLOBE NEWSWIRE) — Arkose Labs, a leading provider of online fraud and abuse prevention technology, today released their global study entitled “Navigating Internet Safety When Screen Time Becomes Full Time” that examines the online habits and cybersecurity knowledge of 129 children ages 6 through 17, as well as 56 parents, spanning the globe. The survey found that the majority of kids (53%) would like to spend less time online, signaling a tipping point. Additionally, 87% of the parents surveyed worry that kids have too much screen time, and not a single parent surveyed believes that their children are benefitting from the increased time spent online.

“One year into the pandemic, we set out to gather insights about kids and cybersecurity, fraud and the sharing of personal information, expecting to find data from the kids and their parents that supports the need for increased security measures,” said Kevin Gosschalk, CEO of Arkose Labs. “What we didn’t expect to learn is that the spike in time spent online for both school and downtime has led to burnout. An astounding 80% of the kids we surveyed reported spending at least four hours online daily. These kids, who just one year ago looked forward to screen time, have had enough, and so have their parents. Ironically, the pandemic and associated in-person restrictions may be what gets kids to finally put down their devices and enjoy offline activities.”

“It’s been a long year, and I definitely see burnout happening with my kids and their friends,” said Kakoli Parai, PhD, parent of two children who participated in the study. “The novelty of being online all the time has worn off, and we are trying to manage that as a family with more unplugged activities when the school day is over.”

The survey also found that while 71% of parents worry about their child’s personal data being captured online, 33% believe that their child is more aware of cybersecurity now that they are spending additional time online. As for the kids, 42% report being more cautious online due to cybersecurity issues. However, 66% of parents don’t think that there are sufficient tools and methods to help protect their child from online dangers.

“The good news is that children are becoming increasingly savvy about internet safety, but there is still significant concern among parents who would like for there to be more resources available to protect their children online,” said Gosschalk.

To complement the study, Arkose Labs talked to some of the children on Zoom to hear more of their thoughts. The summary video can be seen here.

“It’s never too early to instill good cybersecurity habits, and the research Arkose Labs is doing with children and their parents provides invaluable industry insight into a demographic that’s spending a significant amount of time online and therefore is at the most risk,” said Julie Conroy, research director for Aite Group’s Fraud & AML practice and covers fraud, data security, anti-money laundering, and compliance issues. “My kid is more cybersavvy than most, given that his mom is in the anti-fraud field, and I’m still frequently having to coach him about online risks. Many parents and kids are not well attuned to these risks, which represents an increasing attack surface for organized crime rings.”

To learn more about Arkose Labs and its Fraud and Abuse Defense Platform, visit www.arkoselabs.com. To get your copy of the eBook “Navigating Internet Safety When Screen Time Becomes Full Time” visit link: https://www.arkoselabs.com/resource/navigating-internet-safety-when-screen-time-becomes-full-time/

About Arkose Labs

Arkose Labs bankrupts the business model of fraud. Its patented platform combines Arkose Detect, a sophisticated risk engine, with Arkose Enforce, which uses targeted step-up challenges to wear fraudsters down and diminish their ROI. The world’s largest brands trust Arkose Labs to protect their customer journey while delivering unrivaled user experiences. Arkose Labs is based in San Francisco, Calif., with offices in Brisbane, Australia. For more information, visit www.arkoselabs.com or on Twitter @ArkoseLabs.

Media Contact:

Paul Wilke

[email protected]

+1-415-881-7995

A video accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/4bbdbec6-eabf-4428-b63b-fc5beff0d8cf

SAN FRANCISCO, March 16, 2021 (GLOBE NEWSWIRE) — Kenna Security, the enterprise leader in risk-based vulnerability management, is investing in new infrastructure to support operations in Canada, where revenue has seen triple-digit growth over the past four years. The company has launched a new Canada-native instance of its risk-based vulnerability management platform to cater to the growing demand for services that meet national data residency requirements.

“More than half of Canada’s ten largest financial institutions count themselves as Kenna customers,” said Robin Maloney, Kenna Security’s manager of Canadian operations. “We are dedicated to the continued growth in this sector and across all other verticals, including the Government of Canada. This investment reflects a growing commitment to serve Canadian enterprises.”

Canadian companies and government agencies are increasingly seeking services that help them protect the privacy and security of their customers by confining data access and storage within the country’s borders. The Government of Canada in particular requires that sensitive or classified data it exposes to the cloud does not become subject to other countries’ jurisdictions.

“This new instance of the Kenna platform allows companies to meet their data residency needs, while gaining the immense benefits of our industry-leading modern vulnerability management capabilities,” Maloney said.

Kenna.VM leverages more than a decade of real world threat intelligence to help companies transform their vulnerability management strategies into modern, proactive, data-driven programs. The platform uses proven data science to assess the likelihood that threat actors will exploit it, and the risk those vulnerabilities pose to assets within a company. This knowledge allows companies to prioritize mitigation strategies. With Kenna Security, companies can mitigate the riskiest vulnerabilities faster, with less work.

Additional Resources

• Engage with Kenna on Twitter, Facebook, and LinkedIn.

About Kenna Security

Kenna Security is the enterprise leader in risk-based vulnerability management. The Kenna Security Platform enables organizations to work cross-functionally to determine and remediate cyber risks. It leverages machine learning and data science to track and predict real-world exploitations, empowering security teams to focus on what matters most. Headquartered in Santa Clara, Kenna serves nearly every major vertical and counts CVS, KPMG, and many Fortune 100 companies among its customers.

SAN DIEGO, March 16, 2021 (GLOBE NEWSWIRE) — Histogen Inc. (NASDAQ: HSTO) and Amerimmune LLC today announced dosing the first patient in a Phase 1 study of emricasan in mild symptomatic -COVID-19 patients to assess safety, tolerability, and preliminary efficacy. SUNY Downstate Medical Center in Brooklyn, New York, has been selected as the single site for the study conduct.

This double blinded, 1:1 randomized, placebo controlled single site study is expected to enroll 40 symptomatic mild-COVID-19 patients in an outpatient setting using emricasan at 25mg BID dosing for 14 days versus placebo. The study is designed to assess safety and tolerability and will also include various clinical and laboratory measures and patient reported outcomes (PROs) using the FDA COVID-19 Related Symptoms in Outpatient Adult and Adolescent Subjects in Clinical Trials of Drugs and Biological Products for COVID-19 Prevention or Treatment Assessment tool.

“This study of emricasan in symptomatic COVID-19 patients marks a significant milestone for Histogen and our partner Amerimmune as we enter the fight against this unprecedented pandemic,” said Richard W. Pascoe, President and Chief Executive Officer of Histogen. “Moreover, we believe emricasan is potentially an ideal candidate to treat symptomatic patients in the acute phase, as well as addressing the long-term complications in later phases of COVID-19, due to its anti-inflammatory properties.”

“Our first treatment in this clinical trial is an important step toward potentially bringing new and promising treatments to patients with mild COVID-19. SUNY is honored to be involved in this effort to address this medical need,” said Raavi Gupta, M.D. Associate Professor and the Principal Investigator at SUNY Downstate Health Sciences University.

“In early 2020, at the beginning of the pandemic, Amerimmune carried out a pioneering study showing that caspases are over-stimulated in the cells of patients with COVID-19, during both acute, late and chronic phases of the disease, potentially resulting in uncontrolled inflammation,” said Oral Alpan, M.D., President and CEO of Amerimmune. “Amerimmune will support the Phase 1 study of emricasan in mild COVID-19 patients by carefully evaluating biomarkers of antibody, T cell and caspase related immunity in patients receiving the pan-caspase inhibitor.”

About Emricasan

Emricasan is a potential first-in-class, orally active, pan-caspase inhibitor designed to reduce the activity of enzymes that mediate inflammation and apoptosis. Histogen acquired certain rights to emricasan and other caspase inhibitor compounds as a part of its merger with Conatus Pharmaceuticals Inc. in 2020. Histogen believes that by reducing the activity of these enzymes, caspase inhibitors have the potential to interrupt the progression of a variety of diseases.   To date, emricasan has been studied in over 950 patients in 19 completed clinical trials across a broad range of liver diseases. In NASH cirrhosis patients in multiple clinical Phase II trials conducted by Conatus, emricasan demonstrated rapid and sustained reductions in elevated levels of key biomarkers of inflammation and cell death. Similarly, elevated biomarkers are also believed to play a role in the severity and progression of COVID-19.

About Histogen

Histogen Inc. is a clinical-stage therapeutics company focused on developing potential first-in-class restorative therapeutics that ignite the body’s natural process to repair and maintain healthy biological function. Histogen’s innovative technology platform utilizes cell conditioned media and extracellular matrix materials produced by hypoxia-induced multipotent cells. Histogen’s proprietary, reproducible manufacturing process provides targeted solutions across a broad range of therapeutic indications including hair growth, dermal rejuvenation, joint cartilage regeneration and spinal disk repair. For more information, please visit www.histogen.com.

About Amerimmune

Amerimmune LLC is a research center and immunology laboratory with a strong focus on identifying underlying mechanisms of immune disorders. Amerimmune’s mission is to bring relevant science, data, and diagnostic and therapeutic solutions to diseases that involve the immune system. Amerimmune LLC is a spinoff of Amerimmune Diagnostics LLC, which is focused on establishing a network of physician-owned immunology labs across the United States. Amerimmune Diagnostics’ clinical approach led to the development of the innovative therapeutics technology upon which Amerimmune was founded. When the COVID-19 pandemic emerged early this year, Amerimmune brought its expertise to bear against this devastating disease. Amerimmune is a privately held development-stage company based in Fairfax, VA. For more information and to explore partnering opportunities, please visit www.amerimmune.com.
  
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995 and other Federal securities laws. For example, we are using forward-looking statements when we discuss Histogen’s future operations and its ability to successfully complete clinical trials, obtain clinical trial data and achieve regulatory milestones and related timing, including those related to the Phase 1 study of emricasan for the treatment of COVID-19 and the reporting of topline results for the study; the nature, strategy and focus of Histogen’s business; the sufficiency of Histogen and Amerimmune’s cash resources and ability to complete the Phase 1 study of emricasan and achieve value for its stockholders; and the development and commercial potential and potential benefits of any of its product candidates and the Collaborative Development and Commercialization Agreement with Amerimmune or any other collaboration agreements. Histogen may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Because such statements deal with future events and are based on our current expectations, they are subject to various risks and uncertainties and actual results, performance or achievements of ours that could differ materially from those described in or implied by the statements in this press release, including: the uncertainties associated with the clinical development and regulatory approval of Histogen’s product candidates and Amerimmune’s ability to further develop emricasan for the treatment of COVID-19, including the complexity and length of studies required to commercialize emricasan for COVID-19 and potential delays in the enrollment and completion of clinical trials, such as the emricasan Phase 1 study for the treatment of COVID-19; the uncertainties associated with Amerimmune’s pursuit and receipt of non-dilutive capital for the advancement of emricasan, including any potential government grants; Histogen’s dependence on its collaboration partner, Amerimmune, to carry out the development of emricasan and the potential for delays in the timing of regulatory approval; competition in the COVID-19 market and other markets in which Histogen and its collaboration partner operate; risks related to business interruptions to Histogen and/or Amerimmune, including the outbreak of COVID-19 coronavirus, which could seriously harm their respective financial conditions and increase their respective costs and expenses; the potential for adverse reactions to emricasan; and market conditions. 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 those risks discussed in our filings with the Securities and Exchange Commission. Except as otherwise required by law, we disclaim any intention or obligation to update or revise any forward-looking statements, which speak only as of the date hereof, whether as a result of new information, future events, or circumstances or otherwise.

CONTACT:

Susan A. Knudson
Executive Vice President & CFO
Histogen Inc.
[email protected]

SAN DIEGO, March 16, 2021 (GLOBE NEWSWIRE) — Guardion Health Sciences, Inc. (Nasdaq: GHSI) (“Guardion” or the “Company”), a clinical nutrition and diagnostics company that develops clinically supported nutritional supplements, medical foods, and medical devices, announced that it has regained compliance with the minimum bid price requirement for continued listing on The Nasdaq Capital Market pursuant to Listing Rule 5550(a)(2) (the “Minimum Bid Price Rule”). On March 15, 2021, Guardion received a letter from the Office of General Counsel of The Nasdaq Stock Market LLC (“Nasdaq”) stating that because Guardion’s Company’s common stock (the “Common Stock”) had a closing bid price at or above $1.00 per share for a minimum of ten (10) consecutive trading days, its Common Stock had regained compliance with Nasdaq’s Minimum Bid Price Rule.

On September 20, 2019, the Company received notice from Nasdaq indicating that, based upon the closing bid price of the Common Stock, the Company no longer satisfied the Minimum Bid Price Rule. The Company was afforded 180 calendar days, or until March 18, 2020, to regain compliance with the Minimum Bid Price Rule. Thereafter, the Company was afforded a second 180 calendar day compliance period (which 180-day period was extended due to circumstances related to COVID-19), or until November 30, 2020, to regain compliance with the Minimum Bid Price Rule.

The Company was unable to regain compliance with the Minimum Bid Price Rule by November 30, 2020. Accordingly, on December 1, 2020, the Company received a letter from Nasdaq notifying it that its Common Stock would be subject to delisting from Nasdaq unless the Company timely requested a hearing before a Nasdaq Listing Qualifications Panel (the “Panel”). The Company timely requested the hearing.

Following the hearing, on January 26, 2021, the Company received written notification that the Panel had granted the Company an extension for continued listing through March 15, 2021. As referenced above, Nasdaq determined that the Company complied with the Panel’s decision and has regained compliance. Accordingly, Nasdaq has closed the compliance review.

About Guardion Health Sciences

Guardion Health Sciences, Inc. (NASDAQ: GHSI), is a clinical nutrition and diagnostics company. Guardion offers a portfolio of science-based, clinically supported nutrition, medical foods, and diagnostic products that support healthcare professionals, their patients, and consumers in achieving health goals. Guardion’s commercial and developmental initiatives are supported by equally impressive scientific and medical advisory boards, led by seasoned business executives and physicians with many years of experience. This combination of expertise and scientific knowledge forms the foundation of Guardion’s growing position within the eye care industry and the clinical nutrition marketplace. Information and risk factors with respect to Guardion and its business, including its ability to successfully develop and commercialize its proprietary products and technologies, may be obtained in the Company’s filings with the U.S. Securities and Exchange Commission (the “SEC”) at www.sec.gov.

Forward-Looking Statement Disclaimer

With the exception of the historical information contained in this news release, the matters described herein may contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Statements preceded by, followed by or that otherwise include the words “believes,” “expects,” “anticipates,” “intends,” “projects,” “estimates,” “plans” and similar expressions or future or conditional verbs such as “will,” “should,” “would,” “may” and “could” are generally forward-looking in nature and not historical facts, although not all forward-looking statements include the foregoing. These statements involve unknown risks and uncertainties that may individually or materially impact the matters discussed herein for a variety of reasons that are outside the control of the Company, including, but are not limited to, the Company’s ability to raise sufficient financing to implement its business plan, the integration of a new management team, the impact of the COVID-19 pandemic on the Company’s business, operations and the economy in general, the Company’s ability to successfully develop and commercialize its proprietary products and technologies, and the Company’s ability to maintain compliance with Nasdaq’s listing requirements. Readers are cautioned not to place undue reliance on these forward-looking statements, as actual results could differ materially from those described in the forward-looking statements contained herein. Readers are urged to read the risk factors set forth in the Company’s filings with the SEC, which are available at the SEC’s website (www.sec.gov). The Company disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Investor Relations Contact:
CORE IR
Scott Arnold
516-222-2560
[email protected]

Media Relations Contact:
Jules Abraham
Director of Public Relations
CORE IR
917-885-7378
[email protected]

PHILADELPHIA, March 16, 2021 (GLOBE NEWSWIRE) — AgroFresh Solutions, Inc., a global leader in produce freshness solutions, today announced that Peruvian produce leader Camposol has decided to adopt the company’s VitaFresh™ Botanicals plant-based, edible coatings to increase the shelf life of ripened avocados commercialized in Europe, the United States and China. 

VitaFresh Botanicals is a proprietary, plant-based portfolio of solutions for a wide variety of crops including avocados, citrus and mangos. Its coating range utilize “anti-thirst” technology to boost the skin’s natural protection, creating a “double skin” membrane that reduces dehydration, maintains weight and locks in produce freshness throughout the supply chain.

Camposol, a leading vertically integrated global produce grower, exporter and marketer, will utilize AgroFresh’s VitaFresh Botanicals to help expand and grow their business with European, American and Chinese retailers, taking a consumer-marketing end-user perspective. Camposol’s ripenend avocados coated with VitaFresh Botanicals gives retailers a much stronger opportunity to market the best quality produce and increase consumer satisfaction, while reducing food waste and increasing profit potential. By using the VitaFresh Botanicals coatings, Camposol’s ripened avocados will have an added two to four days of extended shelf life after arriving at retail locations (versus uncoated avocados), which will help to reduce retail food waste and potentially generate up to 200% retailer ROI.

“This new strategic relationship represents another step forward in AgroFresh’s decades-long commitment to providing innovative solutions to help our customers extend produce shelf life, and deliver superior eating experiences to consumers,” said AgroFresh CEO Jordi Ferre. “It also represents a major step in our diversification efforts. By using AgroFresh’s VitaFresh Botanicals coatings, Camposol can extend the shelf life of its ripened avocados, improve produce quality throughout their supply chain, and enable retailers to sell more great tasting, ready-to-buy and ready-to-eat avocados,” said Ferre.

“After evaluating multiple options on the market and conducting extensive trials, we chose AgroFresh and VitaFresh Botanicals because of their ability to achieve the technical performance and efficacy that we needed,” said José Antonio Gómez Bazán – Managing Director, Camposol International. “What’s more, as a global company, AgroFresh can support our global expansion and offer the post-harvest expertise and in-depth technical and R&D support that we need to attain our business objectives.”

For easy application of the coatings, Camposol will install AgroFresh’s Control-Tec™ Applicator equipment in their European and U.S. facilities, with plans to add equipment in China. VitaFresh Botanicals coatings are sustainable and created using certified ISO 14001 “environmental management system” standards. 

AgroFresh’s vision is to be the guardian of the world’s fresh produce, and the company is proud to be a member of GLOBALG.A.P., an organization that promotes safe, responsible, and transparent farming for a sustainable future. With VitaFresh Botanicals, AgroFresh offers “Natural-Powered Life Extension for Fruit,” creating new opportunities for retailers and helping to influence consumers’ enjoyment of fresh, tasty produce.

About AgroFresh 
AgroFresh (Nasdaq: AGFS) is an AgTech innovator and global leader with a mission to prevent food loss/waste and conserve the planet’s resources by providing a range of science-based solutions, data-driven digital technologies and high-touch customer services. AgroFresh supports growers, packers and retailers with solutions across the food supply chain to enhance the quality and extend the shelf life of fresh produce. The AgroFresh organization has 40 years of post-harvest experience across a broad range of crops, including revolutionizing the apple industry with the SmartFresh™ Quality System for more than 20 years. This is powered by a comprehensive portfolio that includes plant-based coatings, equipment and proprietary solutions that help improve the freshness supply chain from harvest to the home. Visit agrofresh.com to learn more.

About Camposol

Camposol, the leading agro-industrial company in Peru, is a multinational produce grower and marketer that provides families around the world with fresh and healthy food. The innovative company is involved in the harvest, processing and marketing of high quality agricultural products such as avocados, blueberries, grapes, mangoes and mandarins, among others. Camposol has customers in more than 40 countries and trusting relationships with the main supermarkets worldwide; operations in Peru, Colombia, Uruguay, Chile and Mexico; and commercial offices in the United States, Europe, and Asia. Camposol is a vertically integrated company that is committed to supporting sustainable development through social and environmental responsibility policies and projects. Visit www.camposol.com.pe to learn more.

Michael Wolfe –  Media Relations
ICR Inc.
[email protected]

SAN DIEGO, March 16, 2021 (GLOBE NEWSWIRE) — aTyr Pharma, Inc. (Nasdaq: LIFE), a biotherapeutics company engaged in the discovery and development of innovative medicines based on novel biological pathways, today announced that it will report fourth quarter and full year 2020 financial results and provide a corporate update after the market close on Tuesday, March 23, 2021. Management will host a conference call and webcast to review the results and provide an operational update.

Conference Call and Webcast Details:

Tuesday, March 23rd @ 5:00 p.m. EDT / 2:00 p.m. PDT
Domestic: 844-358-9116
International: 209-905-5951
Conference ID: 3291668
Webcast: http://investors.atyrpharma.com/events-and-webcasts

Abo
ut aTyr

aTyr is a biotherapeutics company engaged in the discovery and development of innovative medicines based on novel biological pathways. aTyr’s research and development efforts are concentrated on a newly discovered area of biology, the extracellular functionality and signaling pathways of tRNA synthetases. aTyr has built a global intellectual property estate directed to a potential pipeline of protein compositions derived from 20 tRNA synthetase genes and their extracellular targets. aTyr’s primary focus is ATYR1923, a clinical-stage product candidate which binds to the Neuropilin-2 receptor and is designed to down-regulate immune engagement in inflammatory lung diseases. For more information, please visit http://www.atyrpharma.com.

Contact:

Ashlee Dunston
Director, Investor Relations and Corporate Communications
[email protected]