Market Newsdesk

Beijing, China, March 16, 2021 (GLOBE NEWSWIRE) — Global Internet of People, Inc. (“SDH” or the “Company”) (NASDAQ: SDH), an operator of a knowledge sharing and enterprise service platform via mobile application and through local centers in China, today announced that the Company plans to enter into strategic cooperation with the Industrial Technology Research Institute of Zhejiang University (“Zhejiang University Institute”), following a meeting between the Company’s management and Professor Shaobo Ren, Party Committee Secretary of Zhejiang University, and Mr. Qilong Ren, Dean of Zhejiang University Institute on February 26 to facilitate the development of real-world applications based on  Zhejiang University Institute’s scientific and technological research achievements. Mr. Haiping Hu, CEO and Chairman of SDH, also accepted an invitation to act as an adviser to Zhejiang University Institution. SDH and Zhejiang University Institution plan to enter into strategic cooperation in fields such as new materials and energy, block chain technology, industrial internet etc.

Mr. Haiping Hu commented: “Through our intended cooperation with Zhejiang University Institute, SDH plans to extensively promote the excellent scientific research achievements of Zhejiang University Institute to more than 5 million users on SDH’s knowledge sharing and enterprise service platform, and to provide channels of scientific research support for small and medium-sized enterprises. At the same time, we believe that Zhejiang University Institute would provide strong support to SDH’s platform assisting technological upgrading for small and medium-sized enterprises. “

About Zhejiang University Industrial Technology Research Institute

Zhejiang University, with its strong scientific and technological strength and cutting-edge talents in many fields, ranks the third of the top 100 universities in China according to Ruilu’s 2020 China university ranking, second only to Tsinghua University and Peking University. Zhejiang University Institute was established on April 20, 2009, and has established 10 sub-institutions and 100 technology transfer sub-centers in China, which bridge and link scientific and technological research achievements and their real-world applications. Mr. Qilong Ren, Dean of Zhejiang University, is a member of the Chinese Academy of Engineering and an expert in the field of chemical separation technology. He has successively presided over and completed key national projects of the nature science foundation since 1997. He has also published more than 190 papers on Science Citation Index (SCI)/Engineering Index (EI), and owns rights to more than 40 invention patents.

About
Global Internet of People, Inc.

Headquartered in Beijing and Shanghai, SDH operates an online knowledge sharing and enterprise service platform, both online, via a mobile application “Shidonghui App” (the “APP”), and offline, through local offices in Beijing, Shanghai and Hangzhou, as well as 51 local centers operated by some of the Company’s members in 35 cities throughout the PRC. The main services SDH offers to App users are (1) Questions and Answers Sessions and (2) streaming of audio and video courses and programs. The offline services SDH offers to its members are study tours and forums. For more information about the Company, please visit: www.sdh365.com.

Forward-looking statement

The statements in this press release regarding the Company’s future expectations, plans and prospects constitute forward-looking statements as defined by Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements about plans, goals, objectives, strategies, future events, expected results, assumptions and any other factual statements that have not occurred. Any words that refer to “may”, “will”, “want”, “should”, “believe”, “expect”, “expect”, “estimate”, “estimate” or similar non-factual words, shall be regarded as forward-looking statements. Due to various factors, the actual results may differ materially from the historical results or the contents expressed in these forward-looking statements. These factors include, but are not limited to, the company’s strategic objectives, the Company’s future plans, market demand and user acceptance of the Company’s products or services, technological updates, economic trends, the Company’s reputation and brand, the impact of industry competition and bidding, relevant policies and regulations, the ups and downs of China’s macroeconomic conditions, and the related risks and assumptions disclosed in the Company’s filings with the U.S. Securities and Exchange Commission (the “SEC”)We urge investors to visit the SEC website to review the Company’s relevant disclosures that may affect the Company’s future operating results. All information provided in this press release is as of the date of this press release, and the Company undertakes no obligation to update any forward-looking statements, except as may be required under applicable law.

For more information, please contact:

The Company:

IR Department
Email: [email protected]

Investor Relations:

Janice Wang   
EverGreen Consulting Inc.
Email: [email protected]
Phone: +1-908-510-2351 (from U.S.)

                        +86 13811768559 (from China)

SOUTH SAN FRANCISCO, Calif., March 16, 2021 (GLOBE NEWSWIRE) — Akero Therapeutics, Inc. (Nasdaq: AKRO), a cardio-metabolic biotechnology company developing transformational treatments for non-alcoholic steatohepatitis (NASH), today reported fourth quarter and full year financial results for the period ending December 31, 2020.

“In 2020 we reported strong results from our Phase 2a BALANCED study in biopsy-confirmed NASH patients suggesting that our lead asset, efruxifermin (EFX), has the potential to be a foundational monotherapy for treatment of NASH,” said Andrew Cheng, M.D., Ph.D., president and chief executive officer of Akero. “We have been particularly pleased with biopsy data that showed rapid improvements in both fibrosis and NASH resolution and look forward to reporting additional biopsy data among cirrhotic patients by April of this year.”

Fourth Quarter Business Highlights

• During the fourth quarter, the Company reported additional analyses for the main portion of the Phase 2a BALANCED study, including proportion of patients who achieved 50% and 70% relative reductions in liver fat, and extent of improvement in fibrosis among patients with F2 or F3 fibrosis at baseline and of glycemic control among patients with Type 2 diabetes mellitus.
• Among all EFX-treated patients who were fibrosis stage F2 or F3 at baseline (n=22), 50% experienced a two-stage improvement in fibrosis (n=11), while 68% experienced at least a one-stage improvement in fibrosis (n=15).
• Based on these rapid improvements in fibrosis observed after only 16 weeks of treatment, the Company believes that EFX has the potential to play an important role in reversing fibrosis for NASH patients.

Phase 2a BALANCED Study Cohort C Update

• Data collection for Cohort C of the BALANCED study, including voluntary end-of-treatment biopsies, was completed in February 2021.
• The Company expects to report preliminary results from Cohort C by April 2021, including safety and tolerability of EFX along with analyses of paired biopsies and non-invasive measures of liver health.

Phase 2b HARMONY Study Update

• Screening of subjects for the HARMONY study, a multicenter, randomized, double-blind, placebo-controlled, clinical trial in biopsy-confirmed NASH patients with fibrosis stage 2 or 3, began in February 2021.
• The Company expects to complete enrollment in 2021 and report preliminary results in the second half of 2022.

Regulatory Update

• An end-of-phase 2 meeting with the U.S. Food and Drug Administration (FDA) to review HARMONY study results and finalize the proposed Phase 3 protocol, including dose selection and study size, will be requested prior to initiating Phase 3.

Manufacturing Update

• Drug substance manufactured by Akero for use in the Phase 2b HARMONY study has been shown to be comparable to that previously manufactured by Amgen.
• The Company anticipates that a lyophilized formulation of drug product will be available for Phase 3 initiation in the first half of 2023.

COVID-19 Update

• The Company’s financial results for the year ended December 31, 2020 were not significantly impacted by COVID-19.
• The COVID-19 pandemic did not materially impact data collection for Cohort C, ongoing enrollment in the Phase 2b HARMONY study or manufacturing of drug substance.

Full Year and Fourth Quarter 2020 Financial Results

• Akero’s cash, cash equivalents and short-term marketable securities for the year ended December 31, 2020 were $268.4 million.
• Research and development expenses for the three-month and twelve-month periods ended December 31, 2020 were $25.7 million and $64.9 million, respectively, compared to $13.1 million and $37.0 million for the comparable periods in 2019. These increases are attributable to higher costs related to Akero’s EFX program, including third-party contract manufacturing, contract research organization costs associated with the BALANCED and HARMONY studies and internal personnel costs.
• General and administrative expenses for the three-month and twelve-month periods ended December 31, 2020 were $4.1 million and $15.2 million, respectively, compared to $3.1 million and $8.6 million for the comparable periods in 2019. These increases are attributable to higher expenses for personnel, including non-cash stock-based compensation, and professional services and other costs associated with operating as a public company.
• Total operating expenses were $29.8 million and $80.2 million for the three-month and twelve-month periods ended December 31, 2020, respectively, compared to $16.2 million and $45.7 million for the comparable periods in 2019.

About NASH

Non-alcoholic steatohepatitis (NASH) is a serious, life-threatening disease that has rapidly emerged as a leading cause of liver failure in the world and is the leading indication for liver transplant among women. An estimated 17.3 million Americans had NASH in 2016, a number that is expected to increase to 27.0 million by 2030. NASH is a severe form of nonalcoholic fatty liver disease (NAFLD) characterized by hepatocyte injury, liver inflammation, and fibrosis that can progress to scarring (cirrhosis), liver failure, cancer and death. There are currently no approved therapies for the disease.

About Cohort C

Cohort C is an expansion cohort of the Phase 2a BALANCED study evaluating EFX in the treatment of patients with NASH who have compensated cirrhosis (F4), Child-Pugh Class A. Thirty cirrhotic NASH subjects with a biopsy-confirmed fibrosis score of F4 were randomized 2:1 to receive either 50mg of EFX or placebo for 16 weeks. The primary objective of the expansion cohort is to assess safety and tolerability of EFX in NASH patients at the greatest risk of progressing to end-stage liver disease, including liver failure and liver cancer. The trial design includes various non-invasive measures of liver health, including fibrosis markers such as the Enhanced Liver Fibrosis (ELF) score and Pro-C3, as well as liver imaging. The trial design also provided that all patients could volunteer to have end-of-treatment biopsies.

About the HARMONY Study

The Phase 2b HARMONY study is a multicenter, randomized, double-blind, placebo-controlled, clinical trial in biopsy-confirmed NASH patients with fibrosis stage 2 or 3. Patients will be randomized to receive once-weekly subcutaneous dosing of 28 or 50mg EFX or placebo. The primary endpoint for the trial is fibrosis regression at 24 weeks. Patients will continue to receive EFX or placebo during a long-term follow-up period to provide additional safety data.

About Efruxifermin

Efruxifermin (EFX) is an Fc-FGF21 fusion protein that has been engineered to mimic the balanced biological activity profile of native FGF21, an endogenous hormone that alleviates cellular stress and regulates metabolism throughout the body. Previous clinical trials show that EFX has the potential to reverse fibrosis, resolve NASH, reduce liver fat, improve glycemic control, improve lipoprotein profile, and reduce body weight. EFX is designed to offer convenient once-weekly subcutaneous dosing.

About Akero Therapeutics

Akero Therapeutics is a clinical-stage cardio-metabolic company developing transformational treatments for non-alcoholic steatohepatitis (NASH), a disease without any approved therapies. Akero’s lead product candidate, EFX, an engineered Fc-FGF21 fusion protein, is currently being evaluated in Phase 2 clinical trials as a potential treatment for NASH. Akero is headquartered in South San Francisco. Visit us at www.akerotx.com for more information.

Forward-Looking Statements

Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements, including, but not limited to, statements regarding the Company’s business plans and objectives, including future plans or expectations for EFX, upcoming milestones, and therapeutic effects of EFX, as well as the dosing, safety and tolerability of EFX; the Company’s plans to report preliminary results for Cohort C of the Phase 2a BALANCED study; the Company’s Phase 2b HARMONY study including expected timing to complete enrollment and report preliminary results; the availability of a new drug product formulation to support Phase 3 clinical trials; expectations regarding the Company’s use of capital, expenses and other future financial results; statements regarding a potential meeting with the FDA and timing thereof and the potential impact of COVID-19 on strategy, future operations, enrollment and clinical trials. Any forward-looking statements in this press release are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. Risks that contribute to the uncertain nature of the forward-looking statements include: risks related to the impact of COVID-19 on the Company’s ongoing and future operations, including potential negative impacts on the Company’s employees, third-parties, manufacturers, supply chain and production as well as on global economies and financial markets; the success, cost, and timing of the Company’s product candidate development activities and planned clinical trials; the Company’s ability to execute on its strategy; positive results from a clinical study may not necessarily be predictive of the results of future or ongoing clinical studies; regulatory developments in the United States and foreign countries; the Company’s ability to fund operations; as well as those risks and uncertainties set forth more fully under the caption “Risk Factors” in the Company’s most recent Annual Report on Form 10-K, as filed with the Securities and Exchange Commission (SEC) as well as discussions of potential risks, uncertainties and other important factors in the Company’s other filings and reports with the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. The Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

Akero Therapeutics, Inc.
Condensed Consolidated Balance Sheets
(Unaudited)
(In thousands)
		December 31, 2020				December 31, 2019
Assets
Cash, cash equivalents and short-term marketable securities		$	268,387			$	136,400
Other current assets			2,958				1,649
Non-current assets			1,994				69
Total assets		$	273,339			$	138,118
Liabilities and Stockholders’ Equity
Current liabilities		$	13,111			$	9,369
Non-current liabilities			1,516				23
Stockholders’ equity			258,712				128,726
Total liabilities and stockholders’ equity		$	273,339			$	138,118
Akero Therapeutics, Inc.
Condensed Consolidated Statements of Operations and Comprehensive Loss
(Unaudited)
(In thousands, except share and per share amounts)
		Three Months Ended December 31,								Twelve Months Ended December 31,
		2020				2019				2020				2019
Operating expenses:
Research and development		$	25,709			$	13,138			$	64,916			$	37,046
General and administrative			4,074				3,083				15,238				8,605
Total operating expenses			29,783				16,221				80,154				45,651
Loss from operations			(29,783	)			(16,221	)			(80,154	)			(45,651	)
Other income			72				610				947				1,896
Net loss		$	(29,711	)		$	(15,611	)		$	(79,207	)		$	(43,755	)
Comprehensive loss		$	(29,730	)		$	(15,617	)		$	(79,204	)		$	(43,761	)
Net loss per common share, basic and diluted		$	(0.86	)		$	(0.55	)		$	(2.52	)		$	(2.90	)
Weighted-average number of shares used in computing net loss per common share, basic and diluted			34,684,466				28,335,405				31,463,248				15,070,728

Investor Contact:

Christina Tartaglia
212.362.1200
[email protected]

Media Contact:

Jennifer Weismann
612.716.0556
[email protected]

LYON, France and NEWTON, Mass., March 16, 2021 (GLOBE NEWSWIRE) — Amolyt Pharma, a global company specializing in developing therapeutic peptides for rare endocrine and metabolic diseases, today announced that it will be presenting four abstracts at the Endocrine Society’s Annual Meeting, ENDO 2021, being held virtually from March 20-23, 2021.

Amolyt will present preliminary data from its Phase 1 clinical trial evaluating AZP-3601, a parathyroid hormone analog specifically designed for the treatment of hypoparathyroidism, in addition to two abstracts detailing a retrospective natural history study of chronic hypoparathyroidism. Amolyt will also present preclinical data for AZP-3404, a peptide with a new and unique mechanism of action on fat and glucose metabolism. Details of the abstracts are as follows:

AZP-3601 Program

Title: A Single Administration of AZP-3601, a Novel, Long-Acting PTH Analog, Induces a Significant and Sustained Calcemic Response: Preliminary Data From a Randomized, Double-Blind, Placebo-Controlled Phase 1 Study
Session: P08 – Parathyroid and Rare Bone Disorders
Session Date/Time: March 20, 2021 at 11:00 AM – 11:59 PM EDT (On Demand)

Title: Clinical Burden And Practice Patterns In Patients With Chronic Hypoparathyroidism In The United States (US): A Claims Data Analysis Using Diagnosis-Based Criteria
Session: P08 – Parathyroid and Rare Bone Disorders
Session Date/Time: March 20, 2021 at 11:00 AM – 11:59 PM EDT (On Demand)

Title: Clinical Burden And Practice Patterns In Patients With Chronic Hypoparathyroidism In The United States (US): A Claims Data Analysis Using Surgery-Based Criteria
Session: P08 – Parathyroid and Rare Bone Disorders
Session Date/Time: March 20, 2021 at 11:00 AM – 11:59 PM EDT (On Demand)

AZP-3404 Program

Title: AZP-3404, a Peptide Analog of IGFBP-2, Induces Weight Loss and Improves Glucose Metabolism in Leptin-Resistant db/db Mice
Session: SESSION P15 – Bench to Bedside: Novel Mechanisms in Diabetes and Metabolism
Session Date/Time: March 20, 2021 at 11:00 AM – 11:59 PM EDT (On Demand)

Additional details can be found on the ENDO website and copies of the posters will be available on the Amolyt website once the presentations conclude.

About Hypoparathyroidism

Hypoparathyroidism is defined by a deficiency of parathyroid hormone (PTH) that results in decreased calcium and elevated phosphorus levels in the blood. Clinical manifestations of hypoparathyroidism vary and impact a large number of tissues and organ systems, including the muscles, brain, heart, and kidneys. Despite available treatments, patients frequently experience persistent, life-altering symptoms and reduced quality of life. In addition, they often develop kidney disease and have abnormal bone architecture. There are approximately 80,000 and 110,000 people with hypoparathyroidism in the U.S. and E.U., respectively, of which about 80% are women. More than two-thirds of women with hypoparathyroidism are peri- and menopausal women who are at an increased risk of developing osteoporosis. It is estimated that about 25% of people with hypoparathyroidism have chronic kidney disease or kidney failure, highlighting the importance of reducing urinary calcium excretion as a key treatment goal.

About AZP-3601

AZP-3601 is a therapeutic peptide designed to target a specific conformation of the parathyroid hormone (PTH) receptor in order to safely produce sustained levels of calcium in the blood and thereby manage the symptoms of hypoparathyroidism. The selective action of AZP-3601 through this distinct conformation of the PTH receptor is also intended to limit urine calcium excretion by stimulating calcium reabsorption by the kidney, consequently preventing chronic kidney disease. In addition, the unique receptor profile and short half-life of AZP-3601 are expected to preserve bone integrity, an important benefit since the majority of patients with hypoparathyroidism are middle-aged women often at increased risk of osteoporosis.

About AZP-3404

AZP-3404 is the first therapeutic peptide to leverage the biology of insulin-like growth factor binding protein 2 (IGFBP2), a key mediator of the beneficial effects of leptin on fat and glucose metabolism. The metabolic-regulating activity of IGFBP2 resides in a small peptide sequence located within its structure. AZP-3404 is a stabilized peptide analog of this sequence and is the first drug candidate to utilize and to reproduce the unique biology of IGFBP2. We are currently conducting pre-investigational new drug activities and exploring target indications for AZP-3404, especially rare metabolic diseases characterized by insulin resistance and/or obesity.

About Amolyt Pharma 

Amolyt Pharma is building on its team’s established expertise in therapeutic peptides to deliver life-changing treatments to patients suffering from rare endocrine and metabolic diseases. Its portfolio includes AZP-3601 as a potential treatment of hypoparathyroidism, AZP-3404, which is undergoing indication prioritization work, and AZP-38XX, a small peptide series under evaluation to select a development candidate for the treatment of acromegaly. Amolyt Pharma aims to further expand and develop its portfolio by leveraging its global network in the field of endocrinology and with support from a strong syndicate of international investors. To learn more, visit www.amolytpharma.com or follow us on Twitter at @AmolytPharma.

Media:

Cherilyn Cecchini, M.D.
LifeSci Communications
[email protected]
+1.646.876.5196

Investors:

Ashley Robinson
LifeSci Advisors, LLC
[email protected]
+1.617.430.7577

– 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.

	Year ended December 31,
(in thousands, except share and per share data)	2020				2019
Operating expenses:
Research and development	$	48,177			$	24,279
General and administrative		10,586				3,830
Total operating expenses		58,763				28,109
Loss from operations		(58,763	)			(28,109	)
Other income, net		1,834				539
Net loss	$	(56,929	)		$	(27,570	)
Per share information:
Net loss per share of common stock, basic and diluted	$	(4.56	)		$	(16.52	)
Weighted average common shares outstanding, basic and diluted		12,478,463				1,668,549

		December 31,
(in thousands, except share and per share data)		2020				2019
Assets
Current assets:
Cash and cash equivalents		$	218,309			$	18,879
Prepaid expenses and other current assets			2,500				1,345
Total current assets			220,809				20,224
Property and equipment, net			2,480				1,647
Deferred offering costs		301					—
Total assets		$	223,590			$	21,871
Liabilities, convertible preferred stock and stockholders’ equity (deficit)
Current liabilities:
Capital lease obligation		$	—			$	258
Accounts payable			3,920				1,974
Accrued expenses and other current liabilities			7,455				2,603
Total current liabilities			11,375				4,835
Other liabilities		32					5
Total liabilities			11,407				4,840
Convertible preferred stock, $0.0001 par value:
Series A convertible preferred stock: No shares and 13,574,008 shares authorized at December 31, 2020 and 2019, respectively; No shares and 11,736,119 shares issued and outstanding at December 31, 2020 and 2019, respectively			—				36,595
Series B convertible preferred stock: No shares and 18,500,000 shares authorized at December 31, 2020 and 2019, respectively; No shares and 7,628,846 shares issued and outstanding at December 31, 2020 and 2019, respectively			—				29,848
Series C convertible preferred stock: No shares authorized, issued or outstanding at December 31, 2020 and 2019			—				—
Total convertible preferred stock			—				66,443
Stockholders’ equity:
Voting common stock, $0.0001 par value: 487,149,741 and 42,000,000 shares authorized at December 31, 2020 and 2019, respectively; 32,595,301and 3,161,653 shares issued and outstanding at December 31, 2020 and 2019, respectively		3					—
Non-voting common stock, $0.0001 par value: 12,850,259 and no shares authorized at December 31, 2020 and 2019, respectively; 11,110,371 and no shares issued and outstanding at December 31, 2020 and 2019, respectively		1					—
Additional paid-in capital			319,605				1,085
Accumulated deficit			(107,426	)			(50,497	)
Total stockholders’ equity (deficit)			212,183				(49,412	)
Total liabilities, convertible preferred stock and stockholders’ equity (deficit)		$	223,590			$	21,871

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.

Media & Analyst Contact:
Matt McLoughlin
Gregory FCA for Kenna Security
Phone: 609-385-2058
Email: [email protected]

 

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]