Market Newsdesk

BOSTON, June 01, 2022 (GLOBE NEWSWIRE) — Paratek Pharmaceuticals, Inc. (Nasdaq: PRTK), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel life-saving therapies for life-threatening diseases or other public health threats for civilian, government and military use, today announced that Evan Loh, M.D., chief executive officer, will participate in a fireside chat June 9 from 3:30 to 3:55 p.m. Eastern Time at the Jefferies Healthcare Conference in New York City.

Dr. Loh’s event will be available to view on-demand at: https://wsw.com/webcast/jeff240/prtk/1871025 and under “Presentations & Events” in the Investors section of the company’s website at https://www.paratekpharma.com/investor-relations beginning June 9 at 3:30 p.m. and for the next 90 days.

Members of Paratek’s senior management team also will be available for one-on-one investor meetings June 9.

About Paratek Pharmaceuticals, Inc.

Paratek Pharmaceuticals, Inc. is a commercial-stage biopharmaceutical company focused on the development and commercialization of novel life-saving therapies for life-threatening diseases or other public health threats for civilian, government and military use.

The company’s lead commercial product, NUZYRA^® (omadacycline), is a once-daily oral and intravenous antibiotic available in the United States for the treatment of adults with community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI). Paratek has a collaboration agreement with Zai Lab for the development and commercialization of omadacycline in the greater China region and retains all remaining global rights.

Paratek is also conducting a Phase 2b study with NUZYRA in a rare disease, nontuberculous mycobacterial (NTM) pulmonary disease, caused by Mycobacterium abscessus complex. Paratek estimates this opportunity represents a potential $1 billion addressable market in the United States.

Paratek exclusively licensed U.S. rights and rights to the greater China territory for SEYSARA® (sarecycline), a once-daily oral therapy for the treatment of moderate to severe acne vulgaris, to Almirall, LLC. Paratek retains the development and commercialization rights for sarecycline in the rest of the world.

In 2019, Paratek was awarded a contract from the U.S. Department of Health and Human Services’ Biomedical Advanced Research and Development Authority (BARDA), now valued at up to $304 million, to support the development and U.S.-based manufacturing of NUZYRA for pulmonary anthrax. For more information, visit www.ParatekPharma.com or follow us on LinkedIn and Twitter.

Forward Looking Statements

This press release contains forward-looking statements. All statements, other than statements of historical facts, included in this press release are forward-looking statements, and are identified by words such as “advancing,” “expect,” “look forward,” “anticipate,” “continue,” and other words and terms of similar meaning. These forward-looking statements are based upon our current expectations and involve substantial risks and uncertainties. We may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in our forward-looking statements and you should not place undue reliance on these forward-looking statements. Our actual results and the timing of events could differ materially from those included in such forward-looking statements as a result of these risks and uncertainties. These and other risk factors are discussed under “Risk Factors” and elsewhere in our Annual Report on Form 10-K for the year ended December 31, 2021 and our other filings with the Securities and Exchange Commission. We expressly disclaim any obligation or undertaking to update or revise any forward-looking statements contained herein.

CONTACT:

For Investors:

Hans Vitzthum
LifeSci Advisors
[email protected]
Phone: 617-430-7578

For Media:


Christine Fanelle
Scient PR
[email protected]
Phone: 215-595-5211

SAN DIEGO, June 01, 2022 (GLOBE NEWSWIRE) — BioAtla, Inc. (Nasdaq: BCAB), a global clinical-stage biotechnology company focused on the development of Conditionally Active Biologic (CAB) antibody therapeutics for the treatment of solid tumors, today announced that Jay M. Short, Ph.D., Chairman, Chief Executive Officer and co-founder, and Scott Smith, President, will provide a corporate update and participate in one-on-one investor meetings at the Jefferies Global Healthcare Conference, to be held in-person in New York, NY June 8-10, 2022.

Jefferies Global Healthcare Conference

Format: In-person presentation (formal remarks with slides) and scheduled one-on-one investor meetings
Date: Wednesday, June 8, 2022
Time: 10:00 a.m. ET
Webcast: https://wsw.com/webcast/jeff240/bcab/1789800

Please contact your Jefferies sales representative to register for a meeting with the Company.

A webcast of the session will be available on the “Events and Presentations” section of the Company’s website at https://ir.bioatla.com. An archived replay of the webcast will be available on the Company’s website for 60 days following the event.

About BioAtla, Inc.

BioAtla is a global clinical-stage biotechnology company with operations in San Diego, California, and in Beijing, China through our contractual relationship with BioDuro-Sundia, a provider of preclinical development services. Utilizing its proprietary Conditionally Active Biologics (CAB) technology, BioAtla develops novel, reversibly active monoclonal antibody and other protein therapeutic product candidates. CAB product candidates are designed to have more selective targeting, greater efficacy with lower toxicity, and more cost-efficient and predictable manufacturing than traditional antibodies. BioAtla has extensive and worldwide patent coverage for its CAB technology and products with more than 500 patents, including over 250 of which are issued. Broad patent coverage in all major markets include methods of making, screening and manufacturing CAB product candidates in a wide range of formats and composition of matter coverage for specific products. BioAtla has two first-in-class CAB programs currently in Phase 2 clinical testing in the United States, mecbotamab vedotin, BA3011, a novel conditionally active AXL-targeted antibody-drug conjugate (CAB-AXL-ADC), and ozuriftamab vedotin, BA3021, a novel conditionally active ROR2-targeted antibody-drug conjugate (CAB-ROR2-ADC). In addition, the company is advancing a Phase 1/2 CAB-CTLA-4 antibody, BA3071, which is a novel CTLA-4 inhibitor designed to reduce systemic toxicity and potentially enable safer combination therapies with checkpoint inhibitors such as anti-PD-1 antibody. To learn more about BioAtla, Inc. visit www.bioatla.com.

Internal Contact:

Richard Waldron
Chief Financial Officer
BioAtla, Inc.
[email protected]
858.356.8945

External Contact:

Bruce Mackle
LifeSci Advisors, LLC
[email protected]

OLD GREENWICH, Conn., June 01, 2022 (GLOBE NEWSWIRE) — Star Equity Holdings, Inc. (Nasdaq: STRR; STRRP) (“Star Equity” or the “Company”), a diversified holding company, announced today that its management is scheduled to present at the LD Micro Invitational Conference to be held at the Four Seasons Westlake Village, California.

Star Equity’s main presentation is scheduled for Wednesday, June 8, 2022, at 7:30 am PT. Investors will be able to access the presentation live over the Internet via the weblink: https://ldinv12.mysequire.com/.

Additionally, management will be speaking with investors throughout the day. Investors interested in scheduling a one-on-one meeting with management can send an email to Investor Relations at [email protected].

Investors can also download a PDF copy of the presentation by visiting Star Equity’s Investor Relations section of the website: https://www.starequity.com/investor-relations.

About Star Equity Holdings, Inc.

Star Equity Holdings, Inc. is a diversified holding company with three divisions: Healthcare, Construction, and Investments.

Healthcare

Our Healthcare division designs, manufactures, and distributes diagnostic medical imaging products and provides mobile imaging services. Our Healthcare division operates in two businesses: (i) diagnostic services and (ii) diagnostic imaging. The diagnostic services business offers imaging services to healthcare providers as an outsourced alternative to purchasing and operating their own equipment. The diagnostic imaging business develops, sells, and maintains solid-state gamma cameras.

Construction

Our Construction division manufactures modular housing units for commercial and residential real estate projects and operates in two businesses: (i) modular building manufacturing and (ii) structural wall panel and wood foundation manufacturing, including building supply distribution operations for professional builders.

Investments

Our Investments division manages and finances the Company’s real estate assets and investments.

Forward-Looking Statements

“Safe Harbor” Statement under the Private Securities Litigation Reform Act of 1995: This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements in this release that are not statements of historical fact are hereby identified as “forward-looking statements” for the purpose of the safe harbor provided by Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking Statements include, without limitation, statements regarding (i) the plans and objectives of management for future operations, including plans or objectives relating to acquisitions and related integration, development of commercially viable products, novel technologies, and modern applicable services, (ii) projections of income (including income/loss), EBITDA, earnings (including earnings/loss) per share, free cash flow (FCF), capital expenditures, cost reductions, capital structure or other financial items, (iii) the future financial performance of the Company or acquisition targets and (iv) the assumptions underlying or relating to any statement described above. Moreover, forward-looking statements necessarily involve assumptions on the Company’s part. These forward-looking statements generally are identified by the words “believe”, “expect”, “anticipate”, “estimate”, “project”, “intend”, “plan”, “should”, “may”, “will”, “would”, “will be”, “will continue” or similar expressions. Such forward-looking statements are not meant to predict or guarantee actual results, performance, events, or circumstances and may not be realized because they are based upon the Company’s current projections, plans, objectives, beliefs, expectations, estimates and assumptions and are subject to a number of risks and uncertainties and other influences, many of which the Company has no control over. Actual results and the timing of certain events and circumstances may differ materially from those described above as a result of these risks and uncertainties. Factors that may influence or contribute to the inaccuracy of forward-looking statements or cause actual results to differ materially from expected or desired results may include, without limitation, the substantial amount of debt of the Company and the Company’s ability to repay or refinance it or incur additional debt in the future; the Company’s need for a significant amount of cash to service and repay the debt and to pay dividends on the Company’s preferred stock; the restrictions contained in the debt agreements that limit the discretion of management in operating the business; legal, regulatory, political and economic risks in markets and public health crises that reduce economic activity and cause restrictions on operations (including the recent coronavirus COVID-19 outbreak); the length of time associated with servicing customers; losses of significant contracts or failure to get potential contracts being discussed; disruptions in the relationship with third party vendors; accounts receivable turnover; insufficient cash flows and resulting lack of liquidity; the Company’s inability to expand the Company’s business; unfavorable changes in the extensive governmental legislation and regulations governing healthcare providers and the provision of healthcare services and the competitive impact of such changes (including unfavorable changes to reimbursement policies); high costs of regulatory compliance; the liability and compliance costs regarding environmental regulations; the underlying condition of the technology support industry; the lack of product diversification; development and introduction of new technologies and intense competition in the healthcare industry; existing or increased competition; risks to the price and volatility of the Company’s common stock and preferred stock; stock volatility and in liquidity; risks to preferred stockholders of not receiving dividends and risks to the Company’s ability to pursue growth opportunities if the Company continues to pay dividends according to the terms of the Company’s preferred stock; the Company’s ability to execute on its business strategy (including any cost reduction plans); the Company’s failure to realize expected benefits of restructuring and cost-cutting actions; the Company’s ability to preserve and monetize its net operating losses; risks associated with the Company’s possible pursuit of acquisitions; the Company’s ability to consummate successful acquisitions and execute related integration, as well as factors related to the Company’s business including economic and financial market conditions generally and economic conditions in the Company’s markets; failure to keep pace with evolving technologies and difficulties integrating technologies; system failures; losses of key management personnel and the inability to attract and retain highly qualified management and personnel in the future; and the continued demand for and market acceptance of the Company’s services. For a detailed discussion of cautionary statements and risks that may affect the Company’s future results of operations and financial results, please refer to the Company’s filings with the Securities and Exchange Commission, including, but not limited to, the risk factors in the Company’s most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. This release reflects management’s views as of the date presented.

All forward-looking statements are necessarily only estimates of future results, and there can be no assurance that actual results will not differ materially from expectations, and, therefore, you are cautioned not to place undue reliance on such statements. Further, any forward-looking statement speaks only as of the date on which it is made, and we undertake no obligation to update any forward-looking statement to reflect events or circumstances after the date on which the statement is made or to reflect the occurrence of unanticipated events.

For more information contact:
Star Equity Holdings, Inc.	The Equity Group
Jeffrey E. Eberwein	Lena Cati
Executive Chairman	Senior Vice President
203-489-9501	212-836-9611
[email protected]	[email protected]

LAKE SUCCESS, N.Y., June 01, 2022 (GLOBE NEWSWIRE) — The Hain Celestial Group, Inc. (Nasdaq: HAIN) (“Hain Celestial”, “Hain” or the “Company”), a leading organic and natural products company with operations in North America, Europe, Asia and the Middle East providing consumers with A Healthier Way of Life^®, today announced that the Company is participating in the following June conferences:

• June 8, 2022: Evercore ISI Consumer & Retail Virtual Conference: Hain is hosting a fireside chat discussion at 12:30 PM Eastern Time.
• June 20-22, 2022: Jefferies Consumer Conference in Nantucket: Hain is hosting a fireside chat discussion that will become available via webcast on June 20, 2022 at 8:00 AM Eastern Time.

The webcasts can be accessed on Hain Celestial’s website at www.hain.com under Investor Relations and the Press & Events section.

About The Hain Celestial Group, Inc.

The Hain Celestial Group, Inc. (Nasdaq: HAIN) is a leading organic and natural products company that has been committed to creating A Healthier Way of Life^® since 1993. Headquartered in Lake Success, NY with operations in North America, Europe, Asia and the Middle East, Hain Celestial’s food and beverage brands include Celestial Seasonings^®, Clarks™, Cully & Sully^®, Earth’s Best^®, Ella’s Kitchen^®, Frank Cooper’s^®, Garden of Eatin’^®, Hain Pure Foods^®, Hartley’s^®, Health Valley^®, Imagine^®, Joya^®, Lima^®, Linda McCartney’s^® (under license), MaraNatha^®, Natumi^®, New Covent Garden Soup Co.^®, ParmCrisps^®, Robertson’s^®, Rose’s^® (under license), Sensible Portions^®, Spectrum^®, Sun-Pat^®, Terra^®, The Greek Gods^®, Thinsters^®, Yorkshire Provender^® and Yves Veggie Cuisine^®. Hain Celestial’s personal care brands include Alba Botanica^®, Avalon Organics^®, JASON^®, Live Clean^® and Queen Helene^® brands.   For more information, visit hain.com.

Contacts:

Investor Relations:
Chris Mandeville and Anna Kate Heller
ICR
[email protected]

Media:
Robin Shallow
[email protected]

– 
Dr. Russell to report to Dr. Erin Quirk, President and Head of Research & Development

FOSTER CITY, Calif., June 01, 2022 (GLOBE NEWSWIRE) — Terns Pharmaceuticals, Inc. (“Terns” or the “Company”) (Nasdaq: TERN), a clinical-stage biopharmaceutical company developing a portfolio of small-molecule single-agent and combination therapy candidates to address serious diseases such as non-alcoholic steatohepatitis (NASH), obesity and cancer, today announced the appointment of Kerry Russell, M.D., Ph.D., as chief medical officer. Dr. Russell will report to Erin Quirk, M.D., who remains president and head of research and development.

“We are thrilled to welcome Kerry to the Terns team; her deep experience broadens our expertise and brings important insights as we progress our pipeline across multiple therapeutic areas,” said Dr. Quirk. “There are exciting times ahead at Terns, with key clinical trial data readouts expected for three of our programs, TERN-501, TERN-601 and TERN-701, across three indications over the next few years. I look forward to working closely with Kerry in advancing these multiple programs.”

Prior to joining Terns, Dr. Russell was vice president of late clinical development at Dicerna Pharmaceuticals, Inc. (acquired by Novo Nordisk A/S in December 2021), where she led the development of siRNA therapeutics for rare diseases from June 2020 until May 2022. Before that, she served as vice president of clinical development at resTORbio, Inc. She previously served as senior director of translational cardiovascular and metabolic medicine at Novartis Institute of Biomedical Research and was an NIH-funded associate professor at Yale University School of Medicine for more than 13 years. Dr. Russell received her Ph.D. in molecular oncology from The University of Texas MD Anderson Cancer Center and her M.D. from the University of Texas Health Science Center at Houston. She completed her internship and residency in internal medicine at Yale New Haven Hospital and both her fellowship in cardiovascular medicine and postdoctoral fellowship in vascular biology at Yale University School of Medicine. She received her B.S. in biochemistry and biology from Rice University.

“Terns is at an important stage of growth,” said Dr. Russell. “With the company’s renewed focus on dedicating resources to advance its most promising pipeline candidates and its multi-faceted, clinically validated approach to address NASH and other serious diseases like obesity and chronic myeloid leukemia, I believe Terns is making significant progress in its efforts to bring much needed, transformative medicines to patients. I look forward to working with the rest of the Terns team to reach this goal.”

About Terns Pharmaceuticals

Terns Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company developing a portfolio of small-molecule single-agent and combination therapy candidates to address serious diseases such as NASH, obesity and cancer. Terns’ pipeline includes four clinical stage development programs including a THR- β agonist, an FXR agonist, an allosteric BCR-ABL inhibitor, a VAP-1 inhibitor, and a preclinical small-molecule GLP-1 receptor agonist program. For more information, please visit: www.ternspharma.com.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements about Terns Pharmaceuticals, Inc. (the “Company,” “we,” “us,” or “our”) within the meaning of the federal securities laws, including those related to the Company’s expectations of timing and potential results of the Company’s clinical trials and other development activities, such as the Phase 2a combination trial of TERN-501 and TERN-101, the Phase 1 clinical program for TERN-601, and the Phase 1 clinical trial for TERN-701; the potential indications to be targeted by the Company with its single-agent and combination therapy candidates; the therapeutic potential of the Company’s single-agent and combination therapy candidates; the potential for the mechanisms of action of the Company’s product candidates to be therapeutic targets for their targeted indications; the potential utility and progress of the Company’s product candidates in their targeted indications, including the clinical utility of the data from and the endpoints used in the Company’s clinical trials; the Company’s clinical development plans and activities; the Company’s expectations regarding the profile of its product candidates, including tolerability, safety, metabolic stability and pharmacokinetic profile and potential differentiation as compared to other products or product candidates; the Company’s plans for and ability to continue to execute on its current clinical strategy; and the Company’s expectations with regard to its cash runway. All statements other than statements of historical facts contained in this press release, including statements regarding the Company’s strategy, future financial condition, future operations, future trial results, projected costs, prospects, plans, objectives of management and expected market growth, are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “design,” “due,” “estimate,” “expect,” “goal,” “intend,” “may,” “objective,” “plan,” “positioned,” “potential,” “predict,” “seek,” “should,” “target,” “will,” “would” and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology. The Company has based these forward-looking statements largely on its current expectations, estimates, forecasts and projections about future events and financial trends that it believes may affect its financial condition, results of operations, business strategy and financial needs. In light of the significant uncertainties in these forward-looking statements, you should not rely upon forward-looking statements as predictions of future events. These statements are subject to risks and uncertainties that could cause the actual results and the implementation of the Company’s plans to vary materially, including the risks associated with the initiation, cost, timing, progress, results and utility of the Company’s current and future research and development activities and preclinical studies and clinical trials. In particular, the impact of the COVID-19 pandemic on the Company’s ability to progress with its research, development, manufacturing and regulatory efforts, including the Company’s clinical trials for its product candidates, will depend on future developments that are highly uncertain and cannot be predicted with confidence at this time, such as the ultimate duration of the pandemic, travel restrictions, quarantines, social distancing and business closure requirements in the United States and in other countries, and the effectiveness of actions taken globally to contain and treat the disease. These risks are not exhaustive. For a detailed discussion of the risk factors that could affect the Company’s actual results, please refer to the risk factors identified in the Company’s SEC reports, including but not limited to its Annual Report on Form 10-K for the year ended December 31, 2021. Except as required by law, the Company undertakes no obligation to update publicly any forward-looking statements for any reason.

Contacts for Terns

Investors

Justin Ng
[email protected]

Media

Jenna Urban
Berry & Company Public Relations
[email protected]

SAN MATEO, Calif. and CAMBRIDGE, Mass., June 01, 2022 (GLOBE NEWSWIRE) — Kronos Bio, Inc. (Nasdaq: KRON), a company dedicated to transforming the lives of those affected by cancer and other serious diseases, today announced that President and Chief Executive Officer Norbert Bischofberger, Ph.D., will participate in fireside chats at the following investor conferences:

• Jefferies Healthcare Conference on Wednesday, June 8, 2022, at 4:30 p.m. ET in New York; and
• Goldman Sachs 43rd Annual Global Healthcare Conference on Wednesday, June 15, 2022, at 3:20 p.m. PT in Rancho Palos Verdes, California.

Live webcasts of the fireside chats will be available on the Investors and Media section of the Kronos Bio website at www.kronosbio.com. A replay of the webcasts will be archived and available for 30 days following the event.

About Kronos Bio, Inc.
Kronos Bio is a clinical-stage biopharmaceutical company dedicated to discovering and developing therapies that seek to transform the lives of those affected by cancer and other serious diseases. The company focuses on targeting dysregulated transcription factors and the regulatory networks within cells that drive cancerous growth. Kronos Bio’s lead investigational therapy is entospletinib, a selective inhibitor targeting spleen tyrosine kinase (SYK) in development for the frontline treatment of NPM1-mutated acute myeloid leukemia (AML). The company is also developing KB-0742, an oral inhibitor of cyclin dependent kinase 9 (CDK9), for the treatment of MYC-amplified solid tumors.

Kronos Bio is based in San Mateo, Calif., and has a research facility in Cambridge, Mass. For more information, visit www.kronosbio.com or follow the company on LinkedIn.

Company Contact:
Marni Kottle
Kronos Bio
650-900-3450
[email protected]

Investors:

Claudia Styslinger
Argot Partners
212-600-1902
[email protected]

Media:

Sheryl Seapy
Real Chemistry
949-903-4750
[email protected]

SAN FRANCISCO and SAN DIEGO, June 01, 2022 (GLOBE NEWSWIRE) — Kinnate Biopharma Inc. (Nasdaq: KNTE) (“Kinnate”), a clinical-stage precision oncology company, today announced that the company will participate in two upcoming in-person investor conferences:

• Thursday, June 9 at 1:00 p.m. ET / 10:00 a.m. PT at the Jefferies Healthcare Conference. Neha Krishnamohan, chief financial officer and executive vice president, corporate strategy, will represent the company in a fireside chat at the conference.
• Wednesday, June 15 at 1:00 p.m. ET / 10:00 a.m. PT at the Goldman Sachs 43rd Annual Global Healthcare Conference. Nima Farzan, chief executive officer, will represent the company in a fireside chat at the conference.

Members of the Kinnate management team will also host investor meetings during the conferences.

Investors and the general public are invited to listen to a live webcast of the session through the “Investors and Media” section on Kinnate.com. A webcast replay will be made available following the event for 30 days.

About Kinnate Biopharma Inc.

Kinnate is focused on the discovery and development of small molecule kinase inhibitors for difficult-to-treat, genomically defined cancers. Kinnate’s mission is to expand the reach of targeted therapeutics by developing products that are designed to address significant unmet need. Kinnate utilizes its deep expertise in structure-based drug discovery, translational research, and patient-driven precision medicine, which it refers to as the Kinnate Discovery Engine, to develop targeted therapies. Based in San Francisco and San Diego, California, the Kinnate team is composed of drug discovery experts supported by a distinguished group of scientific advisors. For more information, visit Kinnate.com or follow us on LinkedIn.

Forward Looking Statements

This press release contains forward-looking statements that involve substantial risks and uncertainties. Words such as “believes,” “anticipates,” “plans,” “expects,” “intends,” “will,” “goal,” “potential” and similar expressions are also intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and trends. Such expectations and projections may never materialize or may prove to be incorrect. These forward-looking statements are subject to a number of risks, uncertainties, assumptions and other factors as described under the heading “Risk Factors” in our Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2022 that we have filed with the Securities and Exchange Commission (the “SEC”), as well as in our subsequent filings we make with the SEC. New risk factors emerge from time to time and it is not possible for our management to predict all risk factors, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in, or implied by, any forward-looking statements. Investors should not rely upon forward-looking statements as predictions of future events. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements. Our forward-looking statements speak only as of the date of this release, and except as required by law, we undertake no obligation to update publicly any forward-looking statements for any reason in the future.

Investor & Media Contact:

Priyanka Shah | [email protected] | +1-908-447-6134

BERKELEY, Calif., June 01, 2022 (GLOBE NEWSWIRE) — Caribou Biosciences, Inc. (Nasdaq: CRBU), a leading clinical-stage CRISPR genome-editing biopharmaceutical company, today announced that the company will host a webcast conference call to share additional initial clinical data from its ANTLER Phase 1 clinical trial of CB-010 in patients with relapsed or refractory B cell non-Hodgkin lymphoma (r/r B-NHL) on Friday, June 10, 2022, at 8:00 am ET. The discussion will include longer duration data on the six patients treated at dose level 1 based on a new data cutoff date.

Webcast presenters will include:

• Rachel Haurwitz, Ph.D., president and chief executive officer, Caribou
• Syed Rizvi, M.D., chief medical officer, Caribou
• Steven Kanner, Ph.D., chief scientific officer, Caribou
• Loretta J. Nastoupil, M.D., section chief of new drug development; associate professor, Department of Lymphoma/Myeloma, The University of Texas MD Anderson Cancer Center
• James H. Essell, M.D., OHC hematologist, medical oncologist, blood and marrow transplant specialist, and Chair, Cellular Therapy, US Oncology Network

The live webcast and conference call at 8:00 am ET, with an accompanying presentation, will be accessible under Events in the Investors section of the company’s website. To participate in the conference call, dial 1-844-862-9351 (domestic) or 1-929-517-0932 (international) and reference conference ID #4657536. The archived audio webcast will be available on Caribou’s website following the call and will be available for 30 days.

Details of the poster presentation at EHA are as follows:

Title: First-in-human trial of CB-010, a CRISPR-edited allogeneic anti-CD19 CAR-T cell therapy with a PD-1 knock out, in patients with relapsed or refractory B cell non-Hodgkin lymphoma (ANTLER study)
Abstract: 3103
Presenter: Loretta J. Nastoupil, M.D.
Date and Time: Friday, June 10, 2022, 16:30 – 17:45 CEST (10:30 – 11:45 am ET)
Session Title: Gene therapy, cellular immunotherapy and vaccination – Clinical
Location: Messe Wien Exhibition & Congress Center, Vienna, Austria

Presentations and posters will be available for registered attendees of EHA for on-demand viewing on the EHA website on June 10, 2022 at 9:00 am CEST (3:00 am ET). Caribou plans to issue a data press release at 9:00 am CEST (3:00 am ET) on Friday June 10, 2022. The poster will be available on the Presentations page of the Investors section of Caribou’s website.

About CB-010

CB-010 is the lead product candidate from Caribou’s allogeneic CAR-T cell therapy platform and is being evaluated in patients with relapsed or refractory B cell non-Hodgkin lymphoma (r/r B-NHL) in the ongoing ANTLER Phase 1 trial. CB-010 is an allogeneic anti-CD19 CAR-T cell therapy engineered using Cas9 CRISPR hybrid RNA-DNA (chRDNA) technology to insert a CD19-specific CAR into the TRAC gene and knock out PD-1 to boost the persistence of antitumor activity. CB-010 is the first allogeneic CAR-T cell therapy in the clinic with a PD-1 knock out. Additional information on the ANTLER trial can be found at https://clinicaltrials.gov using identifier NCT04637763.

About Caribou’s Novel Next-Generation CRISPR Platform 
CRISPR genome editing uses easily designed, modular biological tools to make DNA changes in living cells. There are two basic components of Class 2 CRISPR systems: the nuclease protein that cuts DNA and the RNA molecule(s) that guide the nuclease to generate a site-specific, double-stranded break, leading to an edit at the targeted genomic site. CRISPR systems are capable of editing unintended genomic sites, known as off-target editing, which may lead to harmful effects on cellular function and phenotype. In response to this challenge, Caribou has developed CRISPR hybrid RNA-DNA guides (chRDNAs; pronounced “chardonnays”) that direct substantially more precise genome editing compared to all-RNA guides. Caribou is deploying the power of its Cas12a chRDNA technology to carry out high efficiency multiple edits, including multiplex gene insertions, to develop CRISPR-edited therapies. 

About Caribou Biosciences, Inc.

Caribou Biosciences is a clinical-stage CRISPR genome-editing biopharmaceutical company dedicated to developing transformative therapies for patients with devastating diseases. The company’s genome-editing platform, including its proprietary Cas12a chRDNA technology, enables superior precision to develop cell therapies that are specifically engineered for enhanced persistence. Caribou is advancing a pipeline of off-the-shelf CAR-T and CAR-NK cell therapies for the treatment of patients with hematologic malignancies and solid tumors.

Follow us @CaribouBio and visit www.cariboubio.com.

“Caribou Biosciences” and the Caribou logo are registered trademarks of Caribou Biosciences, Inc.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, without limitation, statements related to Caribou’s strategy, plans, and objectives, and expectations regarding its clinical and preclinical development programs, including its expectations relating to the timing of the release of initial and additional patient data from its ANTLER phase 1 clinical trial for CB-010. Management believes that these forward-looking statements are reasonable as and when made. However, such forward-looking statements are subject to risks and uncertainties, and actual results may differ materially from any future results expressed or implied by the forward-looking statements. Risks and uncertainties include, without limitation, risks inherent in development of cell therapy products; uncertainties related to the initiation, cost, timing, progress, and results of Caribou’s current and future research and development programs, preclinical studies, and clinical trials; and the risk that initial or interim clinical trial data will not ultimately be predictive of the safety and efficacy of Caribou’s product candidates or that clinical outcomes may differ as more patient data becomes available; as well as other risk factors described from time to time in Caribou’s filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K for the year ended December 31, 2021, and subsequent filings. In light of the significant uncertainties in these forward-looking statements, you should not rely upon forward-looking statements as predictions of future events. Except as required by law, Caribou undertakes no obligation to update publicly any forward-looking statements for any reason.

Caribou Biosciences, Inc.

Contacts:

Amy Figueroa, CFA

Investor Relations and Corporate Communications

[email protected]

Investors and Media:

Elizabeth Wolffe, Ph.D., and Sylvia Wheeler

Wheelhouse LSA

[email protected]

[email protected]

• Company expects to complete submission of the NDA using the 505(b)(2) pathway, as previously agreed upon with the FDA, in the second half of 2022
  

SANTA MONICA, Calif., June 01, 2022 (GLOBE NEWSWIRE) — Opiant Pharmaceuticals, Inc. (Opiant) (NASDAQ: OPNT) today announced the filing of the first module of its New Drug Application (NDA) for OPNT003, nasal nalmefene, for the treatment of opioid overdose. The module was submitted pursuant to a rolling submission, as agreed with the U.S. Food and Drug Administration (FDA) during a pre-NDA meeting. As communicated previously, the Company expects to complete the submission of the NDA using the 505(b)(2) pathway in the second half of 2022.

An estimated record 80,816 Americans died of an opioid overdose in 2021, a 17% increase over 2020 and a 62% increase from 2019, according to new data from the U.S. Centers for Disease Control and Prevention (CDC). Deaths involving synthetic opioids, including fentanyl, increased from 36,359 in 2019 and 56,516 in 2020, to an estimated 71,238 in 2021.^1,2 

“The opioid epidemic has evolved with the widening threat from potent synthetic opioids like fentanyl and there is significant evidence indicating that a new treatment option is needed,” said Roger Crystal, M.D., President and Chief Executive Officer of Opiant. “We believe the results from the pharmacokinetic (PK) and pharmacodynamic (PD) studies, in which OPNT003 demonstrated fast, strong, and long-lasting action and a well-tolerated safety profile, support OPNT003 as a potential new treatment option for opioid overdose. We look forward to working with the FDA to complete this rolling submission for OPNT003, nasal nalmefene, and we will provide an update when the NDA is completed.”

Opiant was granted Fast Track designation for OPNT003, nasal nalmefene, in November 2021. The rolling review process allows Opiant to submit completed sections of its NDA for review by FDA, rather than waiting until every section of the NDA is completed before the entire application can be reviewed.

This project has been funded in whole or in part with federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA), under contract number HHSO100201800029C; and the National Institute on Drug Abuse (NIDA).

About OPNT003, nasal nalmefene

OPNT003, nasal nalmefene, is a high-affinity mu-opioid receptor antagonist that reduces the binding of opioids to this receptor, limiting respiratory depression, the primary cause of overdose injury and death. In a head-to-head pharmacodynamic study, OPNT003 produced a reversal of remifentanil-induced respiratory depression that was nearly twice that produced by NARCAN^® Nasal Spray at the primary endpoint of five minutes. The intrinsic properties of nalmefene, taken together with results from Opiant pharmacokinetic and pharmacodynamic studies, are consistent with the potential of OPNT003 to provide fast, strong, and sustained reversal of opioid overdose.

About Opiant Pharmaceuticals, Inc. 

Opiant Pharmaceuticals, Inc., the company that developed NARCAN^® Nasal Spray, is building a leading franchise of new medicines to combat addictions and drug overdose. For more information visit: www.opiant.com.

Forward-Looking Statements


This press release contains forward-looking statements. These statements relate to future events or our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to be materially different from any future results, levels of activity, performance or achievements expressed, implied or inferred by these forward-looking statements, and among other things, completion of the NDA filing in the second half of 2022. In some cases, you can identify forward-looking statements by terminology such as “may,” “will,” “should,” “could,” “would,” “expects,” “plans,” “intends,” “anticipates,” “believes,” “estimates,” “predicts,” “projects,” “potential,” or “continue” or the negative of such terms and other comparable terminology. These statements are only predictions based on our current expectations and projections about future events. You should not place undue reliance on these statements. Actual events or results may differ materially. In evaluating these statements, you should specifically consider various factors. Additional factors that could materially affect actual results can be found in our Form 10-K for the year ended December 31, 2021 and our Form 10-Q for the quarter ended March 31,2022, filed with the Securities and Exchange Commission on March 4, 2022 and May 10, 2022, respectively, including under the caption titled “Risk Factors.”  These and other factors may cause our actual results to differ materially from any forward-looking statement. We undertake no obligation to update any of the forward-looking statements after the date of this press release to conform those statements to reflect the occurrence of unanticipated events, except as required by applicable law.

For Media and Investor Inquiries:
Ben Atkins, Opiant
(310) 598-5410
[email protected]

1. Ahmad FB, Rossen LM, Sutton P. Provisional drug overdose death counts. National Center for Health Statistics. 2022.
2. Hedegaard H, Miniño AM, Spencer MR, Warner M. Drug overdose deaths in the United States, 1999–2020. NCHS Data Brief, no 428. Hyattsville, MD: National Center for Health Statistics. 2021.