Market Newsdesk

BROOMFIELD, Colo., July 27, 2023 (GLOBE NEWSWIRE) — DMC Global Inc. (Nasdaq: BOOM) will announce its 2023 second quarter financial results after the stock market closes on Tuesday, August 8, 2023. Following the earnings release, executive management will host a conference call and simultaneous webcast.

The conference call will begin at 5 p.m. Eastern (3 p.m. Mountain) and will be accessible by dialing
800-245-3047 (or +1 203-518-9765 for international callers) and entering the conference ID: DMCQ2.

Investors are invited to listen to the webcast live via the Internet at: https://event.choruscall.com/mediaframe/webcast.html?webcastid=WCM6TCSK

The webcast also will be available on the Investor page of DMC’s website, located at: ir.dmcglobal.com

A replay of the webcast will be available for 6 months. For additional information, please contact Geoff High at 303-604-3924.

About DMC Global Inc.

DMC Global is an owner and operator of innovative, asset-light manufacturing businesses that provide unique, highly engineered products and differentiated solutions. DMC’s businesses have established leadership positions in their respective markets and consist of: Arcadia, a leading supplier of architectural building products; DynaEnergetics, which serves the global energy industry; and NobelClad, which addresses the global industrial infrastructure and transportation sectors. DMC’s businesses are led by experienced, strategically focused management teams, which are supported with business resources and capital allocation expertise to advance their operating strategies and generate the greatest returns. Based in Broomfield, Colorado, DMC trades on Nasdaq under the symbol “BOOM.” For more information, visit: HTTP://WWW.DMCGLOBAL.COM.

CONTACT:

Geoff High
Vice President of Investor Relations
303-604-3924

• UPLIFT clinical trial did not meet its primary endpoint
• Company realigns focus and significantly reduces expenses to extend cash runway into 2026
• Conference call today at 8:00 a.m. ET
  

CAMBRIDGE, Mass., July 27, 2023 (GLOBE NEWSWIRE) — Mersana Therapeutics, Inc. (NASDAQ: MRSN), a clinical-stage biopharmaceutical company focused on discovering and developing a pipeline of antibody-drug conjugates (ADCs) targeting cancers in areas of high unmet medical need, today announced that the UPLIFT clinical trial of upifitamab rilsodotin (UpRi) did not meet its primary endpoint. UpRi is an ADC targeting the sodium-dependent phosphate transport protein NaPi2b and was developed utilizing the company’s Dolaflexin platform.

UPLIFT was a single-arm clinical trial that enrolled platinum-resistant ovarian cancer patients with one to four prior treatment regimens. The primary endpoint for UPLIFT was the investigator-assessed objective response rate (ORR) in the NaPi2b-positive population. NaPi2b-positive status was defined by a tumor proportion score (TPS) of ≥75%. Secondary endpoints for the trial included the investigator-assessed ORR among all patients in the trial, duration of response (DOR), and safety and tolerability. The trial also included an assessment of ORR and DOR by independent radiology review (IRR).

UPLIFT enrolled a total of 268 patients, 141 of whom were determined to be NaPi2b positive. The median prior lines of systemic therapy among all patients was three, with 31% of the population having received four prior lines of treatment. Additionally, 84% of patients received prior bevacizumab and 69% received prior PARP inhibitor treatment.

Top-line results from UPLIFT as of the May 31, 2023 data cutoff date are as follows:

NaPi2b-Positive Population (n=141)

	Investigator Assessment	IRR Assessment
ORR, n (%) [95% confidence interval]	22 (15.6%) [10.0%, 22.7%]	23 (16.3%) [10.6%, 23.5%]
Partial Response, n (%)	20 (14.2%)	16 (11.3%)
Complete Response, n (%)	2 (1.4%)	7 (5.0%)
Median DOR, months	7.4	Not Reached

Total Population (n=268)

	Investigator Assessment	IRR Assessment
ORR, n (%)	35 (13.1%)	35 (13.1%)
Partial Response, n (%)	32 (11.9%)	24 (9.0%)
Complete Response, n (%)	3 (1.1%)	11 (4.1%)
Median DOR, months	7.4	10.7

Safety and tolerability data in UPLIFT were generally consistent with prior disclosures. Following the completion of its analyses, the company plans to share detailed efficacy and safety data with the medical and scientific community in an appropriate forum.

“We are deeply disappointed that UPLIFT’s efficacy failed to replicate previous data from approximately 100 patients in the dose expansion portion of our Phase 1b clinical trial,” said Dr. Arvin Yang, Senior Vice President and Chief Medical Officer of Mersana Therapeutics. “While the duration of response was longer than that from the dose expansion portion of UpRi’s Phase 1b clinical trial, the lower bound of the confidence interval for the primary endpoint did not meet our goal of excluding a 12% ORR seen with standard-of-care single-agent chemotherapy. We are in the process of conducting an in-depth analysis of various factors to better understand the results as well as the characteristics of patients who responded to UpRi therapy, particularly those whose responses were deep and durable. We extend our deepest gratitude to all of the patients, family members, caregivers and investigators who contributed to UPLIFT.”

Strategic Reprioritization and Financial Update

“As an organization driven by a mission to discover and develop potentially life-changing ADCs for patients fighting cancer, UPLIFT’s outcome is clearly disappointing and requires us to reprioritize our areas of focus,” said Anna Protopapas, President and Chief Executive Officer of Mersana Therapeutics. “In recent years, Mersana has advanced new product candidates and developed new partnerships utilizing its next-generation ADC platforms, Dolasynthen and Immunosynthen. These will be our primary focus moving forward. We plan to complete the dose escalation portion of our Phase 1 clinical trial of XMT-1660 in 2023 and initiate the dose expansion portion of the trial in 2024. Our team continues working diligently to address the clinical hold on the Phase 1 clinical trial of XMT-2056. Additionally, we intend to strongly support Mersana’s collaborators as they leverage our next-generation ADC platforms and advance their product candidates.”

“We also are taking decisive action to extend our cash runway and ensure we have the resources to evaluate the clinical potential of our next-generation ADC product candidates,” Ms. Protopapas continued. “Unfortunately, this necessitates reducing our workforce by approximately 50%. A very talented group of employees who helped to build Mersana will be departing as a result of this strategic reprioritization. We are grateful for their many contributions and intend to provide strong support through their transition.”

Mersana’s restructuring plan includes a wind-down of UpRi-related development activities, including its UP-NEXT and UPGRADE-A clinical trials and the company’s regulatory and commercial readiness efforts. If analyses of data enable the identification of a path forward for UpRi, the company will consider strategic alternatives for the asset, including partnering.

Mersana estimates that its balance of cash, cash equivalents and marketable securities as of June 30, 2023 was $286.6 million. This figure is preliminary and is subject to completion of the company’s financial closing procedures. The company expects to report its cash, cash equivalents and marketable securities, as well as other information necessary for a complete understanding of its financial position, in its Quarterly Report on Form 10-Q for the quarter ended June 30, 2023. The company expects that its available funds will be sufficient to support its current operating plan commitments into 2026.

Conference Call Notice


Mersana will host a conference call today at 8:00 a.m. ET. To access the call, please dial (877) 270-2148 (domestic) or (412) 902-6510 (international). A live webcast of the presentation will be available on the Investors & Media section of the Mersana website at www.mersana.com, and a replay of the webcast will be available in the same location following the conference call for approximately 90 days.

About Mersana Therapeutics

Mersana Therapeutics is a clinical-stage biopharmaceutical company focused on the development of novel antibody-drug conjugates (ADCs) and driven by the knowledge that patients are waiting for new treatment options. The company has developed proprietary cytotoxic (Dolasynthen) and immunostimulatory (Immunosynthen) ADC platforms that are generating a pipeline of wholly-owned and partnered product candidates with the potential to treat a range of cancers. Its pipeline includes XMT-1660, a Dolasynthen ADC targeting B7-H4, and XMT-2056, an Immunosynthen ADC targeting a novel epitope of human epidermal growth factor receptor 2 (HER2). Mersana routinely posts information that may be useful to investors on the “Investors & Media” section of its website at www.mersana.com.

Forward-Looking Statements


This press release contains “forward-looking” statements and information within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “aims,” “anticipates,” “believes,” “could,” “estimates,” “expects,” “forecasts,” “goal,” “intends,” “may,” “plans,” “possible,” “potential,” “seeks,” “will” and variations of these words or similar expressions, although not all forward-looking statements contain these words. Forward-looking statements in this press release include, but are not limited to, statements concerning Mersana’s further data analysis related to its clinical evaluation of UpRi and the presentation of UPLIFT trial data; its strategic priorities; its restructuring plans, including with respect to discontinuing clinical development of UpRi and related efforts and reducing its workforce; any potential path forward for UpRi and consideration of potential strategic alternatives for this asset; plans regarding the clinical development of XTM-1660; Mersana’s efforts to address the clinical hold on XMT-2056; Mersana’s cash runway; Mersana’s financial closing procedures and its expectations to report additional financial information for the period ended June 30, 2023; and the development and potential of Mersana’s product candidates, platforms, technology and pipeline of ADC candidates. Mersana may not actually achieve the plans, intentions or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various factors, including, among other things, uncertainties inherent in research and development, in the advancement, progression and completion of clinical trials and in the clinical development of Mersana’s product candidates, including XMT-1660 and XMT-2056; the risks that Mersana may be unable to resolve the clinical hold with respect to its Phase 1 clinical trial of XMT-2056 and may not be able to resume that trial or to develop or commercialize XMT-2056; the occurrence of impediments to Mersana’s ability to execute its planned restructuring and strategic reprioritization as currently contemplated; the risk that restructuring costs and charges may be greater than anticipated; the risk that Mersana’s restructuring efforts may adversely affect its ability to retain skilled and motivated personnel and may be distracting to employees and management; the risk that Mersana’s restructuring efforts may negatively impact its business operations and reputation; the risk that Mersana’s restructuring efforts may not generate their intended benefits to the extent or as quickly as anticipated; the risk that Mersana may not realize the intended benefits of its platforms, technology and collaborations; and other important factors, any of which could cause Mersana’s actual results to differ from those contained in the forward-looking statements, that are described in greater detail in the section entitled “Risk Factors” in Mersana’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (“SEC”) on May 9, 2023, as well as in other filings Mersana may make with the SEC in the future. Any forward-looking statements contained in this press release speak only as of the date hereof, and Mersana expressly disclaims any obligation to update any forward-looking statements contained herein, whether because of any new information, future events, changed circumstances or otherwise, except as otherwise required by law.

Contact:

Jason Fredette
617-498-0020
[email protected]

— Number of subjects increased from 12 to 60 —

— Portable Neuromodulation Stimulator (PoNS®) will be used to evaluate cranial-nerve non-invasive neuromodulation and dynamic gait/balance in stroke patients —

NEWTOWN, Pa., July 27, 2023 (GLOBE NEWSWIRE) — Helius Medical Technologies, Inc. (Nasdaq:HSDT) (“Helius” or the “Company”), a neurotech company focused on delivering a novel therapeutic neuromodulation approach for balance and gait deficits, today announced the expansion of the previously announced trial in stroke from 12 to 60 patients. This ongoing investigator-initiated study, led by Dr. Steven Kautz at the Medical University of South Carolina (“MUSC”), will evaluate the effects of cranial-nerve non-invasive neuromodulation (“CN-NINM”), delivered using PoNS Therapy™, on gait and dynamic balance in chronic stroke survivors.

“PoNS is already authorized for stroke in Canada, and patients using PoNS Therapy to treat symptoms have seen significant improvement in gait and a reduced risk of falling. Based on this meaningful data, Helius has welcomed the opportunity to support Dr. Kautz’s stroke study by expanding the sample size from twelve to sixty patients,” said Antonella Favit-Van Pelt, M.D., Ph.D., Helius’ Chief Medical Officer. “This is a significant step toward our efforts to leverage the breakthrough designation granted in August 2021 and pursue approval for stroke in the U.S. in the near future.”

“Improving dynamic balance is critical for reducing stroke-related morbidity, and analysis of real-world evidence from Canada has given us great confidence to open the study to more patients. We are excited to begin enrolling patients next month,” stated Steven Kautz, Ph.D., Chair, Department of Health Sciences and Research, College of Health Professions, MUSC.

The study will be a placebo-controlled experimental design in which stroke survivors will undergo a total of twelve weeks of a gait and balance physical therapy training program, performed both in clinic (four weeks) supervised by a physical therapist trained on PoNS therapy and at home (eight weeks) unsupervised with an individualized gait and balance training regimen. MUSC anticipates enrollment of the sixty participants will begin in August 2023, with expected completion by the end of 2024.

About MUSC 

Founded in 1824 in Charleston, South Carolina, MUSC is the state’s only comprehensive academic health system, with a unique mission to preserve and optimize human life in South Carolina through education, research and patient care. Each year, MUSC educates more than 3,200 students in six colleges – Dental Medicine, Graduate Studies, Health Professions, Medicine, Nursing and Pharmacy – and trains more than 900 residents and fellows in its health system. MUSC brought in more than $298 million in research funds in fiscal year 2022, leading the state overall in research funding. MUSC also leads the state in federal and National Institutes of Health funding with more than $220 million. For information on academic programs, visit musc.edu.

As the health care system of the Medical University of South Carolina, MUSC Health is dedicated to delivering the highest-quality and safest patient care while educating and training generations of outstanding health care providers and leaders to serve the people of South Carolina and beyond. Patient care is provided at 16 hospitals (includes owned and affiliated), with approximately 2,700 beds and four additional hospital locations in development; more than 350 telehealth sites and connectivity to patients’ homes; and nearly 750 care locations situated in all regions of South Carolina. In 2022, for the eighth consecutive year, U.S. News & World Report named MUSC Health University Medical Center in Charleston the No. 1 hospital in South Carolina. To learn more about clinical patient services, visit muschealth.org.

MUSC has a total enterprise annual operating budget of $5.1 billion. The nearly 26,000 MUSC family members include world-class faculty, physicians, specialty providers, scientists, students, affiliates and care team members who deliver groundbreaking education, research, and patient care.

About Helius Medical Technologies, Inc.

Helius Medical Technologies is a leading neurotech company in the medical device field focused on neurologic deficits using non-implantable platform technologies that amplify the brain’s ability to compensate and promotes neuroplasticity, aiming to improve the lives of people dealing with neurologic diseases. The Company’s first commercial product is the Portable Neuromodulation Stimulator (PoNS). For more information, visit www.heliusmedical.com.

About the PoNS Device and PoNS Therapy

The Portable Neuromodulation Stimulator (PoNS) is an innovative orally-applied, non-implantable medical device, inclusive of a controller and mouthpiece, which delivers electrical stimulation to the surface of the tongue to improve balance and gait. The PoNS device is indicated for use in the United States as a short-term treatment of gait deficit due to mild-to-moderate symptoms from multiple sclerosis (“MS”) and is to be used as an adjunct to a supervised therapeutic exercise program in patients 22 years of age and over by prescription only.

PoNS is also authorized for sale in Canada for three indications: (i) for use as a short-term treatment (14 weeks) of chronic balance deficit due to mild-to-moderate traumatic brain injury (“mmTBI”) and is to be used in conjunction with physical therapy; and (ii) for use as a short-term treatment (14 weeks) of gait deficit due to mild and moderate symptoms from MS and is to be used in conjunction with physical therapy; and (iii) for use as a short-term treatment (14 weeks) of gait deficit due to mild and moderate symptoms from stroke, to be used in conjunction with physical therapy. PoNS is also authorized for sale in Australia for short term use by healthcare professionals as an adjunct to a therapeutic exercise program to improve balance and gait. For more information visit www.ponstherapy.com.

Cautionary Disclaimer Statement

Certain statements in this news release are not based on historical facts and constitute forward-looking statements or forward-looking information within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and Canadian securities laws. All statements other than statements of historical fact included in this news release are forward-looking statements that involve risks and uncertainties. Forward-looking statements are often identified by terms such as “believe,” “expect,” “continue,” “will,” “goal,” “aim” and similar expressions. Such forward-looking statements include, among others, statements regarding the Company’s ability to obtain approval for stroke in the U.S., the uses and effectiveness of PoNS and PoNS Therapy, the stroke study led by Dr. Kautz and the Company’s strategic operating plans.

There can be no assurance that such statements will prove to be accurate and actual results and future events could differ materially from those expressed or implied by such statements. Important factors that could cause actual results to differ materially from the Company’s expectations include uncertainties associated with the Company’s capital requirements to achieve its business objectives, disruptions in the banking system and financial markets, lingering impacts of the COVID-19 pandemic, the effect of macroeconomic conditions and the Company’s ability to access capital markets, the Company’s ability to train physical therapists in the supervision of the use of the PoNS Treatment, the Company’s ability to secure contracts with rehabilitation clinics, the Company’s ability to obtain national Medicare coverage and to obtain a reimbursement code so that the PoNS device is covered by Medicare and Medicaid, the Company’s ability to build internal commercial infrastructure, secure state distribution licenses, build a commercial team and build relationships with Key Opinion Leaders, neurology experts and neurorehabilitation centers, market awareness of the PoNS device, availability of funds, manufacturing, labor shortage and supply chain risks, our ability to maintain and enforce our intellectual property rights, clinical trials and the clinical development process, the product development process, the regulatory submission review and approval process, our operating costs and use of cash, and our ability to achieve significant revenues, ongoing government regulation, and other risks detailed from time to time in the “Risk Factors” section of the Company’s Annual Report on Form 10-K for the year ended December 31, 2022, and its other filings with the United States Securities and Exchange Commission and the Canadian securities regulators, which can be obtained from either at www.sec.gov or www.sedar.com.

The reader is cautioned not to place undue reliance on any forward-looking statement. The forward-looking statements contained in this news release are made as of the date of this news release and the Company assumes no obligation to update any forward-looking statement or to update the reasons why actual results could differ from such statements except to the extent required by law.

Investor Relations Contact

Lisa M. Wilson, In-Site Communications, Inc.
T: 212-452-2793
E: [email protected]

55% objective response rate; 23% complete response rate in locally advanced cSCC

50% objective response rate; 13% complete response rate in metastatic cSCC

Cosibelimab continues to demonstrate a favorable safety profile

Biologics License Application currently under review by U.S. FDA; PDUFA goal date of January 3, 2024

WALTHAM, Mass., July 27, 2023 (GLOBE NEWSWIRE) — Checkpoint Therapeutics, Inc. (“Checkpoint”) (Nasdaq: CKPT), a clinical-stage immunotherapy and targeted oncology company, today announced new, longer-term data for cosibelimab from its pivotal studies in locally advanced and metastatic cutaneous squamous cell carcinoma (“cSCC”). These results demonstrate a deepening of response over time, resulting in substantially higher complete response rates than previously reported. Furthermore, responses continue to remain durable over time with the median duration of response not yet reached in either group. Results determined by independent central review by treatment group were as follows:

Parameter a	Locally Advanced cSCC (n=31)				Metastatic cSCC (n=78)
Data cutoff	Mar 2022		Jan 2023		Nov 2021		Jan 2023
Objective response rate (95% confidence interval)	55% (36%, 73%)		55% (36%, 73%)		47% (36%, 59%)		50% (39%, 62%)
Complete response rate	10	%	23	%	8	%	13	%
Partial response rate	45	%	32	%	39	%	37	%
Response ongoing	82	%	82	%	73	%	69	%
Median duration of response	Not reached		Not reached		Not reached		Not reached

^a As assessed by independent central review.

“We are excited to see the substantial increases in the rate of patients experiencing a complete response of their cSCC tumors with further cosibelimab treatment in both our locally advanced and metastatic pivotal trials,” said James Oliviero, President and Chief Executive Officer of Checkpoint. “We believe cosibelimab’s strong efficacy and response durability are driven by its unique two-fold mechanism of action in which cosibelimab binds to PD-L1 with sustained high target tumor occupancy to reactivate the body’s T-cell anti-tumor response, with the addition of a functional Fc domain to activate the body’s natural killer immune cells to induce antibody-dependent cell-mediated cytotoxicity of tumor cells, resulting in a powerful one-two punch to eradicate tumors. We expect this dual mechanism of action to benefit not just immunocompetent patients, but also the large number of difficult-to-treat patients with immunosuppressive conditions or taking immunosuppressive medications who continue to suffer poor outcomes with currently available treatments.”

Updated safety data across 247 patients enrolled and treated with cosibelimab in all cohorts of the ongoing study remain consistent with those previously reported, with only 2% of patients experiencing a severe immune-related adverse event (“irAE”) and less than 1% of patients discontinuing treatment due to an irAE of any severity, both substantially lower than the rates observed with currently approved immunotherapies.

Mr. Oliviero continued, “Unlike PD-1 inhibitors, cosibelimab does not interrupt the body’s PD-1/PD-L2 pathway, which we believe results in cosibelimab’s low rates of autoimmunity. We believe cosibelimab’s favorable safety profile should position the product as the preferred immunotherapy of oncologists for the large number of high-risk cSCC patients, such as those with solid organ transplants or autoimmune disease, upon its potential launch early next year. If our Biologics License Application (“BLA”) is approved in the coming months, based on its unique mechanism of action and compelling efficacy and safety profile, we believe cosibelimab, as a differentiated and possibly best-in-class treatment, has the potential to become the market leading immunotherapy for patients with cSCC, which we estimate to be a $1.6 billion annual U.S. market opportunity.”

In January 2023, Checkpoint submitted a BLA to the U.S. Food and Drug Administration (“FDA”) seeking approval of cosibelimab as a treatment for patients with metastatic cSCC or locally advanced cSCC who are not candidates for curative surgery or radiation. The application is filed and under review with a Prescription Drug User Fee Act (“PDUFA”) goal date of January 3, 2024.

Checkpoint plans to present these updated results at an upcoming medical conference.

About Checkpoint Therapeutics
Checkpoint Therapeutics, Inc. (“Checkpoint”) is a clinical-stage immunotherapy and targeted oncology company focused on the acquisition, development and commercialization of novel treatments for patients with solid tumor cancers. Checkpoint is evaluating its lead antibody product candidate, cosibelimab, a potential best-in-class anti-PD-L1 antibody licensed from the Dana-Farber Cancer Institute, in an ongoing open-label, multi-regional, multicohort Phase 1 clinical trial in checkpoint therapy-naïve patients with selected recurrent or metastatic cancers, including cohorts in metastatic and locally advanced cutaneous squamous cell carcinoma (“cSCC”) intended to support one or more applications for marketing approval. Based on positive topline and interim results in metastatic and locally advanced cSCC, respectively, Checkpoint submitted a Biologics License Application (“BLA”) for these indications in January 2023, which application is filed and under review with a Prescription Drug User Fee Act (“PDUFA”) goal date of January 3, 2024. Checkpoint is evaluating its lead small-molecule, targeted anti-cancer agent, olafertinib (formerly CK-101), a third-generation epidermal growth factor receptor (“EGFR”) inhibitor, as a potential new treatment for patients with EGFR mutation-positive non-small cell lung cancer. Checkpoint is headquartered in Waltham, MA and was founded by Fortress Biotech, Inc. (Nasdaq: FBIO). For more information, visit www.checkpointtx.com.

Forward‐Looking Statements

This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, each as amended, that involve a number of risks and uncertainties. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements regarding the FDA review of the BLA for the approval of cosibelimab for the treatment of patients with metastatic or locally advanced cSCC who are not candidates for curative surgery or radiation and the commercial potential of cosibelimab if the BLA is approved, statements relating to the potential differentiation of cosibelimab, including a potentially favorable safety profile as compared to the currently available anti-PD-1 therapies, the two-fold mechanism of action of cosibelimab translating into potential enhanced efficacy, and our projections of publication and regulatory review timelines. Factors that could cause our actual results to differ materially include the following: the risk that topline and interim data remains subject to audit and verification procedures that may result in the final data being materially different from the topline or interim data we previously published; the risk that safety issues or trends will be observed in the clinical trial when the full safety dataset is available and analyzed; the risk that a positive primary endpoint does not translate to all, or any, secondary endpoints being met; risks that regulatory authorities will not accept an application for approval of cosibelimab based on data from the Phase 1 clinical trial; the risk that the clinical results from the Phase 1 clinical trial will not support regulatory approval of cosibelimab to treat cSCC or, if approved, that cosibelimab will not be commercially successful; risks related to our chemistry, manufacturing and controls and contract manufacturing relationships; risks related to our ability to obtain, perform under and maintain financing and strategic agreements and relationships; risks related to our need for substantial additional funds; other uncertainties inherent in research and development; our dependence on third-party suppliers; government regulation; patent and intellectual property matters; competition; unfavorable market or other economic conditions; and our ability to achieve the milestones we project, including the risk that the evolving and unpredictable Russia/Ukraine conflict and COVID-19 pandemic delay achievement of those milestones. Further discussion about these and other risks and uncertainties can be found in our Annual Report on Form 10-K, and in our other filings with the U.S. Securities and Exchange Commission. The information contained herein is intended to be reviewed in its totality, and any stipulations, conditions or provisos that apply to a given piece of information in one part of this press release should be read as applying mutatis mutandis to every other instance of such information appearing herein.

Any forward-looking statements set forth in this press release speak only as of the date of this press release. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law. This press release and prior releases are available at www.checkpointtx.com. The information found on our website is not incorporated by reference into this press release and is included for reference purposes only.

Company Contact:

Jaclyn Jaffe
Checkpoint Therapeutics, Inc.
(781) 652-4500
[email protected]

Investor Relations Contact:

Ashley R. Robinson
Managing Director, LifeSci Advisors, LLC
(617) 430-7577
[email protected]  

Media Relations Contact:

Katie Kennedy
Gregory FCA
610-731-1045
[email protected]

 

• Second quarter 2023 earnings per share of $0.95
  
• Inland marine experienced strong market conditions with a sequential increase in spot market prices and utilization in the low 90% range
• Steady oil and gas demand boosted distribution and services results sequentially despite continued supply chain constraints
• Strong cash flow from operations of $211 million with free cash flow of $113 million
• Kirby repurchased 474,775 shares at an average price of $72.49 for $34.4 million

HOUSTON, July 27, 2023 (GLOBE NEWSWIRE) — Kirby Corporation (“Kirby”) (NYSE: KEX) today announced net earnings attributable to Kirby for the second quarter ended June 30, 2023 of $57.4 million or $0.95 per share, compared with earnings of $28.5 million, or $0.47 per share for the 2022 second quarter. Consolidated revenues for the 2023 second quarter were $777.2 million compared with $698.0 million reported for the 2022 second quarter.

David Grzebinski, Kirby’s President and Chief Executive Officer, commented, “Both of our segments continued to perform well during the quarter and produced higher revenue and operating income sequentially and year-over-year. In marine transportation, pricing on spot and term contracts continued to benefit from strong demand and limited availability of barges. Favorable weather conditions and increased operating efficiency helped improve margins for both inland and coastal. Distribution and services delivered improved margins and business remains stable at a high level. Overall, we had solid results and we generated strong free cash flow which helped support an increase in our share repurchases to $34 million for the quarter.

“In inland marine transportation, our second quarter results reflected continued improvement in pricing together with better weather conditions and operating efficiencies. From a demand standpoint, customer activity was strong in the quarter with barge utilization rates running in the low 90% range. Spot market prices were up in the mid-single digits sequentially and in the mid to high 20% range year-over-year. Term contract prices also renewed up higher with low double digit increases versus a year ago. Overall, second quarter inland revenues increased 11% year-over-year and margins were in the high teens range.

“In coastal, market fundamentals continued to improve with our barge utilization levels running in the mid to high-90% range. During the quarter, we saw solid customer demand and limited availability of large capacity vessels which resulted in high-teens price increases year-over-year on term contract renewals and increases on new spot deals in the high 20% range. As mentioned on our first quarter call, our results this year are being impacted by planned shipyard maintenance on several large vessels. Overall, second quarter coastal revenues decreased slightly year-over-year but operating margins were positive in the low single digits.

“In distribution and services, demand remained steady across our markets with continued new orders combined with high levels of backlog. In manufacturing, revenues were up sequentially and year-over-year driven by healthy demand for our environmentally friendly pressure pumping equipment and power generation equipment for e-frac. In our commercial and industrial market, overall demand remained solid across our different businesses, with growth coming from the marine repair, power generation, and on-highway sectors.” Mr. Grzebinski concluded.

Segment Results – Marine Transportation

Marine transportation revenues for the 2023 second quarter were $427.0 million compared with $405.7 million for the 2022 second quarter. Operating income for the 2023 second quarter was $64.3 million compared with $30.8 million for the 2022 second quarter. Segment operating margin for the 2023 second quarter was 15.0% compared with 7.6% for the 2022 second quarter.

In the inland market, average 2023 second quarter barge utilization was in the low 90% range, roughly flat when compared to the 2022 second quarter. Operating conditions were favorable with limited navigation delays contributing to a 16% decrease in delay days year-on-year. During the quarter, average spot market rates increased in the mid-single digits sequentially and in the mid to-high 20% range compared to the 2022 second quarter. Term contracts that renewed in the second quarter increased in the low double digits on average compared to a year ago. Revenues increased 11% compared to the 2022 second quarter primarily due to increased pricing and volumes. The inland market represented 82% of segment revenues in the second quarter of 2023. Inland’s operating margin was in the high teens for the quarter and benefited from improved navigational conditions and operating efficiencies during the quarter.

In coastal, market conditions continued to improve during the quarter, with barge utilization in the mid to high-90% range. During the quarter, average spot market rates increased in the mid-single digits sequentially and in the high 20% range compared to the 2022 second quarter. Term contracts that renewed in the second quarter increased in the high teens on average compared to a year ago. Despite these improvements, revenues in the coastal market decreased modestly when compared to the 2022 second quarter primarily due to downtime associated with planned shipyard maintenance days. Coastal represented 18% of marine transportation segment revenues during the second quarter. Coastal operating margin was positive in the low single digits as improved pricing was partially offset by lost revenue and costs incurred as a result of planned shipyards.

Segment Results –
Distribution and Services

Distribution and services revenues for the 2023 second quarter were $350.3 million compared with $292.3 million for the 2022 second quarter. Operating income for the 2023 second quarter was $29.8 million compared with $16.7 million for the 2022 second quarter. Operating margin was 8.5% for the 2023 second quarter compared with 5.7% for the 2022 second quarter.

In the commercial and industrial market, revenues and operating income increased compared to the 2022 second quarter, primarily due to strong economic activity across the U.S. which resulted in higher business levels in marine repair and on-highway. Increased product sales in Thermo King also contributed favorably to year-on-year growth. Overall, commercial and industrial revenues represented approximately 52% of segment revenues. Commercial and industrial operating margins were in the high single digits.

In the oil and gas market, revenues and operating income improved compared to the 2022 second quarter due to higher oilfield activity which resulted in increased demand for new transmissions and parts in the distribution business. Although manufacturing was heavily impacted by supply chain delays, the business continued to experience increased year-over-year demand with incremental orders and deliveries of new environmentally-friendly pressure pumping equipment and power generation equipment for electric fracturing. Overall, oil and gas represented approximately 48% of segment revenues. Oil and gas operating margins were in the mid to-high single digits.

Cash Generation

For the 2023 second quarter, EBITDA was $140.3 million compared with $100.2 million for the 2022 second quarter. During the quarter, net cash provided by operating activities was $211.4 million, and capital expenditures were $98.0 million. During the quarter, the Company had net proceeds from asset sales totaling $12.5 million. Kirby also used $34.4 million to repurchase stock at an average price of $72.49. As of June 30, 2023, the Company had $36.6 million of cash and cash equivalents on the balance sheet and $515.9 million of liquidity available. Total debt was $998.4 million and the debt-to-capitalization ratio improved to 24.3%.

2023 Outlook

Commenting on the outlook for the remainder of 2023, Mr. Grzebinski said, “We exited the quarter with continued strength in our businesses. Pricing in the marine market continues to improve and demand is strong. In distribution and services, despite persistent supply chain constraints and delays, demand for our products and services continues to grow, and we continue to receive new orders in manufacturing. Overall, we expect our businesses to deliver improved financial results in the coming quarters. While all of this is encouraging, we are mindful of challenges related to a slowing global economy and additional economic headwinds due to higher interest rates. Also, labor constraints and inflationary pressures continue contributing to rising costs across our businesses, although some of this is starting to moderate. Even with these uncertainties, we remain very positive and expect to drive strong cash flow from operations.”

In inland marine, we anticipate continued gradual upward movement in pricing and margins in the second half of 2023 as steady demand and a limited availability of equipment is expected to keep the market tight. As a result, the Company expects further pricing improvements in the spot market, which currently represents approximately 45% of inland revenues. Term contracts are also expected to continue to reset higher to reflect improved market conditions and offset inflation. Overall, inland revenues are expected to grow by low double digits on a full year basis. Barring unexpected high cost inflation and rising fuel costs, the Company expects operating margins to continue improving as the year progresses and average in the high teens for the full year.

In coastal marine, revenues and operating margins are being impacted this year by an approximate doubling of planned shipyard maintenance days with ballast water treatment installations on certain vessels. Kirby expects modestly improved customer demand through the balance of the year with barge utilization in the low to mid-90% range. Rates are expected to continue gradually improving as the industry is getting very close to supply and demand balance across the fleet. For the full year, coastal revenues are expected to be flat compared to 2022. Coastal operating margins are expected to be near break-even to low single digits on a full year basis.

In distribution and services, favorable oilfield fundamentals and steady demand in commercial and industrial are expected to continue throughout 2023 and into 2024. In the oil and gas market, despite the near-term headwinds of lower commodity prices and flat to declining rig counts, we expect strong demand for manufacturing as well as for OEM products, parts, and services. Within manufacturing, the Company expects demand for environmentally friendly pressure pumping and e-frac power generation equipment to remain strong, with new orders and increased deliveries of new equipment during the year. Supply chain issues and long lead times are expected to persist in the near-term, contributing to some volatility as deliveries of new products shift between quarters and into 2024. In commercial and industrial, steady markets are expected to help drive full year revenue growth in the low double-digit percentage range, with increased activity in power generation, marine repair, and on-highway. Overall, the Company expects segment revenues to grow 10% to 20% on a full year basis with operating margins in the mid to high-single digits.

Kirby expects to generate net cash provided from operating activities of $500 million to $580 million in 2023. 2023 capital spending is expected to range between $300 to $380 million. Approximately $240 million is associated with marine maintenance capital and improvements to existing inland and coastal marine equipment, including ballast water treatment systems on some coastal vessels, and facility improvements. Up to approximately $140 million is associated with growth capital spending in both our businesses.

Conference Call

A conference call is scheduled for 7:30 a.m. Central Daylight Time today, Thursday, July 27, 2023, to discuss the 2023 second quarter performance as well as the outlook for 2023. To listen to the webcast, please visit the Investor Relations section of Kirby’s website at www.kirbycorp.com. For listeners who wish to participate in the question and answer session via telephone, please pre-register at Kirby Earnings Call Registration. All registrants will receive dial-in information and a PIN allowing them to access the live call. A slide presentation for this conference call will be posted on Kirby’s website approximately 15 minutes before the start of the webcast. A replay of the webcast will be available for a period of one year by visiting the News & Events page in the Investor Relations section of Kirby’s website.

GAAP to Non-GAAP Financial Measures

The financial and other information to be discussed in the conference call is available in this press release and in a Form 8-K filed with the Securities and Exchange Commission. This press release and the Form 8-K includes a non-GAAP financial measure, EBITDA, which Kirby defines as net earnings attributable to Kirby before interest expense, taxes on income, and depreciation and amortization. A reconciliation of EBITDA with GAAP net earnings attributable to Kirby is included in this press release. This press release also includes non-GAAP financial measures which exclude certain one-time items, including earnings before taxes on income (excluding one-time items), net earnings attributable to Kirby (excluding one-time items), and diluted earnings per share (excluding one-time items). A reconciliation of these measures with GAAP is included in this press release. Management believes the exclusion of certain one-time items from these financial measures enables it and investors to assess and understand operating performance, especially when comparing those results with previous and subsequent periods or forecasting performance for future periods, primarily because management views the excluded items to be outside of Kirby’s normal operating results. This press release additionally includes a non-GAAP financial measure, free cash flow, which Kirby defines as net cash provided by operating activities less capital expenditures. A reconciliation of free cash flow with GAAP is included in this press release. Kirby uses free cash flow to assess and forecast cash flow and to provide additional disclosures on the Company’s liquidity. Free cash flow does not imply the amount of residual cash flow available for discretionary expenditures as it excludes mandatory debt service requirements and other non-discretionary expenditures. This press release also includes marine transportation performance measures, consisting of ton miles, revenue per ton mile, towboats operated and delay days. Comparable marine transportation performance measures for the 2022 year and quarters are available in the Investor Relations section of Kirby’s website, www.kirbycorp.com, under Financials.

Forward-Looking Statements

Statements contained in this press release with respect to the future are forward-looking statements. These statements reflect management’s reasonable judgment with respect to future events. Forward-looking statements involve risks and uncertainties. Actual results could differ materially from those anticipated as a result of various factors, including adverse economic conditions, industry competition and other competitive factors, adverse weather conditions such as high water, low water, tropical storms, hurricanes, tsunamis, fog and ice, tornados, COVID-19 or other pandemics, marine accidents, lock delays, fuel costs, interest rates, construction of new equipment by competitors, government and environmental laws and regulations, and the timing, magnitude and number of acquisitions made by the Company. Forward-looking statements are based on currently available information and Kirby assumes no obligation to update any such statements. A list of additional risk factors can be found in Kirby’s annual report on Form 10-K for the year ended December 31, 2022.

About Kirby Corporation

Kirby Corporation, based in Houston, Texas, is the nation’s largest domestic tank barge operator transporting bulk liquid products throughout the Mississippi River System, on the Gulf Intracoastal Waterway, and coastwise along all three United States coasts. Kirby transports petrochemicals, black oil, refined petroleum products and agricultural chemicals by tank barge. In addition, Kirby participates in the transportation of dry-bulk commodities in United States coastwise trade. Through the distribution and services segment, Kirby provides after-market service and genuine replacement parts for engines, transmissions, reduction gears, electric motors, drives, and controls, specialized electrical distribution and control systems, energy storage battery systems, and related equipment used in oilfield services, marine, power generation, on-highway, and other industrial applications. Kirby also rents equipment including generators, industrial compressors, high capacity lift trucks, and refrigeration trailers for use in a variety of industrial markets. For the oil and gas market, Kirby manufactures and remanufactures oilfield service equipment, including pressure pumping units, and manufactures electric power generation equipment, specialized electrical distribution and control equipment, and high capacity energy storage/battery systems for oilfield customers.

CONDENSED CONSOLIDATED STATEMENTS OF EARNINGS

	Second Quarter								Six Months
	2023				2022				2023				2022
	(unaudited, $ in thousands, except per share amounts)
Revenues:
Marine transportation	$	426,962			$	405,655			$	839,457			$	761,191
Distribution and services		350,286				292,309				688,235				547,555
Total revenues		777,248				697,964				1,527,692				1,308,746
Costs and expenses:
Costs of sales and operating expenses		546,069				523,862				1,088,149				974,480
Selling, general and administrative		82,896				70,575				171,745				146,340
Taxes, other than on income		9,758				9,621				18,944				19,211
Depreciation and amortization		51,697				50,115				102,806				100,079
Gain on disposition of assets		(472	)			(2,745	)			(2,702	)			(7,594	)
Total costs and expenses		689,948				651,428				1,378,942				1,232,516
Operating income		87,300				46,536				148,750				76,230
Other income		1,264				3,740				7,707				8,048
Interest expense		(12,286	)			(10,640	)			(25,507	)			(20,843	)
Earnings before taxes on income		76,278				39,636				130,950				63,435
Provision for taxes on income		(18,960	)			(11,030	)			(33,011	)			(17,243	)
Net earnings		57,318				28,606				97,939				46,192
Net (earnings) loss attributable to noncontrolling interests		49				(149	)			126				(301	)
Net earnings attributable to Kirby	$	57,367			$	28,457			$	98,065			$	45,891
Net earnings per share attributable to Kirby common stockholders:
Basic	$	0.96			$	0.47			$	1.64			$	0.76
Diluted	$	0.95			$	0.47			$	1.63			$	0.76
Common stock outstanding (in thousands):
Basic		59,806				60,202				59,892				60,188
Diluted		60,085				60,467				60,179				60,465

CONDENSED CONSOLIDATED FINANCIAL INFORMATION

	Second Quarter								Six Months
	2023				2022				2023				2022
	(unaudited, $ in thousands)
EBITDA:(1)
Net earnings attributable to Kirby	$	57,367			$	28,457			$	98,065			$	45,891
Interest expense		12,286				10,640				25,507				20,843
Provision for taxes on income		18,960				11,030				33,011				17,243
Depreciation and amortization		51,697				50,115				102,806				100,079
	$	140,310			$	100,242			$	259,389			$	184,056
Capital expenditures	$	98,046			$	43,984			$	171,245			$	79,059
Acquisitions of businesses	$	—			$	—			$	—			$	3,900

	June 30, 2023				December 31, 2022
	(unaudited, $ in thousands)
Cash and cash equivalents	$	36,603			$	80,577
Long-term debt, including current portion	$	998,401			$	1,079,618
Total equity	$	3,112,809			$	3,045,168
Debt to capitalization ratio		24.3	%			26.2	%

MARINE TRANSPORTATION STATEMENTS OF EARNINGS

	Second Quarter								Six Months
	2023				2022				2023				2022
	(unaudited, $ in thousands)
Marine transportation revenues	$	426,962			$	405,655			$	839,457			$	761,191
Costs and expenses:
Costs of sales and operating expenses		275,618				294,343				557,641				548,702
Selling, general and administrative		33,605				28,294				68,592				60,630
Taxes, other than on income		7,962				7,990				15,269				15,810
Depreciation and amortization		45,526				44,211				90,668				88,297
Total costs and expenses		362,711				374,838				732,170				713,439
Operating income	$	64,251			$	30,817			$	107,287			$	47,752
Operating margin		15.0	%			7.6	%			12.8	%			6.3	%

DISTRIBUTION AND SERVICES STATEMENTS OF EARNINGS

	Second Quarter								Six Months
	2023				2022				2023				2022
	(unaudited, $ in thousands)
Distribution and services revenues	$	350,286			$	292,309			$	688,235			$	547,555
Costs and expenses:
Costs of sales and operating expenses		268,657				229,196				528,521				425,715
Selling, general and administrative		45,686				40,653				94,883				82,575
Taxes, other than on income		1,707				1,590				3,558				3,318
Depreciation and amortization		4,394				4,133				8,639				8,239
Total costs and expenses		320,444				275,572				635,601				519,847
Operating income	$	29,842			$	16,737			$	52,634			$	27,708
Operating margin		8.5	%			5.7	%			7.6	%			5.1	%

OTHER COSTS AND EXPENSES

	Second Quarter								Six Months
	2023				2022				2023				2022
	(unaudited, $ in thousands)
General corporate expenses	$	7,265			$	3,763			$	13,873			$	6,824
Gain on disposition of assets	$	(472	)		$	(2,745	)		$	(2,702	)		$	(7,594	)

ONE-TIME CHARGES

The 2023 and 2022 first six months GAAP results include certain one-time charges. The following is a reconciliation of GAAP earnings to non-GAAP earnings, excluding the one-time items, for earnings before tax (pre-tax), net earnings attributable to Kirby (after-tax), and diluted earnings per share (per share):

	Second Quarter 2023												First Six Months 2023
	Pre-Tax				After-Tax				Per Share				Pre-Tax				After-Tax				Per Share
	(unaudited, $ in millions except per share amounts)
GAAP earnings	$	76.3			$	57.4			$	0.95			$	131.0			$	98.1			$	1.63
Costs related to strategic review and shareholder engagement		—				—				—				3.0				2.4				0.04
IRS refund interest income		—				—				—				(2.7	)			(2.2	)			(0.04	)
Earnings, excluding one-time items(2)	$	76.3			$	57.4			$	0.95			$	131.3			$	98.3			$	1.63

	Second Quarter 2022												First Six Months 2022
	Pre-Tax				After-Tax				Per Share				Pre-Tax				After-Tax				Per Share
	(unaudited, $ in millions except per share amounts)
GAAP earnings	$	39.6			$	28.5			$	0.47			$	63.4			$	45.9			$	0.76
Severance expense		1.5				1.3				0.02				1.5				1.3				0.02
Earnings, excluding one-time items(2)	$	41.1			$	29.8			$	0.49			$	64.9			$	47.2			$	0.78

RECONCILIATION OF FREE CASH FLOW

The following is a reconciliation of GAAP net cash provided by operating activities to non-GAAP free cash flow⁽²⁾:

	Second Quarter								Six Months
	2023				2022 (3)				2023				2022 (3)
	(unaudited, $ in millions)
Net cash provided by operating activities	$	211.4			$	63.4			$	227.9			$	95.6
Less: Capital expenditures		(98.0	)			(44.0	)			(171.2	)			(79.1	)
Free cash flow(2)	$	113.4			$	19.4			$	56.7			$	16.5

MARINE TRANSPORTATION PERFORMANCE MEASUREMENTS

	Second Quarter								Six Months
	2023				2022				2023				2022
Inland Performance Measurements:
Ton Miles (in millions)(4)		3,500				3,536				6,940				6,704
Revenue/Ton Mile (cents/tm)(5)		10.1				9.0				9.9				8.9
Towboats operated (average)(6)		281				270				282				267
Delay Days(7)		2,317				2,762				6,442				5,899
Average cost per gallon of fuel consumed	$	2.87			$	3.98			$	3.09			$	3.27
Barges (active):
Inland tank barges										1,045				1,034
Coastal tank barges										29				30
Offshore dry-cargo barges										4				4
Barrel capacities (in millions):
Inland tank barges										23.3				23.0
Coastal tank barges										3.0				3.1

(1)		Kirby has historically evaluated its operating performance using numerous measures, one of which is EBITDA, a non-GAAP financial measure. Kirby defines EBITDA as net earnings attributable to Kirby before interest expense, taxes on income, and depreciation and amortization. EBITDA is presented because of its wide acceptance as a financial indicator. EBITDA is one of the performance measures used in calculating performance compensation pursuant to Kirby’s annual incentive plan. EBITDA is also used by rating agencies in determining Kirby’s credit rating and by analysts publishing research reports on Kirby, as well as by investors and investment bankers generally in valuing companies. EBITDA is not a calculation based on generally accepted accounting principles and should not be considered as an alternative to, but should only be considered in conjunction with, Kirby’s GAAP financial information.
(2)		Kirby uses certain non-GAAP financial measures to review performance excluding certain one-time items including: earnings before taxes on income, excluding one-time items; net earnings attributable to Kirby, excluding one-time items; and diluted earnings per share, excluding one-time items. Management believes the exclusion of certain one-time items from these financial measures enables it and investors to assess and understand operating performance, especially when comparing those results with previous and subsequent periods or forecasting performance for future periods, primarily because management views the excluded items to be outside of the company’s normal operating results. Kirby also uses free cash flow, which is defined as net cash provided by operating activities less capital expenditures, to assess and forecast cash flow and to provide additional disclosures on the Company’s liquidity. Free cash flow does not imply the amount of residual cash flow available for discretionary expenditures as it excludes mandatory debt service requirements and other non-discretionary expenditures. These non-GAAP financial measures are not calculations based on generally accepted accounting principles and should not be considered as an alternative to, but should only be considered in conjunction with Kirby’s GAAP financial information.
(3)		See Kirby’s annual report on Form 10-K for the year ended December 31, 2022 and its quarterly report on Form 10-Q for the quarter ended June 30, 2022 for amounts provided by (used in) investing and financing activities.
(4)		Ton miles indicate fleet productivity by measuring the distance (in miles) a loaded tank barge is moved. Example: A typical 30,000 barrel tank barge loaded with 3,300 tons of liquid cargo is moved 100 miles, thus generating 330,000 ton miles.
(5)		Inland marine transportation revenues divided by ton miles. Example: Second quarter 2023 inland marine transportation revenues of $351.8 million divided by 3,500 million inland marine transportation ton miles = 10.1 cents.
(6)		Towboats operated are the average number of owned and chartered towboats operated during the period.
(7)		Delay days measures the lost time incurred by a tow (towboat and one or more tank barges) during transit. The measure includes transit delays caused by weather, lock congestion and other navigational factors.

Contact: Kurt Niemietz
713-435-1077

DURHAM, N.C., July 27, 2023 (GLOBE NEWSWIRE) — Chimerix (NASDAQ:CMRX), a biopharmaceutical company whose mission is to develop medicines that meaningfully improve and extend the lives of patients facing deadly diseases, today announced that it will host a live conference call and audio webcast on Thursday, August 3, 2023 at 8:30 a.m. ET to report financial results for the second quarter ended June 30, 2023, and to provide a business overview.

To access the live conference call, please dial (646) 307-1963 (domestic) or (800) 715-9871 (international) at least five minutes prior to the start time, and refer to conference ID 8015897. A live audio webcast of the call will also be available on the Investors’ section of the Company’s website, www.chimerix.com. An archived webcast will be available on the Chimerix website approximately two hours after the event.

About Chimerix

Chimerix is a biopharmaceutical company with a mission to develop medicines that meaningfully improve and extend the lives of patients facing deadly diseases. The Company’s most advanced clinical-stage development program, ONC201, is in development for H3 K27M-mutant glioma.

CONTACTS:      

Michelle LaSpaluto
919 972-7115
[email protected]

Will O’Connor
Stern Investor Relations
212-362-1200
[email protected]

CAMBRIDGE, Mass., July 27, 2023 (GLOBE NEWSWIRE) — Voyager Therapeutics, Inc. (Nasdaq: VYGR) a biotechnology company dedicated to breaking through barriers in gene therapy and neurology, today announced it will report second quarter 2023 financial and operating results before the market opens on Thursday, August 3, 2023. Subsequently, the Company will host a conference call and webcast at 8:30 a.m. ET to review its financial and operating results.

To participate via telephone and join the call live, please register in advance here. Upon registration, telephone participants will receive a confirmation email detailing how to join the conference call, including the dial-in number and a unique passcode. A live webcast of the call will also be available on the Investors section of the Voyager website at ir.voyagertherapeutics.com, and a replay of the call will be available at the same link approximately two hours after its completion. The replay will be available for at least 30 days following the conclusion of the call.

About Voyager Therapeutics

Voyager Therapeutics (Nasdaq: VYGR) is a biotechnology company dedicated to breaking through barriers in gene therapy and neurology. The potential of both disciplines has been constrained by delivery challenges; Voyager is leveraging cutting-edge expertise in capsid discovery and deep neuropharmacology capabilities to address these constraints. Voyager’s TRACER AAV capsid discovery platform has generated novel capsids with high target delivery and blood-brain barrier penetration at low doses, potentially addressing the narrow therapeutic window associated with conventional gene therapy delivery vectors. This platform is fueling alliances with Pfizer Inc., Novartis Pharma AG, Neurocrine Biosciences, Inc. and Sangamo Therapeutics, Inc., as well as multiple programs in Voyager’s own pipeline. Voyager’s pipeline includes wholly-owned and collaborative preclinical programs in Alzheimer’s disease, amyotrophic lateral sclerosis (ALS), Parkinson’s disease, and other diseases of the central nervous system, with a focus on validated targets and biomarkers to enable a path to rapid potential proof-of-biology. For more information, visit www.voyagertherapeutics.com.

Voyager Therapeutics

^®

is a registered trademark, and TRACER™ is a trademark, of Voyager Therapeutics, Inc. 

Contacts

Investors


[email protected]

Media

Peg Rusconi
[email protected]

LEAMINGTON, Ontario, July 27, 2023 (GLOBE NEWSWIRE) — Tilray Brands, Inc. (“Tilray”) (Nasdaq: TLRY; TSX: TLRY), a leading global cannabis-lifestyle and consumer packaged goods company and Great North Distributors, Inc. (Great North), Canada’s leading national sales broker for legalized adult-use cannabis — today announced a renewed national brokerage agreement. Under the agreement, Great North will continue to be the exclusive representative for Tilray’s full portfolio of recreational cannabis products across the Canadian marketplace, with the exception of Quebec. Tilray’s market-leading cannabis portfolio includes Good Supply, RIFF, Solei, Canaca, The Batch, Chowie Wowie, and newly acquired Redecan, Original Stash, and Bake Sale.

Per the renewed 4-year agreement, Great North will invest significant, dedicated, incremental headcount to the Tilray division across all provinces and territories, upgrading key account resources, brand education for budtenders, and enhanced data capabilities to assist retailers in making the best possible decisions to maximize sales revenue.

“As the Canadian cannabis retail landscape continues to evolve, continuity in our distributor allows us to capture significant synergies and further optimize our national sales strategy. Our renewed agreement will further drive exceptional route-to-market efficiencies for our market-leading and growing cannabis portfolio which now includes HEXO brands,” said, Blair MacNeil, President, Tilray Canada. “Great North’s national Canadian network is best positioned to help us accelerate growth and capture even more market share across Canada. As we continue to build our brands, our longstanding relationship with Great North provides us with the flexibility to adjust to market conditions in real time.”

“Securing the trust of Tilray cements our cannabis sales leadership position in Canada,” said Doug Wieland, President, Great North Distributors. “Great North has executed in the Canadian cannabis market since day one and will continue to bring sales execution excellence to Tilray and now Hexo portfolio of brands. Additionally, we are investing resources to bring market-leading brand education and activation to our retail partners to support them in achieving their revenue and profit goals.”

Great North has an extensive reach across every province in Canada, including established relationships and expertise working with provincially owned and operated retailers and private retailers in Canada’s cannabis industry. Great North applies industry-leading data analytics capabilities to the sector, providing suppliers with a powerful data-driven approach to cannabis sales.

About Tilray Brands

Tilray Brands, Inc. (Nasdaq: TLRY; TSX: TLRY), is a leading global cannabis lifestyle and consumer packaged goods company with operations in Canada, the United States, Europe, Australia, and Latin America that is changing people’s lives for the better – one person at a time – by inspiring and empowering a worldwide community to live their very best life, enhanced by moments of connection and wellbeing. Tilray’s mission is to be the most responsible, trusted, and market-leading cannabis and consumer products company in the world with a portfolio of innovative, high-quality, and beloved brands that address the needs of the consumers, customers, and patients we serve. A pioneer in cannabis research, cultivation, and distribution, Tilray’s unprecedented production platform supports over 20 brands in over 20 countries, including comprehensive cannabis offerings, hemp-based foods, and craft beverages.

For more information on Tilray Brands, visit www.Tilray.com and follow @tilray on all social platforms.

About Great North Distributors

Great North Distributors, Inc., established as a joint venture by the owners of Southern Glazer’s Wine & Spirits, is Canada’s first national sales broker for legalized adult-use cannabis. Great North Distributors has reach across every province in Canada, including established relationships and expertise working with provincially owned and operated retailers and private retailers alike. Great North applies industry-leading data analytics capabilities from the wine and spirits industry to the new cannabis industry, providing suppliers with a powerful data-driven approach to cannabis sales. For more information visit Great North Distributors.

Forward-Looking Statements

Certain statements in this communication that are not historical facts constitute forward-looking information or forward-looking statements (together, “forward-looking statements”) under Canadian securities laws and 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, that are intended to be subject to the “safe harbor” created by those sections and other applicable laws. Forward-looking statements can be identified by words such as “forecast,” “future,” “should,” “could,” “enable,” “potential,” “contemplate,” “believe,” “anticipate,” “estimate,” “plan,” “expect,” “intend,” “may,” “project,” “will,” “would” and the negative of these terms or similar expressions, although not all forward-looking statements contain these identifying words. Certain material factors, estimates, goals, projections, or assumptions were used in drawing the conclusions contained in the forward-looking statements throughout this communication. Forward-looking statements include statements regarding our intentions, beliefs, projections, outlook, analyses, or current expectations concerning, among other things, the Company’s ability to commercialize new and innovative products worldwide. Many factors could cause actual results, performance, or achievement to be materially different from any forward-looking statements, and other risks and uncertainties not presently known to the Company or that the Company deems immaterial could also cause actual results or events to differ materially from those expressed in the forward-looking statements contained herein. For a more detailed discussion of these risks and other factors, see the most recently filed annual information form of Tilray and the Annual Report on Form 10-K (and other periodic reports filed with the SEC) of Tilray made with the SEC and available on EDGAR. The forward-looking statements included in this communication are made as of the date of this communication and the Company does not undertake any obligation to publicly update such forward-looking statements to reflect new information, subsequent events, or otherwise unless required by applicable securities laws.

For further information:

Media: Berrin Noorata, [email protected]
Investors: Raphael Gross, (203) 682-8253, [email protected]