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Catalent Delays Third Quarter Results and Conference Call and Provides Update on Fiscal 2023 Guidance

Catalent Delays Third Quarter Results and Conference Call and Provides Update on Fiscal 2023 Guidance

SOMERSET, N.J.–(BUSINESS WIRE)–
Catalent, Inc. (NYSE: CTLT), the leader in enabling the development and supply of better treatments for patients worldwide, today announced that it will be delaying the release of its third fiscal quarter results and investor conference call, previously scheduled for Tuesday, May 9, 2023. The Company currently anticipates filing a Form 12b-25, Notification of Late Filing, with the Securities and Exchange Commission no later than May 11, 2023. The Company now expects to file its Quarterly Report on Form 10-Q on May 15, 2023, prior to the expiration of the extension period provided by Rule 12b-25 under the Securities Exchange Act of 1934.

On April 14, 2023, the Company issued a press release providing a business update, which stated that the Company expected that productivity issues and higher-than-expected costs experienced at three of its facilities, including two of its largest manufacturing facilities, will materially and adversely impact the Company’s financial results for the third fiscal quarter and its outlook for the remainder of the 2023 fiscal year. In addition to these operational challenges, the Company has also since identified significant issues with its forecasts over the past year, which are currently being addressed.

Last week, in the course of finalizing its financial statements for the third fiscal quarter ended March 31, 2023, the Company identified certain potential non-cash adjustments related to its operations in Bloomington, Indiana, and will need more time to review this matter prior to filing its Quarterly Report on Form 10-Q on May 15, 2023.

When combining the operational and productivity issues, the prior forecasting challenges, and, less significantly, the potential non-cash adjustments, the Company expects to significantly reduce both its fiscal 2023 net revenue and Adjusted EBITDA guidance by more than $400 million each. In addition, the Company expects that its income statement and balance sheet will reflect a goodwill impairment in our consumer health business of more than $200 million, primarily related to its October 2021 acquisition of Bettera Wellness.

“We understand the importance of timely financial reporting and apologize for the inconvenience caused by this delay in our quarterly filing and investor conference call. We are dissatisfied with our recent results and are taking the necessary steps to address the issues that negatively impacted our performance, which fell well short of our prior projections,” said Alessandro Maselli, President and Chief Executive Officer of Catalent, Inc. “We are confident that our recent operational challenges are temporary and addressable, and we are working intensively to return to our historic productivity levels. We are also increasing the rigor of our forecasting, to ensure that we can more effectively anticipate and respond to the increased complexity in our business and the challenging macroeconomic environment. We believe the fundamentals of our business remain strong, with a platform that plays a critical role in the global healthcare ecosystem. Furthermore, our reduced outlook for fiscal 2023 was not due to any GMP compliance issue or the loss of any customer or cancelled order. Our customers’ supply situations remain healthy, and we believe we can sufficiently service their demand.”

Third Quarter Fiscal Year 2023 Earnings Conference Webcast

The Company now expects to release financial results for the third quarter of fiscal year 2023, ended March 31, 2023, before the market open on Monday, May 15, 2023, and will host a webcast to discuss the results at 8:15 a.m. ET on the same day. Catalent invites all interested parties to listen to the webcast and view a supplemental slide presentation, both of which will be accessible through Catalent’s website at https://investor.catalent.com. The webcast replay, along with the supplemental slides, will be available for 90 days at https://investor.catalent.com.

About Catalent

Catalent, Inc. (NYSE: CTLT), an S&P 500® company, is the global leader in enabling pharma, biotech, and consumer health partners to optimize product development, launch, and full life-cycle supply for patients around the world. With broad and deep scale and expertise in development sciences, delivery technologies, and multi-modality manufacturing, Catalent is a preferred industry partner for personalized medicines, consumer health brand extensions, and blockbuster drugs. Catalent helps accelerate over 1,000 partner programs and launch over 150 new products every year. Its flexible manufacturing platforms at over 50 global sites supply around 80 billion doses of nearly 8,000 products annually. Catalent’s expert workforce of approximately 18,000 includes more than 3,000 scientists and technicians. Headquartered in Somerset, New Jersey, the company generated nearly $5 billion in revenue in its 2022 fiscal year. For more information www.catalent.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements regarding the expected timing of filing the Company’s Quarterly Report on Form 10-Q for the third fiscal quarter ended March 31, 2023 and release of earnings, the resolution of the Company’s operational, productivity and forecast issues, and the impact of such issues on the Company’s financial results for the fiscal quarter ended March 31, 2023 and the fiscal year to end on June 30, 2023. These forward-looking statements are based on management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause the Company’s actual results, performance or achievements to be materially different from the Company’s expectations and projections expressed or implied by the forward-looking statements, including, but not limited to, general business, financial and accounting risks and the other important factors discussed under the caption “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended June 30, 2022, filed with the U.S. Securities and Exchange Commission, or the SEC, and the Company’s other filings with the SEC. In addition, the statements regarding the impact of the issues identified in this press release on the Company’s financial results for the fiscal quarter ended March 31, 2023 and the fiscal year to end June 30, 2023 and the update on fiscal 2023 guidance are not a comprehensive statement or estimate of the Company’s financial results for such periods or of the events that may have affected the Company’s financial results for the fiscal quarter ended March 31, 2023 or that may affect the Company’s financial results for the fiscal year to end June 30, 2023. The Company’s actual results for the fiscal quarter ended March 31, 2023 and for the fiscal year to end June 30, 2023 may differ materially from what may be implied by, or be expected from, the statements in this press release, including regarding the state of the business and the impact of productivity and forecast issues on the Company’s financial results. These forward-looking statements speak only as of the date of this press release and are based on information available to the Company as of the date of this press release, and the Company assumes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.

Investor:

Paul Surdez, Catalent, Inc.

(732) 537-6325

[email protected]

Media:

Chris Halling

+44 (0)7580 041073

[email protected]

KEYWORDS: New Jersey United States North America

INDUSTRY KEYWORDS: Health General Health Research Pharmaceutical Science Biotechnology

MEDIA:

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Semantix Relaunches its Global Partnership Program

SÃO PAULO, Brazil, May 08, 2023 (GLOBE NEWSWIRE) — Semantix, Inc. (NASDAQ: STIX), a leading Latin American end-to-end data and enterprise AI platform provider (“Semantix”), today announced the relaunch of its global partnership program, Semantix Partner Community, designed to empower businesses and drive growth. The program will build on the success of the company’s existing partnerships and expand its reach to new markets and regions.

With 70 existing partners already on board, Semantix is well positioned to lead the way in delivering value to its customers through innovative and strategic partnerships. The new program will categorize partners into four groups, each with different approaches and benefits.

“Our new partnership program will be a significant lever in scaling our business and helping our customers reach new heights,” said Leonardo Santos, CEO of Semantix. “With our defined partner categories, we will be able to provide tailored benefits and work more closely with each of our partners. This program is a win-win for all parties involved and we look forward to seeing the benefits it brings to our customers.”

Semantix Partner Community’s categories are Semantix Partner, Sales Partner, Implementation Partner, and Independent Software Vendor.

Semantix Partner: Entry-level category, through which newer partners can gain access to our technology, sales and technical collateral, as well as refer new business to Semantix.

Sales Partner: Allows partners to execute the complete sales process for Semantix solutions, from opportunity and discovery to pre-sales and billing. Semantix will create Sales Partner levels (e.g. Bronze, Silver, and Gold) granting different benefits, based on tiered requirements.

Implementation Partner: Allows partners to demonstrate to the market that they have been certified by Semantix and are able to deploy our different solutions. Semantix will only recommend certified partners to customers for project delivery on our platforms.

Independent Software Vendor (ISV): ISV partners are able to provide intellectual property through our platforms. Initially, this partner tier is intended for companies that want to provide data (Data Provider) or algorithms (Intelligence Provider) in our Marketplace, but in the future may be expanded to accommodate partners who want to develop complete solutions on the SDP or embed modules of our products.

Additional benefits of the Semantix Partnership Program include sales and service scalability, increased market penetration, geographic expansion and a reduction in operational costs.

About Semantix

Semantix is Latin America’s first fully integrated data and enterprise AI software platform. Semantix has more than 300 clients with operations in approximately 15 countries using Semantix’s software and services to enhance their businesses. The company was founded in 2010 by CEO Leonardo Santos. For more information, visit ir.semantix.ai.

Forward-Looking Statements

This press release contains statements that constitute “forward-looking statements”. Forward-looking statements may be identified by the use of words such as “estimate,” “plan,” “project,” “forecast,” “intend,” “will,” “expect,” “anticipate,” “believe,” “seek,” “target” or other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These statements are based on various assumptions, whether or not identified in this press release, and on the current expectations of the Company’s management and are not predictions of actual performance. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on by any investor as, a guarantee, an assurance, a prediction or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and will differ from assumptions. Many actual events and circumstances are beyond the control of the Company. These forward-looking statements are subject to a number of risks and uncertainties disclosed in documents that the Company has filed, or will file, with the SEC. In addition, forward-looking statements reflect the Company’s expectations, plans or forecasts of future events and views as of the date of this press release. The Company anticipates that subsequent events and developments may cause its assessments to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing the Company’s assessment as of any date subsequent to the date of this press release. Accordingly, undue reliance should not be placed upon the forward-looking statements.

Investor Contact

Adriano Alcalde
CFO & IRO
[email protected]

Press Contact

[email protected] 



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NOG Announces Proposed Aggregate $450 Million Private Offering of Senior Notes

NOG Announces Proposed Aggregate $450 Million Private Offering of Senior Notes

MINNEAPOLIS–(BUSINESS WIRE)–
Northern Oil and Gas, Inc. (NYSE: NOG) (the “Company” or “NOG”) today announced that it intends to offer for sale (the “Offering”) in a private placement under Rule 144A and Regulation S of the Securities Act of 1933, as amended (the “Securities Act”), to eligible purchasers, $450.0 million in aggregate principal amount of new senior notes due 2031 (the “New Notes”).

The Company intends to use the net proceeds from the Offering for general corporate purposes, including repayment of a portion of the outstanding borrowings under its revolving credit facility.

The New Notes to be offered will not be registered under the Securities Act or under any state or other securities laws, and the New Notes will be issued pursuant to an exemption therefrom, and may not be offered or sold within the United States, or to or for the account or benefit of any U.S. person, absent registration or an applicable exemption from registration requirements.

The New Notes are being offered only to persons who are either reasonably believed to be “qualified institutional buyers” under Rule 144A or who are non-“U.S. persons” under Regulation S as defined under applicable securities laws.

This press release does not constitute an offer to sell, a solicitation to buy or an offer to purchase or sell any securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

ABOUT NORTHERN OIL AND GAS

NOG is a company with a primary strategy of investing in non-operated minority working and mineral interests in oil & gas properties, with focus on the premier hydrocarbon producing basins within the contiguous United States.

SAFE HARBOR

This press release contains forward-looking statements regarding future events and the Company’s future results that are subject to the safe harbors created under the Securities Act and the Securities Exchange Act of 1934, as amended. All statements other than statements of historical facts included in this press release are forward-looking statements, including, but not limited to, statements regarding the Company’s plans to issue the New Notes and the anticipated use of the net proceeds therefrom. When used in this press release, forward-looking statements are generally accompanied by terms or phrases such as “estimate,” “project,” “predict,” “believe,” “expect,” “continue,” “anticipate,” “target,” “could,” “plan,” “intend,” “seek,” “goal,” “will,” “should,” “may” or other words and similar expressions that convey the uncertainty of future events or outcomes. Items contemplating or making assumptions about actual or potential future production, sales, market size, collaborations, cash flows, and trends or operating results also constitute such forward-looking statements.

Forward-looking statements involve inherent risks and uncertainties, and important factors (many of which are beyond the Company’s control) that could cause actual results to differ materially from those set forth in the forward-looking statements, including the following: changes in crude oil and natural gas prices, the pace of drilling and completions activity on the Company’s current properties and properties pending acquisition; infrastructure constraints and related factors affecting the Company’s properties; cost inflation or supply chain disruptions; ongoing legal disputes over, and potential shutdown of, the Dakota Access Pipeline; the Company’s ability to acquire additional development opportunities, potential or pending acquisition transactions, the projected capital efficiency savings and other operating efficiencies and synergies resulting from the Company’s acquisition transactions, integration and benefits of property acquisitions, or the effects of such acquisitions on the Company’s cash position and levels of indebtedness; changes in the Company’s reserves estimates or the value thereof; disruption to the Company’s business due to acquisitions and other significant transactions; general economic or industry conditions, nationally and/or in the communities in which the Company conducts business; changes in the interest rate environment, legislation or regulatory requirements, conditions of the securities markets; risks associated with the Company’s 3.625% convertible senior notes due 2029 (the “Convertible Notes”), including the potential impact that the Convertible Notes may have on the Company’s financial position and liquidity, potential dilution, and that provisions of the Convertible Notes could delay or prevent a beneficial takeover of the Company; the potential impact of the capped call transactions undertaken in tandem with the Convertible Notes issuance, including counterparty risk; increasing attention to environmental, social and governance matters; the Company’s ability to consummate any pending acquisition transactions; other risks and uncertainties related to the closing of pending acquisition transactions; the Company’s ability to raise or access capital; cyber-incidents could have a material adverse effect on the Company’s business, financial condition or results of operations; changes in accounting principles, policies or guidelines; events beyond the Company’s control, including a global or domestic health crisis, acts of terrorism, political or economic instability or armed conflict in oil and gas producing regions; and other economic, competitive, governmental, regulatory and technical factors affecting the Company’s operations, products and prices.

The Company has based any forward-looking statements on its current expectations and assumptions about future events. While the Company’s management considers these expectations and assumptions to be reasonable, they are inherently subject to significant business, economic, competitive, regulatory and other risks, contingencies and uncertainties, most of which are difficult to predict and many of which are beyond the Company’s control. Accordingly, results actually achieved may differ materially from expected results described in these statements. Forward-looking statements speak only as of the date they are made. You should consider carefully the statements under the heading “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022, as updated by the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2023. The Company does not undertake, and specifically disclaims, any obligation to update any forward-looking statements to reflect events or circumstances occurring after the date of such statements, other than as may be required by applicable law or regulation.

Evelyn Leon Infurna

Vice President of Investor Relations

(952) 476-9800

[email protected]

KEYWORDS: Minnesota United States North America

INDUSTRY KEYWORDS: Oil/Gas Energy

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Momentus Achieves First Orbit Raise with Pioneering Propulsion System

Momentus Achieves First Orbit Raise with Pioneering Propulsion System

New Sustainable Spacecraft Engine Uses Distilled Water as Propellant

SAN JOSE, Calif.–(BUSINESS WIRE)–
Momentus Inc. (NASDAQ: MNTS) (“Momentus” or the “Company”), a U.S. commercial space company that offers orbital transportation and in-space infrastructure services, successfully achieved the first orbital raise of its Vigoride-5 spacecraft using its pioneering Microwave Electrothermal Thruster (MET) that uses distilled water as propellant.

The successful maneuvers raised the altitude of the Vigoride Orbital Service Vehicle (OSV) by more than 3 kilometers, taking into account the atmospheric drag that the spacecraft must overcome each day. Orbital altitude raises are an integral part of Momentus’ transportation service offering that aims to deliver customer satellites to precise and custom orbits.

“This initial orbital raise was a key goal of our Vigoride-5 mission and the MET’s performance has exceeded our expectations,” said Momentus Chief Technology Officer Rob Schwarz. “Each ignition has been successful, and we’ve completed more than 35 firings ranging from 30 seconds up to six minutes in duration, which is what we plan to use operationally. Cumulatively, we have accomplished over 140 minutes of firing time of the MET system.”

“We have now operated the MET successfully in space at full power across the range of durations for firing that we plan to use operationally to deliver satellites to precise, custom orbits and to provide in-space infrastructure services like hosted payloads,” said Schwarz. “The MET has shown its ability to operate as intended to perform these missions in space, and we look forward to using it to support commercial and U.S. Government customers.”

The MET is the Vigoride OSV’s primary propulsion method that relies on solar power and uses distilled water as a propellant. It produces thrust by expelling extremely hot gases through a rocket nozzle. Unlike a conventional chemical rocket engine, which heats propellant through a chemical reaction, the MET uses a solar powered, microwave energy source to generate a hot plasma at its core that heats the propellant to generate thrust. The use of non-toxic water propellant ultimately enables simpler, safer, and more cost-efficient operations both on Earth and in space.

“The MET technology can provide future missions with higher efficiency than chemical propulsion systems and higher thrust than electric propulsion systems. With the recent discoveries of large deposits of water on the Moon and its presence on asteroids and other planets, a water-based propulsion system that can be refueled on longer missions provides a unique advantage,” said Momentus Chief Commercial Officer Chris Kinman. “With its technology working in space, Momentus is emerging as a trusted provider of in-space infrastructure services. Our proven flight heritage and MET performance, paired with our focus on affordability, flexibility, and speed, positions Momentus to be a key partner for customers looking to make the most out of their orbit.”

Momentus has flown three of its Vigoride OSVs in less than a year. The Company launched its inaugural mission, Vigoride-3, in May 2022 and deployed eight satellites to orbit from Vigoride and a third-party deployer. The Vigoride-5 spacecraft, launched in January, is providing hosted payload support for Caltech’s Space-based Solar Power Project payload and deploying a satellite with the Qosmosys Zeus-1 payload. Vigoride-6, launched in April 2023, is carrying satellites for NASA and commercial customers, and a solar array developed by Momentus that will be demonstrated in space.

About Momentus

Momentus is a U.S. commercial space company that offers in-space infrastructure services, including in-space transportation, hosted payloads and in-orbit services. Momentus believes it can make new ways of operating in space possible with its planned in-space transfer and service vehicles that will be powered by an innovative water plasma-based propulsion system.

Forward-Looking Statements

This press release contains certain statements which may constitute “forward-looking statements” for purposes of the federal securities laws. Forward-looking statements include, but are not limited to, statements regarding Momentus or its management team’s expectations, hopes, beliefs, intentions or strategies regarding the future, projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, and are not guarantees of future performance. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of Momentus’ control. Many factors could cause actual future events to differ materially from the forward-looking statements in this press release, including but not limited to risks and uncertainties included under the heading “Risk Factors” in the Annual Report on Form 10-K filed by the Company on March 8, 2023, as such factors may be updated from time to time in our other filings with the Securities and Exchange Commission (the “SEC”), accessible on the SEC’s website at www.sec.gov and the Investor Relations section of our website at investors.momentus.space. Forward-looking statements speak only as of the date they are made. Readers are cautioned not to put undue reliance on forward-looking statements, and, except as required by law, the Company assumes no obligation and does not intend to update or revise these forward-looking statements, whether as a result of new information, future events, or otherwise.

Investors: [email protected]

Media: [email protected]

KEYWORDS: California United States North America

INDUSTRY KEYWORDS: Air Technology Satellite Transport Other Transport Hardware

MEDIA:

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Marker Therapeutics Appoints Monic Stuart, M.D., as Chief Medical Officer

Accomplished healthcare executive brings extensive drug development and regulatory experience from global pharmaceutical companies to Marker Therapeutics

HOUSTON, May 08, 2023 (GLOBE NEWSWIRE) — Marker Therapeutics, Inc. (Nasdaq: MRKR), a clinical-stage immuno-oncology company focusing on developing next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications, today announced the appointment of Monic Stuart, M.D., as its new Chief Medical Officer. Dr. Stuart brings more than 20 years of experience as a clinician-scientist and drug developer to Marker Therapeutics where she will be responsible for advancing the development of multi-tumor associated antigen (multiTAA)-specific T cell product pipeline, including the ongoing MT-401 Phase 2 ARTEMIS clinical study and Phase 1 clinical study of MT-601.

“As we undergo a strategic review of our clinical programs, we are thrilled to add Monic to the leadership team at Marker Therapeutics and look forward to benefitting from her deep scientific, industry, and medical knowledge to drive our multiTAA-specific T cell product pipeline across multiple high-need cancer indications,” said Juan F. Vera, M.D., Chief Executive Officer of Marker Therapeutics. “Given Marker’s prioritization of the clinical program in acute myeloid leukemia (AML) and lymphoma, bringing on a CMO who is a transplant physician and has extensive experience in treating AML and lymphoma patients is a tremendous advantage in establishing our clinical strategy. Dr. Stuart’s impressive career both in industry and in the clinic as a treating physician will be key to enabling Marker to identify the optimal paths for advancing our programs targeting hematologic and solid tumors.”

Dr. Stuart joins Marker Therapeutics as a consultant after having most recently worked as interim Chief Medical Officer, Head of Clinical Development or Clinical Advisor for numerous biotechnology and pharmaceutical companies worldwide. In this capacity, Dr. Stuart was responsible for leading each company’s clinical strategy including clinical development plans, Phase 1-3 study designs, and protocol development for a variety of benign and malignant hematologic, solid tumor, and supportive care indications. Dr. Stuart previously served as Vice President of Clinical Development at Geron Corporation, where she spearheaded efforts to develop a telomerase inhibitor in myeloid malignancies. Before her role at Geron Corp., she worked at Genentech Inc. as a Senior Medical Director in the Oncology Division. During her time at Genentech, she served in leadership position for multiple early and late-stage hematology/oncology programs.

Prior to Genentech, Dr. Stuart served as an attending physician in the Division of Blood and Marrow Transplantation at Stanford University, where she led trials in myeloid malignancies. Dr. Stuart received her M.D and B.S. in Biology from the University of North Carolina at Chapel Hill. She completed her medical residency in internal medicine and fellowships in hematology and bone marrow transplantation at Stanford University. Dr. Stuart also holds a Master’s Degree from the School of Public Health at Johns Hopkins University.

“Marker’s unique T cell-based immunotherapies have the potential to transform the treatment of cancer, and I am excited to work with the team to advance the development of these promising therapies,” said Dr. Stuart. “Importantly, the Company’s MT-401 Phase 2 ARTEMIS clinical trial continues to advance with recent data suggesting MT-401 manufactured with the improved T cell manufacturing process would be well suited for AML patients. I am intrigued by this potential as well as the opportunity to advance our MT-601 program in non-Hodgkin lymphoma and pancreatic cancer.”

About Marker Therapeutics, Inc.

Marker Therapeutics, Inc. is a clinical-stage immuno-oncology company specializing in the development of next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications. The cell therapy technology Marker has is based on the selective expansion of non-engineered, tumor-specific T cells that recognize tumor associated antigens (i.e., tumor targets) and kill tumor cells expressing those targets. This population of T cells is designed to attack multiple tumor targets following infusion into patients and to activate the patient’s immune system to produce broad spectrum anti-tumor activity. Because Marker does not genetically engineer its T cell therapies, we believe that our product candidates will be easier and less expensive to manufacture, with reduced toxicities, compared to current engineered CAR-T and TCR-based approaches, and may provide patients with meaningful clinical benefit. As a result, Marker believes its portfolio of T cell therapies has a compelling product profile, as compared to current gene-modified CAR-T and TCR-based therapies.

To receive future press releases via email, please visit: https://www.markertherapeutics.com/email-alerts.

Forward-Looking Statements

This release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Statements in this news release concerning the Company’s expectations, plans, business outlook or future performance, and any other statements concerning assumptions made or expectations as to any future events, conditions, performance or other matters, are “forward-looking statements.” Forward-looking statements include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: our research, development and regulatory activities and expectations relating to our non-engineered multi-tumor antigen specific T cell therapies; the effectiveness of these programs or the possible range of application and potential curative effects and safety in the treatment of diseases; and the timing, conduct and success of our clinical trials of our product candidates. Forward-looking statements are by their nature subject to risks, uncertainties and other factors which could cause actual results to differ materially from those stated in such statements. Such risks, uncertainties and factors include, but are not limited to the risks set forth in the Company’s most recent Form 10-K, 10-Q and other SEC filings which are available through EDGAR at WWW.SEC.GOV. The Company assumes no obligation to update our forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.


Contacts



TIBEREND STRATEGIC ADVISORS, INC.


Investors

Daniel Kontoh-Boateng
(862) 213-1398
[email protected]

Media

Casey McDonald
(646) 577-8520
[email protected]



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Camping World Intends to Acquire I-90 RV, Marking Its Entrance Into the Montana Market

Camping World Intends to Acquire I-90 RV, Marking Its Entrance Into the Montana Market

LINCOLNSHIRE, Ill.–(BUSINESS WIRE)–
Camping World Holdings, Inc. (NYSE: CWH) (“Camping World”), America’s Recreation Dealer, today announced that it intends to acquire I-90 RV in Billings, Montana. The acquisition is anticipated to close in the third quarter of 2023, and it is the Company’s first location in Montana.

Marcus Lemonis, CEO and Chairman of Camping World commented, “This acquisition sets the stage for the beginning of our expansion in Montana, as we complete construction of our new Montana SuperCenter, expected to open upon completion.” He continued, “I-90 RV is a proven operator with real knowledge of the local market, having served the Billings community for over 20 years. As we enter Montana, Billings is a great place to begin, with other markets on our radar.”

Individuals interested in applying for a position may visit http://www.campingworldjobs.com/.

About Camping World Holdings, Inc.

Camping World Holdings, Inc., headquartered in Lincolnshire, IL, (together with its subsidiaries) is America’s largest retailer of RVs and related products and services. Our vision is to build a long-term legacy business that makes RVing fun and easy. Our Camping World and Good Sam brands have been serving RV consumers since 1966. We strive to build long-term value for our customers, employees, and shareholders by combining a unique and comprehensive assortment of RV products and services with a national network of RV dealerships, service centers and customer support centers along with the industry’s most extensive online presence and a highly trained and knowledgeable team of employees serving our customers, the RV lifestyle, and the communities in which we operate. We also believe that our Good Sam organization and family of programs and services uniquely enable us to connect with our customers as stewards of the RV enthusiast community and the RV lifestyle. With RV sales and service locations in 42 states, Camping World has grown to become the prime destination for everything RV. For more information, visit www.CampingWorld.com.

Cautionary Statement Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 concerning Camping World and other matters. All statements other than statements of historical facts contained in this press release may be forward-looking statements, including statements about expected timing of the closure of the announced acquisitions and opening of new stores and expected benefits from the announced acquisitions and new locations. In some cases, you can identify forward-looking statements by terms such as ‘‘may,’’ ‘‘will,’’ ‘‘should,’’ ‘‘expects,’’ ‘‘plans,’’ ‘‘anticipates,’’ ‘‘could,’’ ‘‘intends,’’ ‘‘targets,’’ ‘‘projects,’’ ‘‘contemplates,’’ ‘‘believes,’’ ‘‘estimates,’’ ‘‘predicts,’’ ‘‘potential’’ or ‘‘continue’’ or the negative of these terms or other similar expressions. The forward-looking statements in this press release are only predictions. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our business, financial condition, and results of operations. Forward-looking statements involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance, or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. You should carefully consider the risks and uncertainties that affect our business, including the risk that the acquisitions may not close on the timelines expected or at all and that new stores may not open on the timelines expected or at all, as well as the other important risks described in our filings with the Securities and Exchange Commission (“SEC”), including under the caption “Risk Factors” in our Annual Report on Form 10-K filed for the year ended December 31, 2022. These forward-looking statements speak only as of the date of this communication. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements, whether as a result of any new information, future events or otherwise. You are advised, however, to consult any further disclosures we make on related subjects in our public announcements and filings with the SEC.

Brett Andress

[email protected]

Media Outlets:

[email protected]

KEYWORDS: Illinois Montana United States North America

INDUSTRY KEYWORDS: Sports Transportation Automotive Destinations Vacation Travel Other Automotive General Automotive Recreational Vehicles Outdoors Other Travel

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Zevra Announces Board of Directors and Leadership Changes

CELEBRATION, Fla., May 08, 2023 (GLOBE NEWSWIRE) — Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (“Zevra” or the “Company” and formerly KemPharm, Inc.), a rare disease therapeutics company, today announced changes to the Company’s Board of Directors (“Board”) and leadership. At the Company’s recent 2023 Annual Meeting of Stockholders (“Annual Meeting”), Zevra shareholders elected John B. Bode, Douglas W. Calder and Corey Watton to Zevra’s Board. Additionally, as previously announced, Wendy L. Dixon, Ph.D., joined the Zevra Board on the date of the Annual Meeting. After the Annual Meeting, Zevra’s newly configured Board met and unanimously approved the following changes:

  • The Board accepted the resignation of Richard W. Pascoe from his role as CEO, effective June 1, 2023.
  • Tamara A. Favorito was unanimously appointed Chair of the Board.
  • Directors Matthew R. Plooster and Joseph B. Saluri, J.D. have indicated that they will not stand for re-election at the Company’s 2024 Annual Meeting, and that they intend to retire as soon as replacements are found.  
  • The Board intends to appoint an interim-Chief Executive Officer and will immediately initiate a search to identify both a new Chief Executive Officer and replacement Board members.

“On behalf of the Zevra team, we welcome new directors John, Doug, Corey and Wendy to the Board as we strengthen our commitment to working together towards our shared goal of delivering value for all Zevra shareholders,” stated Tamara A. Favorito, Zevra’s Board Chair. “We also thank Dr. Travis Mickle, Richard Pascoe, Christopher Posner and Dr. David Tierney for their many contributions to the Company during their tenures on the Board and as leaders of the Company. I want to especially recognize their efforts and commitment to our shared vision of creating a commercially focused rare disease therapeutics company .”

John B. Bode, Chair of the Nominating and Corporate Governance Committee, stated, “As we look ahead, we will prioritize a search for a Chief Executive Officer who will continue to execute upon the Company’s rare disease strategy and drive value creation for all shareholders. In the interim, I am confident in the existing management team’s ability to execute on the Company’s strategy.”

About Zevra

Zevra Therapeutics is a rare disease company melding science, data, and patient need to create transformational therapies for diseases with limited or no treatment options. With unique, data-driven clinical, regulatory, and commercialization strategies, the Company is overcoming complex drug development challenges to bring much-needed therapies to patients.

Arimoclomol, Zevra’s orally-delivered, first-in-class investigational product candidate for the treatment of Niemann-Pick disease type C (“NPC”), has been granted orphan drug designation, Fast Track designation, Breakthrough Therapy designation and rare pediatric disease designation for NPC by the U.S. Food and Drug Administration (“FDA”), and orphan medicinal product designation for the treatment of NPC by the European Medicines Agency (“EMA”). The arimoclomol New Drug Application (NDA) is currently being prepared for a resubmission to the FDA.

KP1077 is Zevra’s lead clinical candidate being developed to treat idiopathic hypersomnia (“IH”) and narcolepsy. KP1077 is comprised solely of serdexmethylphenidate (“SDX”), Zevra’s proprietary prodrug of d-methylphenidate (“d-MPH”). The FDA has granted KP1077 orphan drug designation for the treatment of IH, and the U.S. Drug Enforcement Agency (“DEA”) has classified SDX as a Schedule IV controlled substance based on evidence suggesting SDX has a lower potential for abuse when compared to d-MPH, a Schedule II controlled substance.

Early access programs are made available by Zevra Therapeutics, Inc. and its affiliates and are subject to the Company’s Early Access Program (“EAP”) policy as published on its website at zevra.com. Participation in these programs is subject to the laws and regulations of each jurisdiction under which each respective program is operated. Eligibility for participation in any such program is at the treating physician’s discretion.

Caution Concerning Forward-Looking Statements

This press release may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include all statements that do not relate solely to historical or current facts, and which can be identified by the use of words such as “may,” “will,” “expect,” “project,” “estimate,” “anticipate,” “plan,” “believe,” “potential,” “should,” “continue,” “could,” “intend,” “target,” “predict,” or the negative versions of those words or other comparable words or expressions, although not all forward-looking statements contain these identifying words or expressions. Forward-looking statements are not guarantees of future actions or performance. These forward-looking statements include without limitation statements regarding senior leadership and board member transitions and refreshment, or the timing thereof, and our strategic and product development objectives. Forward-looking statements are based on information currently available to Zevra and its current plans or expectations. They are subject to several known and unknown uncertainties, risks, and other important factors that may cause our actual results, performance, or achievements to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. These and other important factors are described in detail in the “Risk Factors” section of Zevra’s (formerly KemPharm) Annual Report on Form 10-K for the year ended December 31, 2022, and Zevra’s (formerly KemPharm) other filings with the Securities and Exchange Commission. While we may elect to update such forward-looking statements at some point in the future, except as required by law, we disclaim any obligation to do so, even if subsequent events cause our views to change. Although we believe the expectations reflected in such forward-looking statements are reasonable, we cannot assure that such expectations will prove correct. These forward-looking statements should not be relied upon as representing our views as of any date after the date of this press release.

Contacts

Nichol Ochsner
+1 (732) 754-2545
[email protected]

Jennifer Arcure
+1 (917) 603-0681
[email protected]



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Altimmune to Participate at Two Upcoming Investor Conferences

GAITHERSBURG, Md., May 08, 2023 (GLOBE NEWSWIRE) — Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today announced that members of the Company’s management team will participate and be available for 1×1 meetings at the following investor conferences:

  • JMP Securities Life Sciences Conference in New York, NY
    Tuesday, May 16, 2023
    Fireside chat at 9:00 am Eastern Time
    The session will be webcast and can be accessed by visiting the Events section of the Altimmune website.
  • Piper Sandler Spring Biopharma Symposium in Boston, MA
    Thursday, May 18, 2023
    One-on-one meetings only

About Altimmune
Altimmune is a clinical-stage biopharmaceutical company focused on the development of novel peptide-based therapeutics for the treatment of obesity and liver diseases. The Company’s lead product candidate, pemvidutide, is a GLP-1/glucagon dual receptor agonist that is being developed for the treatment of obesity and NASH. In addition, Altimmune is developing HepTcell™, an immunotherapeutic designed to achieve a functional cure for chronic hepatitis B. For more information, please visit www.altimmune.com.

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Altimmune Investor & Media Contact:

Richard Eisenstadt
Chief Financial Officer
Phone: 240-654-1450
[email protected]



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SunOpta Inc. to Participate in Upcoming Investor Conferences

SunOpta Inc. to Participate in Upcoming Investor Conferences

MINNEAPOLIS–(BUSINESS WIRE)–
SunOpta Inc. (“SunOpta” or the “Company”) (Nasdaq:STKL) (TSX:SOY), a U.S.-based global pioneer fueling the future of sustainable, plant-based and fruit-based foods and beverages, today announced that the Company will participate in two upcoming investor conferences. These include the BMO Global Farm to Market Conference, to be held May 17-18, 2023 in New York, N.Y. and the Craig-Hallum Institutional Investor Conference to be held May 31, 2023 in Minneapolis, Minn.

At the BMO Global Farm to Market Conference, the Company will meet with investors and participate in a fireside chat at approximately 10:15 a.m. Eastern Daylight Time on Thursday, May 18, 2023. A live webcast of the presentation will be available on the Investor Relations – Events and Presentations section of the Company’s website at https://www.sunopta.com/ during the event. Shortly following the event, a replay of the webcast will be available for approximately thirty (30) days.

At the Craig-Hallum Institutional Investor Conference the Company will meet with investors on Wednesday, May 31, 2023.

About SunOpta Inc.

SunOpta (Nasdaq:STKL) (TSX:SOY) is a U.S.-based, global pioneer fueling the future of sustainable, plant-based and fruit-based food and beverages. Founded nearly 50 years ago, SunOpta manufactures natural, organic and specialty products sold through retail and foodservice channels. SunOpta operates as a manufacturer for leading natural and private label brands, and also proudly produces its own brands, including Sown ®, Dream®, West LifeTM and Sunrise Growers®. For more information, visit www.sunopta.com, LinkedIn and Twitter.

Investor Relations:

Reed Anderson

ICR

646-277-1260

[email protected]

Media Relations:

Konnect Agency

213-988-8344

[email protected]

KEYWORDS: Minnesota New York United States North America Canada

INDUSTRY KEYWORDS: Environment Other Retail Public Relations/Investor Relations Communications Specialty Sustainability Restaurant/Bar Food/Beverage Retail

MEDIA:

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Quipt Home Medical Announces Date and Time for Fiscal Q2 2023 Conference Call and Audio Webcast

CINCINNATI, May 08, 2023 (GLOBE NEWSWIRE) — Quipt Home Medical Corp. (the “Company”) (NASDAQ: QIPT) (TSXV: QIPT), a U.S. based home medical equipment provider, focused on end-to-end respiratory care, today announced that it will host its Fiscal Q2 2023 earnings conference call and audio webcast on Tuesday, May 16, 2023 at 10:00 a.m. (ET).


Conference Call Details:

Tuesday, May 16, 2023 at 10:00 a.m. (ET).
   
Canada/US Toll Free:  1 (800) 319 4610
International: 1 (604) 638 5340




Audio Webcast Details:

The live audio webcast can be found on the investor section of the Company’s website through the following link: www.quipthomemedical.com

ABOUT QUIPT HOME MEDICAL CORP.

The Company provides in-home monitoring and disease management services including end-to-end respiratory solutions for patients in the United States healthcare market. It seeks to continue to expand its offerings to include the management of several chronic disease states focusing on patients with heart or pulmonary disease, sleep disorders, reduced mobility, and other chronic health conditions. The primary business objective of the Company is to create shareholder value by offering a broader range of services to patients in need of in-home monitoring and chronic disease management. The Company’s organic growth strategy is to increase annual revenue per patient by offering multiple services to the same patient, consolidating the patient’s services, and making life easier for the patient.

Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

For further information please visit our website at www.quipthomemedical.com, or contact:

Cole Stevens
VP of Corporate Development
Quipt Home Medical Corp.
859-300-6455
[email protected]

Gregory Crawford
Chief Executive Officer
Quipt Home Medical Corp.
859-300-6455
[email protected]