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Anebulo Pharmaceuticals Announces Positive Regulatory Update for Selonabant in Acute Cannabis-Induced Toxicity in Children and Capital Raise

AUSTIN, Texas–(BUSINESS WIRE)–Anebulo Pharmaceuticals, Inc. (Nasdaq: ANEB), a clinical-stage biopharmaceutical company developing novel solutions for people suffering from acute cannabinoid-induced toxicities (the “Company” or “Anebulo”), today announced a positive regulatory update and the close of a capital raise.

• In a Phase 2 proof-of-concept study, Anebulo enrolled 134 adult subjects challenged with oral delta-9-tetrahydrocannabinoil (“THC”), oral selonabant blocked or reversed key CNS effects of THC, establishing the clinical path for intravenous selonabant for a much-needed targeted therapy for rapidly reversing the serious and life-threatening consequences of acute cannabis-induced toxicity in children

• Anebulo met with FDA to discuss the development of intravenous selonabant and the initial plan for clinical testing

• FDA acknowledged the unmet need for a treatment for children exposed to cannabis toxicity, and proposed a close, ongoing collaboration to efficiently advance the selonabant program for the pediatric indication

• Anebulo plans to begin its Phase I SAD study of IV selonabant in healthy adults in 1H25

• Anebulo entered into a definitive stock purchase agreement with 22NW, a company controlled by one of its directors, Nantahala Capital and an additional existing investor for the issuance and sale of 15.2 million shares of common stock for gross proceeds of $15 million in a private placement offering priced at-the-market under Nasdaq rules

• In exchange for purchasing $10 million of shares of common stock in the private placement, Anebulo intends to modify the Loan and Security Agreement (LSA) that was entered into with 22NW and JFL Capital Management by reducing the maximum loan size to approximately $3 million, which reduces the LSA to just under the securitization threshold, and the removal of any securitization

“We are grateful to have the continued support from current investors. Having secured such meaningful financing without having to issue stock at a discount to the market or include warrant coverage is indicative of the confidence these highly respected institutional investors have in the company’s future,” commented Richie Cunningham, Chief Executive Officer of Anebulo.

Cunningham continued, “In recent interactions, FDA confirmed our belief that there is an unmet need for a treatment for children exposed to cannabis toxicity and suggested a close collaboration with Anebulo to facilitate an efficient development plan for this important pediatric condition. If approved, we believe selonabant has the potential to offer a much-needed targeted therapy for rapidly reversing the serious and life-threatening consequences of acute cannabis-induced toxicity in children. To validate this market opportunity, we hired a top five pharmaceutical consulting firm to complete a market assessment. This team of experts evaluated and confirmed acute cannabis induced toxicity in children as a viable commercial opportunity. In addition, based on an incidence less than 200,000 cases per year we also believe this to be a rare pediatric condition.”

The private placement is expected to close no later than December 24^th, subject to the satisfaction of customary closing conditions. The private placement is being conducted in accordance with applicable Nasdaq rules and was priced at $0.99 per share to satisfy the “Minimum Price” requirement (as defined in the Nasdaq rule).

In connection with the close of the private placement, the Company will amend its LSA that was entered into in November 2023. The LSA allowed the Company to borrow up to $10 million, and to date, no funds have been borrowed. The amended loan agreement will reduce the borrowing limit to approximately $3 million and will be unsecured.

About Selonabant (ANEB-001)

The Company’s lead product candidate is selonabant (ANEB-001), a potent, small molecule antagonist of the cannabinoid receptor type-1 (“CB1”), under development to address the unmet medical need for a specific antidote for acute cannabis-induced toxicity, including acute cannabinoid intoxication (“ACI”) in adults and unintentional cannabis poisoning in pediatric subjects. The Company anticipates that selonabant will rapidly reverse key symptoms of cannabis toxicity. Selonabant has been successfully formulated for oral administration in clinical studies and as a potential IV treatment. In a Phase 2 proof-of-concept study in adult subjects challenged with oral delta-9-tetrahydrocannabinol (“THC”) (www.clinicaltrials.gov/ct2/show/NCT05282797), oral selonabant blocked or reversed key CNS effects of THC. Selonabant was well tolerated in this study and there were no serious adverse events. In the open-label extension of the study, THC challenge doses of 40 mg and 60 mg were well-tolerated when dosed in combination with oral selonabant, and all treatment-related adverse events were mild and transient. The prior Phase 1 and Phase 2 studies of oral selonabant have together enrolled a total of 250 subjects, of which 189 received selonabant. Selonabant is protected by two issued patents covering various methods of use of the compound and composition of matter of the crystalline form of selonabant. Anebulo also has multiple pending applications covering various methods of use of the compound and delivery systems. An observational study in patients presenting to Emergency Departments with cannabis toxicity is currently ongoing. The study is intended to determine concentrations of cannabinoids and metabolites in plasma and gather information on signs and symptoms, patients’ disposition and selected subjective assessments.

About Anebulo Pharmaceuticals, Inc.

Anebulo Pharmaceuticals, Inc. is a clinical-stage pharmaceutical company developing novel solutions for people suffering from acute cannabinoid intoxication and unintentional cannabis intoxication. Its lead product candidate, selonabant, has completed a Phase 2 clinical trial evaluating its utility in blocking and reversing the negative effects of acute cannabinoid intoxication in healthy adults challenged with oral THC. Rather than proceeding directly with Phase 3 studies of oral selonabant in adults with ACI, the Company is prioritizing the advancement of a selonabant IV formulation as a potential treatment for pediatric patients with acute cannabis-induced toxicity, which it believes offers the potential for a faster timeline to approval relative to the adult oral product. Anebulo is currently scaling up the intravenous formulation for initial clinical safety studies. Selonabant is a competitive antagonist at the human CB1 receptor. For further information about Anebulo, please visit www.anebulo.com.

Forward-Looking Statements

Statements contained in this press release that are not statements of historical fact are forward-looking statements as defined in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. In some cases, these forward-looking statements can be identified by words such as “anticipate,” “designed,” “expect,” “may,” “will,” “should” and other comparable terms. Forward-looking statements include statements regarding Anebulo’s intentions, beliefs, projections, outlook, analyses or current expectations regarding: plans to begin its Phase I SAD study of IV selonabant in healthy adults in 1H25; plans to amend the LSA; the unmet need for a treatment for children exposed to cannabis toxicity; the potential for selonabant to offer a much-needed targeted therapy for rapidly reversing the serious and life-threatening consequences of acute cannabis-induced toxicity in children; acute cannabis induced toxicity in children being a viable commercial market opportunity and a rare pediatric condition; the closing of the private placement on December 24, 2024; selonabant rapidly reversing key symptoms of cannabis toxicity; the observational study determining concentrations of cannabinoids and metabolites in plasma and gathering information on signs and symptoms, patients’ disposition and selected subjective assessments; and advancement of a selonabant IV formulation as a potential treatment for pediatric patients with acute cannabis-induced toxicity, offering the potential for a faster timeline to approval relative to the adult oral product. You are cautioned that any such forward-looking statements are not guarantees of future performance and are subject to a number of risks, uncertainties and assumptions, including, but not limited to: the Company’s ability to close its private placement as anticipated; pursue its regulatory strategy including; commencement of the Phase 1 SAD study of IV selonabant in healthy adults in 1H25, having acute cannabis induced toxicity in children treated as a rare pediatric condition; its ability to obtain regulatory approvals for commercialization of product candidates or to comply with ongoing regulatory requirements, the Company’s ability to obtain or maintain the capital or grants necessary to fund its research and development activities, its ability to complete clinical trials on time and achieve desired results and benefits as expected, regulatory limitations relating to the ability to promote or commercialize product candidates for specific indications, acceptance of product candidates in the marketplace and the successful development, marketing or sale of Anebulo’s products, the Company’s ability to maintain its license agreements, the continued maintenance and growth of its patent estate and the Company’s ability to retain its key employees or maintain its Nasdaq listing. These risks should not be construed as exhaustive and should be read together with the other cautionary statements included in the Company’s Annual Report on Form 10-K for the year ended June 30, 2024, and its subsequent filings with the Securities and Exchange Commission, including subsequent periodic reports on Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. All forward-looking statements made in this press release speak only as of the date of this press release and are based on management’s assumptions and estimates as of such date. Except as required by law, Anebulo undertakes no obligation to update or revise forward-looking statements to reflect new information, future events, changed conditions or otherwise after the date of this press release.

View source version on businesswire.com: https://www.businesswire.com/news/home/20241223198725/en/

Anebulo Pharmaceuticals, Inc.

Daniel George

Part time Chief Financial Officer

(512) 598-0931

[email protected]

KEYWORDS: Texas United States North America

INDUSTRY KEYWORDS: Cannabis Health FDA Natural Resources Clinical Trials Pharmaceutical Biotechnology

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Spruce Power Announces First Spruce Pro Servicing Customer

–Multi-year Agreement with ADT for Several Servicing Needs–

DENVER–(BUSINESS WIRE)–
Spruce Power Holding Corporation (NYSE: SPRU) (“Spruce” or the “Company”) today announced the first customer for its Spruce Pro servicing business. Spruce signed a multi-year Service Agreement with ADT, under which Spruce Pro will facilitate the management and resolution of workmanship and equipment warranty claims for customers of ADT’s former solar business, which it wound down earlier in 2024.

“We are proud to partner with ADT to provide a solution set to meet the specific servicing needs of the customers of their former solar business,” said CEO Chris Hayes. “This announcement underscores our strong commitment to grow Spruce Pro. Our goal is to unlock value from the significant investment in our servicing platform. This deal demonstrates our ability to provide tailored servicing solutions to the residential solar industry.”

Spruce Pro leverages the Company’s decade-plus experience in management of its wholly owned residential solar assets. Spruce Pro offers a suite of services that can be tailored for third-party owners of distributed generation assets, including financial and asset management operations, customer service support, and environmental commodities trading. For more information on Spruce Pro, please visit https://sprucepower.com/pro/.

About Spruce Power

Spruce Power Holding Corporation (NYSE: SPRU) is a leading owner and operator of distributed solar energy assets across the United States. We provide subscription-based services that make it easy for homeowners to benefit from rooftop solar power and battery storage. Our power as-a-service model allows consumers to access new technology without making a significant upfront investment or incurring maintenance costs. Our company owns the cash flows from approximately 85,000 home solar assets and contracts across the United States. For additional information, please visit www.sprucepower.com.

Forward Looking Statements

Certain statements in this press release may constitute “forward-looking statements” within the meaning of the federal securities laws, including the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and rules promulgated thereunder. Forward-looking statements generally are characterized by the use of qualified words (and their derivatives) such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “should,” “would,” “plan,” “predict,” “potential,” “seem,” “seek,” “future,” “outlook,” and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. Forward-looking statements in this release include statements regarding the Company’s financial outlook including the Company’s prospects for long-term growth in revenues, cash flows and earnings. These statements are based on various assumptions, whether or not identified in this press release and on the current expectations of management, all of which management believes are reasonable within the bounds of management’s existing knowledge about the Company’s business and operations. These statements are not predictions of actual performance. Forward-looking statements are subject to a number of risks and uncertainties that could cause actual results to differ materially from those expressed in or implied by forward-looking statements, including but not limited to: expectations regarding the growth of the solar industry and home electrification; the ability to identify and complete future acquisitions; our ability to successfully integrate acquisitions; the ability to develop and market new products and services; the effects of pending and future legislation; the highly competitive nature of the Company’s business and markets; the ability to execute on and consummate business plans in anticipated time frames; litigation, complaints, product liability claims, government investigations and/or adverse publicity; cost increases or shortages in the materials necessary to support the Company’s products and services; the introduction of new technologies; the impact of natural disasters and other events beyond our control, such as hurricanes, wildfires or pandemics, on the Company’s business, results of operations, financial condition, regulatory compliance and customer experience; privacy and data protection laws, privacy or data breaches, or the loss of data; general economic, financial, legal, political and business conditions and changes in domestic and foreign markets; risks related to the rollout of the Company’s business and the timing of expected business milestones; the effects of competition on the Company’s future business; the availability of capital, including the availability and cost of borrowings; and the other risks discussed under the heading “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023 filed with the SEC on April 9, 2024, subsequent Quarterly Reports on Form 10-Q and other documents that the Company files with the SEC in the future. These factors are not necessarily all of the factors that could cause the Company’s actual results to materially differ from those expressed in or implied by any of the forward-looking statements. Other factors, including unknown or unpredictable factors, could also harm the Company’s results. If any of these risks, or other unknown or unpredictable risks, materialize or our assumptions prove incorrect, actual results or the timing thereof could differ materially from the results expressed in or implied by these forward-looking statements. These forward-looking statements speak only as of the date hereof and the Company undertakes no obligation to update these forward-looking statements, whether as a result of new information, future events or otherwise, except to the extent required by applicable law. Investors are cautioned not to rely too heavily on any forward-looking statements, and investors are urged to consider all risks, uncertainties and other factors in evaluating any forward-looking statement made by the Company.

View source version on businesswire.com: https://www.businesswire.com/news/home/20241223043072/en/

Investor Contact: [email protected]

Media Contact: [email protected]

KEYWORDS: Colorado United States North America

INDUSTRY KEYWORDS: Environment Construction & Property Finance Professional Services Building Systems Alternative Energy Green Technology Energy Asset Management Residential Building & Real Estate

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Terreno Realty Corporation Announces Lease in Hialeah, FL

BELLEVUE, Wash.–(BUSINESS WIRE)–Terreno Realty Corporation (NYSE:TRNO), an acquirer, owner and operator of industrial real estate in six major coastal U.S. markets, announced today that it has pre-leased 50% of Countyline Corporate Park Phase IV Building 32 in Hialeah, Florida. The ten-year lease for 82,000 square feet, with an aircraft engine maintenance, repair and overhaul provider, will commence upon completion of building construction and tenant improvements expected to be in June 2025. Currently under construction, Building 32 of Terreno Realty Corporation’s Countyline Corporate Park is a 164,000 square foot 36-foot clear height rear-load industrial distribution building on 8.3 acres with 53 dock-high and two grade-level loading positions and parking for 148 cars. The building is expected to achieve LEED certification, the total expected investment is $41.9 million and the estimated stabilized cap rate is 6.0%.

Countyline Corporate Park Phase IV consists of a 121-acre project entitled for 2.2 million square feet of industrial distribution buildings in Miami’s Countyline Corporate Park (“Countyline”), immediately adjacent to Terreno Realty Corporation’s seven buildings within Countyline (Countyline Corporate Park Phase III). Countyline is a landfill redevelopment adjacent to Florida’s Turnpike and the southern terminus of I-75 located at the intersection of NW 170th Street and NW 107th Avenue. At expected completion in 2027, Countyline Corporate Park Phase IV is expected to contain ten LEED-certified industrial distribution buildings totaling approximately 2.2 million square feet providing 660 dock-high and 22 grade-level loading positions and parking for 1,875 cars for a total expected investment of approximately $511.5 million.

Taken together, Terreno Realty Corporation’s Countyline Corporate Park Phase III and IV will contain 17 industrial distribution buildings and 3.5 million square feet.

Estimated stabilized cap rates are calculated as annualized cash basis net operating income stabilized to market occupancy (generally 95%) divided by total acquisition cost. Total acquisition cost includes the initial purchase price, the effects of marking assumed debt to market, buyer’s due diligence and closing costs, estimated near-term capital expenditures and leasing costs necessary to achieve stabilization.

Terreno Realty Corporation acquires, owns and operates industrial real estate in six major coastal U.S. markets: New York City/Northern New Jersey; Los Angeles; Miami; San Francisco Bay Area; Seattle and Washington, D.C.

Additional information about Terreno Realty Corporation is available on the company’s web site at www.terreno.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the federal securities laws. We caution investors that forward-looking statements are based on management’s beliefs and on assumptions made by, and information currently available to, management. When used, the words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “project,” “result,” “should,” “will,” “seek,” “target,” “see,” “likely,” “position,” “opportunity,” “outlook,” “potential,” “enthusiastic,” “future” and similar expressions which do not relate solely to historical matters are intended to identify forward-looking statements. These statements are subject to risks, uncertainties, and assumptions and are not guarantees of future performance, which may be affected by known and unknown risks, trends, uncertainties, and factors that are beyond our control, including risks related to our ability to meet our estimated forecasts related to stabilized cap rates and those risk factors contained in our Annual Report on Form 10-K for the year ended December 31, 2023 and our other public filings. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated, estimated, or projected. We expressly disclaim any responsibility to update our forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by law. Accordingly, investors should use caution in relying on past forward-looking statements, which are based on results and trends at the time they are made, to anticipate future results or trends.

View source version on businesswire.com: https://www.businesswire.com/news/home/20241127442325/en/

Jaime Cannon

415-655-4580

KEYWORDS: Florida Washington United States North America

INDUSTRY KEYWORDS: Commercial Building & Real Estate Construction & Property REIT

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Cadre Holdings Announces Expansion to Credit Facilities

Upsized $590 Million Facility Enhances Flexibility to Support Long-Term Acquisition Strategy and Growth Objectives

JACKSONVILLE, Fla.–(BUSINESS WIRE)–
Cadre Holdings, Inc. (NYSE: CDRE) (“Cadre” or “the Company”), a global leader in the manufacturing and distribution of safety equipment and other related products for the law enforcement, first responder, military and nuclear markets, today announced the closing of a new credit agreement that provides senior secured credit facilities of up to $590 million and matures in five years.

The financing consists of a five-year undrawn revolving credit facility of $175 million, a five-year term loan facility of $225 million, as well as two delayed draw term loans of up to $115 million and $75 million, respectively (collectively, the “Credit Facilities”). The revolving credit facility and $225 million term loan are expected to be used for working capital and general corporate purposes, as well as to refinance existing outstanding debt. Subject to the conditions contained in the Credit Facilities, the $115 million delayed draw term loan is available to the Company for six months from the closing of the facilities to support current acquisition activity, while the $75 million delayed draw term facility is available to the Company for eighteen months from the closing to support future opportunities. The $75 million delayed draw term facility is also available for general corporate purposes. Combined with the approximately $93.0 million of cash and cash equivalents as of September 30, 2024, this provides Cadre with approximately $458.0 million of capital to pursue its growth objectives.

“This strategic refinancing provides more scale and financial flexibility with favorable terms and extended maturities, enabling Cadre to continue to proactively seek to capitalize on meaningful organic and inorganic growth opportunities,” said Warren Kanders, CEO and Chairman. “The agreement includes up to $190 million of delayed draw term loans, which, subject to the conditions contained in the Credit Facilities, are available as we actively pursue deals in our M&A funnel consistent with our patient and disciplined approach. We appreciate the strong support of our banking group and welcome new long-term financing partners, which is a testament to their confidence in our businesses’ attractive fundamentals moving forward.”

PNC Bank is the administrative agent and left-lead arranger. Bank of America, Regions Bank, US Bank and Bank of Montreal acted as Joint Lead Arrangers on the Credit Facilities. Additional lenders are Wells Fargo, SouthState Bank and EverBank.

About Cadre

Headquartered in Jacksonville, Florida, Cadre is a global leader in the manufacturing and distribution of safety products. Cadre’s equipment provides critical protection to allow users to safely and securely perform their duties and protect those around them in hazardous or life-threatening situations. The Company’s core products include body armor, explosive ordnance disposal equipment, duty gear and nuclear safety products. Our highly engineered products are utilized in over 100 countries by federal, state and local law enforcement, fire and rescue professionals, explosive ordnance disposal teams, and emergency medical technicians. Our key brands include Safariland® and Med-Eng®, amongst others.

Forward-Looking Statements

Please note that in this press release we may use words such as “appears,” “anticipates,” “believes,” “plans,” “expects,” “intends,” “future,” and similar expressions which constitute forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are made based on our expectations and beliefs concerning future events impacting the Company and therefore involve a number of risks and uncertainties. We caution that forward-looking statements are not guarantees and that actual results could differ materially from those expressed or implied in the forward-looking statements. Potential risks and uncertainties that could cause the actual results of operations or financial condition of the Company to differ materially from those expressed or implied by forward-looking statements in this release, include, but are not limited to, those risks and uncertainties more fully described from time to time in the Company’s public reports filed with the Securities and Exchange Commission, including under the section titled “Risk Factors” in the Company’s Annual Report on Form 10-K, and/or Quarterly Reports on Form 10-Q, as well as in the Company’s Current Reports on Form 8-K. All forward-looking statements included in this press release are based upon information available to the Company as of the date of this press release and speak only as of the date hereof. We assume no obligation to update any forward-looking statements to reflect events or circumstances after the date of this press release.

View source version on businesswire.com: https://www.businesswire.com/news/home/20241222354010/en/

Contact:

Gray Hudkins

Cadre Holdings, Inc.

203 550 7148

[email protected]

Investor Relations:

The IGB Group

Leon Berman / Matt Berkowitz

212 477 8438 / 212 227 7098

[email protected] / [email protected]

Media Contact:

Jonathan Keehner / Andrew Siegel

Joele Frank, Wilkinson Brimmer Katcher

212 355 4449

KEYWORDS: Florida United States North America

INDUSTRY KEYWORDS: Defense Manufacturing Energy Military Other Manufacturing Nuclear

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Posted on December 23, 2024 9:09 am

PACS GROUP (NYSE: PACS) INVESTOR ALERT: Berger Montague Advises Investors to Inquire About a Securities Fraud Class Action

PHILADELPHIA, Dec. 23, 2024 (GLOBE NEWSWIRE) — Berger Montague PC advises investors that a securities class action lawsuit has been filed against PACS Group, Inc. (“PACS” or the “Company”) (NYSE: PACS) on behalf of purchasers of PACS securities between April 8, 2024 through November 21, 2024, inclusive (the “Class Period”).

Investor Deadline: Investors who purchased or acquired PACS securities during the Class Period may, no later than


JANUARY 13, 2025


, seek to be appointed as a lead plaintiff representative of the class. For additional information or to learn how to participate in this litigation, please contact Berger Montague: Andrew Abramowitz at




[email protected]




or (215) 875-3015, or Peter Hamner at




[email protected]




,


or




CLICK HERE


.

Headquartered in Farmington, Utah, PACS operates skilled nursing facilities and post-acute care facilities in the U.S.

According to the lawsuit, throughout the Class Period, Defendants failed to disclose that: (a) PACS inflated its Medicare revenues by misclassifying lower-acuity patients as high-acuity patients that required skilled care in violation of a Covid-era waiver, thereby securing higher reimbursement rates; and (b) that after the expiration of the COVID-era waiver, PACS inflated its revenues by fraudulently billing for unnecessary treatments and for services never provided to patients.

On November 4, 2024, Hindenburg Research published a report alleging that, among other things, PACS misused COVID waivers to inflate Medicare reimbursements, as well as engaging in other revenue practices which misrepresented the Company’s financial health. On this news, PACS’ share price dropped $11.93 per share – 27.8 percent – to close at $31.01 per share on November 4, 2024.

Then, on November 6, 2024, the Company announced that it would delay the release of its third-quarter 2024 financial results due to an investigation by the Company’s Audit Committee into recent allegations concerning its reimbursement and referral practices. PACS also disclosed that it had received civil investigative demands from the federal government regarding these practices. On this news, PACS’ share price dropped $11.45 per share – 38.8 percent – to close at $18.09 per share on November 6, 2024.

Learn More About the Lawsuit

A lead plaintiff is a representative party who acts on behalf of all class members in directing the litigation. The lead plaintiff is usually the investor or small group of investors who have the largest financial interest and who are also adequate and typical of the proposed class of investors. The lead plaintiff selects counsel to represent the lead plaintiff and the class and these attorneys, if approved by the court, are lead or class counsel. Your ability to share in any recovery is not, however, affected by the decision whether or not to serve as a lead plaintiff. Communicating with any counsel is not necessary to participate or share in any recovery achieved in this case. Any member of the purported class may move the Court to serve as a lead plaintiff through counsel of his/her choice, or may choose to do nothing and remain an inactive class member.

Berger Montague, with offices in Philadelphia, Minneapolis, Delaware, Washington, D.C., San Diego, San Francisco and Chicago, has been a pioneer in securities class action litigation since its founding in 1970. Berger Montague has represented individual and institutional investors for over five decades and serves as lead counsel in courts throughout the United States.

Contact:

Andrew Abramowitz, Senior Counsel
Berger Montague
(215) 875-3015
[email protected]  

Peter Hamner
Berger Montague PC
[email protected]

Posted on December 23, 2024 9:08 am

Thryv Introduces Reporting Center to Give Small Businesses Easy Access to Critical Insights

Thryv Introduces Reporting Center to Give Small Businesses Easy Access to Critical Insights

Reports are designed to help businesses make data-informed decisions

DALLAS–(BUSINESS WIRE)–Thryv® (NASDAQ: THRY), the leading do-it-all small business software platform, has launched Thryv Reporting Center™ which provides the data-driven insights small businesses need to grow and run their business. Thryv’s new reporting capabilities are designed specifically for small businesses, delivering key business metrics in a visual format, complete with mobile access, for business owners looking to reduce inefficiencies, improve customer experience and propel sales.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20241223389363/en/

Thryv Reporting Center provides timely insights that small businesses can use to assess the effectiveness of their efforts in areas like sales and marketing so they can quickly pivot when new trends emerge. (Photo: Business Wire)

The Value of Thryv Reporting Center

Data is the backbone of successful businesses, regardless of size. Thryv Reporting Center provides timely insights that small businesses can use to assess the effectiveness of their efforts in areas like sales and marketing so they can quickly pivot when new trends emerge.

Thryv offers five out-of-box reports that highlight simplicity while providing the metrics that matter:

• Sales: a review of the sales process can help address bottlenecks, ensure timely payments and identify new ways to generate revenue.

• Know Your Customer: a visual depiction of the end-to-end customer journey to gain insights into customer preferences and determine the most profitable ones.

• Team Activity: measurement of team performance helps identify both high-performers and areas for improvement.

• Appointments: identifying peak or high traffic times can help balance workloads and improve business performance.

• SMS and Email Marketing: with a clear picture of campaign performance, SMBs can optimize what is working and move on from what isn’t.

Customization and Mobile Access

Clients can easily build their own customized reports or select from Thryv Reporting Center’s template library by selecting specific metrics and ready-to-use charts. Clients can also zero in on key metrics to gain insights into their business with a detailed view. All reports are mobile-accessible so business owners can make timely decisions wherever they are.

“It’s critical that small businesses have a quick, easy and accurate look at their performance so they can make the best decisions based on trusted data,” said Rees Johnson, Chief Product Officer of Thryv. “With Thryv Reporting Center, small businesses can access charts and graphs that provide a clear view of how they can best resource their business and provide their customers with exactly what they want.”

For more information on Thryv Reporting Center, click here.

ABOUT THRYV

Thryv Holdings, Inc. (NASDAQ:THRY) is the provider of the leading sales and marketing platform designed to help small businesses attract new and repeat customers. Thryv software offers SMBs everything they need to manage day-to-day operations and grow efficiently. The platform’s AI-supported marketing and business automations help business owners save time, compete, and win. More than 100K businesses globally use Thryv software to connect with customers and run and grow their business. For more information, visit www.thryv.com.

View source version on businesswire.com: https://www.businesswire.com/news/home/20241223389363/en/

Media Contact:

Julie Murphy

Thryv, Inc.

617.967.5426

[email protected]

Investor Contact:

Cameron Lessard

Thryv, Inc.

214.773.7022

[email protected]

KEYWORDS: Texas United States North America

INDUSTRY KEYWORDS: Mobile/Wireless Technology Marketing Communications Professional Services Software Small Business Data Analytics Data Management Artificial Intelligence

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Thryv Reporting Center provides timely insights that small businesses can use to assess the effectiveness of their efforts in areas like sales and marketing so they can quickly pivot when new trends emerge. (Photo: Business Wire)

Puma Biotechnology’s NERLYNX^® Included in NCCN Clinical Practice Guidelines for the Treatment of Cervical Cancer with a HER2 Mutation

LOS ANGELES–(BUSINESS WIRE)–
Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, announced that the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology (NCCN Guidelines^®) for Cervical Cancer were updated to include an addition involving neratinib (NERLYNX®).

The updated NCCN Practice Guidelines for Cervical Cancer include neratinib monotherapy for use as second-line or subsequent therapy for recurrent or metastatic disease as an option for patients with HER2-mutated tumors with a designation of Category 2A. The NCCN Guidelines Category of Preference is designated as “useful in certain circumstances” as a treatment option for patients with HER2-mutated tumors.

This addition was based on results from the Phase II SUMMIT trial (NCT01953926), which enrolled a cohort of patients who were required to have histologically confirmed recurrent/metastatic cervical cancer for which no curative treatment existed, along with documented evidence of a somatic, activating HER2 mutation (Friedman CF, D’Souza A, Bello Roufai D, et al. Targeting HER2-mutant metastatic cervical cancer with neratinib: Final results from the Phase II SUMMIT basket trial. Gynecol Oncol. 2024;181:162-169. doi: 10.1016/j.ygyno.2023.12.004).

Alan H. Auerbach, Chief Executive Officer and President of Puma, said, “We are pleased with the additional inclusion of neratinib in the NCCN Guidelines for Cervical Cancer for patients with HER2 activating mutations. Physicians use the NCCN Guidelines as the standard resource for determining the best course of treatment for patients. We believe the updated NCCN guidelines will increase awareness, which will help assist patients, their caregivers and their healthcare providers in making informed decisions while treating this significant unmet need in advanced cervical cancer.”

About HER2-Mutated Cervical Cancer

Despite recent advancements in the therapeutic landscape for recurrent and metastatic cervical cancer, there is a need to identify robust biomarkers to direct therapy choices to target mutational drivers. Somatic HER2 (ERBB2) mutations have been reported in up to 9% ^1,2,3 of cervical cancers and are associated with poor prognosis ^1,2. In a recent real-world study, prospective genomic profiling of cervical cancer patients identified HER2 mutations as one of the more prevalent genomic alterations in the studied cervical cancer population³.

About the National Comprehensive Cancer Network

The National Comprehensive Cancer Network® (NCCN®) is a not-for-profit alliance of leading cancer centers devoted to patient care, research, and education. NCCN is dedicated to improving and facilitating quality, effective, efficient, and accessible cancer care so patients can live better lives. The NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) provide transparent, evidence-based, expert consensus recommendations for cancer treatment, prevention, and supportive services; they are the recognized standard for clinical direction and policy in cancer management and the most thorough and frequently updated clinical practice guidelines available in any area of medicine. The NCCN Guidelines for Patients® provide expert cancer treatment information to inform and empower patients and caregivers, through support from the NCCN Foundation®. NCCN also advances continuing education, global initiatives, policy, and research collaboration and publication in oncology. Visit NCCN.org for more information.

About Puma Biotechnology

Puma Biotechnology, Inc. is a biopharmaceutical company with a focus on the development and commercialization of innovative products to enhance cancer care. Puma in-licensed the global development and commercialization rights to PB272 (neratinib, oral), in 2011. Neratinib, oral was approved by the U.S. Food and Drug Administration in 2017 for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, following adjuvant trastuzumab-based therapy, and is marketed in the United States as NERLYNX® (neratinib) tablets. In February 2020, NERLYNX was also approved by the FDA in combination with capecitabine for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting. NERLYNX was granted marketing authorization by the European Commission in 2018 for the extended adjuvant treatment of adult patients with early stage hormone receptor-positive HER2-overexpressed/amplified breast cancer and who are less than one year from completion of prior adjuvant trastuzumab-based therapy. NERLYNX® is a registered trademark of Puma Biotechnology, Inc.

In September 2022, Puma entered into an exclusive license agreement for the development and commercialization of the anti-cancer drug alisertib, a selective, small molecule, orally administered inhibitor of aurora kinase A. Initially, Puma intends to focus the development of alisertib on the treatment of small cell lung cancer and breast cancer. In February 2024, Puma initiated ALISCA™-Lung1, a Phase II clinical trial of alisertib monotherapy for the treatment of patients with extensive-stage small cell lung cancer. In November 2024, Puma initiated ALISCA™-Breast1, a Phase II clinical trial of alisertib in combination with endocrine therapy for the treatment of patients with HER2-negative, HR-positive metastatic breast cancer.

To help ensure patients have access to NERLYNX, Puma has implemented the Puma Patient Lynx support program to assist patients and healthcare providers with reimbursement support and referrals to resources that can help with financial assistance. More information on the Puma Patient Lynx program can be found at https://www.NERLYNX.com or by dialing 1-855-816-5421.

Further information about Puma Biotechnology may be found at https://www.pumabiotechnology.com.

INDICATIONS

• NERLYNX® (neratinib) tablets, for oral use, is a kinase inhibitor indicated:

• As a single agent, for the extended adjuvant treatment of adult patients with early stage HER2-positive breast cancer, to follow adjuvant trastuzumab-based therapy.

• In combination with capecitabine, for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer, who have received two or more prior anti-HER2 based regimens in the metastatic setting.

Important Safety Information Regarding NERLYNX® (neratinib) U.S. Indication

CONTRAINDICATIONS: None

WARNINGS AND PRECAUTIONS:

• Diarrhea: Manage diarrhea through either NERLYNX dose escalation or loperamide prophylaxis. If diarrhea occurs despite recommended prophylaxis, treat with additional antidiarrheals, fluids, and electrolytes as clinically indicated. Withhold NERLYNX in patients experiencing severe and/or persistent diarrhea. Permanently discontinue NERLYNX in patients experiencing Grade 4 diarrhea or Grade ≥ 2 diarrhea that occurs after maximal dose reduction.

• Hepatotoxicity: Monitor liver function tests monthly for the first 3 months of treatment, then every 3 months while on treatment and as clinically indicated. Withhold NERLYNX in patients experiencing Grade 3 liver abnormalities and permanently discontinue NERLYNX in patients experiencing Grade 4 liver abnormalities.

• Embryo-Fetal Toxicity: NERLYNX can cause fetal harm. Advise patients of potential risk to a fetus and to use effective contraception.

ADVERSE REACTIONS: The most common adverse reactions (reported in ≥ 5% of patients) were as follows:

• NERLYNX as a single agent: Diarrhea, nausea, abdominal pain, fatigue, vomiting, rash, stomatitis, decreased appetite, muscle spasms, dyspepsia, AST or ALT increased, nail disorder, dry skin, abdominal distention, epistaxis, weight decreased, and urinary tract infection.

• NERLYNX in combination with capecitabine: Diarrhea, nausea, vomiting, decreased appetite, constipation, fatigue/asthenia, weight decreased, dizziness, back pain, arthralgia, urinary tract infection, upper respiratory tract infection, abdominal distention, renal impairment, and muscle spasms.

To report SUSPECTED ADVERSE REACTIONS, contact Puma Biotechnology, Inc. at 1-844-NERLYNX (1-844-637-5969) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS:

• Gastric acid reducing agents: Avoid concomitant use with proton pump inhibitors. Separate NERLYNX by at least 2 hours before or 10 hours after H2-receptor antagonists. Or separate NERLYNX by at least 3 hours with antacids.

• Strong CYP3A4 inhibitors: Avoid concomitant use.

• P-gp and moderate CYP3A4 dual inhibitors: Avoid concomitant use.

• Strong or moderate CYP3A4 inducers: Avoid concomitant use.

• Certain P-gp substrates: Monitor for adverse reactions of P-gp substrates for which minimal concentration change may lead to serious adverse reactions when used concomitantly with NERLYNX.

USE IN SPECIFIC POPULATIONS:

• Lactation: Advise women not to breastfeed.

Please see Full Prescribing Information for additional safety information.

¹ Xiang L, Jiang W, Ye S, He T, Pei X, Li J, et al. ERBB2 mutation: A promising target in non-squamous cervical cancer. Gynecol Oncol. 2018;148(2):311-316.

² Zammataro L, Lopez S, Bellone S, Pettinella F, Bonazzoli E, Perrone E, et al. Whole-exome sequencing of cervical carcinomas identifies activating ERBB2 and PIK3CA mutations as targets for combination therapy. Proc Natl Acad Sci U S A. 2019;116(45):22730-22736.

³ Friedman CF, Ravichandran V, Miller K, et al. Assessing the genomic landscape of cervical cancers: clinical opportunities and therapeutic targets. Clin Cancer Res. 2023;29(22):4660-4668. doi: 10.1158/1078-0432.CCR-23-1078. PMID: 37643132; PMCID: PMC10644000.

View source version on businesswire.com: https://www.businesswire.com/news/home/20241223490944/en/

Alan H. Auerbach or Mariann Ohanesian, Puma Biotechnology, Inc., +1 424 248 6500

[email protected]

[email protected]

David Schull or Olipriya Das, Russo Partners, +1 212 845 4200

[email protected]

[email protected]

KEYWORDS: California United States North America

INDUSTRY KEYWORDS: Science Other Science Biotechnology Research Pharmaceutical Oncology Health Clinical Trials

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