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UAVS Long-Term Investor Alert: Did You Acquire AgEagle Before September 3, 2019? Should Management be Held Accountable for Investors Losses?

PR Newswire

SAN DIEGO, July 10, 2021 /PRNewswire/ — Johnson Fistel, LLP is investigating potential claims on behalf of AgEagle Aerial Systems Inc. (“AgEagle” or the “Company”) (NYSE: UAVS) against certain of its officers and directors. 

Recently a class action lawsuit was filed in federal court against the Company on behalf of purchasers of the securities of AgEagle from September 3, 2019 and February 18, 2021 (the “Class Period”).

According to the lawsuit, defendants throughout the Class Period made false and misleading statements and failed to disclose that: (1) AgEagle did not have a partnership with Amazon and, in fact, never had any relationship with Amazon; (2) rather than correct the public’s understanding about a partnership with Amazon, defendants were actively contributing to the rumor that AgEagle had a partnership with Amazon; and (3) as a result, defendants’ statements about AgEagle’s business, operations, and prospects, were materially false and misleading and lacked a reasonable basis at all relevant times. When the true details entered the market, the lawsuit claims that investors suffered damages.


If you are a current, long-term shareholder of


AgEagle Inc


, holding shares before


September 3, 2019
, you may have standing to hold AgEagle harmless from the alleged harm caused by the officers and directors of the Company by making them personally responsible. You may also be able to assist in reforming the Company’s corporate governance to prevent future wrongdoing. 

If you are interested in learning more about the investigation, please contact lead analyst Jim Baker ([email protected]) at 619-814-4471. If emailing, please include a phone number. 


Additionally, if you are a current, long-term shareholder of


AgEagle


, holding shares before



September 3, 2019

, you can [Click here to join this action]. There is no cost or obligation to you.

About Johnson Fistel, LLP:
Johnson Fistel, LLP is a nationally recognized shareholder rights law firm with offices in California, New York and Georgia. The firm represents individual and institutional investors in shareholder derivative and securities class action lawsuits. For more information about the firm and its attorneys, please visit http://www.johnsonfistel.com. Attorney advertising.  Past results do not guarantee future outcomes.

Contact:
Johnson Fistel, LLP
Jim Baker, 619-814-4471
[email protected]

[Click here to join this action]

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SOURCE Johnson Fistel, LLP

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New Data from the Phase 3 HELP Study™ Open-Label Extension Evaluating Safety and Efficacy of TAKHZYRO® (lanadelumab) for Hereditary Angioedema Patients to be Presented at European Academy of Allergy and Clinical Immunology (EAACI) Hybrid Congress

New Data from the Phase 3 HELP Study™ Open-Label Extension Evaluating Safety and Efficacy of TAKHZYRO® (lanadelumab) for Hereditary Angioedema Patients to be Presented at European Academy of Allergy and Clinical Immunology (EAACI) Hybrid Congress

− Analysis of Safety and Efficacy for up to 2.5 years with TAKHYZRO is Consistent with Initial Period of Treatment, Building on Growing Body of Evidence on the Long-term Safety and Efficacy

− Final Patient Subgroup Analysis Suggests Reductions of HAE Attacks Across Range of Patient Demographics and Disease Characteristics with TAKHZYRO

OSAKA, Japan–(BUSINESS WIRE)–Takeda Pharmaceutical Company Limited(TSE:4502/NYSE:TAK) (“Takeda”) today announced results from two final analyses from the Phase 3 HELP (Hereditary Angioedema Long-term Prophylaxis) Study™ Open-label Extension (OLE), which evaluated the long-term safety (primary endpoint) and efficacy of TAKHZYRO® (lanadelumab) 300 mg every two weeks for up to 2.5 years. In the first analysis, the mean (min, max) reduction in the attack rate compared to baseline observed in the study population (N=212) was of 87.4 percent (-100; 852.8), and the median reduction was 97.7 percent and patients received treatment for a mean (standard deviation) duration of 29.6 (8.2) months.1 At steady state – day 70 to the end of the treatment period – attack rates were further reduced to a mean of 92.4 percent and a median reduction of 98.2 percent.2,3 An additional analysis further suggests TAKHZYRO was a well-tolerated treatment that prevented HAE attacks over an extended planned 132 week treatment period across specific HAE patient demographic and disease characteristic subgroups.3 These data are being presented at the 2021 European Academy of Allergy and Clinical Immunology (EAACI) Hybrid Congress in Krakow, Poland and Madrid, Spain.

“Hereditary angioedema is a lifelong condition and research shows that concerns about another attack can limit the way patients lead their lives,” said Prof. Markus Magerl, M.D., Department of Dermatology, Venereology and Allergology, Charité – Universitätsmedizin in Berlin, Germany. “The efficacy of TAKHZYRO to prevent HAE attacks over the long term will be an important consideration for patients and physicians as they develop a treatment plan for patients that is focused on reducing the number of HAE attacks.”

The original Phase 3 HELP Study was conducted in 125 patients aged 12 years and older over 26 weeks, making it the largest randomized, controlled prevention study in HAE, with the longest active treatment duration, to date.4 The HELP Study OLE was designed to evaluate the long-term safety (primary endpoint) and efficacy of TAKHZYRO for up to 2.5 years. The complete results were based on data collected between May 2016 and October 2019 and included 109 rollover patients who were originally evaluated in the HELP Study, and 103 eligible non-rollover patients who did not participate in the initial study but had experienced at least one HAE attack within the previous 12 weeks.1

Attack-free status during steady state of lanadelumab treatment in patients with hereditary angioedema: findings from the HELP open-label extension study (Electronic Poster Presentation: Abstract #342)

Results from the HELP Study OLE found that TAKHZYRO sustained efficacy in the prevention of HAE attacks by reducing attack rates in a treatment period of up to 132 weeks. TAKHZYRO, which has a half-life of approximately 14 days, is expected to reach steady state at approximately 70 days. The HELP Study OLE analysis of attack-free status during the steady state period showed that the efficacy of TAKHZYRO 300 mg administered subcutaneously every two weeks in rollover patients was consistent with the original findings from the HELP Study.2

The mean (min, max) reduction in the attack rate compared to baseline observed in the study population (N=212) was of 87.4 percent (-100; 852.8), and the median reduction was 97.7 percent (98.0 percent rollovers, 96.9 percent non-rollovers).1,2 At steady state, attack rates were further reduced to a mean of 92.4 percent (-100, 0.44) comprised of 92.7 percent rollovers (-100, -40.9) and 91.9 percent non-rollovers (-100, 0.44) and a median reduction of 98.2 percent (98.4 percent rollovers, 97.3 percent non-rollovers). During the first six months of treatment after day 70 during the steady-state period, 58.6 percent of patients (n=119) were attack-free, 54.7 percent rollovers and 62.9 percent non-rollovers. The maximum duration of attack-free period after day 70 ≥ 6 months was 83.7 percent and ≥ 12 months was 70 percent. The means of the average and maximum duration of attack-free period during steady state were 14.8 and 18.6 months, respectively, with 70.0 percent of patients (n=142) having a maximum duration of attack-free period greater than 12 months.2

Long-term prevention of attacks with lanadelumab across subgroups of patients with hereditary angioedema (HAE): final results from the HELP open-label extension study (Oral Presentation: Abstract #392)

In a further HELP Study OLE analysis, treatment with TAKHZYRO 300 mg every two weeks was well-tolerated and effectively reduced attack rates over an extended treatment period across different patient demographic and disease characteristics, including patient age, gender, race, HAE type, body mass index, history of long-term prophylaxis use, and baseline attack rate.3

The safety profile of TAKHZYRO was comparable across all evaluated subgroups with treatment-related TEAEs occurring in 54.7 percent of patients (n=116) and the most common being injection-site pain.3

“For more than a decade, we’ve listened to the HAE community to further understand the need for long-term, preventive targeted therapies and have committed our resources to developing treatment options,” said Neil Inhaber, M.D., Vice President, Global Medical Head, HAE and Transplant at Takeda. “These analyses further assert the important role TAKHZYRO can play in the lives of people who live with HAE.”

About The HELP Study™ Open-label Extension

The HELP (Hereditary Angioedema Long-term Prophylaxis) Study™ Open-label Extension (OLE) is an evaluation of the long-term efficacy and safety of TAKHZYRO in hereditary angioedema (HAE) patients of at least 12 years of age and older. Two hundred and twelve patients received treatment with TAKHZYRO at the start of the OLE Study (109 rollover patients originally evaluated in the HELP Study and who continued into the OLE, and 103 eligible patients who did not participate in the HELP Study but who had experienced at least one attack in the last 12 weeks). Rollover patients received a dose of 300 mg TAKHZYRO on Day 0 and then every two weeks after their first attack. Non-rollover patients were treated with one 300 mg dose every two weeks, beginning on Day 0. One hundred and ninety-six participants completed at least 12 months of treatment and 173 participants completed at least 30 months of treatment.1

About Hereditary Angioedema

Hereditary angioedema (HAE) is a rare genetic disorder that results in recurring attacks of oedema – swelling – in various parts of the body, including the abdomen, face, feet, genitals, hands and throat. The swelling can be debilitating and painful.5,6,7 Attacks that obstruct the airways can cause asphyxiation and are potentially life threatening.7,8 HAE affects an estimated 1 in 50,000 people worldwide. It is often under recognized, under diagnosed and under treated.5,7,8

Takeda in Hereditary Angioedema

Hereditary Angioedema (HAE), like so many other rare diseases, is highly complex, and patients, their families and caregivers often undergo years of strain trying to understand their disease, get a definitive diagnosis and gain access to the medicines they need. At Takeda we are a committed champion for the patients we serve. Every individual living with HAE is unique and by listening and reacting to their needs, we translate the insights we gain into innovative solutions – from diagnosis to ongoing management. Advancing the science is crucial to the way we operate and we are bold in our mission to accelerate diagnosis and develop treatments that will make a difference to the lives of HAE patients, their support networks and those medical professionals who care for them.

About TAKHZYRO® (lanadelumab)

TAKHZYRO® (lanadelumab) is indicated for routine prevention of recurrent attacks HAE in patients aged 12 years and older. TAKHZYRO is a fully human monoclonal antibody that specifically binds and decreases plasma kallikrein activity. TAKHZYRO is produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology.9

TAKHZYRO is formulated for subcutaneous administration and has a half-life of approximately two weeks in patients with HAE. TAKHZYRO is intended for the self-administration or administration by a caregiver, only after training by a healthcare professional.9

TAKHZYRO is not intended for treatment of acute HAE attacks.9

Depending on regional marketing authorization, TAKHZYRO is available as a 300 mg dose in a vial or pre-filled syringe. Please consult local prescribing information for more information.

TAKHZYRO Safety Information for Europe

Please consult the TAKHZYRO Summary Product Characteristics (SmPC) before prescribing.

TAKHZYRO treatment should be initiated under the supervision of a physician experienced in the management of patients with hereditary angioedema (HAE). TAKHZYRO may be self-administered or administered by a caregiver only after training on SC injection technique by a healthcare professional.9

Contraindication

Hypersensitivity to the active substance or to any of the excipients.9

Warnings and Precautions

Traceability: In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.9

Hypersensitivity reactions have been observed. In case of a severe hypersensitivity reaction, administration of TAKHZYRO must be stopped immediately and appropriate treatment must be initiated.9

General: TAKHZYRO is not intended for treatment of acute HAE attacks. In case of a breakthrough HAE attack, individualized treatment should be initiated with an approved rescue medication. There are no available clinical data on the use of lanadelumab in HAE patients with normal C1-INH activity.9

Interference with coagulation test: Lanadelumab can increase activated partial thromboplastin time (aPTT) due to an interaction of lanadelumab with the aPTT assay. The reagents used in the aPTT laboratory test initiate intrinsic coagulation through the activation of plasma kallikrein in the contact system. Inhibition of plasma kallikrein by lanadelumab can increase aPTT in this assay. None of the increases in aPTT in patients treated with TAKHZYRO were associated with abnormal bleeding adverse events. There were no differences in international normalised ratio (INR) between treatment groups.9

Sodium content: This medicinal product contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially ‘sodium-free’.9

Interactions

No dedicated drug-drug interaction studies have been conducted. Based on the characteristics of lanadelumab, no pharmacokinetic interactions with co-administered medicinal products is expected.9

As expected, concomitant use of the rescue medication C1 esterase inhibitor results in an additive effect on lanadelumab-cHMWK response based on the mechanism of action (MOA) of lanadelumab and C1 esterase inhibitor.9

Immunogenicity

Treatment with lanadelumab has been associated with development of treatment emergent anti-drug antibodies (ADA) in 11.9% (10/84) of subjects. All antibody titres were low. The ADA response was transient in 20% (2/10) of ADA positive subjects. 2.4% (2/84) of lanadelumab-treated subjects tested positive for neutralizing antibodies.9

The development of ADA including neutralising antibodies against TAKHZYRO did not appear to adversely affect the pharmacokinetic (PK) and pharmacodynamics (PD) profiles or clinical response.9

Adverse Reactions

The most commonly observed adverse reaction (52.4%) associated with TAKHZYRO was injection site reactions (ISR) including injection site pain, injection site erythema and injection site bruising. Of these ISRs, 97% were of mild intensity, 90% resolved within 1 day after onset with a median duration of 6 minutes.9

Hypersensitivity reaction (mild and moderate pruritus, discomfort and tingling of tongue) was observed (1.2%)

Very common

(frequency ≥1/10):

Injection site reactions*

Common

(≥1/100 to <1/10):

Hypersensitivity**, dizziness, rash maculopapular, myalgia, alanine aminotransferase increased, aspartate aminotransferase increased.

*Injection site reactions include: pain, erythema, bruising, discomfort, haematoma, haemorrhage, pruritus, swelling, induration, paraesthesia, reaction, warmth, oedema and rash.

** Hypersensitivity includes: pruritus, discomfort and tingling of tongue.

For European Union Summary of Product Characteristics, please visit https://www.ema.europa.eu/en/documents/product-information/takhzyro-epar-product-information_en.pdf.

For full U.S. Prescribing Information, including the approved indication and important safety information, please visithttps://www.shirecontent.com/PI/PDFs/TAKHZYRO_USA_ENG.pdf.

About Takeda Pharmaceutical Company Limited

Takeda Pharmaceutical Company Limited (TSE: 4502/NYSE: TAK) is a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan, committed to discover and deliver life-transforming treatments, guided by our commitment to patients, our people and the planet. Takeda focuses its R&D efforts on four therapeutic areas: Oncology, Rare Genetics and Hematology, Neuroscience, and Gastroenterology (GI). We also make targeted R&D investments in Plasma-Derived Therapies and Vaccines. We are focusing on developing highly innovative medicines that contribute to making a difference in people’s lives by advancing the frontier of new treatment options and leveraging our enhanced collaborative R&D engine and capabilities to create a robust, modality-diverse pipeline. Our employees are committed to improving quality of life for patients and to working with our partners in health care in approximately 80 countries. For more information, visit https://www.takeda.com.

Important Notice

For the purposes of this notice, “press release” means this document, any oral presentation, any question and answer session and any written or oral material discussed or distributed by Takeda Pharmaceutical Company Limited (“Takeda”) regarding this release. This press release (including any oral briefing and any question-and-answer in connection with it) is not intended to, and does not constitute, represent or form part of any offer, invitation or solicitation of any offer to purchase, otherwise acquire, subscribe for, exchange, sell or otherwise dispose of, any securities or the solicitation of any vote or approval in any jurisdiction. No shares or other securities are being offered to the public by means of this press release. No offering of securities shall be made in the United States except pursuant to registration under the U.S. Securities Act of 1933, as amended, or an exemption therefrom. This press release is being given (together with any further information which may be provided to the recipient) on the condition that it is for use by the recipient for information purposes only (and not for the evaluation of any investment, acquisition, disposal or any other transaction). Any failure to comply with these restrictions may constitute a violation of applicable securities laws. The companies in which Takeda directly and indirectly owns investments are separate entities. In this press release, “Takeda” is sometimes used for convenience where references are made to Takeda and its subsidiaries in general. Likewise, the words “we”, “us” and “our” are also used to refer to subsidiaries in general or to those who work for them. These expressions are also used where no useful purpose is served by identifying the particular company or companies.

Forward-Looking Statements

This press release and any materials distributed in connection with this press release may contain forward-looking statements, beliefs or opinions regarding Takeda’s future business, future position and results of operations, including estimates, forecasts, targets and plans for Takeda. Without limitation, forward-looking statements often include words such as “targets”, “plans”, “believes”, “hopes”, “continues”, “expects”, “aims”, “intends”, “ensures”, “will”, “may”, “should”, “would”, “could” “anticipates”, “estimates”, “projects” or similar expressions or the negative thereof. These forward-looking statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those expressed or implied by the forward-looking statements: the economic circumstances surrounding Takeda’s global business, including general economic conditions in Japan and the United States; competitive pressures and developments; changes to applicable laws and regulations, including global health care reforms; challenges inherent in new product development, including uncertainty of clinical success and decisions of regulatory authorities and the timing thereof; uncertainty of commercial success for new and existing products; manufacturing difficulties or delays; fluctuations in interest and currency exchange rates; claims or concerns regarding the safety or efficacy of marketed products or product candidates; the impact of health crises, like the novel coronavirus pandemic, on Takeda and its customers and suppliers, including foreign governments in countries in which Takeda operates, or on other facets of its business; the timing and impact of post-merger integration efforts with acquired companies; the ability to divest assets that are not core to Takeda’s operations and the timing of any such divestment(s); and other factors identified in Takeda’s most recent Annual Report on Form 20-F and Takeda’s other reports filed with the U.S. Securities and Exchange Commission, available on Takeda’s website at: https://www.takeda.com/investors/reports/sec-filings/ or at www.sec.gov. Takeda does not undertake to update any of the forward-looking statements contained in this press release or any other forward-looking statements it may make, except as required by law or stock exchange rule. Past performance is not an indicator of future results and the results or statements of Takeda in this press release may not be indicative of, and are not an estimate, forecast, guarantee or projection of Takeda’s future results.

Medical information

This press release contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development.

1 Banerji A, Hao J, Ming Y et al; Long-Term Efficacy and Safety of Lanadelumab: Final Results from the HELP Open-Label Extension Study. ACAAI 2020.

2 Magerl M, Johnston D, et al. Attack-free status during steady state of lanadelumab treatment in patients with hereditary angioedema: findings from the HELP open-label extension study.EAACI 2021.

3 Maurer M, Bernstein J, et al. Long-term prevention of attacks with lanadelumab across subgroups of patients with hereditary angioedema (HAE): final results from the HELP open-label extension study. EAACI 2021.

4 Banerji A, Riedl MA, Bernstein JA, et al; for the HELP Investigators. Effect of lanadelumab compared with placebo on prevention of hereditary angioedema attacks: a randomized clinical trial. JAMA. 2018;320(20):2108-2121.

5 Cicardi M, Bork K, Caballero T, et al; on behalf of HAWK (Hereditary Angioedema International Working Group). Evidence-based recommendations for the therapeutic management of angioedema owing to hereditary C1 inhibitor deficiency: consensus report of an International Working Group. Allergy. 2012; 67(2):147-157.

6 Zuraw BL. Hereditary angioedema. N Engl J Med. 2008;359(10):1027-1036.

7 Banerji A. The burden of illness in patients with hereditary angioedema. Ann Allergy Asthma Immunol. 2013;111(5):329-336.

8 Longhurst HJ, Bork K. Hereditary angioedema: causes, manifestations, and treatment. Br J Hosp Med. 2006;67(12):654-657.

9 TAKHZYRO (lanadelumab) European Summary of Product Characteristics.

Media Contacts:

Japanese Media

Ryoko Matsumoto

[email protected]

+81 (0) 3-3278-3414

Media Outside Japan

Linda Calandra

[email protected]

+1 617-301-2092

KEYWORDS: Europe Japan Asia Pacific

INDUSTRY KEYWORDS: Biotechnology Pharmaceutical Health Clinical Trials

MEDIA:

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Total Specialties USA and Mighty Distributing System enter new partnership

PR Newswire

LINDEN, N.J., July 9, 2021 /PRNewswire/ — Total Specialties USA is proud to announce a new partnership with auto parts wholesaler, Mighty Distributing System (Mighty Auto Parts), a leader in automotive aftermarket products and services. The TotalEnergies range of lubricants will be available in the Mighty network and will initially focus primarily on the Quartz Ineo & Quartz 9000 sub-ranges, designed for light vehicles and which exceed the most demanding requirements for European OEMs.

Total Specialties USA is proud to announce a new partnership with auto parts wholesaler, Mighty Distributing System.

The Quartz Ineo and Quartz 9000 Energy ranges are formulated with Age-Resistance Technology to provide unbeatable engine protection with the highest level of performance and durability. The unique combination of hyperactive molecules creates a strong thick oil film on all concerned engine parts. Engines are protected against a variety of challenges, from wear to oil oxidation even at extreme temperatures and outstanding engine performance, even under frequent stop and start conditions.

“At Total Specialties USA, we share the same beliefs and values as Mighty: proximity, focus to create value for customers, innovation and sustainability. We are excited to have the opportunity to grow the business of Mighty franchises together here in the United States,” according to Senior VP of Lubricants for Total Specialties USA, Franck Bagouet.

“The addition of TotalEnergies’ range of lubricants to our product offerings reinforces our commitment to serve the ever-changing automotive service industry and our nationwide network of franchises with direct sourcing of quality automotive aftermarket products,” said VP of Operations for Mighty Distributing System, Sean Milligan.

About Mighty Distributing System

Headquartered in Peachtree Corners, GA, Mighty supports 100 franchised distributors in 44 U.S. states and five international markets. The Mighty System features local service, inventory management expertise, and training in conjunction with extensive offerings of OE quality underhood and undercar parts, chemical products, lubricants, shop supplies, and PPE products. The Mighty business model attracts independent repair shops, quick lubes, tire centers and new car dealerships across the nation and abroad. Mighty’s unique approach of dealing directly and exclusively with automotive professionals began in 1963.

About Total Specialties USA, Inc.        

Headquartered in Houston, Texas, Total Specialties USA, Inc. is a part of the Americas Division for the Marketing & Services Branch of the TotalEnergies company. Total Specialties USA, Inc. offers a wide range of lubricant products including Quartz synthetic performance engine oils. Our products are sold through a comprehensive network of distributors, direct channels and an online presence.

services.us.totalenergies.com

About the Marketing & Services division of 
TotalEnergies
TotalEnergies’ Marketing & Services business segment offers its professional and private customers a wide range of broad energy products and services—petroleum products, biofuels, charging and related services for electric vehicles, gas for road and maritime transportation—to support them in their mobility and help them reduce their carbon footprint. Every day, over 8 million customers visit our 16,000 service-stations all over the world. As the world’s number four in lubricants, we design and sell high-performance products for the automotive, industrial and maritime sectors. And to provide the best response to the needs of our B2B customers, we deploy our sales forces, our international logistics network and our diverse offering. We operate in 107 countries, where our 31,000 employees stand close to all of our customers. 

About TotalEnergies
TotalEnergies is a broad energy company that produces and markets energies on a global scale: oil and biofuels, natural gas and green gases, renewables and electricity. Our 105,000 employees are committed to energy that is ever more affordable, clean, reliable and accessible to as many people as possible. Active in more than 130 countries, TotalEnergies puts sustainable development in all its dimensions at the heart of its projects and operations to contribute to the well-being of people.

Cautionary note 

This press release, from which no legal consequences may be drawn, is for information purposes only. The entities in which TotalEnergies S E directly or indirectly owns investments are separate legal entities. TotalEnergies S E has no liability for their acts or omissions. In this document, the terms “TotalEnergies”, “TotalEnergies Group” and Group are sometimes used for convenience. Likewise, the words “we”, “us” and “our” may also be used to refer to subsidiaries in general or to those who work for them.

This document may contain forward-looking information and statements that are based on a number of economic data and assumptions made in a given economic, competitive and regulatory environment. They may prove to be inaccurate in the future and are subject to a number of risk factors. Neither TotalEnergies S E nor any of its subsidiaries assumes any obligation to update publicly any forward-looking information or statement, objectives or trends contained in this document whether as a result of new information, future events or otherwise.

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SOURCE TotalEnergies

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NexPoint Strategic Opportunities Fund Extends Offer to Purchase Up to All Shares of United Development Funding IV (UDFI)

DALLAS, July 09, 2021 (GLOBE NEWSWIRE) — NexPoint Strategic Opportunities Fund (NYSE:NHF) (“NHF”) today announced the extension of the offering period for its previously announced offer to purchase any and all Shares of Beneficial Interest (the “Shares”) of United Development Funding IV (“UDFI” or the “Company”) at a price of $1.10 per Share upon the terms and subject to the conditions set forth in the Offer to Purchase and in the related Assignment Form for the offer (which together constitute the “Offer” and the “Tender Offer Documents”). The Offer is now scheduled to expire at 12:00 midnight, Eastern Time, at the end of the day on August 5, 2021, unless the Offer is extended or earlier terminated. The Tender Offer Documents are available at www.UDFITenderOffer.com, or from the information agent for the Offer, as discussed below.

As previously announced on December 14, 2020, the Offer is conditioned upon, among other things, the satisfaction or waiver of the following conditions: (i) there shall not have been threatened, instituted, or pending any action or proceeding before any court or any governmental or administrative agency (a) challenging the acquisition of shares pursuant to the Offer or otherwise relating in any manner to the Offer, or (b) in the sole judgment of NHF, otherwise materially adversely affecting the Company; (ii) NHF shall have received all required governmental approvals, if any, for the Offer; (iii) NHF shall have had the opportunity to conduct sufficient due diligence to determine whether the offered price per share is reasonable given the current financial condition and results of operations of UDFI; (iv) the Board of Trustees of UDFI shall have waived in writing the ownership limitations set forth in Article VII of the Declaration of Trust of UDFI as such limitations would otherwise apply to the Offer; and (v) NHF shall have received satisfactory evidence that UDFI has continued to qualify as a real estate investment trust (“REIT”) under federal tax laws and thereby to avoid any entity-level federal income or excise tax.

On January 8, 2021, UDFI announced that it had reduced the percentage of outstanding Shares that a shareholder may own from 9.8% to 5.0%. The Company took such action in an effort to frustrate the Offer. It also announced it amended the Company’s bylaws to require that certain legal actions could be brought on behalf of or against UDFI only in certain courts in Maryland. NHF and its advisors are reviewing these actions and their legality under applicable law.

Shareholders should read the Offer to Purchase and the related materials carefully because they contain important information. Shareholders may obtain a free copy of the Offer to Purchase and the Assignment Form from D.F. King & Co., Inc., the information agent for the Offer (the “Information Agent”), by calling toll-free at (800) 331-7543. THE OFFER WILL EXPIRE AT 12:00 MIDNIGHT, EASTERN TIME, AT THE END OF THE DAY ON AUGUST 5, 2021, UNLESS THE OFFER IS EXTENDED OR EARLIER TERMINATED.

About the NexPoint Strategic Opportunities Fund (NHF)

The NexPoint Strategic Opportunities Fund (NYSE:NHF) is a closed-end fund managed by NexPoint Advisors, L.P. that is in the process of converting to a diversified REIT. On August 28, 2020, shareholders approved the conversion proposal and amended the Company’s fundamental investment policies and restrictions to permit the Company to pursue its new business. The Company has since realigned its portfolio so that it is no longer an “investment company” under the Investment Company Act of 1940 (the “1940 Act”). On March 31, 2021, the Company filed an application with the Securities and Exchange Commission (the “SEC”) for an order under the 1940 Act declaring that the Company no longer operate as an investment company (the “Deregistration Order”).  During the SEC’s review process, the Company will continue to be structured as a closed-end investment fund. The Company has also completed the repositioning of its investment portfolio sufficient to achieve REIT tax status and is operating during its 2021 taxable year so that it may qualify for taxation as a REIT.

For more information visit www.nexpoint.com/nexpoint-strategic-opportunities-fund

About NexPoint Advisors, L.P.

NexPoint Advisors, L.P. (the “Investment Adviser”) is an SEC-registered adviser on the NexPoint alternative investment platform. It serves as the adviser to a suite of funds and investment vehicles, including a closed-end fund, interval fund, business development company, and various real estate vehicles. For more information visit www.nexpoint.com  

—


Risks and Disclosures

This document is for informational purposes only and is neither an offer to purchase nor a solicitation of an offer to sell any common stock of UDFI or any other securities. The offer to purchase common stock of UDFI will only be made pursuant to the Offer to Purchase, the Assignment Form and related documents. THE TENDER OFFER MATERIALS (INCLUDING THE OFFER TO PURCHASE, THE ASSIGNMENT FORM AND CERTAIN OTHER TENDER OFFER DOCUMENTS) WILL CONTAIN IMPORTANT INFORMATION. STOCKHOLDERS OF UDFI ARE URGED TO READ THESE DOCUMENTS CAREFULLY WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION THAT SUCH STOCKHOLDERS SHOULD CONSIDER BEFORE MAKING ANY DECISION REGARDING TENDERING THEIR SHARES. Investors and security holders may obtain a free copy of these statements (when available) by directing such requests to the Information Agent, by calling toll-free at (800) 331-7543.

###

Media Contact

Lucy Bannon

[email protected]  



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Franklin Resources, Inc. to Announce Third Quarter Results on August 3, 2021

Franklin Resources, Inc. to Announce Third Quarter Results on August 3, 2021

SAN MATEO, Calif.–(BUSINESS WIRE)–
On Tuesday, August 3, 2021 at approximately 8:30 a.m. Eastern Time, Franklin Resources, Inc. (the “Company”) [NYSE:BEN] will release its third quarter 2021 operating results. A written commentary on the results will also be available via investors.franklinresources.com at approximately 8:30 a.m. Eastern Time.

In addition, Jenny Johnson, President and CEO; Greg Johnson, Executive Chairman; Matthew Nicholls, Executive Vice President and CFO; and Adam Spector, Executive Vice President – Global Advisory Services and Head of Global Distribution, will lead a live teleconference at 11:00 a.m. Eastern Time to answer questions of a material nature. Access to the teleconference will be available via investors.franklinresources.com or by dialing (833) 350-1245 in the U.S. and Canada or (236) 712-2205 internationally. A replay of the teleconference can also be accessed by calling (800) 585-8367 in the U.S. and Canada or (416) 621-4642 internationally using access code 6559334 after 2:00 p.m. Eastern Time on August 3, 2021 through August 10, 2021, or via investors.franklinresources.com. Analysts and investors are encouraged to review the Company’s recent filings with the U.S. Securities and Exchange Commission and to contact Investor Relations at (650) 312-4091 before the live teleconference for any clarifications or questions related to the earnings release or written commentary.

About Franklin Templeton

Franklin Resources, Inc. [NYSE:BEN] is a global investment management organization with subsidiaries operating as Franklin Templeton and serving clients in over 165 countries. Franklin Templeton’s mission is to help clients achieve better outcomes through investment management expertise, wealth management and technology solutions. Through its specialist investment managers, the Company brings extensive capabilities in equity, fixed income, multi-asset solutions and alternatives. With offices in more than 30 countries and approximately 1,300 investment professionals, the California-based company has over 70 years of investment experience and more than $1.5 trillion in assets under management as of May 31, 2021. The Company posts information that may be significant for investors in the Investor Relations and News Center sections of its website, and encourages investors to consult those sections regularly. For more information, please visit investors.franklinresources.com.

Franklin Resources, Inc.

Investor Relations: Selene Oh, (650) 312-4091, [email protected]

Media Relations: Matt Walsh, (650) 312-2245, [email protected]

investors.franklinresources.com

KEYWORDS: United States North America California

INDUSTRY KEYWORDS: Professional Services Finance

MEDIA:

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Gainey McKenna & Egleston Announces A Class Action Lawsuit Has Been Filed Against CarLotz, Inc. (LOTZ)

NEW YORK, July 09, 2021 (GLOBE NEWSWIRE) — Gainey McKenna & Egleston announces that a class action lawsuit has been filed against CarLotz, Inc. (“CarLotz” or the “Company”) (NASDAQ: LOTZ) in the United States District Court for the Southern District of New York on behalf of those who purchased or otherwise acquired CarLotz publicly traded securities between December 30, 2020, and May 25, 2021, inclusive (the “Class Period”).

On May 26, 2021, the Company’s stock price fell 13.4% after the consignment-to-retail used vehicle marketplace operator announced its profit-sharing corporate vehicle sourcing partner had paused consignments to the Company. The Company cut its year guidance as a result of the current business climate, as impacted by the lack of vehicles from this profit-sharing account, coupled with the unpredictable timeline of the chip shortage for new cars and its impact on the wholesale and retail automotive markets.

This announcement follows the release of disappointing financial results for the first quarter of 2021, as revealed in a May 10 press release issued by the Company. CarLotz stock dropped more than 20% over two days when it reported first quarter results but did not provide forecasts for gross profit per unit specifically for the second quarter. William Blair analyst Sharon Zackfia said in a report that the omission will cause more “investor angst” about the visibility on its progress toward its full-year targets. While management reiterated that GPU has improved significantly on a sequential basis, CarLotz has missed its original GPU targets for both the fourth and first quarters. Zackfia said CarLotz is also seeing constrained inventory levels due to rapidly rising wholesale prices, which has led to some commercial consignors liquidating via wholesale instead of consignment.

Investors who purchased or otherwise acquired shares of CarLotz during the Class Period should contact the Firm prior to the September 7, 2021 lead plaintiff motion deadline. A lead plaintiff is a representative party acting on behalf of other class members in directing the litigation.  If you wish to discuss your rights or interests regarding this class action, please contact Thomas J. McKenna, Esq. or Gregory M. Egleston, Esq. of Gainey McKenna & Egleston at (212) 983-1300, or via e-mail at [email protected] or [email protected].

Please visit our website at http://www.gme-law.com for more information about the firm.



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NW Natural Holdings Schedules Earnings Release and Conference Call for Thursday, August 5

NW Natural Holdings Schedules Earnings Release and Conference Call for Thursday, August 5

PORTLAND, Ore.–(BUSINESS WIRE)–
Northwest Natural Holding Company (NYSE: NWN) (NW Natural Holdings) announced today it will issue its second quarter and year-to-date 2021 earnings release and conduct an analyst conference call and webcast to review results at 8 a.m. Pacific Time (11 a.m. Eastern Time) on Thursday, August 5, 2021.

To hear the conference by webcast, log on to NW Natural Holdings’ corporate website at ir.nwnaturalholdings.com. To hear the conference call by phone, please dial 1-866-267-6789 within the United States and 1-855-669-9657 from Canada. International callers can dial 1-412-902-4110.

To access the conference replay, please call 1-877-344-7529 within the United States and enter the conference identification pass code 10154449. To hear the replay from Canada, please dial 1-855-669-9658 and from international locations, please dial 1-412-317-0088.

About NW Natural Holdings

Northwest Natural Holding Company, (NYSE: NWN) (NW Natural Holdings), is headquartered in Portland, Oregon and has been doing business for more than 160 years. It owns Northwest Natural Gas Company (NW Natural), NW Natural Water Company (NW Natural Water), and other business interests.

NW Natural is a local distribution company that currently provides natural gas service to approximately 2.5 million people in more than 140 communities through more than 770,000 meters in Oregon and Southwest Washington with one of the most modern pipeline systems in the nation. NW Natural consistently leads the industry with high J.D. Power & Associates customer satisfaction scores. NW Natural owns and operates 20 Bcf of underground gas storage capacity in Oregon.

NW Natural Water provides water distribution and wastewater services to communities throughout the Pacific Northwest and Texas. NW Natural Water currently serves approximately 63,000 people through about 26,000 connections. Learn more about our water business at nwnaturalwater.com.

Additional information is available at nwnaturalholdings.com.

Investor and Media Contact:

Nikki Sparley

Phone: 503-721-2530

Email: [email protected]

KEYWORDS: United States North America Oregon

INDUSTRY KEYWORDS: Energy Utilities Oil/Gas

MEDIA:

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Pharvaris Presents Clinical Data on Oral PHA121 Supporting the Prophylactic Treatment of Hereditary Angioedema at the EAACI Annual Congress 2021

Multiple doses of PHA121 were well-tolerated and showed a favorable pharmacokinetic profile for prophylactic treatment of HAE

ZUG, Switzerland, July 10, 2021 (GLOBE NEWSWIRE) — Pharvaris (Nasdaq: PHVS), a clinical-stage company focused on the development and commercialization of novel oral bradykinin-B2-receptor antagonists for the treatment of hereditary angioedema (HAE) and other bradykinin-B2-receptor-mediated indications, today announced the presentation of clinical data supporting the multiple-dose safety and pharmacokinetic (PK) profile of PHA121 (PHA-022121) for the treatment of hereditary angioedema (HAE) at the European Academy of Allergy and Clinical Immunology (EAACI) Annual Congress 2021, being held virtually from July 10-16, 2021.

The double-blind, randomized, placebo-controlled, multiple ascending dose study included 38 male and female healthy volunteers. PHA121 was orally administered after standardized meals twice daily (BID) for 10 days in four sequential dosing cohorts, ranging from 12 to 50 mg, with safety and PK assessments during treatment and follow-up for 72 hours after the last dose. PHA121 was well-tolerated up to the highest dose of 50 mg BID. All reported treatment-emergent adverse events (TEAEs) were mild in intensity and resolved completely. The total incidence and type of AEs was comparable between active and placebo groups.

The data also show that PHA121 was well absorbed with median times to reach peak plasma levels within 1.00 to 1.75 hours after dosing with standard meals. On both Day 1 and Day 10, plasma exposure of PHA121 increased approximately dose-proportionally over the dose range from 12 to 50 mg with a mean half-life ranging from 4.8 to 7.3 hours after Day 10. At steady state, which was generally reached within three days of treatment, plasma levels of PHA121 remained consistently above the therapeutic threshold EC85 for all doses (as determined in a human bradykinin challenge previously described).

“The pharmacokinetic profile demonstrated in this study suggests that the therapeutic effect of PHA121 can be achieved as early as the first day of dosing, with steady-state plasma levels achieved within three days. PHA121 was well-tolerated in healthy volunteers up to 50 mg dosed twice a day for 10 days,” said Peng Lu, M.D., Ph.D., chief medical officer of Pharvaris. “Coupled with our bradykinin challenge data, which has shown potent inhibition of bradykinin-induced hemodynamic effects, the PK and safety data observed in this study supports future development to assess the efficacy and safety of prophylactic use of PHA121 in HAE patients.”

Berndt Modig, chief executive officer and co-founder of Pharvaris added, “Bradykinin-B2-receptor antagonism has been demonstrated to be effective in treating acute HAE attacks but is currently not available as oral treatment. Pharvaris remains committed to providing patients with oral alternatives both for on-demand and prophylactic treatment in HAE via our softgel capsule formulation, PHVS416, and extended-release tablet formulation, PHVS719.”

A copy of the e-poster, titled “Multiple dose administration of PHA-022121, an orally available, bradykinin B2 receptor antagonist is well tolerated and shows a favorable pharmacokinetic profile for prophylactic treatment of HAE,” can be viewed on the Investor section of the company’s website at https://ir.pharvaris.com/news-events/events-presentations.

About PHVS416

PHVS416 is a softgel capsule formulation containing PHA121, a highly potent, specific, and orally bioavailable competitive antagonist of the bradykinin B2 receptor. Pharvaris is developing this formulation to provide rapid exposure of attack-mitigating medicine in a convenient, small oral dosage form. PHVS416 is currently in Phase 2 clinical development for the on-demand treatment of HAE.

About PHVS719

PHVS719 is an extended-release tablet formulation containing PHA121, a highly potent, specific, and orally bioavailable competitive antagonist of the bradykinin B2 receptor. Pharvaris is developing this formulation to provide sustained exposure of attack-preventing medicine in a convenient, small oral dosage form. PHVS719 is currently in preclinical development for the prophylactic treatment of HAE.

About PHA121

PHA121 (PHA-022121) is a highly potent, specific, and orally bioavailable competitive antagonist of the bradykinin B2 receptor that has completed Phase 1 clinical development for the treatment of HAE. PHA121 utilizes the same mechanism as icatibant, the leading therapy for on-demand treatment of HAE. Pharvaris is developing this novel small molecule for on-demand and prophylactic treatment of HAE and other bradykinin-mediated diseases through formulations optimized for each setting.

About Pharvaris

Pharvaris is a clinical-stage company focused on bringing oral bradykinin-B2-receptor antagonists to patients. By targeting this clinically proven therapeutic target with novel small molecules, the Pharvaris team is advancing new alternatives to injected therapies for all sub-types of HAE and other bradykinin-mediated diseases. The Company brings together executives with a breadth of expertise across pharmaceutical development and rare disorders, including HAE. For more information, visit https://pharvaris.com/.

Forward-Looking Statements

This press release contains certain forward-looking statements that involve substantial risks and uncertainties. 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 containing the words “believe,” “anticipate,” “expect,” “estimate,” “may,” “could,” “should,” “would,” “will,” “intend” and similar expressions. These forward-looking statements are based on management’s current expectations, are neither promises nor guarantees, and involve known and unknown risks, uncertainties and other important factors that may cause Pharvaris’ actual results, performance or achievements to be materially different from its expectations expressed or implied by the forward-looking statements. Such risks include but are not limited to the following: the expected timing, progress, or success of our clinical development programs, especially for PHVS416 and PHVS719, which are in early-stage clinical trials; risks associated with the COVID-19 pandemic, which may adversely impact our business, preclinical studies, and clinical trials; the timing of regulatory approvals; the value of our ordinary shares; the timing, costs and other limitations involved in obtaining regulatory approval for our product candidates PHVS416 and PHVS719, or any other product candidate that we may develop in the future; our ability to establish commercial capabilities or enter into agreements with third parties to market, sell, and distribute our product candidates; our ability to compete in the pharmaceutical industry and with competitive generic products; our ability to market, commercialize and achieve market acceptance for our product candidates; our ability to raise capital when needed and on acceptable terms; regulatory developments in the United States, the European Union and other jurisdictions; our ability to protect our intellectual property and know-how and operate our business without infringing the intellectual property rights or regulatory exclusivity of others;  our ability to manage negative consequences from changes in applicable laws and regulations, including tax laws, our ability to successfully remediate the material weakness in our internal control over financial reporting and to maintain an effective system of internal control over financial reporting; and the other factors described under the heading “Risk Factors” in our Annual Report on Form 20-F and other periodic filings with the Securities and Exchange Commission.

These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. While Pharvaris may elect to update such forward-looking statements at some point in the future, Pharvaris disclaims any obligation to do so, even if subsequent events cause its views to change. These forward-looking statements should not be relied upon as representing Pharvaris’ views as of any date subsequent to the date of this press release.

Investor Contact

Sarah McCabe
Stern Investor Relations, Inc.
+1-212-362-1200
[email protected]

Media Contact

Maggie Beller
Russo Partners, LLC
+1-646-942-5631
[email protected]



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Eagle Bulk Shipping Inc. to Issue Second Quarter 2021 Results and Hold Investor Conference Call

STAMFORD, Conn., July 09, 2021 (GLOBE NEWSWIRE) — Eagle Bulk Shipping Inc. (Nasdaq: EGLE) will report its financial results for the second quarter ended June 30, 2021, after the close of stock market trading on August 5, 2021. Members of Eagle Bulk’s senior management team will host a teleconference and webcast at 8:00 a.m. ET on Friday, August 6, 2021 to discuss the results.

To participate in the teleconference, investors and analysts are invited to call +1 844-282-4411 in the U.S., or +1 512-900-2336 outside of the U.S., and reference participant code 3636539. A simultaneous webcast of the call, including a slide presentation for interested investors and others, may be accessed by visiting http://www.eagleships.com.

A replay will be available following the call from 11:00 AM ET on August 6, 2021 until 11:00 AM ET on August 16, 2021. To access the replay, call +1 855-859-2056 in the U.S., or +1 404-537-3406 outside of the U.S., and reference passcode 3636539.

About Eagle Bulk Shipping Inc.

Eagle Bulk Shipping Inc. (“Eagle” or the “Company”) is a US-based fully integrated shipowner-operator providing global transportation solutions to a diverse group of customers including miners, producers, traders, and end users. Headquartered in Stamford, Connecticut, with offices in Singapore and Copenhagen, Eagle focuses exclusively on the versatile mid-size drybulk vessel segment and owns one of the largest fleets of Supramax / Ultramax vessels in the world. The Company performs all management services in-house (including: strategic, commercial, operational, technical, and administrative) and employs an active management approach to fleet trading with the objective of optimizing revenue performance and maximizing earnings on a risk-managed basis. For further information, please visit our website: www.eagleships.com.

Company Contact
Frank De Costanzo
Chief Financial Officer
Eagle Bulk Shipping, Inc.
Tel. +1 203-276-8100
Email: [email protected]

Media Contact
Rose & Company
Tel. +1 212-359-2228

Source: Eagle Bulk Shipping Inc.



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Celldex Therapeutics Presents Positive Data from CDX-0159 Phase 1b Study in Chronic Inducible Urticaria at EAACI 2021

– 95% complete response rate after single dose of CDX-0159 –

– Rapid, profound and durable responses offer patients opportunity for quick, lasting, meaningful relief –

– Median duration of response 77+ days in Cold Urticaria and 57+ days in Symptomatic Dermographism –

– Serum tryptase and skin mast cell depletion mirror clinical activity –

– Favorable safety profile –

– Company to host webcast conference call on Monday, July 12 at 8:15 a.m. ET –

HAMPTON, N.J., July 09, 2021 (GLOBE NEWSWIRE) — Celldex Therapeutics, Inc. (NASDAQ:CLDX) today announced updated data from the Company’s ongoing, open label Phase 1b clinical trial of CDX-0159 in patients with antihistamine refractory cold urticaria and symptomatic dermographism, the two most common forms of chronic inducible urticaria. These diseases, which are often severe and debilitating, can significantly impact patients’ lives. CDX-0159 is a humanized monoclonal antibody that specifically binds the receptor tyrosine kinase KIT with high specificity and potently inhibits its activity.

All 19/19 (100%) patients who received a single full dose of CDX-0159 experienced a clinical response to provocation testing. 18/19 (95%) experienced a complete response and 1/19 (5%) experienced a marked partial response. Responses were rapid, profound, and durable and correlated with a depletion of skin mast cells. CDX-0159 was generally well tolerated. These data were presented by Dr. Marcus Maurer, Professor of Dermatology and Allergy at Charité – Universitätsmedizin, in Berlin during a late-breaking poster discussion session (#1046) as part of the European Academy of Allergy and Clinical Immunology (EAACI) Annual Congress 2021.

“The achievement of a 95% complete response rate, rapid onset and sustained durability after a single dose is unprecedented in this patient population and clearly demonstrates that CDX-0159 has the potential to become an important new treatment option for patients suffering with chronic inducible urticaria,” commented Anthony S. Marucci, President and Chief Executive Officer of Celldex Therapeutics. “We believe these impressive early data show that CDX-0159 safely depletes mast cells which indicates its potential to impact other diseases with mast cell involvement. We continue to make excellent progress across the CDX-0159 development program in urticaria and expect to expand into prurigo nodularis later this year, and additional indications with mast cell involvement in the future.”

“These early-stage results are stunning and represent a major breakthrough for patients with inducible urticarias where current treatment options have been unable to provide relief from often severe symptoms,” said Marcus Maurer, M.D., Professor of Dermatology and Allergy at Charité – Universitätsmedizin in Berlin, who is conducting the study. “While individuals with inducible urticaria go to great lengths to avoid disease triggers in their daily lives, many find it impossible to do so and are impacted by severe itching and burning hives that impair all parts of their lives—their work, their concentration, their sleep and their social behavior. CDX-0159 clearly provided a real benefit to these patients and has meaningfully improved their lives. This novel mast cell depleting mechanism is especially exciting because it can provide insights into the involvement of mast cells across many diseases where their role is not yet well understood by the scientific community.”

Summary of data from ongoing Phase 1b Trial of CDX-0159:

As of the data cut-off on June 11, 2021, 20 patients had received a single intravenous infusion of CDX-0159 at 3 mg/kg, including 11 patients with cold urticaria and 9 patients with symptomatic dermographism. Patients had high disease activity as assessed by provocation threshold testing. In patients with cold urticaria and symptomatic dermographism baseline critical temperature thresholds were 18.9°C/66°F (range: 5-27°C/41-80.6°F) and FricTest® thresholds were 3.8 (range: 3-4) of 4. Safety results are reported for all 20 patients; activity results are reported for the 19 patients who received a full dose of CDX-0159. 14 of 19 patients completed the 12-week study observation period and five were ongoing (range of 2-8 weeks) as of June 11, 2021.

  • All 19/19 (100%) patients experienced a clinical response as assessed by provocation threshold testing; 18/19 (95%) experienced a complete response and 1/19 (5%) experienced a partial response.
    • 10/10 (100%) patients with cold urticaria experienced a complete response.
    • 8/9 (89%) patients with symptomatic dermographism experienced a complete response and 1/9 (11%) experienced a partial response.
    • Compete responses were observed in all 3 patients (1 cold urticaria; 2 symptomatic dermographism) with prior Xolair® (omalizumab) experience, including two who were Xolair refractory.
  • Rapid onset of responses after dosing and sustained durability were observed.
    • Most patients with cold urticaria and symptomatic dermographism experienced a complete response by week 1 and by week 4, respectively.
    • The median duration of response for patients was 77+ days for cold urticaria and 57+ days for symptomatic dermographism.
  • Improvements in disease activity as reported by physician’s and patient’s global assessment of disease severity were consistent with the complete responses as measured by provocation testing.
  • A single 3 mg/kg dose of CDX-0159 resulted in rapid, marked and durable suppression of serum tryptase and depletion of skin mast cells (87% depletion) as measured through biopsy.
    • The kinetics of serum tryptase and skin mast cell depletion mirrored clinical activity.
    • This confirmed that serum tryptase level is a robust pharmacodynamic biomarker for assessing mast cell burden and clinical activity in inducible urticaria and potentially in other diseases with mast cell driven involvement.
  • CDX-0159 was generally well tolerated. The most common adverse events were hair color changes, mild infusion reactions, and transient changes in taste perception.
    • Hair color changes (generally small areas of hair color lightening) and taste disorders (generally partial changes of ability to taste salt) are consistent with inhibiting KIT signaling in other cell types and are expected to be fully reversible.
    • As previously reported, a single severe infusion reaction of brief loss of consciousness was observed in a patient with a history of fainting. The patient rapidly recovered. Importantly, no evidence of mast cell activation as measured by serum tryptase monitoring was observed.
    • There was no evidence of clinically significant decreases in hematology parameters—an important finding for a KIT inhibitor.
  • One patient with symptomatic dermographism enrolled in the study also had a diagnosis of prurigo nodularis. After a single dose of CDX-0159, this patient experienced both a complete response of symptomatic dermographism and notable improvement of the prurigo nodularis. Celldex plans to initiate a study in prurigo nodularis in the fourth quarter of 2021.

The Phase 1b study is an open label clinical trial designed to evaluate the safety of a single dose of CDX-0159 in patients with cold urticaria or symptomatic dermographism who are refractory to antihistamines. The study was recently amended to also add a cohort of patients with cholinergic urticaria. Patients’ symptoms are induced via provocation testing that resembles real life triggering situations. Secondary and exploratory objectives include pharmacokinetic and pharmacodynamic assessments, including changes from baseline provocation thresholds, measurement of tryptase and stem cell factor levels, clinical activity outcomes (impact on urticaria symptoms, disease control, clinical response), quality of life assessments and measurement of tissue mast cells through skin biopsies. CDX-0159 is administered intravenously (3.0 mg/kg) as add on treatment to H1-antihistamines and patients are followed for 12 weeks after dosing. For additional information on this trial (NCT04548869), please visit www.clinicaltrials.gov.

The poster presented at EAACI can be viewed on the “Publications” page of the Celldex website.

As previously announced here, in addition to the on demand pre-recorded poster discussion at EAACI which was made available today, a Q&A with the session chair will also take place on Monday, July 12, 2021 at 12:30-13:30 p.m. CET (6:30-7:30 a.m. ET).

The subcutaneous formulation of CDX-0159 is planned to enter the clinic in the third quarter of 2021. The Company plans to initiate a study in prurigo nodularis in the fourth quarter of 2021. Celldex remains on track to initiate the Phase 2 studies in both spontaneous and inducible urticaria in the first half of 2022. Initial results from the cholinergic cohort are planned for presentation at a scientific congress in the first quarter of 2022. Treatment results from the Phase 1b study in chronic spontaneous urticaria are planned for presentation at a scientific congress in early summer of 2022. The Company plans to expand development into a fourth indication by year end 2022.

Webcast and Conference Call

The Company will host a conference call/webcast along with Dr. Marcus Maurer to discuss the results at 8:15 a.m. ET on Monday, July 12. The event will be webcast live and can be accessed by going to the “Events & Presentations” page under the “Investors & Media” section of the Celldex Therapeutics website at www.celldex.com. The call can also be accessed by dialing (866) 743-9666 (within the United States) or (760) 298-5103 (outside the United States). The conference ID is 4493642. A replay of the call will be archived on the Company’s website or can be accessed by dialing (855) 859-2056 (within the United States) or (404) 537-3406 (outside the United States). The conference ID is 4493642.

About Chronic Inducible Urticaria

Chronic inducible urticarias are forms of urticaria that have an attributable trigger associated with them, typically resulting in wheals (hives) or angioedema. Approximately 0.5% of the total population suffers from chronic inducible urticarias. Celldex is exploring the three most common forms, cold-induced, dermographism (scratch-induced) and cholinergic (exercise/sweat-induced). People afflicted with cold urticaria experience symptoms like itching, burning wheals and angioedema when their skin is exposed to temperatures below skin temperature. Symptomatic dermographism is characterized by the development of a wheal and flare reaction in response to stroking, scratching or rubbing of the skin and usually occurs within minutes of the inciting stimulus. Cholinergic urticaria is triggered by the body’s sweating response to active or passive body warming, and is characterized by small (1–4 mm) wheals surrounded by bright red flares. Common triggers include exercise, hot baths/showers, fever, occlusive dressings, eating spicy foods and emotional stress. For these diseases, mast cell activation leading to release of soluble mediators is thought to be the driving mechanism leading to the wheals and other symptoms. There are currently no approved therapies for chronic inducible urticarias other than antihistamines and patients attempt to manage symptoms associated with their disease through avoidance of triggers.

About CDX-0159

CDX-0159 is a humanized monoclonal antibody that specifically binds the receptor tyrosine kinase KIT with high specificity and potently inhibits its activity. KIT is expressed in a variety of cells, including mast cells, which mediate inflammatory responses such as hypersensitivity and allergic reactions. KIT signaling controls the differentiation, tissue recruitment, survival and activity of mast cells. In certain inflammatory diseases, such as chronic urticaria, mast cell activation plays a central role in the onset and progression of the disease.

About Celldex Therapeutics, Inc.

Celldex is a clinical stage biotechnology company dedicated to developing monoclonal and bispecific antibodies that address devastating diseases for which available treatments are inadequate. Our pipeline includes antibody-based therapeutics which have the ability to engage the human immune system and/or directly affect critical pathways to improve the lives of patients with inflammatory diseases and many forms of cancer. Visit www.celldex.com.

Forward Looking Statement

This release contains “forward-looking statements” made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements are typically preceded by words such as “believes,” “expects,” “anticipates,” “intends,” “will,” “may,” “should,” or similar expressions. These forward-looking statements reflect management’s current knowledge, assumptions, judgment and expectations regarding future performance or events. Although management believes that the expectations reflected in such statements are reasonable, they give no assurance that such expectations will prove to be correct or that those goals will be achieved, and you should be aware that actual results could differ materially from those contained in the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to, our ability to successfully complete research and further development and commercialization of Company drug candidates, including CDX-0159, in current or future indications; the uncertainties inherent in clinical testing and accruing patients for clinical trials; our limited experience in bringing programs through Phase 3 clinical trials; our ability to manage and successfully complete multiple clinical trials and the research and development efforts for our multiple products at varying stages of development; the effects of the outbreak of COVID-19 on our business and results of operations; the availability, cost, delivery and quality of clinical materials produced by our own manufacturing facility or supplied by contract manufacturers, who may be our sole source of supply; the timing, cost and uncertainty of obtaining regulatory approvals; the failure of the market for the Company’s programs to continue to develop; our ability to protect the Company’s intellectual property; the loss of any executive officers or key personnel or consultants; competition; changes in the regulatory landscape or the imposition of regulations that affect the Company’s products; our ability to continue to obtain capital to meet our long-term liquidity needs on acceptable terms, or at all, including the additional capital which will be necessary to complete the clinical trials that we have initiated or plan to initiate; and other factors listed under “Risk Factors” in our annual report on Form 10-K and quarterly reports on Form 10-Q.

All forward-looking statements are expressly qualified in their entirety by this cautionary notice. You are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date of this release. We have no obligation, and expressly disclaim any obligation, to update, revise or correct any of the forward-looking statements, whether as a result of new information, future events or otherwise.

Company Contact

Sarah Cavanaugh
Senior Vice President, Corporate Affairs & Administration
(508) 864-8337
[email protected]

Patrick Till
Senior Director, Investor Relations & Corporate Communications
(484) 788-8560
[email protected]