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• Resubmitted revised dosing regimen for Libervant to FDA in December 2020, as committed
• Multiple clinical trials demonstrate that AQST-108 can consistently deliver epinephrine

WARREN, N.J., Jan. 07, 2021 (GLOBE NEWSWIRE) — Aquestive Therapeutics, Inc. (NASDAQ: AQST), a pharmaceutical company focused on developing and commercializing differentiated products that address patients’ unmet needs and solve therapeutic problems, today provided an update on recent developments in its business.

“Given the progress on Libervant™ and AQST-108, 2021 will be an exciting and important year in the continued growth of Aquestive and for the execution of our corporate, clinical and commercial strategy,” said Keith J. Kendall, President and Chief Executive Officer of Aquestive. “As we look ahead to 2021, our focus will be on the advancement of Libervant and epinephrine through our regulatory and development pipeline, as well as growing our commercial sales of Sympazan® and continuing to manufacture Suboxone® and other licensed products from our film manufacturing capabilities.”

Key Highlights:

Libervant
. As previously announced, at a Type A meeting held on November 12, 2020, the U.S. Food and Drug Administration (FDA) confirmed that the issues identified in the Complete Response Letter (CRL) related to the New Drug Application (NDA) for the Company’s drug candidate Libervant™ (diazepam) Buccal Film for management of seizure clusters may be addressed by utilizing modeling and simulations based upon the information provided by Aquestive in its FDA meeting package submitted in October 2020. Key updates are:

• The Company resubmitted a revised weight-based dosing regimen along with modeling and simulations in December 2020.
• Based on correspondence from the FDA, the Company expects to receive feedback and guidance from the FDA in late January.  
• The Company expects to resubmit the NDA, based on further FDA feedback, during the first half of 2021.

Epinephrine

. Utilizing Aquestive’s PharmFilm® technologies, AQST-108 is a “first of its kind” oral sublingual film formulation delivering systemic epinephrine that is in development for the treatment of anaphylaxis. Key updates are:

• Aquestive completed its second Phase 1 pharmacokinetic (PK) trial in 24 healthy adult subjects, which featured a 4-treatment crossover design comparing pharmacokinetics, safety and pharmacodynamics of epinephrine administered in a sublingual film to that of epinephrine administered via both subcutaneous and intramuscular injections.
• The data from multiple trials demonstrate that AQST-108 can consistently deliver epinephrine sublingually and all subjects had measurable plasma concentrations of epinephrine.
• Based on top-line study results, AQST-108 was generally well-tolerated, with adverse events observed that are consistent with the known adverse events profile for epinephrine.
• AQST-108 achieved a similar time to maximal concentrations, or median Tmax, when compared to both the subcutaneous and intramuscular injections of epinephrine.
• The Company plans on commencing another PK trial in the first quarter of 2021 as it continues to progress towards a final product formulation and dose.

“The topline data from the second PK study for AQST-108 provides further evidence that we have developed a unique technological solution that can deliver epinephrine through oral administration,” said Mr. Kendall. “The study provides valuable insight into how our technology works. In 2021, we will continue to advance our program by conducting additional human studies as well as working closely with the FDA. We look forward to providing more insight on our technological solution at an R&D day to be scheduled in the first quarter of 2021. Regarding our drug candidate, Libervant, we look forward to receiving feedback from the Agency and resubmitting our NDA as quickly as possible.”  

About Aquestive Therapeutics
Aquestive Therapeutics is a pharmaceutical company that applies innovative technology to solve therapeutic problems and improve medicines for patients. The Company has commercialized one internally-developed proprietary product to date, Sympazan, has a commercial proprietary product pipeline focused on the treatment of diseases of the central nervous system, or CNS, and other unmet needs, and is developing orally administered complex molecules to provide alternatives to invasively administered standard of care therapies. The Company also collaborates with other pharmaceutical companies to bring new molecules to market using proprietary, best-in-class technologies, like PharmFilm®, and has proven capabilities for drug development and commercialization.

Forward-Looking Statements

Certain statements in this press release are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “believe,” “anticipate,” “plan,” “expect,” “estimate,” “intend,” “may,” “will,” or the negative of those terms, and similar expressions, are intended to identify forward-looking statements. These forward-looking statements include, but are not limited to, statements regarding the advancement of Libervant and AQST-108 through the regulatory and development pipeline; the focus on growing the Company’s commercial sales of Sympazan® and continuing to manufacture Suboxone® and other licensed products; ability to address the concerns identified in the FDA’s Complete Response Letter dated September 25, 2020 regarding the New Drug Application for Libervant and obtain FDA approval of Libervant for U.S. market access; clinical trial timing and plans for AQST-108; and business strategies, market opportunities, and other statements that are not historical facts. These forward-looking statements are subject to the uncertain impact of the COVID-19 global pandemic on our business including with respect to our clinical trials including site initiation, patient enrollment and timing and adequacy of clinical trials; on regulatory submissions and regulatory reviews and approvals of our product candidates; pharmaceutical ingredient and other raw materials supply chain, manufacture, and distribution; sale of and demand for our products; our liquidity and availability of capital resources; customer demand for our products and services; customers’ ability to pay for goods and services; and ongoing availability of an appropriate labor force and skilled professionals. Given these uncertainties, the Company is unable to provide assurance that operations can be maintained as planned prior to the COVID-19 pandemic.

These forward-looking statements are based on our current expectations and beliefs and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Such risks and uncertainties include, but are not limited to, risks associated with the Company’s development work, including any delays or changes to the timing, cost and success of our product development activities and clinical trials and plans for AQST-108 and our other drug candidates; risk of delays in FDA approval of Libervant and AQST-108 and our other drug candidates or failure to receive approval; risk of our ability to demonstrate to the FDA “clinical superiority” within the meaning of the FDA regulations of our drug candidate Libervant relative to FDA-approved diazepam rectal gel and nasal spray products including by establishing a major contribution to patient care within the meaning of FDA regulations relative to the approved products as well as risks related to other potential pathways or positions which are or may in the future be advanced to the FDA to overcome the seven year orphan drug exclusivity granted by the FDA for the approved nasal spray product of a competitor in the U.S. and there can be no assurance that we will be successful; risk that a competitor obtains FDA orphan drug exclusivity for a product with the same active moiety as any of our other drug products for which we are seeking FDA approval and that such earlier approved competitor orphan drug blocks such other product candidates in the U.S. for seven years for the same indication; risk inherent in commercializing a new product (including technology risks, financial risks, market risks and implementation risks and regulatory limitations); risks and uncertainties concerning the royalty and other revenue stream of the KYNMOBI monetization, achievement of royalty targets worldwide or in any jurisdiction and certain other commercial targets required for contingent payments under the monetization transaction, and of sufficiency of net proceeds of the monetization transaction after satisfaction of and compliance with 12.5% Senior Notes obligations, as applicable, and for funding the Company’s operations; risk of development of our sales and marketing capabilities; risk of legal costs associated with and the outcome of our patent litigation challenging third party at risk generic sale of our proprietary products; risk of sufficient capital and cash resources, including access to available debt and equity financing and revenues from operations, to satisfy all of our short-term and longer term cash requirements and other cash needs, at the times and in the amounts needed; risk of failure to satisfy all financial and other debt covenants and of any default; our and our competitors’ orphan drug approval and resulting drug exclusivity for our products or products of our competitors; short-term and long-term liquidity and cash requirements, cash funding and cash burn; risk related to government claims against Indivior for which we license, manufacture and sell Suboxone® and which accounts for the substantial part of our current operating revenues; risk associated with Indivior’s cessation of production of its authorized generic buprenorphine naloxone film product, including the impact from loss of orders for the authorized generic product and risk of eroding market share for Suboxone and risk of sunsetting product; risks related to the outsourcing of certain marketing and other operational and staff functions to third parties; risk of the rate and degree of market acceptance of our product and product candidates; the success of any competing products, including generics; risk of the size and growth of our product markets; risks of compliance with all FDA and other governmental and customer requirements for our manufacturing facilities; risks associated with intellectual property rights and infringement claims relating to the Company’s products; risk of unexpected patent developments; the impact of existing and future legislation and regulatory provisions on product exclusivity; legislation or regulatory actions affecting pharmaceutical product pricing, reimbursement or access; claims and risks that may arise regarding the safety or efficacy of the Company’s products and product candidates; risk of loss of significant customers; risks related to legal proceedings, including patent infringement, investigative and antitrust litigation matters; changes in government laws and regulations; risk of product recalls and withdrawals; uncertainties related to general economic, political, business, industry, regulatory and market conditions and other unusual items; and other uncertainties affecting the Company described in the “Risk Factors” section and in other sections included in our Annual Report on Form 10 K, in our Quarterly Reports on Form 10-Q, and in our Current Reports on Form 8-K filed with the Securities Exchange Commission (SEC). Given those uncertainties, you should not place undue reliance on these forward-looking statements, which speak only as of the date made. All subsequent forward-looking statements attributable to us or any person acting on our behalf are expressly qualified in their entirety by this cautionary statement. The Company assumes no obligation to update forward-looking statements or outlook or guidance after the date of this press release whether as a result of new information, future events or otherwise, except as may be required by applicable law.

PharmFilm®, Sympazan® and the Aquestive logo are registered trademarks of Aquestive Therapeutics, Inc. All other registered trademarks referenced herein are the property of their respective owners.

Investor inquiries:

Westwicke, an ICR Company
Stephanie Carrington
[email protected]
646-277-1282

 

WILMINGTON, N.C., Jan. 07, 2021 (GLOBE NEWSWIRE) — nCino, Inc. (NASDAQ: NCNO), a pioneer in cloud banking and digital transformation solutions for the global financial services industry, today announced its participation in the following investor conference:

• 23^rd Annual Needham Virtual Growth Conference
  Presentation: Wednesday, January 13, at 3:30 p.m. ET

A live webcast, as well as a replay, will be available on the Company’s investor relations website at https://investor.ncino.com/news-events/events-and-presentations.

About nCino

nCino (NASDAQ: NCNO) is the worldwide leader in cloud banking. The nCino Bank Operating System^® empowers financial institutions with scalable technology to help them achieve revenue growth, greater efficiency, cost savings and regulatory compliance. In a digital-first world, nCino’s single digital platform enhances the employee and client experience to enable financial institutions to more effectively onboard new clients, make loans and manage the entire loan life cycle, and open deposit and other accounts across lines of business and channels. Transforming how financial institutions operate through innovation, reputation and speed, nCino works with more than 1,200 financial institutions globally, whose assets range in size from $30 million to more than $2 trillion. For more information, visit: www.ncino.com.

INVESTOR CONTACT JoAnn Horne Market Street Partners +1 415.445.3240 [email protected]
MEDIA CONTACTS
Claire Sandstrom, nCino	Natalia Moose, nCino
+1 646.520.0710	+1 910.248.4602
[email protected]	[email protected]

JENA, Germany, Jan. 07, 2021 (GLOBE NEWSWIRE) — InflaRx N.V. (Nasdaq: IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, will present virtually at the 39^th Annual J.P. Morgan Healthcare Conference being held January 11-14, 2021.

Prof. Niels C. Riedemann, Chief Executive Officer and Founder of InflaRx, will give a corporate presentation on Thursday, January 14^th at 7:30 am EST (1:30 pm CET). A live audio webcast of the presentation will be provided on the InflaRx website in the Investors section under Events & Presentations. A webcast replay will be archived for approximately 30 days.

Also, an on–demand webcast of a corporate presentation from the H.C. Wainwright Virtual BioConnect Conference will be available starting Monday, January 11^th at 6:00 am EST (12:00 pm CET) on the InflaRx website in the Investors section under Events & Presentations.

About InflaRx N.V.:

InflaRx (Nasdaq: IFRX) is a clinical-stage biopharmaceutical company focused on applying its proprietary anti-C5a technology to discover and develop first-in-class, potent and specific inhibitors of C5a. Complement C5a is a powerful inflammatory mediator involved in the progression of a wide variety of autoimmune and other inflammatory diseases. InflaRx was founded in 2007, and the group has offices and subsidiaries in Jena and Munich, Germany, as well as Ann Arbor, MI, USA. For further information please visit www.inflarx.com.

Contacts:

InflaRx N.V.

Jordan Zwick – Chief Strategy Officer
Email: [email protected]
Tel: +1 917-338-6523

MC Services AG

Katja Arnold, Laurie Doyle, Andreas Jungfer
Email: [email protected]
Europe: +49 89-210 2280
US: +1-339-832-0752

FORWARD-LOOKING STATEMENTS

This press release contains forward-looking statements. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “believe,” “estimate,” “predict,” “potential” or “continue” and similar expressions. Forward-looking statements appear in a number of places throughout this release and may include statements regarding our intentions, beliefs, projections, outlook, analyses and current expectations concerning, among other things, our ongoing and planned pre-clinical development and clinical trials; the impact of the COVID-19 pandemic on the Company; the timing and our ability to commence and conduct clinical trials; potential results from current or potential future collaborations; our ability to make regulatory filings, obtain positive guidance from regulators, and obtain and maintain regulatory approvals for our product candidates; our intellectual property position; our ability to develop commercial functions; expectations regarding clinical trial data; our results of operations, cash needs, financial condition, liquidity, prospects, future transactions, growth and strategies; the industry in which we operate; the trends that may affect the industry or us and the risks, uncertainties and other factors described under the heading “Risk Factors” in InflaRx’s periodic filings with the Securities and Exchange Commission. These statements speak only as of the date of this press release and involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Given these risks, uncertainties and other factors, you should not place undue reliance on these forward-looking statements, and we assume no obligation to update these forward-looking statements, even if new information becomes available in the future, except as required by law.

— EXPAREL average daily sales at 109% of the prior year for the fourth quarter and 111% of the prior year for the month of December —

PARSIPPANY, N.J., Jan. 07, 2021 (GLOBE NEWSWIRE) — Pacira BioSciences, Inc. (Nasdaq: PCRX), the leading provider of innovative non-opioid pain management options, today reported preliminary unaudited net revenue of $429.6 million for 2020, a 2.0% increase compared with net revenue of $421.0 million reported for 2019. The company’s total revenues include net product sales of EXPAREL and iovera°, which were $125.3 million and $2.4 million for the fourth quarter of 2020 and $46.5 million and $0.6 million for the month of December 2020, respectively. EXPAREL average daily sales were 112 percent, 103 percent, and 111 percent of the prior year for the months of October, November, and December, respectively.

“We are pleased with the solid performance EXPAREL delivered in 2020, with the fourth quarter and full-year 2020 posting record product sales despite ongoing pandemic-related challenges. EXPAREL weekly sales growth continues to outperform the elective surgery market, which we attribute to its critical role in reducing or eliminating the need for opioids and enabling the shift of complex surgical procedures to the 23-hour stay environment. EXPAREL utilization also continues to grow in non-elective procedures, such as cesarean section, oncology, and cardiothoracic surgeries. As we look forward to 2021, the deployment of COVID-19 vaccinations should further support the recovery of elective surgery volumes. EXPAREL remains well positioned for more robust growth as it plays a critical role in revolutionizing the practice of regional anesthesia and enables the ongoing migration of procedures to the ambulatory setting.” said Dave Stack, chairman and chief executive officer of Pacira BioSciences.

2020 Full Year & Fourth Quarter Revenue Highlights

• Fourth quarter net product sales of EXPAREL/bupivacaine liposome injectable suspension were $127.3 million in 2020, compared to $118.6 million in 2019.
• Fourth quarter EXPAREL net product sales were $125.3 million in 2020, compared to $116.9 million in 2019. Sales of bupivacaine liposome injectable suspension to a third-party licensee for use in veterinary practice were $2.0 million in 2020, compared to $1.7 million in 2019.
• Full-year EXPAREL net product sales were $413.3 million in 2020, compared to $407.9 million in 2019. Sales of bupivacaine liposome injectable suspension to a third-party licensee for use in veterinary practice were $4.5 million in 2020, compared to $3.2 million in 2019.
• Full-year iovera° net product sales were $8.8 million in 2020, compared to $7.9 million in 2019. Pacira began recognizing sales of iovera° in April 2019 after completing its acquisition of MyoScience, Inc., a privately held medical technology company.
• Fourth quarter royalty revenue was $1.2 million and full-year was $3.0 million in 2020; compared to $0.6 million and $2.1 million in 2019, respectively.

The company’s 2020 product sales were negatively impacted by the COVID-19 pandemic, which mandated significant postponement or suspension in the scheduling of elective surgical procedures resulting from public health guidance and government directives. Elective surgery restrictions began to lift on a state-by-state basis in April 2020. In order to provide greater transparency, the company will continue to report monthly intra-quarter unaudited net product sales until it has gained enough visibility around the impacts of COVID-19. The financial information included in this press release is preliminary, unaudited and subject to adjustment. It does not present all information necessary for an understanding of the company’s fourth quarter and full-year 2020 financial results. Pacira expects to report its complete financial results for the fourth quarter and full-year 2020 in the first quarter of 2021.

About Pacira BioSciences

Pacira BioSciences, Inc. (Nasdaq: PCRX) is the leading provider of non-opioid pain management and regenerative health solutions dedicated to advancing and improving outcomes for health care practitioners and their patients. The company’s long-acting local analgesic, EXPAREL^® (bupivacaine liposome injectable suspension) was commercially launched in the United States in April 2012. EXPAREL utilizes DepoFoam^®, a unique and proprietary product delivery technology that encapsulates drugs without altering their molecular structure, and releases them over a desired period of time. In April 2019, Pacira acquired the iovera° system, a handheld cryoanalgesia device used to deliver precise, controlled doses of cold temperature only to targeted nerves. To learn more about Pacira, including the corporate mission to reduce overreliance on opioids, visit www.pacira.com.

About EXPAREL

^®

EXPAREL (bupivacaine liposome injectable suspension) is indicated for single-dose infiltration in adults to produce postsurgical local analgesia and as an interscalene brachial plexus nerve block to produce postsurgical regional analgesia. Safety and efficacy have not been established in other nerve blocks. The product combines bupivacaine with DepoFoam, a proven product delivery technology that delivers medication over a desired time period. EXPAREL represents the first and only multivesicular liposome local anesthetic that can be utilized in the peri- or postsurgical setting. By utilizing the DepoFoam platform, a single dose of EXPAREL delivers bupivacaine over time, providing significant reductions in cumulative pain scores with up to a 78 percent decrease in opioid consumption; the clinical benefit of the opioid reduction was not demonstrated. Additional information is available at www.EXPAREL.com.

Important Safety Information for Patients

EXPAREL should not be used in obstetrical paracervical block anesthesia. In studies where EXPAREL was injected into the wound, the most common side effects were nausea, constipation, and vomiting. In studies where EXPAREL was injected near a nerve, the most common side effects were nausea, fever, and constipation. EXPAREL is not recommended to be used in patients younger than 18 years old or in pregnant women. Tell your healthcare provider if you have liver disease, since this may affect how the active ingredient (bupivacaine) in EXPAREL is eliminated from your body. EXPAREL should not be injected into the spine, joints, or veins. The active ingredient in EXPAREL: can affect your nervous system and your cardiovascular system; may cause an allergic reaction; may cause damage if injected into your joints.

About iovera°

^®

The iovera° system is used to destroy tissue during surgical procedures by applying freezing cold. It can also be used to produce lesions in peripheral nervous tissue by the application of cold to the selected site for the blocking of pain. It is also indicated for the relief of pain and symptoms associated with osteoarthritis of the knee for up to 90 days. In one study, the majority of the patients suffering from osteoarthritis of the knee experienced pain and system relief beyond 150 days.¹ The iovera° system’s “1×90” Smart Tip configuration (indicating one needle which is 90 mm long) can also facilitate target nerve location by conducting electrical nerve stimulation from a separate nerve stimulator. The iovera° system is not indicated for treatment of central nervous system tissue.

Important Safety Information

The iovera° system is contraindicated for use in patients with the following: Cryoglobulinemia; Paroxysmal cold hemoglobinuria; cold urticaria; Raynaud’s disease; open and/or infected wounds at or near the treatment line. Potential complications: As with any surgical treatment that uses needle-based therapy, there is potential for temporary site-specific reactions, including but not limited to: bruising (ecchymosis); swelling (edema); inflammation and/or redness (erythema); pain and/or tenderness; altered sensation (localized dysesthesia). Typically, these reactions resolve with no physician intervention. Patients may help the healing process by applying ice packs to the affected sites, and by taking over-the-counter analgesics.

Forward-Looking Statements

Any statements in this press release about the company’s future expectations, plans, trends, outlook, projections and prospects, and other statements containing the words “believes,” “anticipates,” “plans,” “estimates,” “expects,” “intends,” “may,” “will,” “would,” “could,” “can” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including risks relating to: the impact of the worldwide COVID-19 (Coronavirus) pandemic and related global economic conditions; the success of the company’s sales and manufacturing efforts in support of the commercialization of EXPAREL; the rate and degree of market acceptance of EXPAREL; the size and growth of the potential markets for EXPAREL and the company’s ability to serve those markets; the company’s plans to expand the use of EXPAREL to additional indications and opportunities, and the timing and success of any related clinical trials; the ability to realize anticipated benefits and synergies from the acquisition of MyoScience; the ability to successfully integrate iovera° and any other future acquisitions into the company’s existing business; the commercial success of iovera° and other factors discussed in the “Risk Factors” of the company’s most recent Annual Report on Form 10-K and in other filings that the company periodically makes with the SEC. In addition, the forward-looking statements included in this press release represent the company’s views as of the date of this press release. Important factors could cause actual results to differ materially from those indicated or implied by forward-looking statements, and as such the company anticipates that subsequent events and developments will cause its views to change. However, while the company may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing the company’s views as of any date subsequent to the date of this press release.

1 Radnovich, R. et al. “Cryoneurolysis to treat the pain and symptoms of knee osteoarthritis: a multicenter, randomized, double-blind, sham-controlled trial.” Osteoarthritis and Cartilage (2017) p1-10.

Investor Contact:
Susan Mesco, (973) 451-4030
[email protected]

Media Contact:
Coyne Public Relations
Alyssa Schneider, (973) 588-2270
[email protected]

Company launches state-wide program in just 61 days

Program identifies non-compliant vehicles, connects motorists to affordable insurance

COLUMBIA, Md., Jan. 07, 2021 (GLOBE NEWSWIRE) — Rekor Systems, Inc., (NASDAQ: REKR) (“Rekor”) (the “Company”) a Maryland-based company providing real-time roadway intelligence through AI-driven decisions, today announced that the State of Oklahoma has integrated the Company’s Rekor One™ platform across relevant state systems to provide vehicle information associated with uninsured motorists as part of the state’s Uninsured Vehicle Enforcement Diversion (UVED) Program, which is operated by the Oklahoma District Attorneys Council.

Oklahoma’s UVED Program uses Rekor’s vehicle recognition technology to leverage existing state resources to ensure that all drivers have at least the minimum required amount of liability insurance, ultimately leading to safer roadways. The platform allows for real-time detection of non-compliant vehicles and instant data consolidation into a regularly updating insurance system connected to the state’s enforcement and intervention programs. Rekor will assist Oklahoma drivers by providing a one-stop web portal for uninsured motorists to easily find non-standard and standard insurance for their vehicle.

“Since its launch in 2018, the goal of the UVED Program has always been to help Oklahomans, both by increasing compliance and by facilitating access to fair and affordable auto insurance for all,” said Amanda Arnall Couch, Program Director. “Nationwide studies have estimated that up to 26 percent of vehicles traveling on Oklahoma roads are uninsured, a situation that leaves all motorists at risk. Through innovative, focused, and customized solutions, Rekor has addressed the systemic challenges that plagued UVED for two years and has managed to make this program an operational and functioning reality in less than two months.”

Rekor’s technology will assist the State of Oklahoma in identifying uninsured vehicles on the road, and once identified, the enforcement division will issue a “Notice to Respond,” encouraging a vehicle owner to get insurance and comply with the law. Otherwise, uninsured motorists cited on the road by police officers can face stiff penalties, including fines, imprisonment, license plate confiscation and/or reinstatement fees.

A motorist enters the UVED Program by acquiring insurance and paying a $174 enrollment fee, thereby avoiding the possibility of criminal charges, associated penalties, and a permanent mark on their driving record.

“Oklahoma has hundreds of thousands of uninsured motorists on the road right now, which has huge safety and financial implications for the state and its citizens,” said Robert Berman, president and CEO, Rekor. “Rekor One is a single turnkey solution that Rekor can deliver cost-effectively and quickly to any state. It provides all the technology they need, with a high level of data security, to identify uninsured vehicles and take effective measures to ensure compliance.”

According to data derived from the  Insurance Information Institute, nearly one in eight drivers in the U.S. are uninsured, which puts all drivers at greater risk in the event of an accident. In addition to the burden on other drivers, states are deprived of a significant amount of tax revenue from insurance premiums that should be paid by millions of vehicle owners and are used to fund infrastructure and other investments.

All drivers involved in accidents with an uninsured motorist are burdened with the cost of property damage and medical bills, and insured drivers are further saddled with higher premiums to cover those costs.

“The Oklahoma UVED Program is among the first in the country – and something we anticipate will catch on quickly in other states,” said Charles Degliomini, Rekor’s Executive Vice President of Government Relations. “States are doing everything they can to navigate an incredibly challenging revenue environment right now. In fact, we’re in discussion with a number of other states who are interested in leveraging vehicle recognition capabilities in similar revenue-generating ways. The Rekor One platform can be shared among state agencies to support additional community safety, intelligent roadway and revenue generation activities – making wise use of tax dollars.”

About Rekor Systems, Inc.

Rekor (Nasdaq: REKR) is a Maryland-based company providing real-time roadway intelligence through AI-driven decisions. Rekor provides commercial and government customers with actionable, real-time vehicle recognition data to enable informed decisions to be made faster and provide better outcomes. Rekor is transforming industries like Public Safety, Customer Experience and Smart Cities in more than 70 countries across the globe with smarter, quicker, cost-competitive vehicle recognition solutions for security, revenue discovery and recovery, public safety, electronic toll collection, brand loyalty, parking operations, logistics, and traffic management. We use the power of artificial intelligence to analyze video streams and transform them into AI-driven decisions by our clients. Our machine learning software can turn most IP cameras into highly accurate and affordable vehicle recognition devices used to help protect lives, increase brand loyalty and enhance operations and logistics, without the need to install expensive new infrastructure. We make what was once considered impossible, possible. To learn more please visit our website: https://rekor.ai.

Forward-Looking Statements

This press release includes statements concerning Rekor Systems, Inc. and its future expectations, plans and prospects that constitute “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. For this purpose, any statements that are not statements of historical fact may be deemed to be forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “may,” “should,” “expects,” “plans,” “anticipates,” “could,” “intends,” “target,” “projects,” “contemplates,” “believes,” “estimates,” “predicts,” “potential,” or “continue,” by the negative of these terms or by other similar expressions. You are cautioned that such statements are subject to many risks and uncertainties that could cause future circumstances, events, or results to differ materially from those projected in the forward-looking statements, including the risks that actual circumstances, events or results may differ materially from those projected in the forward-looking statements, particularly as a result of various risks and other factors identified in our filings with the Securities and Exchange Commission. Important factors that could have such a result include a decline or weakness in general economic conditions, an outbreak of hostilities, the ongoing pandemic and responses thereto related to COVID-19, a decline or volatility in the securities markets or regulatory changes or other adverse developments with respect to the markets for the Company’s products and services or an inability to obtain adequate financing. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. We do not undertake any obligation to publicly update any forward-looking statements, whether as a result of the receipt of new information, the occurrence of future events, or otherwise.

Media Contact:
Emily Burdeshaw
REQ for Rekor Systems
[email protected] 

Investor Contact:
Charles Degliomini
Rekor Systems, Inc.
[email protected]

Rare disease and gene therapy industry veterans Steven Altschuler, M.D., R. Nolan Townsend and Jay Barth, M.D., team up with gene therapy pioneer Ronald Crystal, M.D., to launch fully integrated gene therapy company

Financing led, structured and syndicated by Longitude Capital and Omega Funds

Comprehensive pipeline includes three clinical-stage gene therapy programs in monogenic diseases and up to 15 potential additional AAV gene therapy programs in monogenic and acquired diseases primarily developed at Weill Cornell Medicine

NEW YORK, Jan. 07, 2021 (GLOBE NEWSWIRE) — LEXEO Therapeutics, a clinical-stage gene therapy company, debuted today with an oversubscribed $85 million Series A financing, led by Longitude Capital and Omega Funds, and joined by Lundbeckfonden Ventures, PBM Capital, Janus Henderson Investors, Invus, Woodline Partners LP, the Alzheimer’s Drug Discovery Foundationⁱ and Alexandria Venture Investments. Proceeds from the financing will help advance the company’s three lead investigational programs, including: LX2006, an IV-administered therapy for cardiomyopathy associated with Friedreich’s ataxia (Phase 1 start planned for 2021); LX1004, a CNS-administered therapy for CLN2 Batten disease (Phase 1/2 completed); and LX1001, a CNS-administered therapy for APOE4-associated Alzheimer’s disease (Phase 1 ongoing).

“We are thrilled to launch today with a mission to advance LEXEO’s promising clinical-stage pipeline of gene therapy treatments for patients diagnosed with some of society’s most challenging diseases,” said R. Nolan Townsend, Chief Executive Officer of LEXEO Therapeutics. “We have the pleasure of collaborating with Dr. Ronald Crystal – one of the industry’s most accomplished pioneers in the gene therapy space – and, drawing on my years of rare disease leadership experience at Pfizer, will together build a world-class gene therapy organization driven by premier science that has the potential to address a range of therapeutic indications.”

Founder and Chief Scientific Advisor Dr. Ronald Crystal is Professor and Chairman of Weill Cornell’s Department of Genetic Medicine and Director of the Belfer Gene Therapy Core Facility. Dr. Crystal has more than 30 years of experience with adenovirus and adeno-associated virus vectors, from basic vector design through clinical development. Dr. Crystal has 14 approved gene therapy investigational new drug applications and has published more than 300 papers on gene therapy, with experience in CNS, cardiac, pulmonary and liver-mediated diseases.

“I am excited to work with LEXEO Therapeutics to move our extensive academic portfolio into clinical development and ultimately bring it to patients,” said Dr. Crystal. “LEXEO’s AAV-mediated gene therapy programs have the potential for broad applicability across a range of therapeutic indications, and in a single company pipeline present an opportunity for the natural evolution of gene therapy from rare genetic conditions to more common diseases.”

LEXEO Therapeutics’ Chairman, Dr. Steven Altschuler, is currently Managing Director at Ziff Capital Investments and was formerly Chairman of gene therapy biotech pioneer Spark Therapeutics, which was responsible for the first FDA-approved gene therapy, Luxturna®, and was acquired by Roche in 2019 for $4.3 billion.

“LEXEO’s impressive management team, with Nolan’s years of rare disease leadership experience at Pfizer, as well as its pioneering scientific founder and high-quality investor syndicate, will propel the development of the company’s pipeline of promising and innovative programs,” said Dr. Altschuler. “I am honored to have the opportunity to partner with Nolan and his team to build a leading gene therapy company.”

LEXEO Therapeutics has also appointed Dr. Jay Barth as Executive Vice President and Chief Medical Officer to oversee Medical Affairs, Regulatory Affairs and Clinical Development. Dr. Barth was formerly the Chief Medical Officer at Amicus Therapeutics and Senior Vice President, Clinical Development, at PTC Therapeutics, where he oversaw all clinical development programs and the approval of Galafold^® for Fabry disease at Amicus, as well as Translarna^®, the first approved treatment for Duchenne muscular dystrophy at PTC Therapeutics.

Other members of LEXEO Therapeutics’ Board of Directors include CEO R. Nolan Townsend, Sandip Agarwala of Longitude Capital, Bernard Davitian of Omega Funds and Mette Kirstine Agger of Lundbeckfonden Ventures.

Initial Indications

Friedreich’s ataxia (FA) is a rare, degenerative multi-system disorder affecting approximately 1 in 50,000 people in the United States. FA is caused by a gene mutation that disrupts the normal production of the protein frataxin, critical to the function of mitochondria (the energy producing factories) in a cell. FA is inherited in an autosomal recessive manner, usually begins in childhood, and leads to impaired muscle coordination (ataxia) that worsens over time, typically progressing to serious heart conditions, including hypertrophic cardiomyopathy and arrythmias. FA is also associated with vision impairment, hearing loss, scoliosis, diabetes and slurred speech. Friedreich’s ataxia can shorten life expectancy, with heart failure the most common cause of death. Supported by de novo, soon to be published pre-clinical research, LX2006 is an IV-administered AAV-mediated frataxin gene therapy treatment focused on the cardiac pathology of FA. The company is completing IND-enabling pre-clinical studies and expects to initiate a Phase 1 trial in 2021.

CLN2 disease (late infantile Batten disease) is an autosomal recessive lysosomal storage disease with fewer than 1,000 cases worldwide, with typical onset in children between 2 and 4 years of age. The disease is caused by mutations in the CLN2 gene, resulting in progressive cognitive impairment, visual failure, seizures and deteriorating motor development. LX1004 is an AAV-meditated gene therapy treatment delivering CLN2 to the central nervous system. In December 2020, clinical data published in Science Translational Medicine found a single administration of AAV-mediated CLN2 gene therapy (LX1004) slowed the progression of CLN2 disease in children. Treatment with LX1004 was well tolerated, with minimal serious adverse events in the acute/post-operative period (0-14 days) and over the 18-month study period (14 days – 18 months). With this Phase 1/2 study complete, the company plans to advance the program into a pivotal study in 2022.

Alzheimer’s disease is the leading cause of late-onset dementia, characterized by progressive memory loss and cognitive decline in humans. APOE is a major cholesterol transporter and is in part linked to the pathogenesis of Alzheimer’s disease due to development of amyloid plaques and tau-tangles in the brain. People who inherit APOE4 alleles are at significantly higher risk for developing Alzheimer’s disease and at an earlier age of onset than people who inherit APOE3 or APOE2 alleles, which have normal and reduced risk of disease onset, respectively.ⁱⁱ LX1001 is an AAV-mediated gene therapy treatment delivering APOE2 to the central nervous system of people with two APOE4 alleles (homozygotes), via a CNS route of administration. A Phase 1 clinical study is ongoing.

About LEXEO Therapeutics, Inc.

LEXEO Therapeutics is a New York City-based, fully integrated biotechnology company currently headquartered at the Alexandria Center^® for Life Science that aims to apply the transformational science of gene therapy to address some of the world’s most devastating genetic and acquired diseases. LEXEO Therapeutics’ pipeline consists of adeno-associated virus (AAV)-mediated therapies primarily developed at Weill Cornell Medicine’s Department of Genetic Medicine. Beyond LEXEO Therapeutics’ lead programs – which are focused on both rare and non-rare monogenic (single gene mutation) diseases – the company’s preclinical pipeline spans monogenic diseases, as well as hereditary and acquired diseases across a spectrum of patient population sizes and a range of unmet medical needs. Importantly, LEXEO Therapeutics will focus on advancing clinical programs through to commercialization, with the goal of maintaining an ongoing research collaboration with Weill Cornell Medicine’s Department of Genetic Medicine to help advance the company’s pre-clinical pipeline. For more information, please visit www.lexeotx.com or LinkedIn.

Investor Contact

LEXEO Therapeutics, Inc.
[email protected]

Media Contact

Sheryl Seapy, W2O Group
(949) 903-4750
[email protected] 

ⁱ https://www.alzdiscovery.org/
ⁱⁱ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1350934/

Company files seven provisional patent applications with United States Patent and Trademark Office

DENVER, Jan. 07, 2021 (GLOBE NEWSWIRE) — Mydecine Innovations Group (CSE: MYCO) (OTC: MYCOF) (FSE: 0NFA (“Mydecine” or the “Company’), an emerging biopharma and life sciences company committed to the research, development, and acceptance of alternative nature-sourced medicine for mainstream use, announced the filing of seven provisional patent applications with the United States Patent and Trademark Office (USPTO) in its efforts to discover valuable novel compounds in fungi for medicinal and pharmaceutical use.

In an effort to better understand the medicinal properties of fungi-based compounds, Mydecine is developing novel intellectual property around medicinal mushrooms and psychedelic medicines for the professional healthcare market. Led by Chief Science Officer Rob Roscow, the developing patent portfolio from Mydecine is targeted at addressing the known shortcomings of psilocybin for medical uses and includes novel drug design and delivery mechanisms, precise doseable formulations and new technologies for improved use of psilocybin in a medical context.

“These patent filings serve as a significant milestone for Mydecine in our efforts to build a unique and proprietary intellectual property portfolio of pharmaceutical and natural health products that address the growing interest in fungi-based solutions,” said Josh Bartch, CEO of Mydecine. “We believe in the power and potential of these compounds to treat and provide incredible relief to those suffering from mental health issues and will continue forward with our research efforts to better understand how they work together to augment the mind and body in new and powerful ways.”

The Mydecine team believes, through its extensive in-house research and development efforts and robust partnerships with world-class research institutions and universities, that it has data-supported evidence of novel compounds in fungi that can be eventually applied to improve the properties of existing over-the-counter products and pharmaceuticals.

“By applying a distinct pharmaceutical chemistry approach in our research and development, we are well on our way to better understanding the key attributes and mechanisms of medicinal and psychedelic mushrooms that allow them to positively impact our thoughts, feelings, beliefs, and attitudes,” said Denton Hoyer, Ph. D and Mydecine Scientific Advisory Board Member. “As this valuable new natural product category continues to evolve, we believe there is great opportunity to use this knowledge to make a sustainable imprint on society and improve the overall health and wellbeing of all.”

About Mydecine Innovations Group

Mydecine Innovations Group™ is a life sciences company dedicated to developing and commercializing innovative solutions for treating mental health problems and enhancing wellbeing. The company’s world-renowned medical and scientific advisory board is progressing a robust R&D pipeline of psychedelic derived therapeutics, novel compounds, therapies, and controlled drug delivery systems. Mydecine has exclusive access to a full cGMP certified pharmaceutical manufacturing facility with the ability to import/export, extract, and analyze natural and synthetic psychedelic compounds with full government approval through Health Canada.

Learn more at: https://www.mydecine.com/ and follow us on Facebook, Twitter, and Instagram.

Mydecine Innovations Group Media Contacts

Anne Donohoe / Nick Opich
KCSA Strategic Communications
[email protected] / [email protected]
212-896-1265 / 212-896-1206

On behalf of the Board of Directors:

Joshua Bartch, Chief Executive Officer
[email protected]

Corp Communication:

Charles Lee, Investor Relations
[email protected]
+1 720-277-9879

For further information about Mydecine Innovations Group, Inc., please visit the Company’s profile on SEDAR at


www.sedar.com


or visit the Company’s website at


www.mydecine.com


.

The Canadian Securities Exchange has neither approved nor disapproved the contents of this news release and accepts no responsibility for the adequacy or accuracy hereof. This news release contains forward-looking statements, which relate to future events or future performance and reflect management’s current expectations and assumptions. Such forward-looking statements reflect management’s current beliefs and are based on assumptions made by and information currently available to the Company. Readers are cautioned that these forward-looking statements are neither promises nor guarantees, and are subject to risks and uncertainties that may cause future results to differ materially from those expected including, without limitation, the availability and continuity of financing, the ability of the Company to adequately protect and enforce its intellectual property, the Company’s ability to bring its products to commercial production, continued growth of the global adaptive pathway medicine, natural health products and digital health industries, and the risks presented by the highly regulated and competitive market concerning the development, production, sale and use of the Company’s products. Although the Company has attempted to identify important factors that could cause actual results to differ materially from those contained in forward-looking information, there may be other factors that cause results not to be as anticipated, estimated or intended. There can be no assurance that such information will prove to be accurate, as actual results and future events could differ materially from those anticipated in such information. These forward-looking statements are made as of the date hereof and the Company does not assume any obligation to update or revise them to reflect new events or circumstances save as required under applicable securities legislation. This news release does not constitute an offer to sell securities and the Company is not soliciting an offer to buy securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction. This news release does not constitute an offer of securities for sale in the United States. These securities have not and will not be registered under United States Securities Act of 1933, as amended, or any state securities laws and may not be offered or sold in the United States or to a U.S. Person unless so registered, or an exemption from registration is relied upon.

Denver, CO , Jan. 07, 2021 (GLOBE NEWSWIRE) — via NewMediaWire — CBD Global Sciences, Inc. (OTC: CBDNF) (CSE: CBDN) (Frankfurt:GS3), “CBD Global” or the “Company”), today announced the launch of the new CBD product line “Dog Unleashed CBD” and new website www.dogunleashedcbd.com.

Dog the Bounty Hunter and CBD Global Sciences have partnered to create a new CBD brand called ‘Dog Unleashed CBD’ which has been rolled out with a robust line of CBD products aimed at addressing multiple ailments in the human body with a holistic approach.  Initial sales of Dog Unleashed CBD can be found at www.dogunleashedcbd.com, an internet sales platform.  The product launch is timed to coincide with his reality TV docudrama Dog Unleashed, that is airing on a subscription-based app and will be streaming online.  

The initial product line will offer 12 different SKUs focused on multi-flavored tinctures offered in three different strengths 1000MG, 2000MG and 3500MG.  In addition to the tincture products, Dog will offer both lotions and salves and all 12 SKUs are infused with a full spectrum CBD oil that is lab tested for quality and accuracy.  All products meet established state and federal requirements of no more than 0.3% delta-9-tetrahydrocannabinol and can be sold in all 50 states.  The Company will expand the product offerings over the next two quarters in 2021 which will include CBD infused confectionary products and a hydration line to include multi flavored energy drinks.  In addition to web-based sales Dog Unleashed CBD will be distributed in conjunction with New Age Beverage into its distribution channel that boasts over 5,000 stores serviced today.

Dog the Bounty Hunter (Duane Chapman) has begun enlisting from his 6,000,000+ followers on multiple social media platforms to sign up for the airing of his new season.  

Duane ‘Dog’ Chapman stated, “I can’t tell you how grateful I am to have the opportunity to bring these products to the market and look forward to a collaborative partnership with CBD Global Sciences.  This product line is something that I have found to relieve my pain and stress and the fact that it is grown in a field, not made in a lab, is very important to me.”

Brad Wyatt, CEO of CBD Global Sciences, shared “I am very excited to have the opportunity to work with Dog and Francie on this CBD project.  Over the past year I have seen Dog in action, and I can assure you he truly cares about his fans and wants to help people feel better with a natural solution like CBD.”

ABOUT DOG UNLEASHED and DOG UNLEASHED CBD 

Dog Unleashed (launching Q2 2021) will be the fourth show that Dog has launched.  This venue has moved to online streaming and subscription-based viewing. While testing the waters on viewership Dog had over 30,000 new subscribers with just two Instagram postings about the new show (go to www.dogunleashed.com to subscribe). Viewership for the new show is expected to beat all previous records.  Past shows have set records on three different networks, A&E, CMT and WGN, of which he still holds the record for the most viewed shows in the past 15 years.  Promotional interviews that will highlight both the upcoming docudrama and the Dog Unleashed CBD have already begun and will continue with several daytime shows including Dr. Oz, Ellen, Tamron Hill, Entertainment Tonight and multiple Fox affiliates.  Most interviews will be completed virtually and through various social media platforms due to COVID -19.

ABOUT CBD GLOBAL SCIENCES INC.

CBD Global Sciences, Inc., is a vertically integrated hemp-based CBD producer and branding investment vehicle which currently owns two product categories, branded under the name AETHICS (www.aethics.com) and CANNAOIL (www.cannaoilshop.com), which include CBD Oil tinctures (liquid products), CBD capsules, CBD topicals, Hydration products and Confectionary products.  CBD Global Sciences hemp-derived CBD extracts are sold through select distributors, bricks and mortar retailers, and online.

CBD Global Sciences, through its wholly owned subsidiary, Strasburg Pharms, grows, and operates irrigated land in Colorado, that grows hemp with Colorado water, soil, sun, and nutrients and NEVER sprayed with pesticides or chemicals.  Our genetics are hand selected and maintained to present the best cannabinoid profile with extremely high CBD.  

For further information, please contact Bruce Nurse, Investor Relations, (888) 401-2239, [email protected]

 NEITHER THE CANADIAN SECURITIES EXCHANGE NOR ITS REGULATION SERVICES PROVIDER HAS REVIEWED OR ACCEPT RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THIS RELEASE.

 
CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING INFORMATION: This news release includes certain “forward-looking statements” under applicable Canadian securities legislation. Forward-looking statements include, but are not limited to, statements with respect to future developments and the business and operations of the Corporation after the CSE listing.  Forward-looking statements are necessarily based upon a number of estimates and assumptions that, while considered reasonable, are subject to known and unknown risks, uncertainties, and other factors which may cause the actual results and future events to differ materially from those expressed or implied by such forward-looking statements. Such factors include, but are not limited to general business, economic, competitive, political, and social uncertainties; and delay or failure to receive board, shareholder, or regulatory approvals.  Readers should not place undue reliance on forward-looking statements.  The Corporation disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

Dallas, Jan. 07, 2021 (GLOBE NEWSWIRE) — Thryv Holdings, Inc. (NASDAQ:THRY), the provider of Thryv^® software, the end-to-end client experience platform for small businesses, today announced that CEO and President Joe Walsh will participate in the Needham Virtual Growth Conference on Monday, January 11 at 4:15 p.m. ET.

A live webcast will be available on Thryv’s Investor Relations page at investor.thryv.com. An archived replay will be made available for a limited time at the same location following the event. 

About Thryv Holdings, Inc.

The company owns the easy-to-use Thryv® end-to-end customer experience software built for small business that helps over 40,000 SaaS clients with the daily demands of running a business. With Thryv, they can get the job, manage the job and get credit. Thryv’s award-winning platform provides modernized business functions, allowing small-to-medium-sized businesses (SMB) to reach more customers, stay organized, get paid faster and generate reviews. These include building a digital customer database, automated marketing through email and text, updating business listings across the internet, scheduling online appointments, sending notifications and reminders, managing ratings and reviews, generating estimates and invoices and processing payments.

Thryv supports franchise operators and multi-location business owners with Hub by Thryv™, a software console that enables businesses managers to oversee their operations using the Thryv software.

Thryv also connects local businesses to consumer services through our search, display and social media management products, our print directories featuring The Real Yellow Pages® tagline, and our local search portals, which operate under the DexKnows.com®, Superpages.com® and Yellowpages.com URLs and reach some 35 million monthly visitors. For more information about the company, visit thryv.com.

Thryv delivers business services to more than 360,000 SMBs across America that enable them to compete and win in today’s economy.       

Learn more about Thryv on LinkedIn and Medium.

 

Media Contact:

Paige Blankenship

Thryv, Inc.

972.453.3012

[email protected]

 

Investor Contact:

Cameron Lessard 

Thryv, Inc.    

214.773.7022 

[email protected]   

 

KJ Christopher

Thryv, Inc.

972.453.7068

[email protected]

 

###

Paige Blankenship
Thryv, Inc.
972.453.3012
[email protected]

SAN DIEGO, Jan. 07, 2021 (GLOBE NEWSWIRE) — Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, today announced its participation at the H.C. Wainwright BioConnect 2021 Conference. Troy Wilson, Ph.D., J.D., President and Chief Executive Officer, is scheduled to participate in a panel discussion on precision medicine on Wednesday, January 13, 2021 at 9:00 a.m. PT / 12:00 p.m. ET. The panel, entitled “The Importance of Biomarkers and Cytogenetic Profiling in Drug Discovery, Development and Commercialization,” will be led by Scott Gottlieb, M.D., 23^rd Commissioner of the U.S. Food and Drug Administration.

A live audio webcast of the panel discussion will be available in the Investors section of Kura’s website at www.kuraoncology.com, with an archived replay available for 30 days following the event.

About Kura Oncology

Kura Oncology is a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer. The Company’s pipeline consists of two wholly owned small molecule drug candidates that target cancer signaling pathways where there is a strong scientific and clinical rationale to improve outcomes by identifying those patients most likely to benefit from treatment. Kura’s most advanced drug candidate is tipifarnib, a potent, selective and orally bioavailable farnesyl transferase inhibitor currently in a registration-directed trial (AIM-HN) in patients with recurrent or metastatic HRAS mutant head and neck squamous cell carcinoma. The Company’s pipeline is also highlighted by KO-539, a potent and selective menin inhibitor currently in a Phase 1/2A clinical trial (KOMET-001) in patients with relapsed/refractory acute myeloid leukemia. For additional information about Kura, please visit the Company’s website at www.kuraoncology.com.

Contacts

Company:
Pete De Spain
Vice President, Investor Relations &
Corporate Communications
(858) 500-8803
[email protected]

Investors:
Robert H. Uhl
Managing Director
Westwicke ICR
(858) 356-5932
[email protected]

Media:
Jason Spark
Managing Director
Canale Communications
(619) 849-6005
[email protected]