Market Newsdesk

RALEIGH, N.C., July 18, 2022 (GLOBE NEWSWIRE) — First Citizens Bank announced that its OneWest Bank division based in Southern California has completed its conversion to First Citizens’ operations and systems. This conversion integrates OneWest Bank customer accounts into First Citizens products and services.

OneWest Bank previously operated as a division of CIT, which merged with and became a division of First Citizens Bank in January 2022. In addition to the OneWest Bank conversion, CIT commercial deposit customers who accessed CIT treasury payment services through the Business eBanking platform have also completed their transition to First Citizens Bank’s treasury management systems platforms.

“While First Citizens and CIT’s multiple business units and corporate functions have already been effectively operating as one company, this conversion marks a major milestone,” said Frank B. Holding Jr., Chairman and CEO of First Citizens. “Now that it’s complete, we’ve deepened our presence in Southern California and converted a great majority of consumer customers’ loans and deposits within the overall CIT portfolio to our systems. We’re creating an even better and stronger bank – with the ability to offer additional convenience and value for our customers. The dedication shown by our bank teams as we’ve joined together has been outstanding.”

Between close of business on July 15 and the reopening of branches on July 18, First Citizens converted 41 OneWest Bank branches to First Citizens Bank. OneWest Bank customers now have access to the wide selection of First Citizens products and services. In addition, they can bank at any First Citizens Bank location, through First Citizens Digital Banking (online and mobile), by ATM and by telephone.

Information detailing the conversion and transition to First Citizens was mailed to these clients in June.

First Citizens Bank helps personal, business, commercial and wealth clients build financial strength that lasts. As the largest family-controlled bank in the United States, First Citizens Bank is continuing a unique legacy of strength, stability and long-term thinking that has spanned generations. Founded in 1898 and headquartered in Raleigh, N.C., First Citizens Bank also operates a nationwide direct bank and a network of more than 550 branches in 22 states. Industry specialists bring a depth of expertise that helps businesses and individuals meet their specific goals at every stage of their financial journey. First Citizens Bank brings together personal service and powerful tools to help customers do more with their money – and make more of their future. Visit First Citizens’ website at firstcitizens.com. First Citizens Bank. Forever First®

Contact:	Barbara Thompson
	First Citizens Bank
	919-716-2716

LITTLE ROCK, Ark., July 18, 2022 (GLOBE NEWSWIRE) — On July 17, 2022, Bank OZK (NASDAQ: OZK) (the “Bank”) marked the 25^th anniversary of its initial public offering (“IPO”) and trading of its shares on the NASDAQ stock exchange.

“We are proud to be celebrating our 25^th anniversary as a public company,” said George Gleason, the Bank’s Chairman and Chief Executive Officer. “Our track record as a public company has been highlighted by excellent asset quality, efficiency and profitability throughout our transformation from a $287 million asset bank at our IPO to the nearly $27 billion asset financial institution we are today. As we mark this important milestone, we thank our team members for the outstanding service they provide to our customers every day and thank our shareholders for their continued support.”

Since its IPO, the Bank has delivered a total shareholder return of 5,869%, for a compounded annual return of 17.8% assuming reinvestment of common stock dividends and has been recognized numerous times as the top performing bank nationally in its asset size.

ABOUT BANK OZK

Bank OZK (Nasdaq: OZK) is a regional bank providing innovative financial solutions delivered by expert bankers with a relentless pursuit of excellence. Established in 1903, Bank OZK conducts banking operations with over 240 offices in eight states including Arkansas, Georgia, Florida, North Carolina, Texas, New York, California and Mississippi and had over $26.56 billion in total assets as of March 31, 2022. Bank OZK can be found at www.ozk.com and on Facebook, Twitter and LinkedIn or contacted at (501) 978-2265 or P.O. Box 8811, Little Rock, Arkansas 72231-8811. Member FDIC.

Media Contact: Michelle Rossow, Chief Communications Officer, (501) 978-3922

Doses up to 10 mg show good tolerability and meaningful clinical activity in multiple domains

U.K. and Canadian health authorities approved escalation to higher doses

Ultragenyx exercises option to acquire GeneTx for $75 million upfront payment

Conference call to discuss update planned for 5 p.m. Eastern Time

NOVATO, Calif., July 18, 2022 (GLOBE NEWSWIRE) — Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE) and GeneTx Biotherapeutics LLC today provided a program update on GTX-102 for the treatment of Angelman syndrome (AS), including encouraging interim data from the open-label, dose-escalating Phase 1/2 study in pediatric patients who have a genetically confirmed diagnosis of full maternal UBE3A gene deletion. Interim results on 9 patients from the U.K./Canada arm and 2 patients from the U.S. arm of the Phase 1/2 study demonstrate a meaningful improvement in clinical disease and an acceptable safety profile. These interim data supported a protocol amendment to the Phase 1/2 study that was approved by the U.K. and Canadian health authorities in May 2022 to initiate additional, new cohorts of patients at higher monthly loading doses. The study has begun to enroll under the amended protocol and has dosed the first patient in these new cohorts.

Ultragenyx also announced it has exercised its option to acquire GeneTx and has closed on the acquisition for an upfront payment of $75.0 million plus future milestone and royalty payments.

“We are seeing encouraging early clinical activity across multiple domains and multiple measurements without any evidence of drug-related safety issues. The therapeutic effect should be further enhanced by starting at higher monthly loading doses that have already been shown to be tolerated,” stated Emil D. Kakkis, M.D., Ph.D., Chief Executive Officer and President of Ultragenyx. “These data combined with the excellent science of Dr. Scott Dindot, the inventor of GTX-102, have given us the confidence to exercise our option to acquire GeneTx at an earlier timepoint so that we can take the lead on advancing GTX-102 into late-stage development for Angelman syndrome.”

“I am convinced we are seeing evidence of a therapeutic effect with GTX-102 though it’s still early in the study,” said Erick Sell, M.D., Associate Professor of Neurology and Director of the Angelman clinic at the Children’s Hospital of Eastern Ontario, and primary investigator on the study. “I am also encouraged by the improvements in quality of life that most of the families at my center are consistently reporting and believe that this could be a promising treatment for patients with Angelman syndrome.”

Study Design and Dosing

The protocol approved in the U.K. and Canada permitted enrollment of up to 12 patients; the companies completed enrollment at 6 patients in the younger Cohort 4 and capped enrollment at 4 patients in the older Cohort 5 based on early encouraging safety and efficacy data in order to amend the protocol and begin dosing newly enrolled patients at higher levels. As of the data cut off, 9 of these 10 patients dosed had reached study Day 128 or further.

Six patients in younger Cohort 4 initiated dosing at 3.3 mg and 4 patients in older Cohort 5 initiated dosing at 5 mg. Patients were titrated on an individual basis. Four patients of the younger Cohort 4 reached the first pre-maintenance dose (PMD) visit at Day 170 and received 7.5 mg doses, and one of these patients reached the second PMD dose at 10 mg. Data were available on 3 patients through the first PMD visit by the data cutoff. Three of the older Cohort 5 patients reached the first PMD dose and received 10 mg doses, and one of these patients had data available by the data cutoff.

The protocol approved in the U.S. permitted enrollment of up to 8 patients enrolled into two groups, an active and an age-matched comparator group. Four patients ages 4 to ≤8 years old have received 4 monthly 2 mg doses of GTX-102 and 2 patients had Day 128 data available at the time of analysis.

Interim Safety Results

There have been 14 patients to receive treatment thus far, 10 under the U.K. and Canada protocol, and 4 under the U.S. protocol. Of these, 7 patients have received cumulative doses over 20 mg, and 13 patients have over 147 days of exposure to treatment. There have been no treatment-related serious adverse events of any type nor adverse events related to lower extremity weakness observed in these patients. The most common adverse events in the U.K./Canada Cohorts (Cohorts 4 and 5) were vomiting (5/10), COVID (4/10), upper respiratory infection (3/10) and transient back pain (2/10). In the U.S. Cohort, 2 of 4 patients had no adverse events, a third had transient difficulty in sleeping and the fourth patient had emesis, upper respiratory infection, and asymptomatic EBV hepatitis that resolved and the patient resumed dosing.

Cerebrospinal fluid (CSF) protein levels have remained stable throughout the course of the study consistent with absence of inflammation. There was one case of CSF protein elevation in the U.K./Canada protocol that was due to an asymptomatic reactivation of Varicella Zoster Virus. The protein normalized and the patient resumed dosing without any issues. One subject in the U.S. protocol had a single modestly elevated CSF protein that resolved on the subsequent assessment.

Interim Efficacy in Cohorts 4 & 5 (9 of 10 patients evaluable)

The “AS Change Scale” (Clinical Global Impression of Change, or CGI-C-AS) and the “AS Severity Scale” (Clinical Global Impression of Severity, or CGI-S-AS) are clinician assessments used to assess patients across five domains (sleep, behavior, communication, gross motor, and fine motor skills) and overall change. The AS Change Scale is a relative scale of improvement, and the AS Severity Scale is an objective scale with criteria for each change in domain severity.

AS Change Scale evaluations at Day 128 show 7 out of 9 patients improved from Baseline in at least 3 of 5 domains and in the overall score. These data are supported by the AS Severity Scale evaluations taken at Baseline and Day 128 where 6 patients exhibited a decrease in severity in at least 2 of 5 domains and in the overall score.

Furthermore, one patient from Cohort 4 showed a 2 or 3-point improvement in the AS Severity Scale across all 5 domains at the PMD assessment at Day 170. This suggests continued improvement from Day 128 prior to receiving the fifth dose.

These promising improvements in the AS Change and Severity Scale scores were also supported by the other clinical measurements including the Bayley Scales of Infant and Toddler Development (Bayley-4), which is administered by a trained psychologist; the Vineland-3 adaptive behavior scale, which is administered by a clinician; and the Observed Reported Communication Ability (ORCA), a caregiver-reported questionnaire.

Interim efficacy in U.S. patients
(2 of 4 patients evaluable)

AS Change Scale evaluations taken at Baseline and Day 128 in 2 patients show both had relative improvement from baseline in at least 3 of 5 domains and overall. These data were supported by AS Severity Scale evaluations taken at Baseline and Day 128 where both patients exhibited a decrease in severity in at least 2 of 5 domains and overall.

“We are treating severely developmentally impaired individuals who are non-verbal and normally have a very slow rate of learning, making only minimal progress over years based on clinical observations and natural history studies,” stated Elizabeth Berry-Kravis, M.D., Ph.D., Professor, Pediatrics at Rush University Medical Center and primary investigator on the study. “The changes that we have seen clinically in less than a year in both the original five patients and the current patients, which are also captured by the AS Change and Severity Scales, may seem small but are truly important improvements, given the rate of developmental progress in Angelman syndrome.”

Domain-specific assessments

Multiple domain specific assessments and caregiver interviews supported AS Change (CGI-C-AS) and Severity (CGI-S-AS) Scale results. Changes in the functional domains of Sleep, Behavior, Communication, Gross Motor and Fine Motor skills across the patients demonstrated positive clinical activity of GTX-102.

Management will be joined by investigators Dr. Sell and Dr. Berry-Kravis to provide a detailed summary of the data across these domains on today’s investor conference call.

Study Amendment and Dose Escalation

Under the new study amendment approved in the U.K. and Canada, additional dose-selection cohorts will sequentially enroll new patients at incrementally higher starting doses ranging from 7.5 to 14 mg based on age. A younger Cohort 6 will begin dosing at 7.5 mg and an older Cohort 7 at 10 mg. Once clinically sufficient efficacy is observed, two expanded cohorts will enroll 20 patients in each age range using the optimal dosing algorithm determined from the dose-selection cohorts. These patients would provide the longer-term efficacy and safety information for the program. Ultragenyx will seek to initiate the amended protocol in the U.S. pending discussions with the FDA.

In the Maintenance phase, patients from all cohorts will receive treatment with GTX-102 once every 3 months after the patient’s last monthly dose of GTX-102, with incremental dose escalations possible to a maximum dose of 14 mg based on achieving an adequate clinical response.

Investor Conference Call and Webcast Information

Ultragenyx will host an investor conference call today, Monday, July 18, 2022, at 2 p.m. PT / 5 p.m. ET to discuss the results. The live and replayed webcast of the call will be available through the company’s website at https://ir.ultragenyx.com/events-presentations. To participate in the live call, please register by clicking on the following link (registration link), and you will be provided with dial in details. The replay of the call will be available for one year.

About Angelman Syndrome

Angelman syndrome is a rare, neurogenetic disorder caused by loss-of-function of the maternally inherited allele of the UBE3A gene. The maternal-specific inheritance pattern of Angelman syndrome is due to genomic imprinting of UBE3A in neurons of the central nervous system, a naturally occurring phenomenon in which the maternal UBE3A allele is expressed and the paternal UBE3A is not. Silencing of the paternal UBE3A allele is regulated by the UBE3A antisense transcript (UBE3A-AS), the intended target of GTX-102. In almost all cases of Angelman syndrome, the maternal UBE3A allele is either missing or mutated, resulting in limited to no protein expression. This condition is typically not inherited but instead occurs spontaneously. It is estimated to affect 1 in 12,000 to 1 in 20,000 people globally.

Individuals with Angelman syndrome have developmental delay, communications issues, balance issues, motor impairment and debilitating seizures. Some individuals with Angelman syndrome are unable to walk and most do not speak. Anxiety and disturbed sleep can be serious challenges in individuals with Angelman syndrome. While individuals with Angelman syndrome have a normal lifespan, they require continuous care and are unable to live independently. Angelman syndrome is not a degenerative disorder, but the loss of the UBE3A protein expression in neurons results in abnormal communications between neurons. Angelman syndrome is often misdiagnosed as autism or cerebral palsy. There are no currently approved therapies for Angelman syndrome; however, several symptoms of this disorder can be reversed in adult animal models of Angelman syndrome suggesting that improvement of symptoms can potentially be achieved at any age.

About GTX-102

GTX-102 is an investigational antisense oligonucleotide delivered via intrathecal administration and designed to target and inhibit expression of UBE3A-AS. Nonclinical studies show that GTX-102 reduces the levels of UBE3A-AS and reactivates expression of the paternal UBE3A allele in neurons of the CNS. Reactivation of paternal UBE3A expression in animal models of Angelman syndrome has been associated with improvements in some of the neurological symptoms associated with the condition. GTX-102 has been granted Orphan Drug Designation, Rare Pediatric Disease Designation, and Fast Track Designation from the U.S. Food and Drug Administration (FDA). In August 2019, GeneTx and Ultragenyx announced a partnership to develop GTX-102, with Ultragenyx receiving an exclusive option to acquire GeneTx.

About Ultragenyx Pharmaceutical Inc.

Ultragenyx is a biopharmaceutical company committed to bringing novel products to patients for the treatment of serious rare and ultra-rare genetic diseases. The company has built a diverse portfolio of approved therapies and product candidates aimed at addressing diseases with high unmet medical need and clear biology for treatment, for which there are typically no approved therapies treating the underlying disease.

The company is led by a management team experienced in the development and commercialization of rare disease therapeutics. Ultragenyx’s strategy is predicated upon time- and cost-efficient drug development, with the goal of delivering safe and effective therapies to patients with the utmost urgency.

For more information on Ultragenyx, please visit the company’s website at: www.ultragenyx.com.

Forward-Looking Statements and Use of Digital Media

Except for the historical information contained herein, the matters set forth in this press release, including statements related to Ultragenyx’s expectations and projections regarding its business plans and objectives for GTX-102, the therapeutic potential and clinical benefits of GTX-102, expectations regarding the safety and tolerability of GTX-102, and future clinical developments for GTX-102 are forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve substantial risks and uncertainties that could cause our clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the ability of the company to successfully develop GTX-102, the effects of the COVID-19 pandemic on the company’s clinical activities, business and operating results, , uncertainty and potential delays related to clinical drug development, the risk that clinical outcomes demonstrated in interim data from our clinical trials may materially change or increased incidents of adverse events as patient enrollment continues and/or more patient data becomes available, the company’s ability to achieve its projected development goals in its expected timeframes, risks and uncertainties related to the regulatory approval process, smaller than anticipated market opportunities for the company’s products and product candidates, manufacturing risks, competition from other therapies or products, our ability to integrate acquired products or businesses, and other matters that could affect sufficiency of existing cash, cash equivalents and short-term investments to fund operations, the company’s future operating results and financial performance, the timing of clinical trial activities and reporting results from same, and the availability or commercial potential of Ultragenyx’s products and drug candidates. Ultragenyx undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of Ultragenyx in general, see Ultragenyx’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on May 6, 2022, and its subsequent periodic reports filed with the Securities and Exchange Commission.

In addition to its SEC filings, press releases and public conference calls, Ultragenyx uses its investor relations website and social media outlets to publish important information about the company, including information that may be deemed material to investors, and to comply with its disclosure obligations under Regulation FD. Financial and other information about Ultragenyx is routinely posted and is accessible on Ultragenyx’s investor relations website (

https://ir.ultragenyx.com/

) and LinkedIn website (

https://www.linkedin.com/company/ultragenyx-pharmaceutical-inc-/mycompany/

).

Contacts

Ultragenyx Pharmaceutical Inc.

Investor Relations
Joshua Higa
[email protected]

Media
Carolyn Wang
415-225-5050
[email protected]

– The event will feature Prometheus management and key opinion leader presentations on PR600 target unveiling, scientific rationale, and corresponding therapeutic candidate, PRA052 –

– PRA052 is a novel, first-in-class monoclonal antibody addressing a target with one of the strongest genetic associations to IBD –

– PRA052 has a pleiotropic effect on both innate and adaptive immunity and targets a pathway that is distinct from TNF –

– IND planned for Q3 2022 with Phase 1 initiation planned for Q4 2022 –

SAN DIEGO, July 18, 2022 (GLOBE NEWSWIRE) — Prometheus Biosciences, Inc. (Nasdaq: RXDX), a clinical-stage biotechnology company pioneering a precision medicine approach for the discovery, development, and commercialization of novel therapeutic and companion diagnostic products for the treatment of immune-mediated diseases, today announced it will host a virtual R&D Day for analysts and investors at 9:00 am ET on Tuesday, July 26, 2022. The presentations will showcase Prometheus’ second program, PR600 and its corresponding clinical candidate, PRA052, reveal the therapeutic target and provide detailed scientific rationale on the approach.

In addition to presentations by Prometheus’ senior management team, the R&D Day will feature key opinion leader, Marla Dubinsky, MD, Chief of the Division of Pediatric Gastroenterology and Director of the Inflammatory Bowel Disease Center at Mount Sinai Health System. Dr. Dubinsky was involved in the early development of Prometheus360^TM while serving as the Director of the Pediatric IBD Center at Cedars Sinai.

The agenda for the Prometheus R&D Day is as follows:

Introduction from the Chairman & CEO

• PR600/PRA052 Target Unveiling: Mark McKenna, Chairman & CEO of Prometheus Biosciences

Scientific Rationale

• Discovery, Scientific Rationale, and Genetic Association: Olivier Laurent, PhD, Chief Scientific Officer of Prometheus Biosciences

Unmet Need: Precision in IBD

• Unmet Need and Implication of Precision Approach in IBD: Marla Dubinsky, MD, Chief, Division of Pediatric Gastroenterology and Director, Inflammatory Bowel Disease Center Mount Sinai Health System

Webcasting Information

The R&D Day will be held on July 26^th at 9:00 am ET. Registration for the event as well as a live and archived webcast of the R&D Day will be available in the Events & Webcasts section of the Prometheus Biosciences website.

About Prometheus Biosciences
Prometheus Biosciences, Inc. is a clinical-stage biotechnology company pioneering a precision medicine approach for the discovery, development, and commercialization of novel therapeutic and companion diagnostic products for the treatment of immune-mediated diseases. The company’s precision medicine platform, Prometheus360^TM, combines proprietary machine learning-based analytical approaches with one of the world’s largest gastrointestinal bioinformatics databases to identify novel therapeutic targets and develop therapeutic candidates to engage those targets.

The Company is currently conducting three Phase 2 studies of its lead therapeutic candidate PRA023 targeting tumor necrosis factor (TNF)-like ligand 1A (TL1A): a Phase 2 trial in UC patients, ARTEMIS-UC, a Phase 2a trial in CD patients, APOLLO-CD, and a Phase 2 clinical trial in SSc-ILD, ATHENA-SSc, each utilizing a genetic-based companion diagnostic candidate designed to identify patients who are predisposed to increased expression of TL1A and therefore potentially more likely to respond to PRA023.

Forward Looking Statements
Prometheus cautions readers that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. These statements are based on the company’s current beliefs and expectations. Such forward-looking statements include, but are not limited to statements regarding: the timing of filing the IND and initiating a Phase 1 clinical trial for PRA052; and the ability of Prometheus’ precision medicine platform to identify potential targets associated with immune-mediated diseases and particular patient subpopulations. The inclusion of forward-looking statements should not be regarded as a representation by Prometheus that any of our plans will be achieved. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in our business, including, without limitation: Prometheus’ approach to the discovery and development of precision medicines based on Prometheus360 ^TM is unproven; potential delays in the commencement, enrollment and completion of clinical trials and preclinical studies; Prometheus’ dependence on third parties in connection with product manufacturing, research and preclinical and clinical testing; Prometheus’ ability to develop companion diagnostics for our therapeutic product candidates; unexpected adverse side effects or inadequate efficacy of our product candidates that may limit their development, regulatory approval and/or commercialization, or may result in recalls or product liability claims; the results of preclinical studies and early clinical trials are not necessarily predictive of future results; Prometheus may not realize any benefits from our current and any future collaborations; regulatory developments in the United States and foreign countries; Prometheus’ ability to obtain and maintain intellectual property protection for our product candidates and maintain our rights under intellectual property licenses; Prometheus’ ability to maintain undisrupted business operations due to the COVID-19 pandemic, including delaying or otherwise disrupting its clinical trials, manufacturing and supply chain; and other risks described in the company’s prior press releases and filings with the Securities and Exchange Commission (SEC), including under the heading “Risk Factors” in our Form 10-K filed with the SEC on March 9, 2022 and any subsequent filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

Contacts:

Noel Kurdi
VP Investor Relations and Communications
(646) 241-4400
[email protected]

Media contact:
Juniper Point
Amy Conrad
(858) 914-1962
[email protected]

Organizational updates are part of plan to bring additional focus on leveraging clinical data to accelerate market development and the pace of innovation

Preliminary unaudited second quarter revenue of approximately $34.4 million

Company will report full second quarter results on August 3, 2022.

ALACHUA, Fla. and TAMPA, Fla., July 18, 2022 (GLOBE NEWSWIRE) — Axogen, Inc. (NASDAQ: AXGN), a global leader in developing and marketing innovative surgical solutions for peripheral nerve injuries, today announced organizational updates and preliminary second quarter revenue.

The company is making certain changes to its commercial organization designed to leverage the strength of its growing portfolio of clinical data and support innovation of advanced nerve repair solutions. As a result of these changes, the sales organization will report directly to Karen Zaderej, Axogen’s chairman, CEO, and president, and the company anticipates appointing a chief marketing officer in the coming months. Eric Sandberg, the Company’s current chief commercial officer will be leaving the organization effective July 19, 2022.

“We are pleased with our performance in the second quarter, and we are encouraged by the strong underlying demand for our products. I would like to thank Eric and wish him well in his future endeavors,” said Karen Zaderej. “These organizational changes are designed to bring additional focus on market development, innovation and sales execution. We have a robust clinical portfolio, which was recently bolstered by the positive top-line results of our RECON study. We plan to leverage this data to drive increased surgeon engagement and adoption, while also supporting an accelerating pace of innovation of advanced nerve repair solutions.”

Second Quarter Business Update

• Preliminary unaudited second quarter revenue is expected to be approximately $34.4 million, representing a 2% increase over the prior year period, and an 8% increase when excluding the impact of $1.8 million revenue of Avive^® Soft Tissue Membrane in the second quarter of 2021. The company voluntarily suspended market availability of Avive on June 1, 2021.
• Company is reaffirming its full-year 2022 financial guidance of revenue between $135 and $142 million, and gross margin above 80%.
• The company will provide further business updates, along with its second quarter 2022 financial results, on Wednesday, August 3, 2022, after the market close.

Second Quarter Conference Call Information

The company will report second quarter 2022 financial results on Wednesday, August 3, 2022 after the market close. Axogen management will host an investment-community conference call and webcast following the release at 4:30 p.m. ET. Investors interested in participating in the August 3, 2022 conference call by phone may do so by dialing toll free at (888) 428-7458 or use the direct dial-in number at (404) 267-0368. Those interested in listening to the conference call live via the Internet may do so by visiting the Investors page of the company’s website at www.axogeninc.com and clicking on the webcast link.

Following the conference call, a replay will be available in the Investors section of the company’s website at www.axogeninc.com.

About Axogen

Axogen (AXGN) is the leading company focused specifically on the science, development, and commercialization of technologies for peripheral nerve regeneration and repair. Axogen employees are passionate about helping to restore peripheral nerve function and quality of life to patients with physical damage or transection to peripheral nerves by providing innovative, clinically proven, and economically effective repair solutions for surgeons and health care providers. Peripheral nerves provide the pathways for both motor and sensory signals throughout the body. Every day, people suffer traumatic injuries or undergo surgical procedures that impact the function of their peripheral nerves. Physical damage to a peripheral nerve, or the inability to properly reconnect peripheral nerves, can result in the loss of muscle or organ function, the loss of sensory feeling, or the initiation of pain.  

Axogen’s platform for peripheral nerve repair features a comprehensive portfolio of products, including Avance^® Nerve Graft, a biologically active off-the-shelf processed human nerve allograft for bridging severed peripheral nerves without the comorbidities associated with a second surgical site; Axoguard Nerve Connector^®, a porcine submucosa ECM coaptation aid for tensionless repair of severed peripheral nerves; Axoguard Nerve Protector^®, a porcine submucosa ECM product used to wrap and protect damaged peripheral nerves and reinforce the nerve reconstruction while preventing soft tissue attachments; and Axoguard Nerve Cap^®, a porcine submucosa ECM product used to protect a peripheral nerve end and separate the nerve from the surrounding environment to reduce the development of symptomatic or painful neuroma. The Axogen portfolio of products is available in the United States, Canada, Germany, the United Kingdom, Spain, South Korea, and several other countries.

Cautionary Statements Concerning Forward-Looking Statements

This press release contains “forward-looking” statements as defined in the Private Securities Litigation Reform Act of 1995. These statements are based on management’s current expectations or predictions of future conditions, events, or results based on various assumptions and management’s estimates of trends and economic factors in the markets in which we are active, as well as our business plans. Words such as “expects,” “anticipates,” “intends,” “plans,” “believes,” “seeks,” “estimates,” “projects,” “forecasts,” “continue,” “may,” “should,” “will,” “goals,” and variations of such words and similar expressions are intended to identify such forward-looking statements. The forward-looking statements may include, without limitation, statements related to the impact of COVID-19 on our business, including but not limited to global supply chain issues, hospital staffing challenges and its impact on our business, statements regarding our growth, our financial guidance and performance, product development, product potential, regulatory process and approvals, APC renovation timing and expense, sales growth, product adoption, market awareness of our products, anticipated capital requirements, including the potential of future financings, data validation, expected clinical study enrollment, timing and outcomes, our assessment of our internal controls over financial reporting, our visibility at and sponsorship of conferences and our educational events, regulatory process and approvals and other factors, including legislative, regulatory, political, geopolitical, and economic developments, including global business disruption caused by Russia’s invasion of Ukraine and related sanctions, not within our control. The forward-looking statements are and will be subject to risks and uncertainties, which may cause actual results to differ materially from those expressed or implied in such forward-looking statements. Forward-looking statements contained in this press release should be evaluated together with the many uncertainties that affect our business and our market, particularly those risk factors described under Part I, Item 1A., “Risk Factors,” of our Annual Report on Form 10-K for the most recently ended fiscal year, as well as other risks and cautionary statements set forth in our filings with the U.S. Securities and Exchange Commission. Forward-looking statements are not a guarantee of future performance, and actual results may differ materially from those projected. The forward-looking statements are representative only as of the date they are made and, except as required by applicable law, we assume no responsibility to publicly update or revise any forward-looking statements, whether as a result of new information, future events, changed circumstances, or otherwise.

Contact:
Axogen, Inc.
Ed Joyce, Director, Investor Relations
[email protected]