Market Newsdesk

SAN JOSE, Calif., Dec. 16, 2020 (GLOBE NEWSWIRE) — Nubeva Technologies Ltd. (“Nubeva” or the “Company“) (TSX-V: NBVA), announces its unaudited consolidated financial statements for the second quarter ended October 31, 2020. Financial statements along with management discussion and analysis of financial results can be found at www.sedar.com. All dollar amounts in this release are quoted in U.S. Dollars.

“We experienced significant momentum in the second quarter as customers began adding Nubeva’s Symmetric Key Intercept solution to their software security and application monitoring tools,” said Randy Chou, Nubeva’s founder and CEO. “We will continue to license our technology to manufacturers, enabling enterprise users to obtain the visibility they need into network traffic “

During the second quarter Nubeva reported revenue of $927,702 compared with revenue from the same quarter of last year of $38,511. The increase in revenue for the quarter was due to the recognition of revenue from the Company’s license of its Symmetric Key Intercept software (“SKI”) and related support and maintenance, and represents part of a seven figure, multi-year deal. The balance of this contract will be recognized over time.

Nubeva reported net income for the quarter of $294,125 compared with a net loss of $953,670 in the second quarter of last year, primarily due to the increase in revenue, as well as a 27% reduction in expenses.

Selected operating data follows:

The Company’s financial position as at October 31, 2020 compared with the Company’s financial position as at April 30, 2020 is as follows:

Assets as at October 31, 2020 decreased by $289,643 over assets as at April 30, 2020 due mainly to a decrease in cash and marketable securities of $418,373. The decrease in cash was due primarily to an outflow of cash used for operations. This decrease was partially offset by an increase in the tax credit receivable of $151,139. Subsequent to the end of the quarter the Company collected tax credits in the amount of $324,015. The Company had a working capital surplus of $1,240,081 (April 30, 2020 – $1,447,203). The available working capital as at the date of this MD&A is estimated to be adequate to finance Nubeva’s planned operations over the ensuing six months.

About Nubeva Technologies Ltd.
 

Nubeva Technologies Ltd. has changed the decrypted visibility game with pure, symmetric decryption. Nubeva helps enterprises gain the visibility needed through decryption so they can fully inspect network traffic. The need to inspect data in motion is fundamental to network security and application monitoring and assurance. The shift to SaaS, the cloud, 5G and stronger encryption practices like perfect forward secrecy and TLS 1.3, create new and unique challenges for in-line and out-of-band decryption and visibility solutions. Nubeva re-imagined TLS visibility and created a new solution for the modern era of strong encryption in dynamic and distributed compute environments. Visit nubeva.com for more information.

Forward Looking Statements

This news release contains “forward-looking information” within the meaning of applicable securities laws relating to the Company’s business plans and the outlook of the cybersecurity industry. Although the Company believes in light of the experience of its officers and directors, current conditions and expected future developments and other factors that have been considered appropriate that the expectations reflected in this forward-looking information are reasonable, undue reliance should not be placed on them because the Company can give no assurance that they will prove to be correct. Actual results and developments may differ materially from those contemplated by these statements. The statements in this press release are made as of the date of this release and the Company assumes no responsibility to update them or revise them to reflect new events or circumstances other than as required by applicable securities laws. The Company undertakes no obligation to comment on analyses, expectations or statements made by third-parties in respect of the Company, its subsidiaries, their securities, or their respective financial or operating results (as applicable).

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

MALVERN, Pa., Dec. 16, 2020 (GLOBE NEWSWIRE) — Recro (Nasdaq:REPH), a leading contract development and manufacturing organization (CDMO), with integrated solutions for formulation, analytical services, regulatory support, manufacturing and packaging of both commercial and development stage oral solid dose drug products, today announced that David Enloe has been named President, Chief Executive Officer and a member of the Company’s Board of Directors, replacing Gerri Henwood, effective today.

Mr. Enloe brings over two decades of executive leadership experience in biotechnology, clinical drug development and GMP manufacturing to Recro, with a proven track record of building and growing CDMO businesses. Most recently, he served as President and Chief Executive Officer of Ajinomoto Bio-Pharma Services, a global, fully integrated CDMO.  Under Mr. Enloe’s leadership, Aji Bio-Pharma’s revenues have increased over 50% in a four-year period and he led the expansion of service offerings and creation of a single business model focused on improving operations across the organization’s multiple global entities and locations.

Wayne B. Weisman, Chairman of the Board of Recro commented: “David has a demonstrable history of success in building CDMO businesses, forming strategic partnerships and leading global organizations. He has also played a pivotal role in the successful growth and development of many innovation-driven companies. We anticipate that the Board’s appointment of David as CEO will allow Recro to leverage the Company’s operations, assets, talent and business partners. We sincerely thank Gerri for her service to the Company these past five years and wish her much success as the CEO of Baudax Bio, Inc.”

“Recro is an exciting innovation story, with a lot of potential for strategic growth, particularly in the areas of commercial manufacturing of complex solid oral dose form therapeutics, as well as drug product formulation and development services, high potency drug products and clinical trials drug supplies and logistics,” said Mr. Enloe. “Our CDMO business has clear strengths versus competitors, and we have a terrific team of engaged, motivated people. I look forward to leading the Recro team as we refine and implement strategies designed to address our many promising opportunities and create value for all of our stakeholders.”

Mr. Enloe was selected after interviewing several well-qualified candidates that were identified during an extensive search conducted by the Board of Directors in conjunction with the executive search firm Heidrick & Struggles.

“I am honored to have served as Recro’s President and Chief Executive Officer and I would like to thank the Board and the management team,” said Ms. Henwood. “It has been a privilege to work with all of the Recro employees and I believe we have done tremendous work together, including transforming the business to be a provider of expanded high-value CDMO services. Recro has a bright future and I look forward to seeing its continued success under David Enloe.”

While at Ajinomoto, Mr. Enloe was awarded “Most Admired CEO” in 2017 by the San Diego Business Journal. This award recognized David for leading the company through a phase of significant growth while fostering several innovation initiatives and creating company stability and scalability.  Before joining Ajinomoto, Mr. Enloe served as Head of Lonza’s Viral Therapeutics Business Unit, which was the result of Lonza’s acquisition of Vivante GMP Solutions, a gene therapy CDMO that Mr. Enloe founded in June 2009 and where he served as President and CEO until its sale to Lonza AG. Under Mr. Enloe’s leadership, the business experienced rapid expansion, with revenues increasing 500% over a three-year period.   Preceding Vivante, Mr. Enloe spent 14 years with biotech company, Introgen Therapeutics, joining as its first employee in 1995 and spending several years as Senior Vice President and COO before ultimately being named President and CEO. In addition to helping start Introgen, Mr. Enloe was an integral part of taking that company through a successful IPO in 2000, as well as several other financial events. In addition, Mr. Enloe oversaw multiple large corporate and academic collaborations, as well as the filing of license applications with both the FDA and European regulatory authorities of Introgen’s lead product. Mr. Enloe received a Bachelor of Business Administration, Accounting from the University of Texas at Austin. He is a Certified Public Accountant and started his career in public accounting with Arthur Andersen & Co.

About Recro

Recro is a contract development and manufacturing organization, or CDMO, with integrated solutions for formulation, analytical services, regulatory support, manufacturing and packaging of both commercial and development stage solid oral dose drug products. Recro’s Clinical Trials Materials and Logistics business, including preparation of double-blind clinical trial supplies and supply logistics is becoming a popular service, as well as capabilities for specialized services dedicated to the development and GMP manufacturing of high potency products. The Company leverages its formulation expertise to develop and manufacture pharmaceutical products using its proprietary delivery technologies and other manufacturing services for commercial and development-stage partners who commercialize or plan to commercialize these products. For more information see www.recrocdmo.com.

Cautionary Statement Regarding Forward Looking Statements

This press release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These statements, among other things, relate to the Company’s ability to manage costs and to achieve its financial goals; to operate under increased leverage and associated lending covenants; to pay its debt under its credit agreement and to maintain relationships with CDMO commercial partners and develop additional commercial partnerships. The words “anticipate”, “believe”, “could”, “estimate”, “upcoming”, “expect”, “intend”, “may”, “plan”, “predict”, “project”, “will” and similar terms and phrases may be used to identify forward-looking statements in this press release. Our operations involve risks and uncertainties, many of which are outside our control, and any one of which, or a combination of which, could materially affect our results of operations and whether the forward-looking statements ultimately prove to be correct. Factors that could cause the Company’s actual outcomes to differ materially from those expressed in or underlying these forward-looking statements include the ongoing economic and social consequences of the COVID-19 pandemic, including any adverse impact on the customer ordering patterns or inventory rebalancing or disruption in raw materials or supply chain; demand for the Company’s services, which depends in part on customers’ research and development and the clinical plans and market success of their products; customers’ changing inventory requirements and manufacturing plans; customers and prospective customers decisions to move forward with the Company’s manufacturing services; the average profitability, or mix, of the products the Company manufactures; the Company’s ability to enhance existing or introduce new services in a timely manner; fluctuations in the costs, availability, and suitability of the components of the products the Company manufactures, including active pharmaceutical ingredients, excipients, purchased components and raw materials, or the Company’s customers facing increasing or new competition. These forward-looking statements should be considered together with the risks and uncertainties that may affect our business and future results presented herein along with those risks and uncertainties discussed in our filings with the Securities and Exchange Commission at www.sec.gov. These forward-looking statements are based on information currently available to us, and we assume no obligation to update any forward-looking statements except as required by applicable law.

Contacts

Investor Relations Contact:
Argot Partners
Sam Martin / Claudia Styslinger
(212) 600-1902
[email protected] 
[email protected] 

Recro
Ryan D. Lake
(484) 395-2436
[email protected] 

Media Contact:
Argot Partners
David Rosen
(212) 600-1902
[email protected] 

Phoenix, AZ, Dec. 16, 2020 (GLOBE NEWSWIRE) — The Ivy Brain Tumor Center at Barrow Neurological Institute today announced the opening of a Phase 0 clinical trial for patients with newly diagnosed and recurrent glioblastoma (GBM) to evaluate pamiparib, an investigational small molecule PARP inhibitor from BeiGene. The Ivy Center’s novel study approach will assess pamiparib’s ability to penetrate the blood-brain barrier, one of the most significant challenges in the mission to treat brain cancer.

This trial adds to the Ivy Center’s already extensive portfolio of Phase 0 clinical trials for patients with glioblastoma and other aggressive brain tumors but marks the first-ever to enroll newly diagnosed GBM patients, in addition to recurrent GBM patients.

The current standard of care for patients with newly diagnosed glioblastoma consists of maximal surgical resection, followed by radiation and a chemotherapy drug called temozolomide (TMZ) to slow the growth of microscopic tumor cells that remain after surgery.

“The trial itself, marking the first time newly diagnosed glioblastoma patients will be enrolled in a Phase 0 clinical trial, is a major milestone for the brain tumor community and the Ivy Brain Tumor Center,” commented Catherine Ivy, founder and board president of the Ben & Catherine Ivy Foundation. “What we learn from this trial represents yet another pivotal step forward in the work to find a cure for glioblastoma patients.”

Worldwide, it has been 20 years since a new drug approval has provided glioblastoma patients with a survival benefit.

“While temozolomide can extend a GBM patient’s survivability to 15-18 months, it is not curative and shows no benefit for patients with an unmethylated MGMT promoter. Radiation, however, is the only modality that has been proven to work in all patients. If we find that pamiparib is capable of reaching the tumor at sufficient levels, and is subsequently developed and approved in this indication, it will add to our arsenal of radiosensitizer drugs to make radiotherapy for patients with glioblastoma even more effective,” said Shwetal Mehta, Ph.D., chief operating officer and deputy director of the Ivy Brain Tumor Center.

Patients enrolled in this clinical trial will take the study drug for five days leading up to a scheduled operation to remove their tumor. Within days of the operation, the Ivy Center’s team will determine the effects of the investigational treatment on the tumor. Patients with positive results may advance to an expansion phase of the study, which combines therapeutic dosing of pamiparib with fractionated radiotherapy. If pamiparib does not show evidence of sufficient tumor penetration, patients can pivot to another therapy or clinical trial without losing time or receiving ineffective treatment.

“There are two underlying problems with identifying new, effective treatment options for brain cancer. First, the blood-brain barrier prevents most new drugs from ever reaching the tumor.  Second, the molecular effects of new drugs are difficult to predict using laboratory animals. Ivy Phase 0 clinical trials address both of these obstacles and accelerate our understanding of treatment in each individual patient,” said Nader Sanai, M.D., director of the Ivy Brain Tumor Center.

“The Ivy Brain Tumor Center’s commitment to their patients, combined with the speed and precision of their clinical trial administration, make them an ideal research partner for this ground-breaking clinical trial,” said Yong (Ben) Ben, M.D., Chief Medical Officer, Immuno-Oncology at BeiGene. “This trial is designed to enable us to understand more about the extent to which pamiparib can cross the blood-brain barrier, and we are hopeful that it could lead to further development, and if approved, bring a much-needed new treatment to the brain tumor community.”

To learn more about this Phase 0 clinical trial, including eligibility criteria, visit: https://clinicaltrials.gov/ct2/show/NCT04614909.

Click to Tweet: @IvyBrainTumorCenter launches first-ever #Phase0 clinical trial for newly diagnosed #glioblastoma, in addition to recurrent glioblastoma, to evaluate @BeiGene’s pamiparib in combination with fractionated radiotherapy.

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About Ivy Brain Tumor Center
Ivy Brain Tumor Center at the Barrow Neurological Institute in Phoenix, AZ is a non-profit translational research program that employs a bold, early-phase clinical trials strategy to identify new treatments for aggressive brain tumors, including glioblastoma. The Ivy Center’s Phase 0 clinical trials program is the largest of its kind in the world and enables personalized care in a fraction of the time and cost associated with traditional drug development. Unlike conventional clinical trials focusing on single drugs, its accelerated trials program tests therapeutic combinations matched to individual patients. Learn more at IvyBrainTumorCenter.org. Follow the Ivy Brain Tumor Center on Facebook, Instagram, Twitter and LinkedIn.

About Pamiparib
Pamiparib (BGB-290) is an investigational inhibitor of PARP1 and PARP2 which has demonstrated pharmacological properties such as brain penetration and PARP-DNA complex trapping in preclinical models. Discovered by BeiGene scientists, pamiparib is currently in global clinical development as a monotherapy or in combination with other agents for a variety of solid tumor malignancies. Clinical trials of pamiparib also include a Phase 1b/2 trial (NCT03150862) in combination with radiation therapy and/or temozolomide in patients with first-line or recurrent/refractory glioblastoma. To date, more than 1,200 patients have been enrolled in clinical trials of pamiparib.

A New Drug Application (NDA) for pamiparib for patients with ovarian cancer has been accepted and granted priority review by Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) for the treatment of patients with deleterious or suspected deleterious germline BRCA-mutated advanced ovarian, fallopian tube, or primary peritoneal cancer who have been treated with two or more lines of chemotherapy.

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