On April 28, 2022 Vivoryon Therapeutics N.V. (Euronext Amsterdam: VVY; NL00150002Q7) (Vivoryon) ), a clinical stage company focused on discovery and development of small molecule medicines to modulate the activity and stability of pathologically altered proteins, reported financial results for the twelve month period ending December 31, 2021 and provided an update on its corporate progress (Press release, Vivoryon Therapeutics, APR 28, 2022, View Source [SID1234613086]). The report is available on the Company’s website View Source." target="_blank" title="View Source." rel="nofollow">View Source
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"2021 was a truly outstanding year for Vivoryon, marked by a number of hugely important achievements in the clinical development of our lead candidate varoglutamstat for the treatment of Alzheimer’s disease. Despite the pandemic-related challenges, we have met the recruitment objectives for our European Phase 2b VIVIAD study and initiated our Phase 2a/b study VIVA-MIND in the U.S. as planned. Clinical development in the U.S. is further supported by the Fast Track designation the FDA has granted for varoglutamstat last December. In addition, the regulatory achievements of our Chinese partner Simcere, enabling near-term clinical development in China, broadens the tremendous opportunity we have to make varoglutamstat available to as many patients as possible. All of these highlights are a testimony to our team’s unwavering dedication to making a difference for those affected by Alzheimer’s disease worldwide," said Dr. Ulrich Dauer, CEO of Vivoryon. "As an oral small molecule designed to target all hallmarks of AD, varoglutamstat is truly differentiated from all other approaches and we are convinced that its unique mode of action positions it as an urgently needed alternative to solely Abeta-focused, antibody-based treatments. For the remainder of the year, we are looking at a number of key milestones and inflection points that we believe will further substantiate the potential of varoglutamstat in AD. The successful placement of new shares amounting to EUR 21 million at the beginning of April this year, with participation of a number of high-quality institutional investors from Europe and the U.S., will enable us to reach these milestones, and we are extremely grateful to all our shareholders for their continued support."
Clinical Portfolio Highlights
In December, the U.S. Food and Drug Administration (FDA) granted Fast Track designation for Vivoryon’s lead product candidate varoglutamstat. Varoglutamstat, an oral QPCT/L inhibitor, is the Company’s lead product candidate and the first small molecule and only project in clinical development selectively targeting the de novo production of neurotoxic N3pE amyloid, a toxic Abeta variant shown to play a pivotal role in the development and progression of Alzheimer’s disease (AD). Fast Track is a process designed to facilitate the development, and expedite the review of drugs with the potential to treat serious conditions and fill an unmet medical need, aiming to bring important new drugs to the patient earlier. With Fast Track designation, the development of varoglutamstat can benefit from more frequent engagement with the FDA to discuss varoglutamstat’s development plan and ensure collection of the appropriate data needed to successfully advance varoglutamstat through clinical development.
In September 2021, Vivoryon initiated its U.S. Phase 2a/b VIVA-MIND study (NCT03919162) for varoglutamstat in patients with early AD. VIVA-MIND is a combined Phase 2a/b study which seeks to enroll 180 patients into the Phase 2a adaptive dose finding part. If predefined criteria are fulfilled, the trial will pass a stage-gate into the Phase 2b part, enrolling an additional 234 patients treated at the selected dose for at least 72 weeks. Thus, taken together, a total of 414 patients will be treated on stable doses of varoglutamstat for 18 months in the course of the study. The primary endpoint for this study is CDR-SB (clinical dementia rating scale – sum of boxes), an established approvable endpoint measuring a combination of cognitive abilities and activities of daily living. The study is coordinated by the Alzheimer’s Disease Cooperative Study (ADCS), and supported by a US$15 million grant from the National Institute on Aging (NIA award number R01AG061146). The study is actively enrolling patients, with currently eleven sites open and on track for an interim futility analysis planned for the first half of 2023.
Vivoryon’s ongoing European VIVIAD study (NCT04498650) is a state-of-the-art Phase 2b study designed to yield important results in early AD for varoglutamstat. Mitigating the effects of the ongoing pandemic, Vivoryon has more than doubled the originally planned number of study centers. The study is enrolling a total of 250 patients with mild cognitive impairment (MCI) and mild AD. Objectives are to evaluate the long-term efficacy (primary endpoint subset of Cogstate NTB), safety and tolerability of oral varoglutamstat. The first 90 patients are randomised 1:1:1 (600 mg twice daily, (BID) or 300 mg BID varoglutamstat or placebo BID). An independent data safety monitoring board (DSMB) will unblind safety results after 90 patients have completed 24 weeks of treatment and select the final varoglutamstat dose to be carried forward for the remainder of the study. Here, all patients will be randomized 1:1 between the final dose of varoglutamstat and placebo and continue treatment up to 48-96 weeks dependent on their study entry date. In addition to the full composite Neuropsychological Test Battery (NTB) score administered throughout the study to assess cognition, a set of exploratory read-outs including cognitive tests, functional electroencephalogram (EEG), magnetic resonance imaging (MRI) assessments and the analysis of new molecular biomarkers in the cerebrospinal fluid (CSF) will be used to evaluate the compound’s effect on disease pathology. Secondary endpoints include long-term safety and tolerability of varoglutamstat and its effect on brain activity, cognition and activities of daily living. Details on the study background and design were published in the Journal "Alzheimer’s Research & Therapy" (Vijverberg et al., View Source). With 22 active study sites VIVIAD remains on track for an interim safety readout in mid-22 and Vivoryon continues to anticipate final data in the second half of 2023.
Further substantiating the rationale for evaluating varoglutamstat in combination with monoclonal antibodies to treat AD, in October 2021, Vivoryon and its collaboration partners published data providing strong preclinical evidence of treatment with a combination of the Company’s small molecule QPCT/L inhibitor varoglutamstat and its N3pE amyloid-specific antibody PBD-C06 having an additive effect on reducing brain Abeta pathology in transgenic mice. The data, published in the "International Journal of Molecular Sciences" (Hoffmann et al., View Source), support the hypothesis of a potential benefit of a combination therapy designed to simultaneously target two different and independent molecular pathways, namely reducing N3pE amyloid production by QPCT/L inhibition and clearing existing Abeta deposits through anti-N3pE-immunotherapy.
Also in October 2021, the Company announced the expansion of its manufacturing capabilities for production of active pharmaceutical ingredient (API) by initiating a second line of manufacturing with an additional partner to ensure sustainable study drug supply with varoglutamstat for VIVA-MIND beyond the ongoing Phase 2a adaptive dose finding part, as well as for potential future studies in other geographies, with the added benefit of increasing flexibility to react to global challenges such as the ongoing pandemic.
Corporate Development Highlights
In June 2021, Vivoryon and Simcere Pharmaceutical Group Ltd entered into a strategic regional licensing partnership to develop and commercialize medicines targeting the neurotoxic amyloid species N3pE (pGlu-Abeta) to treat AD in Greater China. The agreement grants Simcere a regional license to develop and commercialize varoglutamstat (PQ912), Vivoryon’s Phase 2b-stage N3pE amyloid-targeting oral small molecule glutaminyl cyclase (QPCT) inhibitor with disease-modifying potential for AD, as well as the Company’s preclinical monoclonal N3pE antibody PBD-C06 in the Greater China region.
In March 2021, the Extraodinary General Meeting of Vivoryon re-appointed Dr. Ulrich Dauer as CEO and appointed Florian Schmid as CFO as of April 1, 2021. Mr. Schmid joined Vivoryon from InflaRx, where he served as Director Finance & Controlling. In Vivoryon’s 2021 Ordinary Annual General Meeting held June 28, 2021, all items presented for resolution by the Board of Directors were approved with a large majority, including the re-appointment of Dr. Michael Schaeffer as CBO.
Throughout 2021, Vivoryon further expanded its patent portfolio with a total of 55 additional patents that have been granted from January to December for the Company’s small molecule inhibitors and antibody-based medicines in development to treat AD and other diseases with exceptionally high medical need.
Post-period Events
On April 1, 2022, Vivoryon announced that it had successfully completed a private placement by way of accelerated bookbuilding, raising gross proceeds of EUR 21 million. The Company placed 2,000,000 registered shares at an offering price of EUR 10.50 per share. The new shares from the capital increase represent 10% of Vivoryon’s existing issued share capital and have been issued from the Company’s authoritzed capital under exclusion of the existing shareholders’ pre-emptive rights. As a consequence, the Company’s issued share capital has increased to EUR 22,050,482.00. Vivoryon intends to use the net proceeds from the offering to support the ongoing clinical development of its lead candidate varoglutamstat, as well as for general corporate purposes. The new shares have been admitted to trading on Euronext Amsterdam on April 5, 2022. The capital raise was supported by a number of high-quality institutional investors from Europe and the U.S. as well as members of Vivoryon’s Executive and Non-Executive Boards.
On February 28, 2022, Vivoryon and its partner Simcere announced that China’s Center for Drug Evaluation (CDE) of National Medical Products Administration (NMPA) has approved the Clinical Trial Application for varoglutamstat for the development in Greater China by Simcere. Simcere intends to start the clinical Phase 1 study in China in the first half of 2022.
In line with the Company’s efforts to meet international best practice standards, Vivoryon plans to expand and diversify its Non-Executive Board, intending to propose two additional candidates for nomination at its 2022 Annual General Meeting to be held later this year.
Financial Results for the Full Year 2021
The Company generated license revenues of EUR 10.8 million in 2021 from a regional licensing partnership with Simcere Pharmaceutical Group Ltd for Greater China (Mainland China, Hong Kong, Macao and Taiwan) signed on June 29, 2021. No revenues were generated in 2020, respectively.
Research and development expenses increased in 2021 by EUR 4.2 million compared to the year ended December 31, 2020. This increase is primarily attributable to a EUR 3.7 million higher expenses for our clinical trial, VIVIAD, and the related production of PQ912, as well as EUR 0.8 million higher expenses for share-based payments
General and administrative expenses increased by EUR 1.7 million largely attributable to EUR 0.8 million higher expenses for share based payments as well as EUR 0.6 higher expesenses for legal and consulting services in connection with preparation of a US listing.
Net loss for the twelve months ended December 31, 2021 was EUR 12.7 million, compared to EUR 16.5 million for the twelve months ended December 31, 2020. The Company held EUR 14.7 million in cash and cash equivalents as of December 31, 2021, compared to EUR 26.3 million as of December 31, 2020.
Financial Guidance Following the capital raise completed in April 2022, according to current planning and estimates, Vivoryon expects that its existing cash and cash equivalents will be sufficient to fund its research and development expenses as well the general and administrative expenses and cash flows from investing and financing activities at least through end of May 2023. This guidance does not include potential milestone payments from development partnerships, potential payments from licensing agreements and/or additional financing measures, as far as such payments have not yet been recognized in revenues. The financial guidance takes into account all costs to ensure sustainable study drug supply with varoglutamstat for the VIVA-MIND U.S. study.
Annual Financial Report 2021
The financial statements of Vivoryon have been prepared in accordance with International Financial Reporting Standards (IFRS) of the International Accounting Standards Board, as adopted by the European Union (EU-IFRS) and with Section 2:362(9) of the Netherlands Civil Code. The auditor KPMG has issued an unqualified auditor’s report for both statements. The reports are available on the Company’s website (View Source).
Conference Call and Webcast
Vivoryon will host a conference call and webcast today, April 28, 2022, at 3:00 pm CEST (09:00 am EDT). A Q&A session will follow the presentation of the full year results.
Please dial in ten minutes prior to commencement.
A live webcast and slides will be made available at: www.vivoryon.com/investors-news/news-and-events/presentations-webcasts/
Approximately one day after the call, a slide-synchronized audio replay of the conference will be available on: www.vivoryon.com/investors-news/news-and-events/presentations-webcasts/