Vivoryon Therapeutics N.V. to Report Third Quarter 2021 Financial Results on November 4, 2021
Vivoryon Therapeutics Receives FDA Fast Track Designation for Varoglutamstat in Early Alzheimer’s Disease
HALLE (SAALE) / MUNICH, GERMANY, November 4, 2021 – 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, today announced financial results and the corporate update for the third quarter of 2021, ending September 30, 2021. The report is available on the Company’s website at www.vivoryon.com/investors-news/financial-information
“Throughout the third quarter, we made significant progress towards filling the gap of safe, widely available effective disease-modifying therapies in Alzheimer’s disease. Both our newly initiated study VIVA-MIND in the U.S. and our ongoing European study VIVIAD are progressing steadily and we have implemented a number of measures to ensure that the Company is able to deliver on its objectives, including stringent clinical development beyond the currently ongoing studies,” said Dr. Ulrich Dauer, CEO of Vivoryon.
Corporate Highlights and R&D Updates
Varoglutamstat
- In August 2021, details on the study background and design of Vivoryon’s European Phase 2b study VIVIAD in patients with mild cognitive impairment and mild AD were published in the Journal “Alzheimer’s Research & Therapy“ (Vijverberg et al., https://doi.org/10.1186/s13195-021-00882-9). The study is enrolling patients as planned despite the ongoing global pandemic. To avoid delays in recruitment and as a reaction to COVID-19-related patient and staff protection policies implemented at German study sites, Vivoryon is in the process of increasing the overall number of study sites, aiming to more than double the originally planned number. 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.
- In September 2021, Vivoryon initiated its U.S. Phase 2a/b VIVA-MIND study 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, with an interim futility analysis planned for H1/2023. 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, with a total of 414 patients being treated on stable doses of varoglutamstat for 18 months. 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 VIVA-MIND study is sponsored by Vivoryon and the study director is Dr. Howard Feldman, Professor of Neurosciences and Director of the Alzheimer’s Disease Cooperative Study (ADCS) at the University of California San Diego School of Medicine. The study is coordinated by the ADCS, and supported by the National Institute on Aging (NIA), part of the National Institutes of Health (NIH), with a US$15 million grant (NIA award number R01AG061146). The study is ongoing with two sites now approved to screen participants and a group of another seven sites having secured regulatory approval.
Patent Portfolio
In the third quarter of 2021, Vivoryon further expanded its patent portfolio. Year to date (as of October 31, 2021) a total of 16 additional patents have been granted 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
- In October 2021, the Company announced that it has decided to expand 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 the VIVA-MIND U.S. study. This will increase the total number of manufacturing sites for varoglutamstat to three on two different continents, providing supply 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.
- Also 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., https://doi.org/10.3390/ijms222111791), 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. This provides a strong rationale for the evaluation of therapies combining varoglutamstat with monoclonal antibodies to treat AD.
Financial Results for Q3 of 2021
In Q3, the Company generated license revenues of EUR 10.8 million from a strategic regional licensing partnership signed with its partner Simcere on June 29, 2021 for Greater China. No revenues were generated in 2020, respectively.
Research and development expenses incurred for the nine months ended September 30, 2021 increased over the corresponding period in 2020 by EUR 3.6 million. This increase was mainly driven by EUR 2.9 million higher expenses for production and Vivoryon’s clinical studies, as well as EUR 0.7 million higher expenses for share-based payments.
General and administrative expenses increased by EUR 1.2 million for the nine months ended September 30, 2021. This increase is largely attributable to EUR 0.3 million higher consulting costs and EUR 0.7 million higher expenses for share based payments. The increase in consulting costs resulted from preparations for a potential future listing on Nasdaq.
Net loss for the nine months ended September 30, 2021 was EUR 7.3 million, compared to EUR 12.2 million for the nine months ended September 30, 2020. The Company held EUR 19.9 million in cash and cash equivalents as of September 30, 2021, compared to EUR 26.3 million as of December 31, 2020.
Financial Guidance
On October 18, 2021, Vivoryon updated its financial guidance to account for costs associated with 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 the VIVA-MIND U.S. study. According to current planning and estimates, the Company now expects a cash reach until mid-2022. A detailed update on anticipated working capital requirements and associated potential financing activities as well as resulting timelines will be given in the context of Vivoryon’s regular filings.
Unaudited Condensed Interim Financial Statements
Vivoryon Therapeutics N.V.
Condensed Statements of Operations and Comprehensive Income and Loss
| For the three months ended September 30, | For the nine months ended September 30, | |||
| (in k EUR, except for share data) | 2021 | 2020 | 2021 | 2020 |
| Revenue | 10,764 | — | 10,764 | — |
| Cost of Sales | (488) | — | (488) | — |
| Gross Profit | 10,276 | — | 10,276 | — |
| Research and development expenses | (4,128) | (3,653) | (13,584) | (10,032) |
| General and administrative expenses | (857) | (847) | (3,193) | (1,986) |
| Other operating income | — | — | 6 | — |
| Operating profit / (loss) | 5,292 | (4,500) | (6,496) | (12,018) |
| Finance income | 398 | 119 | 617 | 156 |
| Finance expenses | (199) | (251) | (301) | (344) |
| Finance result | 199 | (133) | 316 | (186) |
| Result before income taxes | 5,491 | (4,633) | (6,180) | (12,206) |
| Income taxes | (1,082) | — | (1,082) | — |
| Net profit / (loss) for the period | 4,410 | (4,633) | (7,261) | (12,206) |
| Items not to be reclassified subsequently to profit or loss | ||||
| Remeasurement of the net defined benefit pension liability | 89 | — | 89 | (20) |
| Total other comprehensive profit / (loss) | 89 | — | 89 | (20) |
| Comprehensive profit / (loss) | 4,499 | (4,633) | (7,172) | (12,224) |
| (Earnings)/ Loss per share in € (basic and diluted) | 0.22/ 0.22 | (0.23) | (0.36) | (0.61) |
Vivoryon Therapeutics N.V.
Condensed Statements of Financial Position
| (in k EUR) | September 30, 2021 | December 31, 2020 |
| ASSETS | ||
| Non-current assets | ||
| Intangible assets | 544 | 565 |
| Property, plant and equipment | 74 | 80 |
| Right-of-use assets | 241 | 310 |
| Financial assets | 14 | 3 |
| Total non-current assets | 873 | 958 |
| Current assets | ||
| Other current assets and prepayments | 2,265 | 2,466 |
| Financial assets | 6,387 | 21 |
| Cash and cash equivalents | 19,861 | 26,306 |
| Total current assets | 28,513 | 28,793 |
| TOTAL ASSETS | 29,386 | 29,751 |
| Equity | ||
| Share capital | 20,020 | 19,975 |
| Share premium | 82,784 | 82,143 |
| Other capital reserves | 5,788 | 4,404 |
| Accumulated other comprehensive loss | (566) | (655) |
| Accumulated deficit | (86,906) | (79,646) |
| Total equity | 21,120 | 26,221 |
| Non-current liabilities | ||
| Pension liability | 1,835 | 1,981 |
| Provisions long-term | 12 | — |
| Lease liabilities | 156 | 224 |
| Total non-current liabilities | 2,003 | 2,205 |
| Current liabilities | ||
| Provisions | 35 | 47 |
| Trade payables | 5,284 | 911 |
| Lease liabilities | 92 | 90 |
| Other liabilities | 852 | 276 |
| Total current liabilities | 6,263 | 1,325 |
| Total Liabilities | 8,266 | 3,530 |
| TOTAL EQUITY AND LIABILITIES | 29,386 | 29,751 |
Vivoryon Therapeutics N.V.
Statements of Changes in Shareholders’ Equity for the nine months ended September 30, 2021 and 2020
Vivoryon Therapeutics N.V.
Condensed Statements of Cash Flows
| For the nine months ended September 30, | ||
| (in k EUR) | 2021 | 2020 |
| Operating activities | ||
| Net loss for the period | (7,261) | (12,206) |
| Adjustments for: | ||
| Finance result | (316) | 188 |
| Depreciation and amortization | 125 | 106 |
| Share based payments | 1,384 | 4 |
| Other non-cash adjustments | 524 | (69) |
| Changing in: | ||
| Other current assets and prepayments | 201 | 772 |
| Other financial assets | (6,377) | 307 |
| Pension liabilities | (146) | (32) |
| Provisions | — | (210) |
| Trade payables | 4,372 | 386 |
| Other liabilities | 577 | (8) |
| Interest received | 19 | 27 |
| Interest paid | (5) | (6) |
| Taxes paid | (433) | — |
| Cash flows used in operating activities | (7,336) | (10,741) |
| Investing activities | ||
| Purchase of plant and equipment | (20) | (18) |
| Purchase of intangible assets | (8) | (557) |
| Cash flows used in investing activities | (28) | (575) |
| Financing activities | ||
| Payment of lease liabilities | (67) | (68) |
| Proceeds from exercise of share options | 686 | — |
| Cash flows provided / (used in) by financing activities | 619 | (68) |
| Net decrease in cash and cash equivalents | (6,745) | (11,384) |
| Cash and cash equivalents at the beginning of period | 26,306 | 41,524 |
| Effect of exchange rate fluctuation on cash held | 300 | (160) |
| Cash and cash equivalents at end of period | 19,861 | 29,980 |
For more information, please contact:
Investor Contact
Vivoryon Therapeutics N.V.
Dr. Manuela Bader, Director IR & Communication
Tel: +49 (0)345 555 99 30
Email: IR@vivoryon.com
Media Contact
Trophic Communications
Valeria Fisher / Sophia Hergenhan
Tel: +49 175 8041816
Email: vivoryon@trophic.eu
About Vivoryon Therapeutics N.V.
Vivoryon is a clinical-stage biotechnology company focused on developing innovative small molecule-based medicines. Driven by our passion for ground-breaking science and innovation, we strive to change the lives of patients in need suffering from severe diseases. We leverage our in-depth expertise in understanding post-translational modifications to develop medicines that modulate the activity and stability of proteins which are altered in disease settings. Beyond our lead program, varoglutamstat, which is in Phase 2 clinical development to treat Alzheimer‘s disease, we have established a solid pipeline of orally available small molecule inhibitors for various indications including cancer, inflammatory diseases and fibrosis. www.vivoryon.com
Forward-Looking Statements
This press release includes forward-looking statements, including, without limitation, those regarding the business strategy, management plans and objectives for future operations of the Vivoryon Therapeutics N.V. (the “Company”), estimates and projections with respect to the market for the Company’s products and forecasts and statements as to when the Company’s products may be available. Words such as “anticipate,” “believe,” “estimate,” “expect,” “forecast,” “intend,” “may,” “plan,” “project,” “predict,” “should” and “will” and similar expressions as they relate to the Company are intended to identify such forward-looking statements. These forward-looking statements are not guarantees of future performance; rather they are based on the Management’s current expectations and assumptions about future events and trends, the economy and other future conditions. The forward-looking statements involve a number of known and unknown risks and uncertainties. These risks and uncertainties and other factors could materially adversely affect the outcome and financial effects of the plans and events described herein. Actual results, performance or events may differ materially from those expressed or implied in such forward-looking statements and from expectations. As a result, no undue reliance should be placed on such forward-looking statements. This press release does not contain risk factors. Certain risk factors that may affect the Company’s future financial results are discussed in the published annual financial statements of the Company. This press release, including any forward-looking statements, speaks only as of the date of this press release. The Company does not assume any obligation to update any information or forward-looking statements contained herein, save for any information required to be disclosed by law. This press release does not constitute an offer to sell or the solicitation of an offer to buy any securities of the Company in any jurisdiction.