Conference Call and Webcast Today at 4:30 pm ET
Scientific and Business Highlights
- Based on preclinical efficacy data in our human Rett cortical organoid model, we are advancing VYNT0126 into clinical trials in Rett patients with encouragement and guidance from the International Rett Syndrome Foundation
- Continued progress with efforts towards the divestiture of the vivoPharm business
- Progress with licensing our iPSC technology to transition key product sales customers
Financial Highlights
- $11.7 million of cash and equivalents as of June 30, 2022
- Cash runway approximately 18 months
CHERRY HILL, N.J., Aug. 22, 2022 (GLOBE NEWSWIRE) -- Vyant Bio, Inc. (“Vyant Bio” or “Company”) (Nasdaq: VYNT) is an innovative biotechnology company reinventing drug discovery for complex neurodevelopmental and neurodegenerative disorders. The Company’s proprietary central nervous system (“CNS”) drug discovery platform combines human-derived organoid models of brain disease, scaled biology, and machine learning to elucidate disease pathophysiology and identify and validate drug targets for rare CNS genetic disorders. Today, Vyant Bio filed its Form 10-Q for the Second Quarter 2022 with the Securities and Exchange Commission (“SEC”) and will discuss its Second Quarter 2022 highlights and business updates this afternoon in a conference call and webcast scheduled for 4:30 pm ET.
“We are highly focused on validating the power of our drug discovery platform in a planned human proof-of-concept clinical trial beginning in early 2023,” stated Jay Roberts, CEO of Vyant Bio. “We believe there are significant value creation drivers unique to Vyant Bio in the drug discovery sector. The traditional ‘target-based’ approach to discovering and developing treatments for neurological diseases is not ideal. Current approaches are expensive, inefficient, and almost always unsuccessful. What differentiates Vyant Bio is our ‘disease-first’ approach that brings a human understanding of disease biology into the lab, providing a greater level of certainty to neurological drug discovery”.
“Our proprietary CNS drug discovery platform has led to the identification of a promising FDA-approved repurposing candidate (“VYNT-0126”), and several small molecules against two novel targets showing the molecules robustly and reproducibly rescue the Rett Syndrome disease phenotype in our Rett patient-derived cortical organoid model. These molecules rescue the Rett disease phenotype by a differentiated mechanism of action compared to other advanced Rett clinical candidates,” stated Robert T. Fremeau, Jr., Ph.D., CSO of Vyant Bio.
Dr. Fremeau further noted, “With our preclinical data with VYNT-0126, which we believe is compelling, we met with the Clinical Trial Committee of the International Rett Syndrome Foundation (“IRSF”) on July 19, 2022, to receive their feedback and guidance on our plans to conduct a proof-of-concept clinical trial of VYNT-0126 in adult Rett patients in Australia. We are on track to submit our clinical trial application to the Ethics Committee in Australia in the third quarter of 2022 for a trial to begin in early 2023. In addition, we have initiated a collaboration with the IRSF to advance VYNT-0126 into a proof-of-concept clinical trial in pediatric Rett patients in the U.S. and anticipate filing an IND with the FDA for the pediatric study in 2023. We are excited to share our human preclinical efficacy data for VYNT-0126 in two talks at the Rett Symposium at the Annual Meeting of the Society for Neuroscience on November 16, 2022. Our ongoing work on CDKL5 and familial Parkinson’s disease has further established that our discovery platforms represent a robust model for human-first CNS drug discovery. Phenotypic and target-based screening of our patient-derived CDKL5 organoids has identified several novel small molecule hits and corresponding targets that rescue the hyperexcitability phenotype in our organoid model and represent promising starting points for the identification of disease-modifying therapeutics for CDKL5 disorder. Finally, our Parkinson’s Disease program has identified a disease-relevant biomarker in an hiPSC- derived familial model of PD that we are optimizing for conducting a high throughput drug screen.”
Second Quarter and First Half 2022 Financial Results
Cash and cash equivalents totaled $11.7 million as of June 30, 2022. The Company implemented two new vehicles in the first half of 2022 to facilitate the raising of additional equity capital at the Company’s option with the finalization of the Lincoln Park Equity line of credit, allowing access to raise up to $15 million, as well as signing a $14.5 million ATM with Canaccord Genuity. The Company’s current cash, expected future proceeds from the sale of vivoPharm, the equity line of credit, and ATM, are expected to fund operations for the next 18 months.
During the first half of 2022, the Company continued the process of divesting the vivoPharm business, which is expected to complete in 2022. Therefore, the vivoPharm business is classified as a “held-for-sale” asset, and its financial information as “discontinuing operations.”
The Company’s loss from continuing operations aggregated $4.3 million in the second quarter of 2022, compared with $4.0 million in the second quarter of 2021. The Company’s loss from continuing operations aggregated $8.7 million in the first half of 2022, compared with $11.3 million in the first half of 2021. Net loss from discontinuing operations was $1.5 million for the second quarter of 2022, compared with $232 thousand for the second quarter of 2021. Net loss from discontinuing operations was $6.2 million for the first half of 2022, compared with $240 thousand for the first half of 2021. During the three and six-month periods ended June 30, 2022, the Company recorded non-cash impairment charges of $1.5 million and $5.8 million, respectively, related to the vivoPharm business based on its estimated fair value.
Research and development expenses increased by 85%, or $778 thousand, to $1.7 million for the three months ended June 30, 2022 from $910 thousand for the three months ended June 30, 2021. Research and development expenses increased by 87%, or $1.5 million, to $3.2 million for the six months ended June 30, 2022 from $1.7 million for the six months ended June 30, 2021. This increase is principally due to a $853 thousand increase in payroll-related and consulting expenses, a $417 thousand increase in research and development activities at our Maple Grove facility, and $230 thousand related to moving into a new facility in California. During 2022 we are transitioning our Maple Grove operations to an internal research and development facility.
Selling, general and administrative expenses decreased by 8%, or $228 thousand, to $2.5 million for the three months ended June 30, 2022, as compared with $2.7 million for the three months ended June 30, 2021. Selling, general and administrative expenses increased by 33%, or $1.3 million, to $5.3 million for the six months ended June 30, 2022, as compared with $4.0 million for the six months ended June 30, 2021. The 2021 period reflects the Company as a privately-held company during the first quarter, whereas the 2022 period reflects the Company as a publicly-held company. The six months ended June 30, 2022 includes incremental $717 thousand of payroll-related expenses, including one-time severance benefits for two former employees of $437 thousand. The Company incurred $418 thousand of additional professional service expenses in 2022 compared to the same prior-year period.
In August 2022, in connection with efforts to sell its vivoPharm subsidiary, the Company determined that certain historical vivoPharm tax returns either had not been filed or were incorrectly filed with the U.S. Internal Revenue Service. As a result of this finding and as further detailed in the June 30, 2022 quarterly report on Form 10-Q filed with the SEC today, the Company delayed the timing of this quarterly report to ensure it had properly accounted for this matter.
Vyant Bio’s Conference Call and Webcast and Information
Vyant Bio’s management will host a conference call on Monday, August 22, 2022 at 4:30 pm ET to discuss the second quarter and first half 2022 results and provide strategic business updates, as well as answer questions. Event information is below:
| Event: | Vyant Bio Investor Conference Call and Webcast for the Second Quarter and First Half 2022 |
| Date: | Monday, August 22, 2022 |
| Time: | 4:30 pm ET |
| Dial In: | Toll Free: 1-877-545-0523 Conference ID: 46428 |
| Webcast: | https://www.webcaster4.com/Webcast/Page/2756/46428 |
The event will be recorded and available for replay. The conference call and webcast details are also included inside the Investors section of the Vyant Bio corporate website at www.vyantbio.com.
ABOUT VYANT BIO, INC.
Vyant Bio, Inc. (“Vyant Bio” or the “Company”) (Nasdaq: VYNT), is an innovative biotechnology company focused on identifying unique biological targets and novel and repurposed therapeutics. Vyant Bio has built a platform of therapeutics seeking to treat neurodevelopmental and neurodegenerative diseases, with current programs targeting Rett Syndrome (“Rett”), CDKL5 Deficiency Disorders (“CDD”), and Parkinson’s Disease. The Company’s approach to drug discovery integrates human- derived biology with artificial intelligence and machine learning technologies to de-risk candidate selection, with the goal of improving the potential effectiveness of drugs discovered earlier in the development cycle. Vyant Bio’s management believes that drug discovery needs to progressively shift to more efficient methods as the widely used models for predicting safe and effective drugs have under-performed, as evidenced by the significant time and cost of bringing novel drugs to patients. By combining sophisticated data science capabilities with highly functional human cell derived disease models, Vyant Bio seeks to leverage its current ability to screen and test therapeutic candidates, and create a unique approach to assimilating data that supports decision making iteratively throughout the discovery phase of drug development to identify both novel and repurposed CNS therapeutic candidates.
For more information, please visit or follow Vyant Bio at:
Internet: www.vyantbio.com
LinkedIn: https://www.linkedin.com/company/vyant-bio
Twitter: @VyantBio
Forward Looking Statements:
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements pertaining to Vyant Bio, Inc.’s expectations regarding future financial and/or operating results, the efficacy of our drug screening and discovery process, our ability to divest our vivoPharm subsidiary on satisfactory terms, if at all, and potential for our services, future revenue or growth in this press release constitute forward-looking statements. Any statements that are not historical fact (including, but not limited to, statements that contain words such as “will,” “believes,” “plans,” “anticipates,” “expects,” and “estimates”) should also be considered to be forward-looking statements. Forward- looking statements involve risks and uncertainties, including, without limitation, risks inherent in our attempts to discover drug candidates, partner with pharmaceutical and other biotechnology companies, sell vivoPharm, satisfactorily correct historical vivoPharm tax filings, achieve profitability, adapt to the global coronavirus pandemic, raise capital to meet our liquidity needs, and other risks discussed in the Vyant Bio, Inc. Form 10- K for the year ended December 31, 2021, and any subsequent filings with the Securities and Exchange Commission. These forward-looking statements speak only as of the date hereof. Vyant Bio disclaims any obligation to update these forward-looking statements.
Investor Contact:
Skyline Corporate Communications Group, LLC
Scott Powell, President
One Rockefeller Plaza, 10th Floor
New York, NY 10020 USA
Office: (646) 893-5835 x2
Email: info@skylineccg.com
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Vyant Bio, Inc.
Consolidated Balance Sheets
(unaudited)
(Shares and USD in thousands)
| June 30, | December 31, | |||||||
| 2022 | 2021 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 11,702 | $ | 20,608 | ||||
| Trade accounts and other receivables | 484 | 434 | ||||||
| Inventory | 437 | 475 | ||||||
| Prepaid expenses and other current assets | 1,524 | 895 | ||||||
| Assets of discontinuing operations – current | 2,101 | 802 | ||||||
| Total current assets | 16,248 | 23,214 | ||||||
| Non-current assets: | ||||||||
| Fixed assets, net | 1,101 | 1,020 | ||||||
| Operating lease right-of-use assets, net | 1,691 | 673 | ||||||
| Long-term prepaid expenses and other assets | 1,154 | 1,221 | ||||||
| Assets of discontinuing operations – non-current | 6,617 | 11,508 | ||||||
| Total non-current assets | 10,563 | 14,422 | ||||||
| Total assets | $ | 26,811 | $ | 37,636 | ||||
| Liabilities and Stockholders’ Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 1,040 | $ | 740 | ||||
| Accrued expenses | 1,334 | 764 | ||||||
| Deferred revenue | 72 | 74 | ||||||
| Obligations under operating leases, current portion | 293 | 174 | ||||||
| Obligation under finance lease, current portion | 161 | 157 | ||||||
| Liabilities of discontinuing operations – current | 4,607 | 3,522 | ||||||
| Total current liabilities | 7,507 | 5,431 | ||||||
| Obligations under operating leases, less current portion | 1,463 | 516 | ||||||
| Obligations under finance leases, less current portion | 217 | 293 | ||||||
| Long-term debt | 57 | 57 | ||||||
| Liabilities of discontinuing operations – non-current | 780 | 49 | ||||||
| Total liabilities | $ | 10,024 | $ | 6,346 | ||||
| Commitments and contingencies | - | |||||||
| Stockholders’ equity: | ||||||||
| Preferred stock, authorized 9,764 shares $0.0001 par value, none issued | - | - | ||||||
| Common stock, authorized 100,000 shares, $0.0001 par value, 29,413 and 28,993 shares issued and outstanding as of June 30, 2022 and December 31, 2021, respectively | 3 | 3 | ||||||
| Additional paid-in capital | 110,627 | 110,174 | ||||||
| Accumulated deficit | (93,781 | ) | (78,813 | ) | ||||
| Accumulated comprehensive loss | (62 | ) | (74 | ) | ||||
| Total Stockholders’ equity | 16,787 | 31,290 | ||||||
| Total liabilities and Stockholders’ equity | $ | 26,811 | $ | 37,636 | ||||
Vyant Bio, Inc.
Consolidated Statements of Operations and Comprehensive Loss
(unaudited)
(Shares and USD in thousands, except per share amounts)
| Three months ended June 30, | Six months ended June, 30 | |||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||
| Revenue: | ||||||||||||||||
| Service | $ | - | $ | 213 | $ | 94 | $ | 310 | ||||||||
| Product | 165 | 116 | 374 | 222 | ||||||||||||
| Total revenue | 165 | 329 | 468 | 532 | ||||||||||||
| Operating costs and expenses: | ||||||||||||||||
| Cost of goods sold – service | - | 103 | 38 | 167 | ||||||||||||
| Cost of goods sold – product | 304 | 345 | 652 | 741 | ||||||||||||
| Research and development | 1,688 | 910 | 3,239 | 1,730 | ||||||||||||
| Selling, general and administrative | 2,509 | 2,737 | 5,272 | 3,951 | ||||||||||||
| Merger related costs | - | 165 | - | 2,310 | ||||||||||||
| Total operating costs and expenses | 4,501 | 4,260 | 9,201 | 8,899 | ||||||||||||
| Loss from operations | (4,336 | ) | (3,931 | ) | (8,733 | ) | (8,367 | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Change in fair value of warrant liability | - | - | - | 214 | ||||||||||||
| Change in fair value of share-settlement obligation derivative | - | - | - | (250 | ) | |||||||||||
| Loss on debt conversions | - | (2,518 | ) | |||||||||||||
| Other income (expense), net | - | (28 | ) | - | (28 | ) | ||||||||||
| Interest income (expense), net | 11 | 5 | 2 | (363 | ) | |||||||||||
| Total other income (expense) | 11 | (23 | ) | 2 | (2,945 | ) | ||||||||||
| Loss from continuing operations before income taxes | (4,325 | ) | (3,954 | ) | (8,731 | ) | (11,312 | ) | ||||||||
| Income tax expense (benefit) | - | - | - | - | ||||||||||||
| Loss from continuing operations | (4,325 | ) | (3,954 | ) | (8,731 | ) | (11,312 | ) | ||||||||
| Discontinuing operations (net of $44 tax benefit in 2022 and $0 in 2021) | (1,480 | ) | (232 | ) | (6,237 | ) | (240 | ) | ||||||||
| Net loss | (5,805 | ) | (4,186 | ) | (14,968 | ) | (11,552 | ) | ||||||||
| Cumulative translation adjustment | 8 | - | 12 | - | ||||||||||||
| Comprehensive loss | $ | (5,797 | ) | $ | (4,186 | ) | $ | (14,956 | ) | $ | (11,552 | ) | ||||
| Net loss per share attributed to common stock – basic and diluted: | ||||||||||||||||
| Net loss per share from continuing operations | $ | (0.15 | ) | $ | (0.13 | ) | $ | (0.30 | ) | $ | (0.70 | ) | ||||
| Net loss per share from discontinuing operations | (0.05 | ) | (0.01 | ) | (0.21 | ) | (0.02 | ) | ||||||||
| Net loss per share | $ | (0.20 | ) | $ | (0.14 | ) | $ | (0.51 | ) | $ | (0.72 | ) | ||||
| Weighted average shares outstanding: | ||||||||||||||||
| Weighted average common shares outstanding - Basic and Diluted | 29,413 | 28,986 | 29,214 | 16,156 | ||||||||||||
Vyant Bio, Inc.
Condensed Consolidated Statements of Cash Flows (unaudited)
(USD in Thousands)
| Six months ended June 30, | ||||||||
| 2022 | 2021 | |||||||
| Cash Flows from Operating Activities: | ||||||||
| Net loss | $ | (14,968 | ) | $ | (11,552 | ) | ||
| Net loss from discontinuing operations | 6,237 | 240 | ||||||
| Reconciliation of net loss to net cash used in operating activities, continuing operations: | ||||||||
| Stock-based compensation | 560 | 698 | ||||||
| Amortization of operating lease right-of-use assets | 171 | 79 | ||||||
| Depreciation and amortization expense | 276 | 244 | ||||||
| Change in fair value of share-settlement obligation derivative | - | 250 | ||||||
| Change in fair value of warrant liability | - | (214 | ) | |||||
| Change in fair value of 2020 Convertible Note with fair value election | - | 4 | ||||||
| Accretion of debt discount | - | 173 | ||||||
| Loss on conversion of debt | - | 2,518 | ||||||
| Loss of equipment | - | 6 | ||||||
| Changes in operating assets and liabilities net of impacts of business combination: | ||||||||
| Trade accounts and other receivables | (50 | ) | 34 | |||||
| Inventory | 38 | 8 | ||||||
| Prepaid expenses and other current assets | (562 | ) | (1,016 | ) | ||||
| Accounts payable | 300 | (1,206 | ) | |||||
| Obligations under operating leases | (122 | ) | (103 | ) | ||||
| Accrued expenses and other current liabilities | 570 | (808 | ) | |||||
| Net cash used in operating activities, continuing operations | (7,550 | ) | (10,645 | ) | ||||
| Net cash used in operating activities, discontinuing operations | (585 | ) | (25 | ) | ||||
| Net cash used in operating activities | (8,135 | ) | (10,670 | ) | ||||
| Cash Flows from Investing Activities: | ||||||||
| Equipment purchases and leasehold improvements | (361 | ) | (507 | ) | ||||
| Cash acquired from acquisition | - | 30,163 | ||||||
| Net cash (used in) provided by investing activities, continuing operations | (361 | ) | 29,656 | |||||
| Net cash used in investing activities, discontinuing operations | (72 | ) | (13 | ) | ||||
| Net cash (used in) provided by investing activities | (433 | ) | 29,643 | |||||
| Cash Flows from Financing Activities: | ||||||||
| Issuance of common stock, net of issuance costs | (246 | ) | 4 | |||||
| Issuance of Series C Preferred Stock, net of issuance costs | - | 1,786 | ||||||
| 2020 Convertible Note proceeds | - | 5,022 | ||||||
| Principal payments on long-term debt | - | (82 | ) | |||||
| Principal payments on obligations under finance leases | (72 | ) | - | |||||
| Net cash (used in) provided by financing activities, continuing operations | (318 | ) | 6,730 | |||||
| Net cash used in financing activities, discontinuing operations | (20 | ) | (10 | ) | ||||
| Net cash (used in) provided by financing activities | (338 | ) | 6,720 | |||||
| Net (decrease) increase in cash and cash equivalents | (8,906 | ) | 25,693 | |||||
| Cash and cash equivalents beginning of the period | 20,608 | 792 | ||||||
| Cash and cash equivalents end of the period | $ | 11,702 | $ | 26,485 | ||||
| Supplemental disclosure of cash flow information from continuing operations: | ||||||||
| Cash paid for interest | $ | 14 | $ | - | ||||
| Cash paid for income taxes | 8 | - | ||||||
| Non-cash investing activities from continuing operations: | ||||||||
| Fair value of non-cash merger consideration | $ | - | $ | 59,920 | ||||
| Right-of-use asset obtained in exchange for new lease | 1,189 | 83 | ||||||
| Equipment purchases in accounts payable | - | 37 | ||||||
| Non-cash financing activities from continuing operations: | ||||||||
| Conversion of Preferred Stock to Common Stock upon Merger | $ | - | $ | 30,793 | ||||
| Conversion of 2020 Convertible Notes and Accrued Interest to Common Stock upon Merger | - | 16,190 | ||||||
| Reclass warrant liability to equity upon Merger | - | 421 | ||||||
