Full Press Release Details
Medical Reports Third Quarter 2022 Results and Provides Business Updates
CA. -- (BUSINESS WIRE) -- Nov. 14, 2022 - Vivani Medical, Inc. (Nasdaq: VANI) ("Vivani" or the "Company"),
a biopharmaceutical company developing miniaturized, long-term drug implants including lead asset NPM-119 for the treatment of
patients with type 2 diabetes, today announced financial results for the third quarter ending September 30, 2022 and provides
(GLP-1 receptor agonist implant)
am delighted with the progress of both the Biopharm and Neuromodulation divisions at Vivani and I am very excited as we make our
final preparations to enable initiation of the LIBERATE-1 study, which represents our first opportunity to investigate the performance
of our GLP-1 implant candidate in patients with type 2 diabetes early next year," said Adam Mendelsohn, Chief Executive
Officer. "As a result of the merger, we believe we are well positioned with our experienced leadership and sufficient capital
to support multiple milestones for NPM-119 while we continue to assess the strategic options for advancing Orion II."
Quarter 2022 Financial Results
and development expenses were $3.9 million in the third quarter of 2022, compared to $2.9 million in the third quarter of 2021.
The increase was primarily due to higher product development activities and higher personnel costs as a result of increased headcount
associated with the merger.
and administrative expenses were $1.6 million in the third quarter of 2022, compared to $0.6 million in the third quarter of 2021.
The increase was the result of higher headcount associated with the merger, higher stock-based compensation expenses and an increase
in costs associated with being a public company.
expenses were $5.4 million in the third quarter of 2022, compared to $3.5 million in the third quarter of 2021, representing an
income was $1.4 million in the third quarter of 2022, compared to a net loss of $3.5 million in the third quarter of 2021. The
variance was primarily due to a net bargain purchase gain of $6.9 million associated with the valuation of the merger.
of September 30, 2022, cash and cash equivalents were $51.7 million, and we estimate that these cash resources are sufficient
to fund planned operations into the second half of 2024.
Vivani Medical, Inc.
its proprietary NanoPortal platform, Vivani Medical develops biopharmaceutical implants designed to deliver drug molecules steadily
over extended periods of time, with the goal of guaranteeing patient adherence to their medication. Vivani's lead program,
which is under development within our Biopharm Division, is NPM-119, a miniaturized, 6-month GLP-1 implant under investigation
for the treatment of patients with Type 2 diabetes. NPM-119 is designed to provide patients with the opportunity to realize the
full potential benefit of their medication while avoiding the hassles associated with the daily or weekly administration of oral
and injectable products. Medication non-adherence occurs when patients do not take their medication as prescribed. This affects
an alarmingly significant number of patients, approximately 50%, including those taking daily pills. Medication non-adherence,
which contributes to more than $500B in avoidable healthcare costs and 125,000 potentially preventable deaths per year in the
U.S. alone, is a primary reason why Type 2 diabetes treatments face significant challenges in achieving positive real-world effectiveness.
Vivani's Neuromodulation Division has developed, manufactured, and marketed implantable visual prosthetics that are intended
to deliver useful artificial vision to blind individuals. Vivani continues to assess strategic options for advancing Orion II,
a visual prosthetic device designed to treat profound blindness.
press release contains certain "forward-looking statements" within the meaning of the "safe harbor" provisions
of the US Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as: "target,"
"believe," "expect," "will," "may," "anticipate," "estimate,"
"would," "positioned," "future," and other similar expressions that in this press release,
including statements regarding our business, product candidates, including the therapeutic potential thereof and the planned development
therefor, our planned LIBERATE-1 clinical trial, timing of its initiation and expected results therefrom, technology and strategy,
financial position, and cash runway. Forward-looking statements are neither historical facts nor assurances of future performance.
Instead, they are based only on our current beliefs, expectations, and assumptions. Because forward-looking statements relate
to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and
many of which are outside of our control. Actual results and outcomes may differ materially from those indicated in the forward-looking
statements. Therefore, you should not rely on any of these forward-looking statements. Important factors that could cause actual
results and outcomes to differ materially from those indicated in the forward-looking statements include, among others, risks
related to the development and commercialization of our product candidates, including NPM-119; delays and changes in applicable
laws, regulations and guidelines including potential delays in submitting required regulatory applications to the U.S. Food and
Drug Administration ("FDA"); risks related to the initiation, enrollment and conduct of our planned clinical trials
and the results therefrom; our history of losses and our ability to achieve or sustain profitability in the future; and the impact
of COVID-19 on our business. There may be additional risks that the Company considers immaterial, or which are unknown. A further
list and description of risks and uncertainties can be found in the Company's most recent Quarterly Report on Form 10-Q,
and any subsequent quarterly filings on Form 10-Q filed with the Securities and Exchange Commission (the "Commission"),
and the Company's final proxy statement/prospectus filed with the Commission on June 24, 2022. Any forward-looking statement
made by us in this press release is based only on information currently available to the Company and speaks only as of the date
on which it is made. The Company undertakes no obligation to publicly update any forward-looking statement, whether written or
oral, that may be made from time to time, whether as a result of added information, future developments or otherwise, except as
Chief Business Officer
Chief Financial Officer
Consolidated Balance Sheets (unaudited)
| September 30, | December 31, | |||||||
| 2022 | 2021 | |||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 51,684 | $ | 2,178 | ||||
| Prepaid expenses and other current assets | 2,779 | 291 | ||||||
| Total current assets | 54,463 | 2,469 | ||||||
| Property and equipment, net | 1,250 | 1,173 | ||||||
| Right-of-use assets | 1,050 | 1,611 | ||||||
| Deposits and other assets | 259 | 200 | ||||||
| Total assets | $ | 57,022 | $ | 5,453 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 1,969 | $ | 281 | ||||
| Accrued expenses | 1,853 | 895 | ||||||
| Accrued compensation expense | 555 | - | ||||||
| Current operating lease liabilities | 1,243 | 910 | ||||||
| Total current liabilities | 5,620 | 2,086 | ||||||
| Long term operating lease liabilities | 42 | 902 | ||||||
| Total liabilities | 5,662 | 2,988 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders' equity: | ||||||||
| Preferred stock, no par value, 10,000 shares authorized; none outstanding | - | - | ||||||
| Common stock, no par value; 300,000 shares authorized; shares issued and outstanding: 50,736 as of September 30, 2022 and 36,803 as of December 31, 2021 | 109,050 | 54,649 | ||||||
| Additional paid-in capital | 7,838 | 6,713 | ||||||
| Accumulated other comprehensive loss | (26 | ) | - | |||||
| Accumulated deficit | (65,502 | ) | (58,897 | ) | ||||
| Total stockholders' equity | 51,360 | 2,465 | ||||||
| Total liabilities and stockholders' equity | $ | 57,022 | $ | 5,453 |
Consolidated Statements of Operations (unaudited)
thousands, except per share data)
| Three Months Ended | Nine Months Ended | |||||||||||||||
| September 30, | September 30, | |||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development, net of grants | $ | 3,855 | $ | 2,868 | $ | 9,738 | $ | 8,027 | ||||||||
| Clinical and regulatory, net of grants | 4 | - | 4 | - | ||||||||||||
| General and administrative | 1,585 | 617 | 3,709 | 1,748 | ||||||||||||
| Total operating expenses | 5,444 | 3,485 | 13,451 | 9,775 | ||||||||||||
| Loss from operations | (5,444 | ) | (3,485 | ) | (13,451 | ) | (9,775 | ) | ||||||||
| Other income (expense), net | 6,867 | (6 | ) | 6,846 | 622 | |||||||||||
| Net income/(loss) | $ | 1,423 | $ | (3,491 | ) | $ | (6,605 | ) | $ | (9,153 | ) | |||||
| Net income/(loss) per common share - basic | $ | 0.04 | $ | (0.10 | ) | $ | (0.18 | ) | $ | (0.28 | ) | |||||
| Net income/(loss) per common share - diluted | $ | 0.04 | $ | (0.10 | ) | $ | (0.18 | ) | $ | (0.28 | ) | |||||
| Weighted average common shares outstanding - basic | 37,965 | 33,799 | 37,712 | 32,771 | ||||||||||||
| Weighted average common shares outstanding - diluted | 38,477 | 33,799 | 37,712 | 32,771 |