S-1/A: Avinger Eyes Capital Injection with Proposed Securities Offering

Sentiment:

Amendment to Registration Statement 7 June 2024 8:57 PM

Avinger, Inc. files an amendment to its registration statement for a proposed offering of common stock and warrants to raise capital for working capital and general corporate purposes.

Capital raiseAvinger, Inc. is proposing an offering of common stock, pre-funded warrants, Series A-1, A-2, and A-3 warrants, and placement agent warrants.The company intends to use the net proceeds for working capital and general corporate purposes.

Worse than expectedThe company's revenues declined in 2022 and 2023, primarily due to staffing shortages and resource constraints at customer hospitals.

Summary

Avinger, Inc. has filed an amendment to its registration statement for a proposed securities offering.
The offering includes shares of common stock, pre-funded warrants, Series A-1, A-2, and A-3 warrants, and placement agent warrants.
The company intends to use the net proceeds for working capital and general corporate purposes.
The offering has no minimum amount required to be sold.
The company's common stock is listed on the Nasdaq under the symbol AVGR.
The company has engaged a placement agent to arrange for the sale of the securities.
The company recently announced a plan to reduce operating costs and focus on its coronary artery disease program.
Avinger has been working to regain compliance with Nasdaq listing requirements.
The company has entered into a strategic collaboration with Zylox-Tonbridge for distribution in Greater China.
Avinger generated revenues of $7.7 million in 2023.

Sentiment

Score: 4

Explanation: The document highlights both positive developments (strategic collaborations, regained Nasdaq compliance) and significant challenges (recurring losses, revenue decline, going concern uncertainty), resulting in a neutral to slightly negative sentiment.

Positives

The strategic collaboration with Zylox-Tonbridge provides access to the Greater China market.
The company has regained compliance with Nasdaq's minimum stockholders' equity requirement.
Restructuring activities are expected to reduce operating costs.
The company has extended its lease agreement through November 2025.

Negatives

The company has experienced recurring operating losses and negative cash flows.
There is substantial doubt about the company's ability to continue as a going concern.
The company's revenues declined in 2022 and 2023.
The company may sell fewer than all of the securities offered, which may significantly reduce the amount of proceeds received.
Investors will experience immediate and substantial dilution in the net tangible book value of the shares they purchase.
There is no public market for the pre-funded warrants or the common warrants sold in this offering.

Risks

The company's ability to continue as a going concern is uncertain.
The company may not be able to maintain compliance with Nasdaq listing requirements.
The company may not raise the amount of capital it believes is required for its business plans.
Investors will experience immediate and substantial dilution in the net tangible book value of the shares they purchase.
There is no public market for the pre-funded warrants or the common warrants sold in this offering.
The company has broad discretion in how it uses the net proceeds of this offering.
The company may experience future dilution as a result of future equity offerings or other equity issuances.

Future Outlook

The company expects to expand to full commercial availability of Pantheris LV within the United States around mid-year 2024. The company believes that its cash and cash equivalents of $7.2 million at March 31, 2024 and expected revenues, debt and financing activities and funds from operations will be sufficient to allow it to fund its current operations through the end of the second quarter of 2024.

Industry Context

The market for medical devices in the coronary artery disease (CAD) space is highly competitive, dynamic, and marked by rapid and substantial technological development and product innovation.

Stakeholder Impact

Shareholders will experience potential dilution.
Employees may be affected by the restructuring activities.
Customers may benefit from the company's continued product development and commercialization efforts.
Creditors face risks associated with the company's ability to service its debt.

Next Steps

The company intends to promptly seek Warrant Stockholder Approval.
The company will call a stockholder meeting every 90 days thereafter until the earlier of the date it obtains such approval or the Common Warrants are no longer outstanding.

Key Dates

Date	Description
March 8, 2007	Avinger, Inc. was incorporated in Delaware.
September 2011	CE Marking obtained for original Ocelot product.
November 2012	FDA 510(k) clearance received for original Ocelot product.
October 2015	FDA 510(k) clearance received for Pantheris.
March 2016	FDA 510(k) clearance received for enhanced version of Pantheris.
May 2017	Data collection completed for VISION clinical trial patients at 12 and 24 months.
July 2017	Final 12and 24-month results released for VISION clinical trial.
May 2018	FDA 510(k) clearance received for next-generation version of Pantheris.
April 2019	FDA 510(k) clearance received for Pantheris Small Vessel (SV).
July 2019	Sales of Pantheris Small Vessel (SV) commenced.
September 2020	FDA 510(k) clearance received for Tigereye.
November 2021	FDA 510(k) clearance received for treating in-stent restenosis with Pantheris.
January 2022	FDA 510(k) clearance received for Lightbox 3 imaging console.
April 25, 2023	Received Nasdaq delisting notice for minimum bid price deficiency.
April 2023	FDA 510(k) clearance received for Tigereye Spinning Tip (ST).
May 18, 2023	Received Nasdaq delisting notice for minimum stockholders equity requirement.
June 2023	FDA 510(k) clearance received for Pantheris Large Vessel (LV).
September 12, 2023	1-for-15 reverse stock split became effective.
September 27, 2023	Received notification from Nasdaq that compliance with Bid Price Requirement had been regained.
November 21, 2023	Staff formally notified that the Company was unable to demonstrate compliance with the Equity Requirement.
November 28, 2023	Requested and were granted a hearing before the Panel.
March 4, 2024	Entered into a License and Distribution Agreement with Zylox-Tonbridge.
March 4, 2024	Entered into a Securities Purchase Agreement with Zylox-Tonbridge Medical Limited.
March 5, 2024	Issued shares of Common Stock and Series F Preferred Stock to Zylox-Tonbridge Medical Limited.
March 5, 2024	Entered into a Securities Purchase Agreement to exchange Series A convertible preferred stock for Series A-1 convertible preferred stock.
March 5, 2024	Entered into Amendment No. 9 to the Loan Agreement with CRG.
March 6, 2024	Entered into an amendment to the lease which extended the lease term for a period of one year.
March 14, 2024	The results from the hearing were rendered in which the Company was granted an extension by the Panel.
May 16, 2024	The Company and CRG entered into a Securities Purchase Agreement.
May 20, 2024	The extension granted by the Panel stayed any further action by Nasdaq with respect to the Company's continued listing until this date.
May 29, 2024	The Company received a letter from Nasdaq confirming that the Company has regained compliance with the Equity Requirement.
June 5, 2024	The Company announced a plan of termination as part of its efforts to reduce operating costs.
June 5, 2024	The Company entered into Amendment No. 10 to the Loan Agreement with CRG.

Keywords

securities offering, common stock, warrants, pre-funded warrants, capital raise, Nasdaq, Avinger, AVGR, Zylox-Tonbridge, CRG, delisting, restructuring, compliance

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