Opthea Successfully Closes Well-Backed US$90 Million Equity Financing

Opthea Limited

MELBOURNE, Australia, Aug. 14, 2022 (GLOBE NEWSWIRE) — Opthea Limited (ASX: OPT; NASDAQ: OPT) (Opthea), a clinical-stage biopharmaceutical company developing novel therapies to treat widespread and progressive retinal diseases, is pleased to confirm that it has received binding commitments for a successful two-tranche placement (Placement) new fully paid-up ordinary shares (New actions) to institutional investors to raise approximately $90 million1 (A$128.57 million) at a price of A$1.15 per new share (Location price), representing a 12.6% discount to the 10-day volume-weighted average price (VWAP) as of August 10, 2022.

As noted in Opthea’s announcement today, Opthea has entered into a non-dilutive funding agreement of up to US$170 million with Carlyle and Abingworth, together with their recently formed development company, Launch Therapeutics, of which US$50 million US dollars will be paid shortly after Opthea receives the proceeds of the first tranche of the Placement, with the remainder being funded in two additional future tranches.

Dr. Megan Baldwin, Chief Executive Officer and Managing Director of Opthea, said, “This well-supported placement has generated strong demand from existing and new institutional investors, including large global and US funds. We appreciate the strong support of our current shareholders and are delighted to welcome several new leading institutional investors to the register. This successful fundraising, combined with the significant non-dilutive financing of funds managed by Carlyle and Abingworth, in collaboration with Launch Tx, represents a tremendous achievement for Opthea. Together, these fundings further validate our strategy to develop OPT-302 as a differentiated therapeutic with the potential to improve outcomes for patients with retinal diseases, including age-related macular degeneration.

The details of the placement are as follows:

  • Tranche 1 of the Placement of 52.8 million New Shares for gross proceeds of US$42.5 million1 (A$60.75 million) will be issued in accordance with Opthea’s placement capacity under ASX Listing Rule 7.1, and are expected to settle on or about August 24, 2022; and

  • Tranche 2 of the Placement of 59 million New Shares for gross proceeds of US$47.5 million1 (A$67.82 million) will be issued subject to and subject to shareholder approval at a general meeting scheduled for September 26, 2022 (Australian Eastern Standard Time (AEST)) and should be settled shortly after approval at this meeting. To this end, Opthea will soon send a notice of meeting to its shareholders to convene this general meeting of the company.

The new shares issued under the Placement will rank pari passu with existing fully paid-up Opthea ordinary shares from their date of issue. The Company has attracted strong interest from existing institutional shareholders and new investors.

Opthea will also offer eligible shareholders of Opthea, namely shareholders who had a registered address in Australia or New Zealand on Opthea’s register as of 7:00 p.m. AEST on Friday August 12, 2022, the possibility to request up to AU$30,000 of New Shares free of brokerage, commission and transaction costs pursuant to a share purchase plan (PSP). The SPP will be priced at the placement price. Full details of the SPP will be set out in the SPP offer booklet, which will be communicated to the ASX and made available to eligible shareholders in Australia and New Zealand (and such other jurisdictions as may be specified in the offer booklet). SPP offer) later in August. The SPP will not be underwritten and is expected to raise up to A$5 million2.

Proceeds from the Placement and the SPP, as well as proceeds from the non-dilutive financing agreement and cash, will be used to:

  • Continue to advance phase 3 clinical trials of OPT-302 for the treatment of wet AMD through reading front-line data and funding pre-marketing activities, including manufacturing at scale sales, team building and market training; and

  • Provide additional working capital after reading the primary data from the Phase 3 trial (planned for mid-year 24).

MST Financial (Australia) and Jefferies LLC (US) acted as co-managers of the placement.

Additional details regarding the transactions described in this release and related operational updates will be included in a report on Form 6-K, which Opthea will separately provide to the United States Securities and Exchange Commission and the contents of which will be filed with of the ASX in a separate document. announcement.

About Opthea

Opthea (ASX:OPT; Nasdaq:OPT) is a biopharmaceutical company developing novel therapies to address the unmet need in the treatment of widespread and progressive retinal diseases, including wet age-related macular degeneration (wet AMD). and diabetic macular edema (DME). Opthea’s lead product candidate, OPT-302, is in pivotal Phase 3 clinical trials and is being developed for use in combination with anti-VEGF-A monotherapies to achieve broader inhibition of the VEGF family, with the aim of improving overall efficacy and demonstrating superior vision gains over that which can be achieved by inhibiting VEGF-A alone. To learn more, visit www.opthea.com.com and follow us on Twitter and Linkedin.

Risks inherent in investing in biotechnology companies

There are a number of inherent risks associated with the development of pharmaceutical products to a marketable stage. The lengthy clinical trial process is designed to assess the safety and effectiveness of a drug before it is marketed and a significant proportion of drugs fail one or both of these criteria. Other risks include uncertainty of patent protection and proprietary rights, whether patent applications and granted patents will provide adequate protection to enable product development, obtaining necessary approvals from drug regulatory authorities and the difficulties caused by rapid advances in technology. Companies like Opthea are dependent on the success of their research and development projects and their ability to attract funding to support these activities. Investments in research and development projects cannot be evaluated on the same basis as commercial and manufacturing enterprises. Therefore, investing in drug development companies should be considered highly speculative. Opthea strongly recommends seeking professional investment advice before making such investments.

Forward-looking statements

Certain statements in this announcement may contain forward-looking statements, including within the meaning of the United States Private Securities Litigation Reform Act of 1995. Any statement describing Opthea’s objectives, expectations, intentions or beliefs is a forward-looking statement and should be considered – statement of risk, including but not limited to Opthea’s Phase 3 registration program progress and commercialization efforts for OPT-302, the anticipated schedule of the program and Opthea’s Phase 3 trials, Opthea’s anticipated funding needs and cash flow, including monitoring the funding transactions described in this announcement, Opthea’s ability to meet its payment and other obligations in under the non-dilutive financing agreement, Opthea’s ability to draw all of the financing capacity of US$170 million under this agreement d in a timely manner or not at all, and Opthea’s ability to consume Tranche 2 of the Placement. These statements are based on Opthea’s current plans, objectives, estimates, expectations and intentions and are subject to certain risks and uncertainties, including risks and uncertainties associated with clinical trials and product development, unforeseen costs or delays in the clinical trial process, the risks of the continuation of the COVID-19 pandemic and the impact of general economic, industrial or political conditions in Australia, the United States or internationally. These and other risks and uncertainties are described in more detail in the section titled “Risk Factors” in Opthea’s Annual Report on Form 20-F filed with the SEC on October 28, 2021. The Company does not undertakes no obligation to publicly update any forward-looking statement. , whether as a result of new information, future events or otherwise, except as required by applicable law. You should not place undue reliance on these forward-looking statements as predictions of future events, which statements speak only as of the date of this announcement. Actual results could differ materially from those discussed in this ASX announcement. Actual results could differ materially from those discussed in this announcement.

Not an offer

This ASX announcement is not an informational document and should not be considered investment advice. The information contained in this ASX announcement is for informational purposes only and should not be considered as an offer or invitation to acquire securities of the Company or any other financial product and does not form and will not form part of a contract of acquisition of New Shares.

In particular, this ASX announcement does not constitute an offer to sell or a solicitation of an offer to buy securities in the United States or in any other jurisdiction in which such an offer would be illegal or impermissible. The securities offered and sold under the Offering and the SPP have not been and will not be registered under the US Securities Act of 1933, as amended (the “US Securities Act”), or securities of any state or other jurisdiction of the United States. No public offering of securities is made in the United States. Accordingly, the securities to be offered and sold under the Placement and the SPP may only be offered and sold outside of the United States in “offshore transactions” (as defined in Rule 902(h) ) under Regulation S of the US Securities Act (“Regulation S”)) on the basis of Regulation S, unless offered and sold in a transaction registered under, or exempt from of, or in a transaction not subject to the registration requirements of the US Securities Act and applicable US securities laws.

Cleared for broadcast on ASX by Megan Baldwin, CEO and Managing Director

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1 Assumes an AUD/USD exchange rate of A$1.00/US$0.70
2 Opthea may (in its sole discretion) in a situation where the total request exceeds $5 million, decide to increase the amount to be raised under the SPP to reduce or eliminate the need for a reduction.

Carol M. Barragan