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Outlook Therapeutics Announces Closing of $57.5 Million Bought Deal, Including Full Exercise of Underwriter’s Option to Purchase Additional Shares

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Outlook Therapeutics announced the closing of an underwritten public offering of 46 million shares at $1.25 each, generating gross proceeds of $57.5 million. These funds will support the development of ONS-5010, an ophthalmic formulation of bevacizumab, with an expected biologics license application submission to the FDA in early 2023. The offering was managed by H.C. Wainwright & Co. The shares were offered under a shelf registration statement originally filed in March 2021. This move positions the company to advance its lead product for treating retinal diseases.

Positive
  • Raised $57.5 million from the public offering to fund ONS-5010 development.
  • Plans to submit a biologics license application to the FDA in early 2023.
Negative
  • None.

ISELIN, N.J., Nov. 29, 2021 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK) (“Outlook Therapeutics”), a late clinical-stage biopharmaceutical company working to develop and launch the first FDA-approved ophthalmic formulation of bevacizumab-vikg for use in retinal indications, today announced the closing of its previously announced underwritten public offering of 46,000,000 shares of common stock of the Company at a price to the public of $1.25 per share, which includes the exercise in full of the underwriter’s option to purchase additional shares.

H.C. Wainwright & Co. acted as the sole book-running manager for the offering.

The gross proceeds to Outlook Therapeutics, before deducting underwriting discounts and commissions and offering expenses, are $57.5 million. Outlook Therapeutics intends to use the net proceeds from the offering for working capital and general corporate purposes, including in support of its ONS-5010 development program. The proceeds from this offering are expected to provide funding through the anticipated approval of the ONS-5010 biologics license application (BLA) expected in the first calendar quarter of 2023.

The shares of common stock are being offered by Outlook Therapeutics pursuant to a shelf registration statement on Form S-3 (File No. 333-254778) originally filed with the Securities and Exchange Commission (the “SEC”) on March 26, 2021 and declared effective by the SEC on April 1, 2021. The offering of the shares of common stock was made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and accompanying prospectus relating to, and describing the terms of, the offering have been filed with the SEC and are available on the SEC's website at http://www.sec.gov and may also be obtained by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by telephone at (212) 856-5711 or e-mail at placements@hcwco.com.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

About Outlook Therapeutics, Inc.        

Outlook Therapeutics is a biopharmaceutical company working to develop and launch ONS-5010/ LYTENAVA™ (bevacizumab-vikg) as the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, including wet AMD, DME and BRVO. If ONS-5010 ophthalmic bevacizumab is approved, Outlook Therapeutics expects to commercialize it as the first and only FDA-approved ophthalmic formulation of bevacizumab for use in treating retinal diseases in the United States, United Kingdom, Europe, Japan and other markets. Outlook Therapeutics expects to submit ONS-5010 ophthalmic bevacizumab to the U.S. FDA as a new BLA under the PHSA 351(a) regulatory pathway. For more information, please visit www.outlooktherapeutics.com.

Forward-Looking Statements

This press release contains forward-looking statements. All statements other than statements of historical facts are “forward-looking statements,” including those relating to future events. In some cases, you can identify forward-looking statements by terminology such as “intend,” “will,” “potential,” “may,” “might,” “should,” “expect,” “plan,” “anticipate,” “project,” “believe,” “estimate,” “predict” or “continue,” the negative of terms like these or other comparable terminology, and other words or terms of similar meaning. These include, without limitation, statements related to the use and adequacy of the proceeds from the offering. Although Outlook Therapeutics believes that it has a reasonable basis for the forward-looking statements contained herein, they are based on current expectations about future events affecting Outlook Therapeutics and are subject to risks, uncertainties and factors relating to its operations and business environment, all of which are difficult to predict and many of which are beyond its control. These risk factors include those risks detailed in Outlook Therapeutics’ filings with the Securities and Exchange Commission. These risks may cause actual results to differ materially from those expressed or implied by forward-looking statements in this press release. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Outlook Therapeutics does not undertake any obligation to update, amend or clarify these forward-looking statements whether as a result of new information, future events or otherwise, except as may be required under applicable securities law.

CONTACTS:

Media Inquiries:
Harriet Ullman
Vice President
LaVoieHealthScience
T: 617-669-3082
hullman@lavoiehealthscience.com

Investor Inquiries:       
Jenene Thomas
Chief Executive Officer
JTC Team, LLC
T: 833.475.8247 
OTLK@jtcir.com


FAQ

What was the purpose of the recent public offering by Outlook Therapeutics (OTLK)?

The recent public offering aimed to raise funds for working capital and to support the development of ONS-5010.

How much did Outlook Therapeutics raise from the public offering?

Outlook Therapeutics raised gross proceeds of $57.5 million from the public offering.

When does Outlook Therapeutics expect to submit the BLA for ONS-5010?

Outlook Therapeutics expects to submit the BLA for ONS-5010 in the first calendar quarter of 2023.

How many shares were offered in the public offering by Outlook Therapeutics?

Outlook Therapeutics offered 46 million shares in the recent public offering.

Who managed the underwritten public offering for Outlook Therapeutics?

H.C. Wainwright & Co. acted as the sole book-running manager for the public offering.

Outlook Therapeutics, Inc.

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Biotechnology
Biological Products, (no Disgnostic Substances)
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United States of America
ISELIN