Azitra Announces Proposed Public Offering of Common Stock

Rhea-AI Summary

Azitra (NYSE American: AZTR), a clinical-stage biopharmaceutical company specializing in precision dermatology, has announced the commencement of a public offering of common stock and pre-funded warrants. Maxim Group will serve as the sole placement agent for the offering.

The company plans to utilize the net proceeds for working capital and general corporate purposes. The offering is being conducted through an effective shelf registration statement on Form S-3 filed with the SEC on July 1, 2024, and declared effective on July 8, 2024. The completion, size, and terms of the offering are subject to market conditions and cannot be guaranteed.

Positive

• Access to additional working capital through public markets
• Effective shelf registration statement already in place
• Engagement of established placement agent (Maxim Group )

Negative

• Potential dilution for existing shareholders
• Uncertain offering terms and completion timeline
• Market-dependent conditions may affect offering success

Insights

Investment Banker

This public offering announcement from Azitra represents a significant capital raising initiative that warrants careful scrutiny. The company's market cap of $2.89 million suggests they are a micro-cap company likely seeking essential funding for operations. The use of a shelf registration (Form S-3) filed in July 2024 indicates strategic planning for this capital raise.

The offering's structure, including pre-funded warrants, is a common approach for small biotech companies to provide flexibility to institutional investors. However, the lack of specified pricing and size raises concerns about potential dilution for existing shareholders. With Maxim Group as the sole placement agent, typically associated with smaller offerings, this suggests a targeted raise likely in the $5-15 million range.

The stated use of proceeds for "working capital and general corporate purposes" is notably vague and could indicate cash burn pressures. For clinical-stage companies like Azitra, this type of financing often signals a need to fund ongoing trials or operational expenses, which is critical but typically leads to near-term share price pressure.

Biotech Analyst

As a precision dermatology player, Azitra's need for additional capital is not surprising given the capital-intensive nature of clinical trials. The timing of this offering, coming early in 2025, suggests the company is proactively securing funding for upcoming clinical milestones. However, the offering's structure and lack of specific trial funding allocation raises questions about the company's clinical progress.

For context, clinical-stage dermatology programs typically require $10-20 million per phase and without detailed use of proceeds, investors should closely monitor the company's burn rate and pipeline progression. The shelf registration's recent filing (July 2024) and quick utilization may indicate urgency in capital needs, which could impact negotiating leverage on pricing.

BRANFORD, Conn., Jan. 14, 2025 /PRNewswire/ -- Azitra, Inc. (NYSE American: AZTR), a clinical-stage biopharmaceutical company focused on developing innovative therapies for precision dermatology, today announced that it has commenced a public offering of shares of its common stock (or pre-funded warrants in lieu thereof). All of the shares of common stock (or pre-funded warrants in lieu thereof) to be sold in the proposed offering will be sold by Azitra. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

Maxim Group LLC is acting as the sole placement agent for the proposed offering.

Azitra intends to use the net proceeds of this offering for working capital and general corporate purposes.

The public offering is being made pursuant to an effective shelf registration statement on Form S-3 (File No. 333-280648), previously filed with the U.S. Securities and Exchange Commission (the "SEC") on July 1, 2024, as amended, and declared effective on July 8, 2024. The shares may be offered only by means of a prospectus. A preliminary prospectus supplement and the accompanying prospectus relating to and describing the terms of the public offering will be filed with the SEC and are available on the SEC's website at www.sec.gov. When available, copies of the preliminary prospectus supplement and accompanying prospectus relating to the public offering may also be obtained by contacting Maxim Group LLC, at 300 Park Avenue, 16th Floor, New York, NY 10022, Attention: Prospectus Department, or by telephone at (212) 895-3745 or by email at syndicate@maximgrp.com.

This press release does not constitute an offer to sell or the 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 Azitra, Inc.

Azitra, Inc. is a clinical stage biopharmaceutical company focused on developing innovative therapies for precision dermatology. The Company's lead product, ATR-12, is an engineered strain of S. epidermidis designed to treat Netherton syndrome, a rare, chronic skin disease with no approved treatment options. Netherton syndrome is often fatal in infancy with those living beyond a year having profound lifelong challenges. ATR-12 is being evaluated in a Phase 1b clinical trial in adult Netherton syndrome patients. ATR-04, Azitra's next most advanced product, is being developed for the treatment of EGFR inhibitor ("EGFRi") associated rash. Azitra has received Fast Track designation from the FDA for EGFRi associated rash, which impacts approximately 150,000 people in the U.S. Azitra has an open IND for a Phase 1/2 clinical trial with ATR-04 in patients with EGFRi associated rash. ATR-12 and ATR-04 were developed from Azitra's proprietary platform of engineered proteins and topical live biotherapeutic products that includes a microbial library comprised of approximately 1,500 bacterial strains. The platform is augmented by artificial intelligence and machine learning technology that analyzes, predicts, and helps screen the library of strains for drug like molecules. For more information, please visit https://azitrainc.com.

Forward-Looking Statements:

This press release may contain "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, as amended. These statements may be identified by words such as "aims," "anticipates," "believes," "could," "estimates," "expects," "forecasts," "goal," "intends," "may," "plans," "possible," "potential," "seeks," "will," and variations of these words or similar expressions that are intended to identify forward-looking statements. Any such statements in this press release that are not statements of historical fact may be deemed to be forward-looking statements. These forward-looking statements include, without limitation, statements regarding the expected timing of the presentation of data from the Phase 1b study of ATR-12, the filing of an IND application, and the presentation of data from our Phase 1b for ATR-04, the IND filing for ATR-01, and statements about our clinical and pre-clinical programs, and corporate and clinical/pre-clinical strategies.

Any forward-looking statements in this press release are based on current expectations, estimates and projections only as of the date of this release and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, that we may fail to successfully complete our Phase 1b trial for ATR-12; we may experience delays in the initiation of our Phase 1/2 trial for ATR-04; our product candidates may not be effective; there may be delays in regulatory approval or changes in regulatory framework that are out of our control; our estimation of addressable markets of our product candidates may be inaccurate; we may fail to timely raise additional required funding; more efficient competitors or more effective competing treatment may emerge; we may be involved in disputes surrounding the use of our intellectual property crucial to our success; we may not be able to attract and retain key employees and qualified personnel; earlier study results may not be predictive of later stage study outcomes; and we are dependent on third-parties for some or all aspects of our product manufacturing, research and preclinical and clinical testing. Additional risks concerning Azitra's programs and operations are described in our Annual Report on Form 10-K, subsequent Reports on Form 10-Q, and our other filings we make with the SEC. Azitra explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law.

Contact:

Norman Staskey
Chief Financial Officer
staskey@azitrainc.com

Tiberend Strategic Advisors, Inc.
Jon Nugent
205-566-3026
jnugent@tiberend.com

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SOURCE Azitra, Inc.

FAQ

What is the purpose of Azitra's (AZTR) 2025 public offering?

Azitra plans to use the net proceeds from the public offering for working capital and general corporate purposes.

When was Azitra's (AZTR) shelf registration statement declared effective?

Azitra's shelf registration statement on Form S-3 was declared effective by the SEC on July 8, 2024.

Who is the placement agent for Azitra's (AZTR) 2025 public offering?

Maxim Group is acting as the sole placement agent for the proposed offering.

What securities are being offered in Azitra's (AZTR) 2025 public offering?

Azitra is offering shares of its common stock and pre-funded warrants in lieu of common stock.

How will Azitra's (AZTR) 2025 public offering affect existing shareholders?

The public offering may result in dilution of existing shareholders' ownership stakes, though the exact impact depends on the final size and terms of the offering.