8-K
Azitra, Inc. (AZTR)
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
DC 20549
FORM
8-K
CURRENT
REPORT
Pursuant
to Section 13 OR 15(d) of The Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): November 14, 2023
AZITRA,
INC.
(Exact name of registrant as specified in its charter)
| Delaware | 001-41705 | 46-4478536 |
|---|---|---|
| (State<br> or other jurisdiction<br><br> <br>of<br> incorporation) | (Commission<br><br> <br>File<br> Number) | (IRS<br> Employer<br><br> <br>Identification<br> No.) |
21Business Park Drive
Branford,CT 06405
(Address of principal executive offices)(Zip Code)
(203)646-6446
(Registrant’s telephone number, including area code)
(Former name or former address, if changed since last report.)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligations of the registrant under any of the following provisions:
| ☐ | Written<br> communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|---|---|
| ☐ | Soliciting<br> material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ☐ | Pre-commencement<br> communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ☐ | Pre-commencement<br> communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
| Title<br> of each class | Trading<br> Symbol(s) | Name<br> of each exchange on which registered |
|---|---|---|
| Common<br> Stock: Par value $0.0001 | AZTR | NYSE<br> American |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☒
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item2.02 Results of Operations and Financial Condition.
On November 14, 2023, Azitra, Inc. (the “Company”) issued a press release announcing its financial results for the fiscal quarter ended September 30, 2023. A copy of the press release is attached as Exhibit 99.1 to this Current Report and is incorporated herein by reference.
The information in this Item 2.02, including the press release attached as Exhibit 99.1 hereto, is furnished pursuant to Item 2.02 but shall not be deemed “filed” for any purpose, including for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section, nor shall it be deemed to be incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date hereof, regardless of any general incorporation language in such filing.
Item9.01 Financial Statements and Exhibits
| (d) | Exhibits | MethodFiling |
|---|
The following exhibit is furnished with this report:
| Exhibit<br> 99.1 | Press<br> release dated November 14, 2023 regarding the Registrant’s financial results for the<br> fiscal quarter ended September 30, 2023. | Filed<br> Electronically herewith |
|---|---|---|
| 104 | Cover<br> Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| AZITRA, INC. | |
|---|---|
| Dated:<br> November 14, 2023 | /s/ Francisco D. Salva |
| Francisco<br> D. Salva | |
| Chief<br> Executive Officer |
Exhibit99.1
Azitra,Inc. Announces Third Quarter 2023 Financial Results and Business Updates
BRANFORD, Conn. — Azitra, Inc. (NYSE American: AZTR), a clinical-stage biopharmaceutical company focused on developing innovative therapies for precision dermatology, today reported financial results for the third quarter ended September 30, 2023.
Q3and Recent Business Highlights
| ● | Advanced its pipeline programs including ATR-12 (Netherton syndrome), ATR-4 (EGFRi-associated rash) and its Joint Development Agreement with Bayer |
|---|---|
| ● | Completed and filed post-IND, FDA commitments for characterization of drug product for ATR-12 |
| ● | Selected and hired clinical research organization for ATR-12 clinical trial. Selected initial sites for activation |
Francisco Salva, Chief Executive Officer of Azitra commented:
“During the third quarter, we made important progress towards reaching multiple significant near-term milestones. Firstly, for our lead program ATR-12 for Netherton syndrome, we’ve selected and hired our clinical research organization for the Netherton syndrome clinical trial. Additionally, we are in discussion with our lead sites to get the program activated and start recruiting an initial ~12 patients. We’re now poised for key catalysts, including first patient enrolled, followed by initial clinical data in 2024.”
“Next, for our ATR-04 program targeting EGFRi-associated rash, we’ve been advancing towards our IND (Investigational New Drug) filing to enable clinical development. We are moving through the necessary preclinical and manufacturing activities. We are now building towards several pivotal events over the next 12 to 18 months, starting with IND submission, followed by enrolling ~15 patients, and then announcing data.”
“Additionally, regarding our Joint Development Agreement with Bayer, we are very pleased with the recent progress of our collaboration.”
Pipelineand Upcoming Milestones
| ● | ATR-12 - Netherton syndrome (rare skin disease with no FDA approved treatment options). Global Prevalence: 20K+ patients. Estimated<br> Peak Sales Opportunity: ~$250 million. |
|---|---|
| ○ | Clinical<br> Status: Phase 1b IND cleared |
| --- | --- |
| ○ | Upcoming<br> milestones: |
| ▪ | First<br> patient enrolled (FPI) |
| --- | --- |
| ▪ | Initial<br> clinical data |
| ● | ATR-04 - EGFRi-associated rash (Chemotherapy agents such as EGFR inhibitors and immunotherapies such as early BTK inhibitors lead to an aggressive and debilitating rash on many patients). US Prevalence: 200K+ patients. Estimated Peak Sales Opportunity: >$1B. |
| --- | --- |
| ○ | Clinical<br> Status: Pre-IND |
| --- | --- |
| ○ | Upcoming<br> milestones: |
| ▪ | Preclinical<br> animal data |
| --- | --- |
| ▪ | IND<br> submission |
| ● | Bayer Joint Development Agreement (Joint development on S. epidermidis strains and products for eczema-prone skin.) Global Prevalence:<br> 230 million. Annual economic burden in Europe: $30B. |
| --- | --- |
| ○ | Status:<br> Azitra is responsible for early research, and Bayer is responsible for clinical development and commercialization |
| --- | --- |
| ○ | Upcoming<br> milestones: |
| ▪ | Execution<br> of royalty-bearing licensing agreement |
| --- | --- |
FinancialResults for the Three Months Ended September 30, 2023
| ● | Cash and cash equivalents: As of September 30, 2023, the Company had cash and cash equivalents of $4.4 million. |
|---|---|
| ● | Service Revenue – Related Party: The Company generated $310,700 of service revenue during the three months ended September 30,<br> 2023 compared to $48,500 for the comparable period in 2022. |
| ● | Research and Development (R&D) expenses: R&D expenses for the three months ended September 30, 2023 were $548,524 compared to<br> $1.4 million from the prior year period. |
| ● | General and Administrative (G&A) expenses: G&A expenses for the three months ended September 30, 2023 were $1.8 million compared<br> to $1.1 million from the prior year period. |
| ● | Net Loss was $1.9 million for the three months ended September 30 2023, compared to $2.4 million for the same period in 2022. |
AboutAzitra, Inc.
Azitra, Inc. is an early-stage clinical biopharmaceutical company focused on developing innovative therapies for precision dermatology using engineered proteins and topical live biotherapeutic products. The Company has built a proprietary platform that includes a microbial library comprised of approximately 1,500 unique bacterial strains that can be screened for unique therapeutic characteristics. The platform is augmented by artificial intelligence and machine learning technology that analyzes, predicts and helps screen the Company’s library of strains for drug like molecules. The Company’s initial focus is on the development of genetically engineered strains of Staphylococcus epidermidis, or S. epidermidis, which the Company considers to be an optimal therapeutic candidate species for engineering of dermatologic therapies. For more information, please visit https://azitrainc.com/.
Forward-LookingStatements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, 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, the timing of having a signed license agreement with Bayer, 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 and pre-clinical studies of other product candidates and obtain required approval before commercialization; 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 its registration statement on Form S-1, which is on file with the SEC, and in its most recent quarterly report on Form 10-Q to be filed with the SEC. Azitra explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law.
CompanyContact
Norman Staskey
Chief Financial Officer
staskey@azitra.com
Hayden IR
James Carbonara
(646)-755-7412
james@haydenir.com
CondensedConsolidated Statement of Operations
(Unaudited)
| Three<br> months Ended September 30, | ||||||
|---|---|---|---|---|---|---|
| 2023 | 2022 | |||||
| Service<br> revenue – related party | $ | 310,700 | $ | 48,500 | ||
| Total<br> revenue | 310,700 | 48,500 | ||||
| Operating<br> expenses: | ||||||
| General<br> and administrative | 1,755,908 | 1,054,570 | ||||
| Research<br> and development | 548,524 | 1,364,380 | ||||
| Total<br> operating expenses | 2,304,432 | 2,418,950 | ||||
| Loss<br> from operations | (1,993,732 | ) | (2,370,450 | ) | ||
| Other<br> income (expense): | ||||||
| Interest<br> income | 634 | 3,201 | ||||
| Interest<br> expense | (710 | ) | (31,333 | ) | ||
| Other<br> expense | 50,519 | (19,038 | ) | |||
| Total<br> other income (expense) | 50,443 | (47,170 | ) | |||
| Net<br> loss before income taxes | (1,943,289 | ) | (2,417,620 | ) | ||
| Income<br> tax benefit (expense) | - | |||||
| Net<br> loss | $ | (1,943,289 | ) | (2,417,620 | ) | |
| Dividends<br> on preferred stock | - | (692,246 | ) | |||
| Net<br> loss attributable to common shareholders | $ | (1,943,289 | ) | (3,109,866 | ) | |
| Net<br> loss per Share, basic and diluted | (.16 | ) | (2.95 | ) | ||
| Weighted<br> average common stock outstanding, basic and diluted | $ | 12,097,643 | $ | 1,055,455 |
CondensedConsolidated Balance Sheets
(Unaudited)
| September<br> 30, 2023 | December<br> 31, 2022 | |||||
|---|---|---|---|---|---|---|
| Assets | ||||||
| Current<br> Assets: | ||||||
| Cash<br> and cash equivalents | $ | 4,400,327 | $ | 3,492,656 | ||
| Other<br> receivables | 54,247 | 266,208 | ||||
| Prepaid<br> expenses and other current assets | 409,170 | 377,019 | ||||
| Total<br> current assets | $ | 4,863,744 | $ | 4,135,883 | ||
| Property<br> and equipment, net | 736,423 | 846,958 | ||||
| Other<br> assets | 1,890,077 | 2,184,602 | ||||
| Total<br> assets | $ | 7,490,244 | $ | 7,167,443 | ||
| Liabilities, preferred stock, and stockholders’ equity | ||||||
| Current<br> liabilities: | ||||||
| Accounts<br> payable | $ | 417,928 | $ | 784,687 | ||
| Current<br> financing lease liability | 14,254 | - | ||||
| Current<br> operating lease liability | 301,423 | 287,384 | ||||
| Accrued<br> expenses | 720,095 | 993,961 | ||||
| Contract<br> liabilities | - | 156,000 | ||||
| Total<br> current liabilities | 1,453,700 | 2,222,032 | ||||
| Long-term<br> financing lease liability | 29,952 | - | ||||
| Long-term<br> operating lease liability | 613,572 | 840,896 | ||||
| Warrant<br> liability | 60,933 | 70,283 | ||||
| Convertible<br> notes payable, net | 0 | 6,600,000 | ||||
| Total<br> liabilities | 2,158,157 | 9,733,211 | ||||
| Stockholders’<br> equity (deficit) | ||||||
| Preferred<br> stock | 0 | 33,694,542 | ||||
| Common<br> stock | 1,210 | 104 | ||||
| Additional<br> paid-in capital | 51,475,425 | 1,054,138 | ||||
| Accumulated<br> deficit | (46,144,548 | ) | (37,314,552 | ) | ||
| Total<br> stockholders’ equity (deficit) | 5,332,087 | (36,260,310 | ) | |||
| Total<br> liabilities, preferred stock and stockholders’ equity (deficit) | $ | 7,490,244 | $ | 7,167,443 |