Azitra, Inc. Announces Q3 2024 Financial Results and Provides Business Updates
AZTR 11.12.2024
Drug:ATR-12 ATR-12
Drug:ATR-04 ATR-04
Diseases:Netherton syndrome
Diseases:EGFRi rash
Date of Upcoming Event:2024-10-15
Name of Upcoming Event:European Academy of Dermatology and Venereology (EADV) Congress
About Gravity Analytica
Q3 2024 and Recent Business Highlights:
- Completed a follow-on offering of
$10 million in gross proceeds - Dosed first Netherton syndrome patient with ATR-12
- Submitted an IND to the FDA and received IND clearance for ATR-04 to treat skin rash from EGFR inhibitors
- Received Fast Track designation from the FDA for ATR-04
- Presented positive preclinical data and the clinical plan of a Phase 1/2 clinical study of ATR-04 in a late-breaking presentation at the
European Academy of Dermatology and Venereology (EADV)Congress - Strengthened intellectual property (IP) portfolio with newly granted and allowed patents
"
"With a clear roadmap, strong execution on two programs, and a dedicated team,
Pipeline and Anticipated Milestones
- Q1 2025:Initial safety data from first set of Netherton syndrome patients in the Phase 1b trial
- Q1 2025:First patient dosed with ATR-04 for EGFRi rash in a Phase 1/2 trial
- YE 2025:Topline data of the Phase 1b trial with ATR-12 in Netherton syndrome patients expected
Financial Results for the Three Months Ended
- Service Revenue –
Related Party : The Company generated$0 service revenue during the quarter endedSeptember 30, 2024 , compared to$310,700 for the comparable period in 2023. - Research and Development (R&D) expenses: R&D expenses for the quarter ended
September 30, 2024 , were$1.0 million compared to$0.5 million for the comparable period in 2023. - General and Administrative (G&A) expenses: G&A expenses for the quarter ended
September 30, 2024 , were$1.9 million compared to$1.8 million for the comparable period in 2023. - Net Losswas
$1.0 million for the quarter endedSeptember 30, 2024 , compared to$1.9 million for the comparable period in 2023. - Cash and cash equivalents: As of
September 30, 2024 , the Company had cash and cash equivalents of$7.3 million .
About ATR-12
ATR-12 (also known as ATR12-351) is an engineered strain ofS. epidermidisthat expresses a fragment of human lympho-epithelial Kazal-type-related inhibitor (LEKTI) protein, which is missing in patients with Netherton syndrome, a chronic and sometimes fatal disease of the skin estimated to affect approximately 20,000 patients globally. ATR-12 has been engineered to deliver missing LEKTI protein when applied topically to Netherton syndrome patients.
About ATR-04
ATR-04 is a live biotherapeutic product candidate including an isolated, naturally derivedS. epidermidisstrain that was engineered to be safer by deleting an antibiotic resistance gene and engineering auxotrophy to control the growth of ATR-04. ATR-04 is in development for EGFR inhibitor ("EGFRi") associated rash, which is caused by the suppression of skin immunity by EGFRis and subsequent inflammation and often elevated levels of IL-36γ andS. aureus. There are approximately 150,000 patients suffering from EGFRi rash in
About
Forward-Looking Statements
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, we may experience delays in the initiation of our Phase 1/2 trial fpr 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
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Condensed Statement of Operations (Unaudited) | ||||||||
Three months Ended | ||||||||
2024 | 2023 | |||||||
Service revenue – related party | $ | - | $ | 310,700 | ||||
Total revenue | - | 310,700 | ||||||
Operating expenses: | ||||||||
General and administrative | 1,913,400 | 1,755,908 | ||||||
Research and development | 1,015,807 | 548,524 | ||||||
Total operating expenses | 2,929,207 | 2,304,432 | ||||||
Loss from operations | (2,929,207) | (1,993,732) | ||||||
Other income (expense): | ||||||||
Interest income | 47,389 | 634 | ||||||
Interest expense | (3,851) | (710) | ||||||
Change in fair value of warrants | 4,001,469 | 98,061 | ||||||
Loss on issuance of common stock | (2,132,800) | - | ||||||
Other income (expense) | 7,509 | (47,542) | ||||||
Total other income (expense) | 1,919,716 | 50,443 | ||||||
Net loss before income taxes | (1,009,491) | (1,943,289) | ||||||
Income tax expense | - | - | ||||||
Net loss | $ | (1,009,491) | (1,943,289) | |||||
Dividends on preferred stock | - | - | ||||||
Net loss attributable to common shareholders | $ | (1,009,491) | (1,943,289) | |||||
Net loss per Share, basic and diluted | $ | (.17) | $ | (4.82) | ||||
Weighted average common stock outstanding, basic and diluted | 5,814,350 | 403,255 | ||||||
Condensed Balance Sheets (Unaudited) | ||||||||
2024 | 2023 | |||||||
Assets | ||||||||
Current Assets: | ||||||||
Cash and cash equivalents | $ | 7,260,234 | $ | 1,795,989 | ||||
Other receivables | 9,923 | 223,474 | ||||||
Prepaid expenses and other current assets | 364,673 | 516,116 | ||||||
Total current assets | $ | 7,634,830 | $ | 2,535,579 | ||||
Property and equipment, net | 638,107 | 710,075 | ||||||
Other assets | 1,504,562 | 1,869,832 | ||||||
Total assets | $ | 9,777,499 | $ | 5,115,486 | ||||
Liabilities, and stockholders' equity | ||||||||
Current liabilities: | ||||||||
Accounts payable | $ | 588,460 | $ | 897,272 | ||||
Current financing lease liability | 15,687 | 14,600 | ||||||
Current operating lease liability | 276,839 | 307,655 | ||||||
Accrued expenses | 486,981 | 383,668 | ||||||
Total current liabilities | 1,367,967 | 1,603,195 | ||||||
Long-term financing lease liability | 14,266 | 26,169 | ||||||
Long-term operating lease liability | 336,556 | 537,523 | ||||||
Warrant liability | 457 | 35,453 | ||||||
Total liabilities | 1,719,246 | 2,202,340 | ||||||
Stockholders' equity | ||||||||
Common stock | 763 | 40 | ||||||
Additional paid-in capital | 63,230,182 | 51,510,269 | ||||||
Accumulated deficit | (55,172,692) | (48,597,163) | ||||||
Total stockholders' equity | 8,058,253 | 2,913,146 | ||||||
Total liabilities and stockholders' equity | $ | 9,777,499 | $ | 5,115,486 | ||||
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