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Azitra, Inc. 公布2024年第三季度财务结果并提供业务更新

布兰福德， 康涅狄格州 — Azitra, Inc. (纽交所美国: AZTR)，一家专注于开发创新疗法 以实现精准皮肤病学的临床阶段生物制药公司，今天报告了截至2024年9月30日的三个月财务结果并提供业务更新。

2024年第三季度 及近期业务亮点：

Francisco Salva, Azitra的首席执行官评论道：

“Azitra在2024年第三季度达成了一些重要的里程碑，以推进我们的发展 pipeline，最显著的是在我们进行中的Netherton症候群试验中对首位病人进行ATR-12给药。此外，在本季度，我们完成了1000万美元的后续发行，提交了ATR-04的IND，针对表皮生长因子受体抑制剂(EGFRis)引起的皮肤潮红，获得了IND批准及ATR-04的快速通道资格，并增强了我们的知识产权组合。

“凭借清晰的路线图、对两个项目的强有力执行和一支专注的团队，Azitra已做好充分准备以执行这些里程碑，为需要的病人提供变革性的疗法，并最终最大化股东价值。”

发展 pipeline 和预期的里程碑

截至2024年9月30日三个月的财务 结果

关于 ATR-12

ATR-12 （也称为ATR12-351）是一种工程化的菌株， S. epidermidis 表达人类的 淋巴上皮 Kazal类型相关抑制剂 缺失于Netherton症候群患者中的（LEKTI）蛋白质是一种慢性且有时致命的皮肤疾病，估计全球约有20,000名患者受到影响。ATR-12已被工程设计为在局部应用于Netherton症候群患者时，提供缺失的LEKTI蛋白质。Azitra目前正在进行开放的10亿临床试验，积极招募成人Netherton症候群患者（NCT06137157）。Azitra已识别出Netherton症候群患者参加其12名患者的10亿临床试验，该试验将评估安全性、耐受性及疗效终点。

关于 ATR-04

ATR-04是一种活性交互疗法产品候选者，包括一种分离的、自然来源的 S. epidermidis 菌株经过工程设计，通过删除抗生素抗性基因和设计辅助营养来控制ATR-04的生长，使其更安全。ATR-04正在开发中，用于EGFR抑制剂（“EGFRi”）相关皮疹，该皮疹是由于EGFR抑制剂对皮肤免疫的抑制以及随后的炎症，通常伴随有IL-36γ的升高。 S. aureus在美国约有150,000名患者正遭受EGFRi皮疹。Azitra已获得FDA对EGFRi相关皮疹的快速通道认证，并计划在2025年初启动针对EGFRi皮疹的1/2期临床研究。

关于 Azitra, 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/.

前瞻性陈述

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 10亿study of ATR-12, the filing of an IND application, and the presentation of data from our Phase 10亿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 10亿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 Azitra’s programs and operations are described or incorporated by reference in our prospectus dated July 23, 2024 filed with the SEC on July 25, 2024 in our most recent quarterly report on Form 10-Q filed with the SEC on November 12, 2024. Azitra explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law.

联络我们

诺曼 史达士奇

财务总监

staskey@azitrainc.com

Tiberend 策略顾问公司.

Jon Nugent

205-566-3026

jnugent@tiberend.com

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