展覽 99.1
Azitra, Inc. 公布2024年第三季度財務結果並提供業務更新
布蘭福德, 康涅狄格州 — Azitra, Inc. (紐交所美國: AZTR),一家專注於開發創新療法 以實現精準皮膚病學的臨床階段生物製藥公司,今天報告了截至2024年9月30日的三個月財務結果並提供業務更新。
2024年第三季度 及近期業務亮點:
● | 完成 一次總額為1000萬美元的後續發行 | |
● | 對第一名Netherton綜合症患者使用ATR-12進行給藥 | |
● | 向FDA提交了IND並獲得了ATR-04的IND批准,以治療由EGFR抑制劑引起的皮膚疹 | |
● | 獲得了FDA對ATR-04的快速通道認證 | |
● | 在歐洲皮膚病學和性病學學院(EADV)大會上的重大報告中,展示了ATR-04的正面前臨床數據和一期/二期臨床研究的臨床計畫 | |
● | 加強了知識產權(IP)組合,獲得了新授予和核准的專利 |
Francisco Salva, Azitra的首席執行官評論道:
“Azitra在2024年第三季度達成了一些重要的里程碑,以推進我們的發展 pipeline,最顯著的是在我們進行中的Netherton症候群試驗中對首位病人進行ATR-12給藥。此外,在本季度,我們完成了1000萬美元的後續發行,提交了ATR-04的IND,針對表皮生長因子受體抑制劑(EGFRis)引起的皮膚潮紅,獲得了IND批准及ATR-04的快速通道資格,並增強了我們的知識產權組合。
“憑藉清晰的路線圖、對兩個項目的強有力執行和一支專注的團隊,Azitra已做好充分準備以執行這些里程碑,為需要的病人提供變革性的療法,並最終最大化股東價值。”
發展 pipeline 和預期的里程碑
● | Q1 2025: 來自Netherton症候群首批患者的初步安全數據,來自第10億期試驗 | |
● | Q1 2025: 第一位病人參與ATR-04在第1/2期試驗中治療EGFRi皮疹 | |
● | YE 2025: 預計ATR-12在Netherton綜合症患者中的第十期試驗的主要數據 |
截至2024年9月30日三個月的財務 結果
● | 服務 營業收入 – 相關方: 公司在截至2024年9月30日的季度內產生了$0的服務營業收入, 而2023年同期則為$310,700。 | |
● | 研究 和開發(R&D)費用:截止2024年9月30日的季度,R&D費用為100萬美元,相較於 2023年同期的50萬美元。 | |
● | 一般 和行政(G&A)費用:截止2024年9月30日的季度,G&A費用為190萬美元, 相較於2023年同期的180萬美元。 | |
● | 淨損失 截止2024年9月30日的季度,為100萬美元,相較於2023年同期的190萬美元。 | |
● | 現金及現金等价物截至2024年9月30日,該公司擁有現金及現金等價物730萬美元。 |
關於 ATR-12
ATR-12 (也稱為ATR12-351)是一種工程化的菌株, S. epidermidis 表達人類的 淋巴上皮 Kazal類型相關抑制劑 缺失於Netherton症候群患者中的(LEKTI)蛋白質是一種慢性且有時致命的皮膚疾病,估計全球約有20,000名患者受到影響。ATR-12已被工程設計為在局部應用於Netherton症候群患者時,提供缺失的LEKTI蛋白質。Azitra目前正在進行開放的10億臨床試驗,積極招募成人Netherton症候群患者(NCT06137157)。Azitra已識別出Netherton症候群患者參加其12名患者的10億臨床試驗,該試驗將評估安全性、耐受性及療效終點。
關於 ATR-04
ATR-04是一種活性交互療法產品候選者,包括一種分離的、自然來源的 S. epidermidis 菌株經過工程設計,通過刪除抗生素抗性基因和設計輔助營養來控制ATR-04的生長,使其更安全。ATR-04正在開發中,用於EGFR抑制劑(“EGFRi”)相關皮疹,該皮疹是由於EGFR抑制劑對皮膚免疫的抑制以及隨後的炎症,通常伴隨有IL-36γ的升高。 S. aureus在美國約有150,000名患者正遭受EGFRi皮疹。Azitra已獲得FDA對EGFRi相關皮疹的快速通道認證,並計劃在2025年初啟動針對EGFRi皮疹的1/2期臨床研究。
關於 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/.
前瞻性陳述
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 10億study of ATR-12, the filing of an IND application, and the presentation of data from our Phase 10億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 10億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.
聯絡我們
諾曼 史達士奇
財務總監
staskey@azitrainc.com
Tiberend 策略顧問公司.
Jon Nugent
205-566-3026
jnugent@tiberend.com
簡明 營運報表
(未審核)
截至九月三十日的三個月 | ||||||||
2024 | 2023 | |||||||
服務營業收入 – 關聯方 | $ | - | $ | 310,700 | ||||
總營業收入 | - | 310,700 | ||||||
營業費用: | ||||||||
一般和行政 | 1,913,400 | 1,755,908 | ||||||
研究 與發展 | 1,015,807 | 548,524 | ||||||
總營業費用 | 2,929,207 | 2,304,432 | ||||||
營業虧損 | (2,929,207 | ) | (1,993,732 | ) | ||||
其他收入(費用): | ||||||||
利息收入 | 47,389 | 634 | ||||||
利息費用 | (3,851 | ) | (710 | ) | ||||
權證公允價值的變化 | 4,001,469 | 98,061 | ||||||
普通股發行的損失 | (2,132,800 | ) | - | |||||
其他 收入(費用) | 7,509 | (47,542 | ) | |||||
其他收入(費用)總額 | 1,919,716 | 50,443 | ||||||
收入稅前淨損失 | (1,009,491 | ) | (1,943,289 | ) | ||||
所得稅費用 | - | - | ||||||
净损失 | $ | (1,009,491 | ) | (1,943,289 | ) | |||
優先股分紅派息 股票 | - | - | ||||||
歸屬於普通股股東的淨虧損 | $ | (1,009,491 | ) | (1,943,289 | ) | |||
每股淨虧損,基本及攤薄 | $ | (.17 | ) | $ | (4.82 | ) | ||
加權平均普通股在外流通股數,基本及攤薄 | 5,814,350 | 403,255 |
簡明 資產負債表
(未經審核)
九月 30日, | 十二月三十一日, | |||||||
2024 | 2023 | |||||||
資產 | ||||||||
流動資產: | ||||||||
現金及其等效資產 | $ | 7,260,234 | $ | 1,795,989 | ||||
其他應收款項 | 9,923 | 223,474 | ||||||
預付費用 及其他流動資產 | 364,673 | 516,116 | ||||||
全部流動資產 | $ | 7,634,830 | $ | 2,535,579 | ||||
物業和設備,扣除純額 | 638,107 | 710,075 | ||||||
其他資產 | 1,504,562 | 1,869,832 | ||||||
資產總額 | $ | 9,777,499 | $ | 5,115,486 | ||||
負債與 股東權益 | ||||||||
流動負債: | ||||||||
應付帳款 | $ | 588,460 | $ | 897,272 | ||||
當前融資租賃 負債 | 15,687 | 14,600 | ||||||
當前營業租約 負債 | 276,839 | 307,655 | ||||||
已應計費用 | 486,981 | 383,668 | ||||||
流動負債合計 | 1,367,967 | 1,603,195 | ||||||
長期融資租約 負債 | 14,266 | 26,169 | ||||||
長期營業租約 負債 | 336,556 | 537,523 | ||||||
認股權證 負債 | 457 | 35,453 | ||||||
負債總額 | 1,719,246 | 2,202,340 | ||||||
股東權益 | ||||||||
普通股 | 763 | 40 | ||||||
資本公積額額外增資 | 63,230,182 | 51,510,269 | ||||||
累積虧損 | (55,172,692 | ) | (48,597,163 | ) | ||||
股東權益總額 | 8,058,253 | 2,913,146 | ||||||
總負債及 股東權益 | $ | 9,777,499 | $ | 5,115,486 |