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BiomX to Present Phase 1b/2a Clinical Trial Data for BX004 at the 47th European Cystic Fibrosis Conference and at ASM Microbe 2024
Newsfilter· 2024-05-30 19:00
GAITHERSBURG, Md. and NESS ZIONA, Israel, May 30, 2024 (GLOBE NEWSWIRE) -- BiomX Inc. (NYSE:PHGE) ("BiomX" or the "Company"), a clinical-stage company advancing novel natural and engineered phage therapies that target specific pathogenic bacteria, today announced the Company will present at two upcoming conferences data from BiomX's Phase 1b/2a study of BX004 for the treatment of cystic fibrosis patients with chronic Pseudomonas aeruginosa pulmonary infections. The findings will be presented in an oral pres ...
BiomX(PHGE) - 2024 Q1 - Earnings Call Transcript
2024-05-21 22:25
财务数据和关键指标变化 - 截至2024年3月31日,公司现金余额和短期存款为4410万美元,较2023年3月31日的3030万美元有所增加,主要是由于私募配售带来的资金流入,部分被经营活动现金流出和偿还债务所抵消 [22] - 2024年第一季度研发费用净额为410万美元,较2023年同期的460万美元有所下降,主要是由于CF临床试验结束导致费用减少,部分被来自以色列创新局的拨款减少和与APT合并后新增的研发费用所抵消 [23] - 2024年第一季度一般及行政费用为270万美元,较2023年同期的160万美元有所增加,主要是由于与APT合并和私募配售相关的费用增加 [24] - 2024年第一季度净亏损为1730万美元,较2023年同期的640万美元有所增加,主要是由于本季度发行的私募配售认股权证的公允价值变动所致 [25] - 2024年第一季度经营活动现金流出为1140万美元,较2023年同期的500万美元有所增加 [26] 各条业务线数据和关键指标变化 - 公司已完成与APT的合并,扩大了中期临床阶段的产品管线,包括BX211用于治疗糖尿病足部骨髓炎的II期临床试验 [10][11] - BX004是公司最先进的中期临床阶段候选药物,已显示出有望的临床结果,支持噬菌体疗法治疗囊性纤维化患者潜在的慢性感染的潜力 [12] 各个市场数据和关键指标变化 - 无相关内容 公司战略和发展方向及行业竞争 - 公司通过与APT的合并,扩大了噬菌体疗法管线,现已成为行业内拥有最广泛和最先进噬菌体管线的公司之一 [11] - 公司正在推进BX004和BX211的II期临床试验,预计在2025年第一季度和第三季度分别公布试验结果,这些数据可能为公司股东带来重大价值 [14][19] - 公司最近完成了5000万美元的私募配售,由Deerfield Management、AMR基金等知名投资者参与,进一步验证了噬菌体疗法作为新疗法模式的潜力,以及公司的主要候选药物的实力 [13] 管理层对经营环境和未来前景的评论 - 公司已进入新的发展阶段,通过与APT的合并,扩大了中期临床阶段的产品管线,并筹集到新的资金支持 [10][13] - 公司有望在2025年实现BX004和BX211的重要临床里程碑,这将为公司股东带来重大价值 [14][19][29][30] - 公司有信心通过现有资金可以支持运营至2025年第四季度 [22][27] 问答环节重要的提问和回答 问题1 **Joe Pantginis 提问** - 询问公司是否在与更多医生和关键意见领袖进行沟通,以及是否在BX004 II期临床试验设计上有任何新的进展 [34] - 询问公司在整合制造设施方面的进展情况 [35] **Jonathan Solomon 回答** - 公司已与囊性纤维化基金会进行了大量分析和讨论,对II期临床试验的设计有了更好的把握,希望能提高患者转阴率并获得更明确的微生物学和临床指标信号 [36][37] - 整合过程并非一蹴而就,但公司已做好充分准备,包括明确的工作计划和预算,相信能够继续推进并创造更多价值 [38] 问题2 **Yale Jen 提问** - 询问公司是否考虑在BX004的II期临床试验后增加延长治疗的部分 [42] - 询问公司如何确保所有产品中的噬菌体都处于溶解状态,而不是溶原状态 [45] **Jonathan Solomon 回答** - 公司正在讨论是否在II期临床试验后增加延长治疗的部分,以观察患者转阴后能维持多长时间 [43] - 公司已通过确保所有使用的噬菌体都不含溶原基因来解决这一问题,FDA也明确要求不能使用具有溶原性的噬菌体 [46][47] 问题3 **Sohanna 提问** - 询问公司是否也计划在2024年与欧洲药品管理局就BX004进行沟通 [53] - 询问完成BX211糖尿病足部骨髓炎II期临床试验入组是否存在任何障碍 [52] **Jonathan Solomon 回答** - 公司在BX004的II期临床试验中已经涉及美国、欧洲和以色列的试验点,未来II期临床试验也会继续扩大欧洲的参与 [55] - BX211入组进度良好,已达到目标的70%,公司会继续努力提高入组速度,但临床试验总是存在一定挑战 [56]
BiomX Reports First Quarter 2024 Financial Results and Provides Business and Program Updates
Newsfilter· 2024-05-21 18:30
Following merger with Adaptive Phage Therapeutics in March, combined company reports funding sufficient to support important data readouts for lead clinical programs in 2025 Company will host a conference call and webcast today at 8:00 am ET GAITHERSBURG, Md. and NESS ZIONA, Israel, May 21, 2024 (GLOBE NEWSWIRE) -- BiomX Inc. (NYSE:PHGE) ("BiomX" or the "Company"), a clinical-stage company advancing novel natural and engineered phage therapies that target specific pathogenic bacteria, today reported financi ...
BiomX Reports First Quarter 2024 Financial Results and Provides Business and Program Updates
globenewswire.com· 2024-05-21 18:30
Following merger with Adaptive Phage Therapeutics in March, combined company reports funding sufficient to support important data readouts for lead clinical programs in 2025 Company will host a conference call and webcast today at 8:00 am ET GAITHERSBURG, Md. and NESS ZIONA, Israel, May 21, 2024 (GLOBE NEWSWIRE) -- BiomX Inc. (NYSE American: PHGE) (“BiomX” or the “Company”), a clinical-stage company advancing novel natural and engineered phage therapies that target specific pathogenic bacteria, today report ...
BiomX(PHGE) - 2024 Q1 - Quarterly Report
2024-05-21 05:24
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarter ended March 31, 2024 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-38762 BiomX Inc. (Exact Name of Registrant as Specified in Its Charter) Delaware 82-3364020 (State or other jurisdiction of (I.R.S. Employe ...
BiomX to Host First Quarter 2024 Financial Results Conference Call and Webcast on May 21, 2024
Newsfilter· 2024-05-15 19:00
GAITHERSBURG, Maryland and NESS ZIONA, Israel, May 15, 2024 (GLOBE NEWSWIRE) -- BiomX Inc. (NYSE:PHGE) ("BiomX" or the "Company"), a clinical-stage company advancing novel natural and engineered phage therapies that target specific pathogenic bacteria, today announced that the Company will host a conference call and a live audio webcast on Tuesday, May 21, 2024, at 8:00 a.m. ET, to report first quarter 2024 financial results and provide business and program updates. To participate in the conference call, pl ...
BiomX(PHGE) - 2023 Q4 - Annual Report
2024-04-04 18:30
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 or ☐ TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _________ to _________ Commission file number: 0001-38762 BIOMX INC. (Exact name of registrant as specified in its charter) Delaware 82-3364020 (State or other jurisdiction of (I.R ...
BiomX(PHGE) - 2023 Q4 - Earnings Call Transcript
2024-04-04 00:26
BiomX Inc. (NYSE:PHGE) Q4 2023 Earnings Conference Call April 3, 2024 8:00 AM ET Company Participants Avi Gabay - Interim CFO Jonathan Solomon - CEO Conference Call Participants Joseph Pantginis - H.C. Wainwright Operator Good morning, and welcome to the BiomX Full Year 2023 Financial Results and Corporate Update Conference Call. Currently, all participants are in a listen-only mode. There will be a question-and-answer session at the end of this call. I'd now like to turn the conference over to Avi Gabay, I ...
BiomX(PHGE) - 2024 Q1 - Quarterly Results
2024-04-03 19:40
Exhibit 99.1 BiomX Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update Recent acquisition of Adaptive Phage Therapeutics creates leader in phage therapy with advanced, clinical-stage pipeline Closed concurrent $50 million financing to support BX004 and BX211 programs through key data readouts expected in 2025 Patient recruitment on track in BX211 Phase 2 trial in Diabetic Foot Osteomyelitis (“DFO”), with topline results expected in Q1 2025 Company will host a conference ...
BiomX(PHGE) - 2023 Q3 - Quarterly Report
2023-11-15 02:01
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarter ended September 30, 2023 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-38762 BiomX Inc. (Exact Name of Registrant as Specified in Its Charter) Delaware 82-3364020 (State or other jurisdiction of (I.R.S. Emp ...