Moleculin Reports First Quarter 2024 Financial Results and Provides Corporate Update
Moleculin Reports First Quarter 2024 Financial Results and Provides Corporate Update
– Recently announced interim data from ongoing MB-106 study demonstrating Annamycin in combination with Cytarabine (AnnAraC) achieves CRc rate of 62% (54% CR) in 1st and 2nd line AML subjects (N=13)
— 最近公布的来自正在进行的 MB-106 研究的中期数据表明，安那霉素与阿糖胞苷（AnnaRAC）联合使用 1 中可实现 62%（54% CR）的 cRC 率st 以及 2和 直线反洗钱受试者（N=13）
– Also announced MB-106 reaches 20 subjects enrolled
— 还宣布，MB-106 的注册受试者达到 20 名
– Company to host conference call and webcast today, Monday, May 13th at 8:30 AM ET
— 公司将于今天，即5月13日星期一举办电话会议和网络直播第四 美国东部时间上午 8:30
HOUSTON, May 13, 2024 — Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat tumors and viruses, today reported its financial results for the quarter ended March 31, 2024. As previously announced, the Company will host a conference call and live audio webcast to discuss the operational and financial results at 8:30 AM ET on Monday, May 13, 2024. (details below).
休斯顿，2024 年 5 月 13 日 — Moleculin Biotech有限公司，（纳斯达克股票代码：MBRX）（“Moleculin” 或 “公司”）是一家临床阶段制药公司，拥有广泛的针对难以治疗的肿瘤和病毒的候选药物组合，今天公布了截至2024年3月31日的季度财务业绩。正如先前宣布的那样，该公司将举行电话会议和 网络直播音频 将于美国东部时间2024年5月13日星期一上午8点30分讨论运营和财务业绩。（详情如下）。
"We recently hosted a virtual AML Clinical Day featuring renowned KOLs, Dr. Martin Tallman and Dr. Michael Andreeff. It was great to hear their support of and thoughts on Annamycin's recent developments in AML. You can hear that discussion here. Combined with the encouraging Annamycin data demonstrated to date and the positive feedback from the KOLs, we continue to believe that our results in 2nd line subjects fill a significant unmet need. We believe this is supported by the exceptional CRc rate demonstrated by AnnAraC in 2nd line patients, which substantially exceeds the performance reported by any drug currently approved in the U.S. for use in 2nd line AML. We believe we are well-positioned for a highly productive End of Phase 2 meeting with FDA to discuss our planned pivotal study of Annamycin for AML," commented Walter Klemp, Chairman and Chief Executive Officer of Moleculin.
“我们最近举办了虚拟反洗钱临床日，邀请了知名KOL，即马丁·塔尔曼博士和迈克尔·安德烈夫博士。很高兴听到他们对安那霉素最近在反洗钱领域的进展的支持和想法。你可以听到那个讨论 这里。结合迄今为止令人鼓舞的安那霉素数据以及KOL的积极反馈，我们仍然相信我们的结果是 2和 直线科目填补了大量未满足的需求。我们认为，AnnaRac在 2 中表现出的出色 cRC 速率支持了这一点和 线路患者，这大大超过了美国目前批准用于2类药物的任何药物报告的性能和 线路反洗钱。我们认为，我们完全有能力与美国食品药品管理局举行一次富有成效的第二阶段末会议，讨论我们计划对安那霉素治疗急性髓细胞白血病的关键研究，” 评论道 沃尔特·克莱姆普，Moleculin董事长兼首席执行官。
Recent Highlights
近期亮点
- Bolstered the patent estate with issuance of U.S. patents. We recently received an Issue Notification from the United States Patent and Trademark Office (USPTO) for U.S. Patent number 11,980,634 titled, "Method of Reconstituting Liposomal Annamycin." Earlier, we received an Issue Notification titled, "Preparation of Preliposomal Annamycin Lyophilizate." Both provide claims to compositions that contain Annamycin with a base patent term extending until mid-2040.
- Hosted a virtual AML clinical day highlighting positive interim data for Annamycin from its ongoing acute myeloid leukemia (AML) clinical development program.
- Full MB-106 trial reaches 20 subjects with CRc of 45% in 1st – 7th line, with median durability at 4.9 months and climbing.
- 1st and 2nd line patients reached a CRc rate of 62% and a CR rate of 54%.
- The 2nd line performance from the combination of Annamycin with Ara-C (AnnAraC) exceeds the approval data for all currently approved 2nd line drugs.
- Interim data supports advancement to development of Phase 2 registration-directed clinical trial (MB-108) to further provide data for efficacy to support an eventual application for New Drug Approval (NDA).
- Announced the formation of its Annamycin Scientific Advisory Board and inaugural appointment of Dr. Martin Tallman.
- Granted Orphan Drug Designation of Annamycin for the treatment of AML from the European Medicines Agency (EMA), adding to US Orphan Drug and Fast Track designations.
- Presented positive data demonstrating high anti-cancer activity of Annamycin and non-cardiotoxic properties at the American Association for Cancer Research (AACR) Annual Meeting.
- 通过颁发美国专利，巩固了专利资产。我们最近收到了美国专利商标局（USPTO）的美国专利号为11,980,634的问题通知，标题为”重组脂质体安那霉素的方法。“早些时候，我们收到了一份问题通知，标题为，”前脂质体安那霉素冻干物的制备。“两者都对含有安那霉素的组合物提出索赔，其基本专利期限延长至2040年中期。
- 主持了一场 虚拟反洗钱临床日 重点介绍了安那霉素正在进行的急性髓系白血病（AML）临床开发计划的积极中期数据。
- 完整的 MB-106 试验涉及 20 名受试者，第 1 名 cRC 为 45% — 7第四 防线，平均耐久度为4.9个月，可攀岩。
- 1st 以及 2和 一线患者的cRC率为62％，CR率为54％。
- 这个 2和 安那霉素与Ara-C（AnnaRac）组合后的生产线性能超过了所有目前批准的批准数据 2和 线路药物。
- 临时数据支持推进以注册为导向的2期临床试验（MB-108）的开发，以进一步提供疗效数据，以支持最终的新药批准（NDA）申请。
- 宣布成立安那霉素科学顾问委员会并首次任命马丁·塔尔曼博士。
- 获得欧洲药品管理局（EMA）颁发的用于治疗急性髓细胞白血病的安那霉素孤儿药认定，增加了美国孤儿药和快速通道的称号。
- 在美国癌症研究协会（AACR）年会上提供了阳性数据，表明安那霉素具有很高的抗癌活性和无心脏毒性特性。
Ongoing AML Clinical Trial Summary
正在进行的 AML 临床试验摘要
The Company is currently conducting its Phase 1B/2 clinical trial evaluating Annamycin in combination with Cytarabine (also known as "Ara-C" and for which the combination of Annamycin and Ara-C is referred to as AnnAraC) for the treatment of subjects with AML as both first line therapy and for subjects who are refractory to or relapsed after induction therapy (MB-106). clinicaltrialsregister.eu: EudraCT 2020-005493-10 or clinicaltrials.gov: NCT05319587.
该公司目前正在进行1B/2期临床试验，评估安那霉素与阿糖胞苷（也称为 “Ara-C”，安那霉素和Ara-C的组合被称为AnnaRac）联合用于治疗以急性髓细胞白血病作为一线疗法的受试者和诱导治疗（MB-106）后难治性或复发的受试者。 临床试验 register.eu: Eudract 2020-005493-10 或 clinicaltrials.gov: NCT05319587。
A summary table of the MB-106 preliminary results is shown below. These subjects had 0-6 prior therapies. The preliminary data for MB-106 demonstrate a CRc rate of 45% and an overall remission rate (ORR) of 55% for all subjects, regardless of the number of prior treatments (N=20). Segmenting the MB-106 subject population for 1st line (N=3) and, most notably, 2nd line (N=10) therapies in the trial, yields a CRc rate of 67% and 60% and an ORR of 67% and 70%, both respectively.
MB-106 初步结果的汇总表如下所示。这些受试者之前接受过0-6次治疗。MB-106 的初步数据显示，无论先前的治疗次数是多少，所有受试者的cRC率均为45％，总缓解率（ORR）为55％（N=20）。将 MB-106 受试者群体划分为 1st 直线 (N=3)，最值得注意的是 2和 试验中的线性（N=10）疗法的cRC率分别为67％和60％，ORR分别为67％和70％。
Table 1 – Summary of Annamycin Remissions in MB-106 as of May 2, 2024
表 1 — 截至 2024 年 5 月 2 日 MB-106 中安那霉素缓解情况摘要
| Study MB-106 Combination Therapy – | All Lines (Range | 1st Line | 2nd Line | 1st and 2nd Line |
| All Subjects | ||||
| Recruited and Evaluable | 20 | 3 | 10 | 13 |
| Subjects Evaluable Not Dosed Per Protocol | 2 | 0 | 1 | 1 |
| Median Age – Years (Range) | 69 (19-78) | 49 (19-69) | 71 (53 – 78) | 67 (19-78) |
| Complete Remissions (CR) | 8 | 2 | 5 | 7 |
| CR with incomplete recovery (CRi) | 1 | 0 | 1 | 1 |
| Total Composite Complete Remission (CRc) | 9 | 2 | 6 | 8 |
| Complete Remission (CR) Rate | 40 % | 67 % | 50 % | 54 % |
| Complete Remission Composite (CRc) Rate | 45 % | 67 % | 60 % | 62 % |
| Partial Remissions (PRs) | 2 | 0 | 1 | 1 |
| Overall Response Rate (CRc's + PRs) or ORR | 55 % | 67 % | 70 % | 69 % |
| CRc Relapsed or Death to Date | 2 | 0 | 2 | 2 |
| BMT To Date (in CR's) | 2 | 0 | 1 | 1 |
| See Note 1 below |
| 研究 MB-106 联合疗法 — | 所有线路（范围） | 1st 线 | 2和 线 | 1st 以及 2和 线 |
| 所有科目 | ||||
| 已招募并可评估 | 20 | 3 | 10 | 13 |
| 可评估的受试者未按协议给药 | 2 | 0 | 1 | 1 |
| 平均年龄 — 年（范围） | 69 (19-78) | 49 (19-69) | 71 (53 — 78) | 67 (19-78) |
| 完全缓解 (CR) | 8 | 2 | 5 | 7 |
| 恢复不完全的 CR (CRi) | 1 | 0 | 1 | 1 |
| 总复合完全缓解期 (cRC) | 9 | 2 | 6 | 8 |
| 完全缓解 (CR) 率 | 40% | 67% | 50% | 54% |
| 完全缓解综合 (cRC) 率 | 45% | 67% | 60% | 62% |
| 部分缓解 (PR) | 2 | 0 | 1 | 1 |
| 总回复率（cRC + pR）或 ORR | 55% | 67% | 70% | 69% |
| cRC 迄今为止已复发或死亡 | 2 | 0 | 2 | 2 |
| 迄今为止的 BMT（在 CR 中） | 2 | 0 | 1 | 1 |
| 参见下面的注释 1 |
Notes for Table 1: Data from MB-106 is for Intent To Treat (ITT) subjects and is preliminary and subject to change.
表 1 的注意事项：来自 MB-106 的数据适用于意向治疗（ITT）受试者，是初步数据，可能会发生变化。
Expected Milestones for Annamycin AML Development Program
安那霉素反洗钱开发计划的预期里程碑
- H1 2024: Complete MB-106 Phase 1B/2 clinical trial.
- H1 2024: MB-106 End of Phase 2 Meeting with FDA.
- H2 2024: Feedback from the FDA EOP2 Meeting.
- H1 2025: Initiate pivotal trial.
- H2 2026: Conclude pivotal trial.
- 2027: Potential NDA submission.
- 2024 年上半年：完成 MB-106 1B/2 期临床试验。
- 2024 年上半年：MB-106 与 FDA 的第 2 阶段会议结束。
- 2024 年下半年：来自 FDA EOP2 会议的反馈。
- 2025 年上半年：启动关键试验。
- 2026 年下半年：结束关键试验。
- 2027 年：可能提交保密协议。
Summary of Financial Results for the First Quarter 2024
2024年第一季度财务业绩摘要
Research and development (R&D) expense was $4.3 million and $5.7 million for the three months ended March 31, 2024 and 2023, respectively. The decrease of $1.4 million is mainly related to the clinical trials activity levels.
截至2024年3月31日和2023年3月31日的三个月，研发（R&D）支出分别为430万美元和570万美元。140万美元的减少主要与临床试验活动水平有关。
General and administrative expense was $2.4 million and $2.6 million for the three months ended March 31, 2024 and 2023, respectively. The decrease of $0.2 million is mainly related to a decrease in regulatory and legal fees.
截至2024年3月31日和2023年3月31日的三个月，一般和管理费用分别为240万美元和260万美元。减少20万美元主要与监管和法律费用减少有关。
As of March 31, 2024, the Company had cash and cash equivalents of $16.8 million and believes that this cash is sufficient to meet its projected operating requirements, which includes the Company's current Phase 1B/2 clinical programs and preparations for future clinical trials, into the fourth quarter of 2024.
截至2024年3月31日，该公司的现金和现金等价物为1,680万美元，并认为这笔现金足以满足其2024年第四季度的预计运营需求，包括公司目前的1B/2阶段临床项目和未来临床试验的准备工作。
Conference Call and Webcast
电话会议和网络直播
Moleculin management will host its quarterly conference call and webcast for investors, analysts, and other interested parties Monday, May 13, 2024, at 8:30 AM ET.
Moleculin管理层将于美国东部时间2024年5月13日星期一上午8点30分为投资者、分析师和其他有关各方举办季度电话会议和网络直播。
Interested participants and investors may access the conference call by dialing (877) 407-0832 (domestic) or (201) 689-8433 (international) and referencing the Moleculin Biotech Conference Call. The live audio webcast will be accessible on the Events page of the Investors section of the Moleculin website, moleculin.com, and will be archived for 90 days.
感兴趣的参与者和投资者可以通过拨打（877）407-0832（国内）或（201）689-8433（国际）并参考Moleculin Biotech电话会议来参加电话会议。这个 网络直播音频 将在上面访问 活动 的页面 投资者 Moleculin网站的栏目， moleculin.com，并将存档 90 天。
About Moleculin Biotech, Inc.
关于 Moleculin Biotech, Inc.
Moleculin Biotech, Inc. is a clinical stage pharmaceutical company with a growing pipeline, including Phase 2 clinical programs, for hard-to-treat tumors and viruses. The Company's lead program, Annamycin is a next-generation anthracycline designed to avoid multidrug resistance mechanisms and to eliminate the cardiotoxicity common with currently prescribed anthracyclines. Annamycin is currently in development for the treatment of relapsed or refractory acute myeloid leukemia (AML) and soft tissue sarcoma (STS) lung metastases. All interim and preliminary data discussed above are subject to change.
Moleculin Biotech, Inc. 是一家临床阶段的制药公司，针对难以治疗的肿瘤和病毒的产品线不断扩大，包括二期临床项目。该公司的主要项目安那霉素是下一代蒽环素，旨在避免多药耐药机制，并消除目前处方蒽环类药物常见的心脏毒性。安那霉素目前正在开发中，用于治疗复发或难治性急性髓系白血病（AML）和软组织肉瘤（STS）肺转移。上面讨论的所有中期和初步数据可能会发生变化。
Additionally, the Company is developing WP1066, an Immune/Transcription Modulator capable of inhibiting p-STAT3 and other oncogenic transcription factors while also stimulating a natural immune response, targeting brain tumors, pancreatic and other cancers, and WP1220, an analog to WP1066, for the topical treatment of cutaneous T-cell lymphoma. Moleculin is also engaged in the development of a portfolio of antimetabolites, including WP1122 for the potential treatment of viruses, as well as cancer indications including brain tumors, pancreatic and other cancers.
此外，该公司正在开发免疫/转录调节剂 WP1066，一种免疫/转录调节剂，能够抑制p-stat3和其他致癌转录因子，同时刺激针对脑肿瘤、胰腺和其他癌症的自然免疫反应，以及用于局部治疗皮肤 T 细胞淋巴瘤的 WP1066 类似物 WP1220。Moleculin 还参与开发抗代谢药物产品组合，包括用于潜在病毒治疗的 WP1122，以及包括脑肿瘤、胰腺癌和其他癌症在内的癌症适应症。
For more information about the Company, please visit www.moleculin.com and connect on Twitter, LinkedIn and Facebook.
如需了解有关公司的更多信息，请访问 www.moleculin.com 然后连接 推特， 领英 和 Facebook。
Forward-Looking Statements
前瞻性陈述
Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the Company's forecasted cash burn rate (including its estimate of cash sufficient to meet its projected operating requirements) and the achievement of the expected milestones set forth above. Although Moleculin believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. Moleculin has attempted to identify forward-looking statements by terminology including 'believes,' 'estimates,' 'anticipates,' 'expects,' 'plans,' 'projects,' 'intends,' 'potential,' 'may,' 'could,' 'might,' 'will,' 'should,' 'approximately' or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under Item 1A. "Risk Factors" in our most recently filed Form 10-K filed with the Securities and Exchange Commission ("SEC") and updated from time to time in our Form 10-Q filings and in our other public filings with the SEC. Any forward-looking statements contained in this release speak only as of its date. We undertake no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.
本新闻稿中的一些陈述是1933年《证券法》第27A条、1934年《证券交易法》第21E条和1995年《私人证券诉讼改革法》所指的前瞻性陈述，涉及风险和不确定性。本新闻稿中的前瞻性陈述包括但不限于公司的预测现金消耗率（包括其对足以满足其预计运营需求的现金的估计）以及上述预期里程碑的实现情况。尽管Moleculin认为，截至发布之日，此类前瞻性陈述中反映的预期是合理的，但事实证明，预期可能与此类前瞻性陈述所表达或暗示的结果存在重大差异。Moleculin试图通过包括 “相信”、“估计”、“预期”、“计划”、“项目”、“打算”、“潜力”、“可能”、“可能”、“可能”、“将”、“应该”、“大约” 或其他表示未来事件或结果不确定性的词语来识别这些前瞻性陈述。这些陈述只是预测，涉及已知和未知的风险、不确定性和其他因素，包括在项目1A下讨论的因素。我们最近向美国证券交易委员会（“SEC”）提交的10-K表格中的 “风险因素”，并在我们的10-Q表文件和向美国证券交易委员会提交的其他公开文件中不时更新。本新闻稿中包含的任何前瞻性陈述仅代表截至发布日期。我们没有义务更新本新闻稿中包含的任何前瞻性陈述，以反映其发布日期之后发生的事件或情况，也没有义务反映意外事件的发生。
Investor Contact:
投资者联系人：
JTC Team, LLC
Jenene Thomas
(833) 475-8247
MBRX@jtcir.com
JTC Team, LLC
珍妮·托马斯
(833) 475-8247
MBRX@jtcir.com
| Moleculin Biotech, Inc. | ||||
| Unaudited Condensed Consolidated Balance Sheets | ||||
| (in thousands) | March 31, 2024 | December 31, 2023 | ||
| Current assets: | ||||
| Cash and cash equivalents | $ 16,824 | $ 23,550 | ||
| Prepaid expenses and other current assets | 2,133 | 2,723 | ||
| Total current assets | 18,957 | 26,273 | ||
| Furniture and equipment, net | 240 | 272 | ||
| Intangible assets | 11,148 | 11,148 | ||
| Operating lease right-of-use asset | 500 | 524 | ||
| Total assets | $ 30,845 | $ 38,217 | ||
| Current liabilities: | ||||
| Accounts payable and accrued expenses and other current liabilities | $ 5,408 | $ 6,815 | ||
| Total current liabilities | 5,408 | 6,815 | ||
| Operating lease liability – long-term, net of current portion | 450 | 474 | ||
| Warrant liability – long term | 3,400 | 4,855 | ||
| Total liabilities | 9,258 | 12,144 | ||
| Total stockholders' equity | 21,587 | 26,073 | ||
| Total liabilities and stockholders' equity | $ 30,845 | $ 38,217 | ||
| Unaudited Condensed Consolidated Statements of Operations | ||||
| Three Months Ended March 31, | ||||
| (in thousands, except share and per share amounts) | 2024 | 2023 | ||
| Revenues | $ – | $ – | ||
| Operating expenses: | ||||
| Research and development | 4,252 | 5,687 | ||
| General and administrative and depreciation and amortization | 2,425 | 2,667 | ||
| Total operating expenses | 6,677 | 8,354 | ||
| Loss from operations | (6,677) | (8,354) | ||
| Other income: | ||||
| Gain from change in fair value of warrant liability | 1,455 | 39 | ||
| Other income, net | 11 | 8 | ||
| Interest income, net | 241 | 392 | ||
| Net loss | (4,970) | (7,915) | ||
| Net loss per common share – basic and diluted | $ (2.02) | $ (4.13) | ||
| Weighted average common shares outstanding – basic and diluted | 2,466,174 | 1,916,665 | ||
| Moleculin Biotech有限公司 | ||||
| 未经审计的简明合并资产负债表 | ||||
| （以千计） | 2024年3月31日 | 2023年12月31日 | ||
| 流动资产： | ||||
| 现金和现金等价物 | 16,824 美元 | 23,550 美元 | ||
| 预付费用和其他流动资产 | 2,133 | 2,723 | ||
| 流动资产总额 | 18,957 | 26,273 | ||
| 家具和设备，净额 | 240 | 272 | ||
| 无形资产 | 11,148 | 11,148 | ||
| 经营租赁使用权资产 | 500 | 524 | ||
| 总资产 | 30,845 美元 | 38,217 美元 | ||
| 流动负债： | ||||
| 应付账款和应计费用以及其他流动负债 | 5,408 美元 | 6,815 美元 | ||
| 流动负债总额 | 5,408 | 6,815 | ||
| 运营租赁负债——长期，扣除流动部分 | 450 | 474 | ||
| 认股权证责任——长期 | 3,400 | 4,855 | ||
| 负债总额 | 9,258 | 12,144 | ||
| 股东权益总额 | 21,587 | 26,073 | ||
| 负债和股东权益总额 | 30,845 美元 | 38,217 美元 | ||
| 未经审计的简明合并运营报表 | ||||
| 截至3月31日的三个月 | ||||
| （以千计，股票和每股金额除外） | 2024 | 2023 | ||
| 收入 | $ — | $ — | ||
| 运营费用： | ||||
| 研究和开发 | 4,252 | 5,687 | ||
| 一般和行政费用以及折旧和摊销 | 2,425 | 2,667 | ||
| 运营费用总额 | 6,677 | 8,354 | ||
| 运营损失 | (6,677) | (8,354) | ||
| 其他收入： | ||||
| 认股权证负债公允价值变动的收益 | 1,455 | 39 | ||
| 其他收入，净额 | 11 | 8 | ||
| 净利息收入 | 241 | 392 | ||
| 净亏损 | (4,970) | (7,915) | ||
| 每股普通股净亏损——基本亏损和摊薄后 | 美元 (2.02) | 美元 (4.13) | ||
| 已发行普通股的加权平均值——基本和摊薄后 | 2,466,174 | 1,916,665 | ||
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SOURCE Moleculin Biotech, Inc.
来源 Moleculin Biotech, Inc.
译文内容由第三方软件翻译。