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Panbela Announces Transfer to OTCQB Market

Panbela Announces Transfer to OTCQB Market

Panbela 宣布转入 OTCQB 市场
GlobeNewswire ·  04/16 17:29

MINNEAPOLIS, April  16, 2024  (GLOBE NEWSWIRE) -- Panbela Therapeutics, Inc. (OTCQB: PBLA), ("Panbela"), a clinical stage company developing disruptive therapeutics for the treatment of patients with urgent unmet medical needs, today announced that its common stock has been approved for quotation on the OTCQB market. Panbela's common stock will be eligible for quotation on the OTCQB starting on April 17, 2024, under the symbol "PBLA."

明尼阿波利斯,2024年4月16日(环球新闻专线)——Panbela Therapeutics, Inc.(OTCQB:PBLA)(“Panbela”)是一家开发颠覆性疗法以治疗急需未得到满足的患者的临床阶段公司,今天宣布,其普通股已获准在OTCQB市场上报价。从2024年4月17日起,Panbela的普通股将有资格在OTCQB上报价,股票代码为 “PBLA”。

OTCQB is a venture market operated by the OTC Markets Group Inc. To be eligible for quotation on the OTCQB, companies must be current in their reporting and undergo an annual verification and management certification process. OTCQB is recognized by the U.S. Securities and Exchange Commission (the "SEC") as an established public market and provides current public information to investors who need to analyze, value, and trade securities.

OTCQB是由场外交易市场集团公司运营的风险市场。要获得OTCQB报价的资格,公司必须及时提交报告,并经过年度验证和管理认证程序。OTCQB被美国证券交易委员会(“SEC”)认可为成熟的公开市场,为需要分析、估值和交易证券的投资者提供最新的公开信息。

Panbela's board of directors also has approved the delisting of its common stock from The Nasdaq Stock Market LLC ("Nasdaq"). On April 16, 2024, Panbela notified Nasdaq of its determination to file with the SEC a Form 25 relating to the delisting of its common stock. Panbela intends to file its own Form 25 in advance of Nasdaq's expected filing of a Form 25, primarily to expedite the transition of its common stock to the OTCQB. The Form 25 will also serve to deregister Panbela's common stock under Section 12(b) of the U.S. Securities Exchange Act of 1934, as amended (the "Exchange Act"). As previously disclosed, on March 5, 2024, a Nasdaq hearings panel notified Panbela that it had determined to delist its common stock and trading of Panbela's common stock on Nasdaq was suspended on March 7, 2024. The panel reached its decision because our company did not satisfy the minimum $2.5 million stockholders' equity requirement in Listing Rule 5550(b)(1) and was unable to comply with any of the alternative requirements in Listing Rule 5550(b).

Panbela董事会还批准将其普通股从纳斯达克股票市场有限责任公司(“纳斯达克”)退市。2024年4月16日,Panbela通知纳斯达克,它决定向美国证券交易委员会提交一份与普通股退市有关的25号表格。Panbela打算在纳斯达克预计提交25号表格之前提交自己的25号表格,这主要是为了加快其普通股向OTCQB的过渡。根据经修订的1934年《美国证券交易法》(“交易法”)第12(b)条,25表格还将用于注销Panbela的普通股。正如先前披露的那样,纳斯达克听证会小组于2024年3月5日通知潘贝拉,它已决定将其普通股退市,Panbela在纳斯达克的普通股交易于2024年3月7日暂停。该小组之所以做出决定,是因为我们公司没有满足《上市规则》第5550(b)(1)条中最低250万美元的股东权益要求,也无法遵守《上市规则》第5550(b)条中的任何替代要求。

Neither the filing of the Form 25 nor the official delisting of Panbela's common shares from Nasdaq is expected to impact the eligibility of our common shares for quotation on the OTCQB.

预计25号表格的提交和Panbela普通股从纳斯达克正式退市都不会影响我们的普通股在OTCQB的报价资格。

About Panbela's Pipeline
The pipeline consists of assets currently in clinical trials with an initial focus on familial adenomatous polyposis (FAP), first-line metastatic pancreatic cancer, neoadjuvant pancreatic cancer, colorectal cancer prevention and ovarian cancer. The combined development programs have a steady cadence of anticipated catalysts with programs ranging from pre-clinical to registration studies.

关于 Panbela 的管道
该产品线包括目前正在进行临床试验的资产,最初侧重于家族性腺瘤性息肉(FAP)、一线转移性胰腺癌、新辅助胰腺癌、结直肠癌预防和卵巢癌。联合开发项目有稳定的预期催化剂节奏,项目范围从临床前研究到注册研究不等。

Ivospemin (SBP-101)
Ivospemin is a proprietary polyamine analogue designed to induce polyamine metabolic inhibition (PMI) by exploiting an observed high affinity of the compound for pancreatic ductal adenocarcinoma and other tumors. It has shown signals of tumor growth inhibition in clinical studies of metastatic pancreatic cancer patients, demonstrating a median overall survival (OS) of 14.6 months and an objective response rate (ORR) of 48%, both exceeding what is typical for the standard of care of gemcitabine + nab-paclitaxel suggesting potential complementary activity with the existing FDA-approved standard chemotherapy regimen. In data evaluated from clinical studies to date, ivospemin has not shown exacerbation of bone marrow suppression and peripheral neuropathy, which can be chemotherapy-related adverse events. Serious visual adverse events have been evaluated and patients with a history of retinopathy or at risk of retinal detachment will be excluded from future SBP-101 studies. The safety data and PMI profile observed in the previous Panbela-sponsored clinical trials provide support for continued evaluation of ivospemin in the ASPIRE trial.

Ivospemin (SBP-101)
Ivospemin 是一种专有的多胺类似物,旨在利用该化合物对胰腺导管腺癌和其他肿瘤的观察到的高亲和力,诱导多胺代谢抑制 (PMI)。它在转移性胰腺癌患者的临床研究中显示出肿瘤生长抑制信号,显示平均总存活率(OS)为14.6个月,客观反应率(ORR)为48%,均超过了吉西他滨+ nab-paclitaxel标准护理的典型水平,这表明与美国食品药品管理局批准的现有标准化疗方案具有潜在的互补活性。在迄今为止评估的临床研究数据中,ivospemin尚未显示骨髓抑制和周围神经病变加重,这可能是与化疗相关的不良事件。已经对严重的视觉不良事件进行了评估,有视网膜病变史或有视网膜脱离风险的患者将被排除在未来的 SBP-101 研究之外。在先前Panbela赞助的临床试验中观察到的安全数据和PMI概况为ASPIRE试验中继续评估ivospemin提供了支持。

Flynpovi
Flynpovi is a combination of CPP-1X (eflornithine) and sulindac with a dual mechanism inhibiting polyamine synthesis and increasing polyamine export and catabolism. In a Phase III clinical trial in patients with sporadic large bowel polyps, the combination prevented > 90% subsequent pre-cancerous sporadic adenomas versus placebo. Focusing on FAP patients with lower gastrointestinal tract anatomy in the recent Phase III trial comparing Flynpovi to single agent eflornithine and single agent sulindac, FAP patients with lower GI anatomy (patients with an intact colon, retained rectum or surgical pouch), showed statistically significant benefit compared to both single agents (p≤0.02) in delaying surgical events in the lower GI for up to four years. The safety profile for Flynpovi did not significantly differ from the single agents and supports the continued evaluation of Flynpovi for FAP.

Flynpovi
Flynpovi 是 CPP-1X(eflornithine)和舒林达克的组合,具有抑制多胺合成、增加多胺输出和分解代谢的双重机制。在一项针对散发性大肠息肉患者的III期临床试验中,与安慰剂相比,该组合可预防90%以上的癌前散发性腺瘤。在最近将Flynpovi与单药依氟鸟氨酸和单药舒林达克进行比较的III期试验中,下消化道解剖结构的FAP患者(结肠完好无损、直肠保留或手术袋的患者)在将下消化道手术事件延迟长达四年方面显示出具有统计学意义的显著益处(p≤0.02)。Flynpovi的安全状况与单一制剂没有显著差异,支持继续对FAP的Flynpovi进行评估。

CPP-1X
CPP-1X (eflornithine) is being developed as a single agent tablet or high dose powder sachet for several indications including prevention of gastric cancer, treatment of neuroblastoma and recent onset Type 1 diabetes. Preclinical studies as well as Phase I or Phase II investigator-initiated trials suggest that CPP-1X treatment may be well-tolerated and has potential activity.

CPP-1X
CPP-1X(eflornithine)正在开发为单剂片剂或大剂量粉剂袋,用于多种适应症,包括预防胃癌、治疗神经母细胞瘤和最近发作的 1 型糖尿病。临床前研究以及研究者发起的 I 期或 II 期试验表明,CPP-1X 治疗可能具有良好的耐受性并且具有潜在的活性。

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