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Panbela Announces Transfer to OTCQB Market

Panbela Announces Transfer to OTCQB Market

Panbela 宣佈轉入 OTCQB 市場
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(環球新聞專線)——Panbela Therapeutics, Inc.(OTCQB:PBLA)(“Panbela”)是一家開發顛覆性療法以治療急需未得到滿足的患者的臨床階段公司,今天宣佈,其普通股已獲准在OTCQB市場上報價。從2024年4月17日起,Panbela的普通股將有資格在OTCQB上報價,股票代碼爲 “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是由場外交易市場集團公司運營的風險市場。要獲得OTCQB報價的資格,公司必須及時提交報告,並經過年度驗證和管理認證程序。OTCQB被美國證券交易委員會(“SEC”)認可爲成熟的公開市場,爲需要分析、估值和交易證券的投資者提供最新的公開信息。

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董事會還批准將其普通股從納斯達克股票市場有限責任公司(“納斯達克”)退市。2024年4月16日,Panbela通知納斯達克,它決定向美國證券交易委員會提交一份與普通股退市有關的25號表格。Panbela打算在納斯達克預計提交25號表格之前提交自己的25號表格,這主要是爲了加快其普通股向OTCQB的過渡。根據經修訂的1934年《美國證券交易法》(“交易法”)第12(b)條,25表格還將用於註銷Panbela的普通股。正如先前披露的那樣,納斯達克聽證會小組於2024年3月5日通知潘貝拉,它已決定將其普通股退市,Panbela在納斯達克的普通股交易於2024年3月7日暫停。該小組之所以做出決定,是因爲我們公司沒有滿足《上市規則》第5550(b)(1)條中最低250萬美元的股東權益要求,也無法遵守《上市規則》第5550(b)條中的任何替代要求。

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.

預計25號表格的提交和Panbela普通股從納斯達克正式退市都不會影響我們的普通股在OTCQB的報價資格。

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.

關於 Panbela 的管道
該產品線包括目前正在進行臨床試驗的資產,最初側重於家族性腺瘤性息肉(FAP)、一線轉移性胰腺癌、新輔助胰腺癌、結直腸癌預防和卵巢癌。聯合開發項目有穩定的預期催化劑節奏,項目範圍從臨床前研究到註冊研究不等。

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 是一種專有的多胺類似物,旨在利用該化合物對胰腺導管腺癌和其他腫瘤的觀察到的高親和力,誘導多胺代謝抑制 (PMI)。它在轉移性胰腺癌患者的臨床研究中顯示出腫瘤生長抑制信號,顯示平均總存活率(OS)爲14.6個月,客觀反應率(ORR)爲48%,均超過了吉西他濱+ nab-paclitaxel標準護理的典型水平,這表明與美國食品藥品管理局批准的現有標準化療方案具有潛在的互補活性。在迄今爲止評估的臨床研究數據中,ivospemin尚未顯示骨髓抑制和周圍神經病變加重,這可能是與化療相關的不良事件。已經對嚴重的視覺不良事件進行了評估,有視網膜病變史或有視網膜脫離風險的患者將被排除在未來的 SBP-101 研究之外。在先前Panbela贊助的臨床試驗中觀察到的安全數據和PMI概況爲ASPIRE試驗中繼續評估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)和舒林達克的組合,具有抑制多胺合成、增加多胺輸出和分解代謝的雙重機制。在一項針對散發性大腸息肉患者的III期臨床試驗中,與安慰劑相比,該組合可預防90%以上的癌前散發性腺瘤。在最近將Flynpovi與單藥依氟鳥氨酸和單藥舒林達克進行比較的III期試驗中,下消化道解剖結構的FAP患者(結腸完好無損、直腸保留或手術袋的患者)在將下消化道手術事件延遲長達四年方面顯示出具有統計學意義的顯著益處(p≤0.02)。Flynpovi的安全狀況與單一製劑沒有顯著差異,支持繼續對FAP的Flynpovi進行評估。

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)正在開發爲單劑片劑或大劑量粉劑袋,用於多種適應症,包括預防胃癌、治療神經母細胞瘤和最近發作的 1 型糖尿病。臨床前研究以及研究者發起的 I 期或 II 期試驗表明,CPP-1X 治療可能具有良好的耐受性並且具有潛在的活性。

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