| Yesterday | ||||
Panbela Therapeutics… Panbela Therapeutics announced an Issue Notification for patent JP 7232845 titled "METHODS FOR PRODUCING -3,8,13,18- TETRAAZAICOSANE-6,15-DIOL". This patent, developed in collaboration with Syngene International , an integrated research, development, and manufacturing services company, claims a novel process with a reduced number of synthetic steps from seventeen to six to produce SBP-101, a lead investigational product. The patent is valid till 2039. Jennifer K. Simpson, PhD, MSN, CRNP, President & Chief Executive Officer of Panbela Therapeutics, commented, "We're excited to have this patent in Japan. Expansion of our patent portfolio further supports our global clinical programs. This patent is the outcome of the dedicated efforts of our valued long-term partner Syngene International Ltd. in helping us achieve this important goal." First issued in the United States in 2021, this patent covers a shorter synthesis of SBP-101, which provides many benefits including: the ability to manufacture product with a reduced lead time quicker access to drug supply facilitating expansion into additional indications and 3 enables a scalable, efficient and cost-effective manufacturing process for future commercialization. Jonathan Hunt, Managing Director and Chief Executive Officer, Syngene International Ltd., said, "We have been partnering with Panbela for the last decade, and I am proud of the work achieved through the successful collaboration. In this case, reducing the number of steps in production and simplifying the manufacturing process means that the drug will reach patients faster. The protection of SBP-101 production through patents in the U.S. and now in Japan are significant milestones." Dr. Simpson added, "The Company expects to continue innovation and patent portfolio building to support our clinical programs. This process in this patent utilizes a pharmaceutical starting material that is widely available, increasing the availability of drug supply moving forward. " | ||||
| Monday | ||||
Maxim analyst Jason… Maxim analyst Jason McCarthy upgraded Panbela Therapeutics to Buy from Hold with a $1.50 price target. The Phase 2/3 ASPIRE TRIAL evaluating SBP-101 in combination with gemcitabine + nab-paclitaxel in first-line metastatic pancreatic ductal adenocarcinoma, or PDAC, remains the near-term focus, said the firm, which models commercialization of SBP-101 in pancreatic cancer in 2027. The company raised about $15M in an equity offering in January and given its quarterly burn rate should now have sufficient cash runway into Q4 of 2023, the firm contends. | ||||
| Over a week ago | ||||
Panbela Therapeutics… Panbela Therapeutics announced its first patient enrolled in South Korea for its ASPIRE global clinical trial in the first-line treatment of metastatic pancreatic cancer. ASPIRE is a global randomized, double-blind placebo-controlled clinical trial to evaluate ivospemin in combination with gemcitabine and nab-Paclitaxel in patients with metastatic pancreatic ductal adenocarcinoma. "We're really excited to continue the Country and site initiation for the ASPIRE trial as we aim to have the full complement of sites on board by the middle of this year," said Jennifer K. Simpson, PhD, MSN, CRNP, President & Chief Executive Officer of Panbela. "Having South Korean enrollment underway is highly encouraging as we continue to ramp up the trial. We're targeting the interim analysis in early 2024." | ||||
| Over a month ago | ||||
On January 30, 2023,… On January 30, 2023, Panbela closed its previously announced public offering consisting of 6,675,000 shares of its common stock and warrants to purchase up to 13,350,000 shares of its common stock at a purchase price of $2.25 per share and associated Public Warrants. All of the pre-funded warrants have been exercised. The Public Warrants have a cash exercise price of $2.75 per share of common stock, were exercisable upon issuance, and will expire five years following the date of issuance. The Public Warrants also contain cashless exercise provisions, subject to certain conditions. Roth Capital Partners acted as lead placement agent and Maxim Group LLC acted as co-placement agent of the offering. Gross proceeds from the offering, before deducting placement agent fees and offering expenses, were approximately $15.0 million. Panbela intends to use the net proceeds from the offering for the continued clinical development of its product candidates ivospemin and eflornithine, working capital, business development and other general corporate purposes, which may include repayment of debt. | ||||
Nasdaq has issued notice… Nasdaq has issued notice that Panbela has regained compliance for continued listing of its common stock. On February 9, 2023, Panbela received a letter from Nasdaq confirming that Panbela has cured the previously identified minimum bid price and stockholders' equity deficiencies under Nasdaq Listing Rules 5550(a)(2) and 5550(b)(1), respectively, and that Panbela is in compliance with all applicable listing standards. Panbela's previously scheduled delisting determination appeal hearing has been canceled, and its common stock will continue to be listed and traded on Nasdaq. | ||||
Roth Capital analyst… Roth Capital analyst Jonathan Aschoff resumed coverage of Panbela Therapeutics with a Buy rating and $10 price target. Given Panbela's Q2 acquisition of CPP, it now has several opportunities to create value over the next year, in addition to its original primary value driver of Q1 2024 interim Phase 3 results with SBP-101 in first-line metastatic PDA, the firm says. Roth also notes that Flynpovi is in Phase 3 for colon cancer risk prevention and Phase 3 in FAP starts in the second half of 2023, a design informed by a prior Phase 3. | ||||
The deal priced below… The deal priced below last closing price of $2.71. RBC Capital and Maxim are acting as joint book running managers for the offering. | ||||
Shares of Panbela… Shares of Panbela Therapeutics are up 44c per share or13.10% to $3.80 per share pre-market after EMA decision on orphan product. | ||||
Panbela Therapeutics… Panbela Therapeutics announced that the European Medicines Agency EMA Committee for Orphan Medicinal Products has issued the Adoption of Commission Implementing Decision relating to the designation of ivospemin, SBP-101 as an orphan medicinal product in combination with gemcitabine and nab-Paclitaxel in patients with metastatic pancreatic ductal adenocarcinoma, PDA . The Commission adopted the decision on January 13, 2023 and it will be published for information in all official languages of the EU in the Community Register of Orphan Medicinal Products . Previously, the U.S. Food and Drug Administration granted orphan drug designation to SBP-101. "We are pleased to receive notice that the European Commission has adopted the positive decision for orphan drug designation from EMA's Committee for Orphan Medicinal Products," said Jennifer K. Simpson, PhD, MSN, CRNP, President & Chief Executive Officer of Panbela. "The designation of orphan drug status within the EU is an important achievement as we continue to advance the global ASPIRE trial with the potential that this may be an option for patients with first line metastatic pancreatic cancer in the future." | ||||
