On December 8, 2020 EyePoint Pharmaceuticals, Inc. (NASDAQ: EYPT), a pharmaceutical company committed to developing and commercializing innovative ophthalmic products, reported that it will effect a 1-for-10 reverse stock split at 5:00 p.m. Eastern Time (Press release, pSivida, DEC 8, 2020, View Source [SID1234572431]). Beginning with the opening of trading on December 9, 2020, EyePoint’s common stock will trade on the Nasdaq Global Market on a split-adjusted basis under a new CUSIP number 30233G209.

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The reverse stock split is intended to enable EyePoint to regain compliance with the $1.00 minimum closing bid price required for continued listing on the Nasdaq Global Market.

At EyePoint’s special meeting of stockholders on December 1, 2020, EyePoint’s stockholders approved the proposal to authorize EyePoint’s Board of Directors to file an amendment to EyePoint’s certificate of incorporation to effect the reverse split at a ratio to be determined by the Board, ranging from 1-for-10 to 1-for-25. The specific 1-for-10 ratio was subsequently approved by EyePoint’s Board of Directors and the reverse stock split was effected by filing a Certificate of Amendment to EyePoint’s certificate of incorporation with the Secretary of State of the State of Delaware.

The reverse split will affect all issued and outstanding shares of EyePoint’s common stock. At the effective time of the reverse stock split the number of shares of common stock issued and outstanding will be reduced from approximately 151.3 million shares to approximately 15.13 million shares. All outstanding options, warrants, restricted stock units and deferred stock units entitling their holders to receive or purchase shares of EyePoint’s common stock will be adjusted as a result of the reverse split, as required by the terms of each security. The number of shares reserved for future issuance pursuant to EyePoint’s 2016 Long-Term Incentive Plan and the number of shares reserved for future issuance pursuant to EyePoint’s 2019 Employee Stock Purchase Plan will also be appropriately adjusted. The reverse stock split will affect all stockholders uniformly and will not affect any stockholder’s ownership percentage of EyePoint’s shares (except to the extent that the reverse stock split would result in some of the stockholders receiving cash in lieu of fractional shares). Stockholders will receive cash in lieu of fractional shares based on today’s closing sales price of EyePoint’s common stock as quoted on the Nasdaq Global Market. The reverse stock split will not reduce the number of authorized shares of common stock, or preferred stock, or change the par values of EyePoint common stock (which will remain at $0.001 per share) or preferred stock (which will remain at $0.001 per share).

Computershare Trust Company, N.A. (Computershare) is acting as the exchange agent and transfer agent for the reverse stock split. Computershare will provide instructions to stockholders with physical certificates regarding the process for exchanging their pre-split stock certificates for post-split shares in book-entry form and receiving payment for any fractional shares.

On December 8, 2020 Panbela Therapeutics, Inc. (Nasdaq: PBLA), a clinical stage biopharmaceutical company developing disruptive therapeutics for the treatment of patients with cancer, reported that it has completed patient enrollment in its Phase 1 trial evaluating the safety and tolerability of SBP-101 when used in combination with standard of care agents gemcitabine and nab-paclitaxel for first-line treatment of patients with metastatic pancreatic ductal adenocarcinoma (PDA) (Press release, Sun BioPharma, DEC 8, 2020, View Source [SID1234572430]).

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The trial, which included a dose escalation phase and an expansion phase, enrolled 50 patients, 30 of whom were treated using the dose and schedule that will advance to a randomized trial of the combination versus gemcitabine and nab-paclitaxel alone planned to begin in the first half of 2021. In total, the safety of SBP-101 has been evaluated in 79 patients in two clinical trials.

"We are pleased to have completed enrollment in our Phase 1b trial and expect to announce data in the first half of next year," commented Jennifer Simpson, PhD., M.S.N., C.R.N.P.-President & Chief Executive Officer. "Completing enrollment for SBP-101 marks an important milestone in our quest to bring new therapeutic options to patients with pancreatic cancer, which is an orphan disease and an area of unmet medical need."

SBP-101 is currently being evaluated in a Phase 1a/1b clinical trial of patients with previously untreated metastatic PDA at sites in the United States and Australia. SBP-101 has received Fast Track and orphan drug designation from FDA. For more information, please visit clinicaltrials.gov.

About SBP-101
SBP-101 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. The molecule has shown signals of tumor growth inhibition in clinical studies of US and Australian metastatic pancreatic cancer patients, suggesting complementary activity with an existing FDA-approved chemotherapy regimen. In clinical studies to date, SBP-101 has not shown exacerbation of the typical chemotherapy-related adverse events of bone marrow suppression and peripheral neuropathy. The safety data and PMI profile observed in the current Panbela sponsored current clinical trial provides support for continued evaluation of the compound in a randomized clinical trial. For more information, please visit View Source

On December 8, 2020 The board of directors of Targovax ASA (OSE:TRVX) ("Targovax" or the "Company") reported that resolved to increase the share capital of the Company following the completion of an exercise period for vested share options under the Company’s long-term incentive program for employees (Press release, Targovax, DEC 8, 2020, View Source [SID1234572429]). The exercise period for the employee options commenced on 3 December 2020 at 11:00 hours (CET) and ended on 8 December 2020 at 11:00 hours (CET).

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1. Exercise of options

In total, 10,726 options were exercised, giving the option holders the right to subscribe for 10,726 shares, each with a par value of NOK 0.10, at a subscription price of NOK 7.74 per share.

2. Resolutions to increase the share capital in Targovax ASA

The Company’s board of directors has on 8 December 2020, in accordance with the authorisation granted by the general meeting on 29 April 2020, resolved to increase the share capital with NOK 1,072.60 by the issuance of 10,726 new shares, each with a par value of NOK 0.10 in order to settle the exercise of options.

Accordingly, the new share capital of the Company is NOK 8,653,131.80, divided into 86,531,318 shares, each with a par value of NOK 0.10. The share capital increase will be registered with the Norwegian Register of Business Enterprises (Nw. Foretaksregisteret) as soon as practically possible after the share contribution has been fully paid.

On December 8, 2020 Monopar Therapeutics Inc. (Nasdaq: MNPR), a clinical-stage biopharmaceutical company primarily focused on developing proprietary therapeutics designed to extend life or improve the quality of life for cancer patients, reported that its Phase 2b/3 clinical trial of Validive for the prevention of chemoradiotherapy-induced severe oral mucositis in patients with oropharyngeal cancer (VOICE) is active and recruiting patients (Press release, Monopar Therapeutics, DEC 8, 2020, View Source [SID1234572428]).

"We are pleased to have multiple clinical sites activated," said Andrew Mazar, PhD, Chief Scientific Officer of Monopar, "and are looking forward to dosing the first patients shortly."

"The commencement of our Phase 2b/3 VOICE trial is a significant milestone for Monopar and, it represents a key step in the development of a therapy that could benefit many OPC patients," said Chandler Robinson, MD, Chief Executive Officer of Monopar. "This trial builds on the foundation of the completed Phase 2, and is designed to confirm Validive reduces the incidence of SOM in OPC patients undergoing chemoradiotherapy." The completed Phase 2 trial showed the incidence of SOM in OPC patients receiving Validive 100 µg to be 40% lower compared to those receiving placebo.

It is estimated there will be greater than 40,000 new OPC patients in the U.S. alone in 2021, the majority of whom will be treated with chemoradiation and run substantial risk of developing SOM. Currently, there is no FDA approved preventive or treatment for SOM in these patients, emphasizing the clear unmet medical need in this patient population.

Up to approximately 260 patients will be enrolled in this multi-center, randomized, double-blind, placebo-controlled, Phase 2b/3 clinical trial. The trial includes an interim analysis, which is anticipated to be reached approximately twelve months after the first patient is dosed.

Further information about the Validive Phase 2b/3 VOICE trial is available at www.ClinicalTrials.gov under study identifier NCT 04648020.

About Validive
Validive (clonidine mucobuccal tablet; clonidine MBT) is a novel mucobuccal tablet (MBT) formulation of clonidine which provides for prolonged and enhanced local delivery of clonidine to the regions of mucosal radiation damage in OPC patients. The tablet is self-administered once daily in the patient’s home setting with the patient placing it under the upper lip where it adheres to the gums and dissolves over several hours, continuously releasing the clonidine into the saliva. Clonidine agonizes the alpha-2 adrenergic receptor on macrophages (white blood cells present in the immune tissues of the oropharynx), decreasing the macrophages’ expression of destructive cytokines they tend to release in response to radiotherapy. A completed double-blind, randomized, placebo-controlled Phase 2 clinical trial of Validive showed reduced incidence (absolute decrease of 26%, relative decrease of 40%) in OPC patients treated with Validive 100 µg (a meaningful trend in the Phase 2, which the Phase 2b/3 is designed to confirm with a larger trial in OPC for potential statistical significance), a safety profile similar to the placebo, and a high rate of treatment compliance (over 90%).

About Severe Oral Mucositis
Severe oral mucositis (SOM) is a painful and debilitating inflammation and ulceration of the mucous membranes lining the oral cavity and oropharynx in response to insult such as chemoradiation treatment (CRT). SOM is the most frequent major side effect experienced by oropharyngeal cancer patients, experienced by a majority of those undergoing CRT. SOM impacts both quality of life and clinical outcomes for these patients. SOM prevents patients from drinking and/or eating, and can lead to severe weight loss, opiate usage, and the use of feeding tubes as well as intravenous supplementation to keep alive. Patients who develop SOM can become hospitalized, and symptoms can force patients to prematurely stop cancer treatment, reducing treatment efficacy and long-term survival.

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On December 8, 2020 Regulus Therapeutics Inc. (Nasdaq: RGLS), a biopharmaceutical company focused on the discovery and development of innovative medicines targeting microRNAs, reported the closing of its previously announced private placement of equity (Press release, Regulus, DEC 8, 2020, View Source [SID1234572427]). The Company received gross proceeds of approximately $19.4 million from the sale of 24,341,607 shares of the Company’s common stock ("Common Stock") and accompanying warrants to purchase up to an aggregate of 18,256,204 shares of Common Stock at a purchase price of $0.622 per share of Common Stock and $0.125 for each share of Common Stock underlying such warrants. In addition, the Company sold 272,970 shares of non-voting Class A-3 convertible preferred stock, in lieu of shares of Common Stock, at a price of $6.22 per share, and accompanying warrants to purchase an aggregate of 2,047,276 shares of Common Stock at a price of $0.125 for each share of Common Stock underlying these warrants. Each share of non-voting Class A-3 convertible preferred stock is convertible into 10 shares of Common Stock, subject to certain beneficial ownership conversion limitations. The Company expects to use the net proceeds from the transaction primarily to advance RGLS4326 for the treatment of Autosomal Dominant Polycystic Kidney Disease and for general corporate purposes. H.C. Wainwright and Co. acted as exclusive placement agent for the financing.

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The offer and sale of the foregoing securities were made in a transaction not involving a public offering and have not been registered under the Securities Act of 1933, as amended (the "Securities Act"), or applicable state securities laws. Accordingly, the securities may not be reoffered or resold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws.

This press release does not constitute an offer to sell or the solicitation of an offer to buy the securities, nor shall there be any sale of the securities in any state in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such state.

Additional details regarding the private placement are included in the Form 8-K filed with the Securities and Exchange Commission on December 4, 2020.