On April 3, 2023 AIM ImmunoTech Inc. (NYSE American: AIM) ("AIM" or the "Company"), an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers, immune disorders and viral diseases, reported its financial results for the fourth quarter and full year 2022 and provided a business update (Press release, AIM ImmunoTech, APR 3, 2023, View Source [SID1234629729]). As previously announced, the Company will host its inaugural conference call and audio webcast, today, Monday, April 3, 2023, at 8:30 AM ET (details below).

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"2022 was a year marked by continued successful operational, clinical and regulatory execution across our development pipeline. We made significant progress building upon our solid foundation of pre-clinical and clinical work to advance Ampligen. Our team is committed to the development of Ampligen for unmet medical needs in cancers, immune disorders and viral diseases. Further, we have launched a new corporate website to better communicate our plans and progress. AIM’s goal is to generate near- and long-term value for all stockholders," commented Thomas K. Equels, Chief Executive Officer of AIM.

Recent Highlights

Launched new corporate website to align with the Company’s mission and vision going forward: advancing immunology solutions for a better future.
Nancy K. Bryan, pharmaceutical industry veteran, appointed to Board of Directors.
Announced the publication of a new analysis of the ability of Ampligen (rintatolimod) to inhibit the spread and replication of Ebola virus disease, which adds to the body of evidence supporting Ampligen’s potential as an early-onset prophylactic therapy against human Ebola outbreak. Additionally, the data from the analysis was presented in a late-breaking presentation at the 36th International Conference on Antiviral Research (ICAR).
Commenced its Phase 2 study of Ampligen for the treatment of pancreatic cancer and began recruiting patients.
Entered into an external sponsored collaborative clinical research agreement with Erasmus MC and AstraZeneca to evaluate the potential of AIM’s Ampligen in combination with AstraZeneca’s Imfinzi (durvalumab) for the treatment of pancreatic cancer.
Broadened patent portfolio with new Netherlands utility patent covering Ampligen and other AIM-developed dsRNA products to include rugged dsRNA for use in COVID-19 treatment or prevention.
Appointed Christopher McAleer, Ph.D. as Scientific Officer.
Presented positive safety, tolerability and biological activity data for intranasal Ampligen in healthy subjects at the British Society for Immunology Congress 2022.
Expected Upcoming Pipeline Milestones

Q2 2023

Locally Advanced Pancreatic Cancer: Enroll first patient in Phase 2 study
Locally Advanced Pancreatic Cancer: Dose first patient in Phase 2 study
Post-COVID Conditions: IRB approval to commence Phase 2 study
Post-COVID Conditions: Enroll and dose first patient in Phase 2 study
Q3 2023

Advanced Recurrent Ovarian Cancer: Announce formal interim results
Q4 2023

Metastatic Pancreatic Cancer: Begin clinical trial
Post-COVID Conditions: Enroll last patient in Phase 2 study
Summary of Financial Highlights for Fiscal Year 2022

As of December 31, 2022, AIM reported cash and cash equivalents of $34.2 million, compared to $48.3 million as of December 31, 2021.
Research and development expenses for the year ended December 31, 2022 were $7.0 million, compared to $7.7 million for the year ended December 31, 2021.
General and administrative expenses were $13.1 million for the year ended December 31, 2022 compared to $8.7 million for the year ended December 31, 2021.
Please refer to the full 10-K for complete details.

Conference Call and Webcast Details

As previously announced, the Company will host its inaugural quarterly conference call and live audio webcast to discuss the operational and financial results on today, April 3, 2023, at 8:30 AM ET.

The call will be hosted by members of AIM’s leadership team, Thomas K. Equels, Chief Executive Officer and Christopher McAleer, PhD, Scientific Officer. Interested participants and investors may access the conference call by dialing (877) 407-9219 (domestic) or (201) 689-8852 (international) and referencing the AIM ImmunoTech Conference Call. The live webcast will be accessible on the Events and Presentations page of the Investors section of the Company’s website, aimimmuno.com, and will be archived for 90 days following the live event.

On April 3, 2023 Addex Therapeutics Ltd (SIX: ADXN and Nasdaq: ADXN), a clinical-stage pharmaceutical company pioneering allosteric modulation-based drug discovery and development, reported that it has entered into a definitive agreement with a leading institutional healthcare investor (the "Investor") to sell 7,999,998 shares in the form of 1,333,333 American Depositary Shares ("ADSs") at a gross purchase price of $0.95 per ADS (Press release, Addex Therapeutics, APR 3, 2023, View Source [SID1234629728]). Each ADS represents six shares. Additionally, Addex has agreed to issue unregistered pre-funded warrants to purchase 3,929,825 ADSs (the "Unregistered Pre-Funded Warrants") at a funded amount of $0.94 with $0.01 payable on exercise as well as unregistered warrants to purchase up 5,263,158 ADSs (the "Unregistered Warrants" and together with the "Unregistered Pre-Funded Warrants", the "Warrants") in a concurrent private placement. The Unregistered Warrants have an exercise price of $1 per ADS, will become exercisable in 90 days after their date of issuance and will expire five years from their date of issuance. Each ADS represents 6 ordinary shares.

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The gross proceeds to Addex, before deducting offering expenses, will be $5.0 million. Addex intends to use the net proceeds from this offering to advance its portfolio of drug candidates and for general corporate purposes.

The closing of the offering is expected to occur on or about April 5, 2023, subject to the satisfaction of customary closing conditions.

Addex also entered into warrant repricing transactions with the Investor to amend previously issued warrants to reduce the exercise price of such warrants, as well as to amend certain other terms. The warrants to be amended were originally issued in private placements that closed on December 21, 2021 ("Original 2021 Warrants") and July 26, 2022 ("Original 2022 Warrants"). The Original 2021 Warrants are currently exercisable at $6.50 per ADS to purchase an aggregate of up to 1,538,462 ADSs. The Original 2022 Warrants are currently exercisable at $1.90 per ADS to purchase an aggregate of up to 2,500,000 ADSs.

By letter agreement, dated April 3, 2023, Addex and the Investor agreed to amend the Original 2021 Warrants and Original 2022 Warrants to reduce their exercise price to $1 per ADS ("Reduced Exercise Price") and certain other amendments (the "Amended Warrants"). The Amended Warrants will not be exercisable until July 5, 2023.

The ADSs (but not the Warrants or the shares underlying the Warrants) are being offered by Addex pursuant to a "shelf" registration statement on Form F-3 that was originally filed on April 7, 2021 and declared effective by the Securities and Exchange Commission ("SEC") on April 13, 2021 and the base prospectus contained therein (File No. 333-255089). The offering of the shares is being made only by means of a prospectus supplement that forms a part of the registration statement. Electronic copies of the prospectus supplement and accompanying base prospectus may be obtained, when available, on the SEC’s website at View Source

The Warrants, the shares underlying the Warrants and the Amended Warrants are being offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act"), and Regulation D promulgated thereunder and, along with the shares underlying the Warrants, have not been registered under the Act, or applicable state securities laws. Accordingly, the Warrants, the Amended Warrants and underlying shares may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Act and such applicable state securities laws.

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

On April 3, 2023 Jounce Therapeutics, Inc. ("Jounce" or the "Company") and Redx Pharma plc ("Redx") reported to have agreed to terminate their proposed business combination following the decision by Jounce’s Board of Directors to withdraw the recommendation for the all-share merger transaction with Redx (the "Redx Business Combination") (Press release, Jounce Therapeutics, APR 3, 2023, View Source [SID1234629726]).

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Jounce’s decision was based upon the receipt of an unsolicited proposal from Concentra Biosciences, LLC ("Concentra"), which led to Jounce entering into a merger agreement whereby Concentra will acquire Jounce through a cash tender offer for all of Jounce’s outstanding shares for $1.85 in cash per share plus a non-tradeable contingent value right (the "CVR"). The $1.85 per share upfront consideration represents a premium of approximately 75% to Jounce’s closing share price immediately prior to the March 14, 2023, public disclosure of Concentra’s acquisition proposal.

Jounce conducted a thorough review of both the proposed transaction with Concentra and the proposed Redx Business Combination, with the assistance of its legal and financial advisers, and Jounce’s Board of Directors ultimately concluded that the proposed transaction with Concentra is in the best interest of Jounce stockholders, and therefore, unanimously approved the merger agreement with Concentra and withdrew its recommendation of the Redx Business Combination. On March 27, 2023, Jounce notified Redx of the withdrawal of its recommendation in favor of the Redx Business Combination and termination of the co-operation agreement dated February 23, 2023 between Jounce and Redx.

Given that Jounce’s Board of Directors has withdrawn its recommendation to proceed with the Redx Business Combination, Jounce believes it is unlikely that Jounce stockholders would support the Redx Business Combination, which is a condition to closing the transaction. Accordingly, Jounce and Redx have agreed not to proceed with the proposed scheme of arrangement. In addition, Jounce has confirmed that it does not wish to switch to a contractual takeover offer. As a result, the U.K. Takeover Panel has confirmed that upon Redx announcing:

its withdrawal of its recommendation;
that it will not proceed with the scheme of arrangement; and
it has agreed to the release of Jounce from its obligation to proceed with the offer,
the offer period in respect of the Redx Business Combination will end with effect from the publication of Redx’s announcement, and the transaction will lapse.

As a result, Jounce will not be convening a Jounce meeting of stockholders to consider the Redx Business Combination. Under the U.K. Takeover Code, except with consent of the U.K. Takeover Panel, Jounce must not, among other things, announce a further offer for Redx within 12 months from the date of this announcement.

On April 3, 2023 Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") reported that it has entered into an agreement with the National Cancer Center to collaborate on investigator-initiated clinical research for the EZH2 inhibitor tazemetostat hydrobromide (generic name, product name "Tazverik Tablets 200 mg", "tazemetostat") based on "Patient-Proposed Healthcare Services" system (Press release, Eisai, APR 2, 2023, View Source [SID1234629724]). This clinical research will be conducted by the National Cancer Center Hospital.

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The "Patient-Proposed Healthcare Services" system is a system under which medical treatment using unapproved drugs not covered by insurance is applied for to the government based on the patient’s request, and is conducted as a clinical trial to confirm safety and efficacy. Under the terms of the agreement, Eisai will provide tazemetostat free of charge to the National Cancer Center Hospital as the drug to be used in "A clinical trial of Tazemetostat for pediatric and AYA* patients with malignant tumors which have no standard of care or and which is refractory to standard of care: Patients-Proposed Healthcare Service" to be conducted by the hospital under this program.

Researched and developed by Eisai and Epizyme, Inc.,** an Ipsen (Headquarters: France) company, tazemetostat is a first-in-class, oral small molecule inhibitor of the epigenetic enzyme EZH2. It is one of the histone methyltransferases in the epigenetics-related protein group, and is thought to regulate the expression of cancer-related genes and suppress the growth of cancer cells by specifically targeting EZH2, which contributes to the cancer growth process.1 Eisai holds the rights for development and commercialization of tazemetostat in Japan, where it was approved for the indication of "relapsed or refractory EZH2 gene mutation-positive follicular lymphoma (only when standard treatment is not applicable)" in 2021, and manufactures and distributes the product.

Eisai positions oncology as a key franchise area and aims to create innovative drugs that act towards curing cancer. Eisai is committed to expanding the potential clinical benefits of tazemetostat for cancer treatment, as it seeks to contribute to addressing the diverse needs of, and increasing the benefits provided to, patients with cancer, their families and healthcare professionals.