Entry into a Material Definitive Agreement

On March 6, 2023 Achieve Life Sciences, Inc. (the "Company") reported that it has entered into a Cooperation Agreement (the "Cooperation Agreement") with Dialectic Capital Management, LP ("Dialectic") and related entities (collectively with Dialectic, the "Stockholders") regarding certain changes to the composition of the Company’s board of directors (the "Board") and other related matters (Filing, 8-K, OncoGenex Pharmaceuticals, MAR 6, 2023, View Source [SID1234628289]).

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Pursuant to the terms of the Cooperation Agreement: (1) the Company shall, no later than March 21, 2023, appoint three individuals (the "Designees") to the Board to fill three vacancies created by either (x) the departure of an incumbent member of the Board as designated in the Cooperation Agreement (the "Incumbent Directors") or (y) expanding the Board size to up to 11 directors; (2) the Board shall nominate the Designees for election at the 2023 Annual Meeting of the Company’s stockholders (the "2023 Annual Meeting"); (3) the Board shall appoint at least one of the Designees to each of the committees of the Board, other than the Chemistry, Manufacturing and Controls Committee, as well as any new committee(s) formed prior to the Expiration Date (as defined in the Cooperation Agreement); and (4) the Company shall set the Board size at eight directors no later than the date of the 2023 Annual Meeting (the "Incumbent Director Resignation Date") and, in the event there are more than eight directors serving on the Board as of the Incumbent Director Resignation Date, one or all of the Incumbent Directors, as applicable, shall submit his resignation to be effective no later than the Incumbent Director Resignation Date; provided, that in the event the resignation of any Incumbent Director as of Incumbent Director Resignation Date would cause any violation of the applicable listing rules of The Nasdaq Stock Market LLC, the parties agree that such resignation shall not be effective until such time as would ensure compliance with such listing rules and the parties shall work in good faith to document and approve such necessary modification(s) to the Incumbent Director Resignation Date.

The Cooperation Agreement further provides that if, at any time prior to the Expiration Date, any Designee (or any Replacement Designee (as defined below)) is unable or unwilling to serve and ceases to be a director, resigns as a director or is removed as a director, or for any other reason fails to serve or is not serving as a director, the Company and Dialectic shall work in good faith to promptly mutually agree upon a replacement candidate for appointment to the Board in substantially the same manner as the Company and Dialectic agreed upon the selection of such Designee (any such replacement nominee, when appointed to the Board, shall be referred to as a "Replacement Designee").

The Cooperation Agreement includes certain voting commitments, standstill, and mutual non-disparagement provisions (subject to certain carveouts and exceptions) that generally remain in place during the period beginning upon the execution and delivery of the Cooperation Agreement and ending on the earlier of (i) the date that is fifteen (15) business days prior to the notice deadline under the Company’s Sixth Amended and Restated Bylaws (and all amendments thereto) for stockholders to submit non-proxy access stockholder nominations of director candidates for election to the Board (the "Nomination Notice Deadline") at the 2024 Annual Meeting of the Company’s stockholders (the "2024 Annual Meeting"), (ii) the date the Stockholders, in the aggregate, cease to own at least 10% (on a non-converted basis) of the Company’s issued and outstanding common stock, (iii) any material breach of the Cooperation Agreement by any Stockholder or (iv) the last resignation of all three of the Designees; provided that notwithstanding anything to the contrary in the Cooperation Agreement, if (A) the Company confirms in writing that it will re-nominate the Designees for election as directors at the 2024 Annual Meeting or the 2025 Annual Meeting of the Company’s stockholders, as applicable (and that it will take such further actions as required by the Cooperation Agreement with respect to the Designees with respect to such annual meeting); (B) the Designees consent to such re-nomination(s); and (C) the Stockholders agree to the extension of the Expiration Date, then prong (i) shall be deemed to be automatically extended each such time until the date that is fifteen (15) business days prior to the applicable Nomination Notice Deadline(s) applicable to each such subsequent annual meeting of stockholders of the Company at which the Company has confirmed it will re-nominate the Designees.

The foregoing description of the Cooperation Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of the Cooperation Agreement filed as Exhibit 10.1 hereto.

Isofol initiates a stepwise process for the continued development of its drug candidate arfolitixorin

On March 6, 2023 Isofol Medical AB (publ), (Nasdaq Stockholm: ISOFOL), reported that the company has decided to initiate a stepwise process to enable a cost-effective and risk-minimizing continued development of its drug candidate arfolitixorin (Press release, Isofol Medical, MAR 6, 2023, View Source [SID1234628288]). The company assesses that the planned activities, which are expected to be financed with existing funds, have the potential to bring arfolitixorin significantly closer to a market launch.

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The information in this press release is intended for investors.

Isofol´s drug candidate arfolitixorin has shown potential to improve the efficacy of the anticancer drug 5-FU – the basis of current standard treatment for colorectal cancer. Arfolitixorin is the first and only direct-acting folate-based drug candidate that enhances the anti-tumor effect of 5-FU without causing additional side effects. However, a recent Phase III study, AGENT, showed no statistically significant difference in efficacy between arfolitixorin and current standard treatment.

The strategic plan presented by Isofol Medical today aims to evaluate the result of the Phase III study in further detail. Based on the findings, the company will maximize the opportunities to take arfolitixorin further towards potential commercialization. The plan will be implemented in three steps.

Step 1: In-depth analyses of data from the phase III study
The company believes that further analyses of the extensive data generated in the Phase III study may provide greater clarity on possible reasons why arfolitixorin did not show a statistically significant difference in efficacy compared to the current standard of care in the study. One possible reason for the study outcome could be that the dose of arfolitixorin was not high enough to be comparable to the control group and/or was not administered in an optimal manner. The in-depth analyses of the Phase III study are expected to be completed in the second quarter of 2023.

Step 2: Laboratory study to document the effect of different doses
The next potential step is to initiate a time- and cost-effective laboratory study to document the effect of arfolitixorin in different doses and administration forms in combination with 5-FU. Such a study is expected to be initiated in the second quarter of 2023 and provide indicative information within approximately three months.

Step 3: A small clinical trial with a carefully selected dosing regimen
Assuming a positive outcome in the laboratory study, the company plans to conduct a small efficacy study in patients with a carefully selected dose and administration regimen. The results will be used as a basis for discussions with relevant pharmaceutical authorities regarding the further development plan, and may also increase the attractiveness of the project among potential licensees in the pharmaceutical industry. It is currently difficult to estimate the costs and time required for this type of efficacy study, but the company’s current assessment is that its existing financial means will be sufficient.

"We see great commercial potential for our drug candidate, but at the same time, it is in the nature of research that we cannot give any guarantees that the currently initiated development program will be successful. However, we promise to conduct our work in a scientifically professional manner, at a high pace and with strict cost control," says Mats Franzén, Chairman of the Board of Isofol.

Isofol has engaged several external specialists who will assist the company in the upcoming activities and evaluations of future scientific results, including Professor Anders Vedin (former CEO of Astra Hässle), Professor Bengt Gustavsson (colorectal surgeon, leading international researcher in the folate field and founder of Isofol Medical), Dr Rudolf Moser (formerly with Merck & Cie) and Dr Per Lindberg (specialist in patent strategies). In addition, the company will work closely with both the research organization at Sahlgrenska Östra Sjukhuset in Gothenburg which supported the original development of arfolitixorin, and with the international pharmaceutical company Merck & Cie, which developed the production process for the substance.

"I look forward to leading this step-by-step process with the long-term aim of providing cancer patients with access to an improved treatment based on Isofol Medical’s drug candidate. We are constantly prepared to reassess our plans based on the outcomes of the sequential activities and will of course continuously communicate the results in a transparent manner," says Thomas Andersson, Chief Executive Officer of Isofol.

For more information, please contact
Isofol Medical AB (publ)
Mats Franzén, Chairman of the Board
E-mail: [email protected]
Phone: +46 (0) 704 47 29 09

Thomas Andersson, Chief Executive Officer
E-mail: [email protected]

The information was submitted for publication, through the agency of the contact person set out above, at 10.00 CET, on March 6, 2023.

AnPac Bio-Medical Science Announces US$5 Million Private Placement

On March 6, 2023 AnPac Bio-Medical Science Co., Ltd. (Nasdaq: ANPC) ("AnPac Bio," the "Company" or "we"), a company with operations in the United States and China focused on early cancer screening and detection and plans to enter into the operation of a business-to-business e-commerce food platform focused on the sale of Asian sourced food products, reported that on March 2023, the Company has entered into definitive investment agreements with certain accredited investors in a private placement transaction, pursuant to which the investors agreed to subscribe for and purchase, and the Company agreed to issue and sell an aggregate of 16,666,665 newly issued Class A ordinary shares of the Company, at a price of US$0.30 per ordinary share, or US$6.00 per ADS (1:20 ADS-to-share ratio), for an aggregate purchase price of US$5 million (Press release, Anpac Bio, MAR 6, 2023, View Source [SID1234628238]). The closing of the sale of the securities is expected to occur late March, subject to satisfaction of customary closing conditions

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The Company expects to use the proceeds for working capital and the expansion of its business-to-business Asian food e-commerce business in the US

The ordinary shares sold in the private placement have not been registered under the Securities Act of 1933, as amended, and may not be offered or sold in the United States absent registration with the U.S. Securities and Exchange Commission ("SEC") or an applicable exemption from such registration requirements. The offer and sale of the Company’s Class A ordinary shares under the agreements were made as part of an "offshore transaction" and there was no "directed selling efforts" in the United States and, as such, such offer and sale falls under an exemption provided under Regulation S from the Section 5 registration requirements of the Securities Act of 1933, as amended

This press release shall not constitute an offer to sell or a solicitation of an offer to buy nor shall there be any sale of these securities in any state or 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 jurisdiction.

NantHealth Announces $22.5 Million New Financing with Highbridge and Nant Capital

On March 6, 2023 NantHealth, Inc. (NASDAQ-GS: NH), a leading provider of enterprise solutions that help businesses transform complex data into actionable insights, reported the entry into a credit agreement for a new senior secured term loan in an aggregate principal amount of $22.5 million (Press release, NantHealth, MAR 6, 2023, View Source [SID1234628237]). The company intends to use the proceeds to continue funding its existing businesses and for general corporate purposes. The Term Loan Facility was funded by two existing NantHealth investors: Highbridge Capital Management, LLC and Nant Capital, LLC.

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"The era of digital medicine and augmented intelligence has finally arrived. NantHealth has stood at the forefront of driving evidence based, low cost care to treat the right patient at the right time and the right place. Artificial intelligence and the speed of network computing has reached a level of technological development that can now truly benefit 21st century care. We are pleased at the continued financial support of NantHealth by its institutional investors at this transformational time in healthcare" said Dr. Patrick Soon-Shiong, Chairman and CEO, NantHealth.

"The era of digital medicine and augmented intelligence has finally arrived. NantHealth has stood at the forefront of driving evidence based, low cost care to treat the right patient at the right time and the right place. Artificial intelligence and the speed of network computing has reached a level of technological development that can now truly benefit 21st century care. We are pleased at the continued support of NantHealth at this transformational time in healthcare," said Dr. Patrick Soon-Shiong, Chairman and CEO, NantHealth.

"This investment will enable us to continue the momentum we have generated over the past year," said Ron Louks, NantHealth’s Chief Operating Officer. "The transaction proceeds provide us with the financial resources to invest in our established solutions, NaviNet and Eviti, and our subsidiary, The OpenNMS Group, Inc. We thank our financing partners at Highbridge, NantCapital and our founder Dr. Patrick Soon-Shiong for their continued support."

Jonathan Segal, Co-Chief Investment Officer of Highbridge, said, "We are very pleased to continue our investment in NantHealth. The financing is intended to support NantHealth’s ongoing business, finance the ongoing expansion of SaaS capabilities, and fund future growth initiatives that should benefit the Company and its customers and stakeholders."

A Special Committee of the NantHealth Board of Directors, consisting of disinterested independent directors, undertook a thorough review of the Credit Agreement, Term Loan Facility and related transaction documents, and unanimously recommended that NantHealth proceed with the transaction.

Mission Therapeutics to Present at the Targeted Protein Degradation Europe Conference 2023

On March 6, 2023 Mission Therapeutics ("Mission"), a drug discovery and development company focused on protein homeostasis by selectively inhibiting deubiquitylating enzymes (DUBs), reported that Dr Nick Edmunds, Chief Technology Officer at Mission, will be presenting at the Targeted Protein Degradation Europe conference 2023 (Press release, Mission Therapeutics, MAR 6, 2023, View Source [SID1234628236]).

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Mission Therapeutics’ presentation will take place 9am Thursday, March 30th, 2023, at The Tower Hotel, St Katharine’s Way, London, E1W 1LD. The presentation will cover the Development of a DUB Inhibitor Platform & Emerging Data from a USP30 Inhibitor, based on Mission’s recent research. It has been highlighted as one of 5 key talks not to miss by the conference organisers.

The event, which will take place in London, 28th-30th March, is the Leading Forum Showcasing Key Stakeholders & Expert Minds from the European Degradation Community. The conference is returning to London for its third year to discuss key topics in what is expected to be a landmark year for the degradation community.

Prospective attendees can register for the event here: View Source

If you would like to meet with Nick and the team at TPD Europe, please contact [email protected].