Zerion Pharma ApS extends its licensing agreement with Rousselot B.V to exploit Dispersome® technology platform

On November 24, 2021 Rousselot B.V. and Zerion Pharma ApS reported that they have strengthened their partnership through an extension of an exclusive license agreement entered into in 2019 (Press release, Zerion, NOV 24, 2021, View Source [SID1234598619]). According to the revised license agreement, Rousselot grants Zerion Pharma an exclusive license to exploit the inventions covered by the patent family belonging to international patent application WO 2017/186889. The revision of the license agreement follows the recent grant of a key European Patent No. 17 722 708.9 that is included in the patent family.

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The two companies have worked together since 2019 and Rousselot has supported Zerion Pharma in the development of its Dispersome technology platform that enables significant increase in the solubility of otherwise poorly soluble drug compounds for oral administration. Rousselot has explored early variants of the Dispersome technology and has contributed valuable experimental data including results from pharmacokinetic preclinical studies.

The revised license agreement with Rousselot strengthens Zerion Pharma’s position as an innovative and leading supplier of competitive solutions for addressing one of the pharmaceutical industry’s most pressing problems: poor drug solubility.

"The grant of the European Patent marks an important milestone in our efforts to establish a dominating IP position in the field of preparing amorphous drug formulations using proteins as excipients", says Ole Wiborg, CEO of Zerion Pharma. "We have several other patent families protecting the Dispersome technology but the WO 2017/186889 patent family was filed relatively early and covers certain general aspects of the technology that we consider essential to our business", and continues:
"We are delighted to extend and strengthen our partnership with Rousselot that has done an impressive job in demonstrating the usefulness of proteins as excipients for increasing drug solubility and bioavailability. We are very pleased not only with the license grant that secures our IP position in the field but also with the documentation that Rousselot has established during recent years, including proof-of-concept and the comparative advantages of the Dispersome technology in-vivo."
While Zerion Pharma has been granted a broad exclusive license, Rousselot has retained certain rights to exploit the inventions described in WO 2017/186889 within limited fields. Under the terms of the agreement, Zerion Pharma will pay license fees and royalties to Rousselot. The financial terms are not disclosed.

"We are extremely pleased to have extended our license agreement with Zerion whom we consider an upcoming leader in the field of drug formulation and an optimal partner to further develop our contribution to the Dispersome technology", says Sandor Noordermeer, Vice President Global Marketing & Sales at Rousselot. "Back in 2019, we were impressed to see the promising results Zerion had generated with the use of whey proteins to increase drug solubility. The combination of their strong scientific foundation, innovativeness and Zerion’s fierce efforts to develop the company made the choice easy. I am confident that joining forces through collaboration and this license agreement will ensure successful commercialization of the Dispersome technology as state-of-art in the field of drug formulation".

Nykode Therapeutics (formerly Vaccibody*)) resolves to issue shares to Regeneron

On November 24, 2021 Nykode Therapeutics (formerly Vaccibody*) (Euronext Growth (Oslo): VACC) reported the execution of a multi-target license and collaboration agreement with Regeneron (Press release, Nykode Therapeutics, NOV 24, 2021, View Source [SID1234596383]).

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In accordance with the agreement and as described in the initial announcement, the board of directors of Nykode Therapeutics has today resolved to issue 2,255,034 new shares to Regeneron at a price of NOK 79.07 per share, based on a resolution to increase the share capital granted by the annual general meeting on May 5, 2021.

Following registration of the share capital increase related to the share issue, the share capital of Nykode Therapeutics will be NOK 2,895,027.44, divided into 289,502,744 shares, each with a par value of NOK 0.01. *)

Vaccibody AS, which is changing its company name to Nykode Therapeutics AS, has called for an EGM on November 30, 2021, to vote for the approval of the change of its company name from Vaccibody AS to Nykode Therapeutics AS.

HotSpot Therapeutics Closes $100M Series C to Advance First-in-Class Allosteric Drug Discovery Platform to the Clinic

On November 29, 2021 HotSpot Therapeutics, Inc., a biotechnology company pioneering the discovery and development of first-in-class allosteric therapies targeting regulatory sites on proteins referred to as "natural hotspots," reported the close of its oversubscribed $100 million Series C financing, bringing its total funding to $190 million (Press release, HotSpot Therapeutics, NOV 24, 2021, View Source [SID1234596182]).

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Led by Pivotal bioVenture Partners, with significant participation by LSP and B Capital Group, the round includes new investors Monashee Investment Management, LLC, CaaS Capital Management, Revelation Partners and Pavilion Capital, as well as participation from previous investors, Atlas Venture, Sofinnova Partners, SR One Capital Management, funds managed by Tekla Capital Management, LLC, and MRL Ventures Fund. Ash Khanna, PhD, of Pivotal bioVenture Partners, and Fouad Azzam, PhD, of LSP, will join the HotSpot Board of Directors.

The new financing will be used to continue advancing HotSpot’s Smart AllosteryTM platform, with a focus on undrugged and poorly druggable targets, as well as the company’s existing pipeline.

"With the support of top-tier healthcare and technology investors, we will expand on the significant productivity of the Smart Allostery platform to enable a treasure trove of sought-after disease targets and thereby develop medicines that broadly benefit patients," said Jonathan Montagu, Co-founder and Chief Executive Officer of HotSpot Therapeutics. "We have diligently established a deep pipeline of product opportunities in cancer and autoimmune disease, each offering a clear path to clinical value through precision and patient-targeted trial design."

HotSpot’s Smart AllosteryTM platform unlocks a vast range of disease-relevant proteins for the first time through the identification of protein pockets called "natural hotspots." Natural hotspots are pockets that are decisive in protein function yet previously unexploited using conventional allostery approaches. The Smart Allostery platform encompasses a broad suite of AI-enabled technologies and the industry’s largest and most diverse chemical library tailored to hotspots. The company is leveraging the Smart Allostery platform to uncover, capture, and drug natural hotspots across a wide array of disease-causing proteins.

"Within 36 months, HotSpot has established a new paradigm for allostery drug discovery that is reproducibly delivering small molecules across multiple target classes, including transcription factors and E3 ligases," said Ash Khanna, PhD, Venture Partner at Pivotal bioVenture Partners. "We are thrilled to be partnering with HotSpot as they advance their pipeline to the clinic and realize the promise of delivering potentially lifesaving therapeutics to patients."

Earlier this month, HotSpot announced new data validating its Smart AllosteryTM platform in the elucidation and preclinical evaluation of a novel allosteric inhibitor of the E3 ubiquitin ligase CBL-B, an important target in cancer immunotherapy. The data show successful targeting with the first and only selective small molecule inhibitors of CBL-B. Identified via the company’s Smart AllosteryTM platform, these small molecules promote T cell responses in vitro and in mice. Through allosteric inhibition of this negative regulator of immune cells, HotSpot’s small molecule CBL-B inhibitors offer the potential for increased immunotherapy efficacy for cancer patient populations that have historically exhibited poor treatment responses.

Allarity Therapeutics A/S Publishes Offer Document Offering to Acquire Company Shares in Exchange for Shares in Allarity Therapeutics, Inc. with the Intent to Complete Recapitalization

On November 24, 2021 Allarity Therapeutics A/S ("Allarity A/S" or the "Company") reported a voluntary offer and offer document to the shareholders of Allarity A/S to acquire all shares in Allarity A/S (the "Offer"), with the intent of completing the Company’s recapitalization and reorganization ("Recapitalization") into a US holding company (Allarity Therapeutics, Inc., a Delaware corporation, hereinafter "Allarity Delaware") and listing on the US Nasdaq Stock Market, as initially announced on May 21, 2021 and approved by the shareholders at the extraordinary general meeting on November 22, 2021 (Press release, Allarity Therapeutics, NOV 24, 2021, View Source [SID1234596083]).

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The Tender Period commences on November 25, 2021, and expires on December 9, 2021, at 3:00 pm CET. The Tender Period may be extended by the Board of Directors at its discretion. Settlement is expected to commence on or around December 20, 2021. Allarity A/S has reserved the right to extend the acceptance period for the Offer and to postpone the settlement date.

Summary

The Board of Directors of Allarity A/S unanimously recommends the Company’s shareholders to accept the Offer.
The Offer is being made in connection with the Company’s recapitalization and reorganization into a US holding company, approved by unanimous vote at the Company’s extraordinary general meeting held on November 22, 2021, in order to effect the Company’s migration to the U.S. Nasdaq stock market.
Shareholders in Allarity A/S are being offered the opportunity to swap their existing shares for shares in Allarity Delaware which is currently a wholly-owned subsidiary of Allarity A/S.
Shareholders in Allarity A/S that accept the Offer will receive shares in Allarity Delaware in relation to their existing holding in Allarity A/S, where fifty (50) existing Allarity A/S held shares entitle accepting shareholders to one (1) new share in Allarity Delaware (the "Exchange Ratio").
In the event that the holding is not exactly divisible by fifty (50), the Offer will result in fractional shares. Such fractional shares cannot be validly issued under US law and will therefore be settled in cash.
After having accepted the Offer, shareholders’ nominees (bank, custodian, or other broker) will receive the tradeable US shares on shareholders’ behalf, and thereafter shareholders will be able to trade these new shares on US Nasdaq through each shareholder’s nominee. The immediate availability to trade and transact on your new Allarity Delaware shares may depend on how your nominee (bank, custodian, or other broker) elects to receive such new shares.
Allarity A/S shareholders who participate in the Offer will, as of the completion of the Recapitalization, own the same percentage of Allarity Delaware as they did in Allarity A/S prior to the Recapitalization, subject only to adjustments due to cash compensation being made with regard to fractional shares if any, and subject to ownership dilution due to the announced investment from 3i LP.
The Offer will be completed through one capital decrease of nominal DKK 11,873,736 and up to eight capital decreases of nominal DKK 989,478 each in Allarity A/S down to nominal DKK 400,000.
In the event that not all shareholders sell their Shares to Allarity A/S in the Offer, the remaining shares in Allarity Delaware are expected to be distributed to such shareholders as dividends or as liquidation proceeds in connection with the liquidation of Allarity A/S. Any such distributions may be subject to withholding taxes as applicable.
It is a condition for the acceptance of the Offer that the individual shareholder offers all shares held by the shareholder during the Tender Period. Hence, partial participation in the Offer is not possible.
Steve Carchedi, CEO of Allarity A/S, commented: "We have come a long way since this Company began humbly, more than a decade ago, as a small start-up outside of Copenhagen, Denmark. Now, we stand ready to take a quantum leap forward by migrating onto the US NASDAQ and realizing our true potential. Our Board of Directors, together with our executive management team, universally support this transformative migration of our Company to the US NASDAQ. We believe that this move is not only in the best interests of our shareholders and our Company, but is crucial and necessary for our achievement of Allarity’s vision to realize the promise of personalized cancer care by bringing our novel therapeutics and DRP companion diagnostics to market and to cancer patients."

Further information

For further information about the Offer is available in the Offer Document which is available for download; please visit: www.allarity.com/offer.

The rationale for the proposed combination

The purpose of the recapitalization and reorganization is to enable the Company to further its mission of facilitating personalized medicine for cancer patients through advancing its pipeline programs and DRP companion diagnostics. It is expected that the change of marketplace will enhance the Company’s ability to achieve market values more in line with its US Nasdaq listed peer group and secure the necessary financing for its future success, with greater participation by institutional investors who primarily invest in US listed companies. The USD 20,000,000 investment is subject to, inter alia, a listing of the shares of Allarity Delaware on the US Nasdaq Stock Market.

Background for the Offer

On May 21, 2021 Allarity A/S announced that it has entered into an agreement with 3i LP, a U.S. fund formed under a single family office umbrella investing in public companies, for a USD 20,000,000 investment (the "Securities Purchase Agreement") to support Allarity A/S’ recapitalization and reorganization into Allarity Delaware and an application for listing on the U.S. Nasdaq Stock Market. The USD 20,000,000 investment will be made directly into Allarity Delaware and was subject to, inter alia, completion of the Reorganization and a listing of the Delaware Common Stock on the U.S. Nasdaq Stock Market. Shareholders of Allarity A/S approved the investment by 3i LP and the Reorganization Agreement at the extraordinary general meeting held on November 22, 2021.

Allarity Delaware has initially been organized as a wholly owned subsidiary of Allarity A/S and as of the date of this Offer Document has no business operations or assets and has engaged in no commercial activities other than pursuing the Reorganization described herein and in the information statement/prospectus.

Simultaneously with the execution of the Securities Purchase Agreement, Allarity A/S has entered into a Plan of Reorganization and Asset Purchase Agreement with Allarity Delaware to facilitate Allarity Delaware becoming a U.S. holding company listed on the U.S. Nasdaq Stock Market (the "Reorganization Agreement"). As of November 25, 2021, Allarity Delaware purchased, indirectly through a special purpose wholly owned subsidiary, all of the assets and assumed substantially all of the liabilities of Allarity A/S in exchange for shares of common stock in Allarity Delaware, for which an application for trading on the U.S. Nasdaq Stock Market has been made to be effective on completion of the Recapitalization. The purchase is conditional upon completion of the Recapitalization Agreement.

In connection with receipt by Allarity A/S of the Delaware Common Stock, Allarity A/S is, by way of publication of this Offer Document, commencing a share swap program offering the shareholders of Allarity A/S to exchange their shares in Allarity A/S with Allarity Delaware common stock on the basis of the Exchange Ratio. In the event that not all shareholders exchange their Shares to Allarity A/S in the Offer the remaining Delaware Common Stock are expected to be distributed to such shareholders as dividends or as liquidation proceeds in connection with a liquidation of Allarity A/S. Withholding taxes may apply to such distributions and will be deducted accordingly.

As a result of the Recapitalization, Allarity Delaware will become the direct or indirect holder of all of the assets and substantially all of the liabilities formerly held by Allarity A/S, except for the shareholding in Allarity Delaware and a certain level cash position to defray running costs also related to liquidation. Allarity A/S’ shareholders who participate in the Offer will, as of the completion of the Recapitalization, own the same percentage of Allarity Delaware as they did in Allarity A/S prior to the Recapitalization, subject only to adjustments due to cash compensation being made with regard to fractional shares, if any, and subject to ownership dilution due to the announced investment from 3i LP.

Upon the completion of the Recapitalization, 3i LP will invest USD 20,000,000 in Allarity Delaware in exchange for convertible preferred stock in Allarity Delaware at an initial fixed conversion price of USD 9.906, which, if fully converted, would be convertible into a 20% ownership of the Allarity Delaware shares of common stock over time, subject to the condition that 3i may not beneficially own more than 4.99% of Allarity Delaware shares of common stock at any point in time. There is an implied pre-investment value for Allarity Delaware of USD 80,000,000 and a post-investment implied value of USD 100,000,000 assuming that the Recapitalization is completed and that Allarity Delaware is listed on the U.S. Nasdaq Stock Market.

It is the belief of the Board of Directors that the Reorganization, the listing of Allarity Delaware on the U.S. Nasdaq Stock Market and completion of the 3i LP investment will secure necessary working capital, give better access to future capital, unlock the true value of the Company, and in the end increase the value for the shareholders in a more liquid and accessible market. For further information on the reasons behind the Reorganization please see pages 7 and 8 of the Registration Statement.

Grant of New Warrants and Resolutions on Existing Warrants

On November 24, 2021 Allarity Therapeutics A/S ("Allarity" or the "Company") reported that the Board of Directors of Allarity has exercised the authorization granted by the shareholders at the Extraordinary General Meeting held on November 22, 2021, to issue new warrants (Press release, Allarity Therapeutics, NOV 24, 2021, View Source [SID1234596082]). The Board has resolved to grant a total of 51,292,653 warrants as a part of a new incentive program for the Board of Directors, employees and consultants in Allarity. All warrants are issued free of charge and are issued to ensure alignment of interests between the Company’s employees, management, Board of Directors, and shareholders as the Company completes its recapitalization, restructuring, and migration to the U.S. Nasdaq stock market.

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The 51,292,653 warrants to employees, consultants and board members of the company are granted as follows:

46,608,675 warrants are granted to the employees of Company, including executive management, and a consultant
4,683,978 warrants are granted to members of the Board of Directors
Each warrant confers the right to subscribe for one share of nominal DKK 0.05 in Allarity Therapeutics A/S at the following exercise prices:

For 38,807,413 warrants, the exercise price for each warrant is SEK 0.945 (Grant 1)
For 7,801,262 warrants, the exercise price for each warrant is SEK 1.592 (Grant 2)
For 4,683,978 warrants, the exercise price for each warrant is SEK 1.85 (Grant 3)

By application of the Black-Scholes formula, the aggregate fair value of the issued warrants subject to Grant 1, Grant 2 and Grant 3 can be calculated as USD $5,143,821, USD $1,034,037 and USD $620,849 (corresponding to DKK 34,172,459, DKK 6,869,520 and DKK 4,124,548), respectively.

Additional terms and conditions applicable to the issued warrants are set forth in appendix 14 to the articles of association of Allarity Therapeutics A/S, provided, however, that 38,807,413 warrants to the employees, including executive management, and consultant shall vest with 25% on the grant date and hereafter with 1/36 per month calculated from 7 July 2021, and that 4,683,978 warrants to the board members shall vest with 25% on the grant date and hereafter with 1/48 per month calculated from 24 November, 2021. A further 7,801,262 warrants shall be deemed fully vested at the time of issuance.

In addition to the above the Board of Directors has with regard to existing outstanding warrants resolved that

With respect to 3,996,864 warrants issued on the terms and conditions set out in Appendix 8 to the articles of association, the Board of Directors has pursuant to clause 5 of Appendix 8 resolved that the warrants may be exercised in an extraordinary exercise window in the period 23 November – 8 December 2021. If these warrants are exercised fully, Allarity A/S will receive SEK 13,189,651 in cash proceeds and the warrants will be replaced with 79,937 Delaware Common Stock by applying an exchange ratio corresponding 3,996,864 divided by 50. In the event that these warrants are not exercised these warrants will lapse and become null and void.
The board of directors has resolved that 4,287,381 existing warrants with an exercise price of SEK 2.20 per Share in connection with the Reorganization Exchange Agreement shall be converted into similar instruments of similar value in Allarity Therapeutics Inc.
The Board of Directors has resolved that 1,980,000 existing warrants with an exercise price of SEK 1.41 per Share in connection with the Reorganization Exchange Agreement shall be converted into similar instruments of similar value in Allarity Therapeutics Inc.
The Board of Directors has resolved that 1,409,555 existing warrants with an exercise price of SEK 2.42 per Share in connection with the Reorganization Exchange Agreement shall be converted into similar instruments of similar value in Allarity Therapeutics Inc.