Calliditas announces acquisition of remaining Genkyotex minority shares

On October 7, 2021 Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) ("Calliditas") reported that the company now controls 100% of the share capital of Genkyotex SA ("Genkyotex"), after the completion of a centralized squeeze out offer to all minority shareholders (Press release, Calliditas Therapeutics, OCT 7, 2021, View Source [SID1234590894]).

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Genkyotex’s lead product candidate, setanaxib, is a first-in-class NOX inhibitor that targets NOX 1 and NOX 4, which are major drivers of fibrogenesis in multiple organs. In Q4 2021, Calliditas plans to initiate a 52-week, randomized, placebo-controlled, double-blind, trial with an adaptive phase 2b/3 design with setanaxib in 318 patients with primary biliary cholangitis (PBC). As previously announced in August 2021, Calliditas received FDA fast track designation for setanaxib in PBC. Calliditas will also initiate a Phase 2 proof-of-concept study in head and neck cancer in 2021, which will investigate the administration of setanaxib in conjunction with immunotherapy targeting cancer associated fibroblasts (CAFs).

"We are delighted to have completed our acquisition of Genkyotex, which means that we now can fully integrate the business and thereby leverage the platform optimally", said CEO Renée Aguiar-Lucander.

Subsequent to the squeeze-out, Genkyotex has become a wholly owned subsidiary of Calliditas and have been delisted from the Euronext stock exchanges.

The information was sent for publication, through the agency of the contact persons set out above, on October 7, 2021 at 8:00 a.m. CET.

Alligator carries out a 100 percent secured rights issue of approximately SEK 257 million

On October 7, 2021 The Board of Directors of Alligator Bioscience AB (publ) ("Alligator" or "the Company") reported that , subject to approval by the Extraordinary General Meeting on 8 November 2021, resolved to carry out a rights issue of shares with preferential rights for the Company’s existing shareholders of approximately SEK 257 million (the "Rights Issue") (Press release, Alligator Bioscience, OCT 7, 2021, View Source [SID1234590892]). The Company has received subscription commitments from a selection of the Company’s larger existing shareholders, including the AP4, Roxette Photo NV and Omentum S.A., amounting to approximately SEK 43 million, corresponding to approximately 17 percent of the Rights Issue. Furthermore, the Company has entered into agreements on guarantee commitments of approximately SEK 214 million, which secures the Rights Issue up to 100 percent. In addition, Öhman Fonder and all members of the Company’s board and management with shareholdings in the Company have expressed their intention to subscribe for their respective pro rata share in the Rights Issue. Alligator will use the proceeds from the Rights Issue to conduct phase II studies for mitazalimab, preparations for and initiation of phase II studies for ATOR-1017 and further development of other pipeline candidates. The Rights Issue is subject to approval by the Extraordinary General Meeting on 8 November 2021, and the notice of the Extraordinary General Meeting will be announced in a separate press release.
Summary

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One (1) existing share in the Company entitles to three (3) subscription rights. Two (2) subscription rights entitle to subscription of one (1) new share, i.e., a subscription ratio of 3:2.
The subscription price is SEK 2 per new share, which, assuming the Rights Issue is fully subscribed, results in the Company receiving issue proceeds of approximately SEK 257 million before deduction of transaction costs.
The record date for the Rights Issue is 10 November 2021 and the subscription period runs from and including 12 November 2021 up to and including 26 November 2021.
The last day of trading in the Alligator share including the right to participate in the Rights Issue is 8 November 2021.
The board’s resolution on the Rights Issue is subject to approval by the Extraordinary General Meeting on 8 November 2021. Major shareholders, who together represent approximately 17 percent of the shares and votes in the Company, have undertaken to vote for the Rights Issue at the Extraordinary General Meeting.
Major shareholders have expressed their support for the Rights Issue through subscription commitments amounting to approximately SEK 43 million, corresponding to approximately 17 percent of the Rights Issue. Furthermore, the Company has entered into agreements on guarantee commitments of approximately SEK 214 million, corresponding to approximately 83 percent of the Rights Issue, which secures the Rights Issue up to 100 percent. The guarantee commitments consist partly of a so-called top guarantee and partly of a bottom guarantee. In addition, Öhman Fonder and all members of the Company’s board and management have expressed their intention to subscribe for their respective pro rata share in the Rights Issue.
The Company intends to publish a prospectus regarding the Rights Issue on 9 November 2021.

Background and reason for the Rights Issue

Alligator is active in the phases of drug development that range from idea and early research to clinical phase II studies in patients. This includes, among other things, the development and optimization of new drug candidates, evaluation of preclinical efficacy and safety, and finally confirmatory clinical studies on cancer patients.

Alligator has shown strong Proof of Mechanism data in Phase I studies for mitazalimab, Alligator’s most advanced immuno-oncology candidate. In 2021, the Company’s focus has been on preparations for the inclusion of the first patient in the clinical phase II study OPTIMIZE-1. The first patient was successfully included in September 2021 and interim efficacy data are estimated for the end of the fourth quarter of 2022. In order to balance the risk in the Company’s development portfolio and to increase the likelihood of clinical success, Alligator is planning a second phase II study with mitazalimab, OPTIMIZE-2. In the study, mitazalimab is planned to be combined with current standard of care in renal cell carcinoma, bladder cancer or hepatocellular carcinoma. OPTIMIZE-2 is expected to start in the second half of 2022.

In June 2021, new promising data from the Phase I study with ATOR-1017 were presented, confirming the therapeutic potential and demonstrating clear signals of proof of mechanism in combination with a favorable safety profile. Previous interim data, presented in the fall of 2020, from the ongoing Phase I study in patients with advanced cancer showed a promising safety profile for ATOR-1017, with only a few drug-related side effects all being mild or moderate (grade 1 or 2). Preparations are ongoing to start clinical Phase II studies, which is expected to take place during the third quarter of 2022.

To ensure continued successful development in accordance with the Company’s business plan and strategy, Alligator has resolved to carry out the Rights Issue. The Rights Issue is estimated to provide Alligator with approximately SEK 257 million before transaction costs. The board assesses that the working capital requirement for the coming twelve-month period is met by available cash and the net proceeds from the Rights Issue.

The expected net proceeds from the Rights Issue will, in the following order of priority and with an approximate proportion indicated in parentheses, be used for:

Conduction of phase II studies with mitazalimab (65 percent)
Preparations for and initiation of phase II study for ATOR-1017 (15 percent)
Development of other pipeline candidates (20 percent)

Terms of the Rights Issue

Those who are registered as shareholders on the record date, 10 November 2021, have the preferential right to subscribe for new shares in the Rights Issue in relation to the number of shares held on the record date. One (1) existing share in the Company entitles to three (3) subscription rights. Two (2) subscription rights entitle to subscription of one (1) new share, i.e., a subscription ratio of 3:2. In addition, investors are offered the possibility to subscribe for shares without subscription rights.

If not all newly issued shares are subscribed for by exercise of subscription rights, allotment of the remaining shares shall be made within the highest amount of the Rights Issue: firstly, to those who have subscribed for shares by exercise of subscription rights (regardless of whether they were shareholders on the record date or not) and who have applied for subscription of shares without exercise of subscription rights and if allotment to these cannot be made in full, allotment shall be made pro rata in relation to the number of subscription rights that each and every one of those, who have applied for subscription of shares without exercise of subscription rights, have exercised for subscription of shares; secondly, to those who have applied for subscription of shares without exercise of subscription rights and if allotment to these cannot be made in full, allotment shall be made pro rata in relation to the number of shares the subscriber in total has applied for subscription of shares; and thirdly, to those who have provided underwriting commitments with regard to subscription of shares, in proportion to such underwriting commitments. To the extent that allotment in any section above cannot be done pro rata, allotment shall be determined by drawing of lots.

The subscription price is SEK 2 per new share. Provided that the Rights Issue is fully subscribed, the share capital will increase by a maximum of SEK 51,399,802.80 by a new issue of a maximum of 128,499,507 new shares. In the event of full subscription, the Rights Issue will provide Alligator with approximately SEK 257 million before deduction of issue costs. Shareholders who choose not to participate in the Rights Issue will, provided that the Rights Issue is fully subscribed, have their ownership diluted by approximately 60 percent, but are able to financially compensate for this dilution by selling their subscription rights.

Subscription of shares shall take place during the period from and including 12 November 2021 to and including 26 November 2021. The board has the right to extend the subscription and payment period. A possible extension of the subscription period shall be announced by press release no later than the last subscription day in the Rights Issue, i.e. 26 November 2021. Trading in subscription rights takes place on Nasdaq Stockholm during the period from and including 12 November 2021 to and including 23 November 2021 and trading in paid subscribed shares (Sw. Betalda tecknade aktier) during the period from and including 12 November 2021 until the Rights Issue has been registered with the Swedish Companies Registration Office (Sw. Bolagsverket).

Subscription commitments, guarantee commitments and declarations of intent

Alligator has received subscription commitments from a selection of the Company’s larger existing shareholders, including the AP4, Roxette Photo NV and Omentum S.A., amounting to approximately SEK 43 million, corresponding to approximately 17 percent of the Rights Issue. Furthermore, the Company has entered into agreements on guarantee commitments in the form of a so-called bottom guarantee of approximately SEK 188 million, corresponding to approximately 73 percent of the Rights Issue, and a so-called top guarantee of approximately SEK 26 million, corresponding to approximately 10 percent of the Rights Issue. In addition, Öhman Fonder and all members of the Company’s board and management with shareholdings in the Company, including Søren Bregenholt (CEO), Anders Ekblom (Chairman of the board), Marie Svensson (CFO), Peter Ellmark (CSO), Veronica Wallin (board member) and Hans-Peter Ostler (board member), have expressed their intentions to subscribe for their respective pro rata share in the Rights Issue. The bottom guarantee ensures, provided that subscription corresponds to at least the subscription commitments, that approximately 90 percent of the Rights Issue is subscribed and paid for. Through the top guarantee, provided that subscription corresponds to at least the subscription commitments and the bottom guarantee, that 100 percent of the Rights Issue is subscribed and paid for.

For the guarantee commitments, compensation is paid either in cash or in the form of newly issued shares in the Company. The subscription price for any shares issued to guarantors shall correspond to 90 percent of the volume-weighted average share price (VWAP) for the Company’s share on Nasdaq Stockholm during the subscription period in the Rights Issue (i.e. during the period 12 – 26 November 2021), however no lower than the subscription price in the Rights Issue. In order to enable new issues of shares as guarantee compensation to the guarantors who choose to receive guarantee compensation in newly issued shares, the board has proposed that the Extraordinary General Meeting on 8 November 2021, which is proposed to resolve on the approval of the Rights Issue, also resolves on authorization for the board to resolve on new issues of such shares to guarantors.[1]

Preliminary timeline for the Rights Issue

8 November 2021

Extraordinary General Meeting

8 November 2021

Last day of trading incl. preferential rights

9 November 2021

First day of trading excl. preferential rights

9 November 2021

Estimated publication of prospectus

10 November 2021

Record date

12 November – 23 November 2021

Trading in subscription rights

12 November – 26 November 2021

Subscription period

12 November 2021 – Until the Rights Issue is registered at the Swedish Companies Registration Office

Trading in paid subscription shares (Sw. "BTA")

1 December 2021

Estimated publication of outcome in the Rights Issue

Lock-up agreements

In connection with the Rights Issue, the Company has undertaken towards the Joint Global Coordinators, subject to customary exceptions, not to issue additional shares or other share-related instruments for a period of 180 days after the end of the subscription period in the event of an issue with preferential rights for existing shareholders, and 90 days after the end of the subscription period in the event of an issue without preferential rights for existing shareholders. In addition, the Company’s board members and senior executives who own shares in Alligator, subject to customary exceptions, have undertaken, towards the Joint Global Coordinators, not to transfer or otherwise sell their shares for a period of 180 days after the end of the subscription period.

Extraordinary General Meeting

The board’s resolution on the Rights Issue is subject to approval by the Extraordinary General Meeting on 8 November 2021. Notice of the Extraordinary General Meeting will be announced in a separate press release.

Prospectus

Full terms and conditions for the Rights Issue, as well as other information about the Company and information about subscription commitments, guarantee commitments and lock-up commitments will be presented in the prospectus that the Company is expected to publish around 9 November 2021 (the "Prospectus").

Advisers

DNB Markets, a part of DNB Bank ASA, Sweden Branch and Redeye AB act as Joint Global Coordinators in connection with the Rights Issue. Setterwalls Advokatbyrå AB acts as legal adviser to Alligator and Baker & McKenzie Advokatbyrå KB acts as legal adviser to the Joint Global Coordinators in connection with the Rights Issue. Aktieinvest FK AB acts as the issuing agent in the Rights Issue.

Cothera Bioscience Acquires Zotiraciclib from Adastra Pharmaceuticals

On October 6, 2021 Cothera Bioscience Inc. and Adastra Pharmaceuticals Inc., private biopharmaceutical companies focused on the development of first-in-class therapeutics for the treatment of cancer, reported a definitive agreement under which Cothera has acquired zotiraciclib (ZTR), an oral kinase inhibitor that readily crosses the blood brain barrier and possesses a unique mechanism of action of Myc depletion via the inhibition of cyclin-dependent kinase 9 (CDK9) (Press release, Cothera Bioscience, OCT 6, 2021, View Source [SID1234627381]). Financial terms of the asset purchase were not disclosed.

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In June 2021, the results of the zotiraciclib Phase 1b clinical trial were published in Clinical Cancer Research. The conclusion of the Phase 1b trial found that Zotiraciclib combined with temozolomide (TMZ) is safe in patients with recurrent high-grade astrocytomas.

After the conclusion of the trial a successful Type B meeting with the U.S. Food and Drug Administration Division of Oncology (D02) was held. The transition of ZTR from Adastra to Cothera enables the execution of clinical development plans built on input from the FDA meeting, as well as insight from global neuro-oncology thought-leaders and clinical investigators.

"The acquisition of zotiraciclib fits nicely into the Cothera portfolio of differentiated drug candidates synergistically aligning to our current research efforts to address cancers driven by the Myc oncogene," said Alex Wu, Ph.D., President and Chief Executive Officer and Founder of Cothera. "Importantly, zotiraciclib adds to the Cothera portfolio of therapeutics that hold promise for cancer patients around the world."

Scott Megaffin, Chief Executive Officer of Adastra, said, "I want to thank all the physicians and dedicated healthcare providers who have put forward relentless effort on behalf of their patients as the Adastra team transitions zotiraciclib into Cothera."

Vernon Jiang, Ph.D., Executive Vice President and Co-Founder of Cothera, added, "We are grateful to Adastra for its important work with physicians within neuro-oncology. Cothera is enthusiastic to build upon these relationships, as we believe highly in the promise of zotiraciclib in high-grade gliomas and pediatric mid-line gliomas such as Diffuse Intrinsic Pointe Glioma (DIPG).

Defence therapeutics prepares for phase I trial to test its dc cancer vaccine, accuvac-d002, against melanoma

On October 6, 2021 Defence Therapeutics, a biotechnology company working on cancer therapeutics and infectious disease vaccines is finalizing all required steps in preparation to a pre-IND meeting to initiate a phase I trial against melanoma using its DC cancer vaccine candidate AccuVAC-D002 (Press release, Defence Therapeutics, OCT 6, 2021, View Source [SID1234626237]).

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Defence has successfully exploited the use of its AccumTM technology platform to develop a large pipeline of products in immune-oncology and infectious diseases. Amongst its lead products is AccuVAC-D002, a DC-based cancer vaccine engineered to treat melanoma. The AccumTM technology platform is very efficient at enhancing intracellular delivery of proteins of pharmacological interests such as ADCs or vaccine antigens. Defence’s scientific team recently identified a novel function for the use of "free" AccumTM and its recently developed variants as anti-cancer molecules.

"We have successfully moved our product pipeline forward and developed various cancer vaccines including AccuVAC-D002. With the synopsis in hand, we are actively working with a large established CRO in the USA to identify and set-up the site for our Phase I against melanoma in the first half of 2022", says Mr. Plouffe, CEO of Defence Therapeutics.

Defence Therapeutics has antibody-drug conjugates and vaccines in late-stage pre-clinical development and/or undergoing GLP studies. With two DC cancer vaccines (AccuVAC-D001 and D002) undergoing manufacturing in clean rooms, Defence is most likely to initiate its Phase I trials in Q1/Q2 of 2022.

Skin Cancer Treatment Market to reach USD 14.55 Billion with a 7.5% CAGR by 2027, according to a report by Fortune Business InsightsTM.

Theratechnologies to Present at the H.C. Wainwright 5th Annual Nash Investor Conference

On October 6, 2021 Theratechnologies Inc. (Theratechnologies) (TSX: TH) (NASDAQ: THTX), a biopharmaceutical company focused on the development and commercialization of innovative therapies, reported that Christian Marsolais, Ph.D., Senior Vice President and Chief Medical Officer, will participate at the H.C. Wainwright 5th Annual NASH Investor Conference on Tuesday, October 6, 2021 at 4:30 p.m. ET (Press release, Theratechnologies, OCT 6, 2021, View Source [SID1234596232]).

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A live webcast of Dr. Marsolais’ presentation will be available through the ‘Events’ section of the Company’s investor relations website and will be archived for 90 days.