On November 29, 2021 Alligator Bioscience reported that rights issue of shares (the "Rights Issue") ended on 26 November 2021 (Press release, Alligator Bioscience, NOV 29, 2021, View Source [SID1234596176]). The preliminary outcome shows that the Rights Issue has been oversubscribed. Through the Rights Issue, Alligator will receive approximately SEK 257 million before transaction costs.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Preliminary outcome

The Rights Issue comprised a maximum of 128,499,507 ordinary shares. The preliminary outcome shows that 118,336,211 shares, corresponding to approximately 92.1 per cent of the Rights issue, has been subscribed for by exercise of subscription rights. In addition, applications for subscription of 37,602,276 shares without the exercise of subscription rights, corresponding to approximately 29.3 per cent of the Rights Issue, have been received. Thus, 155,938,487 shares, corresponding to approximately 121.4 per cent of the Rights Issue, has been subscribed for with and without the exercise of subscription rights. The Rights Issue is thus oversubscribed and no guarantee commitments will be utilized.

Notification regarding allocation

Allocation of shares will be made in accordance with the allocation principles described in the prospectus that was published in connection with the Rights Issue (the "Prospectus"). A notification regarding allocation of shares subscribed for without the exercise of subscription rights will be made by post of a settlement note to each subscriber. Allocated shares subscribed for without the exercise of subscription rights shall be paid for in accordance with the instructions in the settlement note.

Trading in BTA

The final outcome of the Rights Issue is expected to be announced on 1 December 2021. Trading in BTA (Sw. betald tecknad aktie) is currently taking place at Nasdaq Stockholm and will cease when the Rights Issue has been registered by the Swedish Companies Registration Office, which is expected to take place around week 50, 2021. BTA:s will then be converted to ordinary shares.

Number of shares and share capital

The Rights Issue provides Alligator with proceeds amounting to approximately SEK 257 million before transaction costs. As a result of the Rights Issue, Alligator’s share capital will increase by SEK 51,399,802.80 to a total of SEK 85,666,338 and the total number of shares will increase by 128,499,507 shares to a total of 214,165,845 shares, all ordinary shares.

Guarantee Commitments

In connection with the Rights Issue, the Company has entered into agreements on guarantee commitments. For the guarantee commitments, a commission 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 has been set to SEK 2.10, corresponding to 90 per cent 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. In case all guarantors would choose to receive guarantee commission in shares, a total of a maximum of 10,660,763 new shares would be issued as guarantee commission.

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.

This information is information that Alligator Bioscience AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 08:30 a.m. CET on 29 November 2021.

On November 29, 2021 ImmuPharma PLC (LSE:IMM), the specialist drug discovery and development company, reported that it has signed a 2-year collaboration agreement with Imperial College London (Press release, ImmuPharma, NOV 29, 2021, View Source [SID1234596195]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Under the collaboration, Imperial College will provide significant intellectual input and guidance on a number of innovative peptide assets being developed at our R&D subsidiary, ImmuPharma Biotech in Bordeaux.

Dr Tim Franklin, Chief Operating Officer of ImmuPharma, added: "We are all extremely excited to be working with such a world leading academic institute. This union will be invaluable in guiding and progressing our earlier stage product development portfolio, as well as enhancing our intellectual property base."

Dr Sébastien Goudreau, Chief Executive Officer of ImmuPharma Biotech, added: "We are delighted that now with the full support from the new Board for our innovative research programs, we have the opportunity of working with collaboration partners which include world leading academic institutes such as Imperial College London."

On November 29, 2021 SQZ Biotechnologies (NYSE: SQZ), focused on unlocking the full potential of cell therapies for multiple therapeutic areas, reported that management will be presenting at the 4th Annual Evercore ISI HealthCONx Conference on December 1st (Press release, SQZ Biotech, NOV 29, 2021, View Source [SID1234596214]). Armon Sharei, Ph.D., Chief Executive Officer, will present a corporate overview and the company will be hosting one-on-one meetings.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

PRESENTATION DETAILS

Wednesday, December 1
4th Annual Evercore ISI HealthCONx Conference
Fireside Chat
9:15-9:35 am ET
Webcast

Specific conference webcast details and the company’s corporate overview presentation will be available on the Investors & Media section of the SQZ website. The webcast will be available for 90 days following the presentation.

On November 29, 2021 Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health, reported the holding of its Investor Day today at its R&D and production center, the Mithra CDMO in Flémalle, Belgium (Press release, BCI Pharma, NOV 29, 2021, View Source [SID1234596177]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

As of 9:00 am CET, all presentations can be simultaneously followed by webcast on the Company’s website or by clicking here. A replay will also be available via this same link shortly after the end of the conference.

Consolidation of Donesta product candidate
Donesta is a next generation orally-administrated estetrol-based hormone therapy product candidate. Launched in late 2019, the phase III Clinical Program carried out on 2,300 postmenopausal women (40-65 years) aims to measure the treatment effects on vasomotor symptoms’ frequency and severity with different doses of E4, especially for hot flashes. Many parameters such as the impact on breast density, endometrial safety, health-related quality of life and lipids, glucose metabolism and hemostasis parameters are also among the secondary objectives of these studies2.

Convinced of the potential of E4 on other major estrogen deficiency symptoms affecting a majority of postmenopausal women, Mithra decided to broaden the scope of its Clinical Program by launching three additional studies: 1 IQVIA FY 2020 2 For more information about the E4 Comfort Phase III Program, please visit the website of Clinicaltrials.gov by clicking here. investors.mithra.com • 2 29-11-2021 PRESS RELEASE 1. A Phase 3 study on the effect of E4 on vulvovaginal atrophy (vaginal dryness, pain during intercourse, urinary tract infections); 2. A Phase 2 study on the effect of E4 on skin texture, quality and appearance; 3. A Phase 2 study on the effect of E4 on hair texture, quality and appearance. These three additional studies funded by Mithra for an amount of approximately EUR 20 million will be launched in 2022, depending on regulatory agencies’ feedback.

Graham Dixon, CSO Mithra Women’s Health, comments on this extension of the Donesta Program: "Following the publication of the WHI study in 2001, more than 65% of women decided to stop their hormonal treatment for fear of developing breast cancer or a cardiovascular disease. While this correlation was categorically denied by the scientific community as early as 2006, only 1 in 10 postmenopausal women in the world today choose to take hormonal treatment to relieve the many side effects impacting both their private and professional lives. We are convinced that thanks to its safety profile, Donesta can offer a real complete alternative to significantly improve these women’s quality of life and therefore be a gamechanger."

The primary efficacy data of the Phase 3 Donesta Program is expected by beginning of 2022. Depending on the evolution of the Covid-19 situation, study results and regulatory authorizations, Mithra believes it could achieve marketing authorization for Donesta in H1 2024 for the United States/Canada and in H2 2024 for Europe. The global menopause market is currently worth nearly USD 10 billion, and is expected to reach around USD 17 billion by 20273.

Dr. Carolyn Myers, BioEnsemble Ltd., added: "Our quantitative market research program surveying over 1000 prescribers and women confirms a large unmet medical need in the menopause market resulting from misperceptions about the use of current HT. The research also highlights the significant opportunity for a novel, safe hormone that will treat menopausal symptoms beyond VMS. Research findings confirmed that Donesta’s profile is attractive to current users of HT from which we believe Donesta can take a large share, and Donesta can make inroads amongst the 54% of women who currently do not seek medical treatment because of their safety concerns of current HT. In addition to Donesta being safe, when approved with the additional indications, it will provide women with a single product option to treat many of their symptoms long term."

Diversification of asset-based pipeline through a partnership with BCI Pharma
Considering its advanced asset-based pipeline, which has seen two major commercial launches over the past two years (the first estetrol-based product Estelle oral contraceptive and Myring vaginal ring), Mithra is strengthening its leadership position in women’s health by acquiring a new innovative development axis in a fast-growing market: inhibitors of tyrosine kinases, notably indicated in the treatment of cancer and endometriosis.

Mithra acquires the rights relating to two development programs led by the Belgian company BCI Pharma on innovative inhibitors of CSF1R kinase. These CSF1R inhibitors are part of a new innovative class of immune-modulatory drugs with established clinical tolerability4 and proven efficacy5. They act on the CSF1 receptor which is involved in many inflammatory processes and is over expressed in many 3 Market Research Future, 2020; IQVIA 2019 4 Cannarile et al. Journal for ImmunoTherapy of Cancer (2017) 5:53 5 Monsestime et al. Drugs in R&D (2020) 20:189–195 investors.mithra.com • 3 29-11-2021 PRESS RELEASE pathologies, in particular cancers, neurological disorders and autoimmune diseases. The innovative class of tyrosine kinases inhibitors represents the third fastest growing therapeutic class in 2020, with a 17% increase in revenues to USD 40.3 billion.

Under the terms of the contract, Mithra has an option to acquire patents covering CSF1R inhibitor series with upfront payment of EUR 2.25 million on execution of option, following the first results conducted by BCI Pharma. Mithra will fund the preclinical and clinical development with a focus on female cancers and endometriosis, while potentially targeting other orphan indications, such as metastatic breast cancer (TNBC). Currently in the preclinical stage, BCI Pharma should initiate clinical development in 2023, with marketing authorizations expected for 2031.

Dominique Surleraux, CEO at BCI Pharma said: "We are very excited to initiate this strategic partnership with Mithra. This collaboration represents the successful execution of our overarching corporate strategy to deliver new therapy from our disruptive technology which delivers novel, potent and selective kinase inhibitors. We look forward to advancing candidates to the clinic and ultimately achieving the company’s vision to bring new treatment options to patients with difficult-to-treat cancer, endometriosis and others. "

Leon Van Rompay, CEO Mithra Women’s Health, commented: "We are very pleased to collaborate with BCI Pharma on this innovative development opportunity in a fast-growing market that will allow us to diversify our pipeline in women’s health and beyond. Selective kinase inhibitors play a crucial role in many diseases and we look forward to seeing the first results of BCI’s studies on their effect on female cancers and endometriosis."

Didier Malherbe, BCI Pharma Board Chairman, added: "I’m really happy about the partnership between the two Walloon biotech companies. This demonstrates the capability of Belgium biotech to create value in a very dynamic health research environment.

On November 29, 2021 Biofrontera AG (ISIN: DE0006046113) (the "Company") with its wholly owned German subsidiaries, and Biofrontera Inc. (Nasdaq: BFRI), a U.S. subsidiary of the Company, in which it holds less than 100% of the shares, reported that they have reached an out-of-court settlement with DUSA Pharmaceuticals, Inc. ("DUSA") (Press release, Biofrontera, NOV 29, 2021, View Source [SID1234596196]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The Company and its defendant subsidiaries were sued in the U.S. by DUSA for alleged patent infringement, unauthorized use of alleged trade secrets, tortious interference with contractual relations and alleged deceptive and unfair trade practices. DUSA has asserted significant damages in this proceeding. In October 2020, the further proceedings, which should now be discontinued, were referred to a jury for a decision.

The settlement was reached based on the following key points: The Company as well as its defendant subsidiaries have agreed to pay DUSA USD 22.5 million in settlement of potential claims. In addition, further mutual claims have been released. Half of the settlement amount is due upon execution of the agreement, thereafter one quarter on each of the first and second anniversaries after execution of the agreement. Of this amount, 50% will be borne by the Company and 50% by Biofrontera Inc.