Brickell Biotech Announces Pricing of $15.0 Million Underwritten Public Offering

On October 22, 2020 Brickell Biotech, Inc. ("Brickell") (Nasdaq: BBI), a clinical-stage pharmaceutical company focused on developing innovative and differentiated prescription therapeutics for the treatment of debilitating skin diseases, reported the pricing of an underwritten public offering of 20,833,322 shares of common stock or common stock equivalents (which includes pre-funded warrants to purchase shares of common stock in lieu of shares of common stock) and investor warrants to purchase up to an aggregate of 20,833,322 shares of common stock (Press release, Vical, OCT 22, 2020, View Source [SID1234568918]). Each share of common stock (or pre-funded warrant in lieu thereof) is being sold together with one, immediately exercisable investor warrant with a five year term to purchase one share of common stock at an exercise price of $0.72 per share. The shares and warrants are being sold at a combined offering price of $0.72, for total gross proceeds of approximately $15.0 million, before underwriting discounts and commissions and offering expenses payable by Brickell. The offering is expected to close on or about October 27, 2020, subject to the satisfaction or waiver of customary closing conditions.

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Brickell anticipates using the net proceeds from the offering for research and development, including clinical trials, working capital and general corporate purposes.

Oppenheimer & Co. Inc. is acting as the sole book-running manager in connection with the offering and Lake Street Capital Markets, LLC is acting as lead manager.

The securities will be offered pursuant to a registration statement on Form S-1, as amended (File No. 333-249441), which was declared effective by the Securities and Exchange Commission (the "SEC") on October 22, 2020. The offering is being made solely by means of a prospectus. A preliminary prospectus relating to and describing the terms of the offering has been filed with the SEC and is available on the SEC’s website at www.sec.gov. Copies of the preliminary prospectus and, when available, copies of the final prospectus relating to this offering can be obtained at the SEC’s website at www.sec.gov or from Oppenheimer & Co. Inc., Attention: Syndicate Prospectus Department, 85 Broad St., 26th Floor, New York, NY 10004, by telephone at (212) 667-8055 or by email at [email protected].
This press release does not constitute an offer to sell or the solicitation of an offer to buy, nor will there be any sales of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction.

Immune Therapeutics, Inc. Announces Signing of Definitive Merger Agreement Between Cytocom and Cleveland BioLabs

On October 22, 2020 Cytocom, Inc. (Cytocom), a leading biopharmaceutical company in the area of immune-modulation, and Cleveland BioLabs, Inc., an innovative biopharmaceutical company developing novel approaches to activate the immune system, reported that they have entered into a definitive merger agreement to combine their businesses in an all-stock transaction (Press release, TNI BioTech, OCT 22, 2020, View Source [SID1234568901]). Cytocom shareholders will have a majority position in the newly combined entity, which the parties anticipate will continue to be listed on the Nasdaq, and the initial Board of Directors for the combined company will consist of four members selected by Cytocom and three members selected by Cleveland BioLabs. The Boards of Directors of both companies have approved the combination.

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For Immune Therapeutics, Inc. (Ticker: IMUN) and it’s shareholders who hold a considerable stake in Cytocom this means that the value for all of the years of support and collaboration with Cytocom can be realized. The Cytocom platform technologies and product pipeline, in combination with Cleveland BioLabs, have the potential to drive significant future growth in Immune’s shareholder value.

Each party to the proposed merger believes that the combined company will create near-term commercial opportunities in numerous areas of significant unmet medical needs including acute radiation injury, oncology, infectious disease, inflammation and autoimmune-mediated conditions, with multiple commercial, regulatory and clinical milestones expected over the next 12 to 18 months. Operating as "Cytocom, Inc." and under the leadership of Cytocom’s experienced management team, the combined company will be positioned for consistent growth.

Overview

Michael K. Handley, President and Chief Executive Officer of Cytocom, stated, "Our merger with Cleveland BioLabs and its subsequent immune-focused platform will be a transformative growth opportunity for Cytocom and Cleveland BioLabs shareholders. We believe that the combination of these highly complementary late-stage pipelines will strengthen our position and advance our efforts to unlock the potential of immune-modulating agents in the treatment of serious medical conditions. Further, this merger will enhance our ability to become a recognized leader in immune-modulating treatments and builds on the momentum created by our recent acquisition of ImQuest Life Sciences. We plan to utilize the combined platform to further drive value with additional clinical and commercial products and continue to seek strategic partnerships and acquisitions."

Dr. Andrei Gudkov, Chief Scientific Officer of Cleveland BioLabs, said: "This is an exciting day for Cleveland BioLabs and a great opportunity for our stockholders. The merger with Cytocom will allow us to add the strength of our science and bright perspectives associated with Entolimod development in cancer treatment and radiation defense arenas with a string of immunomodulators developed by Cytocom to form a powerful blend of conceptually and scientifically aligned products. We believe that the merger with Cytocom is the ideal way to unlock the value of our technology platform and our lead drug candidate, Entolimod, and I look forward to seeing this exciting new therapy advance through the clinic."

Conditions

The proposed transaction is subject to customary closing conditions, including approval by the stockholders of Cleveland Biolabs, the shares of the combined company being approved for listing on Nasdaq and a registration statement under the Securities Act becoming effective. Cytocom and Cleveland Biolabs expect the transaction to close during the first quarter of 2021.

Conference Call

Cytocom will host a conference call and live audio webcast at 8:00 a.m. EDT on October 28th to discuss the merger and provide a strategic vision for the combined company. To access the conference call supported with slides, please dial 646-558-8656 with the meeting ID: 841 7826 2704 and passcode: 281020. The conference call can also be accessed at https://cleartrustonline.com/cytocom. Approximately two hours following the live event, a webcast replay of the conference call will be available on Cytocom’s website https://www.cytocom.com/investors/ for approximately 30 days.

Analysis Group Team Publishes Real-World Evidence in Sequencing of Radium-223 Radiotherapy for Patients with Metastatic Castration Resistant Prostate Cancer

On October 22, 2020 Analysis Group, a global leader in health economics and outcomes research (HEOR), reported the publication of a study addressing the question of when radium-223 should be given to patients with metastatic castration resistant prostate cancer (mCRPC) (Press release, Analysis Group, OCT 22, 2020, View Source [SID1234568893]). The retrospective analysis, published in the Nature journal Prostate Cancer and Prostatic Diseases, focuses on the question of whether radium-223 should be administered before or after patients receive chemotherapy.

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Currently, sequencing decisions are made without treatment selection tools such as validated biomarkers of response, and are based on both patient-provider discussions of overall treatment goals and risk-benefit assessments. This approach has led to widely varying patterns in the contemporary use of radium-223 amid a growing number of treatment options for patients with mCRPC.

Analysis Group Managing Principal Mei Sheng Duh, Manager Rachel Bhak, Consultant Caroline Korves, and Senior Analyst Mu Cheng, in collaboration with investigators from the University of California San Diego, the Dana-Farber Cancer Institute, and Bayer Healthcare Pharmaceuticals, analyzed clinical data from 2013–2018 about treatment patterns in patients treated with radium-223 pre- vs. post-chemotherapy. The results demonstrated that administration of radium-223 pre-chemotherapy increased the likelihood of completion of radium-223 treatment. However, radium-223 treatment pre- or post-chemotherapy and with or without combination therapy did not result in significant differences in overall survival.

"This was a non-interventional, retrospective, longitudinal chart review study of patients at the Dana-Farber Cancer Institute in Boston," said Dr. Duh. "The treatment patters and decisions we studied were particularly difficult to compare given the varied treatment decisions. While the results of the study are clinically relevant, future studies should be done at a scale greater than a single, tertiary cancer center."

The study, "Treatment of Metastatic Castration Resistant Prostate Cancer with Radium-223: A Retrospective Study at a US Tertiary Oncology Center," was published in the August 2020 issue of Prostate Cancer and Prostatic Diseases. Coauthors include Rana McKay of the University of California San Diego, Rebecca Silver and Mary-Ellen Taplin of the Dana-Farber Cancer Institute, and Sreevalsa Appukkuttan and Stacey J. Simmons of Bayer Healthcare Pharmaceuticals. Funding was provided by Bayer Healthcare Pharmaceuticals.

Longevity Acquisition Corporation Announces Signing of Definitive Merger Agreement

On October 22, 2020 Longevity Acquisition Corporation (NASDAQ: LOAC) (the "Company" or "LOAC"), a publicly-traded special purpose acquisition company (SPAC), reported that it has signed a definitive merger agreement with 4D pharma PLC (AIM: DDDD, "4D pharma" or "4D") (Press release, Longevity Biotech, OCT 22, 2020, View Source [SID1234568889]). Upon completion of the merger, shareholders of LOAC will receive American Depositary Shares (ADSs) of 4D and LOAC will become a wholly-owned subsidiary of 4D, subject to customary closing conditions, including that 4D American Depositary Shares ("ADSs") will be approved to be listed and tradable on Nasdaq.

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4D pharma’s Live Biotherapeutic Products (LBPs) are orally delivered single strains of bacteria that are naturally found in the healthy human gut. The Company has six clinical programs, namely a Phase I/II study of MRx0518 in combination with Keytruda (pembrolizumab) in solid tumors, a Phase I study of MRx0518 in a neoadjuvant setting for patients with solid tumors, a Phase I study of MRx0518 in patients with pancreatic cancer, a Phase I/II study of MRx-4DP0004 in asthma, a Phase II study of MRx-4DP0004 in patients hospitalized with COVID-19, and Blautix in Irritable Bowel Syndrome (IBS) which has completed a successful Phase II trial. Preclinical-stage programs include candidates for CNS disease such as Parkinson’s disease and other neurodegenerative conditions, and autoimmune diseases. The Company has a research collaboration with MSD, a tradename of Merck & Co., Inc., Kenilworth, NJ, USA, to discover and develop Live Biotherapeutics for vaccines.

Mr. Matthew Chen, Chief Executive Officer of LOAC remarked, "We are truly excited about the merger with 4D pharma. Our team reviewed many opportunities in a variety of industries, and determined that the transaction with 4D would provide the greatest value to our shareholders. 4D is developing promising novel biotherapeutics to address unmet medical needs. We are impressed by the 4D management team’s track record in drug development and partnership building in the pharmaceutical industry. We are very excited about the future prospects of the combined company."

Duncan Peyton, Chief Executive Officer of 4D pharma, stated, "A Nasdaq listing allows 4D to capitalize on increased interest from US healthcare investors in recent years, providing access to a much larger pool of specialist capital, and increasing our global profile and exposure. Nasdaq is a very positive environment for growing, innovative biotech companies. The merger with LOAC accelerates and de-risks our entry into the US, while providing immediate access to additional funds to support our pipeline. The increased exposure of a US listing will also support ongoing partnering discussions across our pipeline."

Transaction Details

At closing, LOAC will merge with and into 4D Pharma BVI Limited ("Merger Sub"), a wholly owned subsidiary of 4D pharma plc, with Merger Sub continuing as the surviving company. At the effective time of the merger, each of LOAC’s ordinary shares issued and outstanding prior to the effective time of the merger (excluding shares held by 4D and LOAC and dissenting shares, if any) will be automatically converted into the right to receive certain per share merger consideration (as defined below), and each warrant to purchase LOAC’s ordinary shares and right to receive LOAC’s ordinary shares that is outstanding immediately prior to the effective time of the merger will be assumed by 4D pharma and automatically converted into a warrant to purchase ordinary shares of 4D pharma and a right to receive ordinary shares of 4D pharma, payable in 4D pharma ADSs, respectively. The per share merger consideration will consist of 7.5315 ordinary shares of 4D pharma, payable in 4D pharma ADSs (each ADS representing 8 ordinary shares), for each issued and outstanding ordinary shares of LOAC immediately prior to the closing.

The closing conditions of the merger include, among others, the approval of the merger by LOAC’s existing shareholders and approvals from 4D shareholders, the approval for listing of 4D pharma’s ADSs on the Nasdaq Stock Market, and LOAC having at least $11,750,000 of net tangible assets and at least $14,600,000 in cash at the closing.

Upon and immediately following the consummation of the merger, it is anticipated that the shareholders of LOAC prior to the closing will collectively own approximately 13.1% of outstanding ordinary shares of the combined entity.

Concurrently with the execution of the merger agreement, LOAC entered into certain backstop agreements with Whale Management Corporation, the sponsor of LOAC, 4D pharma and certain investors, pursuant to which the investors have committed to provide financial backing to the Company immediately prior to the closing in the event of share redemptions at LOAC in the aggregate amount of up to $14,600,000. On the same date and upon receipt of the principal, LOAC also issued unsecured convertible promissory notes to certain investors in the aggregate principal amount of $1,860,000 in connection with the merger agreement which will be paid by the combined company following closing.

Upon the execution of the Merger Agreement and the receipt of the proceeds from the convertible notes, Messrs. Matthew Chen, Teddy Zheng, Yukman Lau and Pai Liu resigned from their positions of Chief Executive Officer, Chief Financial Officer, director of the Company’s board of directors (the "Board"), and director of the Board, respectively. On the same date, the Board appointed Alex Lyamport as CEO and director of the Board, Matthew Chen as CFO, and Nicholas H. Adler and Jerry L. Hutter as directors of the Board, to fill in the vacancies created by the resignations. Our Board currently consists of two existing directors of the Board, Messrs. Matthew Chen and Jun Liu, and three newly appointed directors, Messrs. Alex Lyamport, Nicholas H. Adler and Jerry L. Hutter. Following completion of the Merger, existing 4D pharma Directors will continue to serve in their current roles in the combined entity.

From the date of execution of the merger agreement through the closing, LOAC shall use all reasonable efforts to remain as a public company on, and for its securities to be tradable over the Nasdaq Capital Market. 4D shall use all reasonable efforts to apply for a listing of 4D ADSs on, and for 4D ADSs to be tradable over, the Nasdaq stock market.

Chardan Capital Markets LLC is acting as financial advisor to LOAC. Hunter Taubman Fischer & Li LLC, Addleshaw Goddard LLP and Ogier are acting as legal counsels to LOAC. Wilson Sonsini Goodrich & Rosati, Professional Corporation, and Pinsent Masons LLP are acting as legal counsels to 4D.

The description of the transaction contained herein is only a summary and is qualified in its entirety by reference to the definitive agreement relating to the transaction, a copy of which will be filed by LOAC with the Securities and Exchange Commission (the "SEC") as an exhibit to a Current Report on Form 8-K.

Hansa Biopharma interim report Jan-Sep 2020

On October 22, 2020 Hansa Biopharma, the leader in immunomodulatory enzyme technology for rare IgG mediated diseases, reported its business update and interim report for January – September, 2020 (Press release, Hansa Biopharma, OCT 22, 2020, View Source [SID1234568888]).

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Highlights for the third quarter 2020

The EU Commission granted conditional approval for Idefirix (imlifidase) in highly sensitized kidney transplant patients in the European Union. Idefirix is the Company’s first approved drug and will transform Hansa Biopharma into a commercial stage biopharmaceutical company.
Entered exclusive agreement with Sarepta Therapeutics to develop and promote imlifidase as pre-treatment ahead of gene therapy in select indications. The agreement with Sarepta includes an upfront payment and will potentially generate milestone payments to Hansa totaling up to USD 397.5m plus royalties on imlifidase enabled gene therapy sales. All imlifidase sales will be booked by Hansa.
Anti-GBM: Reported positive high-level data from investigator-initiated phase 2 trial with imlifidase to treat anti-GBM disease with two-thirds of patients achieving dialysis independence six months after treatment. The positive data marks an important milestone for the Company’s expansion of imlifidase outside transplantation.
US trial in kidney transplantation: Recruitment of first patient expected in H1 2021, given the continued impact of the COVID-19 pandemic in the US and the timeline to finalize the study protocol. Potential BLA submission is expected by 2023 under the accelerated approval path.
Pipeline: Enrollment in both phase 2 studies in GBS and AMR have been temporarily halted for the past months due to the COVID-19 pandemic. Reinitiation of enrollment expected in Q4 2020 under a risk-based site-by-site approach. Completion of enrollment in both studies is expected in the second half of 2021.
Hansa Biopharma AB certified as a Great Place to Work following the results of a company-wide employee survey and a review of policies.
SEK 1.1bn (USD 121m) raised in a directed share issue of 4.4 million ordinary shares. The share issue was multiple times oversubscribed due to high demand from US, European and Swedish institutional investors. The capital raised will help finance the Company’s R&D pipeline as well as fund the launch and commercialization of imlifidase in kidney transplantation.
Max Sakajja, VP Corporate Development, appointed to a new role as VP International Markets to prepare Hansa Biopharma’s expansion strategy outside the EU. The role reports into the CCO and is part of Hansa’s broader leadership team.
Investments in R&D and SG&A increased in the third quarter to SEK 71m (Q3’19: SEK 47m) and SEK 52m (Q3’19: SEK 46m), respectively. Cash position was SEK 1,476m at the end of September 2020. Cash flow from operating activities for the third quarter ended at SEK 5m (Q3’19: SEK -80m).
Søren Tulstrup, President and CEO of Hansa Biopharma, comments

"Hansa Biopharma’s evolution into a fully integrated biopharmaceutical company took a major step forward in the third quarter following the conditional approval of Idefirix (imlifidase) by the European Commission for the desensitization treatment of highly sensitized adult kidney transplant patients with a positive crossmatch against an available deceased donor.

The European approval serves as a validation of the potential of our proprietary drug development platform and will transistion Hansa Biopharma into the next phase as a commercial stage biopharmaceutical company.

We are also excited about the progress of our efforts beyond transplantation. In July we announced the achievement of another landmark milestone with the exclusive agreement with Sarepta Therapeutics to develop and promote imlifidase as a potential pre-treatment prior to the administration of gene therapy. The agreement with Sarepta is exclusive for the use in Duchenne and and Limb-Girdle indications and serves as a validation of our enzyme technology as we expand beyond transplantation.

Late Septermber we also announced positive high-level data from the investigator-initiated phase 2 trial with imlifidase to treat anti-GBM disease. Data from the trial shows that imlifidase leads to rapid clearance of anti-GBM antibodies, with two-thirds of patients achieving dialysis independence six months after treatment. We are very encouraged by the positive outcome as anti-GBM is the first IgG-mediated disease outside transplantation, where imlifidase has been shown to stop an immunologic attack.

Our strong progress across our platform of immunomodulatory enzymes has also been recognized by our investors, as our investor base has continued to expand in Sweden and internationally. End of September, the number of shareholders has increased to more than 18,000 investors, with 45% of the shares now owned by international investors and institutions. We see this as a testimony to our recent progress and a strong and growing international interest in Hansa Biopharma.

While an exciting and transformative year has impacted us in a postive way, we are still seeing negative effects due to the widespread impact from the COVID-19 pandemic. Enrollment in the phase 2 studies in GBS and AMR has been temporarily halted for the past months, and we expect to reinitiate enrollment of these studies in the fourth quarter 2020 under a risk-based, site-by-site approach.

In the US, the proposed study protocol for a randomised controlled trial (RCT) targeting highly-sensitized kidney patients was submitted to the FDA in June, 2020. Discussions are currently ongoing with the FDA and, once the final protocol has been agreed upon, we will proceed to set up centers in the US and start to enroll patients. Given the continued impact of the COVID-19 pandemic and the timeline for finalization of the study protocol, we expect recruitment of the first patient to be in the first half of 2021 with a potential BLA submission in 2023.

Lastly, I also want to highlight that Hansa Biopharma AB recently got certified as a Great Place to Work. This certification reflects our efforts to build a strong organization through attracting, developing and retaining the very best talent in the industry as we continue our growth trajectory and development into a fully integrated biopharmaceutical company.

I look forward to keeping you updated on the progress of our journey."

Upcoming milestones and news flow

Q4 2020 Kidney transplantation EU: Commercial launch

H1 2021 Kidney transplantation US: First patient dosed / RCT

H1 2021 NiceR: Completion of GMP process; initiate IND-enabling tox studies

H2 2021 AMR Phase 2 study: Complete enrollment

H2 2021 GBS Phase 2 study: Complete enrollment

2022 Kidney transplantation US: Complete enrollment / RCT

H2 2022 AMR Phase 2 study: Data read out

H2 2022 GBS Phase 2 study: Data read out

2023 Kidney transplantation US: 12 months follow-up on eGFR completed / RCT

2023 Kidney transplantation US: BLA submission

Capital Markets Day

Hansa Biopharma to host Capital Markets Day on Thursday October 29, 2020 in Copenhagen

The CMD event will be focused around Hansa Biopharma’s transformation into a fully integrated and commercial stage biopharmaceutical company and will highlight the potential of the Company’s unique antibody-cleaving enzyme platform beyond transplantation in areas such as autoimmunity and gene therapy.

The event will feature both senior management and external guest speakers. The event will be livestreamed and available for all viewers on our web at View Source

If you wish to participate in the CMD virtually, kindly sign up using the following link View Source

No conference call scheduled on Oct 22, 2020

Since Hansa Biopharma will host its Capital Markets Day a week later than the Q3’2020 report it has been decided to incoporate relevant elements and updates from the third quarter into the CMD program and presentations rather than hosting a seperate Q3 conference call. There will be opportunites to ask questions during the Capital Markets Day.