BriaCell Announces Closing of US$25 Million Public Offering

On February 26, 2021 BriaCell Therapeutics Corp. (TSX-V:BCT) (NASDAQ: BCTX, BCTXW) ("BriaCell" or the "Company"), a clinical-stage biotechnology company specializing in targeted immunotherapies for advanced breast cancer, reported its previously announced underwritten public offering in the United States. The Company offered 4,852,353 common units at a public offering price of US$4.25 per unit, consisting of one share of common stock and one warrant to purchase one share of common stock ("Warrant"), and 1,030,000 pre-funded units at a public offering price of US$4.24 per unit, consisting of one pre-funded common stock purchase warrant ("Pre-Funded Warrant") and one Warrant (Press release, BriaCell Therapeutics, FEB 26, 2021, View Source [SID1234575804]). The Pre-Funded Warrants are exercisable at any time after the date of issuance at an exercise price of US$0.01 per common share. The Warrants have a per share exercise price of US$5.3125, can be exercised immediately, and expire five years from the date of issuance.

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The aggregate gross proceeds to the Company from the offering were approximately US$25 million, before deducting underwriting discounts, commissions and other offering expenses. The Company has granted the underwriter a 45-day option to purchase up to 882,352 additional shares of common stock and/or Pre-Funded Warrants and/or 882,352 additional warrants to cover over-allotments, if any. In connection with the closing of this offering, the underwriter has exercised its over-allotment option to purchase an additional 882,352 warrants. The underwriter has retained the right to exercise the balance of its over-allotment option within the 45-day period.

The common shares and warrants began trading on the Nasdaq Capital Market under the symbols BCTX and BCTXW respectively, on February 24, 2021.

The Company intends to use the net proceeds to fund clinical trials, research and development, and for general working capital and general corporate purposes.

ThinkEquity, a division of Fordham Financial Management, Inc., acted as sole book-running manager for the offering.

A registration statement on Form F-1 (File No. 333-234292) relating to the shares was filed with the Securities and Exchange Commission ("SEC") and became effective on February 23, 2021. This offering was made only by means of a prospectus. Copies of the final prospectus may be obtained from ThinkEquity, a division of Fordham Financial Management, Inc., 17 State Street, 22nd Floor, New York, New York 10004, by telephone at (877) 436-3673, by email at [email protected] Investors may also obtain these documents at no cost by visiting the SEC’s website at View Source

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 an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

Horizon Therapeutics plc to Present at the Cowen and Company 41st Annual Health Care Conference

On February 26, 2021 Horizon Therapeutics plc (Nasdaq: HZNP) reported that the Company will participate in the following conference in March (Press release, Horizon Pharma, FEB 26, 2021, https://ir.horizontherapeutics.com/news-releases/news-release-details/horizon-therapeutics-plc-present-cowen-and-company-41st-annual [SID1234575793]):

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Cowen and Company 41st Annual Health Care Conference (Virtual)

Date: Tuesday, Mar. 2, 2021
Presentation Time: 1:30 p.m. ET
The conference presentation will be webcast live and may be accessed by visiting Horizon’s website at View Source A replay of the webcast will be available following the event.

NICE recommends routine funding for Novartis’ Kisqali

On February 26, 2021 Novartis reported The UK’s National Institute for Health and Care Excellence (NICE) has recommended routine access to Kisqali in certain advanced breast cancer patients (Press release, Novartis, FEB 26, 2021, View Source [SID1234575790]).

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NICE’s draft guidance recommends Kisqali (ribociclib) in combination with fulvestrant for the treatment of locally advanced or metastatic breast cancer that is hormone receptor-positive and human epidermal growth factor receptor 2 (HER2)-negative.

It will be routinely available on the NHS for adults who have had previous endocrine therapy and where exemestane plus everolimus is the most appropriate alternative treatment.

Kisqali is taken as a once-daily pill and belongs to a class of drugs known as cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitors.

The drug has been available to patients via the Cancer Drugs Fund (CDF) since 2019, while more evidence was collected to address uncertainties around how much it extends overall survival and its cost-effectiveness.

In a statement, NICE said that the new evidence demonstrates that people receiving Kisqali treatment live longer and experience longer periods before disease progression compared to fulvestrant alone.

"We are pleased therefore that our original decision to make Kisqali available through the CDF not only gave people access to it earlier than would otherwise have been possible, but has now, through the data collected during that time, allowed us to recommend it for routine use on the NHS," said Meindert Boysen, deputy chief executive and director of the NICE Centre for Health Technology Evaluation.

Following the recommendation for routine NHS funding, Kisqali treatment could now be an option for up to 3,300 women.

"It’s fantastic news that NICE has approved [Kisqali] ribociclib with fulvestrant for routine use on the NHS – this life-changing treatment will now bring thousands more women living with incurable secondary breast cancer hope of precious extra time to live well" said Baroness Delyth Morgan, chief executive at Breast Cancer Now.

"As well as offering certain patients with incurable breast cancer extra time with loved ones, this innovative drug combination can help delay the need for chemotherapy and its debilitating side effects," she added.

LISCure Biosciences Successfully Raises $21 million in Series B Funding

On February 26, 2021 LISCure Biosciences Inc., a biotech company that focuses on developing bacteria-mediated immunotherapy, reported that it has successfully completed $21 million of a Series B funding round (Press release, LISCure Biosciences, FEB 26, 2021, View Source [SID1234575785]). Participants include institutional investors, venture capitals, and KOSDAQ listed companies (as strategic investors).

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"This investment was made after reviewing the promising pre-clinical results of LISCure’s new drug candidates for each indication and we verified its potential as a new therapeutic treatment. Based on the technologies of both companies, we will actively cooperate in research and development for these innovative new drug candidates in the microbiome field", one of the strategic investors said.

This funding round will help LISCure further develop its pipeline and enhance its R&D capabilities of key technologies. LISCure uses a single strain approach whose strain is a naturally derived as well as non-pathogenic substance so it has a great advantage over other microbiome competitors in terms of safety. LISCure is developing the world’s first microbiome-based NASH(non-alcoholic steatohepatitis) treatment, LB-P8, as well as the rheumatoid arthritis treatment, LB-P6, for global clinical trials.

LISCure’s drug candidates have already been tested for efficacy and safety by a third CRO, and the four of the candidates have been completed the process development by CDMO based in the United States. Two of the candidates are currently in the process of cGMP manufacturing under CDMO based in France. LISCure is expecting the four lead candidates to enter global clinical trials in the next two years and possibly begin phase 2 with two of the candidates. In addition to the funding, LISCure has completed the establishment of corporations in the US and Australia for global clinical development. LISCure is planning to expand indications of each program through the US subsidy, working with global top research institutes.

Immunic, Inc. Reports Year End 2020 Financial Results and Highlights Recent Activity

On February 26, 2021 Immunic, Inc. (Nasdaq: IMUX), a clinical-stage biopharmaceutical company developing a pipeline of selective oral immunology therapies aimed at treating chronic inflammatory and autoimmune diseases, reported financial results for the year ended December 31, 2020 and highlighted recent activity (Press release, Immunic, FEB 26, 2021, View Source [SID1234575784]).

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"2020 was a year marked by significant operational and clinical milestone achievements across our pipeline, culminating most recently in two important data readouts for our lead asset, selective oral DHODH inhibitor, IMU-838," stated Daniel Vitt, Ph.D., Chief Executive Officer and President of Immunic. "The main analysis of our phase 2 CALVID-1 trial showed evidence of clinical activity in hospitalized patients with moderate COVID-19, a highly encouraging result. The trial generated very meaningful clinical data which indicate that IMU-838 may have potential as a more convenient and highly effective therapeutic option for COVID-19. At the same time, we were also pleased to have just reported positive top-line data from the investigator-sponsored phase 2 proof-of-concept trial of IMU-838 in primary sclerosing cholangitis (PSC), which was conducted at Mayo Clinic. Achievement of a therapeutic benefit, combined with a statistically significant decrease in serum alkaline phosphatase in the per-protocol population and the other liver biochemistry parameters showing a stable pattern, is noteworthy and gives real hope to PSC patients, who currently have no treatment options."

"The strength of these results, including confirmation of the safety and tolerability of IMU-838, speaks volumes about its broad potential in numerous indications. Following the excellent efficacy and safety data from our phase 2 EMPhASIS trial in patients with relapsing-remitting multiple sclerosis (RRMS), which we announced in August and September 2020, respectively, we are on track to file our end-of-phase 2 submissions to regulatory authorities around the end of the first quarter and expect the outcome of the meetings, including our plans for a phase 3 program which we intend to begin in the second half of 2021, to be available around May of this year. Data from our fully enrolled 60-subject Cohort 2 sub-trial of IMU-838 in RRMS, intended to obtain dose response data in patients receiving 10 mg/day of IMU-838 or placebo for 24 weeks, is anticipated at the end of March or in early April, and should serve to de-risk our phase 3 discussions with regulatory authorities."

Dr. Vitt continued, "Our ability to measurably bolster our balance sheet in 2020 reflects investors’ belief in the core value of our technology and pipeline potential, and the approximately $127.5 million in cash and cash equivalents at year-end should fund us through significant clinical milestones into the second half of 2022. Given our progress and expectations for each of our clinical programs, during the fourth quarter of 2020, we announced the formation of a Scientific-Medical Advisory Board. The Board’s inaugural members include some of the most highly distinguished authorities in inflammatory and autoimmune diseases, including Drs. Fred D. Lublin, Bruce E. Sands, Jerrold R. Turner and Paul J. Utz. The experience and guidance of these internationally recognized experts will be invaluable as we continue to advance our pipeline going forward."

Fourth Quarter 2020 and Subsequent Highlights

February 2021: Reported positive top-line data from the investigator-sponsored phase 2 proof-of-concept clinical trial of IMU-838 in PSC, conducted in collaboration with investigators at Mayo Clinic. Data showed a statistically significant decrease in serum alkaline phosphatase (ALP) levels (p=0.041) in the 11-patient per-protocol (PP) population after 24-weeks of treatment, as compared to baseline. Additionally, the primary objective, a clinically relevant reduction of serum ALP higher than 25% without an increase in liver biochemistry of more than 33%, was achieved in 27.3% of the patients in the PP population at week 24, as compared to baseline. Other liver biochemistry parameters evaluated, including aspartate aminotransferase (AST), alanine aminotransferase (ALT), and total/direct/indirect bilirubin, remained stable in both the ITT and PP populations, and IMU-838’s favorable safety and tolerability profile was confirmed in the patient population.
February 2021: Announced top-line clinical efficacy, safety, disease marker and virology data from the main analysis of the phase 2 CALVID-1 trial of IMU-838 in hospitalized patients with moderate COVID-19. While primary and key secondary endpoints were not evaluable due to the very low rates of serious complications in the study population of hospitalized patients with moderate COVID-19, the data did show clinical activity based on multiple secondary endpoints, including (1) clinically meaningful improvements in time to clinical recovery and time to clinical improvement; (2) a substantial treatment effect on high-risk patients and those over 65 years of age; (3) an anti-viral effect of IMU-838 on SARS-CoV-2, as observed by viral titers; (4) a robust anti-inflammatory effect, based on a more effective reduction of C-Reactive Protein (CRP) in treated patients, as compared to placebo; and (5) an indication, based on initial data from a post hoc analysis of "Long COVID" symptoms, that IMU-838 may have the potential to contribute to the prevention of long-term fatigue. IMU-838 was also found to be safe and well-tolerated in hospitalized patients with moderate COVID-19.
December 2020: Announced Immunic’s addition to the Nasdaq Biotechnology Index, which is designed to track the performance of a set of securities listed on The Nasdaq Stock Market that are classified as either biotechnology or pharmaceutical according to the Industry Classification Benchmark.
November 2020: Announced the formation of a Scientific-Medical Advisory Board. Initial members include Drs. Fred D. Lublin, Bruce E. Sands, Jerrold R. Turner and Paul J. Utz, all internationally recognized experts in their respective fields of inflammatory and autoimmune diseases.
November 2020: Announced 200 patients enrolled and randomized in phase 2 CALVID-1 trial of IMU-838 for the treatment of moderate COVID-19, allowing for main phase 2 efficacy analysis to proceed.
October 2020: Signed financing agreement with the European Investment Bank for up to €24.5 million (approximately $29 million) to support the development of IMU-838 in patients with moderate COVID-19.
Activities Relating to the Preparation of a Phase 3 Program for IMU-838 in RRMS

As previously announced, the full unblinded clinical data from the company’s phase 2 trial of IMU-838 in patients with RRMS showed achievement of all primary and key secondary endpoints, with high statistical significance. Notably, the 30 and 45 mg/day doses of IMU-838 appear to be equally safe and efficacious, reducing the number of combined unique active (CUA) magnetic resonance imaging (MRI) lesions up to week 24, as compared to placebo. Based on established regulatory guidance that the lowest effective dose should be considered for future clinical trials, Immunic may propose the dose of 30 mg/day of IMU-838 for investigation in a phase 3 program.

Given the relative equal performance of the two doses tested and to allow for pharmacodynamic modeling of the dose-response relationship, data from a lower dose in the effective dose range would be beneficial to complete a dose-effect assessment of IMU-838 in RRMS. For this reason, Immunic is conducting an additional, small Cohort 2 sub-trial to obtain exploratory data on the expanded dose response of IMU–838, as previously announced. This additional, double-blind assessment, now fully enrolled, includes a cohort of approximately 60 patients who receive 10 mg/day of IMU-838 or placebo for 24 weeks. The results are not expected to change any conclusions for dosing of IMU-838 in a future phase 3 program. Rather, the sub-trial is expected to provide additional data to address any potential regulatory requests in the context of the design of a phase 3 program. An unblinded interim analysis of selected MRI data is planned after all Cohort 2 patients have completed week 12 MRI assessments. The Company expects this data to be available at the end of March or in early April 2021. Immunic believes that the foregoing strategy for IMU-838 in RRMS will enable risk reduction for end-of-phase 2 discussions with regulatory agencies.

Immunic intends to submit formal end-of-phase 2 meeting requests to discuss the proposed phase 3 program with major regulatory authorities around the end of the first quarter of 2021. The outcome of the end-of-phase 2 meetings are expected to be available in or about May 2021. As previously announced, in parallel to the preparation and execution of the regulatory discussions, Immunic has begun performing formal feasibility activities for a phase 3 program of IMU-838 in RRMS, including country and site selection, as well as other preparatory activities. Immunic plans to announce details on the design of the envisaged phase 3 program in RRMS after its end-of-phase 2 meetings with regulatory authorities. The phase 3 program is expected to start in the second half of 2021.

Additional Anticipated Clinical Milestones

IMU-838 in COVID-19: A final analysis of all 223 randomized patients from the phase 2 CALVID-1 trial, which will comprise data on all endpoints, including subgroup and sensitivity analyses, is expected to be available in the second quarter of 2021.
IMU-838 in Ulcerative Colitis (UC): Recruitment of the phase 2 CALDOSE-1 trial of IMU-838 in patients with UC is expected to be completed in the second half of 2021 and top-line data of the induction phase is expected to be available in the first half of 2022, as previously announced.
IMU-935 phase 1 program: The current, single ascending dose (SAD) part of the ongoing phase 1 trial of IMU-935 is planned to be followed by a multiple ascending dose (MAD) portion in healthy volunteers, which is expected to start in the first quarter of 2021. Unblinded safety data from the SAD and MAD parts in healthy volunteers is expected to be available in the second half of 2021. Initiation of the third portion of the phase 1 trial in patients with mild-to-moderate psoriasis is expected around mid-2021 and is expected to last approximately 12 months.
Potential IMU-935 phase 2 trial in Guillain-Barré syndrome: Upon completion of at least the first two cohorts of the MAD portion in healthy volunteers of the ongoing phase 1 trial, Immunic anticipates that it may also begin a phase 2a proof-of-concept clinical trial of IMU-935 in Guillain-Barré syndrome. This orphan approach may allow for an accelerated path to approval, in parallel to IMU-935’s previously planned development in psoriasis. The company plans to announce additional details as soon as design and timing of the envisaged trial are defined.
IMU-856 phase 1 program: The current, SAD part of the ongoing phase 1 trial of IMU-856 is planned to be followed by a MAD portion in healthy volunteers, which is expected to start in the first quarter of 2021. Unblinded safety data from the SAD and MAD parts in healthy volunteers is expected to be available in the second half of 2021. Initiation of the third portion of the phase 1 trial in patients with several diseases involving bowel barrier dysfunction is expected in the second half of 2021.
Financial and Operating Results

Research and Development (R&D) Expenses were $38.6 million for the twelve months ended December 31, 2020, as compared to $22.5 million for the same period ended December 31, 2019. The $16.1 million increase was primarily due to (i) a $9.6 million increase in external development costs for IMU-838 related to the phase 2 clinical trial in patients with COVID-19 since the trial was started in 2020, (ii) a $5.0 million increase in license fees, drug supply and phase 1 costs related to IMU-856 since this trial ramped up in 2020, (iii) a $2.1 million increase in drug supply, phase 1 and preclinical costs related to IMU-935 since this trial ramped up in 2020, (iv) a $1.5 million increase in personnel costs, (v) a $0.7 million increase in drug supply costs related to IMU-838, and (vi) a $0.7 million increase for a bioequivalence study related to IMU-838. The increases were partially offset by (i) a $2.0 million decrease related to the phase 2 clinical trial of IMU-838 in patients with RRMS as the clinical trial came to an end in 2020, and (ii) a $1.5 million decrease in costs related to a phase 2 clinical trial in patients with Crohn’s disease.
General and Administrative (G&A) Expenses were $10.3 million for the twelve months ended December 31, 2020, as compared to $14.5 million for the same period ended December 31, 2019. The $4.2 million decrease was primarily due to (i) $5.1 million lower stock compensation expense as a result of non-recurring costs recorded in 2019 related to the transaction with Vital Therapies, (ii) $0.9 million of decreased legal, accounting and consultancy costs, and (iii) a $0.7 million decrease in travel costs due to worldwide travel restrictions in connection with the COVID-19 pandemic. The decrease was partially offset by (i) a $2.2 million increase in personnel expenses, and (ii) $0.3 million of increased costs across numerous categories.
Other Income was $5.0 million for the twelve months ended December 31, 2020, as compared to $2.1 million for the same period ended December 31, 2019. The $2.9 million increase was primarily attributable to (i) a $2.5 million foreign exchange gain on a $68.0 million intercompany loan between Immunic, Inc. and Immunic AG, and (ii) a $0.9 million increase in R&D tax incentives for clinical trials in Australia as a result of increased spending on clinical trials in Australia. This increase was partially offset by (i) the $0.4 million difference between the face value and fair value of the promissory note collected in full in September 2019 in connection with the sale of certain assets of Vital Therapies (ELAD Assets), offset by the $0.1 million write-off of the investment in Vital Therapies (Beijing) Company Limited included in the ELAD Assets sale, and (ii) a $0.2 million decrease of recognized income attributable to reimbursements of R&D expenses in connection with the option and licensing agreement with Daiichi Sankyo Co., Ltd.
Net Loss for the twelve months ended December 31, 2020 was approximately $44.0 million, or $2.81 per basic and diluted share, based on 15,663,826 weighted average common shares outstanding, compared to a net loss of approximately $35.0 million, or $4.52 per basic and diluted share, based on 7,722,269 weighted average common shares outstanding for the same period ended December 31, 2019.
Cash and Cash Equivalents, as of December 31, 2020, were $127.5 million, which management expects to be sufficient to fund operations into the second half of 2022.