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Allogene Therapeutics to Report Fourth Quarter and Year-End 2022 Financial Results on February 28, 2023

On February 21, 2023 Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T) products for cancer, reported that it will report fourth quarter and year-end 2022 financial results on Tuesday, February 28, 2023, after the close of the market (Press release, Allogene, FEB 21, 2023, View Source [SID1234627433]). The announcement will be followed by a live audio webcast and conference call at 2:00 PM Pacific Time/5:00 PM Eastern Time.

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Listen-Only Webcast
The listen-only webcast will be made available on the Company’s website at www.allogene.com under the Investors tab in the News and Events section. A replay will be available on the Company’s website for approximately 30 days.

Conference Call Registration
If you would like the option to ask a question on the conference call, please use this link to register. Upon registering for the conference call, you will receive a personal PIN to access the call.

Biocity has been granted an IND for WEE1 inhibitor SC0191

On February 20, 2023 Biocity Biopharma reported that the US Food and Drug Administration (FDA) has granted its Investigational New Drug (IND) application for SC0191, a WEE1 inhibitor as monotherapy and in combination with chemotherapy for the treatment of cancer (Press release, Biocity Biopharmaceutics, FEB 20, 2023, View Source [SID1234633308]).

"We are thrilled to have received IND approval for SC0191 as monotherapy and in combination with chemotherapy," said Yongjiang Hei, M.D., Ph.D., Co-CEO of Biocity "This is an important milestone for us, and we look forward to advancing SC0191 into clinical trials to assess its safety and efficacy in patients with cancer. We believe that the combination of SC0191 with chemotherapy has the potential to increase the response rate and duration of response in a variety of cancer types, and we look forward to seeing the results of our clinical trials."

The Phase 1/2 clinical trial of SC0191 will evaluate the safety, tolerability, and pharmacokinetics and preliminary anti-tumor effects of SC0191 as monotherapy and in combination with chemotherapy in patients with selected advanced or metastatic solid tumors. The trial is expected to begin enrolling patients in the near future, and Biocity is committed to conducting clinical trials with the highest standards of quality and patient safety.

Revolutionary X-Ray Innovation Set to Transform Cancer Treatment and Clinical Radiography

On February 20, 2023 Lumitron Technologies, Inc., a company pioneering the development of a unique x-ray system, HyperVIEW EBCS, reported its underlying accelerator technology has successfully generated electron beams that, for the first time, enable electron FLASH radiotherapy for a variety of next generation cancer treatments (Press release, Lumitron Technologies, FEB 20, 2023, View Source [SID1234627419]).

"Our accelerator has produced a train of 100 consecutive, high-charge and perfectly timed micro-bunches of electrons at 99.982% of the speed of light or an energy equivalent of 25 MeV, in ten billionths of a second. This ultrashort duration and high energy has the potential to dramatically reduce the side effects of conventional radiotherapy," said Lumitron CTO and co-founder, Dr. Chris Barty.

According to Dr. Charles Limoli, professor radiation oncology at the University of California, Irvine (UCI) School of Medicine and a FLASH radiotherapy expert, "Dr. Barty has advanced electron beam technology to the stage that it can provide clinically relevant doses of Very High Energy Electrons (VHEE) exceeding the requirements of electron FLASH radiotherapy – in an instrument that can fit inside a standard clinical bunker. This remarkable achievement places Lumitron’s technology years ahead of other groups developing high-energy electron irradiators that are more costly and at least five times larger."

The accelerator that produced these electron beams is part of Lumitron Technologies’ compact HyperVIEW EBCS (Extremely Bright Compton Source) x-ray technology. HyperVIEW is the most significant change in clinical and industrial x-ray imaging in over 125 years and will enable revolutionary new capabilities for medical imaging, therapy, materials detection, and other applications across multiple industries. Comparable in size to an MRI or CT instrument, HyperVIEW EBCS is designed to collide a beam of near-light-speed electrons with a laser beam to produce high-energy x-ray beams. These beams will enable medical imaging at resolutions 1,000 times higher and/or doses 100 times lower than conventional x-rays, with dramatically shorter imaging times than conventional MRI of soft tissues.

This will enable the first application of Phase Contrast Imaging outside of billion-dollar, large-scale synchrotron facilities and will allow practitioners to image down to a cellular level at the point of care, in a hospital or clinic. Advanced 3D manufacturing will benefit dramatically from Lumitron Technologies’ ability to image dense objects such as medical implants and aircraft turbine components with unprecedented accuracy and speed.

Australian-based Lumitron Co-Founder and Executive Chairman, Mr. Maurie Stang said, "The system will provide up to a thousand times improvement in image detail, far lower X-ray dose and the ability to treat simultaneously at the same cellular level, which is set to transform the landscape for both patients and practitioners. A range of immunotherapies and contrast agents enabled by the ultra-bright Lumitron laser-based x-ray is being developed here in Australia leveraging the world-class expertise Australia enjoys in life sciences. We aim to not have to remove a breast or prostate due to the unmatched capabilities of the Lumitron system."

Dr. Barty, who was previously the CTO of the National Ignition Facility Directorate at the Lawrence Livermore National Laboratory which recently achieved nuclear fusion ignition for the first time further added, "The Lumitron laser-based x-ray technology leverages hundreds of millions of dollars of investment by the leading US research labs to bring compact, electron beam and x-ray systems into commercial reality. While initial deployment of the technology targets unmet needs in clinical and industrial imaging, Lumitron’s unique platform has applicability across an incredibly wide array of additional and impactful applications."

With respect to HyperVIEW EBCS x-ray source development, Lumitron Technologies has been awarded multiple US Government research contracts in addition to having several active programs with major industry leaders in healthcare and non-destructive materials analysis. Further, the company has signed an agreement with one of the world’s largest commercial imaging groups showing the potential for wide-scale adoption of this breakthrough technology.

Clinical data presented at ASCO GU demonstrates reduced risk of recurrence in non-muscle invasive bladder cancer with the use of BLC

On February 20, 2023 Photocure ASA, The Bladder Cancer Company, reported the presentation of clinical data from the Veterans Affairs (VA) BRAVO study at the ASCO (Free ASCO Whitepaper) Genitourinary Cancers Symposium (ASCO GU) which was held February 16-18, 2023 in San Francisco, USA (Press release, PhotoCure, FEB 20, 2023, View Source [SID1234627418]). The clinical data demonstrated a significant decrease in the risk of recurrence & longer time to recurrence following Blue Light cystoscopy (BLC) with Cysview compared to White Light cystoscopy (WLC) alone.

ASCO GU is a meeting of up to 5 000 healthcare professionals focused on genitourinary cancers, offering the latest information on scientific advances in the study, diagnosis and treatment of GU malignancies. The program is known for being highly interactive with multidisciplinary perspectives and attracts a global audience. Presentations include the latest science and evidence-based information on optimal patient care.

Dr. Steven Williams, University of Texas-Medical Branch, Galveston, presented the study abstract "The Impact of Blue Light Cystoscopy Use Among Non-Muscle Invasive Bladder Cancer Patients in an Equal Access Setting: Implications on Recurrence and Time to Recurrence Stratified by Race".

The study was conducted with support from Photocure and aims to describe bladder cancer outcomes and the impact of blue light cystoscopy (BLC) with Cysview among non-muscle invasive bladder cancer (NMIBC) patients in an equal access setting, i.e., the United States Veterans Affairs Healthcare System (VA). Patients diagnosed with NMIBC within the VA who received BLC were assessed to determine overall recurrence rates as well as the association between race and recurrence, progression, and overall survival outcomes.

A total of 378 patients were included in the analysis, of which 43 (11%) were African American and 300 (79%) were Caucasian. The results showed that the median time to first recurrence following BLC vs. WLC was significantly longer overall (40 vs. 26 months, p<0.001) and across all time points, respectively, in the cohort. A significant decrease in risk of recurrence following BLC utilization compared to WLC alone was also determined (HR, 0.70, p=0.005). With regard to race stratification, the analysis showed no significant difference between African American and Caucasian patients for recurrence, progression and overall survival.

"Our findings demonstrate increased support for blue light cystoscopy’s clinical role in reducing bladder cancer recurrence, and that equal access to health care can achieve equitable outcomes. These data support current AUA/SUO guidelines recommending BLC usage in patients with NMIBC to increase detection and decrease recurrence." said Dr. Steven Williams, Professor and Chief of the Division of Urology, at the University of Texas-Medical Branch, and one of the study authors.

*Read about the abstract: View Source

Note to editors

Hexvix/Cysview and BLC are registered trademarks of Photocure ASA.

This press release may contain product details and information which are not valid, or a product that is not accessible, in your country. Please be aware that Photocure does not take any responsibility for accessing such information, which may not comply with any legal process, regulation, registration, or usage in the country of your origin.

About Bladder Cancer

Bladder cancer ranks as the 8th most common cancer worldwide – the 5th most common in men – with 1 720 000 prevalent cases (5-year prevalence rate)1a, 573 000 new cases and more than 200 000 deaths annually in 2020.1b

Approx. 75% of all bladder cancer cases occur in men.1 It has a high recurrence rate, with up to 61% in year one and up to 78% over five years.2 Bladder cancer has the highest lifetime treatment costs per patient of all cancers.3

Bladder cancer is a costly, potentially progressive disease for which patients have to undergo multiple cystoscopies due to the high risk of recurrence. There is an urgent need to improve both the diagnosis and the management of bladder cancer for the benefit of patients and healthcare systems alike.

Bladder cancer is classified into two types, non-muscle invasive bladder cancer (NMIBC) and muscle-invasive bladder cancer (MIBC), depending on the depth of invasion in the bladder wall. NMIBC remains in the inner layer of cells lining the bladder. These cancers are the most common (75%) of all cases and include the subtypes Ta, carcinoma in situ (CIS), and T1 lesions. In MIBC, the cancer has grown into deeper layers of the bladder wall. These cancers, including subtypes T2, T3, and T4, are more likely to spread and are harder to treat.4

1 Globocan. a) 5-year prevalence / b) incidence/mortality by population. Available at: View Source, accessed [January 2022].
2 Babjuk M, et al. Eur Urol. 2019; 76(5): 639-657
3 Sievert KD et al. World J Urol 2009;27:295–300
4 Bladder Cancer. American Cancer Society. View Source

About Hexvix/Cysview (hexaminolevulinate HCl)

Hexvix/Cysview is a drug that preferentially accumulates in cancer cells in the bladder, making them glow bright pink during Blue Light Cystoscopy (BLC). BLC with Hexvix/Cysview, compared to standard white light cystoscopy alone, improves the detection of tumors and leads to more complete resection, fewer residual tumors, and better management decisions.

Cysview is the tradename in the U.S. and Canada, Hexvix is the tradename in all other markets. Photocure is commercializing Cysview/Hexvix directly in the U.S. and Europe and has strategic partnerships for the commercialization of Hexvix/Cysview in China, Chile, Australia, New Zealand and Israel. Please refer to View Source for further information on our commercial partners.

Bavarian Nordic A/S Announces Completion of Directed Issue of 7,046,839 New Ordinary
Shares

On February 20, 2023 Bavarian Nordic A/S ("Bavarian Nordic" or the "Company") reported its intention to raise new capital through an accelerated bookbuilding process (Press release, Bavarian Nordic, FEB 20, 2023, View Source [SID1234627415]). The offering (the "Offering") of new shares (the "New Shares") in Bavarian Nordic has now been successfully completed. Reference is made to company announcement no. 05 of 20 February 2023.

Bavarian Nordic has successfully completed a directed issue and private placement of 7,046,839 new shares at an offer price of DKK 233 per share, raising gross proceeds to Bavarian Nordic of DKK 1,642 million.

The Offering has not been registered under the U.S. Securities Act and was made pursuant to applicable exemptions from the obligation to publish a prospectus in Denmark as well as exemptions from the U.S. Securities Act and the securities laws of other applicable jurisdictions in a directed issue and private placement and subscribed for by eligible qualified institutional and professional investors in Denmark and in certain other jurisdictions at market price and without pre-emption rights for Bavarian Nordic’s existing shareholders.

The net proceeds from the Offering will be used in accordance with company announcement no. 05 of 20 February 2023.

As the Offering was oversubscribed, an individual allocation of the New Shares was made.

Bavarian Nordic has in connection with the Offering, agreed to undertake a lock-up commitment for 180 calendar days following settlement of the Offering (subject to certain exceptions). In addition, members elected at the general meeting of Bavarian Nordic’s board of directors as well as members of the executive management have in connection with the Offering, agreed to undertake a lock-up commitment for 90 calendar days following settlement of the Offering (subject to certain exceptions).

CAPITAL INCREASE

Subject to settlement, a share capital increase will be registered with the Danish Business Authority and the share capital of Bavarian Nordic will hereafter consist of 77,782,215 shares of DKK 10 each, equivalent to a registered share capital of DKK 777,822,150.

The New Shares represent approximately 9.96% of Bavarian Nordic’s registered share capital before the capital increase and will account for approximately 9.06% of Bavarian Nordic’s registered share capital upon completion of the capital increase.

ADMISSION TO TRADING AND OFFICIAL LISTING

The New Shares will be issued under the temporary ISIN code DK0062266201. No application for admission to trading and official listing has been, or will be, filed for the New Shares issued under the temporary ISIN code, and the temporary ISIN code will only be registered with VP Securities A/S ("Euronext Securities") for subscription of the New Shares. The temporary ISIN code in Euronext Securities will be merged with the permanent ISIN code for the existing shares, DK0015998017, as soon as possible following registration of the share capital increase with the Danish Business Authority. The New Shares are expected to be admitted to trading and official listing on Nasdaq Copenhagen A/S, in the permanent ISIN code for the existing shares, DK0015998017, on or around 24 February 2023.

The admission to trading and official listing of the New Shares is subject to the Offering not being withdrawn prior to the settlement of the Offering and the Company making an announcement to that effect.

EXPECTED TIMETABLE FOR THE OFFERING

Date

Event Expected Thursday 23 February 2023 Settlement and payment for the New Shares
Expected Thursday 23 February 2023 Registration of the capital increase with the Danish Business Authority
Expected Friday 24 February 2023 Admission to trading and official listing of the New Shares on Nasdaq Copenhagen A/S Expected Monday 27 February 2023 Merger of the temporary ISIN code with the permanent ISIN code in the system of Euronext Securities

NEW SHARES

The decision to launch an offering of new shares in a directed issue was made pursuant to Article 5a(2) in Bavarian Nordic’s articles of association pursuant to which its board of directors is authorised to make share capital increases without preemption rights for the existing shareholders at market price.

The New Shares will rank pari passu in all respects with existing shares in Bavarian Nordic. The New Shares will be negotiable instruments, and no restrictions will apply to their transferability. No shares, including the New Shares, carry or will carry any special rights. Rights conferred by the New Shares, including voting rights and dividend rights, will apply from the time when the capital increase is registered with the Danish Business Authority. The New Shares must be registered in the name of the holder in the Company’s register of shareholders.

JOINT GLOBAL COORDINATORS AND JOINT BOOKRUNNERS

Danske Bank A/S, Morgan Stanley & Co. International plc and Nordea Danmark, filial af Nordea Bank Abp, Finland are acting as Joint Global Coordinators and Joint Bookrunners in connection with the Offering (jointly the "Joint Global Coordinators and Joint Bookrunners").

Kromann Reumert and Latham & Watkins LLP act as Danish and U.S. legal advisors respectively to the Company. Plesner acts as Danish legal advisors to the Joint Global Coordinators and Joint Bookrunners.