On February 23, 2023 Theralink Technologies (OTC: THER) ("Theralink" or the "Company"), a precision oncology company with a novel phosphoprotein-based assay for advanced breast cancer, reported that the Company has begun receiving payments from third party payors for its advanced breast cancer assay (Press release, Theralink Technologies, FEB 23, 2023, View Source [SID1234627658]).

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Mick Ruxin, M.D., CEO of Theralink said, "We are extremely pleased to bring our game-changing testing technology to all beneficiaries in the U.S. Access to the latest cancer testing technology is paramount in order to make informed treatment decisions that will affect patient outcomes. The milestone of receiving third party payor paymentsis a testament to the value that Theralink provides to cancer patients and their oncologists by way of actionable information for expanded treatment options."

Theralink empowers physicians with new sources of actionable information with its patented, predictive, proteomic biomarker assay that assists oncologists with treatment decisions for their advanced breast cancer patients. Theralink’s patented Reverse Phase Protein Array (RPPA) technology measures the tumor cell levels of activated proteins, which no other US technology can do in a commercial, multiplexed environment. These activated proteins are the primary targets of most FDA-approved therapies and investigational drugs.

Dr. Ruxin concluded, "The above announcement speaks to our continued business growth and clinical influence as we work in a collaborative way with several U.S.-based cancer programs and private community practices as well as other stakeholders to improve access to care for all Americans affected by cancer."

On February 23, 2023 Amplia Therapeutics Limited (ASX: ATX), ("Amplia" or the "Company"), a company developing new approaches for the treatment of cancer and fibrosis, reported that Amplia Head of Translational Biology, Dr Terrie-Anne Cock, will present a lecture at the 2nd Next Generation Kinase Inhibitors Summit currently underway in Boston, USA (Press release, Amplia Therapeutics, FEB 23, 2023, View Source;[email protected] [SID1234627657]).

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The presentation, entitled ‘Targeting Focal Adhesion Kinase (FAK) for the treatment of cancer and fibrotic diseases’ describes preclinical and Phase 1 clinical data for Amplia’s lead FAK inhibitor AMP945. A copy of the presentation, to be given at Friday 6:30am AEDT, is attached to this announcement.

Amplia CEO, Dr Chris Burns, commented: "Being invited to present our research at such a highly respected, industry-focused conference devoted to kinase inhibitor drug development, reflects the importance of our research at Amplia and our standing in the kinase field, internationally. Further, it allows us to promote the quality of the work being conducted at Amplia to biotech and pharma companies around the world."

This ASX announcement was approved and authorised for release by the CEO of Amplia Therapeutics.

On February 23, 2023 Novocure (NASDAQ: NVCR reported financial results for the fourth quarter and full year ended December 31, 2022 (Press release, NovoCure, FEB 23, 2023, View Source [SID1234627656]). Novocure is a global oncology company working to extend survival in some of the most aggressive forms of cancer by developing and commercializing its innovative therapy, Tumor Treating Fields ("TTFields").

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"2022 was a year of solid execution for Novocure," said William Doyle, Novocure’s Executive Chairman. "In 2022, we generated over half a billion dollars in net revenues, expanded our international footprint, introduced our next generation arrays and announced results from multiple, successful pilot studies; and we have excellent momentum to start 2023. We announced that our pivotal LUNAR study met its primary overall survival endpoint and we have now completed enrollment in our pivotal PANOVA-3 study in pancreatic cancer and are just two patients away from completing enrollment in our pivotal METIS study in brain metastases from non-small cell lung cancer. Our teams are executing well and their achievements are building the foundations for the future of Novocure. We are looking forward to an eventful 2023."

"In my time at Novocure, I have never felt more engaged or excited," said Asaf Danziger, Novocure’s Chief Executive Officer. "The positive top-line readout from the pivotal LUNAR study marked the beginning of a transformational 24 months for Novocure. LUNAR is the first of four pivotal studies we expect to read out in the next two years which could dramatically increase the number of patients eligible for Tumor Treating Fields."

Financial updates for the full year and fourth quarter ended December 31, 2022:

Total net revenues for the year were $537.8 million, an increase of 1% year-over-year.
We recorded $32 million in revenue from the successful appeal of previously denied claims for Medicare fee-for-service beneficiaries billed prior to established coverage. We believe collections from previously denied claims were largely exhausted in 2022 and the remaining outstanding claims will take time to collect. As such, we expect future net revenue to more closely reflect core drivers of net revenue: number of active patients on therapy, duration of therapy, and net released price per month.
Total net revenues for the quarter were $128.4 million, a decrease of 4% year-over-year.
The United States, EMEA and Japan contributed $98.6 million, $17.0 million, and $7.9 million in quarterly net revenues, respectively.
Net revenues were impacted by the volume of cash collections from aged claims in the U.S., the ongoing impact of German coverage updates and foreign exchange fluctuations.
Revenue in Greater China from Novocure’s partnership with Zai Lab totaled $4.9 million.
Gross margin for the quarter was 78%.
Research, development and clinical studies expenses for the quarter were $54.8 million, a decrease of 4% from the same period in 2021.
Sales and marketing expenses for the quarter were $49.6 million, an increase of 27% from the same period in 2021.
General and administrative expenses for the quarter were $38.1 million, an increase of 23% from the same period in 2021.
Net loss for the quarter was $37.3 million with loss per share of $0.36.
Adjusted EBITDA* for the quarter was $(10.5) million.
Cash, cash equivalents and short-term investments were $969.4 million as of December 31, 2022.
Operational updates for the fourth quarter ended December 31, 2022:

As of December 31, 2022, there were 3,430 active patients on therapy, a decrease of 4% year-over-year. Active patients from North America, EMEA and Japan contributed 2,191, 870 and 369 active patients, respectively.
1,373 prescriptions were received in the quarter, a decrease of 4% year-over-year. Prescriptions from North America, EMEA and Japan contributed 956, 312 and 105 prescriptions, respectively.
Quarterly updates and achievements:

In February 2023, we announced that the final patient has been enrolled in the pivotal PANOVA-3 study in locally advanced pancreatic cancer.
In January 2023, we announced the top-line results for our pivotal LUNAR study in NSCLC. The LUNAR study met its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in overall survival over standard therapies (either immune checkpoint inhibitors or docetaxel) alone. The LUNAR study also showed a statistically significant and clinically meaningful improvement in overall survival when patients were treated with TTFields and immune checkpoint inhibitors ("ICI"), as compared to those treated with ICI alone, and a positive trend in overall survival when patients were treated with TTFields and docetaxel versus docetaxel alone.
Today, we are announcing the election of Dr. Allyson J. Ocean to the Board of Directors. Dr. Ocean serves as a medical oncologist and Associate Professor of Clinical Medicine at Weill Cornell Medicine.
Following receipt of CE Mark for its new array in November 2022, Novocure successfully began treating patients through the company’s European limited market release. The new thinner and lighter arrays are designed for more efficient TTFields delivery and greater comfort for patients with glioblastoma.
Anticipated clinical milestones:

Data from the pivotal LUNAR study in non-small cell lung cancer (1H 2023)
Data from the pivotal INNOVATE-3 study in recurrent ovarian cancer (2H 2023)
Top-line data from the pivotal METIS study in brain metastases (Q1 2024)
Data from the pivotal PANOVA-3 study in locally advanced pancreatic cancer (2024)
Conference call details

Novocure will host a conference call and webcast to discuss fourth quarter and full year 2022 financial results at 8:00 a.m. EST today, Thursday, February 23, 2023. Analysts and investors can participate in the conference call by using the following registration link, and dial-in details will be provided..

The webcast, earnings slides presented during the webcast and the corporate presentation can be accessed live from the Investor Relations page of Novocure’s website, www.novocure.com/investor-relations, and will be available for at least 14 days following the call. Novocure has used, and intends to continue to use, its investor relations website, as a means of disclosing material non-public information and for complying with its disclosure obligations under Regulation FD.

On February 23, 2023 Photocure ASA (OSE: PHO) reported Hexvix/Cysview revenues of NOK 94.9 million in the fourth quarter of 2022 (Q4 2021: NOK 94.2 million), and an EBITDA of minus NOK 16.9 million (NOK -5.5 million). The total revenues increased 10% to NOK 104.2 million and there were 57 blue light towers placed in the quarter, a record high for expanding the installed base of blue light cystoscopes (Press release, PhotoCure, FEB 23, 2023, View Source [SID1234627655]). Photocure expects to deliver new Saphira blue light tower installations in the range of 65 to 75, consolidated product revenue growth above 20%, and positive EBITDA (ex-business development spending) in 2023.

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"The fourth quarter of 2022 was highlighted by a record number of Saphira tower installations in the U.S., demonstrating ongoing high demand for blue light capital equipment and serving as a leading indicator of the growth opportunity ahead for Hexvix/Cysview. The fourth quarter also had its challenges as did the full year of 2022, including a multi-quarter delay in the launch of Saphira, healthcare worker staffing shortages which pressured urology procedure volumes, and hospital budget tightening as staffing shortages exacerbated broader inflationary pressures," says Dan Schneider, President & Chief Executive Officer of Photocure.

Photocure reported total group revenues of NOK 104.2 million in the fourth quarter of 2022 (NOK 94.5 million), and an EBITDA* of minus NOK 16.9 million (NOK -5.5 million). The Hexvix/Cysview revenues ended at NOK 94.9 million in the quarter (Q4 2021: NOK 94.2 million). The EBIT was NOK -23.1 million (NOK -11.5 million) and the cash balance at the end of the third quarter 2022 was NOK 268.1 million.

"I am proud of our commercial team’s ability to facilitate the placement of the highest number of towers ever recorded by Photocure in a single quarter, 57 installations of BLC towers. The logistics of placing this many systems in one quarter, with most new account installations occurring toward the end of Q4, required our commercial team to commit the majority of their time and focus on customer relations and training. Even with the unprecedented number of new Saphira and flexible BLC installations in the fourth quarter, the demand for blue light capital equipment remains strong," Schneider adds.

During the quarter, 31 new blue light towers were installed; 24 new Saphira cystoscopes and 7 flexible units. In addition, 26 OPP towers were installed during the fourth quarter. The installed base of blue light cystoscopes in the U.S. was 370 (311) at the end of the fourth quarter, a 19% increase from the same period last year. This includes 69 flexible cystoscopes, an increase of 44%.

"We expect to deliver Hexvix/Cysview revenue growth of 20%+ and generate positive EBITDA excluding business development spending in 2023, given the large number of new accounts that have recently activated blue light equipment in their facility, as well as the strong pipeline for anticipated Saphira tower installations. We are already seeing signs of positive sales trends in our North American business in early 2023, and in Europe, German hospital ordering patterns appear to be phasing back to normalized growth," Schneider continues.

After the closing of the quarter, Karl Storz informed Photocure of supply issues with components of its flexible BLC capital equipment that has paused sales of new flexible towers. Photocure and Karl Storz are in the process of assessing the issues and evaluating options to restore equipment availability. Photocure plans to provide an update on the situation as progress is made on the multiple strategies that it is undertaking to resolve the issue.

"While it is unfortunate that Karl Storz is not expected to ship additional flexible BLC equipment for some time, we expect that the higher Medicare reimbursement rates for blue light surveillance procedures will help us increase the throughput on existing flexible towers. Given these new circumstances, we will now focus on marketing Saphira rigid towers to ASC clinics so they can treat patients in their facilities with positive economics," Schneider says and concludes:

"In 2022, we encountered a series of external business challenges but were able to navigate through and make progress in broadening the access and use of blue light cystoscopy. We generated positive sales growth for the year, successfully worked with Karl Storz to execute a major capital equipment launch after several quarters of delay and strengthened our European commercial readiness for a normalized healthcare delivery environment. With account access now open in our major markets, the Saphira system now in position to create critical mass, and the potential for reclassification of blue light capital equipment in the U.S. market, we believe that 2023 will be an exciting year for Photocure."

Please find the full financial report and presentation enclosed.

EBITDA* and other alternative performance measures (APMs) are defined and reconciled to the IFRS financial statements as a part of the APM section of the fourth quarter 2022 financial report on page 22.

The quarterly report and presentation will be published at 08:00 CEST and will be publicly available at www.photocure.com. Dan Schneider, CEO and Erik Dahl, CFO, will host a live webcast at 14:00 CEST.

The presentation will be held in English and questions can be submitted throughout the event. The streaming event is available through https://channel.royalcast.com/landingpage/hegnarmedia/20230223_8/

The presentation is scheduled to conclude at 14:45 CEST.

On February 23, 2023 Immunic, Inc. (NASDAQ: IMUX), a biotechnology company developing a clinical pipeline of orally administered, small molecule therapies for chronic inflammatory and autoimmune diseases, reported financial results for the year ended December 31, 2022, and provided a corporate update (Press release, Immunic, FEB 23, 2023, View Source [SID1234627654]).

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"We made significant progress throughout the year in advancing our lead asset, vidofludimus calcium, for the treatment of multiple sclerosis (MS). Our next MS-related data inflection point, expected in the second half of 2023, is an interim analysis of our phase 2 CALLIPER trial in progressive MS, which will provide selected biomarker data to guide study progress," stated Daniel Vitt, Ph.D., Chief Executive Officer and President of Immunic. "As previously announced, the CALLIPER trial is designed to corroborate the neuroprotective potential of vidofludimus calcium, which, if confirmed, would provide an additional key differentiator for the drug in the MS market. Furthermore, we look forward to reporting data from the interim analysis of the phase 3 ENSURE program late next year and to read-out the first of our identical, twin phase 3 ENSURE trials in relapsing MS at the end of 2025. Considering the promising clinical activity observed, thus far, along with vidofludimus calcium’s established safety and tolerability profile, we believe that the design of the ENSURE program gives us a straightforward path toward potential regulatory approval in relapsing MS. Vidofludimus calcium has the potential to be a unique treatment option targeted to the biology of MS, differentiated by its combined anti-inflammatory, antiviral and neuroprotective effects."

"Our second clinical asset, IMU-935, recently received the proposed International Nonproprietary Name (INN), izumerogant, from the World Health Organization. We plan to provide further updates and guidance on potential next steps for our phase 1b clinical trial in patients with moderate-to-severe psoriasis towards the end of the first quarter of 2023."

Dr. Vitt continued, "During our recently held celiac disease R&D webcast, we shared that IMU-856 appears to influence the tightly regulated network of genes and proteins associated with intestinal epithelial cell interaction and adhesion, restoring intestinal barrier function while maintaining immunocompetency. These characteristics indicate that IMU-856 could possibly present an entirely new and innovative approach for the treatment of a number of gastrointestinal diseases, including celiac disease, without the serious consequences associated with immunosuppressive therapies. We believe IMU-856 has the potential to be a first-in-class oral celiac disease therapy. We expect to report data from the ongoing Part C of our phase 1 clinical trial in celiac disease patients mid this year."

Fourth Quarter 2022 and Subsequent Highlights

February 2023: Announced that Robert J. Fox, M.D., Staff Neurologist, Mellen Center for Multiple Sclerosis, Vice-Chair for Research, Neurologic Institute, Cleveland Clinic, Cleveland, Ohio, presents data from the blinded and open-label extension parts of the phase 2 EMPhASIS trial of vidofludimus calcium in relapsing-remitting MS at the eighth annual Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum 2023.
February 2023: Hosted a celiac disease R&D webcast. Management was joined by two renowned key opinion leaders to discuss the dynamics of this multifactorial, complex autoimmune disease, immune stimulation and its connection to clinical symptoms, the role of the epithelial barrier in the pathogenesis of the disease, current and potential treatment options and the continued unmet medical need for effective therapeutics, which is driving an increased focus within the industry.
November 2022: Reported new data from the phase 2 EMPhASIS trial of vidofludimus calcium in relapsing-remitting MS. The data was highly encouraging, showing that long-term open-label treatment with vidofludimus calcium was associated with a low rate of confirmed disability worsening over time, which compares favorably to historical trial data for currently available MS medications.
October 2022: Reported a pre-planned interim group-level data analysis of the phase 1b clinical trial of izumerogant in patients with moderate-to-severe psoriasis. Group averages for Psoriasis Area and Severity Index (PASI) reductions in the first two active arms did not separate from placebo at four weeks due to an unexpectedly high placebo rate. Although these active arms performed in line with expectations, based on similarly designed trials, the trial experienced a greater decrease than expected in PASI in the placebo arm. Administration of izumerogant and placebo were demonstrated to be safe and well-tolerated, and no new safety signals were observed.
October 2022: Closed a $60 million private placement with participation from new and existing institutional investors.
Anticipated Clinical Milestones

Vidofludimus calcium in MS: As previously announced, data from the interim analysis of the phase 2 CALLIPER trial of vidofludimus calcium in progressive MS is expected to be available in the second half of 2023 and top-line data at the end of 2024. Moreover, data from the interim analysis of the ENSURE program is expected in late 2024, with the read-out of the first of the ENSURE trials at the end of 2025.
Izumerogant (IMU-935) phase 1 program in psoriasis: Immunic plans to provide further updates and guidance on potential next steps for the phase 1 clinical trial of izumerogant in patients with moderate-to-severe psoriasis towards the end of the first quarter of 2023.
IMU-856 phase 1 program in celiac disease: The ongoing Part C of the phase 1 program is a double-blind, randomized, placebo-controlled trial designed to assess the safety and tolerability of IMU-856 during 28 days of treatment with 80 and 160 mg of IMU-856 or placebo, once daily, in patients with celiac disease during periods of gluten-free diet and gluten challenge. Secondary objectives include pharmacokinetic as well as acute and chronic disease markers, including those evaluating acute response on the biomarker interleukin-2 (IL-2) and gastrointestinal architecture and inflammation. Initial results are expected to be available in mid-2023.
Financial and Operating Results

Research and Development (R&D) Expenses were $71.3 million for the twelve months ended December 31, 2022, as compared to $61.1 million for the twelve months ended December 31, 2021. The $10.1 million increase reflects (i) a $18.4 million increase in external development costs related to the ongoing clinical programs of vidofludimus calcium in relapsing and progressive MS, as well as izumerogant and IMU-856, and (ii) a $2.5 million increase in personnel expense in research and development, $1.5 million of which is related to non-cash stock compensation expense. The increases were partially offset by (i) a decrease of $10.1 million in external development costs related to the clinical trials of vidofludimus calcium in ulcerative colitis, COVID-19 and relapsing-remitting MS, and (ii) a decrease of $0.7 million in external development costs across numerous categories.

General and Administrative (G&A) Expenses were $15.3 million for the twelve months ended December 31, 2022, as compared to $13.3 million for the same period ended December 31, 2021. The $2.0 million increase was primarily due to (i) a $1.6 million increase in personnel expense in general and administrative, $0.5 million of which is related to non-cash stock compensation expense, (ii) a $0.3 million increase in travel expenses, and (iii) a $0.1 million net increase across numerous categories.

Other Income (Expense) was ($0.9 million) for the twelve months ended December 31, 2022, as compared to ($1.3 million) for the same period ended December 31, 2021. The $0.4 million decrease in expense was primarily attributable to (i) a $1.0 million increase in interest income as a result of higher interest rates, and (ii) a $0.5 million increase in research and development tax incentives for clinical trials in Australia as a result of increased spending on clinical trials in Australia. This was offset by a $1.1 million decrease in grants.

Impairment of Goodwill: The company recorded a non-cash, goodwill impairment of approximately $33.0 million in the fourth quarter of 2022, which represents a full write down of its previous goodwill balance. The impairment resulted from the announcement of the interim group-level data of the phase 1b clinical trial of izumerogant in psoriasis on October 20, 2022, the company’s stock price experienced a significant decline from the prices preceding the announcement. The company considered this to be a triggering event, indicating that it is more likely than not that goodwill is impaired.

Net Loss for the twelve months ended December 31, 2022, was approximately $120.4 million, or $3.78 per basic and diluted share, based on 31,819,006 weighted average common shares outstanding, compared to a net loss of approximately $92.9 million, or $3.93 per basic and diluted share, based on 23,652,779 weighted average common shares outstanding for the same period ended December 31, 2021.

Cash, Cash Equivalents and Investments as of December 31, 2022, were $116.4 million. With these funds, Immunic expects to be able to fund its operations into the fourth quarter of 2024.
Webcast Information

Immunic will host a webcast today at 8:00 am ET. To participate in the webcast, please register in advance at: View Source or on the "Events and Presentations" section of Immunic’s website at: ir.imux.com/events-and-presentations. Registrants will receive a confirmation email containing a link for online participation or a telephone number for dial in access.

An archived replay of the webcast will be available approximately one hour after completion on Immunic’s website at: ir.imux.com/events-and-presentations.