On October 25, 2023 Hepion Pharmaceuticals, Inc. (NASDAQ:HEPA), a clinical stage biopharmaceutical company focused on Artificial Intelligence ("AI")-driven therapeutic drug development for the treatment of non-alcoholic steatohepatitis ("NASH"), fibrotic diseases, hepatocellular carcinoma ("HCC"), and other chronic diseases, reported the publication of a new research study in mice, where Hepion’s lead drug candidate, rencofilstat, prevented the growth of liver tumors that occurred as a result of chronic infection with the human hepatitis C virus ("HCV") (Press release, Hepion Pharmaceuticals, OCT 25, 2023, View Source [SID1234636327]).

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

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

                  Schedule Your 30 min Free Demo!

The study was published in the peer-reviewed, open access scientific journal, Viruses, and was conducted by Drs. Winston Stauffer, Philippe Gallay, and colleagues at The Scripps Research Institute (La Jolla, California). Mice were infected with HCV, which caused the development of small liver nodules at around 12 weeks post-infection that progressed to very large tumors by 24 weeks post-infection. Daily rencofilstat treatment was initiated at week 0 or later time points:

When initiated at week 0, rencofilstat treatment completely prevented HCC development measured at week 30 likely because the drug also blocked HCV infection and therefore eliminated a key driver of HCC development;
When initiated at week 12, when tumors were in a small nodular stage, rencofilstat treatment similarly resulted in no visible nodules or tumors at week 30, suggesting that rencofilstat was able to completely regress small cancerous nodules; and
When initiated at week 16, when livers contained many small-to-medium-sized nodules and tumors, rencofilstat treatment resulted in significantly decreased numbers and sizes of tumors ("tumor burden") measured at week 30, which also indicated preventative or regressive anti-tumor activity.
To investigate whether some of rencofilstat’s anti-HCC effects occurred independent of its anti-HCV activity, rencofilstat was compared to the anti-HCV agents sofosbuvir and velpatasvir, which belong to the recently developed direct-acting class of HCV drugs representing billions of dollars in annual sales.

Sofosbuvir, velpatasvir and rencofilstat treatments initiated at week 16 all eliminated HCV infection. However, only rencofilstat decreased tumors when measured at week 30. Sofosbuvir and velpatasvir-treated mice developed the same large tumor burden as mice that received no drug treatment, whereas the tumor burden of rencofilstat-treated mice was 80% lower.

"These results highlight one of rencofilstat’s greatest strengths, which is the ability to exert pleiotropic effects that can be harnessed to treat multiple diseases," said Dr. Daren Ure, Hepion’s Chief Scientific Officer. "This contrasts with highly selective drugs that target single mechanisms, such as the currently available anti-HCV drugs that do not effectively treat liver cancer arising from HCV infection. We believe that rencofilstat is the ideal treatment for this kind of cancer as it stops viral replication and suppresses cancer through separate and complementary pathways."

Dr. Robert Foster, Hepion’s CEO, added "The antiviral, anti-cancer, and antifibrotic activities of rencofilstat address many of the most deadly and prevalent diseases affecting people today. Not only could rencofilstat have an enormous impact on human health, but the investment growth opportunities associated with treating these high-need, global-scale diseases are equally large."

Hepion recently announced a new mechanism by which rencofilstat exerts anti-cancer activity in liver cancer and the drug’s anti-cancer activity in numerous cell lines representing 86% of cancer types.

The Viruses journal article, entitled "The Cyclophilin Inhibitor Rencofilstat Decreases HCV-Induced Carcinoma Independently of Its Antiviral Activity", can be accessed here.

On October 25, 2023 Enterome, a clinical-stage company developing first-in-class immunomodulatory drugs for solid and liquid malignancies and inflammatory diseases based on its unique Mimicry platform, reported that Pierre Bélichard, CEO, will present an overview of the Company and participate in 1-on-1 meetings with institutional investors at the following investor meetings (Press release, Enterome, OCT 25, 2023, View Source [SID1234636326]):

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

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

                  Schedule Your 30 min Free Demo!

10th China Healthcare Summit in Shanghai, China, November 2-3
– Enterome’s presentation is scheduled on November 2 at 2:45 pm in Function Room III.

Inv€$tival Showcase in London, UK, November 13
– Enterome’s presentation is scheduled at 10:30 am on Stage 3.

Jefferies’ London Healthcare Conference, UK, November 14-16
42ndP. Morgan Annual Healthcare Conference in San Francisco, USA,
January 8-11

Additionally, Enterome’s Senior Business Development Manager, Rachel Morra, will engage in 1-on-1 meetings with potential business partners at BIO-Europe, which will take place in Munich, Germany, on November 6-8.

On October 25, 2023 CYTEA|BIO, reported that it has completed a formal pre-IND consultation with FDA for CYT-102, the company’s lead product, consisting of monoclonal antibody armed donor NK cells, constructed using the proprietary Pin arming technology and designed for post-surgery treatment of glioblastoma multiforme (GBM), a devastating disease and the most common form of brain cancer (Press release, CYTEA BIO, OCT 25, 2023, View Source [SID1234636325]).

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

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

                  Schedule Your 30 min Free Demo!

FDA review has confirmed no red flags and no significant CMC, non-clinical or clinical impediments to completion of all pre-clinical activities and progression to first clinical studies. CYTEA|BIO expects clinical studies to commence within about 15-18 months of closing a Series A investment round currently in progress.

The company has also completed an EMA "scientific advice" consultation with a similar outcome.
CYTEA|BIO will also leverage CYT-102 for other oncology applications, and to utilize common manufacturing technologies for multiple additional products without further significant development efforts.

Alan Cookson, CEO of CYTEA|BIO said: "These are important milestones for the company and for our unique Pin platform which will greatly simplify the development, manufacture, and roll out of multiple product configurations. The use of normal allogeneic effector cell constructs using conventional ligands obviates the need for cell modification and secures common manufacturing methodologies for whole families of products. Regulators in the USA and Europe have recognized the potential of this approach and provided encouraging and helpful advice which will now enable the company to plan the completion all pre-clinical activities for the lead indication".

On October 25, 2023 AnaptysBio presented its corporate presentation (Presentation, AnaptysBio, OCT 25, 2023, View Source [SID1234636324]).

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

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

                  Schedule Your 30 min Free Demo!

On October 25, 2023 Alkermes plc (Nasdaq: ALKS) reported financial results for the third quarter of 2023 (Press release, Alkermes, OCT 25, 2023, View Source [SID1234636323]).

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

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

                  Schedule Your 30 min Free Demo!

"With solid performance across our proprietary commercial portfolio, the successful settlement of the VIVITROL patent litigation, and progress toward completion of the separation of our oncology business, we have made significant strides to evolve the business into a pure-play neuroscience company with the potential to generate strong profitability and cash flow," said Richard Pops, Chief Executive Officer of Alkermes. "Our presentation at this week’s World Sleep Congress of the first-in-human safety and tolerability data and initial proof-of-concept data for ALKS 2680, our investigational, orexin 2 receptor agonist for the treatment of narcolepsy, represents an important milestone for that development program. We look forward to sharing additional data from the phase 1 study and advancing ALKS 2680 into a planned phase 2 program next year."

"Our third quarter results demonstrate the financial strength of the business, driven by top-line year-over-year growth, strategic capital allocation and our focus on delivering value to shareholders," commented Iain Brown, Chief Financial Officer of Alkermes. "Upon planned completion of the separation of the oncology business in the coming weeks, the remaining neuroscience business will be positioned to deliver enhanced profitability as we focus on growing our proprietary commercial products and advancing the key programs that we believe will drive future growth."

Quarter Ended Sept. 30, 2023 Financial Results

Revenues

– Total revenues for the quarter were $380.9 million, compared to $252.4 million for the same period in the prior year.

– Net sales of proprietary products for the quarter increased approximately 16% to $231.8 million, compared to $199.4 million for the same period in the prior year.

Net sales of VIVITROL were $99.3 million, compared to $96.5 million for the same period in the prior year, representing an increase of approximately 3%.
Net sales of ARISTADAi were $81.8 million, compared to $75.7 million for the same period in the prior year, representing an increase of approximately 8%.
Net sales of LYBALVI were $50.7 million, compared to $27.1 million for the same period in the prior year, representing an increase of approximately 87%.
– Manufacturing and royalty revenues for the quarter were $149.1 million, compared to $52.9 million for the same period in the prior year.

Royalty revenues from INVEGA SUSTENNA/XEPLION, INVEGA TRINZA/TREVICTA and INVEGA HAFYERA/BYANNLI for the quarter were $76.1 million. The company recorded royalty revenues from these products of $26.7 million for the same period in the prior year. This increase was driven by the favorable resolution of the arbitration proceedings related to these products in the second quarter of 2023.
Manufacturing and royalty revenues from VUMERITY for the quarter were $34.6 million, compared to $26.3 million for the same period in the prior year.
Costs and Expenses

– Total operating expenses for the quarter were $337.1 million, compared to $313.0 million for the same period in the prior year. This increase was driven primarily by investment in the launch of LYBALVI and expenses associated with the planned separation of the oncology business.

Cost of Goods Manufactured and Sold was $61.5 million, compared to $50.6 million for the same period in the prior year.
Research and Development (R&D) expenses were $97.1 million, compared to $100.4 million for the same period in the prior year.
Selling, General and Administrative (SG&A) expenses were $169.4 million, compared to $152.8 million for the same period in the prior year.
Profitability

– Net income according to generally accepted accounting principles in the U.S. (GAAP) was $47.8 million for the quarter, or a GAAP basic earnings per share of $0.29 and diluted earnings per share of $0.28, based on 166.6 million and 171.9 million shares outstanding, respectively. This compared to GAAP net loss of $64.0 million, or a basic and diluted GAAP loss per share of $0.39, for the same period in the prior year.

– Non-GAAP net income was $109.5 million for the quarter, or a non-GAAP basic earnings per share of $0.66 and diluted earnings per share of $0.64, based on 166.6 million and 171.9 million shares outstanding, respectively. This compared to non-GAAP net income of $3.5 million, or a non-GAAP basic and diluted earnings per share of $0.02, for the same period in the prior year.

Balance Sheet

– At Sept. 30, 2023, the company recorded cash, cash equivalents and total investments of $995.6 million, compared to $907.2 million at June 30, 2023. The company’s total debt outstanding as of Sept. 30, 2023 was $291.4 million.

Financial Expectations for 2023

Alkermes reiterated its financial expectations for full-year 2023, as set forth in its press release dated June 6, 2023.

Separation of Oncology Business

– Alkermes expects to complete the separation of its oncology business into a new, independent publicly-traded company, Mural Oncology plc (Mural), in November 2023, subject to various customary conditions, including final approval from Alkermes’ board of directors. Alkermes expects to capitalize Mural with cash of $275 million upon completion of the separation.

– In October 2023, members of Mural’s designated management team held an investor webcast to provide an overview of its pipeline and strategy. A replay is available on the Investors section of Alkermes’ website at www.alkermes.com.

Recent Events

Neuroscience

– In October 2023, the company presented initial phase 1 clinical data related to ALKS 2680, the company’s novel, investigational orexin 2 receptor agonist in development for the treatment of narcolepsy, at the World Sleep Congress. The presentation included safety and tolerability data from single- and multiple-ascending dose evaluations in healthy volunteers and initial Maintenance of Wakefulness Test proof-of-concept data in four patients with narcolepsy type 1.

– In September 2023, the company presented multiple posters highlighting real-world and clinical data related to its psychiatry portfolio at Psych Congress 2023.

Corporate

– In September 2023, the company published its latest Corporate Responsibility Report, which details how the company integrates environmental, social and governance considerations into its business. A copy of the report is available on the Responsibility section of Alkermes’ website.

– In August 2023, the company entered into a settlement agreement with Teva Pharmaceuticals USA, Inc. (Teva) to resolve the patent litigation between the parties related to VIVITROL. Pursuant to the terms of the settlement agreement, the company has granted Teva a license under the company’s U.S. Patent No. 7,919,499 to market a generic version of VIVITROL in the United States beginning Jan. 15, 2027, or earlier under certain customary circumstances.

Conference Call

Alkermes will host a conference call and webcast presentation with accompanying slides at 8:00 a.m. ET (1:00 p.m. BST) on Wednesday, Oct. 25, 2023, to discuss these financial results and provide an update on the company. The webcast may be accessed on the Investors section of Alkermes’ website at www.alkermes.com. The conference call may be accessed by dialing +1 877 407 2988 for U.S. callers and +1 201 389 0923 for international callers. In addition, a replay of the conference call may be accessed by visiting Alkermes’ website.