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]).

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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]).

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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]).

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"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.

On October 24, 2023 Ono reported that it has entered into a research collaboration agreement with Turbine (London, UK; CEO and Co-Founder: Szabolcs Nagy), a computational biology company that deploys empirically validated in silico cell simulations to guide biopharma R&D, to identify and validate novel therapeutic targets in the field of oncology (Press release, Ono, OCT 24, 2023, View Source [SID1234646640]).

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Under the terms of the agreement, Turbine will apply its end-to-end, interpretable cell simulation technology, the Simulated Cell platform, to the in silico discovery of novel targets for potential therapeutic development. Turbine will also conduct in vitro mechanism validation of identified targets in its state-of-the-art laboratory facility and manage in vivo validation studies. Ono will exclusively develop and commercialize drug candidates to the targets identified by Turbine worldwide. Ono will pay to Turbine an up-front payment, research funding, milestone payments based on the completion of target identification and validation by Turbine, as well as milestones on the progress of drug development and commercialization by Ono.

 "We appreciate Turbine’s AI-driven cell simulation platform for discovering novel therapeutic targets that cannot be identified using traditional approaches. Turbine will also provide information on the mechanisms of action and biomarkers of the target, which can accelerate drug development in Ono," said Toichi Takino, Senior Executive Officer / Executive Director, Discovery & Research of Ono. "Through this collaboration, we are committed to expanding our oncology development pipeline and bringing new therapeutic options to cancer patients with high unmet needs."

 "Ono has a history of developing transformative cancer therapies, including its important role in launching Opdivo (Generic name: nivolumab), the first ever approved PD-1 immune checkpoint inhibitor," said Szabolcs Nagy, Chief Executive Officer and Co-Founder of Turbine. "We believe that our cutting-edge cell simulation technology will enable the discovery of additional targets to fuel the expansion of Ono’s oncology pipeline. We are excited for the opportunity to demonstrate the combination of our Simulated Cells and proprietary validation assays that both enable validating computational predictions and drive the development of an ever more predictive simulation of human biology."

About Simulated Cell technology
 Turbine’s Simulated Cell technology leverages machine learning to build an end-to-end, interpretable cell simulation platform based on protein interactome and additional omics layers. The virtual cells capture patient biology better than currently available experimental models and are used for in silico experiments having never been run in the lab, testing more drug-like effects than current high throughput genetic screening approaches. Validating the uncovered hypotheses of causality in Turbine’s state-of-the-art laboratory facility and using the resulting data as feedback further improves the model’s predictive prowess. Informing biopharma R&D through in silico experiments improves the likelihood of success for truly novel therapies and allows existing assets to be optimally targeted at responder patients.

On October 24, 2023 Lipella Pharmaceuticals Inc. (Nasdaq: "LIPO") ("Lipella," "our," "us" or the "Company"), a clinical-stage biotechnology company addressing serious diseases with significant unmet need, reported the entry, on October 23, 2023, into definitive agreements for the purchase and sale, in a private placement transaction priced at-the-market under Nasdaq rules, ofpre-funded warrants to purchase up to an aggregate of 1,315,790 shares and warrants to purchase up to an aggregate of 1,315,790 shares (Press release, Lipella Pharmaceuticals, OCT 24, 2023, View Source [SID1234636377]). The purchase price for each pre-funded warrant and accompanying warrant is $1.519.

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H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

The warrants will have an exercise price of $1.40 per share, will be immediately exercisable upon issuance, and will expire three years from the date of issuance. The offering is expected to close on or about October 25, 2023, subject to the satisfaction of customary closing conditions.

The gross proceeds to Lipella from the private placement are expected to be approximately $2 million, before deducting the placement agent’s fees and other offering expenses payable by the Company. The Company intends to use the net proceeds for working capital and for general corporate purposes.

The offer and sale of the securities described above are being offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act"), and Regulation D promulgated thereunder, and such securities, along with the shares of common stock underlying the warrants and pre-funded warrants, have not been registered under the Act, or applicable state securities laws. Accordingly, the securities issued in the private placement and the shares of common stock underlying the warrants and pre-funded warrants, may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Act and such applicable state securities laws.

The Company has agreed to file an initial registration statement with the Securities and Exchange Commission ("SEC") covering the resale of the shares of common stock underlying the warrants and pre-funded warrants, no later than seven business days following the date of the definitive agreements and to have the registration statement declared effective no later than 75 days following the date of the definitive agreements in the event of a "full review" by the SEC.

This press release does not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or other 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 other jurisdiction.