On August 06, 2024 COSCIENS Biopharma Inc. (formerly Aeterna Zentaris Inc.) (NASDAQ: AEZS) (TSX: AEZS) ("COSCIENS" or the "Company"), a specialty biopharmaceutical company developing and commercializing a diversified portfolio of pharmaceutical and diagnostic products and active ingredients for healthcare and cosmetics industries, reported that the Company’s name has been changed from "Aeterna Zentaris Inc." to "COSCIENS Biopharma Inc.", effective as of August 6, 2024 (the "Name Change") (Press release, COSCIENS Biopharma, AUG 6, 2024, View Source;b=2533&ID=136661&m=rl&g=1592 [SID1234647477]).

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In addition, the Company announces that, effective as of August 9, 2024, the Company’s common shares (the "Common Shares") will begin trading on the Toronto Stock Exchange (the "TSX") and NASDAQ Capital Market (the "NASDAQ") under the trading symbol "CSCI" and will concurrently cease trading thereon under the former trading symbol "AEZS".

At the Company’s annual general and special meeting of shareholders held on July 16, 2024, the shareholders of the Company approved a special resolution authorizing the board of directors of the Company to effect the Name Change. Implementation of the Name Change remains subject to the final approval of the TSX and the NASDAQ.

There is no change in the capitalization of the Company in connection with the Name Change and no action will be required by existing shareholders or warrantholders of COSCIENS in connection with the Name Change. Certificates representing Common Shares and warrants of the Company (the "Warrants") will not be affected by the Name Change and will not need to be exchanged. The Company encourages any shareholder or warrantholder with any questions or concerns to contact the Company or to discuss any of the foregoing with their broker or agent.

The new CUSIP number for the Common Shares is 22112H101, and the new ISIN for the Common Shares is CA22112H1010. In addition, the new CUSIP number for the Warrants is 22112H119, and the new ISIN for the Warrants is CA22112H1192.

On August 6, 2024 Amgen reported second quarter earnings (Presentation, Amgen, AUG 6, 2024, View Source [SID1234647196]).

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On August 6, 2024 Immuneering Corporation (Nasdaq: IMRX), a clinical-stage oncology company seeking to develop and commercialize universal-RAS/RAF medicines for broad populations of cancer patients, reported financial results for the second quarter ended June 30, 2024, and provided business updates (Press release, Immuneering, AUG 6, 2024, View Source [SID1234647169]).

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"Our IMM-1-104 Phase 2a trial is enrolling well across all arms, and we are on track to share initial data from multiple arms this year," said Ben Zeskind, Ph.D., Co-founder, and Chief Executive Officer of Immuneering. "Each arm represents an important unmet need, including first-line pancreatic cancer patients, which are the focus of both our recent Fast Track designation and multiple arms of the trial, including two arms evaluating IMM-1-104 in combination with established chemotherapy regimens. As we reported at AACR (Free AACR Whitepaper) in April, these combinations in animal models showed deeper and more durable tumor growth inhibition than either treatment alone. We believe these arms are also of interest because of the Phase 1 topline data we released in March, in which IMM-1-104 monotherapy was observed to be exceptionally well-tolerated and shrank at least one target lesion in about half of pancreatic cancer patients. We are also evaluating IMM-1-104 in monotherapy arms for patients with RAS mutant melanoma and RAS mutant lung cancer, cancer types for which IMM-1-104 has demonstrated encouraging preclinical data, along with a monotherapy arm evaluating IMM-1-104 in first and second-line pancreatic cancer patients. Finally, the Phase 1 dose escalation of IMM-6-415 is progressing well in patients with advanced solid tumors with RAF or RAS mutations, and we plan to report initial PK, PD and safety data this year. All in all, we are looking forward to a data-rich second half of 2024."

Corporate Highlights

FDA Fast Track Designation for IMM-1-104 in First-line Pancreatic Cancer: In July 2024, the U.S. Food and Drug Administration (FDA) granted Fast Track designation for IMM-1-104, as a first-line treatment for patients with pancreatic ductal adenocarcinoma (PDAC).

Preclinical Data Presented at AACR (Free AACR Whitepaper) Demonstrating that IMM-1-104 is Synergistic with Chemotherapy in Pancreatic Cancer Models: In April 2024, Immuneering presented preclinical data at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, demonstrating that combining IMM-1-104 with chemotherapies used in the treatment of first-line pancreatic cancer yielded deeper and more durable tumor growth inhibition than either treatment alone, which the Company views as supportive of its ongoing Phase 2a clinical trial of IMM-1-104 in RAS-mutated advanced or metastatic solid tumors.
Near-Term Milestone Expectations

IMM-1-104

Initial data from multiple arms of the Phase 2a portion of the Company’s Phase 1/2a trial expected in 2H 2024.
IMM-6-415

Initial pharmacokinetic (PK), pharmacodynamic (PD) and safety data from the Phase 1 portion of the Company’s Phase 1/2a trial expected in 2H 2024.
Second Quarter 2024 Financial Highlights

Cash Position: Cash, cash equivalents and marketable securities as of June 30, 2024 were $59.7 million, compared with $85.7 million as of December 31, 2023.

Research and Development (R&D) Expenses: R&D expenses for the second quarter of 2024, were $10.7 million compared with $9.5 million for the second quarter of 2023. The increase in R&D expenses was primarily attributable to higher clinical costs related to the Company’s lead program and increased personnel to support ongoing research and development activities.

General and Administrative (G&A) Expenses: G&A expenses for the second quarter of 2024 were $4.3 million, compared with $4.0 million for the same period of 2023. The increase in G&A is primarily attributed to an increase in the Company’s stock-based compensation costs and various other costs related to the general and administrative functions.

Net Loss: Net loss attributable to common stockholders was $14.1 million, or $0.47 per share, for the second quarter ended June 30, 2024, compared to $12.2 million, or $0.43 per share, for the second quarter ended June 30, 2023. 

2024 Financial Guidance

Based on cash and cash equivalents as of June 30, 2024, and current operating plans, the Company expects its cash runway to be sufficient to fund operations into the second half of 2025.

On August 6, 2024 Bayer reported its Half-Year Financial Report 2024 (Presentation, Bayer, AUG 6, 2024, View Source [SID1234646084]).

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On August 6, 2024 Precigen, a biopharmaceutical company specializing in the development of innovative gene and cell therapies to improve the lives of patients, reported a strategic reprioritization of the Company’s clinical portfolio and streamlining of resources, including a reduction of over 20% of its workforce, to focus on potential commercialization of the PRGN-2012 AdenoVerse gene therapy for the treatment of recurrent respiratory papillomatosis (RRP) (Press release, Precigen, AUG 6, 2024, View Source [SID1234646014]).

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These strategic changes substantially reduce required resources for non-priority programs and will enable the Company to focus on pre-commercialization efforts on PRGN-2012, including supporting submission of a rolling biologics license application (BLA) under an accelerated approval pathway anticipated in the second half of 2024, conducting the confirmatory clinical trial, and manufacturing of commercial product. Additionally, the Company will continue acceleration of commercial readiness efforts for a potential launch in 2025, led by the Company’s new Chief Commercial Officer, Phil Tennant.

Strategic prioritization will also include:

PRGN-2009 AdenoVerse Gene Therapy Clinical Trials: The Company plans to continue PRGN-2009 Phase 2 trials under a cooperative research and development agreement (CRADA) with the National Cancer Institute (NCI) in recurrent/metastatic cervical cancer and in newly diagnosed HPV-associated oropharyngeal cancer. PRGN-2009 clinical trial enrollment at non-NCI clinical sites will be paused.
UltraCAR-T Clinical Programs: The Company has completed enrollment of the Phase 1b trial for PRGN-3006 in acute myeloid leukemia (AML), which received Fast Track designation from the US Food and Drug Administration (FDA), and is preparing for an end of Phase 1b meeting with the FDA to discuss next steps. The Company will pause all other UltraCAR-T clinical programs, including PRGN-3005 and PRGN-3007. The Company will minimize UltraCAR-T spend and focus on strategic partnerships to further advance UltraCAR-T programs.
Preclinical Programs: The Company will pause all preclinical programs.
ActoBio: The Company has initiated a shutdown of its Belgium-based ActoBio subsidiary operations, including planned elimination of all ActoBio personnel. In conjunction with this shutdown, ActoBio’s portfolio of intellectual property will be made available for prospective transactions.
"We are on track toward our goal of submitting a rolling BLA for PRGN-2012 in the second half of this year and we are pleased to announce that the confirmatory clinical trial, an important step guided by the FDA to support an accelerated approval, has already been initiated and is actively enrolling patients," said Helen Sabzevari, PhD, President and CEO of Precigen. "These prioritization steps enhance our ability to rapidly prepare for potential commercialization of PRGN-2012, which if approved, we believe has the safety, efficacy, and route of administration profile to be the first and best-in-class therapy for RRP patients."

Please refer to the Company’s 8-K filing for additional details.

Precigen: Advancing Medicine with Precision
Precigen (Nasdaq: PGEN) is a dedicated discovery and clinical stage biopharmaceutical company advancing the next generation of gene and cell therapies using precision technology to target the most urgent and intractable diseases in our core therapeutic areas of immuno-oncology, autoimmune disorders, and infectious diseases. Our technologies enable us to find innovative solutions for affordable biotherapeutics in a controlled manner. Precigen operates as an innovation engine progressing a preclinical and clinical pipeline of well-differentiated therapies toward clinical proof-of-concept and commercialization. For more information about Precigen, visit www.precigen.com or follow us on X @Precigen, LinkedIn or YouTube.

AdenoVerse
Precigen’s AdenoVerse platform utilizes a library of proprietary adenovectors for the efficient gene delivery of therapeutic effectors, immunomodulators, and vaccine antigens designed to modulate the immune system. Precigen’s gorilla adenovectors, part of the AdenoVerse library, have potentially superior performance characteristics as compared to current competition. AdenoVerse gene therapies have been shown to generate high-level and durable antigen-specific T-cell immune responses as well as an ability to boost these responses via repeat administration. Superior performance characteristics and high yield manufacturing of AdenoVerse vectors leveraging UltraVector technology allows Precigen to engineer cutting-edge investigational gene therapies to treat complex diseases.

About PRGN-2012 AdenoVerse Gene Therapy
PRGN-2012 is an investigational off-the-shelf AdenoVerse gene therapy designed to elicit immune responses directed against cells infected with human papillomavirus (HPV) 6 or HPV 11 for the treatment of RRP. PRGN-2012 was the first to receive Breakthrough Therapy Designation and an accelerated approval pathway for RRP from the US Food and Drug Administration (FDA). PRGN-2012 received Orphan Drug Designation from the FDA and from the European Commission. Results from the Phase 1 portion of the Phase 1/2 study were published in the peer-reviewed journal, Science Translational Medicine, a leading publication from the American Association for the Advancement of Science (AAAS). Pivotal data was presented at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting.

Trademarks
Precigen, AdenoVerse, UltraVector, and Advancing Medicine with Precision are trademarks of Precigen and/or its affiliates.