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Mural Oncology Announces Fourth Quarter and Year End 2023 Financial Results and Provides Business Update

On March 26, 2024 Mural Oncology plc (Nasdaq: MURA), a clinical-stage immuno-oncology company developing novel, investigational engineered cytokine therapies designed to address areas of unmet need for patients with a variety of cancers, reported its financial results for the fourth quarter and year ended December 31, 2023, and provided a business update (Press release, Mural Oncology, MAR 26, 2024, View Source [SID1234641450]).

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"We have made significant progress since becoming an independent company during the fourth quarter of 2023. We have amplified the company’s strong talent by bringing in world-class leaders in immuno-oncology. To date, nemvaleukin has generated promising data with durable responses both in monotherapy and in PD-1 combination across a range of solid tumor types. We expect our current cash reserves to fund our operations, including multiple clinical development programs, into 4Q 2025 and we are selectively exploring partnerships to further investigate the significant potential of both nemvaleukin and our preclinical programs," said Caroline Loew, Ph.D., Chief Executive Officer of Mural Oncology. "This year, we plan to continue to advance our late-stage clinical trials, including evaluating less frequent IV dosing for nemvaleukin. We also look forward to presenting pre-clinical data from our IL-18 and IL-12 programs at multiple oncology conferences and nominating candidates for each this year."

Recent Corporate Highlights and Upcoming Milestones

Mural Oncology spun out of Alkermes and became an independent, publicly traded immuno-oncology company in November 2023. Now led by an experienced and highly accomplished oncology-focused leadership team and board of directors, the company is leveraging its core competencies in immune cell modulation and protein engineering to develop a portfolio of investigational cytokine therapies designed to address areas of unmet need for patients with solid tumors.

Mural Oncology has completed evaluation of the less frequent IV (LFIV) dosing regimen of nemvaleukin in ARTISTRY-3, and determined the recommended phase 2 dose selection to be 30 µg/kg, to be evaluated in cohort 3 of ARTISTRY-6:

The new dosing regimen, a shift from five daily infusions (days 1-5) per three-week cycle to two infusions (on days 1 and 8) per three-week cycle, did not result in additional observed tolerability issues compared to previous studies of nemvaleukin. Notably, there were no dose-limiting toxicities at any dose tested and the desired pharmacodynamic effects were seen with twice per cycle dosing.
The company plans to evaluate the LFIV nemvaleukin dosing regimen in the open-label cohort 3 of ARTISTRY-6, the company’s ongoing phase 2 trial, to explore the safety and efficacy of this new dosing regimen in a homogeneous patient population.
The company looks forward to presenting data from ARTISTRY-3 at an upcoming medical conference.
Enrollment in ARTISTRY-6 and ARTISTRY-7 is ongoing:

Cohort 2 of ARTISTRY-6 is a potentially registrational, phase 2 trial evaluating nemvaleukin as a monotherapy in 90 mucosal melanoma patients. The company expects to report top-line data results from cohort 2 of ARTISTRY-6 in the first half of 2025.
Cohort 3 of ARTISTRY-6 is an open label extension of the trial that will evaluate the recommended phase 2 LFIV dosing regimen from ARTISTRY-3 as a monotherapy and in combination with pembrolizumab in approximately 50 patients with cutaneous melanoma. The company expects to report top-line data for monotherapy from cohort 3 of ARTISTRY-6 in the first half of 2025 and for the pembrolizumab combination in the second half of 2025.
ARTISTRY-7 is a potentially registrational, phase 3 trial evaluating nemvaleukin in combination with pembrolizumab compared to investigators’ choice chemotherapy in 448 patients with platinum-resistant ovarian cancer. Mural expects to report interim overall survival (OS) results based on approximately 75% of events in the first quarter of 2025 and final OS results in the second quarter of 2026.

Mural Oncology will present preclinical IL-18 and IL-12 data for the first time at the upcoming AACR (Free AACR Whitepaper) conference.

The company intends to nominate development candidates for these engineered IL-18 and IL-12 therapies later this year.
Financial Results for the Quarter Ended December 31, 2023

Cash Position: As of December 31, 2023, cash and cash equivalents were $270.9 million.

R&D Expenses: Research and development expenses were $42.2 million for the fourth quarter of 2023 and were primarily due to employee-related expenses and expenses related to ARTISTRY-7. These expenses included $5.6 million of non-cash, share-based compensation expenses.

G&A Expenses: General and administrative expenses were $16.3 million for the fourth quarter of 2023, including $9.7 million in non-cash, share-based compensation expenses.

Net Loss: Net loss was $59.5 million for the fourth quarter of 2023. This included $15.2 million non-cash, share-based compensation, of which approximately $11.7 million was driven by one-time charges related to the separation from Alkermes and conversion of employee equity during the fourth quarter of 2023.
Financial Guidance

The company’s cash resources are expected to fund its operations into the fourth quarter 2025.
After the spin out from Alkermes on November 15, 2023, the company incurred certain non-cash, share-based compensation, most of which was one-time in nature, and this is reflected in today’s reported results. Furthermore, the company’s 2023 financial results reflect carve-out financials until the date of the spin out. The company anticipates reporting lower operating expenses in the quarters going forward.
About Nemvaleukin
Nemvaleukin is a novel, engineered cytokine designed to leverage antitumor effects of the IL-2 pathway while mitigating its hallmark toxicities that limit its use. Nemvaleukin selectively binds to the intermediate-affinity IL-2 receptor (IL-2R) and is sterically occluded from binding to the high-affinity IL-2R. Because of this molecular design, nemvaleukin treatment leads to preferential expansion of antitumor CD8+ T cells and natural killer cells, with minimal expansion of immunosuppressive regulatory T cells. Nemvaleukin is currently being evaluated in two potentially registrational late-stage trials.

Immunome Completes Acquisition of AL102, a Phase 3 Asset for the Treatment of Desmoid Tumors, From Ayala

On March 26, 2024 Immunome, Inc. (Nasdaq: IMNM), a biotechnology company focused on developing first-in-class and best-in-class targeted cancer therapies, reported the successful completion of its purchase of AL102 and related drug candidate AL101 from Ayala Pharmaceuticals, Inc (Press release, Immunome, MAR 26, 2024, View Source [SID1234641448]).

"AL102 is a high-quality asset that complements our existing pipeline of targeted cancer therapies," said Clay B. Siegall, Ph.D., President and Chief Executive Officer of Immunome. "We believe that AL102 can establish a new standard of care for the treatment of desmoid tumors. In parallel, we are excited to advance our preclinical programs towards Phase 1 trials."

AL102 is an investigational small molecule gamma secretase inhibitor currently being evaluated in the randomized Phase 3 RINGSIDE international trial for the treatment of desmoid tumors – a debilitating soft tissue malignancy. AL102 is a potential once-daily oral treatment for desmoid tumors. Data from clinical trials have shown AL102 may be more effective in treating desmoid tumors than OGSIVEO (nirogacestat), which recently became the first treatment approved for desmoid tumors by the U.S. Food and Drug Administration in November 2023.

iBio Announces $15.0 Million Private Placement

On March 26, 2024 iBio, Inc. (NYSEA:IBIO) ("iBio" or the "Company"), an AI-driven innovator of precision antibody immunotherapies, reported that it has entered into a securities purchase agreement for a private investment in public equity ("PIPE") financing that is expected to result in gross proceeds to the Company of approximately $15.0 million, before deducting placement agent fees and offering expenses (Press release, iBioPharma, MAR 26, 2024, View Source [SID1234641447]).

The fully subscribed PIPE financing included participation from ADAR1 Capital Management, Lynx1 Capital Management, Ikarian Capital and other institutional and accredited investors. The Company intends to use the net proceeds from the offering for general corporate purposes, including research and development and working capital. The Company also expects the net proceeds will extend its cash runway to fund its operating plan through fiscal year 2025.

"We appreciate the support of this outstanding group of healthcare specialist investors that shares the vision of leveraging our cutting-edge AI/Machine learning platform to deliver best-in-class drugs," said iBio’s Chief Executive Officer and Chief Scientific Officer, Martin Brenner, DVM, Ph.D.

Pursuant to the terms of the securities purchase agreement, the Company is selling an aggregate of 5,287,278 shares of common stock (or pre-funded warrant in lieu thereof) and common warrants to purchase up to 5,287,278 shares of common stock at a purchase price of $2.85 per share (or pre-funded warrant in lieu thereof), subject to certain beneficial ownership limitations set by each holder. The warrants issued in the offering are exercisable six (6) months upon issuance at an exercise price of $2.64 per share and will expire five years from the date of issuance.

Chardan acted as the sole placement agent for the PIPE financing.

The unregistered shares of common stock, pre-funded warrants and warrants sold in the PIPE financing described above were offered under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act") and Regulation D promulgated thereunder and, along with the shares of common stock underlying the pre-funded warrants and warrants, have not been registered under the Act or applicable state securities laws. Accordingly, the shares of common stock, the pre-funded warrants, the warrants and the shares of common stock underlying the pre-funded warrants and warrants may not be offered or sold in the United States absent registration with the Securities and Exchange Commission ("SEC") or an applicable exemption from such registration requirements. The securities were offered only to accredited investors. Pursuant to the terms of the securities purchase agreement with the investors, the Company has agreed to file one or more registration statements with the SEC covering the resale of the unregistered shares of common stock and the shares issuable upon exercise of the unregistered pre-funded warrants and warrants.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

FibroGen to Present at 23rd Annual Needham Virtual Healthcare Conference

On March 26, 2024 FibroGen, Inc. (NASDAQ: FGEN) reported that Thane Wettig, Chief Executive Officer, will participate in a corporate presentation at the 23rd Annual Needham Virtual Healthcare Conference on Tuesday, April 9, 2024, from 3:00-3:40 PM Eastern Time (Press release, FibroGen, MAR 26, 2024, View Source [SID1234641446]). Company management will also participate in virtual one-on-one meetings with investors during the conference.

The live audio webcast of the event will be available to investors and other interested parties on the "Events & Presentations" section of the FibroGen Investor webpage at www.fibrogen.com. A replay will be available for 30 days.

Enveric Biosciences Reports Financial Results and Provides Corporate Update for Fourth Quarter and Fiscal Year Ended 2023

On March 26, 2024 Enveric Biosciences (NASDAQ: ENVB) ("Enveric" or the "Company"), a biotechnology company dedicated to the development of novel neuroplastogenic small-molecule therapeutics for the treatment of depression, anxiety, and addiction disorders, reported a corporate update and provided financial results for the fourth quarter of 2023 and fiscal year ended December 31, 2023 (Press release, Enveric Biosciences, MAR 26, 2024, View Source [SID1234641445]).

"The fourth quarter of 2023 and early 2024 was a significant period for Enveric, highlighted by the selection of EB-003 as our lead development candidate. We believe EB-003 is a groundbreaking, neuroplastogen drug candidate that offers the potential to treat severe mental health disorders without the hallucinogenic effect typically associated with psychedelic-based molecules," said Joseph Tucker, Ph.D., Director and CEO of Enveric. "Based on numerous discussions with large pharmaceutical companies, mental health professionals, and leading researchers, we believe it is evident that widespread market acceptance of psychedelic-inspired drugs will ultimately be determined by the ability to administer such medications in an outpatient setting. We believe minimizing the hallucinatory effect will be key to seizing this opportunity and was critical in our decision to select EB-003 as our lead product candidate of the EVM301 series. We now look forward to advancing preclinical activities in early 2024 in support of filing an IND for EB-003 as we seek to introduce a new treatment paradigm for depression and anxiety disorders."

Dr. Tucker continued, "The decision to designate EB-003 as our lead candidate was the culmination of an extensive design and evaluation process. This effort included the creation of more than one thousand compounds around which we have built a substantial intellectual property estate, increasing the attractiveness of these molecules for further development. Already in 2024, we have seen returns on this strategy in the form of out-licensing agreements as partners recognize the value of our innovative compounds that are protected with strong intellectual property and have the potential to exapand therapeutic options for patients with depression and anxiety. We will attempt to pursue additional out-licensing and partnership opportunities throughout the year as we continue to advance discussions with multiple possible partner companies."

Dr. Tucker concluded, "During the fourth quarter, we also continued to progress IND-enabling preclinical work for EB-002, completing important repeat-dose toxicology studies, genotoxicity studies, as well as cardiac, respiratory markers, and CNS safety pharmacology studies. We expect to finalize all preclinical activities for EB-002 soon, making the asset Phase 1 ready in 2024."

FOURTH QUARTER AND YEAR END UPDATES

Pipeline Advances and Highlight

Selected EB-003 as lead drug candidate from the Company’s next-generation EVM301 Series based on the molecule’s pharmacological properties and it’s potential to be a first-in-class treatment that addresses difficult-to-treat mental health disorders.
Presented two posters at the 6th Neuropsychiatric Drug Development Summit and two posters at the Canadian Chemical Engineering Conference (CSChE 2023) providing an update on the Company’s near-term selection EB-003 and highlighting key preclinical examinations of EB-002, a novel prodrug of psilocin.
Published cover article in the Journal of Medicinal Chemistry, a peer-reviewed journal published by the American Chemical Society, describing the development EB-002.
Progressed preclinical development of psilocin prodrug, EB-002, with GLP-toxicology and safety pharmacology studies, repeat dose toxicology studies, as well as cardiac, respiratory, CNS safety pharmacology studies, an in vitro hERG current study, and genotoxicity studies.
Expanded Business Development and Out-Licensing Opportunities in 2023 and 2024

Signed three non-binding term sheets with an undisclosed biotechnology company to pursue the out-licensing of three classes of compounds; future development and sales milestone payments and execution fees for the three licenses could total up to $200 million.
Signed two non-binding term sheets with a second undisclosed biotechnology company to pursue the out-licensing of cannabinoid conjugate compounds for pharmaceutical and non-pharmaceutical applications for the treatement of joint diseases; future development and sales milestone payments and execution fees for the two licenses could total up to $61 million.
Surpassed one thousand synthesized compounds discovered and characterized in our PsybraryTM portfolio of novel psychedelic-inspired molecules, following the acceleration of our AI-backed platform tailored for specific applications in the management of mental health disorders.
Continued to strengthen our intellectual property portfolio, receiving ten patent issuances from the United States Patent and Trademark Office.
FOURTH QUARTER AND FISCAL YEAR ENDED 2023 FINANCIAL RESULTS

Net loss attributable to stockholders was $3.44 million for the fourth quarter ended December 31, 2023, including $1.48 million in net non-cash expense, with a basic and diluted loss per share of $1.46, as compared to a net loss of $8.80 million, including $4.48 million in net non-cash expense, with a basic and diluted loss per share of $4.89 for the quarter ended December 31, 2022.

On December 28, 2023, the Company completed a warrant inducement transaction with two investors in which existing warrants were repriced and exercised and new warrants were issued to the investors. The cash proceeds from that transaction were received on January 4, 2024. Subsequently, on February 29, 2024, approximately 90% of the new warrants were also exercised. The gross proceeds to the Company from the two warrant exercises totaled approximately $4.5 million.