2023 – Page 1065 – 1stOncology™: Cancer Intelligence Service

Fortress Biotech Reports First Quarter 2023 Financial Results and Recent Corporate Highlights

On May 15, 2023 Fortress Biotech, Inc. (Nasdaq: FBIO) ("Fortress"), an innovative biopharmaceutical company focused on efficiently acquiring, developing and commercializing or monetizing promising therapeutic products and product candidates, reported financial results and recent corporate highlights for the first quarter ended March 31, 2023 (Press release, Fortress Biotech, MAY 15, 2023, View Source [SID1234631719]).

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Lindsay A. Rosenwald, M.D., Fortress’ Chairman, President and Chief Executive Officer, said, "Fortress and our subsidiaries and partner companies continued advancing our promising clinical-stage drug candidates for a wide range of diseases during the first quarter of 2023. We expect data updates from multiple clinical programs in the coming months, including Phase 3 topline results for DFD-29 to treat papulopustular rosacea ("PPR") in June of 2023. We also expect to report dose escalation and response data for MB-106, a CD20-targeted, autologous CAR T cell therapy to treat relapsed or refractory B-cell non-Hodgkin lymphomas ("B-NHL") and chronic lymphocytic leukemia ("CLL"), throughout the year. Dotinurad for the treatment of gout and Triplex for the treatment of cytomegalovirus continue to advance in clinical trials and we anticipate a dotinurad Phase 1 topline data readout in U.S. healthy volunteers in the second quarter of this year."

Dr. Rosenwald continued, "On the regulatory front, we expect the rolling New Drug Application ("NDA") submission for CUTX-101 to treat Menkes disease to be complete by the end of 2023. We also anticipate filing an NDA for DFD-29 in the second half of 2023 and look forward to the January 3, 2024, Prescription Drug User Fee Act ("PDUFA") goal date for cosibelimab to treat patients with metastatic or locally advanced cutaneous squamous cell carcinoma ("cSCC"). Overall, it is an exciting time for Fortress as we advance potential treatments for patients in need while focusing on increasing shareholder value."

Recent Corporate Highlights1:

Cosibelimab (Anti PD-L1 antibody)

● Our partner company, Checkpoint Therapeutics, Inc. (Nasdaq: CKPT) ("Checkpoint"), submitted a Biologics License Application ("BLA") to the FDA for cosibelimab, its investigational anti-PD-L1 antibody, as a treatment for patients with metastatic or locally advanced cSCC who are not candidates for curative surgery or radiation, in January 2023. In March 2023, the FDA accepted the BLA filing for cosibelimab and set a PDUFA goal date of January 3, 2024. In its BLA filing acceptance letter, the FDA indicated that no potential filing review issues have been identified, and that an advisory committee
1 The development programs depicted in this press release include product candidates in development at Fortress, at Fortress’ private subsidiaries (referred to herein as "subsidiaries"), at Fortress’ public subsidiaries (referred to herein as "partner companies") and at entities with which one of the foregoing parties has a significant business relationship, such as an exclusive license or an ongoing product-related payment obligation (such entities referred to herein as "partners"). The words "we", "us" and "our" may refer to Fortress individually, to one or more of our subsidiaries and/or partner companies, or to all such entities as a group, as dictated by context.

meeting to discuss the application is not currently planned. According to U.S. prescription claims data, in 2021, approximately 11,000 cSCC patients were treated with systemic therapies. As PD-1 inhibitors comprised less than half of patient prescriptions, cSCC remains a disease with a need for more effective and tolerable treatment options, particularly for the significant number of cSCC patients with immunosuppressive conditions or autoimmune diseases. With its unique mechanism of action and compelling safety profile, we believe cosibelimab, if approved, would be uniquely positioned to provide an important new treatment option for cSCC patients that are currently underserved by available therapies.
● Cosibelimab was sourced by Fortress and is currently in development at Checkpoint.
Dotinurad (Urate Transporter (URAT1) Inhibitor)

● Dotinurad is in development for the treatment of gout. We anticipate topline data from the Phase 1 trial to evaluate dotinurad in healthy volunteers in the United States in the second quarter of 2023 and expect to begin pivotal clinical trials in early 2024.
● Dotinurad (URECE tablet) was approved in Japan in 2020 as a once-daily oral therapy for gout and hyperuricemia. Dotinurad was efficacious and well-tolerated in more than 500 Japanese patients treated for up to 58 weeks in Phase 3 clinical trials. The clinical program supporting approval included over 1,000 patients.
● Dotinurad was sourced by Fortress and is currently in development at Urica.
MB-106 (CD20-targeted CAR T Cell Therapy)

● Mustang Bio, Inc.’s (Nasdaq: MBIO) ("Mustang Bio") lead clinical candidate is MB-106, a CD20-targeted, autologous CAR T cell therapy to treat relapsed or refractory B-NHL and CLL. MB-106 data to date include an overall response rate of 96% and complete response rate of 75% in a wide range of hematologic malignancies, including Waldenstrom macroglobulinemia ("WM"), in a clinical trial conducted by Mustang Bio’s collaborators at Fred Hutch. In parallel, Mustang Bio’s multicenter, open-label, non-randomized Phase 1/2 clinical trial evaluating the safety and efficacy of MB-106 continues to accrue, and Mustang Bio anticipates escalation to the final dose level in the Phase 1 indolent lymphoma arm in the third quarter of this year. The FDA granted Orphan Drug Designation to MB-106 for the treatment of WM, and Mustang Bio has treated the first WM patient in the indolent lymphoma arm of the trial. Results from this arm are expected to support an accelerated Phase 2 registration strategy for WM, with the first pivotal Phase 2 WM patient potentially to be treated in the first quarter of 2024. In the second quarter of this year, Mustang Bio plans to report safety and efficacy data from the indolent lymphoma arm.
● Phase 1/2 data from the Fred Hutch clinical trial on MB-106, a CD20-targeted, autologous CAR T cell therapy for patients with relapsed or refractory B-NHL and CLL, will be presented at the European Hematology Association (EHA) (Free EHA Whitepaper) Hybrid Congress ("EHA2023") taking place June 8-11, 2023, in Frankfurt, Germany and at the International Conference on Malignant Lymphoma ("ICML") taking place June 13-17, 2023, in Lugano, Switzerland. Data from the WM cohort were selected for poster presentation at EHA (Free EHA Whitepaper)2023 and outpatient treatment of follicular lymphoma was selected for oral presentation at ICML.
● MB-106 was sourced by Fortress and is currently in development at Mustang Bio.
CUTX-101 (Copper Histidinate for Menkes disease)

● Our subsidiary, Cyprium Therapeutics, Inc. ("Cyprium") has completed two pivotal studies in patients with Menkes disease treated with CUTX-101, copper histidinate (CuHis). In a pre-specified analysis of the studies, a 79% reduction in the risk of death was observed in patients treated within four weeks of birth, compared with a historical control cohort of untreated patients, and median overall survival (OS) was 177.1 months for CUTX-101 compared to 16.1 months for historical control, with a hazard ratio (HR) of (95% CI) = 0.208 (0.094, 0.463) p<0.0001. A 75% reduction in the risk of death was observed in patients treated after four weeks of birth, compared with untreated historical control subjects, and median OS was 62.4 and 17.6 months, respectively; HR (95% CI) = 0.253 (0.119, 0.537); p<0.0001.
● In 2021, Cyprium signed a Development and Asset Purchase Agreement with Sentynl Therapeutics, Inc. ("Sentynl"), a wholly owned subsidiary of Zydus Lifesciences Ltd., for CUTX-101 to treat Menkes disease. Cyprium is responsible for the development of CUTX-101, and Sentynl will be responsible for commercialization of CUTX-101, as well as progressing newborn screening activities.
● In December 2021, Cyprium initiated the rolling submission of an NDA to the FDA for CUTX-101, which is ongoing and expected to be completed by the end of 2023.
● Cyprium will retain 100% ownership over any FDA priority review voucher that may be issued at NDA approval of CUTX-101.
● CUTX-101 was sourced by Fortress and is currently in development at Cyprium.
CAEL-101 (Light Chain Fibril-reactive Monoclonal Antibody for AL Amyloidosis)

● On October 5, 2021, AstraZeneca plc ("AstraZeneca") acquired Caelum Biosciences, Inc. ("Caelum") for an upfront payment of approximately $150 million paid to Caelum shareholders, of which approximately $56.9 million was paid to Fortress, net of Fortress’ $6.4 million portion of the $15 million, 24-month escrow holdback amount and other miscellaneous transaction expenses. The agreement also provides for additional potential payments to Caelum shareholders totaling up to $350 million, payable upon the achievement of regulatory and commercial milestones. Fortress is eligible to receive 42.4% of all potential milestone payments, which, together with the upfront payment, would total up to approximately $212 million.
● There are two ongoing Phase 3 studies of CAEL-101 for AL amyloidosis. (ClinicalTrials.gov identifiers: NCT04512235 and NCT04504825).2
● AstraZeneca has estimated that it expects the FDA to accept its BLA submission for review during calendar year 2024.
● CAEL-101 (anselamimab) was sourced by Fortress and was developed by Caelum (founded by Fortress) until its acquisition by AstraZeneca in October 2021.
Triplex (Cytomegalovirus ("CMV") vaccine)

● We expect that the Phase 2 clinical trial of Triplex for adults co-infected with HIV and CMV will complete enrollment in the second half of 2023 with topline data anticipated in 2024. The study aims to show potential reduction in intensity of highly active antiretroviral therapy treatment, which is used in up to 1.7 million treated HIV patients.
● Triplex received a grant from the National Institute of Allergy and Infectious Diseases that could provide over $20 million in non-dilutive funding. This will fund a 420 patient multi-center, placebo-controlled, randomized Phase 2 study of Triplex for control of CMV in patients undergoing liver transplantation and is expected to begin enrollment this year. We believe this data set could ultimately be used to support approval of Triplex in this setting.
● Triplex is currently the subject of three ongoing clinical trials including: pediatric patients undergoing stem cell transplant; adults co-infected with CMV and HIV; and in combination with a CAR T cell therapy for adults with NHL.
● Triplex was sourced by Fortress and is currently in development at our subsidiary, Helocyte, Inc.
AJ201

● In March 2023, we announced that our partner company, Avenue Therapeutics, Inc. (Nasdaq: ATXI) ("Avenue"), entered into an exclusive license agreement with AnnJi Pharmaceutical Co., Ltd. for intellectual property related to AJ201, a first-in-class clinical asset currently in a Phase 1b/2a study in the U.S. for the treatment of spinal and bulbar muscular atrophy, also known as Kennedy’s Disease. Kennedy’s Disease is a debilitating rare genetic neuromuscular disease primarily affecting men.
2 Information on clinicaltrials.gov does not constitute part of this release.

Although there is a range of cited prevalence rates in the literature, a recent study used genetic analysis to estimate disease prevalence of 1:6,887 males3.
● AJ201 was sourced by Fortress and is currently in development at Avenue.
IV Tramadol

● In March 2023, Avenue participated in a Type C meeting with the FDA to discuss the proposed study protocol to assess the risk of respiratory depression related to opioid stacking on IV Tramadol compared to IV morphine. The Type C meeting minutes from the FDA indicate that the FDA and Avenue are in agreement with a majority of the proposed protocol items and are in active discussion about remaining open items. The minutes indicate that the FDA also agrees that a successful study will support the submission of a complete response to the second Complete Response Letter for IV Tramadol pending final agreement on a statistical analysis plan and a full review of the submitted data in the complete response as well as concurrence from the Division of Anesthesia, Analgesia and Addiction Products.
● IV Tramadol was sourced by Fortress and is currently in development at Avenue.
In vivo CAR T Platform Technology

● We continue to collaborate with the Mayo Clinic to potentially revolutionize the delivery of CAR T in patients. The technology has the potential to generate CAR T cells within the patient’s body after two outpatient injections, without the need for traditional ex vivo allogeneic or autologous CAR T cell processing wait time and expense.
● We anticipate the publication of proof-of-concept research from in vivo animal studies in 2023.
● The novel CAR T technology was sourced by Fortress and is currently in development at Mustang Bio.
Marketed Dermatology Products and Product Candidates

● Journey Medical Corporation (Nasdaq: DERM) ("Journey Medical"), our partner company, markets prescription dermatology products.
● In January 2023, Journey Medical completed enrollment in its DFD-29 Phase 3 clinical program for the treatment of papulopustular rosacea and achieved the "Last Patient Out" milestone in May 2023. Topline data from the DFD-29 Phase 3 clinical studies are expected in June of 2023. Journey Medical plans to submit its NDA for DFD-29 in the second half of 2023, and an FDA approval decision is anticipated in the second half of 2024.
o

In the Phase 2 clinical trials, DFD-29 (40mg) demonstrated nearly double the efficacy when compared to Oraycea (European equivalent of Oracea) on both co-primary endpoints. For the first co-primary endpoint, Investigator’s Global Assessment ("IGA") treatment success, Oraycea had a 33.33% IGA treatment success rate, while DFD-29 achieved a 66.04% IGA treatment success rate. For the second co-primary endpoint, the change in total inflammatory lesion count, Oraycea had a 10.5 reduction in inflammatory lesions, while DFD-29 achieved a 19.2 reduction in inflammatory lesions.

● Journey Medical’s total product net revenues were $12.2 million for the first quarter of 2023, compared to first quarter 2022 total product net revenues of $20.8 million. Compared to the prior year period, net sales were primarily impacted by Targadox generic competition and gross-to-net deductions for Targadox and Ximino, including returns and managed care rebates. Higher unit sales were seen in Accutane, Amzeeq, Zilxi and Exelderm, while Qbrexza volume decreased but was offset by pricing increases.
3 M. Zanovello et al., Unexpected frequency of the pathogenic ARCAG repeat 2 expansion in the general population. Brain, in press (2023).

General Corporate:

Fortress

● In February 2023, Fortress completed a registered direct offering priced at-the-market under Nasdaq rules for total gross proceeds of approximately $13.9 million, and a concurrent private placement with investors in the registered direct offering for the pro rata rights to acquire, in the aggregate, securities exercisable into common stock in certain future operating subsidiaries that consummate a specified corporate development transaction within the next five years.
Financial Results:

To assist our stockholders in understanding our company, we have prepared non-GAAP financial metrics for the three months ended March 31, 2023 and 2022. These metrics exclude the operations of our four public partner companies: Avenue, Checkpoint, Journey Medical and Mustang Bio, as well as any one-time, non-recurring, non-cash transactions. The goal in providing these non-GAAP financial metrics is to highlight the financial results of Fortress’ core operations, which comprise our privately held development-stage entities, as well as our business development and finance functions.

● As of March 31, 2023, Fortress’ consolidated cash, cash equivalents and restricted cash totaled $154.9 million, compared to $181.0 million as of December 31, 2022, a decrease of $26.1 million during the quarter.
● On a GAAP basis, Fortress’ net revenue totaled $12.4 million for the first quarter of 2023, which included $12.2 million in net revenue generated from our marketed dermatology products. This compares to net revenue totaling $23.9 million for the first quarter of 2022, which included $20.8 million in net revenue generated from our marketed dermatology products.
● On a GAAP basis, consolidated research and development expenses including license acquisitions were $39.5 million for the first quarter of 2023, compared to $36.7 million for the first quarter of 2022. On a non-GAAP basis, Fortress research and development expenses were $2.3 million for the first quarter of 2023, compared to $2.8 million for first quarter of 2022.
● On a GAAP basis, consolidated selling, general and administrative expenses were $25.3 million for the first quarter of 2023, compared to $26.3 million for the first quarter of 2022. On a non-GAAP basis, Fortress selling, general and administrative expenses were $7.0 million, for the first quarter of 2023, compared to $6.2 million for the first quarter of 2022.
● On a GAAP basis, consolidated net loss attributable to common stockholders was $21.5 million, or $0.21 per share, for the first quarter of 2023, compared to consolidated net loss attributable to common stockholders of $15.8 million, or $0.18 per share for the first quarter of 2022.
● Fortress’ non-GAAP loss attributable to common stockholders was $6.5 million, or $0.06 per share, for the first quarter of 2023, compared to Fortress’ non-GAAP loss attributable to common stockholders of $5.7 million, or $0.07 per share, for the first quarter of 2022.
Use of Non-GAAP Measures:

In addition to the GAAP financial measures as presented in our filings with the Securities and Exchange Commission ("SEC"), including our Form 10-Q to be filed on May 15, 2023, the Company, in this press release, has included certain non-GAAP measurements. The non-GAAP net loss attributable to common stockholders is defined by the Company as GAAP net loss attributable to common stockholders, less net losses attributable to common stockholders from our public partner companies Avenue, Checkpoint, Journey Medical and Mustang Bio ("public partner companies"), as well as our former subsidiary, Caelum. In addition, the Company has also provided a Fortress non-GAAP loss attributable to common stockholders which is a modified EBITDA calculation that starts with the non-GAAP loss attributable to common stockholders and removes stock-based compensation expense, non-cash interest expense, amortization of licenses and debt discount, changes in fair values of investment, changes in fair value of derivative liability, and depreciation expense. The Company also provides non-GAAP research and development costs, defined as GAAP research and development costs, less research and development costs of our public partner companies and non-GAAP selling, general and

administrative costs, defined as GAAP selling, general and administrative costs, less selling, general and administrative costs of our public partner companies.

Management believes each of these non-GAAP measures provide meaningful supplemental information regarding the Company’s performance because (i) it allows for greater transparency with respect to key measures used by management in its financial and operational decision-making; (ii) it excludes the impact of non-cash or, when specified, non-recurring items that are not directly attributable to the Company’s core operating performance and that may obscure trends in the Company’s core operating performance; and (iii) it is used by institutional investors and the analyst community to help analyze the Company’s standalone results separate from the results of its public partner companies. However, non-GAAP loss attributable to common stockholders and any other non-GAAP financial measures should be considered as a supplement to, and not as a substitute for, or superior to, the corresponding measures calculated in accordance with GAAP. Further, non-GAAP financial measures used by the Company and the manner in which they are calculated may differ from the non-GAAP financial measures or the calculations of the same non-GAAP financial measures used by other companies, including the Company’s competitors.

Erasca Reports First Quarter 2023 Financial Results and Business Updates

On May 15, 2023 Erasca, Inc. (Nasdaq: ERAS), a clinical-stage precision oncology company singularly focused on discovering, developing, and commercializing therapies for patients with RAS/MAPK pathway-driven cancers, reported financial results for the fiscal quarter ended March 31, 2023, and provided business updates (Press release, Erasca, MAY 15, 2023, View Source [SID1234631718]).

"In 2023, we plan to further refine the developmental focus of our lead clinical programs and accelerate our transition into a late-stage clinical development company. For ERAS-601, we have identified the maximum tolerated dose for the combination with cetuximab and are pleased by the promising preliminary safety and tolerability data with reversible and manageable treatment-related adverse events (TRAEs) seen with our ‘three weeks on, one week off’ dosing regimen. Continued exploration of this combination will be prioritized in patients with human papillomavirus (HPV)-negative head and neck squamous cell carcinoma (HNSCC), with initial data expected in the first half of 2024," said Jonathan E. Lim, M.D., Erasca’s chairman, CEO, and co-founder. "Coming up at ASCO (Free ASCO Whitepaper), two poster presentations will provide initial combination data for our ERK1/2 inhibitor ERAS-007 from our HERKULES-3 trial in patients with advanced gastrointestinal (GI) malignancies."

Dr. Lim continued, "We are looking forward to dosing the first patient in SEACRAFT-1 expected in the second half of this year and continuing clinical development of naporafenib, the latest addition to our pipeline and our most advanced clinical program. The compelling anti-tumor activity demonstrated in the recent Journal of Clinical Oncology publication of the Phase 1b trial for naporafenib plus trametinib in patients with NRAS-mutant (NRASm) melanoma reinforces the potential benefit of our pivotal Phase 3 SEACRAFT-2 trial, which is expected to initiate in the first half of 2024. With our promotions of two strong leaders, Dr. Shannon Morris to Chief Medical Officer and Ms. Chandra Lovejoy to Chief Regulatory Affairs Officer, we are well-positioned for continued clinical and regulatory execution across our multiple near-term clinical milestones."

Research and Development (R&D) Highlights

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Granted FDA Fast Track Designation For ERAS-801 in Glioblastoma: In May 2023, Erasca announced that the United States Food and Drug Administration (FDA) granted Fast Track Designation (FTD) to ERAS-801 (CNS-penetrant EGFR inhibitor) for the treatment of adult patients with glioblastoma (GBM) with EGFR gene alterations.
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Presented Promising Initial Phase 1b Dose Escalation Data for ERAS-601: In April 2023, Erasca presented promising initial Phase 1b dose escalation data from FLAGSHP-1 for ERAS-601 in combination with cetuximab (ERBITUX) in patients with advanced solid tumors as part of a poster presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting.
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Announced Publication of Phase 1b Data for Naporafenib: In April 2023, Erasca announced the publication of results in the Journal of Clinical Oncology from the expansion arm of a Phase 1b open label trial evaluating pan-RAF inhibitor naporafenib plus MEK inhibitor trametinib (MEKINIST) in patients with NRASm melanoma.
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Announced Two Poster Presentations at the 2023 ASCO (Free ASCO Whitepaper) Annual Meeting: In April 2023, Erasca announced that preliminary Phase 1b combination data for potential best-in-class ERK1/2 inhibitor ERAS-007 with encorafenib (BRAFTOVI) and cetuximab or with palbociclib (IBRANCE) in patients with advanced GI malignancies will be presented as part of poster presentations at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.

Corporate Highlights

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Strengthened Clinical and Regulatory Executive Leadership: In April 2023, Erasca promoted Shannon R. Morris, M.D., Ph.D., to Chief Medical Officer, and Chandra D. Lovejoy, M.S., to Chief Regulatory Affairs Officer

Key Upcoming Milestones

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SEACRAFT-1: Phase 1b trial for naporafenib in patients with RAS Q61X tissue agnostic solid tumors
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Dosing of the first patient expected in the second half of 2023
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Initial Phase 1b combination data expected between the second and fourth quarters of 2024
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SEACRAFT-2: Randomized pivotal Phase 3 trial for naporafenib in patients with NRASm melanoma
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Dosing of the first patient expected in the first half of 2024
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HERKULES-1: Phase 1b trial for ERAS-007 plus ERAS-601 in patients with advanced solid tumors
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Initial Phase 1b combination data expected in the first half of 2024
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HERKULES-2: Phase 1b trial for ERAS-007 in patients with advanced non-small cell lung cancer (NSCLC)
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Initial Phase 1b combination data expected in the second quarter of 2023
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HERKULES-3: Phase 1b trial for ERAS-007 in patients with GI malignancies
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Initial Phase 1b combination data in patients with RAS- and BRAF-mutated GI malignancies expected in the second quarter of 2023
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Phase 1b combination expansion data in patients with BRAF-mutated colorectal cancer (CRC) expected between the second half of 2023 and the first half of 2024
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FLAGSHP-1: Phase 1b trial for ERAS-601 in patients with advanced solid tumors
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Phase 1b combination data in patients with HPV-negative advanced HNSCC expected in the first half of 2024
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THUNDERBBOLT-1: Phase 1 trial for ERAS-801 in patients with recurrent glioblastoma (GBM)
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Initial Phase 1 data in patients with recurrent GBM expected in the second half of 2023
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AURORAS-1: Phase 1 trial for ERAS-3490 in patients with KRAS G12Cm NSCLC
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Initial Phase 1 data expected in 2024

First Quarter 2023 Financial Results

Cash Position: Cash, cash equivalents, and marketable securities were $389.7 million as of March 31, 2023, compared to $435.6 million as of December 31, 2022. Erasca expects its current cash, cash equivalents, and marketable securities balance to fund operations into the second half of 2025.

Research and Development (R&D) Expenses: R&D expenses were $27.6 million for the quarter ended March 31, 2023, compared to $27.4 million for the quarter ended March 31, 2022. The quarter ended March 31, 2022 also included $2.0 million of in-process R&D expenses related to a development milestone payment in connection with our license agreement with Katmai Pharmaceuticals, Inc.

General and Administrative (G&A) Expenses: G&A expenses were $9.4 million for the quarter ended March 31, 2023, compared to $7.1 million for the quarter ended March 31, 2022. The increase was primarily driven by personnel costs, including stock-based compensation expense, and facilities and related costs.

Net Loss: Net loss was $33.2 million, or $(0.22) per basic and diluted share, for the quarter ended March 31, 2023, compared to $36.5 million, or $(0.31) per basic and diluted share, for the quarter ended March 31, 2022.

Enveric Biosciences Reports First Quarter 2023 Financial Results and Operational Highlights

On May 15, 2023 Enveric Biosciences, Inc. (NASDAQ: ENVB) ("Enveric" or the "Company"), a biotechnology company dedicated to the development of novel small-molecule therapeutics for the treatment of anxiety, depression, and addiction disorders, reported a corporate update and reported financial results for the first quarter of 2023 ended March 31, 2023 (Press release, Enveric Biosciences, MAY 15, 2023, View Source [SID1234631717]).

Enveric announced a cost reduction plan to extend its financial runway into the first quarter of 2024. The operational streamlining entailed an approximately 35 percent reduction in full-time personnel, the cancelation of 7 consulting contracts focused on the cannabinoid programs and a transition from third-party service providers supporting R&D efforts to internal science teams performing this work. Separately, Enveric announced that the proposed spin-off of cannabinoid clinical development pipeline assets to Akos Biosciences, Inc. ("Akos") is not proceeding due to the holders of the Akos Series A Preferred Stock electing to exercise their right to require Enveric to redeem all of the Akos Series A Preferred Stock due to an inability to meet listing requirements on a national exchange. Enveric now plans to engage with strategic advisors to identify and pursue alternative routes to capture value from these assets.

"Underpinning Enveric’s business and development strategy is a continued focus on maximizing the value of our novel drug development programs to produce positive returns for our shareholders. In this pursuit, the Company has been diligently working to develop a robust and differentiated pipeline of small-molecule therapeutics for the treatment of mental health disorders," said Joseph Tucker, Ph.D., Director and CEO of Enveric Biosciences. "Today’s announcement, including the cost reduction plan and reduction in force, reflects the necessary evolution of this strategy, enabling a greater focus of resources towards Enveric’s most valuable assets, EB-373 and our EVM301 Series."

FIRST QUARTER AND RECENT UPDATES

During the quarter, the company has made progress in delivering on the top near-term priorities:

Priority #1 – Progressing Small Molecule Therapeutics Pipeline Targeting Unmet Needs in Mental Health

Advanced product manufacturing and preclinical activities that support initiation of Phase 1 clinical trial for lead asset, EB-373, for the treatment of anxiety disorder
Continued in vitro and in vivo testing of novel chemical entities developed from the EVM301 Series with the goal of identifying lead molecules by year-end 2023
EVM301 Series of novel molecules are specifically designed to promote neuroplasticity and show efficacy in animal models of depression and anxiety without inducing the hallmark hallucinations of other psychedelic or psychedelic-inspired agents
Established Enveric Therapeutics, an Australia-based subsidiary to manage clinical operations for EB-373 and additional clinical-stage candidates from the EVM201 and EVM301 Series of compounds
Priority #2 – Maximizing Operational Efficiency

Announced cost reduction plan designed to extend financial runway into the first quarter of 2024
Operational streamlining includes an approximately 35% reduction in full-time workforce personnel, the cancelation of 7 contracts for consultants focused on the cannabinoid programs, and a transition from third-party service providers supporting R&D efforts to internal science teams performing this work
Update on Proposed Spin-off of Cannabinoid Clinical Pipeline Assets

On May 11, 2022, the Company announced plans to transfer and spin-off its cannabinoid clinical development pipeline assets (the "Spin-Off") to Akos Biosciences, Inc. (formerly known as Acanna Therapeutics, Inc.), a majority-owned subsidiary of the Company. In connection with the Spin-Off, the Company transferred its cannabinoid clinical development pipeline assets to Akos, while retaining its psychedelics and non-hallucinogenic clinical development pipeline assets. The Spin-Off was subject to various conditions, including Akos meeting the qualifications for listing on the Nasdaq Stock Market, and if successful, would result in two standalone public companies. The new company resulting from the Spin-Off was to be referred to as Akos. As of May 5, 2023, since the Spin-Off had not occurred, the holders of the Akos Series A Preferred Stock had the right, but not the obligation, to cause Enveric to redeem all or a portion of the Akos Series A Preferred Stock. As of May 12, 2023, the holders of the Akos Series A Preferred Stock have exercised this right to require Enveric to redeem all of the Akos Series A Preferred Stock for $1,000 per share, plus accrued but unpaid dividends per share of approximately $50,000 for a total of approximately $1,050,000.

Enveric now plans to seek strategic advisors and alternative routes to capture value from these assets.

FIRST QUARTER 2023 FINANCIAL RESULTS

Net loss attributable to shareholders was $4.80 million for the quarter ended March 31, 2023, including $0.56 million in net non-cash expenses, with a basic and diluted loss per share of $2.31, as compared to a net loss of $4.44 with basic and diluted loss per share of $5.34 per share for the quarter ended March 31, 2022.

Net cash used in operations for the quarter ended March 31, 2023, was $5.14 million consisting of a $4.68 million net loss, adjusted by a net of $0.46 million in non-cash expenses and changes in asset and liability balances of $0.92 million.

As of March 31, 2023, the Company had cash and cash equivalents of $12.56 million and working capital of $10.40 million.

Ensysce Biosciences Reports First Quarter 2023 Financial Results

On May 15, 2023 Elevation Oncology, Inc. (Nasdaq: ELEV), an innovative oncology company focused on the discovery and development of selective cancer therapies to treat patients across a range of solid tumors with significant unmet medical needs, reported financial results for the quarter ended March 31, 2023, and highlighted recent business achievements (Press release, Ensysce Biosciences, MAY 15, 2023, View Source [SID1234631716]).

"Throughout the first quarter of 2023, we made significant progress as a company. Most recently, we presented preclinical data for our lead candidate, EO-3021, demonstrating anti-tumor activity in preclinical models expressing varying levels of Claudin 18.2, and highlighted a clinical case study showing EO-3021 induced a confirmed partial response in a patient with metastatic gastric cancer," said Joseph Ferra, Interim Chief Executive Officer of Elevation Oncology. "This is an exciting time for us as we and our partner, CSPC Pharmaceutical Group Limited, embark on sharing initial clinical data from the ongoing Phase 1 study of EO-3021 at ASCO (Free ASCO Whitepaper) 2023. In addition, we remain on track to initiate our Phase 1 trial evaluating EO-3021 in the US in the second half of 2023."

Recent Business Achievements

EO-3021

Presented preclinical proof-of-concept data at AACR (Free AACR Whitepaper) 2023. Key preclinical findings included demonstrating anti-tumor activity in preclinical xenograft models of pancreatic and gastric cancers expressing varying levels of Claudin 18.2. A single-dose of EO-3021 demonstrated tumor regression across low, medium, and high Claudin 18.2-expressing models, with a lower minimal efficacious dose in models with medium and high levels of Claudin 18.2 relative to models with low levels of Claudin 18.2. EO-3021 also outperformed standard of care chemotherapy in gastric and pancreatic cancer preclinical xenograft models.
Highlighted clinical case study of EO-3021 at AACR (Free AACR Whitepaper) 2023. A clinical case study of a patient with metastatic gastric cancer in an ongoing Phase 1 clinical trial of SYSA1801 (EO-3021) in China (NCT05009966) conducted by CSPC Pharmaceutical Group Limited (HKEX: 01093) was also highlighted. The patient was treated with dose level 2, or 1.0mg/kg EO-3021, intravenously, every three weeks (treatment ongoing). The best overall response, as evaluated per RECIST v1.1, was a confirmed partial response (66.7% maximal tumor reduction), while the duration of response was approximately 11 months and ongoing.
SYSA1801 (EO-3021) Phase 1 data selected for presentation at ASCO (Free ASCO Whitepaper) 2023. An abstract featuring SYSA1801 (EO-3021) Phase 1 clinical data has been selected for a poster presentation and poster discussion at the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2023 Annual Meeting, being held June 2-6, 2023, in Chicago, IL. The ongoing Phase 1 dose escalation and dose expansion study is evaluating SYSA1801 in patients with Claudin 18.2-positive advanced solid tumors and is being conducted in China by Elevation Oncology’s partner, CSPC Pharmaceutical Group Limited (CSPC; HKEX: 01093).
Other Pipeline Programs

Continue research and development efforts to advance novel therapeutic drug candidates and targets. Additional pipeline programs include those through its existing partnership with Caris Life Sciences.
Expected Upcoming Milestones and Operational Objectives

Initiate Phase 1 clinical trial of EO-3021 in the US in the second half of 2023
Ongoing target evaluation for future pipeline expansion
First Quarter 2023 Financial Results

As of March 31, 2022, the Company had cash, cash equivalents and marketable securities totaling $73.9 million, compared to $90.3 million as of December 31, 2022.

Research and development expenses for the first quarter 2023 were $7.3 million, compared to $13.6 million for the first quarter 2022. The decrease in R&D expense in the first quarter of 2023 was primarily related to the decrease in costs related to manufacturing clinical supply of seribantumab for use in the CRESTONE clinical trial. The Company prioritized its pipeline and realigned resources to advance its EO-3021 product candidate.

General and administrative expenses for the first quarter 2023 were $4.3 million, compared to $3.8 million for the first quarter 2022. The increase in G&A expense in the first quarter of 2023 was primarily related to increases in personnel costs, professional services and other administrative costs.

Restructuring charges were $5.1 million for the first quarter 2023, and consisted primarily of one-time charges related to the pipeline prioritization and realignment of resources to advance our EO-3021 product candidate, including $1.6 million of termination and contractual termination benefits for severance, healthcare and related benefits.

Net loss for the first quarter 2023 was $17.1 million, compared to $17.3 million for the first quarter 2022.

About EO-3021

EO-3021 (also known as SYSA1801) is a differentiated, clinical-stage antibody drug conjugate (ADC) comprised of an immunoglobulin G1 (IgG1) monoclonal antibody (mAb) that targets Claudin 18.2 and is site-specifically conjugated to the monomethyl auristatin E (MMAE) payload via a cleavable linker with a drug-to-antibody ratio (DAR) of 2. Claudin 18.2 is a specific isoform of Claudin 18 that is only expressed in gastric epithelial cells. During malignant transformation of gastric cancer, the tight junctions may become disrupted, exposing Claudin 18.2 and allowing them to be accessible by Claudin 18.2 targeting agents. Claudin 18.2 can also be expressed in other solids tumors. An Investigational New Drug application for EO-3021 has been cleared by the U.S. Food and Drug Administration.

Elevation Oncology Reports First Quarter 2023 Financial Results and Highlights Recent Business Achievements

On May 15, 2023 Elevation Oncology, Inc. (Nasdaq: ELEV), an innovative oncology company focused on the discovery and development of selective cancer therapies to treat patients across a range of solid tumors with significant unmet medical needs, reported financial results for the quarter ended March 31, 2023, and highlighted recent business achievements (Press release, Elevation Oncology, MAY 15, 2023, View Source;utm_medium=rss&utm_campaign=elevation-oncology-reports-first-quarter-2023-financial-results-and-highlights-recent-business-achievements [SID1234631715]).