On August 14, 2023 Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage biopharmaceutical company focused on the discovery, development and commercialization of targeted treatments for cancer, reported financial results for the second quarter ended June 30, 2023 and provided a corporate update (Press release, Cellectar Biosciences, AUG 14, 2023, View Source [SID1234634390]).

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Second Quarter and Recent Corporate Highlights

· In June, the company provided an update for its iopofosine I 131 clinical program and guidance related to its Waldenstrom’s macroglobulinemia (WM) CLOVER-WaM pivotal trial, as well as preclinical advancements to its proprietary phospholipid ether drug conjugate platform. The updates included:
o Top-line data from its WM CLOVER-WaM pivotal trial is expected in 2H23 and assuming NDA approval, the company remains on target for a 2024 product launch.
o The company plans to initiate its Phase 1b study in pediatric high-grade gliomas (pHGG) in the third quarter of 2023.
o The central nervous system lymphoma (CNSL) cohort from its Phase 2a trial expanded to further evaluate iopofosine I 131 in this indication. The company previously reported a complete response in a CNSL patient
o The company’s COO, Jarrod Longcor, delivered an oral presentation of iopofosine I 131 for the treatment of multiple myeloma at the Society of Nuclear Medicine and Molecular Imaging Annual Conference. Iopofosine I 131 has been evaluated in over 125 multiple myeloma patients with response rates ranging from 40% to 62% in triple class refractory, quad/penta refractory, post-BCMA and high-risk patients.
o The company presented updates on its phospholipid ether cancer targeting platform at several conferences, including SNMMI, Targeted Radiotherapy Conference, Oncology 2023, and Therapeutic Area Partnership Oncology. The presentations highlighted the platform’s broad utility to provide targeted intracellular delivery of multiple cancer treatment modalities.

"We look forward to reporting top-line data from our WM pivotal trial in the second half of this year. We believe the novel method of action and product profile for iopofosine I 131 is clearly differentiated and can address patients’ needs in relapsed or refractory WM with the potential to establish a new standard of care. Our commercialization efforts will strategically take advantage of the highly scalable and concentrated WM market to drive early use and adoption," said James Caruso, president and CEO of Cellectar. "We also continue to develop iopofosine I 131 across multiple indications, including CNSL and pHGG’s as well as multiple myeloma, and are looking forward to a transformational second half of 2023."

Second Quarter 2023 Financial Highlights

· Cash and Cash Equivalents: As of June 30, 2023, the company had cash and cash equivalents of $5.2 million, compared to $19.9 million as of December 31, 2022. Net cash used in operating activities during the three months ended June 30, 2023 was approximately $7.5 million. The company believes its cash on hand is adequate to fund budgeted operations into the fourth quarter of 2023.

· Research and Development Expense: R&D expense for the three months ended June 30, 2023 was approximately $6.3 million, compared to approximately $4.5 million for the three months ended June 30, 2022. The overall increase in research and development expense was primarily a result of increased manufacturing costs, production sourcing, and general research and development costs due to an increase in personnel, slightly offset by a reduction in clinical project cost and pre-clinical project costs.

· General and Administrative Expense: G&A expense for the three months ended June 30, 2023 was $2.0 million, compared to $2.9 million for the same period in 2022. The overall decrease in G&A costs was primarily driven by a decrease in professional fees and personnel costs.

· Net Loss: The net loss attributable to common stockholders for the three months ended June 30, 2023 was ($8.2) million, or ($0.73) per share, compared to ($7.4) million, or ($1.22) per share, for the three months ended June 30, 2022.

On August 14, 2023 Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, reported that Dr. Pamela D. Garzone, Anixa’s Chief Development Officer, has been invited to present at the 8th Annual CAR-TCR Summit being held from August 29 – September 1, 2023 in Boston, MA (Press release, Anixa Biosciences, AUG 14, 2023, View Source [SID1234634389]).

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The 8th Annual CAR-TCR Summit is the world’s pre-eminent industry-leading comprehensive forum that unites the global cell therapy community across a variety of cell types. During this three-day event over one thousand attendees from over three hundred companies will come together to explore discovery through commercialization to deliver safe, effective and commercially viable CAR and TCR therapies.

Entitled "Developing a CAR-T for Ovarian Cancer and Other Solid Tumors," the presentation will focus on the opportunities and challenges of CAR-T for solid tumors, routes of administration besides intravenous infusions and details of the ovarian cancer CAR-T therapy clinical trial (NCT05316129) under the direction of Dr. Robert Wenham at Moffitt Cancer Center and in collaboration with Anixa. This trial, a Phase I clinical trial of autologous T cells genetically engineered with a chimeric receptor to target the follicle-stimulating hormone receptor (FSHR) in patients with recurrent ovarian cancer, will evaluate intraperitoneal and intravenous administration of the CAR-T and the role of lymphodepletion. The study commenced July of 2022 and is in progress.

Dr. Garzone will also be hosting a roundtable discussion titled, "Impacting CAR-T Efficacy with Pre-Conditioning Regimens." Topics covered during this roundtable will include discussion on differences between lymphodepletion regimens and outcomes for liquid and solid tumors, impact of lymphodeletion intensity on CAR-T cell therapy, and how to achive optimal balance between efficacy and safety.

On August 14, 2023 Sonnet BioTherapeutics Holdings, Inc. (NASDAQ:SONN) ("Sonnet" or the "Company"), a biopharmaceutical company developing innovative targeted biologic drugs, reported its financial results for the three months ended June 30, 2023 and provided a business update (Press release, Sonnet BioTherapeutics, AUG 14, 2023, View Source [SID1234634388]).

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"Sonnet continues to successfully forge ahead with our pipeline development," said Pankaj Mohan, Ph.D., Founder and CEO. "The initiation of the clinical trial with SON-1010 and Roche’s atezolizumab is an important event for the company and for our mission to innovate potentially life-saving treatments for cancer patients. Further, our collaboration with Janssen is ongoing and we hope to have information to share with investors in the coming quarters. During the quarter, we were able to present important data from our SON-1010 clinical trials at the American Association for Cancer Research (AACR) (Free AACR Whitepaper), as well as deliver two FHAB technology presentations at the Cytokine-Based Drug Development Summit. As part of our financing initiative, we completed a $2.25 million registered direct offering and concurrent private placement in June, which was strategically executed to result in the Company remaining in compliance with the Nasdaq continued listing requirement in shareholder equity. Our plan to extend our cash runway into the 2024 calendar year remains in place and involves receiving R&D tax credits from New Jersey and Australia."

"We are quite pleased with the progress of our clinical programs," said Dr. Richard Kenney, CMO. "Both of the SON-1010 Phase 1 first-in-human studies are wrapping up, with final data analysis in the healthy volunteer study and ongoing enrollment of the highest dose cohort in the cancer study, which will establish the maximum tolerated dose. The latter will be expanded in platinum-resistant ovarian cancer (PROC) to confirm the clinical benefit in that population at the maximum tolerated dose before moving on to the next study. Comparing the pharmacokinetics for the two studies shows a compelling difference in SON-1010 excretion patterns that suggests the FHAB molecule is being taken up and retained by the tumors, as it was designed to do. We are starting our combination study using SON-1010 with atezolizumab in Australia and are working to enroll several cohorts by the end of this year. Regarding the SON-080 trial in CIPN, we continue to anticipate a DSMB meeting this calendar year, after which we will be in a position to disclose the early safety findings."

FY 2023 Third Quarter and Recent Corporate Updates

Sonnet provided the following corporate updates:

● On April 18, 2023, we presented additional data from the SB101 study of SON-1010 at the 2023 AACR (Free AACR Whitepaper) Annual Meeting. SB101 is a single-ascending dose (SAD) trial in adult patients with advanced solid tumors that commenced in the second quarter of 2022 and is currently enrolling the final dose cohort. Of the 15 patients from the first five cohorts of SB101 evaluable for follow-up at this latest cutoff, 9 had stable disease at the first follow-up scan, 4 of which were already progressing at study entry. At the four-month follow-up, 5 of 14 patients remained stable at the second scan, suggesting clinical benefit of SON-1010 in 36% of patients. As an example, the very first patient dosed, who has an aggressive endometrial sarcoma, had target tumor shrinkage with complete resolution of ascites at one point and has been clinically stable for over a year. SON-1010 has been safe and tolerable at all doses tested to date. Adverse events have generally been mild/moderate and transient in nature, with no study discontinuations for safety reasons. In addition, adverse effects have been less numerous and less intense with subsequent doses. The geomean half-life (t½) of SON-1010 was 113 hours in SB101 and 122 hours in SB102, compared to the published value of 12 hours for recombinant IL-12 observed in prior studies. Comparison of the PK curves between the two studies suggests that SON-1010 may be targeting tumors, as it was designed to do. Cytokine analysis following each dose revealed controlled and prolonged induction of interferon gamma (IFNγ) that peaked at 24 to 48 hours and returned to baseline after 2 to 4 weeks, which may improve tumor control. A small increase in IL-10 was observed with each dose, as might be expected in response to IFNγ. There was either a minimal or no signal for IL-1β, IL-6, IL-8, and TNFα and no indication of any potential for cytokine release syndrome (CRS) at these doses.

● The ex-U.S. Phase 1b/2a study with SON-080 in CIPN remains ongoing. Pursuant to a license agreement the Company entered with New Life Therapeutics Pte, Ltd. ("New Life") of Singapore in May 2021, Sonnet and New Life will be jointly responsible for developing SON-080 in DPN. The DSMB overseeing the study is expected to meet during the third calendar quarter of 2023. Following the completion of the DSMB review, we anticipate announcing initial safety data from the CIPN study and will consider initiating a Phase 2 study in DPN.

● In February 2023, the Company announced the successful completion of two IND-enabling toxicology studies with SON-1210 in non-human primates. SON-1210 (IL12- FHAB -IL15), Sonnet’s lead bispecific construct, combines the FHAB with fully human IL-12 and fully human IL-15. Sonnet is prepared to initiate the regulatory authorization process for SON-1210 in 2023, pending the outcome of any partnering activity.

● Preclinical development continues for SON-1410 (IL18-FHAB-IL12), Sonnet’s proprietary bispecific combination of IL-18 and IL-12, where cell line development for GMP application is underway. After some delays in 2023, process development activities will continue into 2024, with the potential to generate a drug suitable for human studies.

"Our mission to advance the company’s pipeline while containing our costs remains in place, and we continue to be confident in the potential of our FHAB technology. We are looking forward to our future data releases," commented Jay Cross, CFO.

FY 2023 Third Quarter Ended June 30, 2023 Financial Results

● As of June 30, 2023, Sonnet had $7.0 million cash on hand.

● Research and development expenses were $2.4 million for the three months ended June 30, 2023, compared to $5.6 million for the three months ended June 30, 2022. The decrease of $3.2 million was primarily due to the establishment of cost savings by transitioning product development activities to cost advantaged locations such as India and Australia and by reducing expenditures on tertiary programs such as SON-3015, which has been placed on a development hold, as well as a decrease in share-based compensation expense.

● General and administrative expenses were $1.5 million and $2.3 million for the three months ended June 30, 2023, and 2022, respectively. The decrease in general and administrative expenses is a result of cost-saving initiatives.

On August 14, 2023 Vaccinex, Inc. (Nasdaq: VCNX), a clinical-stage biotechnology company pioneering a differentiated approach to treating neurodegenerative disease and cancer through the inhibition of SEMA4D, reported financial results for the second quarter ended June 30, 2023 and provided a corporate update on progress in key programs (Press release, Vaccinex, AUG 14, 2023, View Source [SID1234634387]). .

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Over the last few months, Vaccinex achieved several important clinical milestones for pepinemab in both Alzheimer’s disease and Head and Neck Cancer.

Alzheimer’s Disease (AD):

Completed enrollment in the randomized, double-blind, Phase 1b/2 SIGNAL-AD trial of pepinemab in patients with mild Alzheimer’s disease (NCT04381468), funded in part by the Alzheimer’s Drug Discovery Foundation and by a grant from the Alzheimer’s Association.
Anticipate completing 12-months treatment in June, 2024 at which time we will evaluate the impact of treatment on brain metabolic activity, a key biomarker of clinical progression in AD, as well as treatment effects on cognition employing several validated, clinically meaningful Alzheimer’s cognitive scales.
An improving AD-drug development environment, based on FDA’s recent full approval of LEQEMBI, enables the pathway to reimbursement and supports further investment in Alzheimer’s Disease drug development.
As previously reported, pepinemab has a differentiated mechanism of action, blocking SEMA4D, which is upregulated in neurons during stress of Alzheimer’s and Huntington’s disease and triggers the transformation of astrocytes and microglia from normal homeostatic functions to neuroinflammatory activity. Blockade of SEMA4D restores healthy astrocyte and neuronal functions while reducing neuroinflammation (Nature Medicine 2022).
Head and Neck Cancer:

Analyzed interim data from the first 36 patients in the single-arm, Phase 2 KEYNOTE B-84 study (NCT04815720) evaluating pepinemab in combination with KEYTRUDA in immunotherapy naïve patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC).
The combination of pepinemab and KEYTRUDA resulted in an approximately 2X increase in objective responses (ORR) and progression free survival (PFS) in patients with hard-to-treat PD-L1-low tumors compared to historical response rates for checkpoint monotherapy in this population.
Biomarker data suggest that treatment induced the formation of highly organized lymphoid aggregates in tumor that correlate with disease control and have previously been shown to be important for response to checkpoint inhibitors.
Vaccinex and Merck are currently in the design stages for an expansion of the KEYNOTE-B84 study that may extend benefits to more patients.
Investors and stakeholders will recall that the design and motivation for this study grew out of very encouraging data from our completed phase 2 SIGNAL study of pepinemab in Huntington’s disease (Nature Medicine 2022) that demonstrated treatment-induced increase in brain metabolic activity and improved cognition in patients with early manifest HD. The known parallels in pathology between Huntington’s and Alzheimer’s disease and the successful outcomes already observed for pepinemab in HD suggest that these may be predictive of similar outcomes in AD. It is noteworthy that pepinemab has a very different mechanism of action in AD than do antibodies to Aβ amyloid and that, to date, pepinemab has shown no evidence of ARIA, which is associated with amyloid-targeted therapies (e,g., Leqembi or donanemab). Pepinemab could be developed as an alternative treatment for AD, or, potentially, in combination with an anti-Aβ for greater efficacy.

In cancer, pepinemab is best employed in combination with an immune checkpoint inhibitor (ICI) such as KEYTRUDA. We are, therefore, pleased to have initiated two additional clinical studies with pepinemab in combination with another ICI in metastatic pancreatic cancer (PDAC) at the University of Rochester and in combination with a cell-based immunotherapy for breast cancer (MBC) at the Moffitt Cancer Center. Continuing progress and expanding interest in these studies affirms our view that pepinemab has the potential to improve outcomes for patients with different serious diseases and highlights the growing compendium of promising clinical data for pepinemab.

Recent Milestones and News

ASCO Presentations: Vaccinex and its collaborators presented two posters in the "Trial in Progress" sessions at the American Society for Clinical Oncology in June 2023 (ASCO23):
Phase 1b/2 PDAC Study: The team from University of Rochester Cancer Center and Wilmot Cancer Institute presented the plan for the single-arm, open-label study to evaluate pepinemab in combination with BAVENCIO (avelumab) as second line combination immunotherapy for patients with metastatic pancreatic ductal adenocarcinoma (PDAC, TPS4195, NCT05102721). The Vaccinex-sponsored study will employ a Bayesian Optimal Interval (BOIN) Design in the Phase 1b segment and a Simon two stage assessment in the Phase 2 segment and is expected to enroll 40 subjects. The trial rationale builds on safety and efficacy of the CLASSICAL-Lung study of pepinemab and avelumab in lung cancer and the observation that pepinemab appears to modulate the TME by increasing effector cell infiltration and reducing immune suppression in the TME, rendering "cold" tumors such as PDAC to become "hot". The study is being conducted with grant support from the Gateway Discovery Award.
Phase 1 Metastatic Breast Cancer Study: The team from the Moffitt Cancer Center presented the plan for an open-label, Phase I study to evaluate up to 28 patients with HER2+ metastatic breast cancer (MBC, TPS1113, NCT05378464). Patients will receive a combination of dendritic cell vaccines (DC1) plus trastuzumab (an anti-HER-2 antibody) and pepinemab, together with adoptive CD4+ T cell therapy. . The study rationale is supported by preclinical and clinical studies suggesting that pepinemab enhances the activity of dendritic cells to organize B cells and CD4+ T cells into productive lymphoid aggregates and boost anti-tumor immunity in cancers like MBC that are resistant to ICI therapies.
Huntington’s Disease:

Following an in-depth analysis of the Phase 2 SIGNAL-HD trial, Vaccinex is evaluating its HD development strategy, including further clinical studies and potential partnering discussions. The Company has an ongoing discussion with the FDA regarding the design of a potential Phase 3 trial. Further updates to be provided as we receive clarification from FDA.
ActivMAb Platform Technology:

The first clinical candidate selected through use of this technology (SRF114, a fully human monoclonal antibody targeting CCR8 for the potential treatment of solid tumors), is in a Phase 1/2 study sponsored by our licensee, Surface Oncology, recently acquired by Coherus Biosciences, Inc. (transaction announced June 16, 2023 and expected to close in Q3 2023). The technology and its potential applications for drug discovery against complex membrane protein targets including the "hard to drug" class of membrane-associated G protein-coupled receptors (GPCRs) and ion channels have been described in several publications and has also been utilized in multiple antibody discovery collaborations with leading biopharmaceutical companies.
Financial Results for the Three Months Ended June 30, 2023:
Cash and Cash Equivalents and Marketable Securities. Cash and cash equivalents and marketable securities on June 30, 2023 were $1.9 million, as compared to $6.4 million as of December 31, 2022.

Financing activities in Q2 2023 included financing of $5.46 million as part of the May 2023 Private Placement, based on a purchase price of $0.37/share. The financing, which included no warrants, derivatives or financial covenants, was completed in two segments. In the first segment, completed on May 12, 2023, Vaccinex sold approximately 7.9 million shares of common stock for aggregate proceeds of $2.96 million. The investors in the March 2023 Private Placement include FCMI, which is controlled by Albert D. Friedberg, the chairman of the Company’s board of directors, and Vaccinex (Rochester) L.L.C., which is majority owned and controlled by Dr. Maurice Zauderer, the Company’s President, Chief Executive Officer, and a member of its board of directors. In the second segment, FCMI purchased approximately 6.7 million shares of common stock for gross proceeds of $2.51 million.

In addition, on May 16, 2023, in connection with the second installment of the Alzheimer’s Drug Discovery Foundation (ADDF) Award, Vaccinex sold approximately 2.5 million shares at a purchase price of $0.39/share for aggregate gross proceeds of $0.99 million. This represents a milestone payment achieved upon completion of enrollment in the SIGNAL-AD study.

Research and Development Expenses. Research and development expenses for the quarter ended June 30, 2023 were $5.1 million as compared to $3.8 million for the comparable period in 2022.

The increase in research and development expenses is primarily attributable to increased patient enrollment in the SIGNAL-AD study and the Phase 1b/2 KEYNOTE B84 study in HNSCC.

General and Administrative Expenses. General and administrative expenses for the quarter ended June 30, 2023 were $2.0 million as compared to $1.6 million for the comparable period in 2022.

The nominal increase in general and administrative expenses reflects careful cost control measures.

Comprehensive loss/Net loss per share. The Comprehensive Loss and Net loss per share for the quarter ended June 30, 2023 was $7.1 million and $(0.12) compared to $5.4 million and $(0.13) for the comparable period in 2022.

Full financial tables are included below. For further details on Vaccinex’s financials, refer to its Form 10Q filed August 14, 2023 with the S.E.C.

Vaccinex has global commercial and development rights to pepinemab and is the sponsor of the KEYNOTE-B84 study which is being performed in collaboration with Merck Sharp & Dohme Corp, a subsidiary of Merck and Co, Inc. Kenilworth, NJ, USA. Additional information about the study is available at: clinicaltrials.gov.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co. Inc., Kenilworth, NJ, USA.

BAVENCIO/avelumab is co-developed and co-commercialized by Merck KGaA, Darmstadt, Germany and Pfizer Inc.

About Pepinemab
Pepinemab is a humanized IgG4 monoclonal antibody. It inhibits SEMA4D which regulates the actin cytoskeleton of cells and plays an important role in tumor immune evasion as well as in inflammatory reactions in the brain. Preclinical and clinical data show that pepinemab promotes infiltration and activation of dendritic cells and CD8+ T cells and reverses immunosuppression within the tumor microenvironment. Separately, studies in neurodegenerative disease show that by preventing deleterious inflammatory gliosis during disease progression, pepinemab preserves normal function of astrocytes and microglia, two types of glial cells that play a crucial role in the function and health of neurons in the brain. Pepinemab is being evaluated in several studies in neurodegenerative disease and cancer. Pepinemab has been administered to more than 400 patients and appears to have a favorable safety and tolerability profile.

On August 14, 2023 Enveric Biosciences, Inc. (NASDAQ: ENVB) ("Enveric" or the "Company"), a biotechnology company dedicated to the development of novel neuroplastogenic small-molecule therapeutics for the treatment of anxiety, depression, and addiction disorders, reported a corporate update and provided financial results for the second quarter of 2023 ended June 30, 2023 (Press release, Enveric Biosciences, AUG 14, 2023, View Source [SID1234634386]).

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"The second quarter of 2023 was an exciting and productive period for Enveric as we made significant steps to advance a pipeline of differentiated neuroplastogenic small-molecule therapeutics that, we believe, have the potential to transform the treatment of mental health disorders," said Joseph Tucker, Ph.D., Director and CEO of Enveric. "Our efforts during the quarter focused on two important elements in realizing this goal – enhancing the intellectual property ("IP") portfolio covering EB-373 and our EVM201 and EVM301 Series and advancing preclinical and manufacturing processes for EB-373 in preparation for an anticipated first-in-human clinical trial."

Dr. Tucker continued: "Securing strong IP coverage is critical to the value potential of our technologies, and we were pleased to have been awarded multiple Notices of Allowance from the USPTO for composition of matter claims involving EB-373 and our EVM201 and EVM301 Series. We are continuing to pursue numerous additional patent filings, which are collectively designed to protect our technological advances as we seek to create a portfolio of novel small-molecule therapeutics for the treatment of mental health disorders."

Dr. Tucker continued: "During the quarter we also completed multiple preclinical studies involving our lead candidate, EB-373, that demonstrated oral bioavailability, and rapid oral absorption and systemic clearance. Additionally, we enhanced our manufacturing capabilities for EB-373, improving yield, purity and production efficiency as we finalize the formulation in preparation for entry into the clinic."

Dr. Tucker concluded: "We are on track to identify a lead candidate from the EVM301 Series by year-end, which will enable us to begin preclinical development in 2024 in preparation for an Investigational New Drug application. We believe that our EVM301 Series of compounds are distinctive as demonstrated by the patentability of our candidate molecules which engage the serotonin 5HT2a receptor and other neurotransmitter receptors in the effort to promote neuroplasticity and, consequently, therapeutic benefit while avoiding inducing the hallmark hallucinations associated with most psychedelic and psychedelic-inspired molecules. We believe that this innovative therapeutic approach could be game-changing in the treatment of depression and anxiety disorders by offering the opportunity to administer medications without requiring a healthcare professional to be present during treatment."

SECOND QUARTER AND RECENT PROGRAM UPDATES

Reported initial results from animal studies of EB-373 demonstrating oral bioavailability and rapid absorption and systemic clearance, improving on PK characteristics of psilocybin
Completed in-vitro absorption, distribution, metabolism, and excretion and toxicology assays demonstrated rapid conversion of EB-373 to the active metabolite psilocin
Announced the development of EB-373 drug substance and initiation of scaled up manufacturing
Expanded existing manufacturing agreement with CDMO partner for enhanced supply of non-GMP and GMP EB-373 drug substance
Received multiple notices of allowance from the USPTO protecting composition of matter claims governing lead clinical candidate, EB-373 and EVM301 Series
Compelling research presented at Canadian Chemistry Conference and Exhibition in June 2023
Announced cost reduction plan designed to extend financial runway into the first quarter of 2024
SECOND QUARTER 2023 FINANCIAL RESULTS

Net loss attributable to shareholders was $6.40 million for the second quarter ended June 30, 2023, including $1.64 million in net non-cash expenses, with a basic and diluted loss per share of $3.04, as compared to a net loss of $2.87 million and non-cash income of $1.04 million, with primary and diluted loss per share of $2.73 per share for the quarter ended June 30, 2022.

Net cash used in operations for the quarter ended June 30, 2023, was $4.47 million consisting of a $6.37 million net loss, adjusted by a net of $1.59 million in non-cash expenses and changes in asset and liability balances of $0.30 million. Included in the net cash used in operations were one-time charges totaling $2.76 million for prepayment of preclinical costs, restructuring costs, and redemption of Akos Series A preferred stock.

As of June 30, 2023, the Company had cash and cash equivalents of $7.08 million.