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Neogap raises SEK 83 million for a clinical phase I/II cancer study

On November 9, 2023 Neogap Therapeutics, a company developing cell therapy for personalised cancer treatment, reported that it has strengthened its financial position through a new share issue of SEK 54 million, before issue costs, with the investment company Sciety and investment syndicate Sciety Venture Partners (Press release, Neogap Therapeutics, NOV 9, 2023, View Source,c3872193 [SID1234637404]). Alongside this, the company has received a grant of just over SEK 29 million from the European Innovation Council (EIC) Accelerator, a part of the EU’s Horizon Europe program.

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The positive comments from the EIC Accelerator evaluation notably underscore the unique nature and potential of Neogap’s treatment: "Neogap has a unique approach to a complete individualised therapy that unlike any other current therapies has curative potential in many types of solid cancer with low risk of serious side effects."

"These capital injections are a clear endorsement of the innovative spirit and dedicated team efforts that define Neogap’s work. The EU funding confirms our ambition to be a driving force in the field of cancer therapy. With these resources, we can continue our development work as planned, bringing us closer to our long-term objective – to improve treatment and increase survival for cancer patients," says Samuel Svensson, CEO of Neogap.

"We are delighted to once again invest in Neogap and thus be able to contribute to important advances in cancer treatment. The company has a unique approach that is based on the realisation that each cancer is unique and differs between different patients and tumours. By using proprietary algorithms for machine learning and patented technology to train the patient’s own T-cells to attack the cancer cells, the company develops a completely individualised treatment," says Andreas Lindblom, Managing Partner at Sciety.

Neogap’s personalised immunotherapy has the potential to tackle a variety of cancer types, with a primary focus on colorectal cancer, which accounts for approximately 10% of all cancer cases and is the second leading cause of death due to cancer. Leveraging its technologies, PIOR and EpiTCer, Neogap is developing personalised therapy strategies for each patient. This bespoke and targeted approach ensures that the therapy selectively attacks cancer cells and minimises impact on healthy tissue, which in turn contributes to a low risk of side effects.

Neogap’s ongoing phase I/II study primarily aims to demonstrate the treatment’s safety, but the company will also explore signs of treatment efficacy, including measurement of tumour growth.

Monte Rosa Therapeutics Announces Third Quarter 2023 Financial Results and Provides Corporate Update

On November 9, 2023 Monte Rosa Therapeutics, Inc. (Nasdaq: GLUE), a clinical-stage biotechnology company developing novel molecular glue degrader (MGD)-based medicines, reported business highlights and financial results for the quarter ended September 30, 2023 (Press release, Monte Rosa Therapeutics, NOV 9, 2023, View Source [SID1234637403]).

"This has been a pivotal time for Monte Rosa as we announced both our first clinical data and our first major strategic collaboration," said Markus Warmuth, M.D., Chief Executive Officer of Monte Rosa Therapeutics. "We’re very excited about the clinical data for MRT-2359, our GSPT1-directed molecular glue degrader, and in particular the early signs of clinical activity in MYC-driven solid tumors. We’re equally excited to partner with Roche to enable and accelerate expansion of our QuEEN discovery engine to discover and develop molecular glues against targets previously considered impossible to drug for cancer and neurological diseases. We also completed a registered direct offering that, together with our ongoing pipeline prioritization efforts, is expected to extend our cash runway into the first half of 2026. We look forward to continuing to execute on our pipeline, including delivering Phase 2 interim data for MRT-2359 and Phase I healthy volunteer data for our immunology and inflammation-directed VAV1 and NEK7 programs."

THIRD QUARTER 2023 AND RECENT HIGHLIGHTS

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Announced interim clinical data from the ongoing MRT-2359 Phase 1/2 study demonstrating favorable pharmacokinetic (PK), pharmacodynamic (PD), and tolerability profiles in heavily pre-treated patients with MYC-driven solid tumors, including lung cancers and high-grade neuroendocrine tumors. MRT-2359 showed evidence of tumor size reductions, including partial responses, in heavily pretreated patients with biomarker-positive tumors. Optimal PD modulation of GSPT1 in peripheral blood mononuclear cells and tumor tissue biopsies was observed at all dose levels, consistent with its designed activity based on preclinical studies.
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Entered into a strategic collaboration and licensing agreement with global healthcare leader Roche to discover and develop MGDs against targets in cancer and neurological diseases. Under the terms of the agreement, Monte Rosa Therapeutics will receive an upfront payment of $50 million, and is eligible to receive future preclinical, clinical, commercial and sales milestone payments that could exceed $2 billion, as well as tiered royalties.

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Completed a $25 million registered direct offering, priced at-the-market under Nasdaq rules, with a life sciences-dedicated investor.
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Presented preclinical data at the American College of Rheumatology (ACR) Convergence Annual Meeting demonstrating the potential of MRT-6160, a VAV1-targeting MGD, to treat immunological and inflammatory diseases. The data show that MRT-6160 attenuated disease progression in a murine collagen-induced arthritis (CIA) model.
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Appointed Anthony M. Manning, Ph.D., to the Company’s Board of Directors. Dr. Manning is a highly accomplished drug discovery leader in the field of autoimmune and inflammatory diseases.
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Discontinued sickle cell disease program to prioritize internal efforts on ongoing clinical-, Investigational New Drug (IND)- and lead optimization-stage programs.

UPCOMING MILESTONES

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The Company now expects to release the recommended Phase 2 dose for the MRT-2359 Phase 1/2 study in Q2 2024.
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On track for planned IND submission for MRT-6160 in the first half of 2024.
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The Company expects to nominate a development candidate for its NEK7 preclinical program in Q1 2024.
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The Company expects to nominate a development candidate for its CDK2 preclinical program in 2024.

THIRD QUARTER 2023 FINANCIAL RESULTS

Research and Development (R&D) Expenses: R&D expenses for the third quarter of 2023 were $28.3 million, compared to $21.3 million for the third quarter of 2022. These increases were driven by the successful achievement of key milestones in our R&D organization, including the advancement of MRT-2359 in the clinic, the progression of our preclinical pipeline, and the continued development of the Company’s QuEEN platform for discovery efforts. The increase in R&D expenses was driven by increased headcount and laboratory-related expenses to achieve these milestones. Non-cash stock-based compensation constituted $2.3 million of R&D expenses for Q3 2023, compared to $1.7 million in the same period in 2022.

General and Administrative (G&A) Expenses: G&A expenses for the third quarter of 2023 were $8.7 million compared to $7.0 million for the third quarter of 2022. The increase in G&A expenses was a result of increased headcount and expenses in support of the company’s growth and operations. G&A expenses included non-cash stock-based compensation of $2.2 million for the third quarter of 2023, compared to $1.5 million for the same period in 2022.

Net Loss: Net loss for the third quarter of 2023 was $34.9 million, compared to $27.3 million for the third quarter of 2022.

Cash Position and Financial Guidance: Cash, cash equivalents, restricted cash, and marketable securities as of September 30, 2023, were $183.0 million, compared to cash, cash equivalents, restricted cash, and marketable securities of $207.6 million as of June 30, 2023. The decrease of $24.6 million was primarily related to cash used to fund operations. The September 30, 2023, cash and equivalents balance does not include the $50 million upfront payment from Roche or the approximately $25 million proceeds from the registered direct offering, which were received after the end of Q3 2023.

The company expects its cash and cash equivalents, including proceeds from the Roche collaboration, will be sufficient to fund planned operations and capital expenditures into the first half of 2026.

About MRT-2359

MRT-2359 is a potent, selective and orally bioavailable investigational molecular glue degrader (MGD) that induces the interaction between the E3 ubiquitin ligase component cereblon and the translation termination factor GSPT1, leading to the targeted degradation of GSPT1 protein. The MYC transcription factors (c‑MYC, L-MYC and N-MYC) are well-established drivers of human cancers that maintain high levels of protein translation, which is critical for uncontrolled cell proliferation and tumor growth. Preclinical studies have shown this addiction to MYC-induced protein translation creates a dependency on GSPT1. By inducing degradation of GSPT1, MRT-2359 is designed to exploit this vulnerability, disrupting the protein synthesis machinery, leading to anti-tumor activity in MYC-driven tumors.

About MRT-6160

MRT-6160 is a potent, highly selective, and orally bioavailable investigational degrader of VAV1, which in our in vitro studies has shown deep degradation of its target with no detectable effects on other proteins. VAV1, a Rho-family guanine nucleotide exchange factor, is a key signaling protein downstream of both the T-and B-cell receptors. VAV1 expression is restricted to blood and immune cells, including T and B cells. Preclinical studies have shown that targeted degradation of VAV1 protein via an MGD modulates both T- and B-cell receptor-mediated activity. This modulation is evident both in vitro and in vivo, demonstrated by a significant decrease in cytokine secretion, proteins vital for maintaining autoimmune diseases. Moreover, VAV1-directed MGDs have shown promising activity in preclinical models of autoimmune diseases and thus have the potential to provide therapeutic benefits in multiple autoimmune indications, such as multiple sclerosis, rheumatoid arthritis, and dermatological disorders. Preclinical studies demonstrate MRT-6160 inhibits disease progression in in vivo autoimmunity models.

Marker Therapeutics Reports Third Quarter 2023 Financial Results and Provides Business Updates

On November 9, 2023 Marker Therapeutics, Inc. (Nasdaq: MRKR), a clinical-stage immuno-oncology company focusing on developing next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications, today reported corporate updates and financial results for the third quarter ended September 30, 2023 (Press release, Marker Therapeutics, NOV 9, 2023, View Source [SID1234637402]).

"During the third quarter of 2023, we continued to diligently advance and execute our clinical objectives across our novel multiTAA-specific T cell pipeline," commented Juan F. Vera, M.D., President and Chief Executive Officer of Marker Therapeutics. "Among the many highlights, we announced in September that we observed a complete response in the first patient with lymphoma treated with MT-601, our multiTAA-specific T cell product candidate targeting six antigens. This study participant was enrolled in our Phase 1 APOLLO trial after failing anti-CD19 CAR T cell therapy. The positive clinical outcome in this CAR T relapsed participant is supported by non-clinical proof-of-concept data and highlights the potential of MT-601 in patients who have relapsed after CAR T cell therapy. Together with the favorable clinical safety and tolerability profile, MT-601 may represent a suitable alternative for the treatment of patients with lymphoma."

"In July, our MT-401 program was granted Orphan Drug Designation by the EMA for the treatment of patients with AML," continued Dr. Vera. "We also reported non-clinical proof-of-concept data from our MT-401-OTS program, which indicated the potential anti-tumor activity of the product in a partially human leukocyte antigen (HLA) matched setting. With the clearance of our clinical protocol for MT-401-OTS from the U.S. FDA and the added validation from our non-clinical work, we anticipate initiating a clinical trial in 2024 to evaluate the potential of this novel therapy in patients with relapsed/refractory AML."

"To maximize shareholder value and accelerate our patient-centric mission, we continue to engage in internal and external conversations with pertinent stakeholders to optimize our clinical development plan, which we expect to announce in the first quarter of 2024. With our healthy balance sheet and clinical progress shown to date, we believe we are well poised to achieve our near-and long-term growth objectives," concluded Dr. Vera.

Program Updates and Expected Milestones:

MT-401 (Acute Myeloid Leukemia)

· Marker was granted ODD from the Committee for Orphan Medicinal Products of the EMA for the treatment of patients with AML. This follows the ODD from U.S. FDA in 2020.

· Marker reported non-clinical proof-of-concept data of MT-401 in an OTS setting and provided updates on clinical readiness for the MT-401-OTS program, which will investigate the treatment of patients with relapsed/refractory AML. Marker has established an inventory for MT-401-OTS and anticipates initial patient treatment in 2024.

· Marker reported non-clinical data to bolster the clinical investigation of MT-401 after hypomethylating agent (HMA) administration and received a $2 million grant from the NIH Small Business Innovation Research (SBIR) program in support of the clinical study.

MT-601 (Lymphoma)

· Complete response in the first patient with lymphoma treated with MT-601 in the Phase 1 multicenter APOLLO trial (clinicaltrials.gov identifier: NCT05798897) following participant’s failure to respond to four prior lines of therapy including anti-CD19 CAR T cell therapy. The study participant was treated with 2 doses of MT-601 at a 200 million cell dose level without prior lymphodepletion and showed no clinically significant treatment-related adverse events. At the first assessment, eight weeks after the second infusion of MT-601, the participant demonstrated a complete metabolic response based on PET-CT scans. MT-601 treatment was well tolerated with no treatment-related adverse events.

· This clinical observation is supported by in vitro data demonstrating the anti-tumor activity of MT-601 in anti-CD19 CAR T resistant lymphoma cells, highlighting the therapeutic potential of MT-601.

· Marker is treating and evaluating additional patients in the Phase 1 APOLLO trial and anticipates reporting additional data in the first half of 2024.

MT-601 (Pancreatic)

· Investigational New Drug (IND) application cleared by U.S. FDA for multicenter Phase 1 trial of MT-601 in patients with metastatic pancreatic cancer in combination with first-line chemotherapy.

· Clinical advancement will be pending additional financial support from non-dilutive grant activities.

Third Quarter 2023 Financial Highlights:

· Cash Position: Cash and cash equivalents of $17.5 million at September 30, 2023.

· R&D Expenses: Research and development expenses were $2.0 million for the quarter ended September 30, 2023, compared to $3.6 million for the quarter ended September 30, 2022. The decrease in R&D expenses was primarily attributable to lower expenses from the sale of Marker’s cell processing facility to Cell Ready, which was completed in June 2023.

· G&A Expenses: General and administrative expenses were $1.4 million for the quarter ended September 30, 2023, compared to $3.2 million for the quarter ended September 30, 2022. The decrease in G&A expenses was also primarily attributable to the sale of Marker’s cell processing facility to Cell Ready.

· Net Loss: Marker reported a net loss of ($3.0) million for the quarter ended September 30, 2023, compared to a net loss of ($6.9) million, inclusive of the $(1.2) million loss from discontinued operations, reflected in the quarter ended September 30, 2022.

Ensysce Biosciences Reports Third Quarter 2023 Financial Results

On November 9, 2023 Ensysce Biosciences, Inc. ("Ensysce" or the "Company") (NASDAQ:ENSC), a clinical-stage company applying transformative chemistry to improve prescription drug safety, reported financial results for the third quarter of 2023 (Press release, Ensysce Biosciences, NOV 9, 2023, View Source [SID1234637401]).

Dr. Lynn Kirkpatrick, Chief Executive Officer of Ensysce, commented, "We continue to execute steps toward meeting our near-term objective of entering Phase 3 evaluation of PF614 with a long-term goal of commercialization. Specifically, we’ve achieved multiple milestones in the third quarter which began with Institutional Review Board approval of the PF614-201 clinical protocol in August followed by the critically important completion of the Site Initiation Visit to commence our PF614-201 clinical trial, and additionally engagement of the strategic advisory group Alacrita Consulting to enhance our partnering and licensing opportunities. Behind the scenes we are continuing manufacturing activities of both PF614 and the combination product PF614-MPAR for overdose protection. The Company’s progress throughout 2023 has further supported our belief that PF614 and PF614-MPAR will become the ‘next generation’ of analgesics that are equally effective in treating severe pain with a safer outcome for pain management than currently marketed opioids.

Looking forward, we are on track for the important readout from the PF614-201 ‘time of onset’ study prior to year-end. The data will support the design of our Phase 3 protocols and add to the favorable results from the three clinical studies completed over the last year. All data generated to date have contributed to the regulatory submission for our End of Phase 2 discussions with the FDA scheduled for January 30, 2024, in advance of initiating Phase 3 studies in 2024. Lastly, we successfully completed a private placement funding round made possible by the support of our long-term investors signaling continued confidence in Ensysce’s PF614 pain management treatment and our mission to improve drug safety," concluded Dr. Kirkpatrick.

TAAPTM (Opioid Abuse Deterrent Program) Updates

Our lead product, PF614, is a Trypsin-Activated Abuse Protection (TAAPTM) extended-release oxycodone and a potential ‘next generation’ analgesic for severe pain. The Company’s TAAPTM technology is designed to control release, be highly resistant to tampering and reduce abuse through a unique chemical modification. PF614’s TAAPTM modification makes it inactive until it is swallowed, following which it is activated or ‘turned on’ to release oxycodone by the body’s owntrypsin, an enzyme in the small intestine. Ensysce completed three clinical trials over the last year and is working to complete enrollment for its latest clinical trial to evaluate the time of onset of pain relief with PF614. Ensysce believes it has a body of evidence showing that PF614 works as designed, is bioequivalent to OxyContin and has a good safety profile. Our most recent studies demonstrate that PF614 is less liked by recreational drug users when taken orally as compared to regular oxycodone, creating what we believe is a safer analgesic.

Most recently, on September 26, 2023, the Company completed the Site Initiation Visit for the PF614-201 study, ‘A Randomized, Double-Blind, Placebo-Controlled Crossover Study of PF614 on Analgesic Response in the Cold Pressor Test in Healthy Male Subjects’ to evaluate time of onset for PF614. The study is being conducted by Dr. George Atiee at Dr. Vince Clinical Research (DVCR) in Overland, KS. The Company expects results from this study in December 2023.

On September 14, 2023, the Company announced that two scale up manufactures had been completed for PF614 in 2023. The success of the scaled manufacturing work positions the Company to begin its strategy of commercial readiness consistent with timeline expectations as it enters the next phase of development, including planning its phase 3 studies.

MPAR (Opioid Abuse Deterrent and Overdose Protection Program) Updates

PF614-MPAR is a combination product to treat severe pain, designed with overdose protection. MPAR (Multi-Pill Abuse Resistance) reduces or ‘turns off’ the release of the opioid to prevent an overdose, providing an additional layer of protection to Ensysce’s TAAP medications. We believe that MPAR is the first technology that may reduce prescription drug overdoses stemming from oral abuse, which can save lives. The clinical data generated over the past year supported the approach that the MPAR combination technology reduces release and absorption of oxycodone from PF614, when consumed in overdose. A regulatory submission is planned to discuss our MPAR development program with the FDA.

On September 7, 2023, the Company hosted a symposium at PAINWeek 2023 to formally present the recent clinical data for PF614 and PF614-MPAR to a global community of leading pain medical professionals. Ensysce’s objectives included conveying an understanding of the current landscape for severe pain treatment and drug use and abuse in America. This overview dovetailed with the Company’s thesis of the unmet medical and societal need for the safety and effectiveness of PF614 and PF614-MPAR, the Company’s two leading next-generation agents which are designed to reduce opioid abuse and prevent overdose deaths.

The results from our clinical trials are evidence that Ensysce’s PF614 and PF614-MPAR analgesics reflect an inflection point in the management of severe pain as a safe and equally effective alternative to prescription opioids that have become less accessible due to the direct correlation to abuse and overdose.

Third Quarter 2023 Financial Results

Cash – Cash and cash equivalents were $1.5 million as of September 30, 2023, as compared to $3.8 million as of June 30, 2023. Subsequent to quarter end, on October 23, 2023, the Company entered into a securities purchase agreement with investors in the form of senior secured convertible notes with a dedicated syndicate of investors for an aggregate investment of $1.7 million to occur in two closings. The initial closing occurred on October 25, 2023, providing $0.6 million prior to fees and offering expenses. The second closing is anticipated prior to year-end.
Federal Grants – Funding under federal grants totaled to $0.4 million for the third quarter of 2023 compared to $0.3 million in the comparable year ago quarter. The increase is due to the timing of research activities eligible for funding, particularly relative to the MPAR program.
Research & Development Expenses – R&D expenses decreased to $1.9 million for the third quarter of 2023 compared to $4.8 million for the same period in 2022. The decrease was primarily the result of changes in timing of external research and development costs related to clinical and pre-clinical programs for PF614 and PF614-MPAR.
General & Administrative Expenses – G&A expenses decreased to $1.2 million for the third quarter of 2023 compared to $1.7 million for the same period of 2022. The decrease was primarily a result of reduced stock-based compensation, employee bonus accrual and consulting fees.
Other Income (Expense) – Total other income (expense), net was income of $16,508 for the third quarter of 2023 compared to expense of $3.7 million for the same period of 2022. The change in other income is primarily due to non-cash fair value adjustments for convertible notes and warrants.
Net Loss – Net loss attributable to common stockholders for the third quarter of 2023 was $2.7 million compared to $9.9 million for the third quarter of 2022. As a clinical stage biotech company, our continued research and development efforts toward regulatory approvals for our product candidates are expected to result in losses for the foreseeable future.

Aura Biosciences Reports Third Quarter 2023 Financial Results and Provides Clinical Development and Operational Highlights

On November 9, 2023 Aura Biosciences, Inc. (NASDAQ: AURA), a clinical-stage biotechnology company developing a novel class of virus-like drug conjugate (VDC) therapies for multiple oncology indications, reported financial results for the third quarter ended September 30, 2023, and provided clinical development and operational highlights (Press release, Aura Biosciences, NOV 9, 2023, View Source [SID1234637400]).

"In the third quarter we made meaningful progress across our portfolio," said Elisabet de los Pinos, Ph.D., Chief Executive Officer of Aura. "We are encouraged by the agreement with the FDA under the SPA, as it reinforces the plan for our CoMpass trial and further supports our goal of having the first approved vision-preserving therapy for patients with early-stage choroidal melanoma. The Phase 2 data presented at AAO, with 90% of patients at twelve months follow-up, show results that are highly consistent with, and strongly support, the assumptions for the design of the CoMpass Phase 3 trial."

Dr. de los Pinos added, "We are pleased with the preliminary data from our ongoing Phase 1 trial in bladder cancer, where the first patient who received a single dose of bel-sar with light activation demonstrated a clinical complete response evidenced by absence of cancer cells on histopathology, and we look forward to additional data from the program in mid-2024. With a strong balance sheet from our recent financing, we are well-positioned to execute our pipeline to meaningful clinical milestones."

Recent Pipeline Developments

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The CoMpass trial is designed as a superiority trial comparing bel-sar versus sham. The trial is a global Phase 3, randomized, multi-center, masked study, and it is intended to enroll approximately 100 patients randomized 2:1:2 to receive high dose regimen of bel-sar, low dose regimen of bel-sar with suprachoroidal (SC) administration, or a sham control.

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The Company received written agreement from the FDA under an SPA for the overall design of the CoMpass trial. The primary endpoint is time to tumor progression and the first key secondary endpoint is a composite time to event analysis that will compare the tumor control and visual acuity of the bel-sar high dose regimen to sham when the last patient completes their 15 months of follow up.
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The Company is planning to dose the first patient in Q4 2023.

Positive updated Phase 2 data evaluating SC administration of bel-sar for the first-line treatment of adult patients with early-stage CM was presented at AAO 2023.

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The results, with 90% of patients at twelve months of follow-up who received three cycles of therapy in Cohorts 5 and 6, and who match the criteria for the global Phase 3 trial, showed a tumor control rate of 80% (8/10) and the visual acuity preservation rate was 90% (9/10), with the majority of patients being at high-risk for vision loss with tumors close to the fovea or optic disk. For the 80% of patients that responded, data showed a statistically significant reduction in tumor growth rate (-0.382 mm/yr, p = <0.0001) compared to each patient’s documented growth rate at study entry. The overall tolerability profile of bel-sar was favorable, with no dose-limiting toxicities, treatment-related SAEs or significant AEs reported as of August 3, 2023. There was no posterior inflammation and only mild anterior inflammation (Grade 1) in ~18% of the patients which was self-limited or resolved with a short course of topical steroids. Treatment-related AEs were predominantly mild and resolved without sequelae.
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Beyond early-stage CM, the Company continues to build its ocular oncology franchise. The Company’s goal is to initiate clinical development in choroidal metastasis, an indication with a high unmet medical need and no approved therapies, as the second ocular oncology indication. The Company is on track to initiate the Phase 2 trial in 2024, with initial data by year-end 2024.
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The Phase 1 trial of bel-sar for the treatment of muscle invasive bladder cancer (MIBC) and non-muscle invasive bladder cancer (NMIBC) is currently ongoing, and the Company expects to report data in mid-2024. This represents an area of high unmet need with approximately 80,000 patients diagnosed in the United States every year. The Company received Fast Track Designation from the Oncology Division of the FDA for NMIBC in June 2022.
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The FDA has allowed an amendment to the protocol of the ongoing Phase 1 trial allowing the inclusion of adult patients with MIBC, in addition to NMIBC.
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The ongoing Phase 1 multi-center, open-label clinical trial is expected to enroll approximately 19 adult patients. The trial is designed to assess the safety and tolerability of bel-sar as a single agent. The trial will provide histopathological evaluation after the local treatment to assess bel-sar’s biological activity. The trial has completed enrollment of the cohort that received bel-sar injection without light activation. Protocol mandated safety review found no safety issues and the study has proceeded to the bel-sar injection plus light activation cohorts. Preliminary data from the first patient in the light activated cohort of the trial, utilizing a single dose of bel-sar with light activation, demonstrated a clinical complete response demonstrated by absence of cancer cells on histopathology with evidence of extensive necrosis and immune activation.
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The Company expects to provide additional data in mid-2024.

Recent Corporate Events

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Raised Gross Proceeds of $99.0 million in an underwritten public offering. In November 2023, the Company announced the pricing of an underwritten public offering of 11,000,000 shares of its common stock at a price to the public of $9.00 per share. The offering closed on November 9, 2023. In addition, Aura has granted the underwriters a 30-day option to purchase up to 1,650,000 additional shares of common stock at the public offering price, less the underwriting discount.
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Strengthened the clinical leadership team with the following key appointments:
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J. Jill Hopkins, M.D., appointed as Chief Medical Officer and President of Research and Development. Dr. Hopkins previously served as Senior Vice President, Global Head of Ophthalmology and Exploratory Development at Novartis, and Chief Executive Officer of Gyroscope Therapeutics, a Novartis Company. Dr. Hopkins brings over 30 years of cross-sector experience in ophthalmology, spanning clinical care, academia, education, industry, advocacy and innovation.
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Mark Plavsic, Ph.D., appointed as Chief Technology Officer. Dr. Plavsic previously served as Chief Technology Officer at Fate Therapeutics, a clinical-stage biopharmaceutical company dedicated to bringing a first-in-class pipeline stem celled-derived cellular immunotherapies to patients with cancer and autoimmune disorders. Dr. Plavsic brings 30 years of global biopharmaceutical experience including end-to-end technical operations in the United States, Europe, and Australasia and successful translation and scale-up of complex biologics from preclinical development through commercial launch and distribution.

Third Quarter 2023 Financial Results

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As of September 30, 2023, the Company had cash and cash equivalents and marketable securities totaling $149.1 million. This excludes the net proceeds from the underwritten public offering received in November 2023. The Company believes its current cash and cash equivalents, marketable securities, and proceeds from the underwritten public offering are sufficient to fund its operations into the second half of 2026.
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Research and development expenses increased to $15.4 million for the three months ended September 30, 2023 from $11.3 million for the three months ended September 30, 2022, primarily due to ongoing clinical costs associated with the progression of the Company’s Phase 2 study and CRO costs associated with the start of the Company’s Global Phase 3 trial, and manufacturing and development costs for bel-sar.
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General and administrative expenses increased to $5.1 million for the three months ended September 30, 2023 from $4.8 million for the three months ended September 30, 2022. General and administrative expenses include $1.2 million and $1.1 million of stock-based compensation for the three months ended September 30, 2023 and 2022, respectively. The increase was primarily driven by personnel expenses, as well as increases in general corporate expenses related to growth of the Company.
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Net loss for the three months ended September 30, 2023 was $18.5 million compared to $15.9 million for the three months ended September 30, 2022.