On November 10, 2022 Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, reported its recent accomplishments and financial results for the quarter ended September 30, 2022 (Press release, Soligenix, NOV 10, 2022, View Source [SID1234623750]).

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"We have continued to achieve significant milestones across our development pipeline in 2022. The most important is still to come this quarter with the filing of our new drug application (NDA) with the U.S. Food and Drug Administration (FDA) for HyBryte (synthetic hypericin) in the treatment of cutaneous T-cell lymphoma (CTCL)," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "We were also pleased with the FDA Orphan Products Development grant award of a $2.6 million over 4 years to support the evaluation of HyBryte for expanded treatment in patients with early-stage CTCL, including in the home setting. Additionally, we are advancing synthetic hypericin development into other disease indications, such as psoriasis, where we plan to work in conjunction with our recently established Medical Advisory Board (MAB) to initiate a Phase 2a clinical study for the treatment of mild-to-moderate psoriasis in December.

Supported by funding from the National Institute of Allergy and Infectious Diseases, we were able to demonstrate 100% protection of non-human primates against both lethal Sudan ebolavirus and Marburg marburgvirus challenge with our SuVax and MarVax vaccines, respectively. With the achievement of these important milestones, we were fortunate to receive an invitation by the Biomedical Advanced Research and Development Authority (BARDA) Division of Chemical, Biological, Radiological and Nuclear (CBRN) Medical Countermeasures to submit a full contract proposal for the further development of these novel vaccine candidates as medical countermeasures for use in the event of a Sudan ebolavirus or Marburg marburgvirus outbreak. While an invitation to submit a contract proposal is not a guarantee of funding, we believe that we are well-positioned to receive BARDA development support for this indication allowing us to further demonstrate the growing body of compelling scientific evidence supporting our heat stable filovirus vaccine platform, including vaccine candidates directed towards Sudan ebolavirus and Marburg marburgvirus."

Dr. Schaber continued, "With approximately $16.9 million in cash, not including our non-dilutive government funding, we anticipate having the necessary capital to achieve our near-term milestones, as we continue to assess various strategic options, including but not limited to, partnership and merger and acquisition opportunities."

Soligenix Recent Accomplishments

On October 27, 2022, the Company announced it had been invited by BARDA Division of CBRN Medical Countermeasures to submit a full contract proposal for the development of single-vial, adjuvanted, heat stable subunit vaccines to prevent filovirus infection. To view this press release, please click here.

On October 25, 2022, the Company announced the formation of a MAB to provide medical/clinical strategic guidance to the Company as it advances the Phase 2a clinical development of SGX302 (synthetic hypericin) for the treatment of mild-to-moderate psoriasis. To view this press release, please click here.

On September 6, 2022, the Company announced the FDA had awarded an Orphan Products Development grant to support the evaluation of HyBryte for expanded treatment in patients with early-stage CTCL. To view this press release, please click here.
Financial Results – Quarter Ended September 30, 2022

Soligenix’s revenues were $0.2 million for the quarter ended September 30, 2022 and 2021, respectively. Revenues primarily relate to third party licensing and the government contracts and grants awarded in support of RiVax, its ricin toxin vaccine candidate; SGX943, for treatment of emerging and/or antibiotic-resistant infectious diseases; ThermoVax, its thermostabilization platform technology; and CiVax, its vaccine candidate for the prevention of COVID-19.

Soligenix’s net loss was $3.3 million, or ($0.08) per share, for the quarter ended September 30, 2022, as compared to $3.6 million, or ($0.09) per share, for the three months ended September 30, 2021. The decrease in net loss was primarily attributed to decrease in research and development expenses partially offset by an increase in legal and consulting expenses associated with the arbitration against Emergent BioSolutions, Inc. (EBS) and certain of its subsidiaries.

Research and development expenses were $1.9 million as compared to $2.2 million for the quarter ended September 30, 2022 and 2021, respectively. The decrease in research and development spending for the quarter ended September 30, 2022 was primarily attributable to the completion of the oral mucositis Phase 3 clinical trial.

General and administrative expenses were $1.2 million and $1.1 million for the quarter ended September 30, 2022 and 2021, respectively. This increase in general and administrative expenses is primarily attributable to an increase in expenses associated with the 2022 Annual Shareholder Meeting as well as increased expenses associated with the commercialization of HyBryte.

As of September 30, 2022, the Company’s cash position was approximately $16.9 million.

On November 10, 2022 Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a clinical-stage biotechnology company developing innovative therapies designed to treat immune-mediated diseases, reported recent corporate highlights and financial results for the quarter ended September 30, 2022 (Press release, Aldeyra Therapeutics, NOV 10, 2022, View Source [SID1234623748]).

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"Now with two product candidates that could generate revenue as soon as next year, Aldeyra remains a leader in the development of systems-based therapeutic approaches for the treatment of diseases characterized by inflammation," stated Todd C. Brady, M.D., Ph.D., President and CEO of Aldeyra.

Recent Corporate Highlights

Pre-NDA Meeting with the FDA for Reproxalap in Dry Eye Disease: Following the receipt of official minutes from its pre-NDA meeting with the FDA, Aldeyra remains on schedule to submit an NDA requesting marketing approval of the novel RASP modulator reproxalap in the fourth quarter of 2022. With results from five adequate and well-controlled completed clinical trials, Aldeyra intends to submit the NDA with data for ocular dryness symptom score, ocular redness, Schirmer test, and Schirmer test ≥10 mm responder analysis. The NDA efficacy package is expected to include activity ranging from within minutes of drug administration to up to 12 weeks of treatment, crossover and parallel-group clinical trial designs, and assessment in dry eye chamber challenge and natural environment settings. In addition to efficacy data, Aldeyra plans to submit up to 12 months of reproxalap safety data. Topical ocular reproxalap has been studied in more than 2,000 patients with no observed clinically significant safety concerns; mild and transient instillation site irritation is the most commonly reported adverse event in clinical trials.
Results from the Phase 3 GUARD Trial of ADX-2191 in Proliferative Vitreoretinopathy: ADX-2191 was statistically superior to historical control1 for the prevention of retinal detachment due to proliferative vitreoretinopathy over six months (P=0.024). Although not statistically powered for secondary or exploratory endpoints, the results of the GUARD Trial demonstrated numerical superiority of ADX-2191 over routine surgical care in reducing the dichotomous endpoints of retinal detachment rate over six months, hypotony (low intraocular pressure), complete retinal attachment by six months, macular attachment by six months, and epiretinal membrane formation (overall P=0.047). The most common adverse event associated with ADX-2191 treatment was punctate keratitis, a well-known side effect of intravitreal methotrexate, that was most commonly mild in severity. Across all other treatment-emergent adverse events occurring in at least 10% of patients in either treatment arm, relative to patients treated with routine surgical care, ADX-2191-treated patients had numerically fewer side effects, including pain, cystoid macular edema, corneal edema, macular fibrosis, corneal epithelial defects, anterior uveitis, ocular hypertension, and post-operative inflammation (overall P=0.0002).
Additional Upcoming Planned Clinical and Regulatory Milestones

Pre-NDA Meeting with the FDA for ADX-2191 in Primary Vitreoretinal Lymphoma: Aldeyra has scheduled a pre-NDA meeting with the FDA in the fourth quarter of 2022 to discuss ADX-2191 for the treatment of primary vitreoretinal lymphoma. Pending the results of the pre-NDA meeting, NDA submission may occur as soon as the end of 2022.
Type C meeting with the FDA for ADX-2191 in Proliferative Vitreoretinopathy: Aldeyra plans to conduct a Type C meeting with the FDA in the first half of 2023 to discuss the completion of clinical development of ADX-2191 for the prevention of proliferative vitreoretinopathy.
Results from the Phase 2 Clinical Trial of ADX-2191 in Retinitis Pigmentosa: Top-line results from the Phase 2 clinical trial of ADX-2191 in patients with retinitis pigmentosa are expected in the first half of 2023.
Results from Phase 2 Clinical Trials of ADX-629 in Systemic Immune-Mediated Diseases: By the end of this year, Aldeyra expects to report top-line results from a Phase 2 clinical trial in acute alcoholic hepatitis, and to initiate Phase 2 clinical trials in Sjögren-Larsson Syndrome and minimal change disease. Top-line results from the ongoing Phase 2 clinical trial of ADX-629 in chronic cough are anticipated in the first half of 2023.
Third-Quarter 2022 Financial Results

Cash, cash equivalents, and marketable securities as of September 30, 2022 were $185.3 million. Based on its current operating plan, Aldeyra believes that existing cash, cash equivalents, and marketable securities will be sufficient to fund currently projected operating expenses through the end of 2023, including NDA submissions and initial commercialization of reproxalap and ADX-2191, if approved; and continued early and late-stage development of Aldeyra’s product candidates in ocular and systemic immune-mediated diseases.

Net loss for the three months ended September 30, 2022 was $14.6 million, or $0.25 per share, compared with a net loss of $15.8 million, or $0.27 per share, for the comparable period of 2021. Losses have resulted from the costs of clinical trials and research and development programs, as well as from general and administrative expenses.

Research and development expenses for the three months ended September 30, 2022 were $11.5 million, compared with $12.9 million for the same period in 2021. The decrease of $1.4 million is primarily related to a decrease in external clinical development costs, offset by an increase in Aldeyra’s external preclinical development costs, drug product manufacturing expenditures, personnel costs, and consulting expenditures.

General and administrative expenses for the three months ended September 30, 2022 were $3.2 million, compared with $2.5 million for the same period in 2021. The increase of $0.7 million was primarily related to higher personnel costs and consulting expenditures.

Total operating expenses for the three months ended September 30, 2022 were $14.8 million, compared with total operating expenses of $15.4 million for the same period in 2021.

Conference Call & Webcast Information

Aldeyra will host a conference call at 8:00 a.m. ET today to discuss recent corporate highlights and financial results for the quarter ended September 30, 2022. The dial-in numbers are (844) 200-6205 for domestic callers and (929) 526-1599 for international callers. The access code is 048610. Please dial in at least 10 minutes prior to the start time.

A live webcast of the conference call can be accessed via the Investors & Media page of the Aldeyra website at View Source After the live webcast, the event will remain archived on the website for 90 days.

On November 10, 2022 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, 2022 and provided clinical development and operational highlights (Press release, Aura Biosciences, NOV 10, 2022, View Source [SID1234623747]).

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"We are encouraged by the meaningful clinical advances that we have made in both our ocular and urologic oncology programs in the third quarter," said Elisabet de los Pinos, Ph.D., Chief Executive Officer of Aura. "Aligning with regulatory agencies on the global Phase 3 trial design with suprachoroidal administration following positive Phase 2 data are key milestones supporting our goal of having the first approved vision preserving therapy for patients with early-stage choroidal melanoma. In addition, successfully dosing a first patient in non-muscle invasive bladder cancer is a meaningful achievement as we expand our platform into broad oncology indications."

Recent Pipeline Developments

Belzupacap Sarotalocan (bel-sar) is being developed for the first-line treatment of early-stage choroidal melanoma (CM), a life-threatening rare disease with no approved therapies.
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Aura finalized the global Phase 3 design in alignment with regulatory agencies and selected suprachoroidal (SC) route of administration to evaluate the efficacy and safety of bel-sar in early-stage CM. The Phase 3 trial is randomized and masked and will include three arms, where the primary analysis will compare bel-sar to sham. Aura is planning to enroll approximately 75 adult patients with early-stage CM, including patients with indeterminate lesions and small choroidal melanoma. Patients will be enrolled with documented growth as an enrichment strategy intended to increase the efficiency of the trial and which will include an adaptive design to further increase the probability of success.

ACTIVE/119779930.3

Positive interim Phase 2 data evaluating SC administration of bel-sar for the first-line treatment of patients with early-stage CM were presented at AAO 2022. The results, with an average of six-months follow up in patients that received three cycles of therapy in Cohorts 5 and 6, showed a statistically significant reduction in the tumor growth rate (-0.296 mm/yr, p = 0.0007) compared to each patient’s documented growth rate at study entry, and an 88.9% (8/9) tumor control rate. In addition, the visual acuity preservation rate was 88.9% (8/9) in these cohorts, with the majority of patients being at high risk for vision loss with tumors close to fovea or optic disk. The overall safety profile of bel-sar was favorable, with no dose-limiting toxicities or treatment-related serious adverse advents reported as of August 19, 2022. There was no posterior inflammation and only mild anterior inflammation (Grade 1) in 20% of the patients. Treatment-related adverse events (AEs) were predominantly mild and resolved quickly without sequalae.

Aura dosed the first patient in a Phase 1 clinical trial of bel-sar for the treatment of non-muscle invasive bladder cancer (NMIBC) an area of high unmet need with approximately 80,000 patients diagnosed in the U.S. every year. Aura received Fast Track Designation from the U.S. Food and Drug Administration in Q2.

The Phase 1 multi-center, open-label clinical trial is expected to enroll approximately 23 adult patients. The trial is designed to assess the safety and tolerability of bel-sar as a single agent. The primary endpoint of the Phase 1 clinical trial is the incidence and severity of treatment-related AEs and serious adverse events and the incidence of dose-limiting toxicities. Aura expects to report initial Phase 1 data in 2023.

Beyond early-stage CM, the Company continues to build its ocular oncology franchise, with the goal of having choroidal metastasis, an unmet medical need with no approved therapies, as the second ocular indication. Aura plans to file an IND for choroidal metastasis with the FDA in Q4 of 2022.

Preclinical data supporting bel-sar’s broad tumor targeting potential and immune mediated mechanism of action was presented at the 22nd EURETINA Congress. Preclinical results highlighted bel-sar’s targeted cytotoxicity towards tumor cells derived from the most common cancer types known to metastasize to the choroid, supporting its potential use for the treatment of choroidal metastases, a key second ocular oncology indication. The presentation also included preclinical data that supported the activity of bel-sar as a single agent as well as in combination with checkpoint inhibitors, highlighting the possibility to treat not only primary tumors in the eye but also potentially distant metastases by an abscopal effect.

Recent Event

Aura hosted a virtual Investor Day on October 3, 2022. The program included preclinical data on bel-sar as a single agent and in combination with checkpoint inhibitors, two-year visual acuity data from the retrospective matched case control study of bel-sar vs. plaque radiotherapy, and interim data from the ongoing Phase 2 trial evaluating SC administration in early-stage choroidal melanoma. Aura’s executive management team was joined by ocular oncology leaders Dr. Carol Shields, Chief of the Ocular Oncology Service at Wills Eye Hospital and Professor of Ophthalmology at Thomas Jefferson University; Dr. Martine Jager, Professor of Ophthalmology, Leiden University, and Past President of the International Society of Ocular Oncology and the Association for Research in Vision and Ophthalmology; and Dr. Ivana Kim, Director of the Ocular Melanoma Center, Massachusetts Eye and Ear and Associate Professor of Ophthalmology, Harvard Medical School. The webcast is available here.

Third Quarter 2022 Financial Results

As of September 30, 2022, Aura had cash and cash equivalents and marketable securities totaling $111.5 million. Aura believes its current cash and cash equivalents and marketable securities are sufficient to fund its operations into 2024.

Research and development expenses increased to $11.3 million for the three months ended September 30, 2022 from $6.4 million for the three months ended September 30, 2021, primarily due to ongoing preclinical costs, manufacturing and development costs for bel-sar, and higher personnel expenses from growing headcount.

General and administrative expenses increased to $4.8 million for the three months ended September 30, 2022 from $2.5 million for the three months ended September 30, 2021. General and administrative expenses include $1.1 million and $0.4 million of stock-based compensation for the three months ended September 30, 2022 and 2021, respectively. The increase was primarily driven by personnel expenses, as well as increases in general corporate expenses related to operating as a public company.

Net loss for the three months ended September 30, 2022 was $15.9 million compared to $8.8 million for the three months ended September 30, 2021.

On November 10, 2022 Werewolf Therapeutics, Inc. (the "Company" or "Werewolf") (Nasdaq: HOWL), an innovative biopharmaceutical company pioneering the development of conditionally activated therapeutics engineered to stimulate the body’s immune system for the treatment of cancer, reported financial results for the third quarter ended September 30, 2022 (Press release, Werewolf Therapeutics, NOV 10, 2022, View Source [SID1234623746]).

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"Werewolf continues to deliver against key corporate objectives with notable pipeline progress highlighted by our transition into a clinical-stage company," said Daniel J. Hicklin, Ph.D., President and Chief Executive Officer of Werewolf. "During the third quarter, we initiated the first-in-human clinical trial of our lead program, WTX-124, for treatment of advanced solid tumors. In addition, we have received IND clearance from the FDA for WTX-330, our IL-12 program, which puts us on track to have two actively enrolling clinical trials in 2023. Finally, Werewolf remains well-capitalized with runway that we project will carry us through at least the second quarter of 2024, which supports the development plans for both clinical programs and continued value creation for our early-stage pipeline assets."

Recent Highlights and Upcoming Milestones

WTX-124: a systemically delivered, conditionally activated Interleukin-2 (IL-2) INDUKINE molecule being developed as monotherapy and in combination with pembrolizumab in multiple solid tumor types.

•During the third quarter of 2022, Werewolf announced the initiation of patient dosing in its Phase 1/1b clinical trial evaluating WTX-124 (WTX-124×2101), the Company’s lead INDUKINE molecule, targeting IL-2 for the treatment of solid tumors. The Phase 1/1b clinical trial is a first-in-human, multi-center, open-label trial evaluating WTX-124 as a monotherapy and in combination with KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 (programmed death receptor-1) therapy, in patients with immunosensitive advanced or metastatic solid tumors who have failed standard of care, including checkpoint inhibitor therapy.
•Werewolf is actively enrolling patients in monotherapy dose-escalation cohorts in Study WTX-124×2101. The Company anticipates reporting preliminary interim data from this study in the fourth quarter of 2023. These data are expected to provide initial safety and activity profiles of WTX-124.

WTX-330: a systemically delivered, conditionally activated Interleukin-12 (IL-12) INDUKINE molecule being developed as monotherapy in relapsed/refractory and/or immunologically resistant or unresponsive tumors.

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•Following submission in the third quarter of 2022, Werewolf received clearance from the U.S. Food and Drug Administration (FDA) of its IND application for WTX-330. The Company has begun activating sites for a Phase 1 clinical trial (WTX-330×2101) evaluating the safety and tolerability of WTX-330 monotherapy in patients with advanced or metastatic tumors which are either immunotherapy resistant or unresponsive.

Third Quarter 2022 Financial Highlights

•Cash position: As of September 30, 2022, cash and cash equivalents decreased to $140.5 million, compared to $157.5 million as of December 31, 2021. Based on updated forecasting, the Company has extended its runway to project that its existing cash and cash equivalents, together with anticipated collaboration revenue and access to the term loan agreement with Pacific Western Bank, will be sufficient to fund its operational expenses and capital expenditure requirements through at least the second quarter of 2024.
•Collaboration revenue: Collaboration revenue was $5.0 million for the third quarter of 2022, compared to zero for the same period in 2021. Collaboration revenue is related to amortization of the $15.0 million upfront payment received in April 2022 upon the execution of Werewolf’s licensing agreement with Jazz and costs incurred for research services to be reimbursed by Jazz.
•Research and development expenses: Research and development expenses were $13.1 million for the third quarter of 2022, compared to $9.8 million for the same period in 2021. The increase in research and development expenses was primarily due to manufacturing expenses incurred to support the production of preclinical and current and future clinical trial materials associated with the Company’s product candidates WTX-124, WTX-330 and WTX-613 and increased employee compensation costs related to increased headcount.
•General and administrative expenses: General and administrative expenses were $4.4 million for the third quarter of 2022, compared to $4.0 million for the same period in 2021.
•Net loss: Net loss was $11.9 million for the third quarter of 2022, compared to $13.8 million for the same period in 2021.

On November 10, 2022 Xenetic Biosciences, Inc. (NASDAQ:XBIO) ("Xenetic" or the "Company"), a biopharmaceutical company focused on advancing innovative immune-oncology technologies addressing hard to treat oncology indications, reported its financial results for the third quarter of 2022 and provided a business update (Press release, Xenetic Biosciences, NOV 10, 2022, View Source [SID1234623745]).

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"We have continued to make encouraging progress with our recently in-licensed DNase-based oncology asset over the course of the past quarter and are excited about the potential of this platform technology," commented Jeffrey Eisenberg, Chief Executive Officer of Xenetic. "Looking ahead, our top priority remains on the advancement of our DNase oncology platform and moving it closer towards the clinic."

DNase Oncology Platform: Targeting Neutrophil Extracellular Traps ("NETs") to improve cancer therapies with a focus on advancing systemic DNase program into the clinic as an adjunctive therapy for pancreatic carcinoma and other locally advanced or metastatic solid tumors.

Program Highlights:

Systemic DNase program initially targeting multi-billion-dollar indications including pancreatic carcinoma.
Advancing toward planned first-in-human study to evaluate DNase combined with immune checkpoint inhibitors or chemotherapy.
In August 2022, entered into a research and development collaboration agreement with VolitionRX Limited to develop NETs targeted, adoptive cell therapies potentially targeting multiple types of solid cancers.
In June 2022, entered into a manufacturing agreement with Catalent Pharma Solutions LLC, which will include cGMP manufacturing of Phase 1 clinical supply.
PolyXen Platform Technology: Patent-protected platform technology designed for protein or peptide therapeutics, enabling next-generation biological drugs by prolonging a drug’s circulating half-life and potentially improving other pharmacological properties.

Program Highlight:

Royalty payments of approximately $0.4 million were received in the three months ended September 30, 2022, representing an approximate 18.6% increase over the same period in 2021 as Takeda’s sublicensee continued its worldwide launch of the product.
Summary of Financial Results for Third Quarter 2022

Net loss for the quarter ended September 30, 2022 was approximately $0.8 million. Research and development expenses for the three months ended September 30, 2022 decreased by approximately $0.4 million, or 48.9%, to approximately $0.4 million from approximately $0.8 million in the comparable quarter in 2021 due to decreased spending related to our XCART platform technology program partially offset by spending related to our DNase oncology platform. General and administrative expenses for the three months ended September 30, 2022 decreased by approximately $82,000, or 8.7%, to approximately $863,000 from approximately $945,000 in the comparable quarter in 2021. The decrease was primarily due to a decrease in costs related to our intellectual property during the three months ended September 30, 2022, compared to the same period in 2021.

The Company ended the quarter with approximately $13.8 million of cash.