On February 9, 2023 Replimune Group, Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development of a novel portfolio of tumor-directed oncolytic immunotherapies, reported its financial results for the fiscal third quarter ended December 31, 2022 and provided a business update (Press release, Replimune, FEB 9, 2023, View Source [SID1234627005]).

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"We ended 2022 with a data update from our registration directed IGNYTE cohort of RP1 in anti-PD1 failed melanoma that demonstrated impressive and clinically meaningful activity in a patient population of major unmet need and with limited treatment options," said Philip Astley-Sparke CEO of Replimune. "As we turn the page to 2023, we believe this data has significantly de-risked our overall skin cancer franchise with RP1, and we look forward to providing additional updates on all of our skin cancer programs, including topline primary analysis data from our registration-directed CERPASS clinical trial evaluating RP1 in CSCC. As we prepare for a potential commercial launch we have made further key appointments to strengthen our commercial team and are well financed to build a commercial capability in the US. With RP2/3 we look forward to commencing our Phase 2 clinical trials and providing further updates from our Phase 1 program this year."

Corporate Updates

Entered into clinical collaboration and supply agreement with Roche for the initial development of RP2/3 in third-line (3L) colorectal cancer (CRC) and in first- and second-line (1L & 2L) hepatocellular carcinoma (HCC). Under the terms of the agreement, the companies will share costs and Roche will supply its currently approved drugs, atezolizumab and bevacizumab in combination with RP3 in 1L & 2L HCC and 3L CRC and supply atezolizumab and bevacizumab for combination with RP2 in 3L CRC. Replimune will have responsibility for operationalizing these clinical trials.
Announced leadership appointments in preparation for potential 2024 commercial launch of RP1. The Company appointed Christopher Sarchi, former Sanofi U.S. Commercial Oncology Head, as Chief Commercial Officer and Sushil Patel, Ph.D., previously Chief Commercial Officer, to a newly created position of Chief Strategy Officer. These appointments were made to prepare the Company as it begins to ramp up its commercial planning ahead of the potential 2024 commercial launch of RP1.
Increased operational and strategic flexibility and extended cash runway into H2 2025. In December, the Company closed on an offering of common stock and pre-funded warrants raising approximately $259 million in gross proceeds and received aggregate net proceeds of approximately $243 million after deducting underwriting discounts, commissions, and other offering expenses. This includes the exercise in full by the underwriters of their option to purchase additional shares of common stock. In October, the Company secured a $200 million non-dilutive debt facility of which $30 million gross was funded at closing, the remaining $170 million can largely be drawn at the Company’s option with satisfaction of certain milestones. Excluding any further debt draws the Company expects that its cash, cash equivalents and short-term investments of $616 million as of December 31, 2022 will fund its operating expenses and capital expenditure requirements into H2 2025.

Program Highlights & Milestones:

RP1

RP1 combined with Libtayo (cemiplimab-rwlc) in cutaneous squamous cell carcinoma (CSCC)
Completed enrollment of 211 patients in the CERPASS registration-directed clinical trial evaluating RP1 combined with Libtayo in patients with CSCC.
Topline primary analysis data from this clinical trial is expected to be announced in Q3 2023 updated from H1 2023. This is due to the time being taken and required for responses to be documented and confirmed, including per protocol response confirmation biopsies, and for central reviews to complete.
RP1 combined with Opdivo in anti-PD1 failed melanoma
Presented data evaluating the first 75 patients with at least six-months follow up in the anti-PD1 failed melanoma cohort of the IGNYTE clinical trial in December.
The data demonstrated an overall response rate (ORR) of 36% and complete response (CR) rate of 20%, with clinically meaningful activity across a broad range of anti-PD1 failed cutaneous melanoma settings observed, including in patients with high tumor burden and visceral disease.
Systemic activity was seen in both injected and in un-injected lesions responding, including in un-injected visceral disease, with most responses seen in patients who did not respond to prior anti-PD1 therapy.
Safety data with RP1 in combination with nivolumab assessed across all skin cancer patients treated with RP1 combined with nivolumab (all studies, N=187), including the 75 patients reported on in December, continues to demonstrate an attractive safety profile, with predominantly ‘on target’ Grade 1-2 side effects indicative of systemic immune activation.
Target enrollment of 125 patients was reached in January with patients in screening at that time continuing to be enrolled. Enrollment is expected to complete this month with a final total study size of approximately 140 patients. The primary analysis is expected in Q1 2024, 12 months after the enrollment of the last patient.
RP1 combined with Opdivo in anti-PD1 failed non-melanoma skin cancers
Recruitment remains ongoing into the cohorts of patients with anti-PD1 failed non-melanoma skin cancers, including CSCC, with a data update expected in Q3 2023.
RP1 in solid organ transplant recipients with skin cancers
The Company continues to enroll patients into its ARTACUS clinical trial of RP1 monotherapy in solid organ transplant recipients with skin cancers and expects to provide a data update in Q3 2023.
RP1 in other skin cancer indications
The Company is currently evaluating all strategic opportunities for RP1 in skin cancers, including the setting for the confirmatory clinical trial in melanoma which is expected to be required to support an accelerated approval of RP1 in anti-PD1 failed melanoma.
RP2 and RP3

RP2 alone and in combination with Opdivo in difficult-to-treat cancers
Completed enrollment (N=17) in the uveal melanoma expansion cohort of the Phase 1 clinical trial evaluating RP2 monotherapy (N=4) and RP2 in combination with Opdivo (N=13) and presented updated data in December further demonstrating the potential to treat a range of intractable tumor types, including those which metastasize to the liver.
The Company continues to enroll patients in the expansion cohorts of the Phase 1 clinical trial evaluating RP2 in patients with tumor types of particular interest (gastro-intestinal [GI] cancers, breast cancer, lung cancer, head and neck cancer), with a data update expected in H2 2023.
RP3 alone and in combination with Opdivo in difficult-to-treat cancers
The Company continues to enroll patients in its Phase 1 cohort evaluating RP3 combined with Opdivo with a focus on patients with GI cancers, breast cancer, lung cancer and head and neck cancer and expects to provide an update in H2 2023.
In December, the Company presented data from previously enrolled patients with multiple soft tissue sarcomas including in leiomyosarcoma, osteosarcoma, chondrosarcoma, and epithelioid sarcomas who had all failed standard of care.
At the data cut-off date, 3 of 5 patients had sufficient follow up for response assessment, and all three were responding to therapy in settings with no viable alternative treatment option, indicating the potential utility of RP3 in treating this difficult tumor type.
Phase 2 Program

RP3 in combination with standard of care therapy in squamous cell carcinoma of the head and neck (SCCHN)
A two-cohort clinical trial will be conducted, with the first cohort of 100 patients with locally advanced disease being randomized to receive either standard of care (SOC) chemotherapy combined with radiation or RP3 combined with chemotherapy and radiation followed by adjuvant nivolumab therapy. The second, signal finding cohort, will enroll 30 patients with recurrent or metastatic SCCHN with low PDL1 levels (CPS<20) who will be treated with chemotherapy, nivolumab and RP3.
RP3 in combination with atezolizumab and bevacizumab in first- and second-line (1L & 2L) hepatocellular carcinoma (HCC)
Two signal finding cohorts of 30 patients each will be conducted in collaboration with Roche. The first cohort will enroll 1L patients treated with SOC atezolizumab combined with bevacizumab and RP3, and the second cohort will enroll patients who have progressed on 1L immunotherapy (including atezolizumab/bevacizumab), and will be treated with atezolizumab combined with bevacizumab and RP3.
RP2/3 in combination with atezolizumab and bevacizumab in third-line (3L) colorectal cancer (CRC)
Two signal finding cohorts of 30 patients each will be conducted in collaboration with Roche. The first cohort will enroll 3L patients to be treated with atezolizumab combined with bevacizumab and RP2 and the second cohort with atezolizumab and bevacizumab and RP3. The Company believes that data with both RP2 and RP3 in CRC will allow the comparative efficacy of RP2 and RP3 to be evaluated in a particularly difficult to treat patient population.
These Phase 2 clinical trials are expected to initiate around mid-year.

Financial Highlights

Cash Position: As of December 31, 2022, cash, cash equivalents and short-term investments were $616.4 million, as compared to $395.7 million as of fiscal year end March 31, 2022. The increase in cash as of December 31, 2022 reflects net proceeds from equity offerings and the initial debt tranche resulting in approximately $311.4 million of year-to-date financing inflows partially offset by cash utilized in operating activities in advancing the Company’s clinical development plans.

Based on the current operating plan, the Company believes that existing cash, cash equivalents and short-term investments, as of December 31, 2022, will enable the Company to fund operations into the second half of calendar year 2025.
R&D Expenses: Research and development expenses were $30.3 million for the third quarter ended December 31, 2022, as compared to $19.4 million for the third quarter ended December 31, 2021. This increase was primarily due to increased clinical and manufacturing expenses driven by the Company’s lead programs and increased personnel expenses. Research and development expenses included $2.6 million in stock-based compensation expenses for the third quarter ended December 31, 2022.
S,G&A Expenses: Selling, general and administrative expenses were $11.4 million for the third quarter ended December 31, 2022, as compared to $10.3 million for the third quarter ended December 31, 2021. The increase was primarily driven by personnel related costs, including sales and marketing personnel associated with pre-launch planning and build of the Company’s commercial infrastructure. Selling, general and administrative expenses included $4.4 million in stock-based compensation expenses for the third quarter ended December 31, 2022.
Net Loss: Net loss was $39.7 million for the third quarter ended December 31, 2022, as compared to a net loss of $29.7 million for the third quarter ended December 31, 2021.
About CERPASS
CERPASS is Replimune’s registration-directed randomized, global Phase 2 clinical trial to compare the effects of Libtayo (cemiplimab-rwlc) alone versus a combination of Libtayo and Replimune’s investigational oncolytic immunotherapy RP1. The clinical trial recently completed enrollment and enrolled 211 patients with locally advanced or metastatic cutaneous squamous cell carcinoma (CSCC) who are naïve to anti-PD-1 therapy. The clinical trial will evaluate complete response (CR) rate and overall response rate (ORR) as its two independent primary efficacy endpoints as assessed by independent review, as well as secondary endpoints including duration of response, progression-free survival (PFS), and overall survival (OS). The clinical trial is being conducted under a clinical trial collaboration agreement with Regeneron and full commercial rights retained by Replimune. Libtayo is a registered trademark of Regeneron.

About IGNYTE
IGNYTE is Replimune’s multi-cohort Phase 1/2 trial of RP1 plus nivolumab. The leading IGNYTE cohort is a 125-patient cohort in anti-PD1 failed cutaneous melanoma with registrational intent. This cohort was initiated after completing enrollment in a prior Phase 2 cohort in the same clinical trial of approximately 30 patients with melanoma. The additional cohort is enrolling in non-melanoma skin cancers which includes both naïve and anti-PD1 failed CSCC. This trial is being conducted under a collaboration and supply agreement with Bristol-Myers Squibb.

About RP1
RP1 is Replimune’s lead product candidate and is based on a proprietary new strain of herpes simplex virus engineered and genetically armed with a fusogenic protein (GALV-GP R-) and GM-CSF to maximize tumor killing potency, the immunogenicity of tumor cell death, and the activation of a systemic anti-tumor immune response.

About RP2 & RP3
RP2 and RP3 are derivatives of RP1 that express additional immune-activating proteins. RP2 expresses an anti-CTLA-4 antibody-like molecule and RP3 additionally expresses the immune co-stimulatory pathway activating proteins CD40L and 4-1BBL, but does not express GM-CSF. RP2 and RP3 are intended to provide targeted and potent delivery of these proteins to the sites of immune response initiation in the tumor and draining lymph nodes, with the goal of focusing systemic immune-based efficacy on tumors and limiting off-target toxicity.

On February 9, 2023 Rain Oncology presented its corporate presentation (Presentation, Rain Oncology, FEB 9, 2023, View Source [SID1234627004]).

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On February 9, 2023 Prokarium, a biopharmaceutical company leading the oncology field of microbial immunotherapy, has raised $30 million in new funding (Press release, Prokarium, FEB 9, 2023, View Source [SID1234627003]). This follows Prokarium’s announcement of partnering with Ginkgo Bioworks to leverage its world-class Foundry and extensive Codebase to develop a bactofection platform technology.

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"We are excited to advance our vision to create living cures," said Kristen Albright, PharmD, Chief Executive Officer of Prokarium. "Proceeds of this financing will fund our lead oncology program entering clinical development this year and enable platform expansion for the delivery of novel therapeutic payloads, including RNA, via our proprietary bacteria. With Ginkgo’s partnership and their expertise in strain engineering and optimization we look forward to working towards unlocking a new generation of immuno-oncology therapeutics."

Prokarium’s lead program has the potential to transform the treatment paradigm in bladder cancer, one of the costliest cancers to treat, in its efforts to become the new standard-of-care in a market that has seen little innovation in over 30 years and to offer advanced therapies an alternative to Bacillus Calmette-Guérin (BCG). Prokarium’s pipeline leverages evolutionary advantages of a proprietary strain of Salmonella and combines them with bespoke synthetic circuits to deliver diverse therapeutic cargo for difficult-to-treat cancers.

"We believe Prokarium is a truly differentiated company," added Thomas Eldered, Executive Chairman, Flerie Invest. "The new funds and Prokarium’s partnership with Ginkgo Bioworks will accelerate the cutting-edge innovation essential to lead the advancements in the field of synthetic biology and immunotherapy for years to come."

"Our partnership with Prokarium will utilize Ginkgo’s leading platform capabilities and services to pioneer technological developments that we believe will revolutionize the immuno-oncology field," added Ena Cratsenburg, Chief Business Officer at Ginkgo Bioworks. "Ginkgo is excited to partner with Prokarium to work to build a versatile Salmonella-based bactofection platform capable of delivering targeted, localized RNA therapeutics."

In addition to the financing, Prokarium has announced the addition of two scientific advisors, Professor Adrian Hayday, PhD and Sam Chang, MD, MBA. "We are thrilled to welcome Adrian and Sam as advisors as we transition into a clinical-stage company," concluded Albright. "Adrian brings the deep immunology and immunotherapy expertise, and Sam possesses invaluable clinical experience being involved in numerous bladder cancer clinical trials." Professor Hayday is the founding Chair of Peter Gorer Department of Immunobiology at King’s College London and is currently Principal Group Leader at the Francis Crick Institute. Sam currently serves as the Chief Surgical Officer at the Vanderbilt Ingram Cancer Center.

On February 9, 2023 Ocean Biomedical and Aesther Healthcare Acquisition Corp. (NASDAQ: AEHA) reported that Scientific Co-founder Dr. Jack A. Elias has been awarded multiple patents for his discoveries related to suppressing tumors by regulating CHI3L1 and several connected pathways (Press release, Ocean Biomedical, FEB 9, 2023, View Source [SID1234627002]). Dr. Elias, the former Chair of Yale’s Department of Medicine, and the Dean Emeritus of Medicine and Biological Sciences at Brown University, has been granted Methods and Compositions patents for mono-specific and bi-specific antibody approaches for use in multiple cancer types, including Prostate Cancer, Colon Cancer, Rectal Cancer, Ovarian Cancer, Kidney Cancer, Breast Cancer, Glioblastoma, Melanoma, Malignant Melanoma, and Lung Cancer.

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These novel approaches to tumor suppression, are focused on controlling CHI3LI, other immune checkpoint inhibitors, and T-cell co-stimulators and have the potential to inhibit multiple different cancer pathways, and Dr. Elias is working with Ocean Biomedical to accelerate the translation of these discoveries into new treatments for patients in need. Recent studies from Ocean Biomedical have demonstrated that CHI3L1 is a critical regulator of a number of key cancer-causing pathways, highlighting its ability to inhibit tumor cell death (apoptosis), its inhibition of the expression of the tumor suppressors P53 and PTEN and its stimulation of the B-RAF protooncogene. Most recently Dr. Elias’s research team has discovered that CHI3L1 is a "master regulator" of ICPI, including key elements of the PD-1 and CTLA4 pathways. In accord with the importance of these pathways, he has also generated antibodies: 1.) a monoclonal antibody against CHI3L1, 2.) bispecific antibodies that simultaneously target CHI3L1 and PD-1, and 3.) a new bispecific antibody that simultaneously targets CHI3L1 and CTLA4. The impressive ability of these bispecific antibodies to control primary and metastatic lung cancer in murine experimental modeling systems have been discussed in detail in articles in the Journal of Clinical Investigation, and Frontiers in Immunology.

"We are especially excited that these mechanisms are not limited to one cancer type, but seem to operate across many anti-cancer pathways," Dr. Elias said recently. "This is an unprecedented leap forward and we are very pleased to have their significance so broadly recognized by the Patent Office."

"This patent protection will help Ocean Biomedical efficiently transform these CHI3L1 discoveries into treatments that have the potential to help patients in multiple cancer areas," commented Dr. Chirinjeev Kathuria, the co-founder and Executive Chairman of Ocean Biomedical.

Suren Ajjarapu, Chairman and CEO of Aesther, commented, "Immunotherapy is the future of cancer care, and Aesther is proud to be partnering with Ocean Biomedical in advancing the development of their cancer treatments, along with their fibrosis treatments, and their global malaria program. We look forward to working with Ocean Biomedical to bring all of these therapies to patients, for the long-term shareholder value and the continued advancement of medical science."

On February 9, 2023 Nurix Therapeutics, Inc. (Nasdaq: NRIX), a clinical stage biopharmaceutical company developing targeted protein modulation drugs designed to treat patients with hematologic malignancies and solid tumors,reported financial results for the fourth quarter and fiscal year ended November 30, 2022 and provided a corporate update (Press release, Nurix Therapeutics, FEB 9, 2023, View Source [SID1234627001]).

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"In 2022, Nurix achieved multiple ‘firsts’ in oncology with our drug candidates, establishing Nurix as the leader in the targeted protein modulation field," said Arthur T. Sands, M.D., Ph.D., president and chief executive officer of Nurix. "Clinical data from Nurix’s NX-2127 Bruton’s tyrosine kinase degrader program demonstrated the ability to overcome BTK inhibitor resistance mutations including those lacking catalytic function, resulting in the first evidence from a BTK degrader of clinical benefit in CLL patients with no alternative approved therapies. We have also established mechanistic proof of concept with our first-in-class CBL-B inhibitor. In 2023, we look forward to maintaining the momentum we have built as we continue to advance our pipeline for patients with significant unmet medical needs in both hematologic malignancies and solid tumors."

Recent Business Highlights

Provided updated clinical data from NX-2127 Bruton’s tyrosine kinase (BTK) degrader program at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting: In December 2022, two oral presentations were given at the ASH (Free ASH Whitepaper) meeting by Nurix collaborators Anthony Mato, M.D., MSCE, former director of the Chronic Lymphocytic Leukemia (CLL) Program at Memorial Sloan Kettering Cancer Center, and Omar Abdel-Wahab, M.D., Chair of Sloan Kettering Institute (SKI) Molecular Pharmacology Program at Memorial Sloan Kettering Cancer Center. Specifically, the first presentation described positive data from the ongoing Phase 1 trial of NX-2127 demonstrating clinically meaningful objective responses in a heavily pretreated patient population harboring multiple BTK inhibitor resistance mutations. The second presentation detailed the variety of emerging BTK inhibitor resistance mutations identified in the trial, all of which remain susceptible to BTK degradation. These new scientific findings support the rationale for BTK degradation as a novel mechanism of action to address the current and emerging unmet need in patients whose cancer has relapsed following multiple prior lines of therapy.

Presented clinical data from NX-5948 BTK degrader program and expanded geographical reach of ongoing clinical trial: At an analyst event held by Nurix at the ASH (Free ASH Whitepaper) Annual Meeting, Nurix presented initial PK/PD data from the Phase 1 clinical trial of NX-5948 in adults with relapsed or refractory B-cell malignancies demonstrating early evidence of target engagement with rapid and sustained BTK degradation in all patients and no evidence of immunomodulatory-associated adverse events. An archived webcast of the event, which also covered the ASH (Free ASH Whitepaper) Annual Meeting presentations of NX-2127 data, can be accessed via the Events and Presentations page of the Investor section of the Nurix website. In addition, in December 2022, Nurix announced that it received clearance from the U.S. Food and Drug Association (FDA) for its investigational new drug (IND) application to expand the drug candidate’s Phase 1a/1b trial, which is ongoing in the United Kingdom, into sites in the United States. The trial is designed to evaluate the safety and tolerability of NX-5948 in adults with relapsed and refractory B-cell malignancies.

Presented multiple posters highlighting data from Nurix’s Casitas B-lineage lymphoma proto-oncogene (CBL-B) inhibitor programs at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting: At the SITC (Free SITC Whitepaper) Annual Meeting in November 2022, Nurix presented six posters focused on its CBL-B inhibitor programs, including initial biomarker data demonstrating successful target engagement of CBL-B in patients treated in the ongoing Phase 1 clinical trial of NX-1607. The development and implementation of a novel proprietary biomarker indicate that the doses of NX-1607 currently being tested in the study are achieving biologic activity anticipated to be within the therapeutic range based on the results from relevant animal models.

Completed safety run-in portion of the Phase 1 clinical trial of DeTIL-0255: In November 2022, Nurix announced the successful completion of the safety run-in portion of the Phase 1 clinical trial of DeTIL-0255 in patients with advanced gynecologic malignancies. Based on the preliminary safety profile of DeTIL-0255 and feedback from the FDA, Nurix may explore a potential combination of NX-1607 with cell therapy.
Advanced preclinical discovery programs with collaboration partners Gilead Sciences and Sanofi: Nurix is advancing ten discovery programs under its collaboration partnerships with Gilead Sciences and Sanofi. Of its ten partnered programs, Nurix has options to co-develop and co-promote a total of four programs in the United States. Throughout 2022, Nurix made significant progress within its collaborations as evidenced by the receipt of multiple milestone payments from both partners.

Upcoming Program Highlights*

•NX-2127: Nurix’s lead drug candidate from its protein degradation portfolio, NX-2127, is an orally bioavailable degrader of BTK with immunomodulatory activity for the treatment of patients with relapsed or refractory B-cell malignancies. Nurix anticipates presenting additional clinical results in the second half of 2023. Nurix also anticipates defining a regulatory strategy for NX-2127 in the second half of 2023 based on emerging clinical data and feedback from the FDA. Additional information on the clinical trial can be accessed at www.clinicaltrials.gov (NCT04830137).
•NX-5948: Nurix’s second drug candidate from its protein degradation portfolio, NX-5948, is an orally bioavailable BTK degrader designed without immunomodulatory activity for certain B-cell malignancies and autoimmune diseases. Nurix is evaluating NX-5948 in a Phase 1 clinical trial in adults with relapsed or refractory B-cell malignancies and expects to present initial clinical data from the Phase 1a portion of the study in the second half of 2023. In addition, Nurix expects to define a dose for Phase 1b cohort expansion. Additional information on the clinical trial can be accessed at www.clinicaltrials.gov (NCT05131022).
•NX-1607: Nurix’s lead drug candidate from its targeted protein elevation portfolio, NX-1607, is an orally bioavailable inhibitor of the E3 ligase CBL-B for immuno-oncology indications including a range of solid tumor types and lymphoma. Nurix is evaluating NX-1607 in an ongoing, Phase 1 trial in adults with a variety of oncology indications and expects to present clinical data from the Phase 1a portion of the study and to define a dose for Phase 1b cohort expansion in the second half of 2023. Additional information on the clinical trial can be accessed at www.clinicaltrials.gov (NCT05107674).
•Selection of new drug candidate: Nurix expects to select a new targeted protein degrader development candidate in 2023.

•Continued advancement of strategic collaborations with Gilead Sciences and Sanofi: Nurix expects to continue to achieve substantial research collaboration milestones throughout 2023 from its collaborations with Gilead Sciences and Sanofi.

*Expected timing of events throughout the press release are based on calendar year quarters.
Fiscal Fourth Quarter and Full Year 2022 Financial Results
Collaboration revenue for the three months and twelve months ended November 30, 2022 was $6.8 million and $38.6 million, respectively, compared with $7.4 million and $29.8 million for the three and twelve months ended November 30, 2021, respectively. The increase for the twelve-month period was primarily due to the continued scale up of internal resources and external spending for Nurix’s collaborations with Gilead Sciences and Sanofi as compared to the prior year, resulting in a higher percentage of completion in the current year. During the year ended November 30, 2022, Nurix achieved several research milestones under its collaboration with Gilead and Sanofi totaling $10 million and $3 million, respectively.
Research and development expenses for the three months and twelve months ended November 30, 2022 were $46.1 million and $184.5 million, respectively, compared with $36.5 million and $116.4 million for the three and twelve months ended November 30, 2021, respectively. The increase for the twelve-month period was primarily related to an increase in compensation and personnel costs, including in non-cash stock-based compensation expense, attributable to an increase in headcount, an increase in clinical and contract manufacturing costs due to ramping up of our clinical programs and patient enrollment, an increase in supplies and contract research cost and preclinical activities, and an increase in facility and other costs primarily due to the expansion of leased premises and investments in information technology.

General and administrative expenses for the three months and twelve months ended November 30, 2022 were $9.4 million and $38.0 million, respectively, compared with $8.8 million and $31.2 million for the three and twelve months ended November 30, 2021, respectively. The increase for the twelve-month period was primarily related to compensation expenses including an increase in non-cash stock-based compensation, which were primarily attributable to higher headcount and the issuance of restricted stock units and incentive stock options.
Net loss for the three months and twelve months ended November 30, 2022 was $46.7 million or ($0.87) per share and $180.4 million or ($3.71) per share, respectively, compared with $37.7 million or ($0.85) per share and $117.2 million or ($2.73) per share for the three and twelve months ended November 30, 2021, respectively.
Cash, cash equivalents and marketable securities was $373.0 million as of November 30, 2022, compared with $432.9 million as of November 30, 2021.