On June 29, 2023 BioNTech SE (Nasdaq: BNTX, "BioNTech") and OncoC4, Inc. ("OncoC4") reported that the first patient with non-small cell lung cancer (NSCLC) has been treated in a pivotal Phase 3 trial evaluating the companies’ next-generation anti-CTLA-4 antibody candidate BNT316/ONC-392 (gotistobart) (Press release, BioNTech, JUN 29, 2023, View Source [SID1234632954]). The trial is part of BioNTech’s strategy to initiate multiple pivotal trials in 2023 and 2024.

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The two-stage, open-label, randomized Phase 3 trial, PRESERVE-003 (NCT05671510), will assess the efficacy and safety of BNT316/ONC-392 as monotherapy compared to the standard-of-care chemotherapy (docetaxel) in patients with metastatic NSCLC that progressed under previous PD-(L)1-inhibitor treatment. Approximately 600 patients are planned to be enrolled at clinical sites in the United States, Europe and other countries and regions, including Belgium, Germany, Italy, Spain, and Türkiye. The primary endpoint measure will be overall survival. Secondary endpoints include overall response rate, progression-free survival and adverse event profile. The program received Fast Track Designation from the U.S. Food and Drug Administration (FDA) in 2022 and represents an innovative approach which aims to leverage the full potential of CTLA-4-targeting therapies.

"We believe this investigational treatment has the potential to become a new option for patients with late-stage NSCLC who have an otherwise poor prognosis. Given its specific mode of action, this treatment approach may also be applicable in a synergistic combination with other immunotherapeutic modalities to provide benefit to further patient populations," said Prof. Özlem Türeci, M.D., Chief Medical Officer and Co-Founder at BioNTech. "We are committed to rapidly advancing our oncology pipeline towards late-stage development for multiple product candidates in cancer indications with high unmet medical need."

"Today represents a significant landmark for the differentiated program we developed with BNT316/ONC-392, aiming to overcome current challenges of CTLA-4-targeting cancer therapeutics and in particular the very narrow therapeutic window that restricts them from delivering on their full potential," said Pan Zheng, M.D., Ph.D., Chief Medical Officer and Co-Founder at OncoC4. "With less than three years from first-in-human dosing to Phase 3 initiation, we are hopeful these results will build on the responses we have seen so far."

The initiation of the Phase 3 trial is based on positive safety and efficacy data from an ongoing Phase 1/2 study (NCT04140526) with BNT316/ONC-392 alone and in combination with pembrolizumab in patients with advanced solid tumors. Follow-up data recently presented at the ASCO (Free ASCO Whitepaper) 2023 Annual Meeting demonstrate an encouraging anti-tumor activity and a manageable safety profile for BNT316/ONC-392 in a patient cohort with metastatic, anti-PD-(L)1-resistant NSCLC.

The Phase 3 trial initiation marks the first landmark of BioNTech’s and OncoC4’s strategic collaboration initiated in March 2023. Under the terms of the collaboration agreement, OncoC4 received a $200 million upfront payment and is eligible to receive development, regulatory and commercial milestone payments as well as double-digit tiered royalties. BioNTech and OncoC4 will jointly develop BNT316/ONC-392 as monotherapy and in combination with anti-PD-(L)-1 antibodies in a range of solid tumor indications until regulatory authorization, with the parties equally sharing development costs for such studies. Combinations outside of PD-1 inhibition, in particular all combinations with a compound in BioNTech’s pipeline, will be solely developed by BioNTech. BioNTech will hold the exclusive worldwide commercialization rights for any of these products with participation of OncoC4 in certain markets to be negotiated in the future.

About BNT316/ONC-392 (gotistobart)
BNT316/ONC-392 (gotistobart) is a next-generation anti-CTLA-4 antibody candidate jointly developed by BioNTech and OncoC4. BNT316/ONC-392 is currently in late-stage clinical development as monotherapy or combination therapy in various cancer indications. The immune checkpoint receptor CTLA-4 inhibits T cell immune response and reduces the activity of T cells in recognizing and eliminating cancer cells1. This mechanism is also exploited by cancer cells to prevent them from being eliminated by T cells2. Blocking CTLA-4 may help to preserve T cell activity and enhance anti-tumor activity. BNT316/ONC-392 was designed with the aim to address this mechanism while preserving CTLA-4 recycling and thus the immunosuppressive T cell (regulatory T cells, or "Tregs") function in the peripheral tissues. This approach, which is currently in clinical evaluation, aims to give rise to fewer immune-related adverse effects and a more favorable safety profile. BNT316/ONC-392 is currently being evaluated in an ongoing Phase 1/2 trial, PRESERVE-001, (NCT04140526) in patients with advanced solid tumors as single agent or in combination with pembrolizumab. An ongoing registrational Phase 3 trial, PRESERVE-003 (NCT05671510) evaluates the candidate as monotherapy in patients with metastatic, immunotherapy-resistant non-small cell lung cancer (NSCLC). In addition, the candidate is also being evaluated in a Phase 2 trial as a combination therapy with pembrolizumab in platinum-resistant ovarian cancer (NCT05446298).

About NSCLC
Non-small cell lung cancer (NSCLC) covers all epithelial lung cancers other than small cell lung cancer and includes squamous cell carcinoma, large cell carcinoma, and adenocarcinoma of the lung. It is the most common type of lung cancer, accounting for up to 85% of cases3, with risk factors ranging from smoking to asbestos exposure and pulmonary fibrosis4. With a 5-year relative survival rate of 23% in the United States (2012-2018), NSCLC is a devastating disease with limited treatment options depending on the stage and location of the tumor4. Current standard of care includes surgery, radiotherapy in combination with chemotherapy and immunotherapy

On June 28, 2023 Viracta Therapeutics, Inc. (Nasdaq: VIRX), a precision oncology company focused on the treatment and prevention of virus-associated cancers that impact patients worldwide, reported that the relapsed or refractory EBV+ peripheral T-cell lymphoma (R/R EBV+ PTCL) cohort of its pivotal NAVAL-1 clinical trial has met the pre-specified efficacy threshold for expansion into Stage 2 of the study (Press release, Viracta Therapeutics, JUN 28, 2023, View Source [SID1234632969]). The efficacy threshold for expansion of NAVAL-1 cohorts from Stage 1 to Stage 2 is based upon a pre-specified minimum number of objective responses achieved within the first 10 patients enrolled.

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"Initial data from the PTCL cohort in NAVAL-1 show a strong signal of efficacy that is in-line with our promising Phase 1b/2 data and sufficient to advance to Stage 2. We now look forward to completing enrollment in Stage 1 and are taking steps to further accelerate enrollment through Stage 2," said Mark Rothera, President and Chief Executive Officer of Viracta. "Given the lack of effective therapies available for patients with PTCL, today’s announcement represents an important step towards addressing a pressing unmet medical need. The advancement of the first cohort into Stage 2 establishes PTCL as the leading indication for the NAVAL-1 clinical trial and provides added momentum to our global clinical program."

NAVAL-1 enrollment continues worldwide with updates on potential additional cohort advancements expected in the second half of 2023.

About NAVAL-1

NAVAL-1 (NCT05011058) is a global, multicenter trial of Nana-val in relapsed or refractory (R/R) EBV+ lymphoma. The trial employs a Simon two-stage design where, in Stage 1, participants are enrolled into six indication cohorts based on EBV+ lymphoma subtype. If a pre-specified activity threshold is reached within a lymphoma subtype in Stage 1 (n=10), additional patients will be enrolled in Stage 2 for a total of 21 patients. EBV lymphoma subtypes demonstrating promising activity in Stage 2 may be further expanded following discussion with regulators to potentially support registration.

About Nana-val (Nanatinostat and Valganciclovir)

Nanatinostat is an orally available histone deacetylase (HDAC) inhibitor being developed by Viracta. Nanatinostat is selective for specific isoforms of Class I HDACs, which are key to inducing viral genes that are epigenetically silenced in Epstein-Barr virus (EBV)-associated malignancies. Nanatinostat is currently being investigated in combination with the antiviral agent valganciclovir as an all-oral combination therapy, Nana-val, in various subtypes of EBV-associated malignancies. Ongoing trials include a pivotal, global, multicenter, open-label Phase 2 basket trial in multiple subtypes of relapsed or refractory EBV+ lymphoma (NAVAL-1) as well as a multinational Phase 1b/2 trial in patients with EBV+ recurrent or metastatic nasopharyngeal carcinoma and other EBV+ solid tumors.

About EBV-Associated Cancers

Approximately 90% of the world’s adult population is infected with Epstein-Barr virus (EBV). Infections are commonly asymptomatic or associated with mononucleosis. Following infection, the virus remains latent in a small subset of cells for the duration of the patient’s life. Cells containing latent virus are increasingly susceptible to malignant transformation. Patients who are immunocompromised are at an increased risk of developing EBV+ lymphomas. EBV is estimated to be associated with approximately 2% of the global cancer burden including lymphoma, nasopharyngeal carcinoma and gastric cancer.

On June 28, 2023 Sonnet BioTherapeutics Holdings, Inc. (NASDAQ:SONN) ("Sonnet" or the "Company"), a biopharmaceutical company developing innovative targeted biologic drugs, reported that it has entered into a definitive agreement with a single institutional investor for the purchase and sale of an aggregate of 5,000,000 shares of its common stock (or common stock equivalents in lieu thereof), at a purchase price of $0.45 per share of common stock (or common stock equivalent in lieu thereof), in a registered direct offering (Press release, Sonnet BioTherapeutics, JUN 28, 2023, View Source [SID1234632968]). The Company has also agreed to issue to the investor, in a concurrent private placement, warrants to purchase up to an aggregate of 5,000,000 shares of common stock. The warrants will have an exercise price of $0.6749 per share, are exercisable six months from issuance, and will expire three and one-half years from the date of issuance. The closing of the registered direct offering and the concurrent private placement is expected to occur on or about June 30, 2023, subject to the satisfaction of customary closing conditions.

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Chardan is acting as the exclusive placement agent for the offering.

The gross proceeds to the Company from the registered direct offering and the concurrent private placement are expected to be approximately $2.25 million, before deducting the placement agent’s fees and other offering expenses payable by the Company. The Company intends to use the net proceeds for research and development, including clinical trials, working capital and general corporate purposes.

The securities described above (excluding the warrants and the shares of common stock underlying the warrants) are being offered and sold by the Company in a registered direct offering pursuant to a "shelf" registration statement on Form S-3 (File No. 333-251406) that was originally filed with the Securities and Exchange Commission (the "SEC") on December 17, 2020, and declared effective on December 29, 2020. The offering of such securities in the registered direct offering is being made only by means of a prospectus supplement that forms a part of the effective registration statement. A final prospectus supplement and the accompanying base prospectus relating to the registered direct offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Electronic copies of the final prospectus supplement and the accompanying base prospectus may also be obtained, when available, from Chardan Capital Markets, LLC, 17 State Street, Suite 2130, New York, New York 10004, at (646) 465-9000, or by email at [email protected].

The warrants described above are being offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act"), and Regulation D promulgated thereunder and, along with the shares of common stock underlying such warrants, have not been registered under the Act, or applicable state securities laws. Accordingly, the warrants and the underlying shares of common stock may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Act and such applicable state securities laws.

On June 28, 2023 SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) ("SELLAS" or the "Company"), a late-stage clinical biopharmaceutical company focused on developing novel therapies for a broad range of cancer indications, reported topline clinical data from a Phase 1 investigator-sponsored clinical trial of its lead clinical candidate, galinpepimut-S (GPS), combined with the checkpoint inhibitor nivolumab (Opdivo) in patients with malignant pleural mesothelioma (MPM) who were either refractory to or relapsed after at least one line of the standard of care therapy (Press release, Sellas Life Sciences, JUN 28, 2023, View Source [SID1234632967]).

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Nine of the ten patients enrolled received at least three doses of GPS, with the third GPS dose given in combination with nivolumab. All enrolled patients had either received and progressed with or were refractory to frontline pemetrexed-based chemotherapy. Additional immune response data from all ten patients is expected by Q4 2023.

The study details are as follows:

70.3 weeks (17.6 months) median overall survival (OS) in patients who received the combination therapy (9/10 patients) and 54.1 weeks (13.5 months) for all ten patients (nine patients with combination therapy and one GPS only patient). Median overall survival for patients who entered the study as Stage IV patients was 62.3 weeks (15.6 months). OS was calculated as the time from cessation of the most recent previous therapy until confirmed death or most recent data update for patients who are still alive (40 percent of patients)
11.9 weeks median progression-free survival (PFS) for all patients
30% disease control rate (DCR) with three patients achieving stable disease per RECIST criteria with the tumor volume decrease of up to 17%. DCR is the sum of overall response rate and rate of stable disease.
As expected in this high-risk advanced cancer population, all patients experienced adverse events, unrelated and related. Seven out of ten patients (70%) had treatment related toxicities and six (60%) had nivolumab related toxicities. Grade 3 (G3) and higher toxicities were observed in three patients (30%). None of the G3 and higher toxicities were related to GPS. GPS related toxicities were observed in three patients (30%), all were Grade 1 (G1) and included G1 skin induration at the site of injection/injection site reaction and/or fatigue in two patients and G1 dizziness and non-cardiac chest pain, each in one patient.
Of the ten evaluable patients, eight were male and two were female, with a median age of 69 years. Sixty percent of entered the study as Stage III or IV patients. Initial tumor stages were I (one patient), II (three patients), III (two patients) and IV (four patients).
All patients had MPM epithelioid and/or sarcomatoid variant, a tumor which universally expresses Wilms Tumor 1 (WT1), one of the most widely expressed cancer antigens, ranked by the National Cancer Institute as the top priority among cancer antigens for immunotherapy.
"In our GPS trials completed in previous years we have observed and reported increased survival in the maintenance therapy setting, which is the primary setting for our GPS therapy. This year, we have seen in two studies where GPS appears to increase the survival benefit in active disease when combined with checkpoint blockade drugs, one with relapsed/refractory WT1 positive ovarian cancer and now in relapsed/refractory WT1 positive mesothelioma. We believe that these observed survival benefits in the active disease setting further confirms strong biological effect of GPS in even the most challenging settings," said Angelos Stergiou, M.D., Sc.D. h.c., President and CEO, SELLAS. "This is demonstrated by a very promising disease control rate where GPS seems to contribute to stopping progression of extremely aggressive cancers."

"It is important to note that the positive survival outcomes seen in this study are accompanied with a safety profile which is similar to that of the checkpoint inhibitor alone," commented Dragan Cicic, MD, SVP Clinical Development, SELLAS. "It is rare for a drug used to treat advanced cancers to result in no toxicities higher than Grade 1. Interestingly, patients in this trial in whom low toxicities were observed all had survival at the median or higher."

About MPM
With approximately 3,300 cases in the United States each year, accompanied by a rising incidence in developing countries, MPM is notoriously difficult to treat and can lead to poor clinical outcomes with respect to both OS and PFS, especially for those patients with the sarcomatoid variant who show a median OS of approximately 4.0 to 5.0 months. In relapsed and refractory patients who progressed after the first line standard of care pemetrexed, a similar patient population to that in the GPS nivolumab combination trial, the common treatment regimen is vinorelbine and OS in those patients is reported to be between 4.5 and 6.2 months. In patients treated with other chemotherapy regimens, such as carboplatin and irinotecan, median OS is reported to be approximately 7.0 months.

On June 28, 2023 Roivant (Nasdaq: ROIV) reported its financial results for the fourth quarter and fiscal year ended March 31, 2023, and provided an update on the business (Press release, Roivant Sciences, JUN 28, 2023, View Source [SID1234632966]).

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Roivant’s Chief Executive Officer, Matt Gline, noted: "I’m incredibly pleased with the progress we’ve made in recent months. Last week, we reported RVT-3101 data from the chronic period of TUSCANY-2, our Phase 2b study in ulcerative colitis. These data surpassed our expectations, demonstrating improvement from the induction period at week 14 to the chronic period at week 56 across all key efficacy endpoints for patients treated with the expected Phase 3 dose. In addition, earlier this spring we announced positive topline results for VTAMA’s ADORING 1 and ADORING 2 Phase 3 trials in atopic dermatitis. The results reported across both studies showed efficacy comparable to that of many systemic products, and we feel VTAMA has the potential to be a safe and efficacious topical option for adults and children as young as 2 years old. Finally, we reported strong growth in VTAMA revenue this past quarter in psoriasis with over 75% of US commercial lives now covered. These recent developments, combined with our strong balance sheet, continue to support Roivant’s growing leadership in the treatment of immunological and inflammatory disease, and we are proud of our continued track record in clinical execution."

Recent Developments

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Dermavant: For the quarter and fiscal year ended March 31, 2023, Roivant reported VTAMA net product revenue of $13.7 million and $28.0 million, respectively, representing a 25% gross-to-net yield for the quarter. As of June 2023, over 170,000 VTAMA prescriptions have been written by approximately 11,000 unique prescribers for psoriasis, based on IQVIA data. Coverage has been expanded to 125 million US commercial lives, representing 76% of the total. VTAMA met the primary and all secondary endpoints in two Phase 3 studies, evaluating 813 moderate-to-severe atopic dermatitis patients. Importantly, no new safety or tolerability signals were observed in this population, which included children as young as 2 years old.

•
Immunovant: In May 2023, Immunovant announced its Investigational New Drug (IND) application and Clinical Trial Application (CTA) for IMVT-1402 were cleared by the FDA and MEDSAFE, respectively, and its Phase 1 clinical trial in healthy subjects was initiated in New Zealand. Additionally, a Phase 2 proof-of-concept clinical trial of batoclimab in Graves’ disease (GD) was initiated.

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Telavant: In June 2023, Telavant reported positive data from the chronic period of TUSCANY-2, a large, global Phase 2b study evaluating RVT-3101 for the treatment of ulcerative colitis. Outcomes were measured at week 56 for the chronic period (vs. week 14 from the previously reported induction period). At the expected Phase 3 dose in the overall population and in the biomarker positive populations, RVT-3101 treatment produced clinically meaningful efficacy results with improved Clinical Remission, Endoscopic Improvement, and Endoscopic Remission at week 56.

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Roivant: Roivant reported its consolidated cash, cash equivalents and restricted cash of $1.7B at March 31, 2023, supporting cash runway into the second half of calendar year 2025.

Major Upcoming Milestones

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Dermavant plans to submit its sNDA for VTAMA in atopic dermatitis to the FDA in the first quarter of calendar year 2024.

•
Immunovant expects IMVT-1402 Phase 1 initial data from single-ascending dose cohorts in August/September 2023 and initial data from multiple-ascending dose cohorts in October/November 2023. Additionally, for batoclimab: top-line results from the ongoing myasthenia gravis (MG) trial are expected in the second half of calendar year 2024. Top-line results from the Phase 3 thyroid eye disease (TED) program, consisting of two Phase 3 clinical trials, are expected in the second half of calendar year 2025. Initial data from period 1 of the Phase 2B trial in chronic inflammatory demyelinating polyneuropathy (CIDP) is expected to be available in the first half of calendar year 2024. Initial results from the Phase 2 proof-of-concept trial in GD are expected in the fourth quarter of calendar year 2023.

•
Telavant has initiated a Phase 2 dose-ranging study of RVT-3101 in Crohn’s disease with data expected in the fourth quarter of calendar year 2024.

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Priovant plans to announce topline results from the potentially registrational trial evaluating brepocitinib for the treatment of patients with systemic lupus erythematosus (SLE) in the fourth quarter of calendar year 2023. Priovant also expects to announce topline results from the Phase 3 trial in dermatomyositis (DM) in calendar year 2025.

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Hemavant plans to announce data from the ongoing open-label Phase 1/2 trial evaluating RVT-2001 for the treatment of transfusion-dependent anemia in lower-risk myelodysplastic syndromes (MDS) patients in the second half of calendar year 2023.

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Kinevant plans to report topline data from the ongoing Phase 2 trial of namilumab for the treatment of sarcoidosis in the second half of calendar year 2024.

Matt Gline added: "I am incredibly pleased to welcome Meghan FitzGerald to our Board of Directors. Meghan’s deep expertise in healthcare and her extraordinary commitment to patients will be invaluable to Roivant’s mission to accelerate the development and commercialization of medicines that matter."

Fourth Quarter and Fiscal Year Ended March 31, 2023, Financial Summary

Cash Position

As of March 31, 2023, the company had cash, cash equivalents and restricted cash of approximately $1.7 billion.

Research and Development Expenses

Research and development (R&D) expenses decreased by $3.2 million to $131.9 million for the three months ended March 31, 2023, compared to $135.1 million for the year ended March 31, 2022, primarily due to decreases in share-based compensation of $11.9 million and other expenses of $3.7 million, partially offset by an increase in program specific costs of $12.3 million, largely driven by the anti-FcRn franchise.

Non-GAAP R&D expenses were $126.0 million for the three months ended March 31, 2023, compared to $117.8 million for the three months ended March 31, 2022.

R&D expenses increased by $42.2 million to $525.2 million for the year ended March 31, 2023, compared to $483.0 million for the year ended March 31, 2022, primarily due to increases in program-specific costs of $45.8 million and personnel-related expenses of $28.1 million, partially offset by a decrease in share-based compensation of $32.8 million. The increase of $45.8 million in program-specific costs largely reflects the progression of our programs and drug discovery, including the anti-FcRn franchise, RVT-2001, brepocitinib, and RVT-3101. The asset acquisitions of brepocitinib, RVT-2001, and RVT-3101 were completed in September 2021, November 2021, and November 2022, respectively. Increases in program-specific costs were partially offset by certain decreases, including $19.3 million for tapinarof, which was primarily due to the completion of ADORING 1 and ADORING 2 phase 3 atopic dermatitis clinical trials during the year ended March 31, 2023. The increase of $28.1 million in personnel-related expenses largely reflects the progression of our programs, particularly the anti-FcRn franchise. The decrease of $32.8 million in share-based compensation expense was primarily due to the achievement of the liquidity event vesting condition for certain equity instruments upon the closing of the Business Combination in September 2021, resulting in the recognition of a one-time catch-up expense of $22.9 million relating to cumulative service rendered between the grant date of the respective awards and completion of the Business Combination and continued recognition of expense over the requisite service periods.

Non-GAAP R&D expenses were $489.2 million for the year ended March 31, 2023, compared to $416.1 million for the year ended March 31, 2022.

Acquired In-Process Research and Development Expenses

There was no acquired in-process research and development (IPR&D) expense for the three months ended March 31, 2023. Acquired IPR&D expenses were $1.5 million for the three months ended March 31, 2022.

Acquired IPR&D expenses decreased by $42.1 million to $97.7 million for the year ended March 31, 2023, compared to $139.9 million for the year ended March 31, 2022. The decrease was primarily due to higher consideration for the purchase of IPR&D during the year ended March 31, 2022 as a result of consideration for the purchase of IPR&D of $82.1 million relating to the acquisition of brepocitinib, a one-time milestone expense of approximately $39 million due to the achievement of a development milestone related to tapinarof, and consideration for the purchase of IPR&D of $14.1 million relating to the acquisition of RVT-2001. Acquired IPR&D expenses for the year ended March 31, 2023, was driven by consideration for the purchase of IPR&D of $87.7 million relating to the acquisition of RVT-3101 and the achievement of a development milestone relating to batoclimab, which resulted in a one-time milestone expense of $10.0 million.

Selling, General and Administrative Expenses

Selling, general and administrative (SG&A) expenses decreased by $13.5 million to $125.5 million for the three months ended March 31, 2023, compared to $139.0 million for the three months ended March 31, 2022. The decrease was primarily due to a decrease in share-based compensation of $40.0 million, partially offset by higher SG&A expenses at Dermavant as a result of the commercial launch of VTAMA.

Non-GAAP SG&A expenses were $102.6 million for the three months ended March 31, 2023, compared to $77.3 million for the three months ended March 31, 2022.

SG&A expenses decreased by $174.5 million to $600.5 million for the year ended March 31, 2023, compared to $775.0 million for the year ended March 31, 2022. The decrease was primarily due to a decrease in share-based compensation expense of $314.6 million, partially offset by higher SG&A expenses at Dermavant as a result of the commercial launch of VTAMA. The decrease in share-based compensation resulted from the achievement of the liquidity event vesting condition for certain equity instruments upon the closing of the Business Combination in September 2021, resulting in the recognition of a one-time catch-up expense of $350.0 million for the year ended March 31, 2022, for cumulative service rendered between the grant date of the respective awards and completion of the Business Combination.

Non-GAAP SG&A expenses were $407.6 million for the year ended March 31, 2023, compared to $271.1 million for the year ended March 31, 2022.

Loss from Continuing Operations

Loss from continuing operations was $175.4 million for the three months ended March 31, 2023, compared to $291.3 million for the three months ended March 31, 2022. On a per common share basis, loss from continuing operations was $0.20 for the three months ended March 31, 2023, and $0.39 for the three months ended March 31, 2022. Non-GAAP loss from continuing operations was $189.4 million for the three months ended March 31, 2023, compared to $187.7 million for the three months ended March 31, 2022.

Loss from continuing operations was approximately $1.2 billion for the year ended March 31, 2023, compared to $924.1 million for the year ended March 31, 2022. On a per common share basis, loss from continuing operations was $1.58 for the year ended March 31, 2023, and $1.26 for the year ended March 31, 2022. Non-GAAP loss from continuing operations was $924.3 million for the year ended March 31, 2023, compared to $784.2 million for the year ended March 31, 2022.