On February 14, 2022 PharmaCyte Biotech, Inc. (NASDAQ: PMCB), a biotechnology company focused on developing cellular therapies for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box, reported an update on PharmaCyte’s activities to lift the U.S. Food and Drug Administration’s (FDA) clinical hold on PharmaCyte’s treatment for locally advanced, inoperable pancreatic cancer (LAPC) (Press release, PharmaCyte Biotech, FEB 14, 2022, View Source [SID1234608086]). After submission of an initial Investigational New Drug Application (IND), the FDA requested additional studies and information as a prerequisite for approval of PharmaCyte’s IND. A number of additional studies and assays have already been completed; several others are quite lengthy and are underway or are slated to begin soon. As each study and assay is completed, the results are being compiled and will make up PharmaCyte’s complete IND submission package to the FDA.

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PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, explained, "Given our treatment is a biologic and our technology is a one of a kind live-cell encapsulation, we completely understand the FDA’s need for more information. We are confident that with the data we’re producing in our additional studies and assays that the FDA will grant us an open IND just as the FDA granted us the Orphan Drug Designation for our treatment for LAPC.

"Last June, we provided an update on efforts being made by our team of regulatory and scientific experts that are addressing the FDA’s requirements to have the clinical hold lifted. Today, we would like to update that list and explain where we are in the process of delivering our updated IND package to the FDA. We have brought additional regulatory and scientific experts onboard the team, and we continue to engage closely with leading Contract Research Organizations (CROs) and our partner Austrianova to ensure a successful IND submission.

"We also want to make it clear that PharmaCyte and its service providers are under the same constraints as everyone else globally with supply chain issues, Covid related delays, and late delivery of materials that are needed to complete studies and assays required by the FDA. This also applies to the manufacturing of empty capsules and encapsulated live cells that are necessary to complete many of these required studies and assays. Moreover, many of the laboratories that are conducting our studies and assays are being met with long delays in receiving the consumables needed to conduct the specific studies for which they are responsible. So, we’re at the mercy of what is a global problem, which obviously makes it more difficult to offer any accurate timelines for completion of the FDA required assays and studies."

Below is the list of items on which PharmaCyte has been working, including updates on those tests previously reported.

Additional Regulatory Expertise Added to IND Team – In addition to its established team of experts, PharmaCyte has retained Biologics Consulting as a fresh set of regulatory eyes to perform a regulatory "Gap Analysis" and to assist with PharmaCyte’s IND submission. Biologics Consulting is a full-service regulatory and product development consulting firm for biologics, pharmaceuticals and medical devices and has personnel with extensive FDA experience. Although it took a lengthy amount of time to onboard Biologics Consulting, this should augment PharmaCyte’s ability to submit an acceptable IND to the FDA.
Stability Studies on PharmaCyte’s Clinical Trial Product – PharmaCyte has now successfully completed a product stability study after 3, 6, 9, 12 and 18-months of storage frozen at -80C on PharmaCyte’s clinical trial product known as CypCaps, including container closure integrity testing for certain timepoints. The next time point in this ongoing stability study will be at 24 months of product stability of the CypCaps. This 24-month time point analysis is ready to commence, and data will be available in the coming weeks.
Additional Studies Requested by the FDA – PharmaCyte has designed and commenced various additional studies requested by the FDA, including a stability study on the cells from its Master Cell Bank (MCB) used to make the CypCaps. PharmaCyte is already at the 3-year stability timepoint for the cells from its MCB.
Determination of the Exact Sequence of the Cytochrome P450 2B1 Gene – PharmaCyte has completed the determination of the exact sequence of the cytochrome P450 2B1 gene inserted at the site previously identified on chromosome 9 using state-of-the-art nanopore sequencing, a cutting edge, unique and scalable technology that permits real-time analysis of long DNA fragments. The result of this analysis of the sequence data confirmed that the genes are intact.
Biocompatibility Studies – PharmaCyte has designed and commenced 8 biocompatibility studies, 6 of which have been completed successfully. The remaining 2 studies are underway. Those studies are the Acute Systemic Toxicity Study of Empty Cellulose Sulphate Capsules in Mice and the Skin Sensitization Study of Empty Cellulose Sulphate Capsules in Guinea Pigs. To enable these studies to be performed, Austrianova manufactured and delivered an additional 400 syringes of empty capsules. Some of the data being generated will also be used to demonstrate comparability with the CypCaps successfully used in two earlier clinical trials for pancreatic cancer.
Micro-Compression and Swelling Assays – This project is underway. The project is developing and optimizing two reproducible methods for testing and confirming the physical stability and integrity of the CypCaps produced under GMP. These studies required the acquisition of new equipment by Austrianova as well as validation and integration into Austrianova’s Quality Control laboratory.
Break Force and Glide Testing – PharmaCyte is in the process of developing a protocol to measure whether the syringe, attached to the catheter when used to expel the capsules, will still have a break and glide force that is within the specification that PharmaCyte has established. PharmaCyte will set this specification based on the syringe/plunger manufacturer’s measured break and glide forces, or alternatively, accepted ranges for glide forces routinely used in the clinic.
CypCaps Capsules Compatibility with the Syringe and Other Components of the Microcatheter Delivery System – PharmaCyte has commenced studies designed to show that CypCaps are not in any way adversely affected by the catheters used by interventional radiologists to deliver them into a patient. Compatibility data is being generated to demonstrate that the quality of the CypCaps is maintained after passage through the planned microcatheter systems.
CypCaps Capsules and Cell Viability after Exposure to Radiological Contrast Medium – PharmaCyte has designed and commenced a project to test the effect of the exposure of CypCaps to two routinely used types of contrast medium that interventional radiologists use to implant the CypCaps in a patient. The contrast medium is used to visualize the blood vessels during implantation of the CypCaps.
Master Drug File Information- Austrianova is providing additional detailed confidential information to the FDA on the manufacturing process, including information on the improvements and advancements made to the product since the last clinical trials were conducted with respect to reproducibility and safety. However, Austrianova has not changed the overall physical characteristics of the CypCaps. PharmaCyte is supporting Austrianova financially in this work.
Additional Documentation Requested by the FDA – PharmaCyte is in the process of updating its documentation including extending its discussion on immunological aspects of its LAPC treatment.
Pig Study – Finally, the Company has designed a study in pigs to address biocompatibility and long-term implantation and dispersion of the CypCaps. This animal study will complement the positive data already available from the previous human clinical trials showing the safety of CypCaps implantation in human patients.

On February 14, 2022 Mirati Therapeutics, Inc. (NASDAQ: MRTX), a clinical-stage targeted oncology company, reported that it will announce financial results for the fourth quarter and full year of 2021 along with recent corporate updates on February 28, 2022 (Press release, Mirati, FEB 14, 2022, View Source [SID1234608084]). During a conference call at 4:30 p.m. ET / 1:30 p.m. PT on February 28, company executives will provide company updates and review financial results.

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Investors and the general public are invited to listen to a live webcast of the call at the "Investors and Media" section on Mirati.com or by dialing the U.S. toll free +1 313-209-4906 or international +1 877-502-9276, confirmation code: 6820152. A replay of the call will be available approximately 2 hours after the event has ended at the same website or by dialing in the U.S. toll free 1+ 719-457-0820 or international +1 888-203-1112, confirmation code: 6820152.

On February 14, 2022 Veracyte, Inc. (Nasdaq: VCYT) reported that new data validating the clinical utility of the company’s Decipher Prostate Genomic Classifier for guiding treatment selection in men with intermediate-risk prostate cancer will be presented Thursday, February 17, at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary (ASCO GU) Symposium (Poster #M1) (Press release, Veracyte, FEB 14, 2022, View Source [SID1234608083]). The data, from the randomized, Phase 3 NRG/RTOG 0126 study, confirm initial findings that the Decipher Prostate Genomic Classifier is a prognostic biomarker that can help physicians and patients make personalized treatment decisions in the intermediate-risk setting.

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"These findings represent the first high-level evidence of any genomic classifier in intermediate-risk prostate cancer and demonstrate that the Decipher 22-gene biomarker significantly improves prognostic performance across numerous clinically meaningful endpoints," said Daniel Spratt, M.D., chair of Radiation Oncology at University Hospitals Seidman Cancer Center and professor and chair of the Department of Radiation Oncology at Case Western Reserve University School of Medicine, and lead investigator for the study.

Prostate cancer deemed "intermediate risk" by the National Comprehensive Cancer Network (NCCN) Guidelines for Prostate Cancer is the most heterogenous of all risk groups in prostate cancer, and there are a wide variety of treatment options available. The Decipher Prostate Genomic Classifier is a prognostic biomarker that provides additional information about the aggressiveness of individual patients’ cancer to help physicians more accurately categorize their risk and select appropriate treatments. The study conducted by Dr. Spratt and colleagues confirms findings from prior Phase 2 studies and validates for the first time the test’s performance in men with intermediate-risk disease using multi-center Phase 3 trial data.

To assess the prognostic performance of the Decipher Prostate test in the intermediate-risk, post-biopsy setting, researchers utilized patient biopsy samples from the phase 3, randomized NRG/RTOG 0126 trial. This study enrolled men with intermediate-risk prostate cancer, and then compared clinical outcomes following randomization to two different doses of radiation therapy (70.2 Gy vs 79.2 Gy) without hormone therapy. Researchers generated classifier data for each of 215 biopsy samples, then linked the data with clinical outcomes assessing multiple oncologic and survival endpoints. Patients were followed for a median of 12.8 years.

The findings, which will be presented for the first time at ASCO (Free ASCO Whitepaper) GU this week, show that the Decipher Prostate test was independently prognostic for all clinical endpoints, including disease progression (sub-distribution hazard ratio [sHR] 1.12, 95%CI 1.0-1.26, p=0.04), biochemical failure (sHR 1.22, 95%CI 1.1-1.37, p<0.001), distant metastasis (sHR 1.28, 95%CI 1.06-1.55, p=0.01), prostate cancer-specific mortality (sHR 1.45, 95%CI 1.2-1.76, p<0.001), distant metastasis-free survival (sHR 1.12, 95%CI 1.03-1.23, p=0.009), and overall survival (sHR 1.11, 95%CI 1.01-1.21, p=0.03).

Men in the study with disease classified as Decipher "high-risk" had worse 10-year oncologic and survival outcomes compared to those whose disease was classified as Decipher "low-risk." Based on this finding, men with NCCN intermediate-risk prostate cancer whose disease is classified as Decipher "high-risk" may have improved outcomes with treatment intensification (i.e., the addition of hormone therapy), while men with disease classified as Decipher "low-risk" may have favorable outcomes with radiotherapy alone.

The study also evaluated – within Decipher risk groups – the clinical impact of receiving lower- vs. higher-dose radiation. Among patients with lower Decipher risk scores, the difference in 10-year distant metastasis rates between those who received 70.2Gy vs. 79.2Gy was low (5%). However, among those with higher Decipher scores, the difference was 26%, suggesting that men whose disease is Decipher "high-risk" receive more benefit from the higher dose of radiation than their "low-risk" counterparts.

"This is an important study that provides further evidence for Decipher Prostate and demonstrates how this test could help physicians better personalize treatment for their patients with intermediate-risk prostate cancer," said Elai Davicioni, Ph.D., Veracyte’s senior vice president of Scientific and Clinical Operations, Urologic Cancers.

Informing Treatment in Asian Men with Prostate Cancer

In a second ASCO (Free ASCO Whitepaper) GU Symposium presentation scheduled for this Thursday (Poster #M4), researchers will share data from a study that evaluated the clinical utility of the Decipher Prostate Genomic Classifier in Asian men with prostate cancer, as well as the genomic differences between prostate cancer in Asian vs. Caucasian men enrolled in a 80,829-patient cohort. In a retrospective analysis of Asian men treated at the National Cancer Centre of Singapore, researchers found that Decipher "high-risk" scores were significantly associated with worse metastasis-free survival (hazard ratio 5.22, 95% CI:1.08–25.3, p=0.04). Additionally, the study found substantial differences in tumor biology between Asian and North American men with prostate cancer.

"This is the first report on the performance of the Decipher Prostate test for predicting aggressive disease in Asian men. We commend the researchers in Singapore for their efforts to investigate this question and to add to the existing body of evidence supporting Decipher’s validity in men of African and European descent," said Dr. Davicioni. "The findings from this study could help inform personalized treatment recommendations for Asian men with prostate cancer, and, more broadly, deepen our understanding of tumor biology that could benefit all men with the disease."

On February 14, 2022 2seventy bio, Inc. (NASDAQ: TSVT) reported that Steven Bernstein, M.D. will join the company effective today and assume the role of chief medical officer (CMO) (Press release, 2seventy bio, FEB 14, 2022, View Source [SID1234608082]). Also announced today, Susan Abu-Absi, Ph.D. has been appointed chief technology & manufacturing officer at 2seventy bio.

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"We are thrilled to welcome Steve to the 2seventy team as we bring our next-generation cell therapy product engine to the clinic. He brings both experience as a treating heme/oncology physician as well as extensive translational clinical expertise, including a deep knowledge of T-cell biology and immunology," said Nick Leschly, chief kairos officer. "I’m also pleased to share the promotion of Dr. Susan Abu-Absi to chief technology & manufacturing officer, leading 2seventy’s manufacturing and supply chain organization. Susan has already made significant contributions during her time at bluebird and now 2seventy as we continue to build both our collaborative manufacturing network and in-house capabilities. We look forward to both Susan and Steve’s contributions toward the development and delivery of transformational cell therapies for people living with cancer."

"I am excited to join 2seventy during the company’s first full year and am inspired by their patient-driven mission to outmaneuver cancer and provide people with the chance for more time. As a treating physician, I have witnessed firsthand the devastating impact that cancer can have and understand how precious time is to all of us," said Steven Bernstein, M.D., chief medical officer. "I look forward to applying my experience in early clinical development to support the team in evolving the treatment landscape in cell therapy to make a meaningful impact on the lives of patients, their families and care partners."

Steven Bernstein, M.D., has more than 25 years of experience as a treating physician, translational scientist, and pharmaceutical executive. Prior to joining 2seventy, Dr. Bernstein served as Chief Translational Officer at Turnstone Biologics. Before that, he served as Chair, Immuno-Oncology Translational Research and Development, and Head, Integrated Science, at Bristol-Myers Squibb (BMS). Prior to BMS, he was an academic physician scientist most recently at the University of Rochester’s James P. Wilmot Cancer Institute, where he was Professor of Medicine, Co-Director of the Hematological Malignancy and Lymphoma Biology Programs and Co-Principal Investigator of the University of Rochester/Arizona Cancer Center NCI SPORE grant in lymphoma. Dr. Bernstein was a member of the Lymphoma Working Group of SWOG, and the Scientific Advisory Boards of both the Lymphoma Research Foundation and the Leukemia and Lymphoma Society. He has a B.A. from Brandeis University and a M.D. from New York University School of Medicine.

Susan Abu-Absi, Ph.D. has over 20 years of experience in biologics and cell & gene therapy process development and manufacturing. She most recently served as our Senior Vice President and Head of Technical Development & Operations at 2seventy bio. Previously, Susan led the oncology manufacturing organization at bluebird bio, having joined in 2017 as Head of Process and Analytical development and advancing through roles of increasing responsibility during her tenure. Prior to joining bluebird, she spent more than ten years in the Global Product Development & Supply organization at Bristol Myers Squibb supporting clinical and commercial biologics drug substance manufacturing at internal sites and at contract manufacturers. Before BMS, Susan was a member of the Process Sciences organization at Bayer Healthcare in Berkeley, CA. Susan has led several teams developing the manufacturing processes, analytical methods and CMC packages for license applications and has directly contributed to the approval of seven products, including Abecma, Zynteglo, and Skysona. Susan earned a Ph.D. in Chemical Engineering from the University of Minnesota, where she was a National Science Foundation Fellow, and a B.S. in Chemical Engineering, Summa Cum Laude with Honors, from the University of Toledo (Toledo, OH).

On February 14, 2022 Roivant Sciences Ltd. (Nasdaq: ROIV), a next-generation biopharmaceutical company dedicated to improving the delivery of healthcare to patients, reported its financial results for the third fiscal quarter ended December 31, 2021 and provided an update on the Company’s operations (Press release, Roivant Sciences, FEB 14, 2022, View Source [SID1234608081]).

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Roivant’s Chief Executive Officer, Matt Gline, noted: "We are looking forward to the upcoming launch of tapinarof this year and to the impact we believe it can have for psoriasis patients. We are also pleased with the continued enrollment in Dermavant’s registrational studies in atopic dermatitis. We remain on track this year to initiate multiple Phase 2 and Phase 3 clinical trials, including at Immunovant and Kinevant, and to expand the ongoing Phase 1/2 trial in MDS patients at newly launched Hemavant. RVT-2001, the lead product candidate at Hemavant, is a great example of our plans for pipeline expansion, which will come from both in-licensing and from our internal computational discovery efforts."

Recent Developments

Hemavant: Roivant has launched a new Vant, Hemavant, which entered into a licensing agreement with Eisai Co., Ltd. for exclusive global rights to the investigational agent RVT-2001, a potential first-in-class small molecule SF3B1 modulator. RVT-2001 has achieved a red blood cell transfusion independence rate of over 30% in 19 patients with lower-risk, transfusion-dependent MDS, 15 of whom had documented prior treatment with lenalidomide and/or hypomethylating agents. Hemavant plans to develop RVT-2001 as an oral therapy for transfusion-dependent anemia in patients with lower-risk MDS, with a robust open-label expansion of the ongoing Phase 1/2 clinical trial for RVT-2001 in the first half of calendar year 2022.
Genevant: The Federal Circuit Court of Appeals rejected Moderna’s appeal of the prior Patent Trial and Appeal Board decision holding all claims of U.S. Patent 8,058,069 patentable. The court also dismissed Moderna’s appeal challenging a similar finding of patentability of certain claims of U.S. Patent 9,364,435 for lack of standing. Together, the decisions confirm the strength of Genevant’s nucleic acid delivery-related patent portfolio.
Dermavant: Dermavant’s NDA submission for tapinarof remains on track, with no expectation of an FDA advisory committee and an assigned PDUFA date in Q2 2022. Dermavant continues to build out its organization, with key commercial leadership in place, and manufacturing remains on track for launch upon FDA approval. In December 2021, results from the PSOARING 1 and PSOARING 2 pivotal trials of tapinarof in plaque psoriasis were published in The New England Journal of Medicine. In January 2022, Dermavant presented patient satisfaction data demonstrating consistently high rates of satisfaction and positive perception of treatment with tapinarof, with 81.1% preferring tapinarof to topical drugs used in the past and 67.8% preferring tapinarof to systemic drugs used in the past.
Aruvant: Punam Malik, M.D., Director of the Cincinnati Comprehensive Sickle Cell Center and Program Leader of the Hematology and Gene Therapy Program at the Cincinnati Children’s Hospital Medical Center, presented data highlighting the clinically meaningful reduction in vaso-occlusive events for participants in the ongoing ARU-1801 Phase 1/2 trial and the unique attributes that contribute to the potency of ARU-1801 at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting on December 13, 2021.
Immunovant: In December 2021, Immunovant announced it had achieved alignment with the FDA Division of Neurology 1 to move forward in myasthenia gravis. The Phase 3 trial will include an induction (primary efficacy) period during which Immunovant plans to study doses of 680mg and 340mg of batoclimab delivered weekly by subcutaneous injection, followed by alternative dosing regimens (including potential lower maintenance and higher rescue doses) in subsequent study periods. The trial is designed to address unmet patient needs by leveraging batoclimab’s broad therapeutic window and simple subcutaneous delivery device to provide a differentiated treatment option.
Kinevant: In December 2021, the FDA cleared the IND submitted by Kinevant for a Phase 2 trial evaluating namilumab for the treatment of sarcoidosis.
Lysovant: In January 2022, the FDA cleared the IND submitted by Lysovant for a multiple ascending dose study of LSVT-1701 in patients with complicated Staph aureus bacteremia including infective endocarditis.
Major Upcoming Milestones

Dermavant: Dermavant expects a decision from the FDA on the approval of tapinarof for the treatment of adults with plaque psoriasis in the second quarter of calendar year 2022. Dermavant also expects to report topline data from the Phase 3 clinical trial of tapinarof for the treatment of atopic dermatitis in the first half of calendar year 2023.
Immunovant: Immunovant plans to initiate a pivotal trial evaluating batoclimab for the treatment of myasthenia gravis in 1H 2022, with topline results expected in 2024. Immunovant also plans to re-initiate its programs in thyroid eye disease and warm autoimmune hemolytic anemia in 2022, and to announce at least two new indications by August 2022. Immunovant expects to initiate pivotal trials for two of these four indications in 2022, with a total of three pivotal trials initiating in 2022.
Aruvant: Aruvant expects to announce ongoing new patient and follow up data through 2022 and to initiate its Phase 3 trial for ARU-1801 for the treatment of sickle cell disease in 2023.
Kinevant: Kinevant remains on track to initiate its Phase 2 trial evaluating namilumab for the treatment of sarcoidosis in the first half of calendar year 2022.
Hemavant: Hemavant plans to amend its ongoing open-label Phase 1/2 trial evaluating RVT-2001 for the treatment of transfusion-dependent anemia in lower-risk MDS patients in the first half of calendar year 2022, with initial data expected in 2023.
Lysovant: Lysovant remains on track to initiate its multiple ascending dose study of LSVT-1701 in patients with complicated Staph aureus bacteremia including infective endocarditis in the first half of calendar year 2022.
Fiscal Quarter Ended December 31, 2021 Financial Summary

Cash Position

As of December 31, 2021, we had cash and cash equivalents of approximately $2.2 billion.

On February 14, 2022, Roivant entered into a committed equity facility with an affiliate of Cantor Fitzgerald & Co. ("Cantor"). Under the terms of the facility, Cantor has committed to purchase up to an aggregate of $250.0 million in the Company’s common shares from time to time at the request of the Company. This at-the-market-style facility will provide Roivant with the ability to raise additional capital opportunistically in the future.

Research and Development Expenses

Research and development (R&D) expenses were $153.5 million for the three months ended December 31, 2021 compared to $202.3 million for the three months ended December 31, 2020. The decrease was primarily due to reduced consideration for the purchase of in-process research and development through asset acquisitions and license agreements as compared to the comparable prior year period, partially offset by increases in program-specific costs relating to our product candidates, personnel-related expenses, and share-based compensation expense. Non-GAAP R&D expenses were $118.9 million for the three months ended December 31, 2021 compared to $50.8 million for the three months ended December 31, 2020.

General and Administrative Expenses

General and administrative (G&A) expenses were $115.5 million for the three months ended December 31, 2021 compared to $61.9 million for the three months ended December 31, 2020. The increase was largely due to higher share-based compensation expense as compared to the comparable prior year period, primarily as a result of the ongoing vesting of certain equity instruments for which the liquidity event vesting condition was met upon the closing of the business combination with MAAC in September 2021. We did not recognize share-based compensation expense related to these equity instruments during the three months ended December 31, 2020 as the liquidity event requirement had not been met and was not deemed probable of being met. Non-GAAP G&A expenses were $61.4 million for the three months ended December 31, 2021 compared to $47.7 million for the three months ended December 31, 2020.

Net Loss

Net loss for the three months ended December 31, 2021 was $306.1 million compared to $275.6 million for the three months ended December 31, 2020. On a per common share basis, net loss was $0.41 for both the three months ended December 31, 2021 and 2020. Non-GAAP net loss was $157.0 million for the three months ended December 31, 2021 compared to $87.6 million for the three months ended December 31, 2020.

Notes to non-GAAP measures:

(1) Represents share-based compensation expense.

(2) Represents one-time development milestone payments.

(3) Represents one-time in-process research and development expense.

(4) Represents depreciation and amortization expense.

(5) Represents the unrealized loss (gain) on equity investments in unconsolidated entities that are accounted for at fair value with changes in value reported in earnings. This loss (gain) has no direct correlation to the operation of Roivant’s business.

(6) Represents a one-time gain on sale of investment resulting from the merger of Datavant and CIOX Health in July 2021.

(7) Represents the change in fair value of debt and liability instruments, which primarily includes the unrealized loss relating to the measurement and recognition of fair value on a recurring basis of certain liabilities.

(8) Represents the one-time gain on termination of the options held by Sumitomo Dainippon Pharma Co., Ltd. to purchase Roivant’s ownership interest in certain Vants (the "Sumitomo Options").

(9) Represents one-time gain on deconsolidation of a subsidiary and the remeasurement of a previously held interest in an unconsolidated entity upon its consolidation.

(10) Represents the estimated tax effect of the adjustments.

The information presented in this document has been prepared in accordance with U.S. generally accepted accounting principles ("GAAP"), unless otherwise noted as non-GAAP. Roivant believes that its presentation of non-GAAP financial measures provides useful supplementary information to and facilitates additional analysis by investors. Management uses certain non-GAAP information internally for its operating, budgeting and financial planning purposes. Non-GAAP information is not prepared under a comprehensive set of accounting rules and should only be used to supplement an understanding of Roivant’s operating results as reported under GAAP. Non-GAAP financial information generally excludes (i) share-based compensation expense and the change in fair value of debt and liability instruments, (ii) consideration for the purchase of in-process research and development through asset acquisitions and license agreements, including upfront cash payments, the fair value of equity liability instruments issued, and the fair value of certain future contingent consideration payments, and (iii) other items that are considered unusual or not representative of underlying trends of Roivant’s business. Non-GAAP measures may be defined and calculated differently by other companies in the same industry. Reconciliations of the non-GAAP financial measures to the most directly comparable GAAP financial measures are provided in the tables above.

Investor Conference Call Information

Roivant will host a live conference call and webcast at 8:00 a.m. ET on Monday, February 14, 2022 to report its third fiscal quarter ended December 31, 2021 financial results, and provide a corporate update.

To access the live conference call, please dial +1-844-224-1923 (domestic) or +1-214-989-7105 (international) and use conference ID 8648616. A webcast of the call will also be available under "Events & Presentations" in the Investors section of the Roivant website at https://investor.roivant.com/news-events/events. The archived webcast will be available on Roivant’s website after the conference call.

Upcoming Investor Events

SVB Leerink Global Healthcare Conference on February 17, 2022 at 1:00 p.m. ET
Truist AI Symposium on Tuesday, March 1, 2022 at 10:10 a.m. ET
Cowen Healthcare Conference on Tuesday, March 8, 2022 at 9:10 a.m. ET