FOLR1 x CD16a

AFM13: Secured access to commercially viable natural killer (NK) cell product to accelerate clinical development of AFM13 and address the high unmet need of CD30-positive lymphoma patients through a collaboration with Artiva Biotherapeutics; an Investigational New Drug (IND) application filing is expected in H1 2023 AFM13 combination with NK cells: As of July 31, 2022 in 24 patients with CD30-positive lymphoma treated at the highest dose level of the combination treatment of AFM13 with allogeneic cord-blood derived NK cells continues to achieve a 100% overall response rate (ORR) and an improved 70.8% complete response rate (CR) AFM13 monotherapy: On track to report topline data of the registration-directed REDIRECT trial in mid-December 2022 AFM24: Updated data from AFM24-101 and AFM24-102 presented at the Society for Immunotherapy of Cancer (SITC) show first partial response to AFM24 in combination with atezolizumab; data updates from the three ongoing studies are expected at major scientific conferences in Q2 and Q3 of 2023 AFM28: Clinical trial applications (CTA) have been filed in European countries and initiation of phase 1 study is expected in the H1 of 2023 Net cash used in operating activities for the quarter ended September 30, 2022, was €19.0 million Cash and cash equivalents as of September 30, 2022, were approximately €222.9 million with anticipated cash runway into mid-2024 Conference call and webcast scheduled for November 15, 2022, at 8:30 a.m. EST / 14:30 CET HEIDELBERG, Germany, Nov. 15, 2022 (GLOBE NEWSWIRE) -- Affimed N.V. (Nasdaq: AFMD) (“Affimed” or the “Company”), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, today reported financial results for the third quarter ended September 30, 2022 and provided an update on clinical and corporate progress. “We are excited to have secured a partner that is able to provide a commercially viable NK cell product that enables us to start a registration directed, multicenter clinical trial in order to bring this promising treatment to patients in need as fast as possible. This collaboration builds on the foundation of the exceptional data of AFM13 in combination with NK cells that will be presented at ASH,” said Dr. Adi Hoess, CEO of Affimed. “The progress we are making across our pipeline has laid the foundation for the next steps of development. We are looking forward to sharing key clinical milestones before the end of this year, including topline data from the REDIRECT study and data from the combination of AFM13 with NK cells.” Clinical Stage Program Updates AFM13 (CD30/CD16A) Affimed expects to report topline data from the phase 2 REDIRECT study (AFM13-202) of AFM13 monotherapy in patients with relapsed / refractory (r/r) CD30-positive peripheral T-cell lymphoma (PTCL) in mid-December. REDIRECT is a phase 2, registration-directed study of AFM13 monotherapy that has completed enrollment of more than 100 r/r PTCL patients. The focus of the topline data will be the overall response rate and preliminary assessment of response duration. A clinical update from the ongoing phase 1/2 trial with Affimed’s lead innate cell engager (ICE®) AFM13 precomplexed with cord blood-derived NK cells followed by three weekly infusions of AFM13 in patients with CD30-positive r/r Hodgkin and non-Hodgkin lymphomas will be provided at the upcoming ASH conference in an oral presentation by Dr. Yago Nieto, M.D., Ph.D., Professor of Stem Cell Transplantation and Cellular Therapy at The University of Texas MD Anderson Cancer Center and principal investigator of the study, on Saturday, December 10, 2022 at 1:15 p.m. CST / 2:15 p.m. EST. Since the last study update in April 2022 until July 31, 2022 an additional 11 patients were enrolled, resulting in 24 patients treated at the recommended phase 2 dose (RP2D) with up to 4 cycles; a total of 30 patients have been enrolled in the study. The combination treatment continues to show a 100% ORR at the highest dose level and a further improvement in the CR rate, from the previously reported 61.5% to 70.8%. The safety pro AFM13 is consistent with previously reported data of infusion related reactions being manageable, with the main treatment-related side-effect being infusion-related reactions. The side effects observed in the trial were transient and did not lead to treatment delays or discontinuations. Affimed plans to host an in-person investor meeting and webcast in conjunction with the American Society of Hematology (ASH) Annual Meeting and Exposition on Saturday, Dec. 10, 2022. Partnership with Artiva In November 2022, Affimed announced a strategic partnership with Artiva Biotherapeutics to jointly develop, manufacture and commercialize a combination therapy of AFM13 and Artiva’s cord blood-derived, cryopreserved/off-the-shelf, allogeneic NK cell product candidate, AB-101 in CD30-positive lymphomas. Affimed submitted a pre-IND meeting request for the AFM13 and AB-101 co-administered combination therapy to the U.S. Food and Drug Administration (FDA) requesting feedback on the clinical trial design in relapsed/refractory (r/r) Hodgkin lymphoma with an exploratory arm evaluating the combination in r/r CD30-positive peripheral T-cell lymphoma and potential path to registration. The FDA is expected to provide feedback by Q1 2023. The companies expect to submit an Investigational New Drug (IND) application to the FDA in H1 2023. AFM24 (EGFR/CD16A) AFM24-101: Affimed continues to enroll patients in the expansion phase of the AFM24 monotherapy study at the RP2D. The expansion cohorts include patients with renal cell carcinoma (clear cell), non-small cell lung cancer (EFGR mutant) and colorectal cancer. Comprehensive correlative science findings of the AFM24-101 study presented in a poster at the 37th SITC Annual Meeting showed that starting at low doses of AFM24, NK cell activation was seen in peripheral blood. CD16A receptor occupancy leveled off at doses of 320mg and above, indicating receptor saturation. Activation of the adaptive immune system was also seen at higher doses of AFM24. When tissue biopsies were analyzed, AFM24-treated patients had an increase in NK cells and cytotoxic T cells in the tumor, suggesting that treatment with AFM24 activates both the innate and adaptive immune system in the periphery of the tumor as well as the tumor microenvironment. AFM24-102: Enrollment continues in the phase 1/2a combination study of AFM24 with the anti-PD-L1 checkpoint inhibitor atezolizumab (Tecentriq®) in patients with advanced epidermal growth factor receptor-expressing solid tumors. AFM24-102 includes patients with non-small cell lung cancer (EGFR wildtype), gastric and gastroesophageal junction adenocarcinoma and pancreatic/hepatocellular/biliary tract cancer. Patients being enrolled in the study are required to have progressed or relapsed on standard of care therapies. The first cohort (160 mg) was completed successfully with no reports of dose-limiting toxicities (DLTs). Enrollment is ongoing in the second dose escalation cohort treating patients with a weekly AFM24 dose of 480 mg. No DLTs were observed in the first three patients treated in this cohort and three additional patients are being enrolled at this dose level to confirm 480 mg as the RP2D. Data from the first cohort of the phase 1 dose escalation study presented at SITC showed that clinical activity was observed in two patients at the 160 mg dose level. A patient with gastric cancer and skin metastases who had rapidly progressed following four prior lines of therapy, including a PD-1 inhibitor, achieved a partial response (PR). The second patient with pancreatic adenocarcinoma showed stable disease (SD) beyond four months. AFM24-103: In the phase 1/2a combination study of AFM24 with SNK01, NKGen Biotech’s ex vivo expanded and activated autologous NK cell therapy, enrollment has been completed in the first dose cohort (160 mg AFM24 weekly), with no DLTs observed. The Company is currently enrolling patients at the 480 mg dose level. AFM24-103 is focused on the treatment of patients with non-small cell lung cancer (NSCLC, EGFR-wildtype), squamous cell carcinoma of the head and neck, and colorectal cancer. Affimed expects to provide data updates from the three ongoing studies at major scientific conferences in Q2 and Q3 of 2023. Preclinical Programs AFM28 (CD123/CD16A) Affimed’s AFM28 ICE® targets CD16A on NK cells and macrophages, and CD123 on leukemic blasts and leukemic stem cells that are prevalent in acute myeloid leukemia (AML). Pre-clinical data from a collaboration between Affimed and the Department of Hematology and Oncology, Medical Faculty Mannheim, Heidelberg University will be presented at the ASH conference. The study evaluated the efficacy of AFM28 in preclinical AML models. In a panel of AML cell lines, AFM28 successfully engaged allogeneic NK cells to destroy CD132-positive tumor cells through antibody-dependent cytotoxicity (ADCC). ADCC induced by AFM28 was independent of leukemic cell mutational profiles and was also effective in targeting cells with low levels of CD123 surface expression. Residual leukemic stem cells are a frequent cause for relapse and associated with poor prognosis. Patient-derived AML cell cultures incubated with AFM28 and allogeneic NK cells showed significantly reduced numbers of outgrowing colonies compared to controls. That indicates that LSCs and progenitor cells were eliminated. These results were confirmed in an AML mouse model demonstrating complete inhibition of tumor growth throughout a 42-day treatment period in comparison to untreated control mice who all developed systemic disease. The Company anticipates initiating the phase 1 clinical study for AFM28 in the first half of 2023. Partnerships and Collaborations Partnered programs with Genentech and Roivant continue to progress. Roivant presented a poster at SITC that AFVT-2101/AFM32 represents a novel approach to treating folate receptor alpha (FRα) expressing tumors by engaging the innate immune response for safe and effective tumor cell killing. The company announced that it is expecting to enter phase 1 clinical trial in 2023. Affimed is eligible for additional proceeds including pre-clinical milestones as well as milestones based on early regulatory achievements. Third Quarter 2022 Financial Highlights Affimed's consolidated financial statements are prepared in accordance with International Financial Reporting Standards (IFRS) as issued by the International Accounting Standard Board (IASB). The consolidated financial statements are presented in Euros (€), the Company's functional and presentation currency. As of September 30, 2022, cash and cash equivalents totaled €222.9 million compared to €197.6 million on December 31, 2021. Based on the Company’s current operating plan and assumptions, cash and cash equivalents are expected to support operations into mid-2024. Net cash used in operating activities for the quarter ended September 30, 2022, was €19.0 million compared to €25.6 million for the quarter ended September 30, 2021. Total revenue for the quarter ended September 30, 2022, was €14.9 million compared with €8.7 million for the quarter ended September 30, 2021. Revenue predominately relates to the Genentech and Roivant collaborations. Research and development expenses for the quarter ended September 30, 2022, increased by 27% from €20.6 million to €26.1 million compared to the quarter ended September 30, 2021. Research and development expenses increased primarily due to higher expenses associated with the development of the AFM13 and AFM24 programs and included costs to produce clinical trial material, clinical patient trial costs and manufacturing, an increase in costs associated with other early-stage programs and infrastructure, and an increase in share-based payment expenses. General and administrative expenses increased 19% from €6.8 million in the quarter ended September 30, 2021 to €8.1 million in the quarter ended September 30, 2022. The increase predominately relates to an increase in headcount, higher share-based payment expenses, an increase in insurance premiums and higher consulting costs. Net finance income for the quarter ended September 30, 2022 increased by 84% from €1.5 million in the quarter ended September 30, 2021, to €2.7 million. Net finance income is largely the result of foreign exchange gains related to assets denominated in U.S. dollars as a result of currency fluctuations between the U.S. dollar and the Euro during the year. Net loss for the quarter ended September 30, 2022, was €16.5 million, or €0.11 loss per common share compared with a net loss of €17.1 million, or €0.14 loss per common share, for the quarter ended September 30, 2021. The weighted number of common shares outstanding for the quarter ended September 30, 2022 was 149.3 million. Additional information regarding these results is included in the notes to the consolidated financial statements as of September 30, 2022, which will be included in Affimed’s filings with the U.S. Securities and Exchange Commission (SEC). Note on International Financial Reporting Standards (IFRS) Affimed prepares and reports consolidated financial statements and financial information in accordance with IFRS as issued by the IASB. None of the financial statements were prepared in accordance with Generally Accepted Accounting Principles in the United States. Affimed maintains its books and records in Euro. Conference Call and Webcast Information Affimed will host a conference call and webcast November 15, 2022, at 8:30 a.m. EST / 14:30 CET to discuss third quarter 2022 financial results and corporate developments. The conference call will be available via phone and webcast. The live audio webcast of the call will be available in the “Webcasts” section on the “Investors” page of the Affimed website at . To access the call by phone, please use link , and you will be provided with dial-in details and a pin number. Notes: To avoid delays, we encourage participants to dial into the conference call 15 minutes ahead of the scheduled start time. A replay of the webcast will be accessible at the same link for 30 days following the call. About Affimed N.V. Affimed (Nasdaq: AFMD) is a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer by actualizing the untapped potential of the innate immune system. The Company’s proprietary ROCK® platform enables a tumor-targeted approach to recognize and kill a range of hematologic and solid tumors, enabling a broad pipeline of wholly-owned and partnered single agent and combination therapy programs. The ROCK® platform predictably generates customized innate cell engager (ICE®) molecules, which use patients’ immune cells to destroy tumor cells. This innovative approach enabled Affimed to become the first company with a clinical-stage ICE®. Headquartered in Heidelberg, Germany, with offices in New York, NY, Affimed is led by an experienced team of biotechnology and pharmaceutical leaders united by a bold vision to stop cancer from ever derailing patients’ lives. For more about the Company’s people, pipeline and partners, please visit: . Forward-Looking Statements This press release contains forward-looking statements. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “goal,” “intend,” “look forward to,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would” and similar expressions. Forward-looking statements appear in a number of places throughout this release and include statements regarding the Company’s intentions, beliefs, projections, outlook, analyses and current expectations concerning, among other things, the potential of AFM13, AFM24, AFM28 and the Company’s other product candidates, the value of its ROCK® platform, its ongoing and planned preclinical development and clinical trials, its collaborations and development of its products in combination with other therapies, the timing of and its ability to make regulatory filings and obtain and maintain regulatory approvals for its product candidates, its intellectual property position, its collaboration activities, its ability to develop commercial functions, clinical trial data, its results of operations, cash needs, financial condition, liquidity, prospects, future transactions, growth and strategies, the industry in which it operates, the trends that may affect the industry or the Company, impacts of the COVID-19 pandemic, the benefits to Affimed of orphan drug designation, the impact on its business by political events, war, terrorism, business interruptions and other geopolitical events and uncertainties, such as the Russia-Ukraine conflict, the fact that the current clinical data of AFM13 in combination with NK cell therapy is based on AFM13 precomplexed with fresh allogeneic cord blood-derived NK cells from The University of Texas MD Anderson Cancer Center, as opposed to Artiva’s AB-101 and other uncertainties and factors described under the heading “Risk Factors” in Affimed’s filings with the SEC. Given these risks, uncertainties, and other factors, you should not place undue reliance on these forward-looking statements, and the Company assumes no obligation to update these forward-looking statements, even if new information becomes available in the future. Investor Relations Contact Alexander Fudukidis Director, Investor Relations E-Mail: a.fudukidis@affimed.com Tel.: +1 (917) 436-8102 Unaudited consolidated interim statements of comprehensive income / (loss) (in € thousand) For the three months ended September For the nine months ended September 2022 2021 2022 2021 Revenue 14,888 8,662 30,195 30,028 Other income – net 118 231 642 710 Research and development expenses (26,126) (20,621) (65,333) (53,826) General and administrative expenses (8,089) (6,841) (23,509) (16,766) Operating loss (19,209) (18,569) (58,005) (39,854) Finance income / (costs) – net 2,719 1,474 5,443 5,421 Loss before tax (16,490) (17,095) (52,562) (34,433) Income taxes 0 0 (2) (2) Loss for the period (16,490) (17,095) (52,564) (34,435) Other comprehensive income / (loss) Items that will not be reclassified to profit or loss Equity investments at fair value OCI – net change in fair value (73) (3,489) (6,846) (8,838) Other comprehensive income / (loss) (73) (3,489) (6,846) (8,838) Total comprehensive income / (loss) (16,563) (20,584) (59,410) (43,273) Basic and diluted earnings / (loss) per share in € per share (undiluted = diluted) (0.11) (0.14) (0.38) (0.29) Weighted number of common shares outstanding 149,339,335 119,786,695 140,036,614 118,545,453 Consolidated interim statements of financial position (in € thousand) September 30, 2022 December 31, 2021 (unaudited) ASSETS Non-current assets Intangible assets 1,555 1,607 Leasehold improvements and equipment 3,584 3,814 Long-term financial assets 0 12,348 Right-of-use assets 710 972 5,849 18,741 Current assets Cash and cash equivalents 222,895 197,630 Trade and other receivables 1,691 4,809 Inventories 673 421 Assets held for sale 1,731 0 Other assets and prepaid expenses 3,560 3,534 230,550 206,394 TOTAL ASSETS 236,399 225,135 EQUITY AND LIABILITIES Equity Issued capital 1,493 1,234 Capital reserves 578,390 474,087 Fair value reserves (5,954) (5,973) Accumulated deficit (392,826) (333,397) Total equity 181,103 135,951 Non current liabilities Borrowings 13,027 17,060 Contract liabilities 1,238 7,209 Lease liabilities 203 368 Total non-current liabilities 14,468 24,637 Current liabilities Trade and other payables 15,078 18,860 Borrowings 4,957 580 Lease liabilities 541 683 Contract liabilities 20,252 44,424 Total current liabilities 40,828 64,547 TOTAL EQUITY AND LIABILITIES 236,399 225,135 Unaudited consolidated interim statements of cash flows (in € thousand) For the nine months ended September 30, 2022 2021 Cash flow from operating activities Income / (loss) for the period (52,564) (34,435) Adjustments for the period: - Income taxes 2 2 - Depreciation and amortization 1,066 935 - Net gain / loss from disposal of leasehold improvements and equipment 0 (2) - Share-based payments 14,779 8,117 - Finance income / costs – net (5,443) (5,421) (42,160) (30,804) Change in trade and other receivables 3,118 (1,320) Change in inventories (252) (446) Change in other assets and prepaid expenses (26) 1,064 Change in trade, other payables, provisions and contract liabilities (33,888) (26,802) (73,208) (58,308) Interest received 228 0 Paid interest (950) (647) Paid income tax (2) (2) Net cash used in operating activities (73,932) (58,957) Cash flow from investing activities Purchase of intangible assets (30) (5) Purchase of leasehold improvements and equipment (263) (1,527) Cash received from the sale of financial assets 3,772 0 Net cash used for investing activities 3,479 (1,532) Cash flow from financing activities Proceeds from issue of common shares, including exercise of share-based payment awards 95,907 103,379 Transaction costs related to issue of common shares (6,159) (6,548) Proceeds from borrowings 0 10,000 Transaction costs related to borrowings 0 (236) Repayment of lease liabilities (538) (372) Repayment of borrowings (70) (69) Cash flow from financing activities 89,140 106,154 Exchange-rate related changes of cash and cash equivalents 6,578 6,223 Net changes to cash and cash equivalents 18,687 45,665 Cash and cash equivalents at the beginning of the period 197,630 146,854 Cash and cash equivalents at the end of the period 222,895 198,742 Unaudited consolidated interim statements of changes in equity (in € thousand) Issued capital Capital reserves Fair Value reserves Accumulated deficit Total equity Balance as of January 1, 2021 983 345,164 1,720 (275,874) 71,993 Issue of common shares 205 94,138 94,343 Exercise of share-based payment awards 10 2,667 2,677 Equity-settled share-based payment awards 8,117 8,117 Loss for the period (34,435) (34,435) Other comprehensive loss (8,838) (8,838) Balance as of September 30, 2021 1,198 450,086 (7,118) (310,309) 133,857 Balance as of January 1, 2022 1,234 474,087 (5,973) (333,397) 135,951 Issue of common shares 259 89,423 89,682 Exercise of share-based payment awards 101 101 Equity-settled share-based payment awards 14,779 14,779 Transfer of cumulative loss on sale of financial assets 6,865 (6,865) 0 Loss for the period (52,564) (52,564) Other comprehensive loss (6,846) (6,846) Balance as of September 30, 2022 1,493 578,390 (5,954) (392,826) 181,103

Expected cash runway extended into the second half of calendar year 2025First major PBM/payer contract signed for VTAMA, effective October 1Over 54,000 VTAMA prescriptions written by approximately 6,400 prescribers since launch show strong demand, with fiscal Q2 2022 net product revenue of $5.0 millionUnveiled IMVT-1402, a next generation anti-FcRn which showed deep IgG lowering similar to batoclimab with no or minimal impact observed on albumin and LDL (low-density lipoprotein) levels in animal studiesCompleted enrollment for potentially registrational trial for brepocitinib in systemic lupus erythematosus (SLE), with topline data on track to be announced in the second half of calendar year 2023Federal court denied Moderna’s partial motion to dismiss Genevant and Arbutus’s pending IP infringement suit BASEL, Switzerland and LONDON and NEW YORK and BOSTON, Nov. 14, 2022 (GLOBE NEWSWIRE) -- Roivant Sciences Ltd. (Nasdaq: ROIV) today reported its financial results for the second quarter ended September 30, 2022 and provided an update on the Company’s operations. Roivant’s chief executive officer, Matt Gline, noted: “This has been a great quarter for Roivant. In addition to VTAMA’s strong performance and the enthusiastic feedback we’ve received from patients and providers, we executed our first major PBM contract. This provides immediate coverage for millions of lives associated with that PBM, establishes a national template for unrestricted access to VTAMA, and supports a paradigm shift to VTAMA as the mainstay of psoriasis therapy. Our fully enrolled potentially registrational SLE study for brepocitinib, which reads out next year, and Immunovant’s broadened anti-FcRn portfolio, represent notable progress in our immunology pipeline. Between cost reduction and multiple recent infusions of capital, we’ve extended our runway into the second half of calendar year 2025 – and we’re looking forward to multiple key catalysts between now and then, including many in the next year.” Recent Developments Roivant: On November 8, priced $150 million total gross primary and secondary offering, consisting of gross primary proceeds to Roivant of $100 million. Roivant continued its cost optimization and pipeline reprioritization initiatives initially announced in June 2022 in order to focus capital on the most valuable and meaningful opportunities in the pipeline, while maintaining the financial flexibility to opportunistically in-license assets. Roivant expects that its consolidated cash, cash equivalents and restricted cash of $1.6 billion at September 30, 2022, or $1.9 billion after giving effect to subsequent Roivant and Immunovant follow-on offerings and anticipated proceeds from the sale of Myovant equity rights to Sumitomo Pharma, along with continued cost savings initiatives, support cash runway into second half of calendar year 2025.Dermavant: Through November 4, VTAMA has had over 54,000 prescriptions written by approximately 6,400 unique prescribers, based on IQVIA data. For the quarter ended September 30, 2022, Roivant reported VTAMA net product revenue of $5.0 million, representing a gross-to-net yield of approximately 12%. Dermavant also entered into a reimbursement contract with one of the three largest PBMs, effective October 1, 2022. Finally, Dermavant announced results from its maximal use pharmacokinetic study of VTAMA in atopic dermatitis, which showed minimal to no systemic absorption and favorable tolerability when used in pediatric patients down to age two.Priovant: Completed enrollment for its ongoing potentially registrational global trial evaluating oral brepocitinib for the treatment of SLE in August 2022. Oral brepocitinib is a potential first-in-class dual, selective inhibitor of TYK2 and JAK1 licensed from Pfizer that has been evaluated in 14 completed Phase 1 and Phase 2 trials, including 5 placebo-controlled Phase 2 trials in psoriatic arthritis, plaque psoriasis, ulcerative colitis, alopecia areata and hidradenitis suppurativa that generated statistically significant and clinically meaningful efficacy results. With over 1,000 patients exposed in these studies, brepocitinib showed a safety and tolerability profile in line with other class agents. Priovant is also developing oral brepocitinib for the treatment of dermatomyositis, for which it recently initiated a single potentially registrational Phase 3 trial.Immunovant: At Roivant’s Investor Day on September 28, Immunovant unveiled IMVT-1402, a next generation anti-FcRn which showed deep IgG lowering similar to batoclimab with no or minimal impact observed on albumin and LDL levels in a head-to-head animal study with batoclimab and placebo. Additionally, on September 7 Immunovant unveiled two new development programs for batoclimab in Graves’ disease and chronic inflammatory demyelinating polyneuropathy (CIDP). Immunovant also completed a $75.0 million follow-on offering in October, with leading life sciences investors including Logos Capital, Deep Track Capital, Frazier Life Sciences, TCGX, BVF Partners, and Commodore Capital participating.Genevant: On November 2, the federal district court in Delaware issued an opinion and order in the patent infringement suit brought by Genevant and Arbutus against Moderna. The court denied Moderna’s partial motion to dismiss the suit based on the government-contractor defense under 28 U.S.C. Section 1498, which was an attempt by Moderna to shift liability for an unspecified portion its alleged infringement to the US government and taxpayers. The case is now expected to proceed to the pre-trial discovery phase.Proteovant: Disclosed today data from its preclinical estrogen receptor (ER) degrader demonstrating equal or better tumor reduction in an in vivo model in a head-to-head comparison with the most advanced degrader in its class. Affivant: Affivant and Affimed jointly unveiled AFVT-2101 at the Society for Immunotherapy of Cancer (SITC) Annual Meeting in Boston on November 8. AFVT-2101 is a tetravalent, bispecific ICE® (innate cell engager) that selectively targets folate receptor alpha (FRα) and CD16A (FcγR3A). AFVT-2101 directs innate immune cells to kill tumor cells selectively and potently with a wide range of FRα expression. Due to the high avidity for CD16A, AFVT-2101 is more efficacious and potent in both antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP) assays than farletuzumab, a monoclonal antibody targeting FRα. Major Upcoming Milestones Dermavant: Expects to provide updates on the commercial launch of VTAMA for psoriasis on a periodic basis and to report topline data from the Phase 3 trials of VTAMA for the treatment of atopic dermatitis in the first half of calendar year 2023.Priovant: Plans to announce topline results from the potentially registrational trial evaluating brepocitinib for the treatment of patients with SLE in the second half of calendar year 2023.Immunovant: Phase 3 trials of batoclimab in myasthenia gravis (MG) and thyroid eye disease (TED) progressing and expects to have top-line results from the MG trial in the second half of calendar year 2024 and from the two TED trials in the first half of calendar year 2025. A pivotal Phase 2b trial in CIDP is planned to be initiated by the end of calendar year 2022, with initial results from the open label period expected in the first half of calendar year 2024. In Graves’ disease, a Phase 2 trial is planned to be initiated in early calendar year 2023 with initial results expected in the second half of calendar year 2023. Immunovant plans to finalize the lead asset and trial design in WAIHA following an expected engagement with the hematology division of the FDA before the end of calendar year 2022. Immunovant plans to submit an IND and initiate a Phase 1 study for IMVT-1402 in early 2023 with initial human data expected in mid-2023; Immunovant believes these Phase 1 results together with strong IgG biomarker data from batoclimab may accelerate the development program for 1402.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 MDS patients in the second half of calendar year 2023.Kinevant: Plans to report topline data from the ongoing Phase 2 trial of namilumab for the treatment of sarcoidosis in the first half of calendar year 2024. Second Quarter Ended September 30, 2022 Financial Summary Cash Position As of September 30, 2022, we had cash, cash equivalents and restricted cash of approximately $1.6 billion. Giving effect to Immunovant’s October 2022 follow-on offering for $75 million in gross proceeds, Roivant’s November follow-on offering for $100 million in gross primary proceeds, and $115 million in expected proceeds from the planned sale of the Myovant top-up shares in connection with the pending acquisition of Myovant by Sumitomo Pharma, Roivant’s consolidated cash, cash equivalents and restricted cash would have been approximately $1.9 billion. The Myovant transaction is expected to close in the first calendar quarter of 2023, subject to customary closing conditions. Research and Development Expenses Research and development (R&D) expenses were $132.0 million for the three months ended September 30, 2022 compared to $132.1 million for the three months ended September 30, 2021. The quarter-over-quarter decrease was primarily due to a decrease in share-based compensation expense due to the achievement of the liquidity event vesting condition for certain equity instruments upon the closing of the Business Combination with MAAC in September 2021, resulting in the recognition of a one-time catch-up expense. This decrease was offset by increases in personnel-related expenses and program-specific costs, reflecting the progression of our programs and drug discovery. Non-GAAP R&D expenses were $123.3 million for the three months ended September 30, 2022 compared to $103.2 million for the three months ended September 30, 2021. Selling, General and Administrative Expenses Selling, general and administrative (SG&A) expenses were $157.7 million for the three months ended September 30, 2022 compared to $437.8 million for the three months ended September 30, 2021. The quarter-over-quarter decrease was primarily due to a decrease in share-based compensation expense, partially offset by higher selling, general and administrative 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 with MAAC in September 2021, resulting in the recognition of a one-time catch-up expense. This decrease was partially offset by continued vesting of the equity instruments. Non-GAAP SG&A expenses were $101.5 million for the three months ended September 30, 2022 compared to $68.0 million for the three months ended September 30, 2021. Net Loss Net loss was $315.9 million for the three months ended September 30, 2022 compared to $225.6 million for the three months ended September 30, 2021. On a per common share basis, net loss was $0.42 for the three months ended September 30, 2022 and $0.32 for the three months ended September 30, 2021. Non-GAAP net loss was $226.8 million for the three months ended September 30, 2022 compared to $290.0 million for the three months ended September 30, 2021. ROIVANT SCIENCES LTD. Selected Balance Sheet Data (unaudited, in thousands) September 30, 2022 March 31, 2022 Cash, cash equivalents and restricted cash$1,612,646 $2,074,034Total assets 2,215,534 2,585,129Total liabilities 701,385 523,695Total shareholders’ equity 1,514,149 2,038,943Total liabilities, redeemable noncontrolling interest and shareholders’ equity 2,215,534 2,585,129 ROIVANT SCIENCES LTD. Condensed Consolidated Statements of Operations (unaudited, in thousands, except share and per share amounts) Three Months Ended September 30, Six Months Ended September 30, 2022 2021 2022 2021 Revenue, net$12,533 $13,987 $16,852 $21,722 Operating expenses: Cost of revenues 3,641 6,381 5,367 7,123 Research and development (includes $7,417 and $28,157 of share-based compensation expense for the three months ended September 30, 2022 and 2021 and $19,660 and $29,772 for the six months ended September 30, 2022 and 2021, respectively) 131,995 132,098 267,825 210,613 Acquired in-process research and development — 122,161 — 122,272 Selling, general and administrative (includes $54,479 and $369,155 of share-based compensation expense for the three months ended September 30, 2022 and 2021 and $115,030 and $386,809 for the six months ended September 30, 2022 and 2021, respectively) 157,663 437,776 306,735 520,530 Total operating expenses 293,299 698,416 579,927 860,538 Loss from operations (280,766) (684,429) (563,075) (838,816) Change in fair value of investments 54,678 (32,273) 79,225 (23,654)Gain on sale of investment — (443,754) — (443,754)Change in fair value of debt and liability instruments (13,541) 13,145 27,672 17,730 Gain on termination of Sumitomo Options — — — (66,472)Gain on deconsolidation of subsidiary (16,762) — (16,762) — Other expense, net 8,615 3,692 10,331 3,558 Loss before income taxes (313,756) (225,239) (663,541) (326,224)Income tax expense 2,165 401 6,164 494 Net loss (315,921) (225,640) (669,705) (326,718)Net loss attributable to noncontrolling interests (24,331) (17,159) (46,306) (36,054)Net loss attributable to Roivant Sciences Ltd.$(291,590) $(208,481) $(623,399) $(290,664)Net loss per common share—basic and diluted$(0.42) $(0.32) $(0.89) $(0.45)Weighted average shares outstanding—basic and diluted 699,888,061 650,225,764 697,894,414 650,041,993 ROIVANT SCIENCES LTD. Reconciliation of GAAP to Non-GAAP Financial Measures (unaudited, in thousands) Three Months Ended September 30, Six Months Ended September 30, Note 2022 2021 2022 2021 Net loss $(315,921) $(225,640) $(669,705) $(326,718)Adjustments: Cost of revenues Amortization of intangible assets(1) 2,200 — 2,942 — Research and development: Share-based compensation(2) 7,417 28,157 19,660 29,772 Depreciation and amortization(3) 1,230 780 2,300 1,523 General and administrative: Share-based compensation(2) 54,479 369,155 115,030 386,809 Depreciation and amortization(3) 1,646 589 2,512 1,333 Other: Change in fair value of investments(4) 54,678 (32,273) 79,225 (23,654)Gain on sale of investment(5) — (443,754) — (443,754)Change in fair value of debt and liability instruments(6) (13,541) 13,145 27,672 17,730 Gain on termination of Sumitomo Options(7) — — — (66,472)Gain on deconsolidation of subsidiary(8) (16,762) — (16,762) — Estimated income tax impact from adjustments(9) (2,219) (156) (346) 60 Adjusted net loss (Non-GAAP) $(226,793) $(289,997) $(437,472) $(423,371) Three Months Ended September 30, Six Months Ended September 30, Note 2022 2021 2022 2021 Research and development expenses $131,995 $132,098 $267,825 $210,613Adjustments: Share-based compensation(2) 7,417 28,157 19,660 29,772Depreciation and amortization(3) 1,230 780 2,300 1,523 Adjusted research and development expenses (Non-GAAP) $123,348 $103,161 $245,865 $179,318 Three Months Ended September 30, Six Months Ended September 30, Note 2022 2021 2022 2021 Selling, general and administrative expenses $157,663 $437,776 $306,735 $520,530Adjustments: Share-based compensation(2) 54,479 369,155 115,030 386,809Depreciation and amortization(3) 1,646 589 2,512 1,333 Adjusted selling, general and administrative expenses (Non-GAAP) $101,538 $68,032 $189,193 $132,388 Notes to non-GAAP financial measures: (1) Represents non-cash amortization of intangible assets associated with milestone payments made in connection with regulatory approvals. (2) Represents non-cash share-based compensation expense. (3) Represents non-cash depreciation and amortization expense, other than amortization of intangible assets associated with milestone payments made in connection with regulatory approvals. (4) 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. (5) Represents a one-time gain on sale of investment resulting from the merger of Datavant and CIOX Health in July 2021. (6) Represents the change in fair value of debt and liability instruments, which is non-cash and primarily includes the unrealized (gain) loss relating to the measurement and recognition of fair value on a recurring basis of certain liabilities. (7) 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”). (8) Represents the one-time gain on deconsolidation of a subsidiary. (9) Represents the estimated tax effect of the adjustments. Beginning in the fourth quarter of the fiscal year ended March 31, 2022, the Company no longer excludes from its non-GAAP financial measures acquired IPR&D expenses, which include consideration for the purchase of IPR&D through asset acquisitions and license agreements as well as payments made in connection with asset acquisitions and license agreements upon the achievement of development milestones. Previously, these items were excluded from the Company’s non-GAAP financial measures. In conjunction with this change, acquired IPR&D expenses are now reported as a separate line item in its consolidated statements of operations. Prior period amounts have been revised to conform to the current presentation. There was no acquired IPR&D expense for the three and six months ended September 30, 2022. For the three and six months ended September 30, 2021, acquired IPR&D expense was $122.2 million and $122.3 million, respectively. Roivant also announced today that it will participate in three additional upcoming investor conferences: Cantor Medical & Aesthetic Dermatology, Ophthalmology & MedTech Conference in Miami from December 7-8. CFO Richard Pulik will participate in the panel “Commercial Successes, Current & Upcoming Launches” at 9:00 a.m. EST on Thursday, December 8 Jefferies Healthcare Summit in Denver from December 14-1541st Annual J.P. Morgan Healthcare Conference in San Francisco from January 9-12 Investor Conference Call Information Roivant will host a live conference call and webcast at 8:00 a.m. EST on Monday, November 14, 2022 to report its financial results for the fiscal quarter ended September 30, 2022 and provide a corporate update. To access the conference call by phone, please register online using this registration link. 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. About Roivant Sciences Roivant’s mission is to improve the delivery of healthcare to patients by treating every inefficiency as an opportunity. Roivant develops transformative medicines faster by building technologies and developing talent in creative ways, leveraging the Roivant platform to launch “Vants” – nimble and focused biopharmaceutical and health technology companies. For more information, please visit www.roivant.com. Roivant Sciences Forward-Looking Statements This press release contains forward-looking statements. Statements in this press release may include statements that are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), which are usually identified by the use of words such as “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intends,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “would” and variations of such words or similar expressions. The words may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. We intend these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act. Our forward-looking statements include, but are not limited to, statements regarding our or our management team's expectations, hopes, beliefs, intentions or strategies regarding the future, and statements that are not historical facts, including statements about the clinical and therapeutic potential of VTAMA and our other existing and future product candidates, the timing and expectations of potential regulatory submissions, the availability and success of topline results from our ongoing clinical trials, any commercial potential of VTAMA and our other product candidates, including but not limited to the anticipated timeline of commercial coverage of VTAMA, the receipt of proceeds from the expected sale of the Myovant top-up shares to Sumitomo Pharma, any pending or potential litigation, including but not limited to our expectations regarding the outcome of any such litigation and costs and expenses associated with such litigation, and our business strategies, financial condition, and trends, competitive position, potential growth opportunities, and expectations or probabilities for success. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. Although we believe that our plans, intentions, expectations and strategies as reflected in or suggested by those forward-looking statements are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a number of risks, uncertainties and assumptions, including, but not limited to, those risks set forth in the Risk Factors section of our filings with the U.S. Securities and Exchange Commission. Moreover, we operate in a very competitive and rapidly changing environment in which new risks emerge from time to time. These forward-looking statements are based upon the current expectations and beliefs of our management as of the date of this press release, and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Except as required by applicable law, we assume no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise. Contacts Investors Roivant Investor Relations ir@roivant.com Media Stephanie LeeRoivant Sciences stephanie.lee@roivant.com

NEW YORK and BASEL, Switzerland, Nov. 10, 2022 (GLOBE NEWSWIRE) -- Affivant, a biotechnology company dedicated to developing novel immune-oncology approaches to activate and enable the innate immune system to fight cancer, will present a poster at the 37th Annual Meeting of The Society for Immunotherapy of Cancer (SITC) highlighting preclinical data for AFVT-2101 (previously AFM32). AFVT-2101 is a tetravalent, bispecific Innate Cell Engager (ICE®) that bridges folate receptor alpha (FRα) on tumor cells with CD16A expressing innate immune cells, to induce potent and selective targeted tumor cell killing. FRα is a tumor-associated antigen which is highly overexpressed on a variety of epithelial tumors. The following poster will be presented live at SITC on November 11th: Title: AFVT-2101, an innate immune-cell engager that selectively targets FOLR1 expressing tumor cells to safely harness potent anti-cancer responses Poster #: 1212 Authors: Ahmad Trad, Michael Tomaszowski, Josef Caslavsky, Robert Freitag, Sudhir Penugonda, Keith Haan, Markus Rohrwild, Daniel O’Shannessy, Jana Siegler, Peter Sandy, Eric Gaukel, Daniela Penston, Zoë Johnson The poster shows that AFVT-2101 binds selectively to CD16A (both 158V and 158F variants). Physiological levels of competing IgG do not alter binding efficacy. AFVT-2101 induces potent and selective ADCC, even on FRα low expressing cell lines. AFVT-2101 is also shown to induce efficient ADCP in vitro. Co-culture of PBMCs, tumor cells and AFVT-2101 showed concentration-dependent release of pro-inflammatory cytokines (IFNγ, IP-10, TNFα) and minimal off-target cytokine release, confirming a potent but safe in vitro profile of AFVT-2101. About ICE molecules Innate Cell Engager (ICE®) molecules are designed to bivalently bind CD16A+ cells of the innate immune system and a tumor associated antigen, inducing potent, tumor-directed cytotoxicity via antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP). About Affivant Affivant, a Roivant Sciences company, is dedicated to developing novel immune-oncology approaches to activate and enable the innate immune system to fight cancer. Our innovative bi-specific innate cell engagers are designed to target specific patient populations as powerful monotherapies and combination treatments. AFVT-2101 is currently in IND-enabling studies. For more information, visit www.affivant.com. Contact: Zoë Johnson, Chief Scientific Officerzoe.johnson@affivant.com