On March 30, 2021 Immatics N.V. (NASDAQ: IMTX; "Immatics"), a clinical-stage biopharmaceutical company active in the discovery and development of T cell redirecting cancer immunotherapies, reported financial results for the quarter and full year ended December 31, 2020 (Press release, Immatics, MAR 30, 2021, View Source [SID1234577334]).

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Harpreet Singh, Ph.D., CEO of Immatics commented, "The past year was exceptional for Immatics with the advancement of our pipeline programs, expansion of our leadership team and scientific advisory board and the completion of our listing on the Nasdaq. Building on this foundation, we have recently delivered encouraging data from three clinical TCR-T studies demonstrating first anti-tumor activity in heavily pre-treated solid cancer patients. This early data also constitutes a first clinical validation for our differentiated TCR therapeutics platform. We look forward to reporting further data from our Phase 1 ACTengine TCR-T trials as well as the progress in our TCR Bispecifics programs (TCER) in the latter part of this year."

Fourth Quarter 2020 and Subsequent Company Progress

Adoptive Cell Therapy Programs

·ACTengine IMA200 series – Immatics provided a clinical data update from three ongoing ACTengine Phase 1 trials for its engineered Adoptive Cell Therapy approach (also known as TCR-T) in March. The combined data readout during early phases of dose escalation for the ACTengine programs, IMA201, IMA202 and IMA203, indicated first anti-tumor activity with tumor shrinkage observed in 8 out of 10 patients including one unconfirmed partial response as of data cut-off. This was consistent with the observed robust engraftment, persistence and tumor infiltration of infused ACTengine T cells. Overall, all product candidates demonstrated a manageable safety and tolerability profile. An additional Phase 1a read-out for IMA201 and IMA203 and initial Phase 1b data for IMA202 from the dose expansion cohort is planned for H2 2021. Submission of a clinical trial application (CTA) for the fourth IMA200 series program, IMA204, remains anticipated for H2 2021. The company presented the first preclinical data for the program in September 2020, which is directed at a novel target, COL6A3 exon 6 that is expressed in the tumor stroma of a variety of solid cancers.

Immatics Press Release March 30, 2021 1 | 9

TCR Bispecifics Programs

·IMA401 – Immatics presented preclinical proof-of-concept data from its lead TCER program, IMA401, at the European Antibody Congress 2020 in November. IMA401 is an antibody-like, "off-the-shelf" biologic directed against a high-density peptide target derived from MAGEA4/8. Submission of a CTA for IMA401 remains on track by the end of 2021.

·IMA402 – Immatics plans to announce preclinical proof-of-concept data for its second TCER program, IMA402 in Q2 2021. GMP process development activities are targeted to begin at the same time to advance this program towards the Investigational New Drug (IND) stage and clinical development.

Corporate Developments

Scientific Advisory Board Update

·Immatics has established a new Scientific Advisory Board (SAB) comprised of several leaders and scientific pioneers in immuno-oncology, adoptive cell therapies, clinical oncology and cancer biology. The members of the new SAB include Gwendolyn Binder, Dirk Busch, Christoph Huber, Patrick Hwu, Roland Kontermann, Crystal Mackall, Hidde Ploegh, Hans-Georg Rammensee, and Cassian Yee. Patrick Hwu and Crystal Mackall will co-chair the SAB. Additional information about the members can be found on the Immatics website.

Amendment to Resale Registration Statement

·In connection with the filing of the Annual Report on Form 20-F, Immatics will file an amendment to its existing resale registration statement on Form F-1 to update certain information. This registration statement relates solely to the resale of shares by certain stockholders, and the filing of the amendment is not necessarily indicative of any sales by the holders of their shares. No shares will be issued or sold by Immatics pursuant to the registration statement.

Full Year 2020 Financial Results

Cash Position: Cash and cash equivalents as well as other financial assets total €232.0 million ($284.7 million1) as of December 31, 2020 compared to €119.4 million ($146.5 million1) as of December 31, 2019. The increase is mainly the result of the business combination with ARYA Sciences Acquisition Corporation completed in July 2020 (ARYA merger) and the concurrent PIPE Financing.

Immatics Press Release March 30, 2021 2 | 9

Revenue: Total revenue, consisting of revenue from collaboration agreements, was €31.3 million ($38.4 million1) for the year ended December 31, 2020, compared to €18.4 million ($22.6 million1) for the year ended December 31, 2019.

Research and Development Expenses: R&D expenses were €67.1 million ($82.3 million1) for the year ended December 31, 2020, compared to €40.1 million ($49.2 million1) for the year ended December 31, 2019. The increase is mainly due to an increase in preclinical and clinical development expenses and an increase in share-based compensation (€14.5 million; $17.8 million1 for the year ended December 31, 2020 compared to €1.6 million; $1.9 million for the year ended December 31, 2019).

General and Administrative Expenses: G&A expenses were €34.2 million ($42.0 million1) for the year ended December 31, 2020, compared to €11.8 million ($14.5 million1) for the year ended December 31, 2019. The increase is mainly due to an increase in share-based compensation (€10.9 million; $13.4 million1 for the year ended December 31, 2020 compared to €0.5 million; $0.6 million for the year ended December 31, 2019) as well as one-time transaction costs of the NASDAQ listing in connection with the ARYA merger in July.

Net Loss: Net loss was €229.6 million ($281.7 million1) for the year ended December 31, 2020, compared to €32.5 million ($39.9 million1) for the year ended December 31, 2019, of which €152.8 million ($187.5 million1) resulted from a one-time, non-cash expense in connection with the ARYA merger. The main part of this €152.8 million ($187.5 million1) non-cash expense resulted from the share price increase between signing and closing of the ARYA merger.

Full financial statements can be found in the Annual Report on Form 20-F filed with the Securities and Exchange Commission (SEC) and published on the SEC website under www.sec.gov.

1 All amounts translated using the exchange rate published by the European Central Bank in effect as of December 31, 2020 (1 EUR = 1.2271 USD).

Upcoming Investor Conferences

·Kempen Life Science – April 28, 2021

·Bank of America Healthcare Conference – May 11-13, 2021

·Jefferies Virtual Healthcare Conference – June 1-3, 2021

To see the full list of events and presentations, visit www.investors.immatics.com/events-presentations.

On March 30, 2021 CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a U.S. biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, reported financial results for the year ended December 31, 2020 and provided an update on key highlights for 2021 (Press release, CASI Pharmaceuticals, MAR 30, 2021, View Source [SID1234577360]).

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Wei-Wu He, Ph.D., CASI’s Chairman and Chief Executive Officer, commented, "Despite the ongoing challenges presented by the pandemic, we are continuing to execute across each of our targeted initiatives, chiefly with respect to strategic growth through tactical business development, as evidenced by our recently announced in-licensing of a first-in-class VCP/p97 inhibitor for hematological malignancies and solid tumors from Cleave Therapeutics. Additionally, we remain laser focused on driving commercial preparations in advance of the CAR-T NDA filing, which is well positioned for success given the relatively lower cost of goods and potentially swifter regulatory pathway afforded by launching in the Greater China market."

Dr. He continued, "As we continue assembling a world class pipeline of assets and driving existing development forward, we are encouraged by the steady EVOMELA patient uptake we have observed, further underscored by the greater than 50% revenue growth we have forecasted in 2021. The EVOMELA launch has informed our business development strategy to a large extent, as we now possess a clear picture of the potential challenges and opportunities associated with launching a successful patient and physician marketing campaign, achieving regulatory support, and appropriately scaling manufacturing. We look forward to leveraging our existing commercial infrastructure as we continue evaluating new potentially complementary pipeline assets and move preparations along in advance of upcoming regulatory filings. Finally, we were pleased to report the closing of an underwritten public offering for gross proceeds of $32.5 million and adding a few new fundamentally-driven, long-term oriented, healthcare-dedicated investors to the CASI story, as well as continued investment by our management. We look forward to continuing to expand our U.S. investor base, and importantly, positioning CASI to accelerate long-term value creation for our shareholders."

Key Highlights for 2021

EVOMELA (melphalan for injection)

In August 2019, the Company launched its first product, EVOMELA (melphalan for injection), in China, marking the transition of CASI to an integrated commercial operation. EVOMELA is unique in that the Captisol-enabled formulation avoids the use of propylene glycol, which is used as a co-solvent in other forms of melphalan. EVOMELA has greater stability when reconstituted, allowing longer preparation and infusion times, and is currently the only intravenous form of melphalan commercially available in China. CASI has built a strong sales and marketing team that is detailing all major hospitals and physicians in the hematology/oncology therapeutic area. CASI intends to continue to drive market awareness and market penetration for EVOMELA in 2021 and beyond. A post-marketing study for EVOMELA in China is currently underway.

CNCT19 (CD19 CAR-T)

In June 2019, CASI acquired CNCT19 (CD19 CAR-T) from Juventas Cell Therapy Ltd., a China-based domestic company specializing in innovative immune cell therapy. CNCT19 targets CD19, a B-cell surface protein widely expressed during all phases of B-cell development and a validated target for B-cell driven hematological malignancies. Other CD19-targeted CAR constructs from several different institutions have demonstrated antitumor efficacy in children and adults with relapsed B-cell acute lymphoblastic leukemia (B-ALL), chronic lymphocytic leukemia (CLL), and B-cell non-Hodgkin lymphoma (B-NHL). CNCT19 received Breakthrough Therapy Designation based on initial data from the ongoing single-arm, open-label, non-randomized, dose-escalation, Phase 1 study designed to determine the safety and efficacy of CNCT19 in B-ALL. The Phase 2 registration study in patients with B-NHL is currently enrolling, and we expect Juventas to initiate the Phase II registration study in B-ALL in Q1 2021. The commercial team is making preparations for the launch of CNCT19, for which Juventas is expecting to file an NDA with the NMPA in 2021. Currently, there are no CD-19 CAR-T therapy products marketed in China. CASI intends for CNCT (CD19 CAR-T) to be locally developed and manufactured so that it can be more affordable and widely accessible to patients.

CB-5339 (VCP/p97 inhibitor)

In March of 2021, CASI acquired CB-5339 (VCP/p97 inhibitor) from Cleave. CB-5339, an oral second-generation, small molecule VCP/p97 inhibitor, is being evaluated in a Phase 1 clinical trial in patients with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS), while the National Cancer Institute (NCI) is sponsoring and evaluating CB-5339 in a Phase 1 clinical trial of patients with solid tumors and lymphomas.

BI-1206 (Anti-FcyRIIB antibody)

In October of 2020, CASI acquired BI-1206, Checkpoint Inhibitor Targeting FcγRIIB, from BioInvent. BI-1206 has a novel mode-of-action, blocking the single inhibitory antibody checkpoint receptor FcγRIIB to unlock anti-cancer immunity in both liquid and solid tumors. BI-1206 is BioInvent’s lead drug candidate and is being investigated in a Phase I/II trial, in combination with anti-PD1 therapy Keytruda (pembrolizumab), in solid tumors, and in a Phase I/IIa trial in combination with MabThera (rituximab) for the treatment of non-Hodgkin lymphoma (NHL). Recently, BioInvent presented early clinical data from their Phase 1/2a trial on BI-1206. Objective responses (2CRs, 4 PRs) were demonstrated in 6 out of 9 patients evaluated, providing exciting evidence that BI-1206 has the potential to restore the activity of rituximab in non-Hodgkin’s lymphoma patients who have relapsed after treatment with rituximab. CASI intends to file an IND for BI-1206 with the NMPA in 2021 to start the clinical trials in China.

CID-103 (Anti-CD38 Mab)

In April 2019, CASI acquired exclusive global rights to CID-103, a novel anti-CD38 monoclonal antibody program. Preclinical data demonstrate CID-103 to have enhanced activity against a broad array of malignancies which express CD38, and potentially better safety and best in class when compared to other CD38 monoclonal antibodies. The CID-103 Phase 1 study was initiated in March 2021.

Full Year 2020 Highlights

Product Sales:

Revenues consist of product sales of EVOMELA that launched during August 2019. Revenue was $15.0 million for the year ended 2020 compared to $4.1 million for the year ended December 31, 2019.

Costs of Revenues:

Costs of revenues were $9.5 million for the year ended December 31, 2020 compared to $3.9 million for the year ended December 31, 2019. The increase is due to the launch of EVOMELA that occurred during August 2019. The increase in cost of revenues is partially offset by a decrease in unit cost of inventories of EVOMELA as a result of the new alternate manufacturer now in place.

Research and Development Expenses:

Research and development expenses for the year ended December 31, 2020 were $11.5 million, compared with $9.3 million for the year ended December 31, 2019. The increase in R&D expenses primarily due to an increase in R&D expenses incurred related to the development of CID-103 and costs associated with the EVOMELA post marketing study. These costs were partially offset by reduced regulatory costs associated with our ANDAs and reduced costs associated with preclinical development activities related to an immune-oncology program terminated in 2019.

General and Administrative Expenses:

General and administrative expenses for the year ended December 31, 2020 were $19.7 million, compared with $27.3 million for the year ended December 31, 2019. The decrease in general and administrative expenses was primarily because the 2019 period included costs related to sales and marketing efforts to prepare for the August 2019 launch of EVOMELA, as well as lower professional fees and travel costs incurred during the 2020 period.

Selling and Marketing Expenses:

Selling and marketing expenses for the year ended December 31, 2020 were $7.8 million, compared with $3.1 million for the year ended December 31, 2019. The increase is due to selling costs related to the launch of EVOMELA that began during August 2019.

Acquired In-Process Research and Development:

Acquired in-process R&D expenses for the year ended December 31, 2020 were $17.8 million, compared with $7.0 million for the year ended December 31, 2019. Acquired in-process R&D expenses for the year ended December 31, 2020 comprised of the two 2020 milestone fees paid related to Pharmathen of $1.7 million, the 2020 milestone fees paid to Juventas of $10.3 million and fees paid to BioInvent of $5.9 million. Acquired in-process R&D expenses for the year ended December 31, 2019 included the $5.8 million acquisition of the Black Belt’s license in April 2019 and $1.1 million milestone fee paid to Pharmathen.

Net Loss:

Net loss for the year ended December 31, 2020 was $47.5 million compared to $45.4 million for the year ended December 31, 2019. The increase is primarily due to the Company’s increasing acquisitions of additional targeted drugs and activities in Research and Development.

On March 30, 2021 Schrödinger (Nasdaq: SDGR), whose physics-based software platform is transforming the way therapeutics and materials are discovered, reported that it will host a webcast to review the preclinical data being presented from its CDC7 program during a virtual poster session at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting (Press release, Schrodinger, MAR 30, 2021, View Source [SID1234577376]). The company will also provide an overview of two other internal programs, MALT1 and Wee1, as well as highlight the role of its computational platform in accelerating the discovery of its novel molecules. The webcast will take place Monday, April 12, 2021, at 10:00 a.m. ET.

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The webcast will be available under "News & Events" in the investors section of Schrödinger’s website, View Source and will be archived for approximately 7 days.

On March 30, 2021 AffaMed Therapeutics ("AffaMed"), a global clinical-stage biopharmaceutical company dedicated to addressing critical unmet patient need in ophthalmic, neurological and psychiatric disorders, reported the completion of over US$170 million in Series B financing (Press release, AffaMed Therapeutics, MAR 30, 2021, View Source [SID1234577392]). The oversubscribed financing was led by Lake Bleu Capital, with participation by new investors including Partners Investment, Superstring Capital, Orion Science Capital, and Fountainhead Partners, and with continuing support of its founding investor CBC Group. Proceeds from the financing will be used to advance clinical development of AffaMed’s robust pipeline of innovative therapeutic candidates, progress business development and partnering activities, and support preparations for future commercialization.

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Since its inception in 2019, AffaMed has built an exceptional global platform to develop therapeutics and solutions to serve patients in Greater China and worldwide. AffaMed has assembled world-class capabilities in clinical development, regulatory affairs and business development under the leadership of its CEO, Dr. Dayao Zhao, a seasoned industry veteran who has previously served as Head of China R&D for Pfizer; as Head of China R&D at the Janssen Pharmaceutical Companies of Johnson & Johnson; and as Genzyme’s head of Japan and Asia Pacific R&D.

Dr. Zhao commented: "AffaMed has established a strong portfolio of therapeutic candidates in ophthalmology and neuroscience and has made significant progress in developing its pipeline over the past year. With the support of this outstanding syndicate of investors who share our vision, we are well-positioned to transform AffaMed into a leading biopharmaceutical company in our chosen therapeutic areas while advancing our pipeline and pursuing new strategic partnerships."

Dr. Bin Li, Founding Partner, CEO and Chief Investment Officer of Lake Bleu Capital said: "AffaMed is a promising biopharmaceutical company with an unparalleled pipeline targeting neurological, psychiatric and ophthalmic disorders. We believe in AffaMed’s world-class management team, clear China and global business development plan, and impressive execution capabilities. Lake Bleu Capital is delighted to partner with the AffaMed team to support their globalization strategy and help unlock new treatment paradigms that will ultimately make a tangible difference to patients globally."

Wei Fu, CEO of CBC Group, commented: "AffaMed has built a robust clinical-stage portfolio with significant market potential, and has articulated a clear and transformative strategy for developing new therapies. Investing in the human talent behind biopharmaceutical companies like AffaMed is at the core of CBC Group’s value creation strategy. We look forward to continuing to support AffaMed’s strong leadership team as it accelerates growth to the next level."

AffaMed Appoints Dr. Ji Li as President and Board Member

In addition to today’s financing news, AffaMed has announced the appointment of Dr. Ji Li as President and member of its Board of Directors. A highly accomplished senior pharmaceutical executive with extensive business development and R&D experience, Dr. Li has previously served as Executive Vice President and Global Head of Business Development at BeiGene; as Vice President of Business Development and Licensing at Merck Research Laboratories, a subsidiary of Merck & Co. Inc.; and as Executive Director of External R&D at Amgen. Dr. Li holds a Ph.D. in Neuroscience from Mount Sinai School of Medicine, and a B.S. in Pharmacology from Shanghai Medical University.

Dr. Li commented: "I am pleased to join AffaMed at this pivotal time in the company’s development. The management team deeply appreciates the trust shown in AffaMed by our existing and new investors, and we are confident we will successfully advance AffaMed’s strategic plan to strengthen and broaden our portfolio towards serving the unmet medical needs of millions of patients in Greater China and the rest of the world."

On March 30, 2021 Acacia Pharma Group plc ("Acacia Pharma", the "Group" or the "Company") (EURONEXT: ACPH), a hospital pharmaceutical company focused on the development and commercialization of new products aimed at improving the care of patients undergoing significant treatments such as surgery, other invasive procedures or cancer chemotherapy, reported the publication of its Annual Report and Financial Statements for the Year ended 31 December 2020 (Press release, Acacia Pharma, MAR 30, 2021, View Source [SID1234577279]).

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The Annual Report is attached below and also available on www.acaciapharma.com in the Investors/Financial Reports and Presentations section.