Immatics Announces Full Year 2021 Financial Results and Corporate Update

On March 23, 2022 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, 2021 (Press release, Immatics, MAR 23, 2022, View Source [SID1234610736]).

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Harpreet Singh, Ph.D., CEO and Co-Founder of Immatics commented, "Over the course of 2021, Immatics has continued to deliver important milestones across both our clinical and preclinical portfolio. Our Phase 1a data presentation at SITC (Free SITC Whitepaper) demonstrated high initial objective response rates in solid cancer patients treated with our ACTengine IMA203 TCR-T candidate, and we have achieved preclinical proof-of-concept for our TCR Bispecific candidate, TCER IMA402 – both targeting PRAME, a target frequently expressed on multiple solid cancers. We have also expanded our collaboration with Bristol Myers Squibb to jointly develop our TCER IMA401 targeting MAGEA4 and MAGEA8 and we plan to initiate the first-in-man clinical trial of IMA401 in the first half of 2022. Together with the company’s strong cash position and further potential opportunities to create valuable partnerships based on our differentiated TCR-based platforms, we are very well positioned to deliver on all relevant upcoming value inflections points across our cell therapy and bispecifics portfolio."

1 Clinical Trial Application (CTA) approved, the equivalent of an Investigational New Drug (IND) application in Europe

2 All amounts translated using the exchange rate published by the European Central Bank in effect as of December 31, 2021 (1 EUR = 1.1326 USD)

Immatics Press Release March 23, 2022 1 | 10

Fourth Quarter 2021 and Subsequent Company Progress

Adoptive Cell Therapy Programs

·ACTengine IMA203 (PRAME) – Immatics provided an interim update on its most advanced Phase 1a TCR-T trial with IMA203 targeting PRAME in a late-breaking oral presentation by Dr. Martin Wermke, coordinating investigator of the trial, at the 36th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) in November 2021. Objective responses (confirmed and unconfirmed partial responses, RECIST 1.1) were observed in 8 out of 16 patients (50%), and 8 out of 13 patients (62%) who were treated at intermediate dose levels 2 and 3 in the dose escalation part of the trial. Objective responses were associated with tumor infiltration and peak T cell persistence in the blood. Treatment-emergent events were transient and manageable; no grade 3 or higher cytokine release syndrome or neurological toxicities were observed.

·Patient treatment in the Phase 1a study with IMA203 has been completed. Dose level 4 (up to 1.2 billion transduced T cells per m2) has been determined as the provisional Recommended Phase 2 Dose (RP2D). The next data read-out for IMA203 monotherapy is planned for 2H 2022.

·Based on these interim results, Immatics is expanding the IMA203 study to three Phase 1b dose expansion cohorts, each designed to evaluate the observed objective response rate, demonstrate durability of response and provide the basis for entering registration trials. Cohorts include IMA203 as monotherapy in focus indications, IMA203 in combination with an immune checkpoint inhibitor and IMA203CD8, a 2nd generation monotherapy where IMA203 is co-transduced with a CD8 co-receptor, thereby inducing anti-tumor activity of both CD4 and CD8 T cells. These three Phase 1b IMA203 expansion cohorts are being initiated in Q2 2022. An initial data read-out for the IMA203/immune checkpoint inhibitor combination therapy cohort and the IMA203CD8 cohort is planned for YE2022.

·ACTengine IMA201 (MAGEA4/8) and IMA202 (MAGEA1) – In November 2021, Immatics presented interim data on 12 heavily pre-treated patients that were treated with product candidates IMA201 and IMA202. 8 out of 12 patients (67%) showed disease control, and tumor shrinkage was observed in 6 patients (50%). All adverse events for IMA201 and IMA202 were transient and manageable with no dose-limiting toxicities observed. For IMA202, patient recruitment in the dose escalation part of the Phase 1 trial has been completed. For IMA201, dose escalation is ongoing.

·ACTengine IMA204 (COL6A3 exon 6) – IMA204 is a first-in-class TCR-T directed against COL6A3 exon 6, a novel tumor stroma target highly expressed in several solid cancers. IMA204 utilizes a next-generation CD8-independent TCR with full functionality in both CD4 and CD8 T cells. IND-enabling studies are nearing completion. Submission of the IND application for IMA204 is expected by the end of 2022.

Immatics Press Release March 23, 2022 2 | 10

TCR Bispecifics Programs

·TCER IMA401 (MAGEA4/8) – Immatics entered a global exclusive licensing deal with Bristol Myers Squibb for its most advanced TCER product candidate, IMA401. The agreement included an upfront payment of $150 million as well as up to $770 million in additional milestone payments plus tiered double-digit royalties on net product sales, and includes the retention of the option to co-fund U.S. development in return for further enhanced U.S. royalties. Both companies will collaborate to advance the program through clinical development with Immatics retaining a co-promotion option in the U.S. In preclinical proof-of-concept studies, IMA401 demonstrated anti-tumor activity with complete remissions in different in vivo tumor models including patient-derived xenograft models. A clinical trial application (CTA, the equivalent of an IND in Europe) for the IMA401 program was filed in November 2021 with the Paul-Ehrlich-Institute, the relevant German regulatory authority and approved in February 2022. Start of the Phase 1 clinical trial is planned for the first half of 2022.

·TCER IMA402 (PRAME) – Immatics presented data from its second TCER program IMA402 at the 17th Annual PEGS Boston Protein Engineering and Cell Therapy Summit in May 2021 demonstrating preclinical proof-of-concept for the program. IMA402 showed in vitro anti-tumor activity and consistent tumor regression including complete responses in an in vivo tumor model. Continuation of GMP process development and IND-enabling activities for IMA402 is anticipated in 2022. Manufacturing of the clinical batch is targeted for the second half of 2022 and initiation of the Phase 1 trial is planned in 2023.

Corporate Developments

Board of Directors Update

·In March 2022, Nancy Valente, M.D., was appointed to the Immatics’ Board of Directors and will be nominated for election at the Company’s Annual General Meeting in June 2022. Nancy Valente brings to Immatics over 20 years of experience in oncology and hematology drug development. In her last position at Genentech/Roche, she was Senior Vice President, Oncology Product Development, where she helped to build a diverse portfolio of new oncology therapies encompassing small molecules, antibodies, bispecific antibodies and antibody drug conjugates including Gazyva, Polivy, Hemlibra and Venclexta, a first-to-market BCL-2 inhibitor. Additional information about Nancy Valente and the other members of Immatics’ Board of Directors can be found on the Immatics website.

·In July 2021, Immatics adopted a one-tier structure for its Board of Directors. As part of this process, the company’s CEO Harpreet Singh, Ph.D., joined the Board.

·In June 2021, Friedrich von Bohlen und Halbach, Ph.D., Managing Director of dievini Hopp BioTech Holding GmbH & Co. KG was elected to Immatics’ Board of Directors. Dr. von Bohlen und Halbach replaced Christof Hettich, L.L.D., who stepped down from the Board of Directors after 15 years of valuable service to the company.

Immatics Press Release March 23, 2022 3 | 10

Full Year 2021 Financial Results

Cash Position: Cash and cash equivalents as well as other financial assets total €145.1 million ($164.3 million2) as of December 31, 2021 compared to €232.0 million ($262.7 million2) as of December 31, 2020. The decrease is mainly the result of financing of our ongoing research and development activities. This does not include $150 million cash received in February 2022 from the collaboration agreement signed with Bristol Myers Squibb in December 2021. Adding this upfront payment, the Company projects a cash runway into 2024.

Revenue: Total revenue, consisting of revenue from collaboration agreements, was €34.8 million ($39.4 million2) for the year ended December 31, 2021, compared to €31.3 million ($35.4 million2) for the year ended December 31, 2020.

Research and Development Expenses: R&D expenses were €87.6 million ($99.2 million2) for the year ended December 31, 2021, compared to €67.1 million ($76.0 million2) for the year ended December 31, 2020. The increase mainly resulted from higher costs associated with the advancement of the clinical and pre-IND pipeline of candidates.

General and Administrative Expenses: G&A expenses were €33.8 million ($38.3 million2) for the year ended December 31, 2021, compared to €34.2 million ($38.7 million2) for the year ended December 31, 2020.

Net Loss: Net loss was €93.3 million ($105.7 million2) for the year ended December 31, 2021, compared to €211.8 million ($239.9 million2) for the year ended December 31, 2020. The decrease mainly resulted from a one-time, non-cash expense in connection with the ARYA merger in 2020 of €152.8 million ($173.0 million2).

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.

Upcoming Investor Conferences

·Bank of America Healthcare Conference (in person) Las Vegas, NV – May 10-12, 2022

·Jefferies LLC Healthcare Conference (in-person) New York, NY – June 8-10, 2022

·Goldman Sachs Global Healthcare Conference, Rancho Palos Verdes, CA – June 14-16, 2022

·Jefferies LLC London Healthcare Conference, London, U.K. – November 15-17, 2022

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

2 All amounts translated using the exchange rate published by the European Central Bank in effect as of December 31, 2021 (1 EUR = 1.1326 USD).

Immatics Press Release March 23, 2022 4 | 10

PAVmed Subsidiary Lucid Diagnostics Launches Next Phase of Lucid Test Centers

On March 23, 2022 Lucid Diagnostics Inc. (Nasdaq: LUCD) ("Lucid"), a commercial-stage cancer prevention medical diagnostics company, and majority-owned subsidiary of PAVmed Inc. (Nasdaq: PAVM, PAVMZ) ("PAVmed"), reported that it has launched Lucid Test Centers in three new metropolitan areas—Seattle, Washington, Portland, Oregon, and Boise, Idaho. Patients in these cities with chronic heartburn, also known as gastroesophageal reflux disease ("GERD"), and an order from their own physician or from a telemedicine physician provided to them after self-referral, can now undergo a brief, non-invasive, office-based test to detect esophageal precancer before it progresses to deadly esophageal cancer (Press release, Lucid Diagnostics, MAR 23, 2022, View Source [SID1234610759]). The test centers are staffed with Lucid-employed nurse practitioners who use Lucid’s EsoCheck Cell Collection Device ("EsoCheck") to collect surface esophageal cells which are sent for Lucid’s EsoGuard DNA Esophageal Test ("EsoGuard"). Lucid believes EsoGuard and EsoCheck constitute the first and only commercially available test capable of serving as a widespread screening tool to prevent esophageal cancer deaths, through the early detection of esophageal precancer in at-risk GERD patients.

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"This launch represents another important milestone for Lucid and our EsoGuard commercialization efforts"

"This launch represents another important milestone for Lucid and our EsoGuard commercialization efforts," said Lishan Aklog, M.D., Lucid’s Chairman and Chief Executive Officer. "We now have completed the first stage of our Lucid Test Center program, an important pillar of our growth strategy—with test centers in seven metropolitan areas in the Southwest and Pacific Northwest".

"Our experience since the launch of our first test center in Phoenix, approximately six months ago, has validated our commercial strategy, which places a strong emphasis on driving primary care physician (PCP) orders for EsoGuard testing at Lucid Test Centers. During this period, we have honed our sales processes and training programs to drive this strategy. We are well positioned to proceed to the next stage of our Lucid Test Center program, with accelerated expansion into larger states across the nation. We have built a robust compliance program which allows us to proceed with this expansion, including in states with more complex laboratory regulations," Dr. Aklog added.

The new Lucid Test Centers operate in leased medical office suites located in Seattle, Washington, Portland, Oregon, and Boise, Idaho. Each test center is staffed by an EsoCheck-trained nurse practitioner and medical assistant employed by Lucid. Lucid estimates that a single nurse practitioner can perform up to twenty EsoCheck procedures per day and expects each center to cover its personnel and medical office leases costs with only a few tests per week. Each test center will initially be supported with two highly experienced sales representatives targeting PCPs. The test centers will also support Lucid’s EsoGuard Telemedicine Program, operated in partnership with independent third-party telemedicine provider, UpScript, to accommodate EsoGuard self-referrals.

About EsoGuard and EsoCheck

Millions of patients with GERD are at risk of developing esophageal precancer and a highly lethal form of esophageal cancer ("EAC"). Over 80% of EAC patients die within five years of diagnosis, making it the second most lethal cancer in the U.S. The mortality rate is high even in those diagnosed with early stage EAC. The U.S. incidence of EAC has increased 500% over the past four decades, while the incidences of other common cancers have declined or remained flat. In nearly all cases, EAC silently progresses until it manifests itself with new symptoms of advanced disease. All EAC is believed to arise from esophageal precancer, which occurs in approximately 5% to 15% of at-risk GERD patients. Early esophageal precancer can be monitored for progression to late esophageal precancer which can be cured with endoscopic esophageal ablation, reliably halting progression to cancer.

Esophageal precancer screening is already recommended by clinical practice guidelines in millions of GERD patients with multiple risk factors, including age over 50 years, male gender, White race, obesity, smoking history, and a family history of esophageal precancer or cancer. Unfortunately, fewer than 10% of those recommended for screening undergo traditional invasive endoscopic screening. The profound tragedy of an EAC diagnosis is that likely death could have been prevented if the at-risk GERD patient had been screened and then undergone surveillance and curative treatment.

The only missing element for a viable esophageal cancer prevention program has been the lack of a widespread screening tool that can detect esophageal precancer. Lucid believes EsoGuard and EsoCheck are the missing element and constitute the first and only commercially available test capable of serving as a widespread screening tool to prevent esophageal cancer deaths through the early detection of esophageal precancer in at-risk GERD patients.

EsoGuard is a bisulfite-converted NGS DNA assay performed on surface esophageal cells collected with EsoCheck which quantifies methylation at 31 sites on two genes, Vimentin (VIM) and Cyclin A1 (CCNA1). The assay was evaluated in a 408-patient, multicenter, case-control study published in Science Translational Medicine and showed greater than 90% sensitivity and specificity at detecting esophageal precancer and cancer.

EsoCheck is an FDA 510(k) and CE Mark cleared noninvasive swallowable balloon capsule catheter device capable of sampling surface esophageal cells in a less than five-minute office procedure. It consists of a vitamin pill-sized rigid plastic capsule tethered to a thin silicone catheter from which a soft silicone balloon with textured ridges emerges to gently swab surface esophageal cells. When vacuum suction is applied, the balloon and sampled cells are pulled into the capsule, protecting them from contamination and dilution by cells outside of the targeted region during device withdrawal. Lucid believes this proprietary Collect+Protect technology makes EsoCheck the only noninvasive esophageal cell collection device capable of such anatomically targeted and protected sampling. The sample is sent by overnight express mail to Lucid’s third-party CLIA-certified laboratory partner for EsoGuard testing.

XNK Therapeutics Reports First Patient Treated in Phase II Study in Multiple Myeloma

On March 23, 2022 XNK Therapeutics AB ("XNK") reported that the first patient has been treated in a Phase II clinical study using XNK’s leading autologous natural killer (NK) cell-based candidate drug in combination with Sanofi’s anti-CD38 antibody Sarclisa (Isatuximab) (Press release, XNK Therapeutics, MAR 23, 2022, View Source [SID1234610775]).

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"Having the first patient treated with NK cells in this clinical study is an important milestone in the clinical development of our leading drug candidate," said Johan Aschan, CMO of XNK Therapeutics. "The study is progressing well, and we look forward to the results."

The present investigator-initiated, open, randomized, controlled, Phase II study ISA-HC-NK (EudraCT: 2020-000994-26) compares XNK’s leading candidate drug combined with Sanofi’s anti-CD38 antibody Isatuximab with Isatuximab alone as a consolidation treatment following autologous stem cell transplantation in patients with newly diagnosed multiple myeloma. The clinical study takes place at the Karolinska University Hospital at its Huddinge site and encompasses at total of 60 patients with 30 patients in each treatment arm.

Inhibikase Therapeutics to Participate in the Maxim Group 2022 Virtual Growth Conference

On March 23, 2022 Inhibikase Therapeutics, Inc. (Nasdaq: IKT) (Inhibikase), a clinical-stage pharmaceutical company developing therapeutics to modify the course of Parkinson’s disease and related disorders, reported that Dr. Milton Werner, Ph.D., the Company’s President & Chief Executive Officer will present in the Maxim Group 2022 Virtual Growth Conference, being held from March 28th through 30th (Press release, Inhibikase Therapeutics, MAR 23, 2022, View Source [SID1234610678]).

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The presentation will be available for on-demand viewing starting at 9:00am ET on Monday, March 28, 2022, and may be accessed under "News & Events" in the Investors section of the Company’s website, www.inhibikase.com.

CDH17 CAR T Preclinical Data featured as cover story for prestigious journal Nature Cancer

On March 23, 2022 Chimeric Therapeutics (ASX:CHM, "Chimeric"), a clinical-stage cell therapy company and an Australian leader in cell therapy, reported that the discovery and preclinical characterization of a CAR T targeting CDH17, currently under development by Chimeric as CHM 2101 has been published as the cover story for the highly prestigious journal Nature Cancer (Press release, Chimeric Therapeutics, MAR 23, 2022, View Source [SID1234610740]).

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Key findings highlighted in the Nature Cancer publication included:

• Strong preclinical safety and efficacy: the CDH17 CAR T completely eradicated tumours, with no relapse or toxicity, in 8 different in vivo models including colorectal cancer (CRC), gastric cancer, pancreatic cancer, and neuroendocrine tumours (NETs).
• Optimal CAR T construct design: the CDH17 CAR T as a third-generation CAR T cell construct was shown to be superior to the 2nd-generation CAR T cell construct, demonstrating complete elimination of solid tumours in vivo. Construct optimization with a very short linker domain further enhanced tumour cell killing.
• Tumour-specific activity: CDH17 CAR T cells infiltrated and destroyed CDH17+ tumours, but not normal CDH17-expressing tissues such as small and large intestines, creating a therapeutic window for CAR T treatment of solid tumours.

The authors conclude that their "findings indicate that CDH17 is an ideal target of CART therapy for GICs (Gastrointestinal Cancers) and NETs (Neuroendocrine Tumours)" and that their studies "suggest that CDH17 is a safe and efficacious target for developing CART therapy to treat GICs and NETs, without toxicity to healthy tissues, motivating further clinical investigation."1

The Nature Portfolio publishes a range of academic journals, magazines and online databases covering science and medicine, and is known to publish some of the world’s most highly prestigious scientific journals. The Nature Cancer journal ‘aims to publish the most significant advances across the full spectrum of cancer research in the life, physical, applied and social sciences, spanning basic preclinical, translational and clinical work’. In July 2021, Chimeric acquired the exclusive rights to develop and commercialize CDH17 (CHM 2101), and in February 2022 announced its commitment to a three-year sponsored research program with the inventors to further the development and understanding of CHM 2101.

"The data published in Nature Cancer are rigorous, scientifically elegant, and suggest great promise for CHM 2101 as a potential CAR T-cell therapy for solid tumours," said Eliot Bourk, Ph.D., Chimeric’s Chief Business Officer and Head of External Innovation. "The optimized construct targeting CDH17 presents a novel and highly differentiated approach to overcoming the challenges observed to date with T-cell therapies in solid tumours."

"We are now rapidly advancing CHM 2101 toward first-in-human clinical studies, with the hope of bringing the promise of cell therapy to life for patients with currently incurable GI cancers," said Chimeric CEO and Managing Director, Jennifer Chow. 1. Feng et al. Nature Cancer, 2022. View Source Authorised on behalf of the Chimeric Therapeutics board of directors by Chairman Paul Hopper