On August 10, 2021 Fusion Pharmaceuticals Inc. (Nasdaq: FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, reported financial results for the second quarter ended June 30, 2021 and provided an update on clinical and corporate developments (Press release, Fusion Pharmaceuticals, AUG 10, 2021, View Source [SID1234586249]).

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"We are building a fully integrated radiopharmaceutical company based upon our platform, reflecting a diverse pipeline of targeted alpha therapies in development supported by manufacturing and supply chain expertise," said Chief Executive Officer John Valliant, Ph.D. "We expect to have three clinical programs employing differentiated radiopharmaceuticals underway by mid-next year. In addition to our ongoing Phase 1 study of FPI-1434, the investigational new drug application (IND) of FPI-1966 was recently cleared by the U.S. Food & Drug Administration (FDA), and we intend to submit an IND application for FPI-2059 in the first half of 2022. In parallel, we are quickly advancing programs under our partnership agreement with AstraZeneca and are planning for a combination study of FPI-1434 with KEYTRUDA (pembrolizumab)."

Dr. Valliant continued, "These programs, along with our work to build Fusion’s radiopharmaceutical manufacturing capabilities with a new facility, demonstrate the depth and versatility of our pipeline and the potential to use our expertise to create innovative treatments for a broad array of solid tumors with high unmet medical need."

Recent Highlights and Future Milestones

Corporate Updates

On July 28, Fusion announced the FDA cleared the Company’s Investigational New Drug (IND) application for FPI-1966. FPI-1966 is a targeted alpha therapy (TAT) designed to use vofatamab, a human monoclonal antibody, to target and deliver actinium-225 to tumor sites expressing fibroblast growth factor 3 (FGFR3), a protein that is overexpressed in multiple tumor types, particularly head and neck and bladder cancers. Fusion plans to initiate a Phase 1, non-randomized, open-label clinical trial in patients with solid tumors expressing FGFR3 intended to investigate safety, tolerability and pharmacokinetics and to establish the recommended Phase 2 dose. The Company anticipates initiating the Phase 1 study around the end of 2021 and reporting interim data from the first patient cohort around the end of 2022.
On June 14, Fusion announced the presentation of preliminary Phase 1 data from the single-dose portion of the study at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) Virtual Annual Meeting. Results from the first three patient cohorts (n=12) demonstrated a favorable safety profile for FPI-1434. No drug-related serious adverse events and/or dose limiting toxicity were reported in administered activity up to 40kBq/kg body weight and dosimetric results were within normal organ radiation tolerability limits.
On June 14, Fusion also announced preclinical data demonstrating synergistic efficacy against olaparib-resistant colorectal and radioresistant lung cancer xenografts when combining FPI-1434 with olaparib, and preclinical data showing that treatment with FPI-1434 in combination with immune checkpoint inhibitors resulted in complete tumor eradication.
On June 2, Fusion announced that the Company entered a 15-year lease agreement with Hamilton, Ontario-based McMaster University to build a 27,000 square foot current Good Manufacturing Practice (GMP) compliant radiopharmaceutical manufacturing facility. The facility, to be built by McMaster and equipped and validated by Fusion, will be designed to support manufacturing of the Company’s growing pipeline of targeted alpha therapies (TATs).
FPI-1434 Monotherapy

Fusion continues to advance the multi-dose portion of its Phase 1 study evaluating FPI-1434 in patients with advanced solid tumors. The dose-finding study is enrolling patients at sites in Canada, the United States and Australia.
Fusion anticipates reporting Phase 1 multi-dose safety and imaging data, and the recommended Phase 2 dose and schedule, in the first half of 2022.
FPI-1434 Combination Therapy

Fusion has evaluated FPI-1434 in preclinical studies in combination with approved checkpoint and DNA damage response inhibitors, including PARP inhibitors, and believes the synergies observed could expand the addressable patient populations for FPI-1434 and allow for potential use in earlier lines of treatment.
Fusion anticipates the initiation of a Phase 1 combination study with FPI-1434 and KEYTRUDA (pembrolizumab) to occur six to nine months following determination of the recommended Phase 2 dose of FPI-1434 monotherapy.
FPI-2059

FPI-2059 is a small molecule radioconjugate in development as a targeted alpha therapy for various solid tumors. The molecule targets neurotensin receptor 1 (NTSR1), a promising target for cancer treatment, that is overexpressed in multiple solid tumors. FPI-2059 combines Ipsen’s IPN-1087, which Fusion acquired in 2021, with actinium-225. Fusion anticipates submitting an IND application for FPI-2059 in the first half of 2022.
Second Quarter 2021 Financial Results

Cash and Investments: As of June 30, 2021, Fusion held cash, cash equivalents and investments of $260.5 million, compared to cash, cash equivalents and investments of $299.5 million as of December 31, 2020. Fusion expects its cash, cash equivalents and investments as of June 30, 2021 will enable the Company to fund its operations through the end of 2023.
Collaboration Revenue: For the second quarter of 2021, Fusion recorded $0.5 million of revenue under the AstraZeneca collaboration agreement.
R&D Expenses: Research and development expenses for the second quarter of 2021 were $21.1 million, compared to $3.3 million for the same period in 2020. The increase was primarily related to increased platform development and research activities, clinical activities related to the ongoing Phase 1 clinical trial of FPI-1434, asset purchase agreements and preclinical research and manufacturing costs.
G&A Expenses: General and administrative expenses for the second quarter of 2021 were $6.6 million, compared to $4.0 million for the same period in 2020. The increase was primarily related to personnel related costs, including salary, benefits and stock compensation due to hiring, as well as general corporate costs, including expenses for general corporate, director and officer insurance.
Net Loss: For the second quarter of 2021, Fusion reported a net loss of $26.9 million, or $0.63 per share, compared with a net loss of $44.7 million, or $18.91 per share, for the same period in 2020. On a non-GAAP basis, excluding a change in fair value of preferred share tranche right liability and warrant liability, net loss was $7.1 million for the second quarter of 2020.
Impact of COVID-19

While Fusion is progressing the multi-dosing portion of the Phase 1 clinical trial of FPI-1434, the Company has experienced material delays in patient recruitment and enrollment as a result of continued resourcing issues related to COVID-19 at trial sites.

Moreover, there remains uncertainty relating to the trajectory of the pandemic and whether it may cause further delays in patient study recruitment. The impact of related responses and disruptions caused by the COVID-19 pandemic may result in difficulties or delays in initiating, enrolling, conducting or completing the planned and ongoing trials and the incurrence of unforeseen costs as a result of disruptions in clinical supply or preclinical study or clinical trial delays. The continued impact of COVID-19 on results will largely depend on future developments, which are highly uncertain and cannot be predicted with confidence.

On August 10, 2021 Decibel Therapeutics (Nasdaq: DBTX), a clinical-stage biotechnology company dedicated to discovering and developing transformative treatments to restore and improve hearing and balance, reported financial results for the second quarter ended June 30, 2021 and provided a corporate update (Press release, Decibel Therapeutics, AUG 10, 2021, View Source [SID1234586248]).

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"The second quarter of 2021 has been a time of continued progress across the business as we gear up for meaningful milestones expected in 2022. We have several 2022 catalysts slated for our pipeline programs, including advancing our DB-OTO program into clinical development and the planned interim analysis from our human Phase 1b clinical trial of DB-020 for cisplatin-induced hearing loss," said Laurence Reid, Ph.D., Chief Executive Officer of Decibel. "We were pleased to welcome Dr. William H. Carson as Chairman of the Board of Directors and also announced several significant appointments to our Scientific Advisory Board, further bolstering our team of academic and industry experts. We look forward to working with these world-class experts as we work to pursue our goal of delivering novel therapies to patients with hearing loss and balance disorders."

Company Highlights:

Appointed New Chairman of Board of Directors: In June 2021, Decibel announced the appointment of William H. Carson, M.D., as Chairman of the Board of Directors.
Expanded Scientific Advisory Board: In May 2021, Decibel announced the appointment of several leading experts in gene therapy, cochlear development and molecular genetics to its Scientific Advisory Board (SAB). Appointees included Connie Cepko, Ph.D., Guangping Gao, Ph.D., Matthew Kelley, Ph.D., Glenn Pierce, M.D., Ph.D. and Dinah Sah, Ph.D.
Pipeline Progress

Gene Therapies for Congenital, Monogenic Hearing Loss

On Track to Achieve DB-OTO Key Milestones in 2022: Decibel expects to submit an investigational new drug application (IND) with the U.S. Food and Drug Administration (FDA) and/or a Clinical Trial Application (CTA) in Europe for DB-OTO and initiate a Phase 1/2 clinical trial of DB-OTO for pediatric patients with congenital hearing loss due to an otoferlin deficiency in 2022.
Preclinical Pipeline Continues to Progress: Decibel expects to announce the program target for its AAV.104 discovery program in patients with autosomal recessive hearing disorders in 2021.
Gene Therapies for Hair Cell Regeneration

On Track to Announce AAV.201 Program Target: Decibel continues to advance AAV.201, its gene therapy program for regeneration of hair cells in the vestibule for the treatment of bilateral vestibulopathy (BVP). Decibel plans to announce the program target for AAV.201 in 2022.
Otoprotection Therapeutic

On Track to Report Interim Results from Phase 1b Proof-of-Concept Trial of DB-020 for the Treatment of Cisplatin-Induced Hearing Loss: Decibel expects to report interim results from the ongoing Phase 1b clinical trial of DB-020 in patients with cisplatin-induced hearing loss in the first half of 2022.
Second Quarter 2021 Financial Results:

Cash Position: As of June 30, 2021, cash, cash equivalents and available-for-sale securities were $184.6 million, compared to $54.3 million as of December 31, 2020. The increase in cash, cash equivalents and available-for-sale securities was due to receipt of the proceeds from the issuance and sale of our Series D convertible preferred stock and from our initial public offering (IPO) in the first quarter of 2021.
Research and Development Expenses: Research and development expenses were $6.8 million for the second quarter of 2021, compared to $5.3 million for the second quarter of 2020. The increase in research and development expenses for the second quarter of 2021 was driven primarily by an increase in manufacturing costs related to toxicology studies of DB-OTO.
General and Administrative Expenses: General and administrative expenses were $4.9 million for the second quarter of 2021, compared to $2.6 million for the same period in 2020. The increase in general and administrative expenses for the second quarter of 2021 was primarily attributable to increases in professional fees, personnel costs and directors’ and officers’ insurance costs incurred as a result of becoming a public company.
Financial Guidance:

Based on its current operating and development plans, Decibel believes that its existing cash, cash equivalents and available-for-sale securities will fund its pipeline programs and operating expenses into 2024.

On August 10, 2021 Foghorn Therapeutics Inc. (Nasdaq: FHTX), a clinical stage biotechnology company pioneering a new class of medicines that modulate gene expression through selectively targeting the chromatin regulatory system, reported a corporate update in conjunction with the Company’s From 10-Q filing for the quarter ended June 30, 2021 (Press release, Foghorn Therapeutics, AUG 10, 2021, View Source [SID1234586247]). With an initial focus in oncology, Foghorn’s Gene Traffic Control Platform and resulting broad pipeline has the potential to transform the lives of people suffering from a wide spectrum of diseases.

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"We continue to make solid progress advancing our two first-in-class clinical programs to emerge from our proprietary Gene Traffic Control Platform," said Adrian Gottschalk, President and Chief Executive Officer. "We anticipate having initial phase I data of FHD-286, our selective, oral inhibitor of BRG1/BRM in metastatic uveal melanoma and relapsed or refractory AML and myelodysplastic syndromes (MDS), as early as the fourth quarter of 2021, and phase I data of FHD-609, our first protein degrader clinical candidate, for the treatment of synovial sarcoma as early as the first half of 2022."

Continued Mr. Gottschalk, "Beyond these two clinical programs, we continue to expand our robust pipeline of precision therapeutic candidates targeting different aspects of the chromatin regulatory system, including our protein degrader programs and platform, including FHD-609, our BRM-selective degrader, ARID1B protein degrader and other undisclosed programs."

Recent Corporate Highlights:

Dosed First Patient with FHD-286. In May 2021, Foghorn announced the dosing of the first patient in its first-in-human clinical trial of FHD-286, an inhibitor of BRG1/BRM, in metastatic uveal melanoma and relapsed or refractory AML and MDS, areas of high unmet medical need. This is Foghorn’s first drug candidate to enter the clinic and the first of a new class of therapeutics directly targeting the chromatin regulatory system. To learn more about these studies please visit ClinicalTrials.gov. (Link here for metastatic uveal melanoma and here for AML and MDS)
Received investigational new drug application (IND) clearance for FHD-609. Foghorn received FDA clearance of its IND application for FHD-609. FHD-609 is a highly potent, selective, intravenous, small molecule protein degrader of BRD9, initially being developed for the treatment of synovial sarcoma with the intention to expand into additional indications, including SMARCB1 deleted tumors. Sites for the phase 1 study have been initiated and are currently screening patients. To learn more about this study, please visit ClinicalTrials.gov.
BRM Selective Inhibitor Program Advanced to Lead Optimization. Data presented during Foghorn’s 2021 Research & Development Webinar demonstrated robust tumor growth inhibition with the Company’s BRM-selective inhibitor. The program has advanced into lead optimization with an IND planned for 2022.
Participation at AACR (Free AACR Whitepaper) 2021. In April 2021, Foghorn presented a poster titled "Discovery of novel BAF inhibitors for the treatment of transcription factor-driven cancers" (Link to poster here) and chaired a panel at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2021. Key highlights of the data presented included a novel series of compounds discovered and developed by Foghorn that potently and selectively inhibit the ATPase components of the BAF complex, BRG1 and BRM. These preclinical data provided the foundation for first-in-human studies of BAF ATPase inhibition as a novel therapeutic to treat uveal melanoma.
Appointed Ian Smith to Board of Directors. On April 27th, 2021, Foghorn appointed Ian Smith to its Board of Directors, adding a diverse skill set spanning decades as a proven biotechnology leader. The addition of Ian to the Board brings significant business development and capital formation expertise to Foghorn.
Held First Research and Development Day Webinar. On June 15th, 2021, Foghorn held its inaugural Research and Development Day Webinar showcasing presentations from key opinion leaders and the Foghorn management team highlighting the biological importance of the chromatin regulatory system in gene expression and human disease and its broad applicability in precision oncology. The replay can be accessed here.
Key Upcoming Milestones:

FHD-286 data. Foghorn expects initial data from the Company’s phase 1 studies of FHD-286 in both metastatic uveal melanoma and relapsed/refractory AML and MDS as early as the fourth quarter of 2021.
FHD-609 data. Foghorn expects initial data from the Company’s phase 1 study in synovial sarcoma as early as the first half of 2022.
Upcoming Events

The Wedbush PacGrow Healthcare Virtual Conference, panel discussion, "Bullseye – Targeted Oncology Part 2," Wednesday, August 11 at 10:20 a.m. ET. The webcast can be accessed here.
The Morgan Stanley Global Healthcare Conference, September 13-15, 2021.
Financial Condition

Foghorn reported cash, cash equivalents and marketable securities of $141.3 million as of June 30, 2021, as compared to $160.9 million as of March 31, 2021, and $185.8 million as of December 31, 2020.

On August 10, 2021 Galera Therapeutics, Inc. (Nasdaq: GRTX), a clinical-stage biopharmaceutical company focused on developing and commercializing a pipeline of novel, proprietary therapeutics that have the potential to transform radiotherapy in cancer, reported financial results for the second quarter ended June 30, 2021, and highlighted recent corporate accomplishments (Press release, Galera Therapeutics, AUG 10, 2021, View Source [SID1234586246]).

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"We had a highly productive quarter in the clinic, including completion of enrollment in our 455-patient pivotal Phase 3 ROMAN trial of our lead product candidate, avasopasem, for SOM in patients with head and neck cancer, promising tumor outcome and survival data in an interim analysis of our 42-patient pancreatic cancer trial, and initiation of our 160-patient double-blinded placebo-controlled GRECO-2 pancreatic cancer trial," said Mel Sorensen, M.D., President and CEO. "We look forward to reporting clinical trial results from our key programs later this year. In parallel, Galera continues to strengthen our cash position and build our commercial capabilities as we work toward potential FDA approval of avasopasem in radiotherapy-induced SOM."

Recent Corporate Highlights

Severe Oral Mucositis (SOM)

Completed enrollment in the pivotal Phase 3 ROMAN trial of avasopasem for SOM in patients with locally advanced head and neck cancer (HNC) undergoing standard-of-care radiotherapy, which triggered a $37.5 million milestone payment from funds managed by Blackstone Life Sciences (Blackstone) received in July 2021. The Company expects to report topline data in the fourth quarter of 2021.

The Company expects to report topline data from the Phase 2a EUSOM multi-center trial of avasopasem in Europe in patients with HNC undergoing standard-of-care radiotherapy in the fourth quarter of 2021.
Locally Advanced Pancreatic Cancer (LAPC)

Reported updated data from the placebo-controlled 42-patient trial of Galera’s dismutase mimetic in patients with LAPC who are undergoing stereotactic body radiation therapy (SBRT). The updated results include a minimum follow-up of six months on all 42 patients. As of the interim data analysis, median overall survival in the treatment arm (20.1 months) was nearly twice as long as observed in the placebo arm (10.9 months); and positive results were also observed in local tumor control, time to metastases and progression-free survival. The Company expects to report final results from the trial, with at least one year of follow-up on all patients, in the third quarter of 2021.

Initiated the 160-patient randomized, multicenter, placebo-controlled GRECO-2 trial of GC4711, Galera’s second dismutase mimetic product candidate, in combination with SBRT in patients with LAPC in May 2021, which triggered a $20 million milestone payment from Blackstone received in June 2021.
Non-Small Cell Lung Cancer (NSCLC)

Enrollment is ongoing in the Phase 1/2 GRECO-1 trial of GC4711 in combination with SBRT in patients with NSCLC. The Company expects to report initial data from this trial in the first half of 2022.
Esophagitis

Enrollment is ongoing in the Phase 2a AESOP trial of avasopasem evaluating its ability to reduce the incidence of esophagitis induced by radiotherapy in patients with lung cancer. The Company expects to report topline data in the first half of 2022.
Second Quarter 2021 Financial Highlights

Research and development expenses were $16.0 million in the second quarter of 2021, compared to $13.8 million for the same period in 2020. The increase was primarily attributable to avasopasem development costs due to increased clinical expenses, primarily related to the ROMAN trial, and an increase in manufacturing and regulatory activities.

General and administrative expenses were $5.1 million in the second quarter of 2021, compared to $3.9 million for the same period in 2020. The increase was primarily attributable to employee-related costs from increased headcount and share-based compensation expense, increased expenses related to pre-commercial activities for avasopasem, and increased insurance expense and professional fees.

Galera reported a net loss of $(22.4) million, or $(0.88) per share, for the second quarter of 2021, compared to a net loss of $(18.7) million, or $(0.75) per share, for the same period in 2020.

As of June 30, 2021, Galera had cash, cash equivalents and short-term investments of $66.5 million. Galera expects that its existing cash, cash equivalents and short-term investments, together with the payment from Blackstone in the amount of $37.5 million received in July 2021, will enable Galera to fund its operating expenses and capital expenditure requirements for at least the next twelve months.

On August 10, 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 its financial results for the quarter ended June 30, 2021 and provided a business update on its progress over the reporting period (Press release, Immatics, AUG 10, 2021, View Source [SID1234586245]).

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"An important development during the second quarter of 2021 was a significant increase in patient enrollment for our ACTengine programs," said Harpreet Singh, Ph.D., CEO of Immatics. "Following the positive initial results we provided in the first quarter, we now look forward to announcing more advanced data including safety, biological activity and the assessment of anti-tumor activity for a range of different cancer indications in the second half of 2021."

"In addition to the upcoming clinical data for our ACTengine trials, we are excited to move our second therapeutic modality towards the clinic," added Carsten Reinhardt, M.D., Ph.D., Chief Development Officer at Immatics. "We are encouraged by the entirety of the IMA401 data set, which following discussions with regulatory authorities puts us in a strong position to submit our IMA401 Clinical Trial Application during the fourth quarter of 2021. Our TCER pipeline is further strengthened by our second TCR Bispecifics program, IMA402, for which we recently presented preclinical proof-of-concept data."

Second Quarter 2021 and Subsequent Company Progress

Adoptive Cell Therapy Programs

ACTengine IMA200 series – Patient recruitment remains on track and the additional trial sites initiated in Europe and the US have supported the acceleration of recruitment. As of end of July, 27 patients have been treated in the IMA200 series. The first-in-human basket trials for IMA201, IMA202 and IMA203 include patients with recurrent and/or refractory solid cancers utilizing TCR-engineered T cells (TCR-T) directed against the cancer targets MAGEA4/A8, MAGEA1 and PRAME, respectively.
In March 2021, Immatics reported initial safety and biological data as well as data showing first clinical anti-tumor activity for 10 patients enrolled in these trials. Patients were treated at initial dose levels below one billion transduced cells, which was presumed to be sub-therapeutic as per data published from across the industry.
The next data update, which will cover safety, biological activity, and the assessment of anti-tumor activity across different cancer indications, including patients treated at higher dose levels (dose levels 2 and 3), will be provided by the company within the second half of 2021.

TCR Bispecifics Programs

IMA401 – Immatics has discussed the proposed clinical trial design for its first TCER program IMA401, as well as the preclinical data package covering safety and efficacy data in a scientific advisory meeting2 with the Paul-Ehrlich Institute, the German regulatory authority. The company also completed the first Good Manufacturing Practices (GMP) production batch delivering a high production yield. IMA401 remains on track for submission of a CTA in the fourth quarter of 2021 and patient recruitment will be initiated in the first half 2022.
IMA402 – The company presented preclinical proof-of-concept data on IMA402 at the 17th Annual PEGS Boston Protein Engineering and Cell Therapy Summit in May. IMA402 is directed against a peptide derived from the cancer target PRAME, a protein that is frequently expressed in many solid cancers, thereby supporting the program’s potential to address a broad range of cancer patients and indications. Data demonstrated tumor cell killing in vitro and complete regressions of established tumors in an in vivo tumor model. Immatics has selected a lead candidate for the clinical program and initiated manufacturing activities.
Corporate Development

As of July 1, 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., has joined the Board.
Friedrich von Bohlen und Halbach, Ph.D., was appointed as successor of Christof Hettich, L.L.D. Dr. von Bohlen und Halbach is Managing Partner and co-founder of dievini Hopp BioTech Holding, managing the investments of Dietmar Hopp and family.
Second Quarter 2021 Financial Results

Cash Position: Cash and cash equivalents as well as Other financial assets total €192.8 million ($229.1 million1) as of June 30, 2021, compared to €216.7 million ($257.5 million1) as of March 31, 2021.

Revenue: Total revenue, consisting of revenue from collaboration agreements, was €5.2 million ($6.2 million1) for the three months ended June 30, 2021, compared to €6.9 million ($8.2 million1) for the three months ended June 30, 2020.

Research and Development Expenses: R&D expenses were €20.3 million ($24.1 million1) for the three months ended June 30, 2021, compared to €16.5 million ($19.7 million1) for the three months ended June 30, 2020. The increase is mainly due to expanded clinical activities for the ACTengine IMA200 series, as well as GMP manufacturing for the TCER compound, IMA401.

General and Administrative Expenses: G&A expenses were €8.3 million ($9.9 million1) for the three months ended June 30, 2021, compared to €10.1 million ($12.0 million1) for the three months ended June 30, 2020. The decrease is mainly due to one-time expenses in connection with the listing of the Company in 2020.

Net Loss: Net loss was €23.8 million ($28.3 million1) for the three months ended June 30, 2021, compared to €21.3 million ($25.3 million1) for the three months ended June 30, 2020.

Upcoming Investor Conferences

BTIG Virtual Biotechnology Conference – August 9-10, 2021
Goldman Sachs London Biotech Symposium – September 7, 2021
Jefferies London Healthcare Conference – November 16-18, 2021

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

Full financial statements can be found in the current report on Form 6-K 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 June 30, 2021 (1 EUR = 1.1884 USD).

2 in Europe, equivalent to a pre-IND meeting at FDA.

About ACTengine IMA200 series
Each of the product candidates of the IMA200 series is based on Immatics’ proprietary ACTengine approach in which the patient’s own T cells are genetically engineered to express a novel, proprietary TCR directed against a defined cancer target. The modified T cells are then reinfused into the patient to attack the tumor, an approach also known as TCR-T. ACTengine programs IMA201, IMA202 and IMA203 are currently in clinical development for the treatment of solid tumor indications, both in the US and in Germany. All ACTengine product candidates can be rapidly manufactured utilizing a proprietary manufacturing process designed to enhance T cell engraftment and persistence in vivo.

The ACTengine T cell products are manufactured at the Evelyn H. Griffin Stem Cell Therapeutics Research Laboratory in collaboration with UTHealth and co-funded by the Cancer Prevention and Research Institute of Texas (CPRIT).

About TCER
Immatics’ TCER molecules are antibody-like "off-the-shelf" biologics that leverage the body’s immune system by redirecting and activating T cells towards cancer cells expressing a specific tumor target. To do so, the proprietary biologics are engineered to have two binding regions. The first region contains an affinity- and stability-improved TCR that binds specifically to the cancer target on the cell surface presented by a human leukocyte antigen (HLA) molecule. The second region is derived from an antibody domain that recruits endogenous T cells to the tumor to become activated. The design of the TCER molecules enables the activation of any T cell in the body to attack the tumor, regardless of the T cells’ intrinsic specificity. In addition, the TCER molecule has a Fc-part conferring stability, half-life extension and enhanced manufacturability.