On August 9, 2022 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, 2022 and provided an update on clinical and corporate developments (Press release, Fusion Pharmaceuticals, AUG 9, 2022, View Source [SID1234617877]).

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Chief Executive Officer John Valliant, Ph.D. commented, "We are pleased with the recent FDA clearance of our FPI-2059 investigational new drug (IND) application and the initiation of the Phase 1 clinical study demonstrating our ability to progress into the clinic targeted alpha therapies based on various targeting molecules. The FPI-2059 small molecule targeting NTSR1 has the potential to address several solid tumor indications, including neuroendocrine differentiated prostate, colorectal and pancreatic cancers, for which there is substantial unmet clinical need. Further, we are encouraged by the imaging data we presented at the SNMMI 2022 Annual Meeting that showed pre-administration of cold antibody with FPI-1434 increased tumor binding with a good safety profile."

Dr. Valliant continued, "With three clinical programs and our multi-program partnership with AstraZeneca, we are committed to building a fully integrated radiopharmaceutical organization, marked most recently by our actinium-225 collaboration and supply agreement with Niowave. The agreement provides access to a pre-determined percentage of Niowave’s capacity, access to any excess supply, and the option to invest in future production facilities. This agreement, together with our collaborations with TRIUMF and the Department of Energy, extend our leadership position in actinium supply and meet the needs of our growing pipeline."

Portfolio Update

FPI-1434

In the Phase 1 study, Fusion is exploring various dose levels of FPI-1434 as well as two dosing regimens: one with FPI-1434 alone, and another in which a small dose of cold antibody (naked IGF-1R antibody without the isotope) is administered prior to each dose of FPI-1434. The Company anticipates reporting Phase 1 safety, pharmacokinetics, and imaging data, including any evidence of anti-tumor activity, and details on the dosing regimen, in the first half of 2023. Fusion continues to anticipate 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-1966

The Phase 1, non-randomized, open-label clinical trial of FPI-1966 in patients with solid tumors expressing FGFR3, intended to investigate safety, tolerability and pharmacokinetics and to establish the recommended Phase 2 dose, has been initiated. Fusion expects to dose the first patient in the second half of 2022 and plans to provide updated guidance for preliminary pharmacokinetic, imaging and safety data from the first patient cohort following initial experience with patient screening in order to better predict the cadence of patient enrollment.

FPI-2059

FPI-2059 is a small molecule radioconjugate in development as a targeted alpha therapy for various solid tumors, including neuroendocrine differentiated (NED) prostate, colorectal, and pancreatic cancers. The molecule targets neurotensin receptor 1 (NTSR1), a promising target for cancer treatment, which is overexpressed in several solid tumors. FPI-2059 is based upon Ipsen’s IPN-1087 (previously studied in a Phase 1 clinical trial as a beta-emitting radiopharmaceutical), which Fusion acquired in 2021, and converted to an alpha-emitting radiopharmaceutical using actinium-225.

The U.S. Food and Drug Administration (FDA) cleared Fusion’s IND application for FPI-2059 in June 2022 and study initiation activities are ongoing in a Phase 1, non-randomized, open-label clinical trial in patients with solid tumors expressing NTSR1, intended to investigate safety, tolerability and pharmacokinetics and to establish the recommended Phase 2 dose. Fusion plans to provide guidance on timelines for the FPI-2059 program following site activations and initial experience with patient screening and patient enrollment.

Recent Updates

In June, Fusion presented imaging data from the cold antibody sub-study in the Phase 1 study of FPI-1434 at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) 2022 Annual Meeting. Imaging data from the study demonstrate a favorable gain in [111In]-FPI-1547, the investigational imaging agent, tumor lesion uptake versus normal tissue when FPI-1175, the naked antibody without the isotope, was pre-administered and compared to dosing with FPI-1547 alone. Importantly, sites of improved tumor lesion uptake were independent of anatomic location of disease and included bone, lung, liver, and lymph nodes. Administration of FPI-1547 with and without pre-administration of FPI-1175 was safe without any drug-related Serious Adverse Events or Dose Limiting Toxicities.
In June, Fusion and Niowave, Inc. announced an agreement for the development, production, and supply of actinium-225. Fusion will invest up to $5 million in Niowave to further develop their technology to increase current production capacity of actinium-225, and in return Fusion will have guaranteed access to a pre-determined percentage of Niowave’s capacity of the resulting actinium-225, as well as preferred access to any excess supply produced. As part of the agreement, Fusion will also have an option to invest in future production of actinium-225 to scale with Fusion’s needs.
Second Quarter 2022 Financial Results

Cash and Investments: As of June 30, 2022, Fusion held cash, cash equivalents and investments of $198.4 million, compared to cash, cash equivalents and investments of $220.8 million as of December 31, 2021. Fusion expects its existing cash, cash equivalents and investments as of June 30, 2022, will be sufficient to fund operations into the first quarter of 2024.
Collaboration Revenue: For the second quarter of 2022, Fusion recorded $0.6 million of revenue under the AstraZeneca collaboration agreement.
R&D Expenses: Research and development expenses for the second quarter of 2022 were $12.1 million, compared to $21.1 million for the same period in 2021. The decrease was primarily due to a decrease in platform development and unallocated research and development costs driven by discrete items that occurred during the second quarter of 2021, including common share issuances pursuant to our asset purchase agreements with Ipsen and Rainier Therapeutics, and payments made under our agreement with CPDC for services relating to the validation of Fusion’s manufacturing facility currently under construction which resulted in the recognition of research and development expense during that quarter.
G&A Expenses: General and administrative expenses for the second quarter of 2022 were $7.8 million, compared to $6.6 million for the same period in 2021. The increase was primarily due to an increase in personnel-related costs, corporate costs and professional fees.
Net Loss: For the second quarter of 2022, Fusion reported a net loss of $19.1 million, or $0.44 per share, compared with a net loss of $26.9 million, or $0.63 per share, for the same period in 2021.
Impact of COVID-19

Fusion is experiencing material delays in patient recruitment, enrollment and study site initiations as a result of continued resourcing issues related to COVID-19 at trial sites.

There also remains uncertainty relating to the trajectory of the pandemic, hospital staffing and resource issues, and whether they may cause further delays in patient study recruitment. The impact of related responses and disruptions caused by the COVID-19 pandemic may result in further 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 9, 2022 Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a precision oncology medicine company pioneering the discovery and development of MasterKey therapies, reported financial results for the second quarter ended June 30, 2022 and provided a corporate update (Press release, Black Diamond Therapeutics, AUG 9, 2022, View Source [SID1234617876]).

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"Black Diamond is well positioned for strong clinical and discovery execution with clear scientific and operational strategies laid out across our business. We are excited to have our newly appointed Chief Medical Officer, Dr. Sergey Yurasov, on board as we continue to progress our Phase 1 global study of BDTX-1535, with the goal of sharing a clinical update in 2023," said David Epstein, Ph.D., President and Chief Executive Officer of Black Diamond Therapeutics. "Our precision medicine approach to cancer treatment centers on our proprietary ability to identify drug families of oncogenic mutations. Our recent publication in the American Association for Cancer Research (AACR) (Free AACR Whitepaper)’s journal demonstrates this by revealing previously overlooked oncogenic mutations in HER2. This is a clear example of our Mutation-Allostery-Pharmacology (MAP) discovery engine at work, supporting the value of oncogenicity prediction, biological validation, protein conformation-based drug design and MasterKey inhibitor development against mutation families. There remains an unmet need for patients with genetically defined cancers and we believe that these key facets of our scientific approach have the potential to bolster the current precision cancer medicine landscape."

Recent Developments

BDTX-1535:

BDTX-1535 is designed to be a potent, selective, irreversible and brain-penetrant MasterKey inhibitor of epidermal growth factor receptor (EGFR) mutations expressed in glioblastoma multiforme (GBM) and resistance mutations in non-small cell lung cancer (NSCLC), including de novo resistance and acquired resistance to third generation EGFR inhibitors.
In April 2022, the first patient was dosed in the Phase 1 study of BDTX-1535 and the Company expects to provide a clinical update on BDTX-1535 in 2023.
BDTX-4933:

BDTX-4933 is designed to be a brain-penetrant BRAF inhibitor against families of Class I, II, and III canonical and non-canonical mutations being developed for the treatment of patients with or without brain tumors. BDTX-4933 is also designed to be highly selective and potent, with the ability to avoid paradoxical activation.
Black Diamond expects to submit an investigational new drug (IND) application for BDTX-4933 with the U.S. Food and Drug Administration (FDA) in the first half of 2023.
Discovery-Stage Pipeline and MAP Discovery Engine:

In May 2022, Black Diamond announced the publication of new computational and functional analyses, identifying 22 new oncogenic human epidermal growth factor receptor 2 (HER2) allosteric mutations that support the Mutation-Allostery-Pharmacology (MAP) discovery engine’s capabilities. The paper, titled, "Computational and Functional Analyses of HER2 Mutations Revealing Allosteric Activation Mechanisms and Altered Pharmacologic Effects" by Ishiyama et al. was published online by the American Association for Cancer Research (AACR) (Free AACR Whitepaper)’s Cancer Research Journal.
Black Diamond continues to leverage its MAP drug discovery engine to advance its discovery-stage pipeline and anticipates progressing its fibroblast growth factor receptor (FGFR) program towards development candidate nomination in 2022, in addition to disclosing a development candidate against a new target in 2023.
Corporate:

In June 2022, Black Diamond appointed Sergey Yurasov, M.D., Ph.D., as its Chief Medical Officer, bringing over 25 years of oncology drug development experience and regulatory expertise. Dr. Yurasov joined Black Diamond from Nuvation Bio, where he served as Chief Medical Officer and spearheaded multiple clinical development programs for oncology indications and small molecule programs.
Financial Highlights

Cash Position: Black Diamond ended the second quarter of 2022 with approximately $160.9 million in cash, cash equivalents, and investments compared to $209.8 million as of December 31, 2021. Net cash used in operations was $18.1 million for the second quarter of 2022 compared to $25.2 million for the second quarter of 2021.
Research and Development Expenses: Research and development (R&D) expenses were $16.2 million for the second quarter of 2022 compared to $26.7 million for the second quarter of 2021. The decrease in R&D expenses was primarily due to reduced activities on the BDTX-189 program and reduced spending on early discovery projects.
General and Administrative Expenses: General and administrative (G&A) expenses were $7.0 million for the second quarter of 2022, compared to $8.0 million for the second quarter of 2021.
Net Loss: Net loss for the second quarter of 2022 was $22.9 million, as compared to $34.4 million for the same period in 2021.
Financial Guidance

Following the Company’s pipeline prioritization and workforce realignment announcement in April 2022, Black Diamond has extended its cash runway, which is expected to be sufficient to fund its anticipated operating expenses and expenditure requirements into the third quarter of 2024.

On August 9, 2022 BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a commercial-stage biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncology, reported its financial results for the second quarter ended June 30, 2022 and provided an update on key strategic initiatives (Press release, BioXcel Therapeutics, AUG 9, 2022, View Source [SID1234617875]).

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"BioXcel Therapeutics made tremendous progress in its journey to becoming a fully integrated AI-driven commercial-stage company with the potential to transform the agitation treatment landscape," said Vimal Mehta, Ph.D., CEO of BioXcel Therapeutics. "This transformation is being driven by the continued execution of our land and expand strategy within our neuroscience franchise. We are focused on the commercial launch for our recently FDA approved drug IGALMI while significantly increasing the opportunity for BXCL501 through at-home, medical setting expansion and the pursuit of multiple additional indications for our BXCL501 franchise. We believe we are well-positioned and have laid a strong foundation to drive long-term sustainable growth."

Company Highlights

Neuroscience Franchise

IGALMI (dexmedetomidine) sublingual film

IGALMI was approved by the U.S. Food and Drug Administration (FDA) on April 5, 2022 for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults.2 Within these two patient populations in the U.S., up to 25 million agitation episodes occur each year.3-5

Trade and Market Access: Key focus on unlocking access and supporting unencumbered demand generation for IGALMI.
IGALMI made available in 120mcg and 180mcg doses through the Company’s third-party logistics provider and for order through wholesalers as of early July.
Engagement underway with 59 high-value Integrated Delivery Networks (IDNs) and their affiliated hospitals.
Discussions and negotiations ongoing with major national Group Purchasing Organizations (GPOs), representing over 90% of beds in target hospitals.
Institutional Sales Force: Deployed first phase of our national sales force to target high-priority accounts in late May, with expansion of commercial footprint in process. Engaging multiple stakeholders in target hospitals and progressing P&T formulary review discussions. Gathered field level market intelligence which further reinforces and augments current and future commercial strategy.
Early response to the IGALMI value proposition exceeding expectations across full spectrum of institutional and healthcare stakeholders.
Market dynamics are rapidly evolving, favoring a less invasive and voluntary approach to treating agitation.
Marketing: Strategic marketing focused on branded campaigns to support sales force activities.
Peer-to-peer speaker programs educating healthcare providers (HCPs) of the importance of early intervention to mitigate agitation episodes.
Digital marketing efforts driving significant engagement resulting in over 100,000 visits to IGALMI HCP website.
Investigating Potential Expansion of BXCL501 for At-Home Use for Agitation Associated with Bipolar Disorders and Schizophrenia: Planning SERENITY III double-blinded, placebo-controlled, pivotal study designed to evaluate BXCL501 60mcg dose for at-home use. This strategic trial decision follows successful completion of Type B meeting with FDA and observed dose-dependent responses in a prior Phase 1/2b study assessing 60mcg, 80mcg, 120mcg, and 180mcg doses. Of the approximately 25 million agitation episodes that occur in the U.S. each year related to schizophrenia and bipolar disorders, approximately one-third occur outside of the institutional setting.6
SERENITY III will consist of two parts:

First part of SERENITY III is similar to the SERENITY I and II pivotal trials and designed to assess efficacy and safety in acutely agitated bipolar and schizophrenia patients.
Primary efficacy endpoint is change from baseline in Positive and Negative Syndrome Scale-Excitatory Component (PEC) total score at two hours after dosing compared to placebo.
Second part of SERENITY III designed to assess safety compared to placebo when self-administered at home.
SERENITY III will utilize many of the same investigators and clinical sites as SERENITY I and II and is expected to initiate in 2H 2022.

Clinical Pipeline

BXCL501, a proprietary, sublingual film formulation of dexmedetomidine, has received Breakthrough Therapy and Fast Track designation for the acute treatment of agitation associated with dementia.

Indication Expansion

Alzheimer’s Disease-related Agitation: TRANQUILITY program is designed to capture Alzheimer’s-related agitation market opportunity. There are an estimated 100 million agitation episodes in Alzheimer’s patients occurring in the U.S. annually.7
TRANQUILITY II: top-line data readout expected in 1H 2023.
TRANQUILITY III: enrollment expected to begin in 2H 2022.
Adjunctive Treatment for Major Depressive Disorder (MDD): Ongoing Phase 1 trial evaluating BXCL501 daily dosing designed to inform dose selection in future proof-of-concept study evaluating daily BXCL501 dosing in MDD patients. Over 300 million antidepressant prescriptions are filled annually in the U.S. and current treatments are limited by slow onsets of action and incomplete responses.8
Double-blind, placebo-controlled, multiple ascending dose (MAD) selection trial in healthy volunteers includes two cohorts of 18 patients, each having completed seven days of daily dosing of 30mcg or 60mcg compared to placebo.
Dose escalation in current cohort also enrolling to evaluate 80mcg.
Additional cohorts planned to evaluate safety and assess tolerability of a range of doses administered once daily and twice daily.
Top-line results expected in 1H 2023.
OnkosXcel Therapeutics

Established a wholly owned subsidiary to focus on the sustained expansion and optimization of the Company’s immuno-oncology (I-O) franchise, including its most advanced I-O program, BXCL701. BXCL701 is an investigational orally administered, systemic innate immune activator in development for the treatment of aggressive forms of prostate cancer.

Strategic Advancements: Fully functioning subsidiary dedicated to executing focused strategy and developing innovative oncology pipeline. Evaluating strategic options, which may include third party investments, aimed to fully capture unique value creation opportunity in areas of high unmet medical need.

Metastatic Castration-Resistant Prostate Cancer (mCRPC) Program: Continued ongoing Phase 2 trial for BXCL701 in combination with KEYTRUDA (pembrolizumab) in mCRPC patients with small cell neuroendocrine carcinoma (SCNC) or adenocarcinoma phenotype.
Expect to complete enrollment of 28-patient SCNC cohort in 2H 2022.
Continued enrollment in adenocarcinoma randomized trial expansion evaluating BXCL701 monotherapy vs. BXCL701-KEYTRUDA combination therapy.
Corporate Updates

Strengthened Board of Directors: Appointed Michael P. Miller to the Company’s Board of Directors, to provide strategic leadership and commercial growth expertise.
Enhanced Intellectual Property: Received two Notices of Allowance for patents (issued from patent application numbers 17/560,392 and 17/560,423) related to IGALMI to cover film formulations containing dexmedetomidine and methods of treating agitation using the films.
Second Quarter 2022 Financial Results

Research and Development Expenses: Research and development expenses were $17.9 million for the second quarter of 2022, compared to $13.5 million for the same period in 2021. The increased expenses were primarily attributable to clinical trial costs related to the Company’s TRANQUILITY program.

Selling, General and Administrative Expenses: Selling, general and administrative expenses were $18.4 million for the second quarter of 2022, as compared to $14.1 million for the same period in 2021. The increase was primarily due to personnel and costs related to the launch of IGALMI in the U.S.

Net Loss: BioXcel Therapeutics reported a net loss of $37.7 million for the second quarter of 2022, compared to a net loss of $27.6 million for the same period in 2021.

As of June 30, 2022, cash and cash equivalents totaled approximately $233.5 million. This excludes $30 million of contributions from the $260 million strategic financing announced in April. To date the Company has met the milestones and has received $100 million from the agreement.

Conference Call

BioXcel Therapeutics will host a conference call and webcast August 9, 2022, at 8:30 a.m., ET, to discuss its second quarter 2022 financial results and provide an update on recent operational highlights. To access the call, please dial 877-407-5795 (domestic) and 201-689-8722 (international). A live webcast of the call will be available on the Investors section of the BioXcel website, www.bioxceltherapeutics.com, and a replay of the call will be available through November 9, 2022.

BioXcel Therapeutics may use its website as a distribution channel of material information about the Company. Financial and other important information regarding the Company is routinely posted on and accessible through the Investors sections of its website at www.bioxceltherapeutics.com. In addition, you may automatically receive email alerts and other information about the Company when you enroll your email address by visiting the "Email Alerts" option under the News/Events menu of the Investors & Media section of its website.

About TRANQUILITY II and III
Initiated in December of 2021, TRANQUILITY II and III are pivotal Phase 3 trials evaluating BXCL501 for the acute treatment of agitation in patients with probable Alzheimer’s disease (AD). The trials expand the evaluation of patients who experience agitation across diverse medical settings and across the range of dementia severity. TRANQUILITY II and III are designed to maximize the opportunity of BXCL501 for the potential treatment of the full spectrum of agitation associated with AD. Each trial will enroll approximately 150 dementia patients 65 years and older who will self-administer 40 mcg or 60 mcg of BXCL501 or placebo whenever agitation episodes occur over a three-month period. TRANQUILITY II will assess patients in assisted living or residential facilities requiring minimal assistance with activities of daily living. TRANQUILITY III will assess patients residing in nursing homes with moderate to severe dementia and require moderate or greater assistance with activities of daily living. The studies will assess agitation as measured by the changes from baseline in the Positive and Negative Syndrome Scale-Excitatory Component (PEC) and Pittsburgh Agitation Scale (PAS) total scores. The primary efficacy endpoint for both studies is change in PEC score from baseline measured at two hours after the initial dose and subsequent doses.

On August 9, 2022 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, 2022 and provided recent corporate updates (Press release, Galera Therapeutics, AUG 9, 2022, View Source [SID1234617874]).

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"During this past quarter, we made substantial progress in advancing our product candidates, avasopasem and rucosopasem, across all programs," said Mel Sorensen, M.D., Galera’s President and CEO. "We continue to prepare for submission of an NDA for avasopasem for the treatment of radiotherapy-induced SOM and are on track to submit it by the end of the year. Further, data from our Phase 3 ROMAN trial were presented at multiple prestigious medical conferences, including ASCO (Free ASCO Whitepaper), underscoring the significant unmet need for an FDA-approved treatment option for radiotherapy-induced SOM in patients with head and neck cancer. In addition, we recently announced data from the open-label Phase 1 stage of GRECO-1 investigating rucosopasem in combination with SBRT in patients with NSCLC and are pleased to report that rucosopasem seems to exhibit a favorable benefit-risk profile, with in-field partial responses or stable disease seen in six of the seven patients at six months follow-up."

Recent Corporate Updates

Radiotherapy-Induced Toxicity Programs:

Severe Oral Mucositis (SOM)

The Company remains on track to submit a New Drug Application (NDA) for avasopasem for the treatment of radiotherapy-induced SOM to the U.S. Food and Drug Administration (FDA) by the end of 2022.

An oral presentation on Phase 3 ROMAN data of avasopasem for SOM was given at the 2022 ASCO (Free ASCO Whitepaper) Annual Meeting. Avasopasem produced a clinically meaningful reduction in patients’ SOM burden across multiple endpoints, with statistically significant reductions on the primary endpoint of incidence of SOM and the secondary endpoint of number of days of SOM, more than halving the median number of days a patient suffered SOM. Avasopasem also appeared to be well tolerated compared to placebo.

Data from the Phase 3 ROMAN trial of avasopasem for SOM was presented at the Multinational Association of Supportive Care in Cancer (MASCC)/International Society for Oral Oncology (ISOO) Annual Meeting in June 2022.
Esophagitis

The Company reported positive topline data from the open-label, single-arm Phase 2a AESOP trial of avasopasem for the treatment of severe acute radiation-induced esophagitis in patients with lung cancer receiving concurrent chemoradiotherapy. Overall, avasopasem was well tolerated and the incidence of Grade 3 esophagitis was substantially reduced in comparison to expectations based on review of historical data in the literature. No patients experienced Grade 4 or 5 esophagitis at any point during the trial.
Anti-Cancer Programs:

Locally Advanced Pancreatic Cancer (LAPC)

A Trials in Progress poster on the Phase 2b GRECO-2 trial was presented at the 2022 ASCO (Free ASCO Whitepaper) Annual Meeting.

Enrollment is ongoing in the Phase 2b GRECO-2 trial of rucosopasem in combination with SBRT in patients with LAPC. The primary endpoint of the trial is overall survival. Completion of enrollment is expected in the second half of 2023.
Non-Small Cell Lung Cancer (NSCLC)

The Company recently reported results from the open-label, seven-patient Phase 1 stage of the GRECO-1 trial of rucosopasem in combination with SBRT in patients with NSCLC. Through six months follow-up, in-field partial responses were observed in three patients and stable disease was observed in three others based on RECIST criteria. These include target tumor reductions in five patients of 61%, 58%, 33%, 29% and 27% and one patient with an 8% increase. Preservation of pulmonary lung function was also observed in comparison to expectations based on review of historical data in the literature. Completion of enrollment in the randomized, placebo-controlled Phase 2 stage of this trial is expected in the second half of 2023.
Second Quarter 2022 Financial Highlights

Research and development expenses were $6.7 million in the second quarter of 2022, compared to $16.0 million for the same period in 2021. The decrease was primarily attributable to a decrease in avasopasem development costs, partially offset by an increase in rucosopasem development costs.

General and administrative expenses were $5.3 million in the second quarter of 2022, broadly consistent with the second quarter of 2021.

Galera reported a net loss of $(14.6) million, or $(0.54) per share, for the second quarter of 2022, compared to a net loss of $(22.4) million, or $(0.88) per share, for the same period in 2021.

As of June 30, 2022, Galera had cash, cash equivalents and short-term investments of $52.0 million. Galera expects that its existing cash, cash equivalents and short-term investments will enable Galera to fund its operating expenses and capital expenditure requirements for at least the next twelve months.

On August 9, 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 and provided a business update for the quarter ended June 30, 2022 (Press release, Immatics, AUG 9, 2022, View Source [SID1234617873]).

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"Immatics has now initiated all three IMA203 TCR-T Phase 1b expansion cohorts with the objective to deliver durable objective responses in heavily pre-treated solid cancer patients. Our IMA203 TCR-T therapy as well as IMA402, our TCR Bispecific, both target a PRAME peptide which represents one of the most promising and prevalent targets in the solid cancer space," commented Harpreet Singh, Ph.D., CEO and Co-Founder of Immatics. "We are also very excited to have recently announced two new agreements with Bristol Myers Squibb and Editas Medicine that strengthen our capabilities in the field of allogeneic gamma delta T cell therapies. By combining our strengths through such partnerships, we can accelerate the development of our pipeline and increase its potential to deliver a meaningful impact on the lives of cancer patients."

Second Quarter 2022 and Subsequent Company Progress

Adoptive Cell Therapy Programs

ACTengine IMA203 (PRAME) – Following interim results from the IMA203 monotherapy during Phase 1a dose escalation, Immatics has extended the clinical trial to three Phase 1b expansion cohorts to realize a high rate of durable responses with TCR-T against PRAME.

Cohort A – IMA203 as monotherapy at the provisional recommended Phase 2 dose (RP2D) plus exploration of a higher dose level (dose level 5, DL5; up to 4.7 billion transduced CD8 T cells per m² body surface area)
Cohort B – IMA203 in combination with the PD-1 immune checkpoint inhibitor Opdivo (nivolumab)
Cohort C – IMA203CD8, a 2nd generation monotherapy where IMA203 is co-expressed with a CD8 co-receptor to leverage functional CD4 T cells in addition to CD8 T cells in the anti-tumor response

As per the respective announcements made in March and May, the first patients have been treated in Cohort A and Cohort B, with the first patient expected to be treated in Cohort C in August, 2022. The next data readout for the IMA203 monotherapy cohort at RP2D is expected for 2H 2022 and an initial data readout for Cohort B and Cohort C is planned for YE2022.

ACTallo – On June 2nd, 2022, Immatics announced a multi-program collaboration with Bristol Myers Squibb to develop allogeneic TCR-T/CAR-T programs. Immatics received an upfront payment of $60 million and is eligible for up to $700 million per Bristol Myers Squibb program through milestone payments and tiered royalties. Under the collaboration agreement, Bristol Myers Squibb receives access to Immatics’ proprietary gamma delta T cell-derived allogeneic Adoptive Cell Therapy (ACT) platform, ACTallo, and can bring in up to 4 TCR-T targets based on the 2019 collaboration agreement or CAR-T targets. Immatics receives access to Bristol Myers Squibb’s next-generation technologies. The companies will work together to develop and commercialize two of Bristol Myers Squibb’s allogeneic TCR-T/CAR-T programs. Under the terms of the collaboration, both companies have an option to develop up to four additional programs each. Immatics may also develop additional allogeneic programs based on its ACTallo platform outside of the collaboration.

ACTallo – Immatics entered a strategic research collaboration and licensing agreement with Editas Medicine, Inc., combining gamma delta T cell adoptive cell therapies and gene editing to develop medicines for the treatment of cancer. As part of the agreement, Immatics gains non-exclusive rights to Editas Medicine’s CRISPR technology and intellectual property.

Autologous TCR-T – Immatics and Bristol Myers Squibb expanded their autologous T cell receptor-based therapy (TCR-T) collaboration signed in 2019 by including one additional TCR-T target discovered by Immatics. Immatics received a payment of $20 million and is eligible for milestone payments as well as royalties.

ACTengine IMA201 (MAGEA4/A8) – The Phase 1a dose escalation cohort is ongoing and is expected to be completed by YE2022.

TCR Bispecifics Programs

Immatics’ TCER candidates are next-generation, half-life extended TCR Bispecific molecules designed to maximize efficacy while minimizing toxicities in patients through its proprietary format using a low-affinity T cell recruiter and a high-affinity TCR domain.

TCER IMA401 (MAGEA4/8) – On May 10, 2022, Immatics announced the initiation of its Phase 1 trial evaluating the company’s most advanced T cell engaging receptor (TCER) IMA401 in patients with recurrent and/or refractory solid tumors. The Phase 1 clinical trial is expected to include approximately 50 patients at up to 15 centers in Germany. IMA401 is developed in collaboration with Bristol Myers Squibb.

TCER IMA402 (PRAME) – A preclinical data update will be presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Annual Meeting (September 9-13, 2022). Manufacturing of the clinical batch is on track for 2H 2022 and initiation of the Phase 1 trial is planned in 2023.

Corporate Developments

Board of Directors Update

At Immatics’ Annual General Meeting in June 2022, Nancy Valente, M.D., was elected as a member of the company’s Board of Directors. Dr. Valente brings 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. Additional information on all members of Immatics’ Board of Directors can be found on the Immatics website.

Second Quarter 2022 Financial Results

Cash Position: Cash and cash equivalents as well as other financial assets total €324.4 million ($337.0 million1) as of June 30, 2022, compared to €252.7 million ($262.5 million1) as of March 31, 2022. The increase is mainly due to the receipt of the upfront payment in connection with the collaboration agreement with Bristol Myers Squibb on allogeneic ACT as well as the addition of one additional autologous TCR-T target as part of a 2019 collaboration agreement, partly offset by the financing of our ongoing research and development activities. With the addition of these upfront payments, the Company projects a cash runway into 2H 2024.

Revenue: Total revenue, consisting of revenue from collaboration agreements, was €17.2 million ($17.9 million1) for the three months ended June 30, 2022, compared to €5.2 million ($5.4 million1) for the three months ended June 30, 2021. The increase is mainly related to the increased recognition of revenue for the multiple collaboration agreements Immatics has in place.

Research and Development Expenses: R&D expenses were €25.2 million ($26.2 million1) for the three months ended June 30, 2022, compared to €20.3 million ($21.1 million1) for the three months ended June 30, 2021. The increase is mainly related to increased spending on clinical trials.

General and Administrative Expenses: G&A expenses were €8.7 million ($9.0 million1) for the three months ended June 30, 2022, compared to €8.3 million ($8.6 million1) for the three months ended June 30, 2021.

Net Income/Loss: Net loss was €14.0 million ($14.5 million1) for the three months ended June 30, 2022, compared to a net loss of €26.5 million ($27.5 million1) for the three months ended June 30, 2021. The decrease was primarily the result of the increased revenue from multiple collaboration agreements.

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, 2022 (1 EUR = 1.0387 USD).

Upcoming Investor Conferences

Jefferies Cell and Genetic Medicine Summit, New York – September 29-30, 2022
Jefferies 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.