On March 10, 2022 Applied Therapeutics, Inc. (Nasdaq: APLT), a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates against validated molecular targets in indications of high unmet medical need, reported financial results for the fourth quarter and full year ended December 31, 2021 (Press release, Applied Therapeutics, MAR 10, 2022, View Source [SID1234609906]).

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"We remain committed to bringing new treatments to patients in areas of high unmet need," said Shoshana Shendelman, PhD, Founder and CEO of Applied Therapeutics. "With three ongoing Phase 3 studies across Galactosemia, Sorbitol Dehydrogenase (SORD) Deficiency and Diabetic Cardiomyopathy, we are advancing treatments forward, and expect multiple catalysts and opportunities for value creation in 2022 and 2023."

Recent Highlights

Provided Regulatory Update on Galactosemia Program. In January 2022, the Company provided a regulatory update on the AT-007 Galactosemia program. Following discussions with the FDA at the end of the year, the Company decided to hold on submitting an NDA for AT-007 for treatment of Galactosemia pending additional discussions with the agency. Although the Galactosemia program had previously been discussed in the context of an NDA for Accelerated Approval based on reduction in galactitol, the FDA has now indicated that clinical outcomes data will likely be required for approval. Clinical outcomes are assessed every 6 months by a firewalled committee until the study reaches statistical significance. All children enrolled in the study have completed the 6-month clinical outcomes visits. The Company is in active dialogue with the FDA regarding a potential NDA submission and expects to complete the statistical analysis of the 6-month clinical outcomes in the second quarter. The Company expects to provide an update accordingly.
Announced Initiation of Registrational Phase 2/3 Study of AT-007 in SORD Deficiency. In December 2021, the Company initiated the global registrational phase 2/3 study of AT-007 in Sorbitol Dehydrogenase (SORD) Deficiency. The study, termed INSPIRE (INhibition of Sorbitol Production through Inhibition of the Aldose Reductase Enzyme), will investigate biomarker efficacy, clinical outcomes and safety in people living with SORD Deficiency treated with AT-007 vs. placebo.
Financial Results

Cash and cash equivalents and short-term investments totaled $80.8 million as of December 31, 2021, compared with $96.8 million at December 31, 2020.
Research and development expenses for the year ended December 31, 2021 were $62.6 million, compared to $61.8 million for the year ended December 31, 2020. The increase of approximately $0.8 million was primarily related to an increase in clinical and pre-clinical expense of $11.6 million, primarily related to the progression of the AT-007 ACTION-Galactosemia adult extension and the AT-007 ACTION-Galactosemia Kids pediatric registrational study; a decrease in drug manufacturing and formulation expenses of $12.5 million primarily related to the completion and release of AT-001 and AT-007 drug product batches in the three months ended March 31, 2021; an increase in personnel expenses of $2.2 million due to the increase in headcount in support of our clinical program pipeline; an increase in stock-based compensation of $0.2 million due to new stock option and restricted stock unit grants, offset by forfeitures of stock option and restricted stock unit grants; and a decrease of regulatory and other expenses of $0.6 million primarily related to the UM license fees recognized during the year ended December 31, 2020.
General and administrative expenses were $43.0 million for the year ended December 31, 2021, compared to $32.7 million for the year ended December 31, 2020. The increase of approximately $10.4 million was primarily related to a decrease in professional and legal fees of $2.1 million due to lower external consulting and legal fees; an increase of $5.6 million related to increased commercial expenditures; an increase in personnel expenses of $1.0 million and an increase in stock-based compensation of $3.0 million due to an increase in headcount; an increase of insurance expenses of $0.6 million related to increased directors and officers liability insurance costs; and an increase in other expenses of $2.3 million, primarily relating to increased costs of rent and other office expenses.
Net loss for the year ended December 31, 2021 was $105.6 million, or $4.12 per basic and diluted common share, compared to a net loss of $94.0 million, or $4.28 per basic and diluted common share, for the year ended December 31, 2020.

On March 10, 2022 Sensei Biotherapeutics, Inc. (NASDAQ: SNSE), an immunotherapy company focused on the discovery and development of next generation therapeutics for cancer, reported financial results for 2021 and provided recent corporate updates (Press release, Sensei Biotherapeutics, MAR 10, 2022, View Source [SID1234609905]).

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"In 2021, we established important proof points for our SNS-101 program, which is designed to block the VISTA immune checkpoint," said John Celebi, president and chief executive officer of Sensei Biotherapeutics. "VISTA is widely expressed on myeloid cells, presenting a challenge for drug development, yet plays a decisive role in suppressing the immune system in a broad set of tumor types. SNS-101 is a potent and pH-selective fully human anti-VISTA antibody that is designed to be highly selective for tumors and therefore has potential to overcome historical challenges associated with targeting VISTA."

Mr. Celebi continued, "More broadly, our TMAb platform represents a fundamental advance for a number of important immune targets that are expressed in both normal tissues and tumors, avoiding potential pharmacokinetic sinks and on-target, off-tumor toxicities. Importantly, we are well funded with more than $147 million as of December 31, 2021 to advance our programs."

2021 Highlights and Milestones:

Pipeline

SNS-101 is a monoclonal antibody targeting the immune checkpoint VISTA and is currently in IND-enabling studies. VISTA (V-domain Ig suppressor of T cell activation) is an immune checkpoint that is implicated in resistance to PD-1/PD-L1 and correlates with poor survival across numerous cancers. In 2021, Sensei achieved the following milestones for this program:

In August, Sensei announced it had identified SNS-101, a potent pH-dependent product candidate that selectively blocks the interaction of VISTA with its receptor, PSGL-1, which occurs at low pH, as seen in the tumor microenvironment. The identification of SNS-101 was partly based on nonclinical data from a human VISTA knock-in mouse model, which showed that TMAb antibodies significantly enhanced anti-tumor responses in combination with PD-1 blockade compared to treatment with PD-1 blockade alone.
In November, Sensei presented a poster for SNS-101 at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) Annual Meeting being held in Washington, D.C. Data highlighted in the poster were the first preclinical data to be presented by Sensei in a scientific forum and highlighted the potency, selectivity, and mechanism of action of SNS-101.
In November, Sensei hosted a virtual science symposium to discuss the potential of the VISTA checkpoint inhibitor to address current limitations of immune checkpoint therapy.
Sensei entered into an agreement with a high-quality CDMO for the manufacture of GMP-grade material to advance toward clinical studies.
Sensei has initiated IND-enabling studies for SNS-101. Key nonclinical studies include the generation of a broader set of in vivo efficacy data from Sensei’s human VISTA knock-in mouse models, nonclinical pharmacokinetic data, and nonclinical safety data. Sensei expects to receive pharmacokinetic and toxicology data from its single dose non-human primate studies in mid-2022 and submit an IND in the first half of 2023.
SNS-102 is a monoclonal antibody targeting VSIG4 (V-Set and Immunoglobulin Domain Containing 4), a B7-family related protein that is frequently overexpressed on tumor-associated macrophages. VSIG4 is a potent inhibitor of T-cell activity and potential driver of immunosuppressive macrophage polarization. Expression of VSIG4 is also found within normal tissues, presenting potential safety challenges, making VSIG4 an ideal candidate for Sensei’s TMAb platform.

Sensei has initiated its TMAb antibody discovery campaign aimed at developing an inhibitory antibody with high selectivity for VSIG4 in the TME versus normal tissue environments.
Sensei plans to select a product candidate and initiate IND-enabling studies in 2023.
SNS-103 is a monoclonal antibody targeting ENTPDase1 (ecto-nucleoside triphosphate diphosphohydrolase-1), also known as CD39. ENTPDase1 is the upstream, rate-limiting enzyme, leading to the breakdown of extracellular ATP. Extracellular ATP represents a potent immunologic "danger signal", which drives immune activation. The ultimate downstream product of this pathway, adenosine, has potent immunosuppressive activity through binding to adenosine receptors. Upregulation of ENTPDase1 by tumors is common and leads to a diminished anti-tumor immune response.

Sensei has initiated a TMAb antibody campaign aimed at developing an inhibitory antibody with high selectivity for ENTPDase1 in the TME versus normal tissue environments.
Sensei expects to select a product candidate in 2023.
SNS-401-NG is a potential first-in-class, multi-antigenic personalized ImmunoPhage candidate being developed in collaboration with the University of Washington designed to treat a broad range of cancers. The first proof-of concept clinical application is directed to the treatment of Merkel cell carcinoma (MCC), an aggressive form of skin cancer commonly driven by the Merkel Cell Polyoma Virus. Sensei plans to conduct a broader study in patients with multiple tumor types, potentially including head and neck cancer, lung cancer, melanoma, and triple negative breast cancer based on the prevalence of Phortress antigens.

Sensei is finalizing the genetic design of its next generation ImmunoPhage, which will serve as the backbone for delivery of anti-tumor antigens to the immune system.
Sensei intends to initiate IND-enabling studies for this product candidate in the second half of 2022.
Corporate

Sensei completed an upsized initial public offering of its common stock in February 2021. The gross proceeds to Sensei, before deducting underwriting discounts and commissions and other offering expenses payable by Sensei, were approximately $152.6 million.
Sensei Biotherapeutics completed the move of its corporate headquarters to the Seaport Innovation District in Boston, MA. The new space more than doubles the size of the company’s current research and development footprint. The company’s manufacturing operations remain in Rockville, MD.
Sensei strengthened its board of directors with the appointments of Deneen Vojta, Kristian Humer, and Jessie English.
In January 2022, Sensei announced the promotions of Erin Colgan as Chief Financial Officer and Robert Pierce, M.D., as Chief R&D Officer.
On March 9, 2022, Sensei announced the appointment William Ringo as the Chair of the Board of Directors.
Year End 2021 Financial Results

Cash Position – Cash, cash equivalents and marketable securities were $147.6 million as of December 31, 2021, as compared to $16.6 as of December 31, 2020. Sensei expects the current cash balance to fund operations at least into the first half of 2024.

Research and Development (R&D) Expenses – R&D expenses were $21.7 million for the year ended December 31, 2021, compared to $11.9 million for the year ended December 31, 2020, including Alvaxa IPR+D. The increase in R&D expenses was primarily attributable to increased headcount to support Sensei’s research, development, and manufacturing activities.

General and Administrative (G&A) Expenses – G&A expenses were $15.8 million for the year ended December 31, 2021, compared to $7.5 million for the year ended December 31, 2020. The increase in G&A expenses was primarily attributable to higher personnel costs, including stock-based compensation expense, and costs associated with operating as a public company.

Net Loss – Net loss was $36.8 million, for the year ended December 31, 2021, compared to $20.1 million for the year ended December 31, 2020.

On March 10, 2022 Theseus Pharmaceuticals, Inc. (NASDAQ: THRX) (Theseus or the Company), a clinical-stage biopharmaceutical company focused on improving the lives of cancer patients through the discovery, development and commercialization of transformative targeted therapies, reported financial results for the fourth quarter and full year ended December 31, 2021 (Press release, Theseus Pharmaceuticals, MAR 10, 2022, View Source [SID1234609904]).

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"2021 was a transformative year for Theseus—we evolved into a clinical stage company, strengthened our team, and completed a successful IPO," said Tim Clackson, Ph.D., President and Chief Executive Officer of Theseus. "In January 2022 we initiated a Phase 1/2 clinical trial to evaluate our lead candidate, THE-630, in patients with advanced GIST and continue to drive towards development candidate nomination for our fourth-generation EGFR program in non-small cell lung cancer. Over the course of this year, we look forward to executing across our pipeline, which includes advancing THE-630 in the clinic, initiating IND-enabling studies of our second development candidate targeting EGFR, and expanding our pipeline with one or more additional kinase targets."

Recent Business Highlights and Anticipated Milestones:

Initiated Phase 1/2 clinical trial to evaluate THE-630 in patients with GIST. First patient treated in January 2022 in a Phase 1/2 dose escalation and expansion clinical trial of THE-630 in patients with advanced GIST. THE-630 is a pan-variant inhibitor of the receptor tyrosine kinase KIT designed for patients with advanced GIST whose cancer has developed resistance to earlier lines of therapy. Initial data from the Phase 1 portion of the clinical trial is expected to be presented at a scientific meeting in the first half of 2023.
Nomination of development candidate for fourth-generation EGFR program expected in the third quarter of 2022. Theseus expects to nominate an EGFR candidate designed to inhibit the full range of single-, double-, and triple-mutant EGFR variants found in the tumors of patients with EGFR-mutant NSCLC that have developed resistance to osimertinib, including the C797S mutation. Preclinical data is expected to be presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in April and at a scientific conference in the second half of 2022. IND submission is expected in 2023.
One or more additional kinase targets expected to be nominated by the end of 2022.
Successfully completed initial public offering (IPO). In October 2021, the Company completed a successful IPO, raising $178.8 million in aggregate gross proceeds, and listed on the Nasdaq Global Select Market.
Fourth Quarter and Full Year Financial Results:

Cash Position: As of December 31, 2021, Theseus had cash and cash equivalents of $244.7 million. Theseus expects its cash and cash equivalents, including proceeds from the IPO, to fund operations and capital expenditures into the second half of 2024 based on its current operating plan.
R&D Expenses: Research and development expenses were $5.0 million for the fourth quarter of 2021, as compared to $2.5 million for the fourth quarter of 2020. This increase was primarily due to $1.6 million of increased employee-related costs, and $0.9 million in increased expenses for clinical and preclinical studies. Research and development expenses were $18.3 million for the full year 2021, as compared to $6.0 million for the full year 2020.
G&A Expenses: General and administrative expenses were $3.6 million for the fourth quarter of 2021, as compared to $0.4 million for the fourth quarter of 2020. This increase was primarily due to $1.6 million of increased employee-related costs, primarily due to increases in our headcount, as well as $1.7 million of increased general expenses, primarily driven by public company-related costs. General and administrative expenses were $9.0 million for the full year 2021, as compared to $0.9 million for the full year 2020.
Net Loss: Net loss was $8.7 million for the fourth quarter of 2021, as compared to a net loss of $2.9 million for the fourth quarter of 2020. Net loss was $27.3 million for the full year 2021, or a net loss per share of $2.84, as compared to a net loss of $12.0 million for the full year 2020, or a net loss per share of $21.10.

On March 10, 2022 Omega Therapeutics, Inc. (Nasdaq: OMGA) ("Omega"), a development-stage biotechnology company pioneering the first systematic approach to use mRNA therapeutics as a new class of programmable epigenetic medicines by leveraging its OMEGA Epigenomic Programming platform, reported financial results for the fourth quarter and full year ended December 31, 2021 (Press release, Omega Therapeutics, MAR 10, 2022, View Source [SID1234609903]).

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"In 2021, we made significant strides across all aspects of our business highlighted by the successful completion of our initial public offering, the nomination of OTX-2002 as the industry’s first programmable epigenetic medicine to be developed for the treatment of c-Myc (MYC)-driven hepatocellular carcinoma (HCC), and the continued development of our groundbreaking platform and pipeline," said Mahesh Karande, President and Chief Executive Officer of Omega Therapeutics. "With our funding in 2021 and recent key additions to our team, we are well positioned to steadily advance a broad portfolio of Omega Epigenomic Controllers (OECs). Looking ahead, we are targeting to submit an Investigational New Drug application (IND) for OTX-2002 and nominate two OEC candidates in the first half of 2022. We are also planning for an additional IND in the second half of 2022 or early 2023 and several scientific presentations and publications throughout the year."

Recent Business Highlights and Corporate Update

Development Pipeline and Platform

American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2022: An abstract titled, "Epigenetic Modulation of the MYC oncogene as a potential novel therapy for HCC" was selected for a poster presentation at the upcoming AACR (Free AACR Whitepaper) 2022 Annual Meeting. The presentation will highlight the mechanism of action of OTX-2002 and its potential as a differentiated and viable approach to the treatment of HCC.
OTX-2002: IND-enabling studies are ongoing for Omega’s lead OEC candidate OTX-2002, a novel, engineered, and programmable mRNA therapeutic targeting the MYC oncogene in patients with HCC. In preclinical studies, OTX-2002 demonstrated its ability to potently downregulate MYC oncogene expression. The Company continues to be on track to file an IND for OTX-2002 in the first half of 2022.
Additional OEC Development: The Company is working on multiple programs in pre-clinical studies, including acute respiratory distress syndrome (ARDS) with CXCL1-3/IL8, non-small cell lung cancer (NSCLC) with MYC, alopecia with SFRP1, and liver disease with HNF4a.
OMEGA Epigenomic Programming Platform: Omega is creating a new generation of programmable epigenetic mRNA medicines that are designed to control the fundamental epigenetic processes to correct the root cause of disease by restoring aberrant gene expression to a normal range without altering native nucleic acid sequences. Omega has developed a highly rational and deterministic approach to drug design that enables the Company to rapidly develop and optimize novel OECs with high target specificity to durably tune the expression of single or multiple genes. Omega is advancing multiple pre-clinical development programs in oncology, multigenic diseases including immunology, regenerative medicine, and select monogenic diseases.
Corporate

In January 2022, Yan Moore, M.D., was appointed Chief Medical Officer of Omega. Dr. Moore has extensive management, research, translational drug development and medical affairs experience across various pharmaceutical and biotechnology companies.
Anticipated Milestones and Key Priorities for 2022

Complete IND-enabling studies for OTX-2002 and file the Company’s first IND to the U.S. Food and Drug Administration (FDA) during the first half of 2022.
Declare two OEC development candidates in the first half of 2022.
Target submission of an additional IND application in the second half of 2022 or early 2023.
Continue to develop the OMEGA Epigenomic Programming platform and investigate additional development programs to expand pipeline.
Publish and present relevant preclinical and early clinical data supporting programs and platform development.
Fourth Quarter and Full Year 2021 Financial Results

As of December 31, 2021, the Company had cash, cash equivalents and marketable securities totaling $225.3 million.

Research and development (R&D) expenses for the fourth quarter of 2021 were $14.7 million, compared with $7.1 million for the fourth quarter of 2020. R&D expenses for 2021 were $47.9 million, compared to $21.1 million in 2020. The $26.8 million increase in R&D expenses in 2021 compared to 2020 was primarily due to an increase in discovery and preclinical development costs and personnel and related expenses as the Company continues to advance its pipeline and discovery portfolio.

General and administrative expenses (G&A) for the fourth quarter of 2021 were $5.7 million, compared with $1.9 million for the fourth quarter of 2020. G&A expenses for 2021 were $16.6 million, compared to $6.2 million in 2020. The $10.4 million increase in G&A expenses in 2021 compared to 2020 was primarily due to higher personnel and related expense and increased costs to operate as a public company, in addition to the higher professional fees to support business growth.

Net loss for the fourth quarter of 2021 was $20.9 million, compared with $9.5 million for the fourth quarter of 2020. Net loss for the year ended December 31, 2021 was $68.3 million, compared to a net loss of $29.4 million for the year ended December 31, 2020. The increase in net loss for 2021 compared to 2020 was primarily due to increased R&D and G&A expenses to support the Company’s growth and operations as a public company.

On March 10, 2022 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 including the Company’s 2021 key achievements and 2022 strategic priorities in conjunction with its 10-K filing for the year ended December 31, 2021 (Press release, Foghorn Therapeutics, MAR 10, 2022, View Source;22.htm [SID1234609902]). 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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"The Company completed 2021 with an important strategic collaboration with Lilly for multiple novel oncology targets to come from our Gene Traffic Control Platform, helping to set up a transformative 2022 and beyond. Our strong balance sheet allows us to invest through multiple inflection points, including advancing our clinical stage pipeline, with initial phase 1 data anticipated for both FHD-286 and FHD-609 this year, while also progressing our platform and earlier stage pipeline towards INDs and clinical studies," said Foghorn CEO Adrian Gottschalk.

Gottschalk continued, "Foghorn made significant progress in 2021, and we continue to execute on our strategy to systematically drug the chromatin regulatory system and build our capabilities to support the different modalities we use including targeted protein degradation, enzymatic inhibition, and protein disruptors, and all supported by a strong financial position."

2022 Outlook; Key Milestones

FHD-286 data. Foghorn expects to provide initial Phase 1 clinical data for FHD-286, an inhibitor of BRG1/BRM, in metastatic uveal melanoma (mUM), relapsed and/or refractory acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS), in the first half of 2022.

FHD-609 data. Foghorn anticipates providing initial Phase 1 clinical data for FHD-609, a potent and selective heterobifunctional protein degrader of BRD9, initially being developed for the treatment of synovial sarcoma, as early as the first half of 2022.

BRM-selective Progress. Foghorn is advancing its BRM-selective program in collaboration with Loxo Oncology at Lilly, with the BRM-selective inhibitor in lead optimization and the protein degrader program in the hit-to-lead stage. BRG1 is mutated in ~5% of tumors. Over 30 different cancer types have BRG1 mutations, including up to 10% of NSCLC.

Pipeline Advancement. Foghorn anticipates advancing its broad therapeutic pipeline of which the majority are wholly owned including protein degraders, enzymatic inhibitors and transcription factor disruptors targeting cancers impacted by breakdowns in the chromatin regulatory system.

Protein Degrader Platform. In January 2022, Foghorn added Dannette Daniels as our Vice President, Protein Degrader Platform, continuing our investment in and expansion of our protein degrader capabilities.

Financial. Foghorn significantly strengthened its balance sheet and cash runway in 2021. As of December 31, 2021, the Company had $154.3 million in cash, cash equivalents and marketable securities at year-end, plus the $300 million received as part of the Lilly collaboration in January equating to $454.3 million in year-end pro forma cash, cash equivalents and marketable securities.
2021 Key Achievements

Dosed First Patient with FHD-286. In May 2021, Foghorn announced the first patient was dosed in a first-in-human Phase 1 clinical trial of FHD-286, a highly potent, selective, allosteric and orally available, small-molecule, enzymatic inhibitor of BRG1 and BRM, being developed as a treatment in i) metastatic uveal melanoma (mUM) and ii) relapsed and/or refractory acute myelogenous leukemia (AML) and myelodysplastic syndrome (MDS).

Dosed First Patient with FHD-609. In August 2021, Foghorn announced the first patient was dosed in a first-in-human Phase 1 clinical trial of FHD-609, a potent, selective protein degrader of BRD9 (bromodomain-containing protein 9), a subunit of ncBAF (non-canonical BAF complex), which is being developed as a treatment for synovial sarcoma.

Established Strategic Collaboration with Loxo Oncology at Lilly. In December 2021, Foghorn and Lilly announced a strategic collaboration for novel oncology targets using Foghorn’s proprietary Gene Traffic Control Platform. The collaboration established a co-development and co-commercialization agreement on Foghorn’s BRM-selective program and an undisclosed program, as well as three discovery programs. Foghorn received upfront consideration of $300 million in cash under the collaboration agreement and an equity investment by Lilly of $80 million in Foghorn common stock at a price of $20 per share. Foghorn is eligible to receive up to $1.3 billion in potential milestones and retains significant financial upside through profit-sharing agreements in the U.S. on several programs coupled with significant royalties ex-U.S.

Advanced Top Synthetic Lethal Relationship Targets. BRM and ARID1B represent two of the top synthetic lethal targets in cancer, where the mutation occurs in BRG1 and ARID1A paralogues, respectively. In June Foghorn announced its BRM selective inhibitor program transitioned into lead optimization. This program is now part of the Lilly collaboration. During 2021, Foghorn screens led to validated selective chemical matter against ARID1B and the Company is now using its degrader capabilities to convert these protein hits into novel selective protein degraders.
About FHD-286

FHD-286 is a highly potent, selective, allosteric and orally available, small-molecule, enzymatic inhibitor of BRG1 and BRM, two highly similar proteins that are the ATPases, or the catalytic engines across all forms of the BAF complex, one of the key regulators of the chromatin regulatory system. In preclinical studies, FHD-286 has shown anti-tumor activity across a broad range of malignancies including both hematologic and solid tumors. To learn more about these studies please visit ClinicalTrials.gov. (Link here for metastatic uveal melanoma and here for AML and MDS).

About AML

Adult acute myeloid leukemia (AML) is a cancer of the blood and bone marrow and the most common type of acute leukemia in adults. AML is a diverse disease associated with multiple genetic mutations. It is diagnosed in about 20,000 people every year in the United States.

About Uveal Melanoma

Uveal (intraocular) melanoma (UM) is a rare eye cancer that forms from cells that make melanin in the iris, ciliary body, and choroid. It is the most common eye cancer in adults. It is diagnosed in about 2,000 adults every year in the United States and occurs most often in lightly pigmented individuals with a median age of 55 years. However, it can occur in all races and at any age. UM metastasizes in approximately 50% of cases, leading to very poor prognosis.

About FHD-609

FHD-609 is a potent, selective, intravenously administered protein degrader of BRD9, a component of the ncBAF complex. Preclinical studies have demonstrated tumor growth inhibition in synovial sarcoma, a cancer genetically dependent on BRD9. To learn more about the first-in-human clinical trial of FHD-609 in synovial sarcoma, please visit ClinicalTrials.gov.

About Synovial Sarcoma

Synovial sarcoma is a rare, often aggressive soft tissue sarcoma that originates from different types of soft tissue, including muscle or ligaments. Synovial sarcoma can occur at any age but is most common among adolescents and young adults. It represents around 5-10% of all soft tissue sarcomas, with ~800 new cases each year in the United States. Surgery remains the most effective treatment for synovial sarcoma, and there are limited therapeutic treatment options.

About the Strategic Collaboration with Loxo Oncology at Lilly

In December 2021, Foghorn and Loxo Oncology at Lilly entered into a strategic collaboration for novel oncology targets. Under the terms of the agreement, Foghorn received upfront consideration of $300 million in cash for the collaboration agreement and an equity investment by Lilly of $80 million in Foghorn common shares at a price of $20 per share. The collaboration includes a co-development and co-commercialization agreement for Foghorn’s selective BRM oncology program and an additional undisclosed oncology target. In addition, the collaboration includes three additional discovery programs using Foghorn’s proprietary Gene Traffic Control platform.

For the BRM-selective program and the additional undisclosed target program, Foghorn will lead discovery and early research activities, while Lilly will lead development and commercialization activities with participation from Foghorn in operational activities and cost sharing. Foghorn and Lilly will share 50/50 in the U.S. economics, and Foghorn is eligible to receive royalties on ex-U.S. sales starting in the low double-digit range and escalating into the twenties based on revenue levels.

For the additional discovery programs, Foghorn will lead discovery and early research activities. Foghorn may receive up to a total of $1.3 billion in potential development and commercialization milestones. Additionally, Foghorn will have an option to participate in a percentage of the U.S. economics and is eligible to receive tiered royalties from the mid-single digit to low-double digit range on sales outside the U.S. that may be exercised after the successful completion of the dose-finding toxicity studies.