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.

On March 10, 2022 Sierra Oncology, Inc. (NASDAQ: SRRA), a late-stage biopharmaceutical company dedicated to delivering targeted therapies for rare cancers, reported its financial and operating results for the fourth quarter and fiscal year ended December 31, 2021 (Press release, Sierra Oncology, MAR 10, 2022, View Source [SID1234609901]).

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"Last year was a great year for Sierra. We accelerated timelines in the midst of a global pandemic to over enroll the pivotal MOMENTUM clinical trial, achieving statistical significance in the primary and all pre-specified secondary endpoints. This year, we’ll be focused on our regulatory submission and the continued build out of our commercial team to prepare for the anticipated approval of momelotinib in early 2023," said Stephen Dilly, MBBS, PhD, President and Chief Executive Officer at Sierra Oncology. "Financially, we are in a strong position to support ongoing pre-commercialization activities for momelotinib, and continued development of our myelofibrosis franchise with a combination study of momelotinib and our novel BET inhibitor, SRA515."

The pivotal Phase 3 MOMENTUM clinical trial enrolled 195 symptomatic and anemic myelofibrosis patients previously treated with an approved JAK inhibitor. Data from this study, as well as previous data from the SIMPLIFY-1 and SIMPLIFY-2 Phase 3 studies, will serve as the foundation for the submission of a New Drug Application to the US Food & Drug Administration in the second quarter of 2022. If approved, the company anticipates momelotinib being commercially available early in the first half of 2023.

Key 2021 and Recent Business Highlights

Momelotinib achieved positive topline results in the pivotal Phase 3 MOMENTUM clinical trial for myelofibrosis, reporting a statistically significant benefit on symptoms, anemia and splenic size. The company plans to submit a New Drug Application with the US Food & Drug Administration in the second quarter of this year.

Sierra had cash and cash equivalents of $104.7 million as of December 31,2021 and has significantly strengthened its financial position during the first quarter of 2022 by raising a total of $155.3 million in gross proceeds from a public equity offering, and securing a debt facility with Oxford Finance, LLC for up to $125.0 million. Under the terms of the loan agreement, Sierra drew an initial $5.0 million at closing and has the ability to access up to an additional $120 million in a series of tranches (of which $50.0 million is at the discretion of the lender). Also, the company received proceeds of $30.5 million from the cash exercise of Series B warrants. The outstanding Series B warrants will expire on April 10, 2022, and if fully exercised would provide an additional $2.8 million in proceeds to the company. Additionally, in connection with a previously issued securities purchase agreement to Gilead, the related warrant was exercised, providing $9.6 million of proceeds to the company.

On January 19, 2022, the Journal of Hematology and Oncology published a review article on momelotinib, titled "Momelotinib: an emerging treatment for myelofibrosis patients with anemia." The article highlights the use of momelotinib for the potential treatment of myelofibrosis patients who are anemic based on published data from the SIMPLIFY studies as well as earlier Phase 2 studies. The full article is available for review here.

An exclusive global in-licensing agreement for SRA515 (formerly AZD5153), a potent and selective BRD4 BET inhibitor with a novel bivalent binding mode, was announced on August 5, 2021. The initiation of a Phase 2 study examining momelotinib in combination with SRA515 for the treatment of myelofibrosis is planned for the first half of 2022.

Year End 2021 Financial Results

Research and development expenses were $67.2 million for the year ended December 31, 2021, compared to $45.1 million for the year ended December 31, 2020. The increase was attributable to a $9.1 million increase in personnel-related and allocated overhead costs primarily due to headcount additions to support the continued development and preparation for the regulatory submission of momelotinib. Also attributing to the increase was an upfront cash payment of $8.0 million that was made to AstraZeneca for the exclusive global license of SRA515, and external costs for momelotinib, including a $4.4 million increase in third-party manufacturing costs primarily pertaining to the production of pre-approval inventory and a $2.2 million increase in clinical trial and development costs primarily pertaining to the MOMENTUM clinical trial and the related preparation for regulatory submission. These increases were partially offset by a $1.5 million non-cash charge incurred in 2020 to recognize the change in fair value of an obligation to issue securities to Gilead until the issuance of the securities in January 2020 and a $0.2 million decrease in costs for SRA737. Research and development expenses included non-cash stock-based compensation of $7.2 million and $4.3 million for the year ended December 31, 2021 and 2020, respectively.

General and administrative expenses were $27.4 million for the year ended December 31, 2021, compared to $20.1 million for the year ended December 31, 2020. The increase was due to a $4.9 million increase in personnel-related and allocated overhead costs primarily due to headcount additions for the expansion and the continued buildout of our infrastructure to support our potential commercialization efforts, including the

establishment of key commercial functions such as marketing and market access. Also attributing to the increase in expense was an increase of $2.4 million in professional fees primarily relating to pre-commercial costs for momelotinib. General and administrative expenses included non-cash stock-based compensation of $5.7 million and $5.2 million for the year ended December 31, 2021 and 2020, respectively.

Total other expense (income), net was $0.1 million of total other expense, net for the year ended December 31, 2021, compared to $15.8 million of total other expense, net for the year ended December 31, 2020. The difference was primarily attributable to a non-cash charge of $16.2 million incurred during the year ended December 31, 2020, related to the change in fair value of warrant liabilities until the reclassification to equity in January 2020.

For the year ended December 31, 2021, Sierra incurred a Generally Accepted Accounting Principles (GAAP) net loss of $94.7 million compared to a GAAP net loss of $80.9 million for the year ended December 31, 2020. The GAAP net loss for the year ended December 31, 2021 includes an upfront cash payment of $8.0 million that was made to AstraZeneca for the exclusive global license of SRA515. The GAAP net loss for the year ended December 31, 2020, includes a non-cash charge of $16.2 million related to the change in fair value of warrant liabilities included in total other expense (income), net and a $1.5 million non-cash charge pertaining to the obligation to issue securities to Gilead included in research and development expenses as mentioned above.

Non-GAAP adjusted net loss was $81.8 million for the year ended December 31, 2021, compared with a non-GAAP adjusted net loss of $53.7 million for the year ended December 31, 2020. Non-GAAP adjusted net loss for the year ended December 31, 2021 and 2020 excludes expenses related to stock-based compensation. For the year ended December 31, 2020, non-GAAP net loss also excludes expenses related to the change in fair value of warrant liabilities and the change in fair value of the securities issuance obligation. See "Non-GAAP Financial Measures" and "Reconciliation of GAAP to Non-GAAP Financial Measures" below for a reconciliation of this GAAP measure to non-GAAP financial measure.

Cash and cash equivalents totaled $104.7 million as of December 31, 2021, compared to $104.1 million as of December 31, 2020.

As of December 31, 2021, there were 15,571,656 total shares of common stock outstanding and warrants to purchase 11,040,894 shares of common stock, with an exercise price equal to $13.20 per share. There were 4,937,189 shares issuable upon exercise of stock options and an additional warrant to purchase 1,839 shares.

Recent Financial Highlights

On January 31, 2022, the company completed an underwritten public offering of 4,074,075 shares of common stock and pre-funded warrants to purchase up to 925,925 shares of common stock. As part of the underwritten public offering, on February 3, 2022, the company issued an additional 750,000 shares of common stock representing the underwriters’ full exercise of their over-allotment option. The shares of common stock and the pre-funded warrants were offered by the company at a price to the public of $27.00 and $26.999 per share, respectively. The aggregate net proceeds received by the company from the offering were $145.6 million, net of underwriting discounts and commissions and estimated offering expenses of $9.7 million.

In the first quarter of 2022, the company has issued 18,937, 2,312,257 and 725,283 shares of common stock pertaining to the cash exercise of Series A warrants, Series B warrants, and the previously issued warrant related to a securities purchase agreement, respectively, providing proceeds to the company of $40.3 million. As of March 7, 2022, there were 23,665,100 shares of common stock outstanding and 925,925 pre-funded warrants to purchase shares of common stock. There were Series B warrants with an exercise price of $13.20 to purchase 212,477 shares of common stock which expire on April 10, 2022, and if exercised in full would provide $2.8 million of additional proceeds to the company. In addition, there were Series A warrants that contain a cash and/or cashless exercise provision to purchase 7,791,951 shares of common stock, with an exercise price equal to $13.20 per share. Additionally, there were 4,871,157 shares of common stock issuable upon exercise of stock options and a warrant.

On March 10, 2022 IMV Inc. (NASDAQ: IMV; TSX: IMV), a clinical-stage company developing a portfolio of immune-educating therapies, based on its novel DPX platform, to treat solid and hematologic cancers, reported that it will hold a conference call and webcast on Thursday, March 17, 2022, at 8:00 a.m. ET to discuss the company’s 2021 fourth quarter and fiscal year-end financial and operational results (Press release, IMV, MAR 10, 2022, View Source [SID1234609900]).

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Financial analysts are invited to join the conference call by dialing 1-844-461-9932 (U.S. and Canada) or 1-636-812-6632 (international) and using the conference ID: 5049587

Other interested parties will be able to access the live audio webcast at this link: View Source The webcast will be recorded and will then be available on the IMV website for 30 days following the call.

On March 10, 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 fourth quarter and year ended December 31, 2021 and provided recent corporate updates (Press release, Galera Therapeutics, MAR 10, 2022, View Source [SID1234609899]).

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"In 2021, we were pleased to report positive data from our lead program evaluating avasopasem for the treatment of severe oral mucositis, a radiotherapy-induced toxicity, in patients with head and neck cancer," said Mel Sorensen, M.D., Galera’s President and CEO. "The Phase 3 ROMAN trial demonstrated a statistically significant reduction in the incidence of SOM, the primary endpoint, and in the number of days patients experienced SOM. This data is in line with the topline results observed in the Phase 2a EUSOM trial and our previously completed randomized Phase 2b trial, reinforcing avasopasem’s potentially transformative clinical benefit for patients undergoing radiotherapy for head and neck cancer. With this robust package of data in hand, we are preparing to meet with the FDA to discuss the potential NDA submission. Concurrently, we remain on track to report data from our Phase 2a AESOP trial evaluating avasopasem in esophagitis in the first half of this year."

Dr. Sorensen continued: "We also continue to progress our Phase 1/2 GRECO-1 and Phase 2b GRECO-2 clinical trials evaluating our second product candidate, rucosopasem, in increasing the anti-cancer efficacy of higher daily doses of radiotherapy in patients with non-small cell lung cancer and locally advanced pancreatic cancer, respectively. We look forward to reporting initial data from our GRECO-1 trial in the first half of this year."

Recent Corporate Updates

Radiotherapy-Induced Toxicity Programs:

Severe Oral Mucositis (SOM)

On December 14, 2021, the Company announced corrected topline efficacy results from the Phase 3 ROMAN trial of avasopasem for the reduction of SOM in patients with locally advanced head and neck cancer (HNC). The Company had previously announced topline results from the ROMAN trial on October 19, 2021. Upon further analysis following the October announcement, an error by the contract research organization was identified in the statistical program. Correction of this error resulted in improved p-values for the primary and secondary endpoints. The corrected results demonstrated efficacy across multiple SOM endpoints with a statistically significant reduction 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 experienced SOM. Avasopasem appeared to be generally well tolerated compared to placebo. The Company announced that it plans to meet with the U.S. Food and Drug Administration (FDA) in 2022 to discuss a potential New Drug Application (NDA) submission.
On December 14, 2021, the Company also reported topline data from the Phase 2a EUSOM multicenter trial of avasopasem in Europe in patients with HNC undergoing standard-of-care radiotherapy. Avasopasem appeared to be generally well tolerated and the incidence and number of days of SOM was in line with the avasopasem data reported in the Phase 3 ROMAN trial.
Esophagitis

The Company expects to report topline data from the Phase 2a AESOP trial of avasopasem evaluating its ability to reduce the incidence of esophagitis induced by radiotherapy in patients with lung cancer in the first half of 2022.
Anti-Cancer Programs:

Locally Advanced Pancreatic Cancer (LAPC)

Enrollment is ongoing in the Phase 2b, 160-patient randomized, multicenter, placebo-controlled GRECO-2 trial of rucosopasem, Galera’s second dismutase mimetic product candidate, in combination with stereotactic body radiation therapy (SBRT) in patients with LAPC. The primary endpoint of the trial is overall survival.
Non-Small Cell Lung Cancer (NSCLC)

Enrollment is ongoing in the Phase 1/2 GRECO-1 trial of rucosopasem in combination with SBRT in patients with NSCLC. The Company expects to report initial data from this trial in the first half of 2022.
Fourth Quarter 2021 Financial Highlights

Research and development expenses were $9.2 million in the fourth quarter of 2021, compared to $14.6 million for the same period in 2020. 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 fourth quarter of 2021, compared to $4.3 million for the same period in 2020. The increase was primarily attributable to employee-related costs from increased headcount and share-based compensation expense, and increased insurance expense and professional fees.
Galera reported a net loss of $(16.8) million, or $(0.64) per share, for the fourth quarter of 2021, compared to a net loss of $(20.1) million, or $(0.80) per share, for the same period in 2020.
As of December 31, 2021, Galera had cash, cash equivalents and short-term investments of $71.2 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 into the second half of 2023.
Full Year 2021 Financial Highlights

Research and development expenses were $52.4 million for the year ended December 31, 2021, compared to $54.8 million for the year ended December 31, 2020. 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 $21.0 million for the year ended December 31, 2021, compared to $15.7 million for the year ended December 31, 2020. The increase was primarily attributable to employee-related costs from increased headcount and share-based compensation expense, increased expenses related to preparation for potential commercialization of avasopasem, and increased insurance expense and professional fees.
Galera reported a net loss of $(80.5) million, or $(3.12) per share, for the year ended December 31, 2021, compared to a net loss of $(74.2) million, or $(2.98) per share, for the year ended December 31, 2020.

On March 10, 2022 Oncorus, Inc. (Nasdaq: ONCR), a viral immunotherapies company focused on driving innovation to transform outcomes for cancer patients, reported that President and Chief Executive Officer, Theodore (Ted) Ashburn, M.D., Ph.D., will present at the Oppenheimer 32nd Annual Healthcare Conference on Tuesday, March 15, 2022 at 4:40 p.m. ET (Press release, Oncorus, MAR 10, 2022, View Source [SID1234609898]).

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A live webcast of the presentation can be accessed by visiting the Investors & Media section of Oncorus’ website at View Source A replay of the presentation will be archived on Oncorus’ site for 30 days following the event.