Sensei Biotherapeutics Reports Second Quarter 2022 Financial Results and Recent Business Highlights

On August 9, 2022 Sensei Biotherapeutics, Inc. (NASDAQ: SNSE), an immuno-oncology company focused on the discovery and development of next generation therapeutics for cancer, reported financial results for the second quarter ended June 30, 2022 and provided recent business updates (Press release, Sensei Biotherapeutics, AUG 9, 2022, View Source [SID1234617937]).

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"This has been a productive and rewarding time as we progress our TMAb platform in pursuit of potentially revolutionary therapies for cancer patients that address the challenge of resistance to checkpoint blockade. Our TMAb platform is designed to generate conditionally active antibodies with enhanced tumor specificity. Notably, we have been pleased with the breakthrough preclinical data on SNS-101, our anti-VISTA antibody, which we believe support our hypothesis that an antibody binding selectively in low-pH environments has the potential to effectively inhibit tumor growth across a range of indications without on-target, off-tumor effects," said John Celebi, president and chief executive officer of Sensei Biotherapeutics. "We have also achieved a milestone with the generation of pH-sensitive antibodies for a second program targeting VSIG4. With cash runway into 2025, we believe we are well positioned to achieve near-term milestones, including the anticipated submission of an Investigational New Drug application for SNS-101 in the first half of 2023."

Highlights and Milestones

SNS-101

Sensei continues preclinical studies to evaluate SNS-101, a monoclonal antibody targeting the immune checkpoint VISTA (V-domain Ig suppressor of T cell activation), which is implicated in resistance to PD-1/PD-L1 therapy and correlates with poor survival across numerous cancers. Recent updates for SNS-101 include:

Sensei has received pre-IND meeting feedback from the U.S. Food and Drug Administration and expects to submit an IND in the first half of 2023.
The Company plans to present new data from a single dose pharmacokinetic (PK) and toxicology model in non-human primates in the third quarter of 2022.
Sensei will present new preclinical cytokine release data comparing SNS-101 to a non-pH-selective anti-VISTA antibody at the Sixth CRI-ENCI-AACR International Cancer Immunotherapy Conference (CIMT) (Free CIMT Whitepaper): Translating Science Into Survival, being held September 28 – October 1, 2022 in New York City.
In April 2022, Sensei presented preclinical data demonstrating that SNS-101 had a favorable pharmacokinetic profile in a single-dose mouse model. Notably, SNS-101 demonstrated a long mean residence time in the blood, indicating a lack of significant target-mediated drug disposition and clearance in non-malignant tissues.
Also in April 2022, preclinical data in an MC38 syngeneic tumor model in human VISTA knock-in mice demonstrated synergistic anti-tumor activity in combination with anti-PD-1 therapy.
SNS-101 has demonstrated excellent manufacturing productivity to date and GMP manufacturing timelines remain on track.
SNS-102

Sensei is advancing several pH-sensitive antibodies targeting VSIG4 (V-Set and Immunoglobulin Domain Containing 4). VSIG4 is a B7-family related protein that is a potent inhibitor of T cell activity and is frequently overexpressed on tumor-associated macrophages.

Sensei remains on track to select a product candidate and initiate IND-enabling studies in 2023.
Sensei has identified eight parental pH-sensitive antibodies targeting VSIG4 for further optimization.
The Company aims to develop a pH-dependent, high-affinity inhibitory antibody which selectively binds VSIG4 in the tumor microenvironment versus normal tissue.
SNS-103

Sensei remains on track to select a product candidate in 2023 for SNS-103, a monoclonal antibody targeting ENTPDase1 (ecto-nucleoside triphosphate diphosphohydrolase-1, also known as CD39), the upstream, rate-limiting enzyme that leads to the breakdown of extracellular ATP.
Second Quarter 2022 Financial Results

Cash Position: Cash, cash equivalents and marketable securities were $123.7 million as of June 30, 2022, as compared to $147.6 million as of December 31, 2021. Sensei expects its current cash balance to fund operations into the first quarter of 2025.

Research and Development (R&D) Expenses: R&D expenses were $6.4 million for the quarter ended June 30, 2022, compared to $5.9 million for the quarter ended June 30, 2021. The increase in R&D expenses was primarily attributable to increased headcount and inflation on supplies to support Sensei’s research, development, and manufacturing activities.

General and Administrative (G&A) Expenses: G&A expenses were $4.3 million for the quarter ended June 30, 2022, compared to $3.9 million for the quarter ended June 30, 2021, with the increase mainly driven by franchise tax increases.

Net Loss: Net loss was $10.5 million for the quarter ended June 30, 2022, compared to $9.8 million for the quarter ended June 30, 2021.

Epizyme Reports Second Quarter 2022 Financial Results and Provides Business Update

On August 9, 2022 Epizyme (Nasdaq: EPZM), a fully integrated, commercial-stage biopharmaceutical company developing and delivering transformative therapies for cancer patients against novel epigenetic targets, reported second quarter 2022 financial results and provided a business update (Press release, Epizyme, AUG 9, 2022, View Source [SID1234617936]).

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"I am pleased with the progress we made as an organization in the second quarter. In addition to the growth of TAZVERIK net product revenue, we are continuing to advance several of our tazemetostat clinical studies, and we also dosed the first patient in the Phase 1 portion of our SET-101 study with our SETD2 inhibitor candidate. For TAZVERIK, we saw double-digit quarter-over-quarter growth in total end user demand and continued improvement in key metrics suggesting greater prescriber understanding and adoption of TAZVERIK, consistent with our label," said Grant Bogle, President and Chief Executive Officer. "Most importantly, the quarter brought with it news of Epizyme’s decision to enter into a definitive merger agreement with Ipsen. Through this merger, we expect continued investment in our epigenetic pipeline for the benefit of patients."

Recent Progress

TAZVERIK commercial progress:
TAZVERIK generated net product revenue of $11.0 million for the second quarter of 2022, including $8.9 million related to TAZVERIK commercial net sales, representing an increase of approximately 10% when compared to $8.1 million in the first quarter of 2022. Sales of TAZVERIK commercial product for third-party pharmaceutical company use in clinical trials was $2.1 million in the second quarter of 2022.
Total end user demand grew 17% in the second quarter of 2022 when compared to the first quarter of 2022, which includes commercial demand and free goods supplied through Epizyme’s patient assistance program. Commercial demand grew 8% when compared to the first quarter of 2022.
The amount of free goods supplied to patients through the patient assistance program was approximately 22% of total end user demand for the second quarter of 2022 as compared to approximately 15% in the first quarter of 2022. The free goods level in the second quarter of 2022 was consistent with the second quarter of 2021.
First patient dosed in the Phase 1 portion of the SET-101 Phase 1/1b study of EZM0414 in multiple myeloma (MM): Dosing of the first patient was recently completed in SET-101, the Phase 1/1b study of EZM0414, Epizyme’s novel, first-in-class, oral SETD2 inhibitor candidate, which is being developed for the treatment of adult patients with relapsed/refractory (R/R) MM and R/R diffuse large B-Cell lymphoma (DLBCL).
Merger with Ipsen: In June, Ipsen and Epizyme executed a definitive merger agreement under which Ipsen has initiated a tender offer to acquire all outstanding shares of Epizyme for $1.45 per share, plus a contingent value right (CVR) of $1.00 per share. The merger is expected to close by the end of the third quarter of 2022 (subject to the satisfaction of all closing conditions). Additional details can be found in the announcement press release as well as in Epizyme’s recent SEC filings.
Tazemetostat Clinical Updates

Presented updates from SYMPHONY-1 tazemetostat + R2 combination study in R/R follicular lymphoma (FL) at ASCO (Free ASCO Whitepaper) 2022: In June, Epizyme presented updated safety and activity data from the Phase 1b portion of the SYMPHONY-1 study at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. The Phase 1b portion of the study showed continued improvement in both objective and complete response rates, as well as response data for a subgroup of patients who are rituximab-refractory and/or relapsed within 24 months (POD24). The study is open for enrollment globally, and Epizyme anticipates providing longer term follow-up data from the Phase 1b portion of the study at a medical conference later this year.
CELLO-1 Phase 1b/2 study has completed enrollment; updated safety run-in data expected later in 2022: The Phase 2 randomized portion of the CELLO-1 study (EZH-1101), which is evaluating tazemetostat plus enzalutamide compared to enzalutamide monotherapy in metastatic castration-resistant prostate cancer patients, has completed enrollment with a total of 80 patients. Epizyme expects to present updated data from the safety run-in portion later in 2022.
LYSA Phase 1/2 combination study has completed enrollment; top-line results expected later in 2022: Enrollment in both the DLBCL and FL arms of this study is complete. The Lymphoma Study Association (LYSA) study is a Phase 1/2 combination study of tazemetostat with R-CHOP in high-risk, front-line FL and DLBCL patients. Epizyme, in collaboration with LYSA, anticipates sharing top-line results from the Phase 2 portion of the study later in 2022.
ARIA hematological basket study (EZH-1501) open for enrollment: The Company continues to screen patients for ARIA, the Phase 1b/2 basket study evaluating tazemetostat combinations in patients with hematological malignancies.
Updates on tazemetostat development in China: On August 1, Epizyme’s collaboration partner, HUTCHMED, announced the initiation of a bridging study of tazemetostat in China with the first patient dosed on July 29, 2022. This multicenter, open-label, Phase 2 study will evaluate the efficacy, safety, and pharmacokinetics of tazemetostat for the treatment of patients with R/R FL.
Second Quarter 2022 Financial Results

Cash Position: Cash, cash equivalents and marketable securities were $144.4 million as of June 30, 2022, compared to $199.7 million as of March 31, 2022.
Revenue: Total revenue was $27.5 million for the second quarter of 2022, an increase of 112% vs. $13.0 million for the second quarter of 2021. Total revenue for the second quarter of 2022 consisted of $11.0 million of net product revenue and $16.5 million of collaboration and other revenue. The net product revenue was comprised of $8.9 million in commercial net sales of TAZVERIK and $2.1 million of TAZVERIK related to the sale of commercial product by one of the Company’s customers to a third-party pharmaceutical company for use in its clinical trials. Net product revenue of TAZVERIK in the U.S. in the second quarter of 2022 increased 38% vs. $8.0 million for the second quarter of 2021. The $16.5 million of collaboration and other revenue was recognized under our license agreement with HUTCHMED, $11.8 million of which related to the recognition of revenue that had previously been deferred.
Operating Expenses: Total GAAP operating expenses were $57.3 million for the second quarter of 2022, a decrease of 20% vs. $71.2 million for the second quarter of 2021, reflecting focused efforts on streamlining operations. Total non-GAAP adjusted operating expenses were $51.6 million for the second quarter of 2022, compared to $63.2 million for the second quarter of 2021.
R&D expenses: GAAP R&D expenses were $28.1 million for the second quarter of 2022, a 19% decrease compared to $34.9 million for the second quarter of 2021. Non-GAAP adjusted R&D expenses were $26.5 million for the second quarter of 2022, compared to $32.7 million for the second quarter of 2021.
SG&A expenses: GAAP SG&A expenses were $24.1 million for the second quarter of 2022, compared to $33.9 million for the second quarter of 2021, representing a 29% decrease following the previously announced operating expense and workforce reductions. Non-GAAP adjusted SG&A expenses were $21.0 million for the second quarter of 2022, compared to $29.1 million for the second quarter of 2021.
Net Loss (GAAP): Net loss attributable to common stockholders was $35.7 million, or $0.21 per share, for the second quarter of 2022, compared to $64.4 million, or $0.63 per share, for the second quarter of 2021.
A reconciliation of non-GAAP adjusted financial measures directly comparable to GAAP financial measures is presented in the table attached to this press release.
About Non-GAAP Financial Measures

In addition to financial information prepared in accordance with the U.S. generally accepted accounting principles (GAAP), this press release includes the following non-GAAP financial measures: total non-GAAP adjusted operating expenses on a historical basis, non-GAAP adjusted R&D expenses on a historical basis and non-GAAP adjusted SG&A expenses on a historical basis. Epizyme derives these non-GAAP financial measures by excluding certain expenses and other items from the respective GAAP financial measure that is most directly comparable to each non-GAAP financial measure. Specifically, the non-GAAP financial measures exclude stock-based compensation expense and depreciation and amortization of intangibles. The Company’s management believes that these non-GAAP financial measures are useful to both management and investors in analyzing its ongoing business and operating performance. Management does not intend the presentation of these non-GAAP financial measures to be considered in isolation or as a substitute for results prepared in accordance with GAAP, but as a complement to provide greater transparency. In addition, these non-GAAP financial measures may differ from similarly named measures used by other companies.

About TAZVERIK (tazemetostat)

TAZVERIK is a methyltransferase inhibitor indicated for the treatment of:

Adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection.
Adult patients with relapsed or refractory follicular lymphoma whose tumors are positive for an EZH2 mutation as detected by an FDA-approved test and who have received at least two prior systemic therapies.
Adult patients with relapsed or refractory follicular lymphoma who have no satisfactory alternative treatment options.
These indications are approved under accelerated approval based on overall response rate and duration of response. Continued approval for these indications is contingent upon verification and description of clinical benefit in confirmatory studies.

The most common (≥20%) adverse reactions in patients with epithelioid sarcoma are pain, fatigue, nausea, decreased appetite, vomiting and constipation. The most common (≥20%) adverse reactions in patients with follicular lymphoma are fatigue, upper respiratory tract infection, musculoskeletal pain, nausea and abdominal pain.

View the U.S. Full Prescribing Information here: Epizyme.com.

About EZM0414

EZM0414 is a potent selective, oral, small molecule, investigational drug agent that inhibits the histone methyltransferase, SETD2, which plays a role in oncogenesis. SETD2 methylates histone as well as non-histone proteins, and this activity is involved in several key biological processes including transcriptional regulation, RNA splicing, and DNA damage repair. Based on the preclinical data on SETD2 inhibition by EZM0414 in multiple settings, including high risk t(4;14) multiple myeloma (MM) and in other B-cell malignancies such as diffuse large B-cell lymphoma (DLBCL), the Company is conducting SET-101, a Phase 1/1b study of EZM0414, for the treatment of adult patients with relapsed or refractory MM and DLBCL.

Foghorn Therapeutics Provides Second Quarter 2022 Financial and Corporate Update

On August 9, 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, today provided a financial and corporate update in conjunction with the Company’s 10-Q filing for the quarter ended June 30, 2022 (Press release, Foghorn Therapeutics, AUG 9, 2022, View Source [SID1234617935]). 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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"During the second quarter, supported by a strong balance sheet, Foghorn continued to advance its broad and deep pipeline of more than a dozen highly differentiated programs while making important progress towards our goal of becoming a fully integrated biotech company," said Foghorn CEO Adrian Gottschalk. "We continue to enroll patients in the Phase 1 dose escalation study of FHD-286 in uveal melanoma and FHD-609 in synovial sarcoma, and we have been working diligently to resolve the partial clinical hold of FHD-286 in AML and MDS. In addition, we are pleased with the continued progress with our Merck collaboration, and in particular, the achievement of the first research milestone."

Key Recent Updates

FHD-286 AML/MDS Update. In May, the Food and Drug Administration (FDA) placed the Phase 1 dose escalation study of FHD-286 in relapsed and/or refractory acute myelogenous leukemia (AML) and myelodysplastic syndrome (MDS) on a partial clinical hold. The partial clinical hold was initiated by the FDA following the report of a recent death that occurred in a subject with potential differentiation syndrome. Differentiation syndrome is associated with AML/MDS therapeutics that induce differentiation, an effect that is believed to be on-target for the proposed mechanism of action for FHD-286. The Company continues to work to resolve the partial clinical hold with the FDA.

FHD-286 mUM Update. The dose escalation Phase 1 study in metastatic uveal melanoma (mUM) continues to enroll patients per protocol. The partial clinical hold does not apply to this study of FHD-286.

FHD-609 Update. Patient enrollment is continuing in the Phase 1 dose escalation clinical study of FHD-609, a potent and selective heterobifunctional protein degrader of BRD9, initially being developed for the treatment of synovial sarcoma with initial data expected in 2023.

Merck Collaboration Update. In July 2022, a research milestone was achieved under the Merck collaboration triggering a $5 million milestone payment to Foghorn which will be reflected in the quarter ended September 30, 2022 financials.

BRM-selective Progress. Foghorn is advancing its BRM-selective programs in collaboration with Loxo@Lilly, with the BRM-selective inhibitor program in lead optimization and the protein degrader program in hit-to-lead stage. Foghorn is leading discovery and early research activities, and Lilly is leading development and commercialization activities with participation from Foghorn. U.S. economics will be shared equally, and Foghorn is eligible to receive royalties on ex-U.S. sales in the low double-digit to twenties range based on revenue levels.

Pipeline Advancement. Foghorn continued to advance 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. We continue to invest in our protein degradation capabilities with approximately half of our pipeline programs utilizing this modality. This investment includes our protein degrader asset, ARID1B, for which we have identified several different biophysically validated chemical scaffolds.

Second Quarter 2022 Financial Highlights

Strong Balance Sheet and Cash Runway. As of June 30, 2022, the Company had $394.7 million in cash, cash equivalents and marketable securities.
Collaboration Revenues. Collaboration revenues were $4.5 million for the second quarter of 2022 compared to $0.3 million the second quarter of 2021. The increase was driven by revenue recognized under the Lilly Collaboration Agreement which was entered into in December 2021.
Research and Development Expenses. Research and development expenses were $26.0 million for the second quarter of 2022 compared to $18.6 million for the second quarter of 2021. This increase was primarily due to costs associated with the Phase 1 studies for both FHD-286 and FHD-609, which were initiated in 2021, and continued investment in R&D personnel, the platform and other early-stage research.

General and Administrative Expenses. General and administrative expenses were $7.7 million for the second quarter of 2022, compared to $4.9 million for the second quarter of 2021. This increase was primarily due to an increase in headcount to support the growing business.

Net Loss. Net loss was $27.3 million for the second quarter of 2022 compared to a net loss of $23.1 million for the second quarter of 2021.

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.

Beam Therapeutics Announces Pipeline and Business Highlights and Reports Second Quarter 2022 Financial Results

On August 9, 2022 Beam Therapeutics Inc. (Nasdaq: BEAM), a biotechnology company developing precision genetic medicines through base editing, reported financial results for the second quarter ended June 30, 2022 (Press release, Beam Therapeutics, AUG 9, 2022, View Source [SID1234617934]).

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"2022 is a critical year for Beam’s transition to becoming a multi-program clinical-stage company, as we prepare for the near-term initiation of patient enrollment in our BEACON Phase 1/2 trial, the first clinical trial evaluating BEAM-101 in patients with sickle cell disease," said John Evans, chief executive officer of Beam. "In June, we submitted our IND for BEAM-201 for CD7-positive T-cell malignancies and recently received notification from the FDA of a clinical hold on the IND. We look forward to receiving more detail from the FDA and working with them in an effort to advance BEAM-201 for these difficult-to-treat cancer indications. We are on track to further expand our portfolio with a steady cadence of clinical and preclinical milestones expected in the quarters ahead, including the IND submission for BEAM-102, our second program in sickle cell disease, and the initiation of IND-enabling studies for BEAM-301, our first liver-directed base editing program in glycogen storage disease, both targeted in the second half of this year."

Mr. Evans added, "As pioneers and leaders in the field of base editing, we’ve continued to extend the potential reach of our base editing technology and applications with the development of new base editors, as well as novel base editing-enabled therapeutic strategies, such as our work on non-genotoxic conditioning to improve transplant regimens. We’ve also continued to enhance our team, and I’m thrilled to welcome John Lo as chief commercial officer. John has a deep science background and an extensive track record in the strategic development and commercialization of novel medicines, including cell therapy products, at leading companies. I can’t wait to work with him to advance our portfolio and our vision of providing a new class of precision genetic medicines to patients."

Pipeline Updates & Anticipated Milestones
Ex Vivo HSC Programs

Beam remains on track to begin patient enrollment in its BEACON trial, an open-label, single-arm, multicenter, Phase 1/2 clinical trial evaluating the safety and efficacy of BEAM-101 in adult patients with severe sickle cell disease (SCD) in the second half of 2022.
BEAM-102 continues to progress, and the company plans to submit an investigational new drug (IND) application for BEAM-102 for the treatment of SCD in the second half of 2022.
Ex Vivo T Cell Programs

Beam submitted its IND for BEAM-201 to the U.S. Food and Drug Administration (FDA) in June 2022, and on July 29, 2022, was notified via e-mail that the IND was placed on clinical hold. The FDA indicated it will provide an official clinical hold letter to Beam within 30 days. Beam plans to provide additional updates pending interaction with the FDA.
Beyond BEAM-201, Beam is focused on identifying the collection of multiplex base edits required to make cells fully allogeneic, with internal and external data suggesting a higher number of edits will be required to meet this goal. As a result, Beam does not expect to nominate a second CAR-T development candidate in 2022 and anticipates providing further updates in 2023.
In Vivo LNP Liver-targeting Programs

Beam presented updated preclinical data from its BEAM-301 program at the American Society of Cell and Gene Therapy (ASGCT) (Free ASGCT Whitepaper) meeting, highlighting that BEAM-301 demonstrated high and durable editing efficiency in a mouse model of glycogen storage disease 1a (GSDIa) out to 35 weeks. BEAM-301, a liver-targeting lipid nanoparticle (LNP) formulation of base editing reagents designed to correct the R83C mutation, the most common disease-causing mutation of GSDIa, is on track for initiation of IND-enabling studies in the second half of 2022.
At ASGCT (Free ASGCT Whitepaper), Beam also presented new preclinical data from its base editing program targeting the treatment of alpha-1 antitrypsin deficiency, highlighting optimizations made to the editor and the guide RNA that have led to two-fold increases in observed editing potency in mice, leading to potentially clinically relevant increases in circulating alpha-1 antitrypsin at doses below 1 mg/kg.
Beam plans to present new in vivo preclinical data from its multiplex base editing program for the potential treatment of hepatitis B virus (HBV) in a poster titled, "Cytosine base editing inhibits Hepatitis B Virus replication and reduces HBsAg expression in vitro and in vivo," at the 2022 International HBV Meeting from Sept. 18-22. The data will build on initial in vitro data presented in September 2021, which showed that base editing can introduce permanent mutations in covalently closed circular DNA (cccDNA) and prevent HBV rebound in relevant models.
Beam continues to anticipate the nomination of a second liver-targeted development candidate in 2022.
Recent Research Highlights

At the Federation of American Societies for Experimental Biology (FASEB) Genome Engineering Conference in June, Beam presented the first research highlighting the company’s internal efforts to develop improved transplant conditioning regimens for patients with SCD undergoing hematopoietic stem cell transplantation (HSCT). With a goal of overcoming limitations of today’s conditioning regimens, Beam leveraged its base editing capabilities to develop a potentially non-genotoxic approach that combines antibody-based conditioning with multiplex gene-edited hematopoietic stem cells (HSCs) called ESCAPE, or Engineered Stem Cell Antibody Paired Evasion. These improved conditioning regimens could potentially be paired with BEAM-101 and BEAM-102, as well as other future programs.
At the CRISPR 2.0 conference in June, Beam highlighted research that led to the creation of an improved class of cytosine base editors (CBEs), leveraging a TadA enzyme-based CBE (CBE-T), that are capable of editing at levels comparable to traditional CBEs but with lower off-target editing potential. Further, Beam disclosed an additional editor, CABE-T, that can conduct both C-to-T and A-to-G edits with a single TadA deaminase.
Business Updates

Beam recently appointed John Lo, Ph.D., as chief commercial officer, where he will be responsible for commercial readiness, as well as leading product and portfolio strategy. Dr. Lo joins Beam after serving as an advisor to multiple private- and public-stage biotechnology companies, including Beam. Dr. Lo has held a number of global strategic and operating roles of increasing responsibility within the biopharmaceutical industry, including as senior vice president, worldwide hematology at Bristol Myers Squibb; head of global marketing and market access at Astra Zeneca; corporate vice president, hematology and oncology at Celgene; and multiple P&L roles at Novartis. While at these companies, Dr. Lo successfully helped launch numerous drugs in the U.S. and globally, including Tagrisso in lung cancer and two cell therapies. Dr. Lo has also helped build strategies and grow R&D pipelines as co-chair of the Development Committee at Celgene, leading to multiple pivotal study investments. Dr. Lo also spent several years as an associate principal at McKinsey & Company and holds a Ph.D. in molecular biology from MIT.
In July, Beam and Verve Therapeutics amended their collaboration and license agreement, originally executed in April 2019. The amended agreement returned two targets to Beam, while adding a new, third target toward an additional liver-mediated, cardiovascular disease target. Beam has the right to opt in on this target after Phase 1 to share 35% of worldwide costs and profits from the program. The two lead targets in the collaboration, PCSK9 and ANGPTL3, are unchanged. Verve also granted to Beam licenses and options to certain delivery technologies.
Second Quarter 2022 Financial Results

Cash Position: Cash, cash equivalents and marketable securities were $1.2 billion as of June 30, 2022, as compared to $965.6 million as of December 31, 2021.
Research & Development (R&D) Expenses: R&D expenses were $74.6 million for the second quarter of 2022, compared to $45.6 million for the second quarter of 2021.
General & Administrative (G&A) Expenses: G&A expenses were $24.1 million for the second quarter of 2022, compared to $13.4 million for the second quarter of 2021.
Net Loss: Net loss was $72.0 million for the second quarter of 2022, or $1.02 per share, compared to $76.3 million for the second quarter of 2021, or $1.23 per share.

PERRIGO REPORTS SECOND QUARTER FISCAL YEAR 2022 FINANCIAL RESULTS FROM CONTINUING OPERATIONS

On August 9, 2022 Perrigo Company plc (NYSE: PRGO) ("Perrigo" or the "Company"), a leading provider of Consumer Self-Care Products, reported financial results for the second quarter ended July 2, 2022 (Press release, Perrigo Company, AUG 9, 2022, View Source [SID1234617933]). All comparisons are against the prior year fiscal second quarter, unless otherwise noted.

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President and CEO, Murray S. Kessler commented, "This was a truly remarkable quarter for the Perrigo team. During the quarter: we closed the HRA transaction, closed on $2.6 billion senior secured credit facilities, received FDA approval for and launched the Company’s first led Rx-to-OTC switch of Nasonex 24HR, filed with the FDA for the first ever Rx-to-OTC switch for a daily birth control pill, and worked around the clock at our infant formula facilities to help mitigate the shortage in the United States – all the while delivering a constant currency 20% increase in net sales and a 310 basis points sequential improvement in our consolidated adjusted gross margin. All of this was achieved despite a dynamic external environment, including severe inflationary headwinds. I couldn’t be prouder of the performance of my Perrigo colleagues as our self-care strategy is being executed with excellence."

Kessler continued, "While we remain certain that the self-care strategy is the correct approach and we are executing well against it, we recognize that the macro-economic environment has and will continue to present significant headwinds in the near-term. Based on the strong performance of the business, as evident in continued strong demand, increased organic net sales outlook and sequentially improving margins, we expect to cover incremental headwind costs with the exception of the massive negative impact from foreign currency exchange. We continue to be excited about our future and look forward to delivering double-digit top and bottom line growth over the next few years as we ‘Optimize and Accelerate’ the newly transformed Perrigo Consumer Self-Care Company."

Refer to Tables I – VI at the end of this press release for a reconciliation of non-GAAP adjustments to the current year and prior year periods and additional non-GAAP information. The Company’s reported results are included in the attached Consolidated Statements of Operations, Balance Sheets and Statements of Cash Flows.

Global Reporting Category Updates
As a result of the completed acquisition of HRA, the Company has updated its global reporting categories beginning in the second quarter of 2022 as follows:

The creation of a new "Women’s Health" reporting category, comprised of the women’s health portfolio of HRA, including ellaOne and Hana, in addition to legacy Perrigo women’s health products, including feminine hygiene and pregnancy products.
The creation of a new "Skin Care" reporting category, comprised of Compeed, Mederma, and all of the products in the legacy Perrigo "Skincare and Personal Hygiene" category except for legacy Perrigo women’s health products.
The "Other" category now includes the HRA Rare Diseases business.
These product category updates have been adjusted retrospectively to reflect this change. These updates have no impact on the Company’s historical consolidated financial position, results of operations, or cash flows.

Second Quarter 2022 Perrigo Results from Continuing Operations
Perrigo net sales for the second quarter were $1.1 billion, an increase of $141 million or 14.3%, including a positive impact of 6.8 percentage points from acquisitions, and negative impacts of 5.9 percentage points and 3.8 percentage points from adverse currency translation and divested businesses, respectively. Organic net sales increased 17.2%.

Net sales were driven by 1) $65 million in constant currency net sales from the April 29, 2022 closing of the acquisition of HRA, 2) higher global incidences of cough/cold and flu-like illnesses, including COVID-19, leading to an increase of $72 million in cough/cold-related sales that benefited the Upper Respiratory and Pain and Sleep Aids categories, 3) contract manufacturing sales to the divested RX business of $38 million, and 4) strong growth of $29 million in the Nutrition category stemming from store brand infant formula share gains amid a national brand recall. These drivers also benefited from increased pricing across both Consumer Self-Care segments, strong e-commerce growth and new product sales. These increases were partially offset by 1) the impact of adverse currency translation of $58 million, and 2) $30 million from divested businesses.

Second quarter reported operating loss was $7 million, compared to an operating loss of $126 million in the prior year period, due primarily to the absence of $159 million of prior year impairment charges related to the divested Latin American businesses. Adjusted operating income decreased $1 million, or 0.9%, to $116 million. Constant currency adjusted operating income increased 7.9% driven by 1) higher gross profit flow-through resulting from higher volumes and increased pricing, 2) the addition of HRA, and 3) cost savings from Project Momentum. These factors were partially offset by 1) $39 million in cost headwinds, including cost of goods sold inflation, increased freight expenses and lower plant productivity stemming from a tight labor market, and 2) higher operating expenses, driven primarily by the inclusion of HRA, in addition to higher employee and distribution costs compared to the prior year.

Reported net loss was $65 million, or $0.48 per diluted share, compared to reported net loss of $112 million, or $0.84 per diluted share, in the prior year period. Excluding certain charges as outlined in Table I, second quarter 2022 adjusted net income was $59 million, or $0.43 per diluted share, compared to $68 million, or $0.50 per diluted share, in the prior year. Constant currency EPS for the quarter was $0.49.

Cough/cold-related net sales includes the cough/cold sub-category within Upper Respiratory and the adult and children’s analgesics sub-categories within the Pain and Sleep Aids category.

Second Quarter 2022 Business Segment Results from Continuing Operations
Consumer Self-Care Americas Segment

CSCA second quarter net sales of $728 million increased $106 million, or 17.0%, including a positive impact of 1.6 percentage points from acquisitions, and a negative impact of 5.8 percentage points from divested businesses. Organic net sales growth was 21.2%. Primary category drivers are provided below.

Upper Respiratory
Net sales of $146 million increased 38.6% due primarily to higher incidences of cough/cold and flu-like illnesses, including COVID-19, that led to strong demand, online and in-store, for cough/cold-related products. Sales of allergy products were higher, despite lower levels of incidence compared to the year ago period, due primarily to increased promotions at a particular customer.

Digestive Health
Net sales of $125 million increased 8.8% due primarily to growth in store brand proton pump inhibitor products, including the store brand versions of Esomeprazole and Omeprazole, driven by share gains, in addition to growth in store brand versions of Famotidine.

Nutrition
Net sales of $125 million increased 30.6% due primarily to strong growth in infant formula stemming from store brand share gains, due in part to new product launches and a national brand recall, as well as third-party contract sales. Continued growth in the oral electrolytes business also contributed to the quarter.

Pain & Sleep-Aids
Net sales of $103 million increased 14.8% due primarily to strong demand, online and in-store, for analgesics products stemming from higher incidences of cough/cold and flu-like illnesses, including COVID-19.

Oral Care
Net sales of $77 million increased 1.2% due primarily to sales of store brand products, particularly non-power toothbrushes, mostly offset by a decline in branded offerings stemming from delayed receipt of products manufactured outside the U.S., leading to unfulfilled customer orders.

Healthy Lifestyle
Net sales of $67 million increased 4.0% due primarily to increased distribution of store brand smoking cessation products, partially offset by the discontinuation of diabetes products.

Skin Care
Net sales of $49 million increased 3.2% due primarily to the addition of HRA brands, including Mederma and Compeed, partially offset by the divested ScarAway brand asset and discontinued product in non-strategic category segments.

Women’s Health
Net sales of $12 million increased 48.1% due primarily to the addition of HRA brands, including ella.

Vitamins, Minerals, and Supplements ("VMS") and Other
Net sales of $25 million increased 17.0% due primarily to contract manufacturing sales to the divested RX business in the Other category.

Reported operating income was $86 million in the quarter compared to an operating loss of $72 million in the prior year period, due primarily to the absence of $159 million of prior year impairment charges related to the divested Latin American businesses. Adjusted operating income decreased $2 million to $105 million due primarily to 1) cost headwinds, including cost of goods sold inflation and increased freight expenses, 2) lower plant productivity, including reduced volumes due to a tight labor market, 3) the impact of divestitures, and 4) higher operating expenses to support net sales growth. These factors were mostly offset by higher gross profit flow-through resulting from higher net sales growth and the addition of HRA.

Consumer Self-Care International Segment

CSCI net sales of $394 million increased $35 million, or 9.7%, including a positive impact of 15.2 percentage points from acquisitions, partially offset by negative impacts of 16.1 percentage points and 0.9 percentage points from currency translation and lower sales in Ukraine and Russia, respectively. Organic net sales growth was 10.6%. Primary category drivers are provided below.

Skin Care
Net sales of $120 million increased 21.9%, or an increase of 43.0% excluding the impact from currency translation, driven primarily by the addition of HRA brands, including Compeed, strong performance in the Sebamed and ACO skincare lines, and increased net sales of anti-parasite offerings, due to the easing of COVID-19-related restrictions. These benefits were partially offset by lower sales in Ukraine and Russia.

Upper Respiratory
Net sales of $60 million increased 41.0%, or 59.0% excluding the impact of currency, as the higher incidences of cough/cold and flu-like illnesses, including COVID-19, led to strong demand for cough/cold products, including Bronchonolo, Bronchostop and Coldrex and U.K. store brands. In addition, a relatively stronger hayfever season drove net sales performance of allergy products, particularly the Beconase brand in the U.K.

VMS
Net sales of $48 million decreased 11.9%, or 0.4% excluding the impact of currency, due primarily to lower overall category consumption and lower sales of the probiotic brand Probify in certain geographies, partially offset by the restocking of the Abtei brand in Germany following the third quarter 2021 recall of certain batches.

Pain & Sleep-Aids
Net sales of $49 million increased 0.4%, or 12.8% excluding the impact of currency, due primarily to higher demand for Solpadeine, a paracetamol-based analgesics product, as well as an increase in U.K. store brand consumption within the category. These increases were driven primarily by strong demand for analgesics products stemming from higher incidences of cough/cold and flu-like illnesses, including COVID-19.

Healthy Lifestyle
Net sales of $39 million decreased 17.6%, or 7.7% excluding the impact of currency, due primarily to lower net sales in the XLS Medical weight management franchise stemming from lower category consumption, partially offset by stronger performance of NiQuitin smoking cessation products, due to customer restocking following supply constraints earlier in the year.

Women’s Health
Net sales of $24 million increased 69.4%, or an increase of 93.3% excluding the impact of currency, due primarily to the addition of HRA brands, including ellaOne and NorLevo.

Digestive Health, Oral Care and Other
Net sales of $54 million increased 0.6%, or an increase of 17.1% excluding the impact of currency, due primarily to the addition of the HRA Rare Diseases portfolio in the Other category.

Reported operating income was $2 million in the quarter compared to $1 million in the prior year quarter. Adjusted operating income increased $7 million, or 15.1%, to $54 million. Constant currency adjusted operating income grew 36.3%, driven by higher gross profit flow-through resulting from higher volumes, increased pricing and the addition of HRA. These factors were partially offset by 1) cost headwinds, including cost of goods sold inflation and increased freight expenses, and 2) higher operating expenses, driven primarily by the inclusion of HRA, in addition to higher employee and distribution costs compared to the prior year.

Fiscal 2022 Outlook
The Company is increasing its fiscal 2022 organic net sales growth range outlook to 9.0%-10.0%, from 8.0%-9.0%, versus the prior year, due to continued strong global consumer demand. The Company is reaffirming its fiscal 2022 total net sales growth range outlook of 8.5%-9.5%, as the organic net sales growth outlook increase is expected to be offset by the worsening impact of currency translation.

The Company expects to achieve a fiscal 2022 constant currency adjusted EPS range outlook of $2.40-$2.50 per diluted share and is updating its fiscal 2022 adjusted EPS range outlook to $2.25-$2.35 from $2.30-$2.40, due entirely to the worsening impact of currency translation.

The Company continues to expect an adjusted effective tax rate of approximately 23% and cash flow from operations as a percentage of adjusted net income above its long-term range outlook of 95%-105%.

The Company cannot reconcile its organic net sales growth to reported net sales or its expected adjusted diluted EPS or constant currency adjusted EPS to diluted EPS under "Fiscal 2022 Outlook" without unreasonable effort because certain items that impact net income and other reconciling metrics are out of the Company’s control and/or cannot be reasonably predicted at this time. These items include taxes, interest costs that would occur if the Company issued debt, and costs to acquire and or sell a business if the Company executed such transactions, which could significantly affect our financial results. These items depend on highly variable factors and any such reconciliations would imply a degree of precision that would be confusing or misleading to investors.