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ReCode Therapeutics to Participate in Upcoming November Investor Conferences?

On November 2, 2022 ReCode Therapeutics, a genetic medicines company using superior delivery to power the next wave of mRNA and gene correction therapeutics, reported that Company leadership will participate in two upcoming investor conferences in November (Press release, ReCode Therapeutics, NOV 2, 2022, View Source;utm_medium=rss&utm_campaign=recode-therapeutics-to-participate-in-upcoming-november-investor-conferences%25ef%25bf%25bc [SID1234622814]):

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Credit Suisse 31st Annual Healthcare Conference

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Charles River Laboratories Announces Third-Quarter 2022 Results

On November 2, 2022 Charles River Laboratories International, Inc. (NYSE: CRL) reported its results for the third quarter of 2022 (Press release, Charles River Laboratories, NOV 2, 2022, View Source [SID1234622813]). For the quarter, revenue was $989.2 million, an increase of 10.4% from $895.9 million in the third quarter of 2021.

Acquisitions contributed 1.7% to consolidated third-quarter revenue growth. The divestitures of the Research Models and Services operations in Japan (RMS Japan) and CDMO site in Sweden (CDMO Sweden) in October 2021 reduced reported revenue growth by 2.1%. The impact of foreign currency translation reduced reported revenue growth by 4.5%. Excluding the effect of these items, organic revenue growth of 15.3% was driven by contributions from all three business segments, particularly the Discovery and Safety Assessment (DSA) business segment.

On a GAAP basis, third-quarter net income attributable to common shareholders was $96.5 million, a decrease of 6.7% from net income of $103.4 million for the same period in 2021. Third-quarter diluted earnings per share on a GAAP basis were $1.88, a decrease of 6.5% from $2.01 for the third quarter of 2021.

On a non-GAAP basis, net income was $134.7 million for the third quarter of 2022, a decrease of 3.2% from $139.1 million for the same period in 2021. Third-quarter diluted earnings per share on a non-GAAP basis were $2.63, a decrease of 2.6% from $2.70 per share for the third quarter of 2021.

The decreases in GAAP and non-GAAP net income and earnings per share were primarily driven by lower operating margins, as well as increased interest expense and a higher tax rate. These factors were largely offset by higher revenue. On a GAAP basis, higher acquisition-related adjustments were offset by the performance of venture capital and other strategic investments, which totaled a gain of $0.04 per share in the third quarter of 2022, compared to a loss of $0.15 per share for the same period in 2021. The Company’s venture capital and other strategic investment performance has been excluded from non-GAAP results.

James C. Foster, Chairman, President and Chief Executive Officer, said, "We are pleased with our third-quarter operating performance, which demonstrates the power of our unique portfolio that is centered on preclinical R&D services to support the biopharmaceutical industry. With a large and diversified client base and a broad, non-clinical portfolio that differentiates Charles River from other outsourced service providers, we believe that we are an excellent barometer of the sustained health of the biopharmaceutical industry."

"The third-quarter results reflect substantial revenue growth acceleration in the DSA segment, resulting from the strength of the Safety Assessment backlog that continues to afford us with excellent visibility into future client demand. We are confident that we will finish 2022 on a strong note and are encouraged by the solid growth prospects as we look into the new year," Mr. Foster concluded.

Third-Quarter Segment Results

Research Models and Services (RMS)

Revenue for the RMS segment was $180.1 million in the third quarter of 2022, an increase of 5.2% from $171.3 million in the third quarter of 2021. Organic revenue growth of 8.0% was primarily driven by research model services, particularly the Insourcing Solutions (IS) business, as well as small research models in North America and China.

In the third quarter of 2022, the RMS segment’s GAAP operating margin decreased to 19.9% from 22.8% in the third quarter of 2021, and on a non-GAAP basis, the operating margin decreased to 23.5% from 26.1%. The GAAP and non-GAAP operating margin decreases were primarily driven by the revenue mix and higher costs in China, as well as expansion costs related to opening new CRADL and Explora sites in the Insourcing Solutions business.

Discovery and Safety Assessment (DSA)

Revenue for the DSA segment was $619.5 million in the third quarter of 2022, an increase of 16.5% from $531.8 million in the third quarter of 2021. Organic revenue growth of 20.8% was primarily driven by broad-based growth in the Safety Assessment business, resulting from meaningful price increases and substantially higher study volume, both year-over-year and from first-half levels.

In the third quarter of 2022, the DSA segment’s GAAP operating margin increased to 22.9% from 21.9% in the third quarter of 2021, and on a non-GAAP basis, the operating margin increased to 26.2% from 24.3%. The GAAP and non-GAAP operating margin increases were driven primarily by operating leverage from higher revenue in the Safety Assessment business.

Manufacturing Solutions (Manufacturing)

Revenue for the Manufacturing segment was $189.6 million in the third quarter of 2022, a decrease of 1.7% from $192.9 million in the third quarter of 2021. Organic revenue growth of 6.0% reflected higher revenue in the Biologics Testing and Microbial Solutions businesses. These trends were partially offset by a revenue decline in the CDMO business.

In the third quarter of 2022, the Manufacturing segment’s GAAP operating margin decreased to 16.6% from 25.2% in the third quarter of 2021, and on a non-GAAP basis, the operating margin decreased to 28.6% from 32.7%. The GAAP and non-GAAP operating margin decreases were primarily as a result of lower revenue in the CDMO business.

Avian Vaccine Divestiture

The Company announced that it has signed a definitive agreement to divest its Avian Vaccine business for approximately $170 million in cash with potential contingent payments of up to an additional $30 million, subject to certain closing adjustments.

The Avian Vaccine business, which is part of Charles River’s Manufacturing Solutions segment, produces specific-pathogen-free (SPF) chicken eggs and associated products and services, principally for avian vaccine manufacturers and researchers. It has approximately 250 employees across approximately 20 sites in the United States.

The transaction is expected to close by the end of the year, and will not have a meaningful impact on 2022 revenue and non-GAAP earnings per share. In 2023, the divestiture is expected to reduce annual revenue by approximately $80 million and non-GAAP earnings per share by approximately $0.35, prior to any benefit from redeploying the proceeds towards other capital priorities. Items excluded from non-GAAP diluted earnings per share are expected to include gains on the sale of the businesses and all divestiture-related costs, which primarily include advisory fees and certain other transaction-related costs.

Updates 2022 Guidance

The Company is updating 2022 financial guidance, which was previously provided on August 3, 2022.

Revenue growth and non-GAAP earnings per share guidance are being narrowed to the upper end of the prior ranges, reflecting the solid, third-quarter performance. GAAP earnings per share guidance is being narrowed to the low end of the prior range, primarily as a result of contingent consideration adjustments related to the CDMO Sweden divestiture. The planned divestiture of the Avian Vaccine business will not have a meaningful impact on revenue and non-GAAP earnings per share in 2022, and an estimate for the gain on the sale of the business has not been included in the GAAP earnings per share guidance below.

The impact of foreign exchange on reported revenue growth continues to be a meaningful headwind in 2022, which is unchanged from our prior outlook in August. Compared to 2021, foreign currency translation is expected to reduce GAAP and non-GAAP earnings per share by $0.43 per share this year, which will reduce the earnings per share growth rates by approximately 550 basis points and 400 basis points on a GAAP and non-GAAP basis, respectively.

The Company’s guidance includes the addition of a 53rd week this year, which is necessary to true up to a December 31 year-end. The 53rd week, which will occur in the fourth quarter, was previously incorporated into our 2022 financial guidance and is characterized by a light week of sales but normal costs. This is expected to result in a 1.5% benefit to full-year reported revenue growth, but generate a modest operating margin headwind in the fourth quarter.

(1) Organic revenue growth is defined as reported revenue growth adjusted for completed acquisitions and divestitures, the 53rd week in 2022, and foreign currency translation.
(2) These adjustments are related to the evaluation and integration of acquisitions and divestitures, and primarily include transaction, advisory, certain third-party integration costs, and certain costs associated with acquisition-related efficiency initiatives, offset by adjustments related to contingent consideration and certain indirect tax liabilities.
(3) Venture capital and other strategic investment performance only includes recognized gains or losses. The Company does not forecast the future performance of these investments.
(4) These items primarily relate to charges associated with U.S. and international tax legislation that necessitated changes to the Company’s international financing structure; certain third-party legal costs related to (a) environmental litigation related to the Microbial Solutions business and (b) responses to a U.S. government industry-wide supply chain management inquiry applicable to our Safety Assessment business; and severance and other costs related to the Company’s efficiency initiatives.

Webcast

Charles River has scheduled a live webcast on Wednesday, November 2nd, at 9:00 a.m. ET to discuss matters relating to this press release. To participate, please go to ir.criver.com and select the webcast link. You can also find the associated slide presentation and reconciliations of GAAP financial measures to non-GAAP financial measures on the website.

Kura Oncology to Participate in Two Upcoming Investor Conferences

On November 2, 2022 Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, reported that Troy Wilson, Ph.D., J.D., President and Chief Executive Officer, is scheduled to participate in two upcoming investor conferences (Press release, Kura Oncology, NOV 2, 2022, View Source [SID1234622812]):

A fireside chat at the Credit Suisse Healthcare Conference in Ranch Palos Verdes, Calif. at 1:25 p.m. ET / 10:25 a.m. PT on November 9, 2022; and

A fireside chat at the Jefferies Global Healthcare Conference in London at 3:15 p.m. GMT / 10:15 a.m. ET / 7:15 a.m. PT on November 16, 2022.
Audio webcasts will be available in the Investors section of Kura’s website at www.kuraoncology.com, with archived replays available following both events.

Oncorus Reports Third Quarter 2022 Financial Results and Provides Business Updates

On November 2, 2022 Oncorus, Inc. (Nasdaq: ONCR), a viral immunotherapies company focused on driving innovation to transform outcomes for cancer patients, reported financial results for the third quarter of 2022 and highlighted recent achievements and developments (Press release, Oncorus, NOV 2, 2022, View Source [SID1234622811]).

"We continue to focus on our differentiated portfolio of intratumorally and intravenously administered viral immunotherapies across our two platforms. We’ve been tracking well against our set milestones for this year and are well positioned for further advancement across our portfolio," said Theodore (Ted) Ashburn, M.D., Ph.D., President and Chief Executive Officer of Oncorus. "We’ve bolstered our position within the viral immunotherapy landscape with the recent relocation of our company to our facility in Andover, Massachusetts, bringing research, process development and GMP-compliant manufacturing under one roof. With the completion of Andover, we are realizing our goal of becoming a fully integrated viral immunotherapies company. We are preparing to announce further data from our ongoing clinical trial of ONCR-177 in the fourth quarter of this year. In parallel, we are rapidly progressing our vRNA/LNP immunotherapy platform, further supported by the recent publication of promising preclinical results in Nature Communications. We expect an IND submission for our lead vRNA/LNP product candidate, ONCR-021, in mid-2023."

Third Quarter 2022 and Recent Business Highlights

On track to report combination data and additional monotherapy data for ONCR-177 in the fourth quarter of 2022. Oncorus continues to dose patients in its Phase 1 open-label, multi-center clinical trial in patients with advanced and/or refractory cutaneous, subcutaneous or metastatic nodal solid tumors or with liver metastases of solid tumors. The company expects to report initial surface lesion combination expansion data for ONCR-177 administered with Merck’s KEYTRUDA and additional surface lesion monotherapy expansion data in the fourth quarter of 2022.

Preclinical results featured in Nature Communications supporting intravenously administered self-amplifying viral RNA (vRNA)/lipid nanoparticle (LNP) immunotherapy platform. In October 2022, Oncorus published preclinical data in Nature Communicationshighlighting the potential of its vRNA/LNP immunotherapy platform as a novel approach to treating cancer through repeat intravenous (IV) administration. The data demonstrate vRNA/LNP delivery and selective replication, virus assembly, spread and lysis of tumor cells, leading to potent anti-tumor efficacy even in the presence of virus neutralizing antibodies in the bloodstream. Oncorus remains on track to submit an investigational new drug application (IND) for the company’s lead product candidate from this platform, ONCR-021, in mid-2023.

Completed construction phase of Good Manufacturing Practice (GMP) -compliant manufacturing facility in Andover, Massachusetts.Oncorus built its state-of-the-art, 105,000 square foot process development and GMP-compliant clinical manufacturing facility as a comprehensive solution for its Chemistry, Manufacturing and Controls (CMC) development needs, allowing for the manufacture, quality control and supply of clinical-grade viral immunotherapies for its IND-enabling and clinical studies. The company also relocated all
personnel and corporate activities to the facility, enabling collaboration among company personnel and enhanced efficiency.

Third Quarter 2022 Financial Results

Cash and cash equivalents and investments totaled $81.5 million as of September 30, 2022 compared to $123.9 million as of December 31, 2021.

Research and development expenses for the quarter ended September 30, 2022 were $14.1 million compared to $11.3 million for the corresponding quarter in 2021. The increase was primarily attributable to increased headcount, which drove higher employee compensation and stock-based compensation, increased development costs related to the company’s nominated candidates, as well as increased rent expense related to the company’s manufacturing facility.

General and administrative expenses for the quarter ended September 30, 2022 were $5.2 million compared to $5.4 million for the corresponding quarter in 2021. The slight decrease was primarily attributable to lower recruiting and consulting costs.

Net loss for the quarter ended September 30, 2022 was $19.6 million, or $0.76 per share, as compared to a net loss of $16.7 million, or $0.65 per share for the corresponding quarter in 2021.

Financial Guidance

Oncorus expects its cash, cash equivalents and investments to fund its capital expenditures and operating expenses into early 2024.

Seres Therapeutics Reports Third Quarter 2022 Financial Results and Provides Business Updates

On November 2, 2022 Seres Therapeutics, Inc. (Nasdaq: MCRB), a leading microbiome therapeutics company, reported third quarter 2022 financial results and provided business updates (Press release, Seres Therapeutics, NOV 2, 2022, View Source [SID1234622810]).

"Our recent progress, highlighted by the FDA acceptance of our SER-109 BLA for Priority Review, brings us closer to potentially offering a transformative new medicine to individuals caught in the vicious cycle of recurrent C. difficile infection," said Eric Shaff, President and Chief Executive Officer at Seres. "With a PDUFA date of April 26, 2023, we are closely engaging with the FDA and preparing for a potential product approval and commercial launch shortly thereafter. Alongside our collaborator, Aimmune Therapeutics, Inc., a Nestlé Health Science company, we are making excellent progress advancing educational efforts with physicians and payors in support of broad patient access, pending FDA approval. We look forward to hosting an investor event on December 8th to provide detailed information on the recurrent CDI market opportunity and our launch preparations."

Program and Corporate Updates

SER-109 Phase 3 program in recurrent C. difficile infection: SER-109, an investigational oral, live microbiome therapeutic, achieved its primary endpoint of superiority to placebo in reducing recurrence in patients with rCDI in the ECOSPOR III study. These results, initially published in the New England Journal of Medicine (NEJM), showed that 88% of SER-109 patients achieved a sustained clinical response compared to 60% on placebo at eight weeks. SER-109 was observed to be well tolerated with no drug-related serious adverse events in a Phase 3 study.

In October 2022, Seres announced the publication of additional ECOSPOR III results in the Journal of the American Medical Association (JAMA), highlighting that the clinical benefits of SER-109 in preventing recurrent rCDI were apparent as early as two weeks post-treatment and sustained for at least 24 weeks.

In June 2022, Seres reported positive confirmatory results from ECOSPOR IV, an open-label study of SER-109 in patients with rCDI (ClinicalTrials.gov identifier: NCT03183141) designed to expand the SER-109 safety database in support of the BLA filing. As recently presented at the IDWeek and American College of Gastroenterology (ACG) 2022 Annual Meetings, the ECOSPOR IV study evaluated adults with rCDI, providing 24-week data for an additional 263 subjects administered SER-109. ECOSPOR IV enrolled subjects with a clinical profile consistent with those commonly treated in clinical practice. The overall safety profile observed through the 24-week follow-up showed that SER-109 was well tolerated, consistent with the profile observed in ECOSPOR III.

In ECOSPOR IV, 91.3% of patients in the overall population achieved a sustained clinical response at eight weeks. Similarly low recurrence rates were observed in key subpopulations at eight weeks, including subjects with a first recurrence (6.5%), second recurrence (6.1%) and three or more recurrences (13.8%).

In October 2022, Seres announced its Biologics License Application for SER-109 was accepted for Priority Review by the FDA. A Prescription Drug User Fee Act (PDUFA) target action date has been set for April 26, 2023. The FDA has conveyed that they are not currently planning to hold an Advisory Committee Meeting to discuss the SER-109 application.

Seres has an active SER-109 expanded access program at various sites across the U.S. The program is designed to enable eligible adults with rCDI to obtain access to the investigational therapeutic prior to a potential FDA product approval.

Seres continues to execute pre-commercialization activities in collaboration with Aimmune Therapeutics, including appropriate market education and data dissemination to the medical community. In addition, activities are ongoing to engage payers in accordance with FDA guidance on pre-approval information exchange. The Company has SER-109 drug supply ready in anticipation of product approval and continues to make progress expanding commercial-scale production of SER-109 to prepare for anticipated future market demand. An ongoing agreement with Bacthera, a global leader in biopharmaceutical product manufacturing, is designed to increase longer-term SER-109 product supply and adds to existing manufacturing capabilities.

Seres plans to host a SER-109 investor event, including participation by Aimmune, focused on the rCDI market opportunity and launch preparations on December 8, 2022.

SER-155 Phase 1b clinical study activities: Seres continues to advance a Phase 1b clinical study of SER-155 designed to evaluate safety and microbiome drug pharmacology. The trial will also assess the impact on infections and/or graft versus host disease (GvHD) associated with SER-155 in adult subjects who are undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT). SER-155 is an investigational oral, rationally designed, cultivated microbiome therapeutic designed to reduce the incidence of gastrointestinal (GI) infections, bloodstream infections, and GvHD in patients receiving allo-HSCT. The study is currently being conducted at Memorial Sloan Kettering Cancer Center, University of Chicago Medical Center, Harvard Medical School – Massachusetts General Hospital Cancer Center, Mayo Clinic (Scottsdale, Arizona) and with additional leading medical centers to be added.

Seres recently completed enrollment of cohort 1 and anticipates conducting a pre-planned meeting with the study’s Data and Safety Monitoring Board (DSMB) to review SER-155 cohort 1 safety data by the end of the year. In addition, the Company plans to announce initial safety and pharmacological data, including drug bacterial species engraftment from cohort 1, in early 2023.

SER-155 is a consortium of bacterial species selected using Seres’ reverse translation discovery and development platform technologies. The design incorporates microbiome biomarker data from human clinical data and nonclinical human cell-based assays and in vivo disease models. The SER-155 composition aims to decrease the colonization and abundance of bacterial pathogens that can harbor antibiotic-resistant and to enhance epithelial barrier integrity in the GI tract to both reduce the likelihood of pathogen translocation and decrease the incidence of bloodstream infections. Further, SER-155 is designed to modulate host immune responses to decrease GvHD.

Infection Protection research: The Company continues to conduct research to bring forward new clinical candidates related to using microbiome therapeutics as a novel approach for Infection Protection for medically compromised individuals, including those with cancer neutropenia, cirrhosis, or solid organ transplant. Preclinical studies are evaluating the potential to reduce the abundance of targeted pathogens to decrease the potential for pathogen transmission, strengthen epithelial barriers to further reduce translocation and the frequency of bloodstream infections, and to modulate immune responses to tackle medical complications such as graft versus host disease GvHD. The Company plans to announce an additional Infection Protection clinical development program in 2023.

Ulcerative Colitis (UC) research: The Company previously reported clinical, microbiome and metabolomic data from the SER-287 Phase 2b study and the first cohort of its SER-301 Phase 1b study. Available data for these investigational microbiome therapeutics suggest that there may be an opportunity to utilize biomarker-based patient selection and stratification for future studies. Research activities remain ongoing to inform potential further development activities.

Registered direct common stock offering: In July 2022, the Company closed a registered direct equity offering of its common stock resulting in proceeds, net of placement agent fees, of approximately $96.7 million.

Financial Results

Seres reported a net loss of $60.0 million for the third quarter of 2022, as compared with net income of $68.2 million for the same period in 2021.

Research and development expenses for the third quarter of 2022 were $43.1 million, compared with $39.9 million for the same period in 2021. The research and development expenses were primarily related to Seres’ late-stage SER-109 clinical development program and manufacturing costs, as well as personnel expenses.

General and administrative expenses for the third quarter of 2022 were $18.4 million, compared with $19.6 million for the same period in 2021. General and administrative expenses were primarily related to personnel expenses, professional fees, including SER-109 commercial readiness and pre-launch expenses, and facility costs.

As of September 30, 2022, Seres had approximately $233.0 million in cash, cash equivalents and marketable securities as compared with $291.2 million at the end of 2021.

Conference Call Information

Seres’ management will host a conference call today, November 2, 2022, at 8:30 a.m. ET. To access the conference call, please dial 800-715-9871 (domestic) or 646-307-1963 (international) and reference Conference ID 8315051. To join the live webcast, please visit the "Investors and News" section of the Seres website at www.serestherapeutics.com.

A webcast replay will be available on the Seres website beginning approximately two hours after the event and will be archived for at least 21 days.