Selvita Q1 2023 financial results exceed initial estimates, the Company is preparing for further dynamic growth

On May 31, 2023 Selvita S.A. [WSE: SLV], one of the largest contract research organization companies in Europe, reported its financial report for Q1 2023 (Press release, Selvita, MAY 31, 2023, View Source [SID1234632289]). The Group is growing despite the demanding market, taking on numerous actions to strengthen sales and optimize the business.

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In Q1 2023, Selvita Group (excl. Ardigen) generated EUR 19.5 million in revenues, up by 9% y/y. The EBITDA profit in this period reached EUR 4.1 million, which translates into a margin of 20.8%. Thus, the Group has generated better results than the estimates published in March (revenues in the range of 4-7%, EBITDA margin in the range of 19-21%).
As previously announced, the Company is undertaking numerous business development activities, focusing on markets and clients with the largest potential and research budgets. Since the beginning of 2023, Selvita has been gradually strengthening its sales forces in the United States and Europe.
The Company opened its new Selvita Research Centre in Kraków. The new location will provide a workplace for approximately 250 scientists, thus significantly increasing Selvita’ capabilities to provide the highest quality services in the area of drug discovery. The investment is a significant milestone in the Company’s development and creates a foundation for further organic growth of the Company.
Selvita’s backlog for 2023 amounts to EUR 51.7 million (as of May 28, 2023) and is 2% higher than the value reported a year earlier (as of May 24, 2022). The Company observes increased caution among its clients, resulting in the orders being concluded for shorter periods, which has a significant impact on the presented backlog in the first half of the year.
The company continues to implement numerous optimizations and enforce its savings policy, which should have a positive impact on margins both in 2023 and in the longer term.
We are very glad that the first quarter turned out to be better than expected. We continue focusing on activities aimed at increasing the revenue base, while paying great attention to our expenses. Our priority remains to return to the revenue dynamics and margins levels to which our investors have become accustomed. We have a strong scientific team on board and infrastructure to support further development, – comments Bogusław Sieczkowski, co-founder and Chief Executive Officer at Selvita.
The market we operate in remains demanding, however, as already announced, we expect an increase in contracting dynamics in the second half of the year. Industry reports indicate that both pharma and biotech companies have high cash reserves and, statistically, increasing amount of research work is outsourced to subcontractors. However, there are many indications that due to the slowdown in financing the sector, they are more careful with their budgets, – comments Dr. Milosz Gruca, Executive Vice President, and Chief Commercial Officer at Selvita.
While in the pandemic years – 2020-2021 – financing of the global biopharmaceutical sector more than doubled, in 2022 it returned to the levels from 2019. Most of the capital dedicated to the drug discovery and development (over 70%) went to companies on the U.S. market. In Europe, the British market stands out positively. Selvita is very active on both of these markets, taking advantage of the local sales offices in the largest biotechnology hubs.

We have intensified sales activities and strengthened the BD team, acquiring several experienced specialists operating in the most promising markets – in particular in the United States. We strongly focus on Big Pharma companies. At the same time, in the coming quarters, we expect the extension of numerous orders which some customers contracted exceptionally for a shorter than usual period, – adds Dr. Gruca.
FINANCIAL RESULTS AND MARKET ENVIRONMENT

In 2023 the cost base will be higher than in 2022, mainly due to the increase in employment in 2022 and the costs related to the launch of the new building. Despite the pressure on margins, we maintain a very good financial position and low debt ratios. We focus on increasing revenues and optimizations that will have a positive impact on Selvita’s finances in both the short and long term, – adds Dariusz Kurdas, Chief Financial Officer at Selvita.
In Q1 2023, Selvita generated EUR 18.9 million in revenues from commercial services, up by 9% y/y and more than the preliminary estimates of 4-7% as published in March.

Drug discovery services provided by Selvita generated EUR 15.5 million (an increase of 5% y/y) and accounted for 82% of revenues from commercial services provided by the Company. Services provided in the area of regulatory research accounted for the remaining part of commercial revenues and amounted to EUR 3.4 million (up 29% y/y).

The EBITDA profit in Q1 2023 amounted to EUR 4.1 million compared to EUR 5.4 million a year earlier. The EBITDA margin reached 20.8%, i.e. in the upper range of the 19-21% estimations made by the Company in March.

There are many indications that in 2023 the dynamics of contracting between quarters will be different than usual. Selvita’s backlog for 2023 amounts to EUR 51.7 million (as of May 28, 2023) and is 2% higher than the value reported a year earlier (as of May 24, 2022), despite the demanding market and high base. The company expects contracting to accelerate in the second half of the year.

*The results do not include non-cash costs of the non-dilutive incentive program for employees. Backlog as of May 28, 2023.

Sana Biotechnology to Present at June 2023 Investor Conferences

On May 31, 2023 Sana Biotechnology, Inc. (NASDAQ: SANA), a company focused on changing the possible for patients through engineered cells, reported that it will webcast its presentations at two investor conferences in June (Press release, Sana Biotechnology, MAY 31, 2023, View Source [SID1234632288]). The presentations will feature a business overview and update by Steve Harr, Sana’s President and Chief Executive Officer.

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Sana will present at the Jefferies Healthcare Conference at 9:30 a.m. ET on Wednesday, June 7, 2023.
Sana will present at the Goldman Sachs 44th Annual Global Healthcare Conference at 10:00 a.m. PT on Monday, June 12, 2023.
The webcasts will be accessible on the Investor Relations page of Sana’s website at View Source A replay of each presentation will be available at the same location for 30 days following the corresponding conference.

Rigel to Present at the Jefferies 2023 Global Healthcare Conference

On May 31, 2023 Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) reported that Raul Rodriguez, the company’s president and chief executive officer, will present on Wednesday, June 7, 2023 at 2:30 p.m. ET at the Jefferies 2023 Global Healthcare Conference, being held June 7-9, 2023 in New York, NY (Press release, Rigel, MAY 31, 2023, View Source [SID1234632287]).

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To access the live and subsequent archived webcast, visit the Investor Relations section of the company’s website at www.rigel.com. Please connect to Rigel’s website prior to the start of the live webcast to allow for any software downloads.

Promontory Therapeutics to Participate in Business Development Strategies Panel at the Sachs 9th Annual Immuno-Oncology Innovation Forum

On May 31, 2023 Promontory Therapeutics Inc., a clinical stage pharmaceutical company advancing small molecule immunotherapies in oncology, reported that it will participate in a panel discussion on maximizing value in a capital efficient manner at the Sachs 9th Annual Immuno-Oncology Innovation Forum, taking place June 2, 2023 in Chicago (Press release, Promontory Therapeutics, MAY 31, 2023, View Source [SID1234632285]). The company will also provide a presentation on its corporate and clinical progress with lead therapeutic candidate, PT-112, a small molecule immunotherapy.

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Panel Discussion Details
Panel Session: Business Development Strategies Panel: How to Maximize Value in a Capital Efficient Manner
Speaker: Matthew Price, EVP & COO, Promontory Therapeutics
Date: June 2, 2023
Time: 9:30am CDT
Location: Sinclair Ballroom, Waldorf Astoria Hotel, Chicago

Corporate Presentation Details
Presentation Session: Track A
Speaker: Johan Baeck, CMO, Promontory Therapeutics
Date: June 2, 2023
Time: 11:00am CDT
Location: Room Faulkner, Waldorf Astoria Hotel, Chicago

More information about the event and agenda is available on the Sachs Forum website.

Precision BioSciences Provides Update on Allogeneic CAR T Programs and Regulatory Path Forward

On May 31, 2023 Precision BioSciences, Inc. (Nasdaq: DTIL) a clinical stage gene editing company developing ARCUS-based in vivo gene editing and ex vivo allogeneic CAR T therapies, reported program updates across its allogeneic CAR T pipeline. The Company highlighted new interim clinical data for its lead candidate, azercabtagene zapreleucel (azer-cel), as a potential first-in-class allogeneic CD19 CAR T for the growing CAR T relapsed patient population with DLBCL (Press release, Precision Biosciences, MAY 31, 2023, View Source [SID1234632283]). The Company also provided the first clinical update on PBCAR19B stealth cell, which is in development as a potential best-in-class allogeneic CAR T therapy for patients with relapsed or refractory (r/r) non-Hodgkin lymphoma (NHL), with primary focus on DLBCL.

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"Over the last two years, we have pursued a deliberate, multi-faceted approach in the development of our CAR T programs with the aim of bringing off-the-shelf therapies to patients. In the process, we have built one of the most extensive data packages for an allogeneic product, with the goal of tailoring azer-cel for patients who have relapsed following autologous CAR T treatment," said Michael Amoroso, Chief Executive Officer at Precision BioSciences. "With the updated clinical data presented today, including safety, efficacy, and durability, we believe we have identified the recommended azer-cel dosing regimen to discuss in a clinical meeting with the U.S. Food and Drug Administration (FDA) to align on next steps."

Mr. Amoroso continued, "In addition to azer-cel, we are also advancing our CD19-targeted program, PBCAR19B stealth cell, which incorporates an immune cloaking approach designed to allow greater CAR T expansion and persistence. Last year, we applied platform-wide manufacturing optimizations using ARCUS for CAR T insertion for both of our clinical candidates. We believe the optimized stealth cell product resulted in preliminary efficacy and safety on par with autologous CAR T in the r/r DLBCL setting. The interim data highlighted today supports further investigation of the stealth cell product candidate in DLBCL patients. Looking ahead, we will continue to evaluate the durability of response in the stealth cell patients and seek potential partnerships in this larger, earlier line setting."

Azer-cel as a Potential First-in Class Allogeneic CAR T Product Candidate for CD19+ CAR T Relapsed Patients

As of May 30, 2023, we observed continued high response rates with an acceptable safety profile in r/r NHL patients. Among all evaluable subjects (n=61), ORR was 58% with 41% achieving a CR, across all doses and lymphodepletion regimen.

Activity was most compelling among the azer-cel treated subjects who had relapsed following autologous CAR T therapy (n=18); ORR was achieved in 83% of subjects and 61% achieved CR.
In CAR T relapsed evaluable subjects (n=11), 55% had ongoing durable responses for ≥ 6-months.
In the most recent CAR T relapsed cohort receiving optimized Dose Level 4b with FluCy7501 (n=5), 60% ORR was achieved, and 66% of evaluable patients achieved a full molecular remission (MRD-) which may be predictive of durability.
No Grade 3 or greater cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), infection or graft versus host disease was observed in the most recent cohort.
"Azer-cel continues to demonstrate promising results in DLBCL patients who relapsed following CAR T, and we are encouraged by the high overall response rates with molecular remissions in this patient setting," said Alan List, M.D., Chief Medical Officer at Precision BioSciences. "Based on this dataset, azer-cel has the potential to improve outcomes in this large and growing population with high unmet need. Also based on these results, a clinical meeting with the FDA has been scheduled in June to discuss next steps for azer-cel in the CAR T relapsed setting. We look forward to providing updates on the path forward in the near future."

PBCAR19B Stealth Cell as a Potential Best-in Class Allogeneic CAR T Product Candidate for Earlier Line CAR T Naïve CD19+ DLBCL

PBCAR19B is Precision’s anti-CD19 targeting allogeneic CAR T candidate designed to evade immune rejection by host T cell and NK cells with a single ARCUS gene edit to insert a CD19 CAR transgene, knock-down beta-2 microglobulin, and insert an HLA-E transgene. The treatment goal of this program is to potentially displace autologous CAR T in the 2nd line DLBCL setting.

As of May 30, 2023, in Phase 1 results we observed an acceptable safety profile with high overall response rates among all evaluable subjects with evidence of molecular remission (MRD-) and preliminary durability at Dose Level 2 (540 million cells)2.

Out of seven evaluable subjects at Dose Level 2, five with DLBCL and two with mantle cell lymphoma, PBCAR19B achieved 71% ORR and 43% CR rate.
In DLBCL patients, ORR was achieved in 80% of subjects and 60% achieved a CR (MRD-).
No Grade 3 or greater cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), infection or graft versus host disease was observed.
PBCAR19B stealth cell achieved proof of concept and appeared to be effective in delaying recovery of host T- and NK-cells.
PBCAR19B stealth cell dosed at 540M cells + FluCy750 has been established as the dosing regimen for further investigation in DLBCL patients.
"We are impressed with our PBCAR19B stealth cell construct which appeared to delay host rejection through immune cloaking. Stealth cell achieved a high response rate, especially in DLBCL subjects with a high frequency of MRD- complete responses, and acceptable safety with our improved manufacturing process at Dose Level 2 in the Phase 1 study," said Dr. List. "The next steps for stealth cell will be to await further durability data and seek thoughtful partnership for ongoing development in the earlier line DLBCL setting."

Company-Hosted Webcast and Conference Call Information

Precision will host a conference call and webcast today, May 31, 2023, at 8:30 AM ET. The dial-in conference call number is (800) 715-9871 and the conference ID number for the call is 4729500. Participants may access the live webcast, and accompanying presentation materials, as well as the archived webcast on Precision’s website in the Investors section under Events & Presentations: View Source