On March 31, 2022 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) reported the successful completion of the three-patient safety run-in for the third-line metastatic colorectal cancer (mCRC) cohort of the phase 1/2 GOBLET study following an independent review by the study’s Data Safety Monitoring Board (DSMB) (Press release, Oncolytics Biotech, MAR 31, 2022, View Source [SID1234611269]). The DSMB noted no safety concerns in these patients and has recommended that the study proceed to full enrollment pending clearance by the Paul Ehrlich Institute (PEI; Germany’s medical regulatory body). The PEI recently cleared the study’s pancreatic cancer cohort for full enrollment following a similar recommendation by the DSMB. The trial’s anal cancer and first-line mCRC cohorts do not include safety run-ins and are proceeding as planned.

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The GOBLET study is designed to evaluate the safety and efficacy of pelareorep in combination with Roche’s anti-PD-L1 checkpoint inhibitor atezolizumab in patients with metastatic pancreatic, metastatic colorectal, and advanced anal cancers. The study includes 14 clinical trial sites across Germany and is being managed by AIO, a leading academic cooperative medical oncology group.

"The successful completion of GOBLET’s final safety run-in underscores the trial’s strong momentum and supports the ability of pelareorep to be safely combined with checkpoint inhibitors," said Thomas Heineman, M.D., Ph.D., Chief Medical Officer of Oncolytics. "This achievement positions us to continue building on prior clinical data that demonstrate the potential of pelareorep to provide a clinical benefit in colorectal and other gastrointestinal (GI) cancers. Existing data suggest this clinical benefit likely results from the stimulation of protective immune responses that may be enhanced by the addition of checkpoint inhibition. Given the high prevalence of GI malignancies, including colorectal and pancreatic cancer, and the fact that most cases do not respond to checkpoint inhibition, we view GOBLET as an important opportunity to evaluate a novel therapeutic approach that may address a pressing unmet medical need."

The GOBLET study’s metastatic colorectal cancer cohorts are supported by prior clinical data demonstrating adaptive anti-tumor immune responses and a 90% clinical benefit rate in KRAS-mutated mCRC patients treated with a pelareorep-based combination (link to PR, link to study). In addition to primary endpoints evaluating safety and efficacy, GOBLET also includes exploratory endpoints designed to explore the potential of CEACAM6 and T cell clonality to serve as predictive biomarkers. This may increase the likelihood of success of future registrational studies by allowing for the selection of the most appropriate patients.

About GOBLET
The GOBLET (Gastrointestinal tumOrs exploring the treatment comBinations with the oncolytic reovirus peLarEorep and anTi-PD-L1) study is a phase 1/2 multiple indication study in advanced or metastatic gastrointestinal tumors. The study is being conducted at 14 centers in Germany. The co-primary endpoints of the study are objective response rate (ORR) assessed at week 16 and safety. Key secondary and exploratory endpoints include additional efficacy assessments and evaluation of potential biomarkers (T cell clonality and CEACAM6). The study employs a Simon two-stage design with Stage 1 comprising four treatment groups expected to enroll a total of approximately 55 patients:
1.Pelareorep in combination with atezolizumab, gemcitabine, and nab-paclitaxel in 1st line metastatic pancreatic cancer patients (n=12);
2.Pelareorep in combination with atezolizumab in 1st line MSI (microsatellite instability)-high metastatic colorectal cancer patients (n=19);

3.Pelareorep in combination with atezolizumab and TAS-102 in 3rd line metastatic colorectal cancer patients (n=14); and
4.Pelareorep in combination with atezolizumab in 2nd line advanced and unresectable anal cancer patients (n=10).

Any cohort showing an ORR above a pre-specified threshold in Stage 1 may be advanced to Stage 2 and enroll additional patients.

About AIO
AIO-Studien-gGmbH (AIO) emerged from the study center of the internal oncology working group within the German Cancer Society (DKG). AIO operates with a non-profit purpose of promoting science and research with a focus on internal oncology. Since its foundation, AIO has become a successful sponsor and study management company and has established itself both nationally and internationally.

About Gastrointestinal Cancer
Excluding skin cancers, colorectal cancer is the third most common cancer, with estimates indicating that 106,180 new cases of colon cancer and 44,850 new cases of rectal cancer will be diagnosed in the U.S. in 20221. Also, for the 2022 year, the American Cancer Society estimates there will be 62,210 new cases of pancreatic cancer2 and 9,440 new cases of anal cancer3 in the U.S.

On March 31, 2022 Vaccinex, Inc. (Nasdaq: VCNX), a clinical-stage biotechnology company pioneering a differentiated approach to treating cancer and neurodegenerative disease through the inhibition of SEMA4D, reported financial results for the year ended December 31, 2021 and provided a corporate update on key events since the start of 2021 (Press release, Vaccinex, MAR 31, 2022, View Source [SID1234611268]).

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"I am pleased to report that the last 15 months have been extremely productive for Vaccinex. We are advancing the development of pepinemab for oncology and neurodegenerative disease and have made good progress in each of the clinical programs in these diseases. These programs build on a comprehensive body of prior preclinical and clinical studies that provide a strong foundation of understanding of the mechanism of action of this novel immunomodulator," said Maurice Zauderer, Ph.D., President and Chief Executive Officer of Vaccinex.

Dr. Zauderer continued, "In the open label, Phase 1b/2 KEYNOTE-B84 trial of pepinemab in combination with KEYTRUDA (pembrolizumab) as first-line treatment for recurrent or metastatic head and neck cancer, we observed two complete responses (CRs) in the first three patients enrolled. We will review details of those responses and promising Phase 1b safety results that opened enrollment into the Phase 2 expansion of this study at the American Society for Cancer Research (AACR 2022) on Monday, April 11, 2022."

"In addition, phase 1 has been completed and enrollment is underway in Phase 2a expansion of the SIGNAL-AD trial in early Alzheimer’s Disease. Looking ahead to 2022 and early 2023, we expect to complete enrollment in the KEYNOTE-B84 and SIGNAL-AD trials. Data from these studies will help to guide the regulatory and product development path for the pepinemab programs. We look forward to continue to update the clinical community and investors on our progress at other medical conferences in 2022."

Pepinemab Clinical Updates:

Oncology: Head and Neck Cancer

Enrollment is underway in the Phase 1b/2 clinical trial evaluating pepinemab in combination with Merck’s anti-PD-1 therapy KEYTRUDA (pembrolizumab) for first-line treatment in recurrent or metastatic head and neck cancer.

Multiple prior studies suggest that inhibition of SEMA4D increases immune infiltration and alters the balance of cytotoxic and immunosuppressive cells in the tumor microenvironment. As SEMA4D is highly expressed and has been shown to promotes immunosuppression in head and neck cancer, there is strong rationale for development in this indication.

In January 2022, Vaccinex reported that, based on data from the phase 1b segment, the Data Safety Monitoring Board approved the recommended phase 2 dose and initiation of enrollment into the Phase 2 expansion segment of the trial. Importantly, two complete responses were observed among the three patients enrolled in phase 1b.

Vaccinex expects to report further data from this study (Abstract CT-111) at the AACR (Free AACR Whitepaper) 2022 on Monday, April 11, 2022 in the Phase II Clinical Trials session.

The KEYNOTE-B84 study is expected to enroll up to 65 subjects across 18 U.S. trial sites and will assess whether immunotherapy with pepinemab in combination with pembrolizumab can improve responses in the front-line setting. The primary outcome of the study is objective response, and additional outcomes include progression free survival and overall survival.

Vaccinex anticipates that study enrollment will conclude in 2023. The Company expects to continue to provide additional updates from this open label trial at medical conferences in 2022 and results for the primary outcome in 2023.

Other Oncology Trials. Pepinemab is also being evaluated in multiple investigator-sponsored trials (ISTs) in pancreatic and breast cancer and in "window of opportunity" studies, including head and neck cancer and melanoma to evaluate pepinemab in several combination treatments.

Neurodegenerative Disease:

Alzheimer’s Disease. Enrollment continues in the Phase 1/2a SIGNAL-AD trial of pepinemab as a single agent in early Alzheimer’s disease. This trial is being funded in part by the Alzheimer’s Drug Discovery Foundation and by the Alzheimer’s Association under the 2020 Part the Cloud Program.

The randomized, double-blind, placebo-controlled, multi-center safety and biomarker study of pepinemab in early AD is planned to enroll 40 subjects across 15 U.S. trial sites. Vaccinex anticipates topline data from this study in 2023.

Huntington’s disease. The Phase 2 double-blind, placebo-controlled SIGNAL trial of pepinemab in patients with early Huntington’s disease (HD) has been completed, and Vaccinex believes the program is Phase-3 ready.

While the Phase 2 study did not meet the prespecified primary endpoints, we believe that multiple exploratory and post-hoc analyses support the potential cognitive benefit of treatment with pepinemab in early manifest HD patients, particularly those with evidence of mild cognitive or functional deficits at baseline including:

Highly significant improvement (p=0.007) in the Huntington’s Disease Cognitive Assessment Battery (HD-CAB) Composite score, a measure comprised of 6 different cognitive assessments that has also been employed in other HD trials.
Significant benefit in reducing apathy severity (p=0.017, 1-sided), a problem behavior that has previously been correlated with cognition in both HD and AD.
Reduced atrophy (p=0.017) in caudate region of striatum, a brain region known to degenerate early in HD progression, along with a striking increase in brain metabolic activity as measured by FDG-PET in most brain regions. Decline in FDG-PET signal has been reported to correlate with cognitive decline and clinical progression in several studies of AD.
The Company continues to actively explore advancing pepinemab into a Phase 3 HD trial in collaboration with biopharmaceutical partners.

Upcoming Anticipated Milestones:

Oncology:

Phase 1b/2 Keynote B84 Trial: Open label head and neck cancer trial of pepinemab in combination with KEYTRUDA/pembrolizumab. Multiple interim data read-outs expected in 2022. Enrollment is expected to be completed and primary outcome data presented in 2023.
AACR Presentation: Monday, April 11 in the Phase II Clinical Trials 1 between 9:00 a.m. and 12:30 p.m. CST.
Neurodegenerative Disease:

Phase 1/2a Alzheimer’s Disease Trial: Topline data are expected in 2023.
ActivMAb Updates:

As previously announced, the Company has entered into several collaborations with pharmaceutical and biotechnology companies employing the unique capabilities of our ActivMAb antibody discovery platform to address difficult to drug multi-pass membrane receptors including G-protein Coupled Receptors (GPCRs) and ion channels known to be strongly associated with diseases.

Financial Results for the Twelve Months Ended December 31, 2021:

Cash and Cash Equivalents and Marketable Securities. Cash and cash equivalents and marketable securities on December 31, 2021 were $8.6 million, as compared to $10.6 million as of December 31, 2020. In January, 2022, the Company sold 3,115,197 shares of its common stock at a weighted average price of $1.16 through the Open Market Sale Agreement, and 8,747,744 shares of the Company’s common stock at a price of $1.11 through a private placement sale.

Research and Development Expenses. Research and development expenses for the year ended December 31, 2021 were $17.2 million as compared to $21.5 million for the comparable period in 2020.

Research and Development expenses are lower in 2021 compared to 2020 primarily attributed to a smaller number of patients enrolled in clinical trials, especially the CLASSICAL-Lung and SIGNAL studies.

General and Administrative Expenses. General and administrative expenses for the year ended December 2021 were $6.2 million as compared to $7.4 million for the comparable period in 2020.

The difference in general and administrative expenses is primarily attributable to planned cost reductions, as part of cost control measures.

Comprehensive loss/Net loss per share. The Comprehensive Loss and Net loss per share for the year ended December 31, 2021 was $22.4 million and $0.78 compared to $28.9 million and $1.54 for the comparable period in 2020.

Financial results are included below. For further details on Vaccinex’s financials, refer to its Form 10-K filed March 31, 2022 with the Securities and Exchange Commission.

About Pepinemab
Pepinemab is a humanized IgG4 monoclonal antibody that inhibits SEMA4D, which regulates chronic inflammation in the tumor microenvironment. Preclinical and clinical data show that pepinemab promotes infiltration of activated immune cells while reducing immune suppression in tumors and repair or prevention of neurological damage in neuroinflammatory and neurodegenerative diseases.

Results of a Phase 1b/2 study were presented at ASCO (Free ASCO Whitepaper) 2020 and were highlighted in the July 2021 publication of Clinical Cancer Research. The Company believes that results of this Phase 1b/2 CLASSICAL-Lung trial supports increased benefit of combination immunotherapy relative to historical results for checkpoint inhibitor alone as a treatment for immunotherapy naïve patients with PD-L1 low non-small cell lung cancer (NSCLC). In addition, the Company believes that its recently completed phase 2 study of single agent pepinemab in Huntington’s disease indicated both cognitive benefit and a reduction in brain atrophy and reversal of disease-associated loss of brain metabolic activity. Topline data for the SIGNAL Phase 2 trial was reported in September 2020 and more detailed analysis of the data was presented at medical conferences in April and September of 2021.

Vaccinex has global commercial and development rights to pepinemab and is the sponsor of SIGNAL trials for HD and AD, as well as the KEYNOTE-B84 study which is being performed in collaboration with Merck Sharp & Dohme Corp, a subsidiary of Merck and Co, Inc. Kenilworth, NJ, USA. Additional information about the study is available at: clinicaltrials.gov link.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co. Inc., Kenilworth, NJ, USA.

On March 31, 2022 Immunomic Therapeutics, Inc., ("ITI"), a privately-held clinical-stage biotechnology company pioneering the study of LAMP-mediated nucleic acid-based immunotherapy reported that the company will be presenting two posters at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2022 being held in New Orleans, Louisiana, from April 8-13 (Press release, Immunomic Therapeutics, MAR 31, 2022, View Source [SID1234611267]). The posters to be presented at AACR (Free AACR Whitepaper) are developed from the investigational nucleic acid platform, UNITE (UNiversal Intracellular Targeted Expression) for two vaccines, ITI-3000 for Merkel cell carcinoma and Her2/Neu-LAMP DNA vaccine, both which fuse a tumor associated antigen with lysosomal associated membrane protein 1 (LAMP-1). This proprietary lysosomal targeting technology results in enhanced antigen presentation and a balanced T cell response.

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"Both ITI-3000 and Her2/Neu-LAMP DNA vaccines are innovative and novel targeted approaches," says Teri Heiland, Ph.D., Immunomic’s Chief Scientific Officer. "We are highly encouraged by the data and look forward to a first-in-human trial for ITI-3000, a vaccine for Merkel cell carcinoma, and further pre-clinical development for Her2/Neu-LAMP vaccine."

Poster Title: LAMP1 targeting of the large T antigen of Merkel cell polyomavirus elicits potent CD4+ T cell responses, tumor inhibition, and provides rationale for first-in-human trial

Session Category: Immunology

Session Title: Immune Response to Therapies 1

Session Date and Time: Monday April 11, 2022, 1:30 PM – 5:00 PM ET

Location: New Orleans Convention Center, Exhibit Halls D-H, Poster Section 37

Poster Number: 10

Poster Title: Harnessing soluble CD40L to enhance anti-tumor efficacy of Her2-LAMP DNA vaccine using UNITE platform

Session Category: Immunology

Session Title: Vaccines: Oncolytic and Prophylactic

Session Date and Time: Tuesday April 12, 2022, 1:30 PM – 5:00 PM ET

Location: New Orleans Convention Center, Exhibit Halls D-H, Poster Section 40

Poster Number: 3

Poster Availability: e-Posters will be on display in the AACR (Free AACR Whitepaper) Gallery

About UNITE

ITI’s investigational UNITE platform, UNiversal Intracellular Targeted Expression, leverages the ability to engineer chimeric proteins, directing antigen presenting cells to present antigens to the immune system through a targeted pathway and driving a robust immune response. UNITE vaccines are distinct in that they combine two components: nucleic acid constructs that encode a specific antigen and an endogenous Lysosomal Associated Membrane Protein (LAMP-1) sequence. The UNITE platform harnesses LAMP-1 as a means of presenting the vaccine target to the immune system, resulting in antibody production, inflammatory cytokine release, and establishing critical immunological memory, something that other vaccine approaches commonly lack. This approach could put UNITE technology at the crossroads of immunotherapies in multiple indications, including cancer, human allergy, animal health, and infectious disease. Preclinical data is currently being developed to explore whether LAMP-1 nucleic acid constructs may amplify and activate the immune response in highly immunogenic tumor types and used to create immune responses in tumor types that otherwise do not provoke an immune response.

On March 31, 2022 VBL Therapeutics (Nasdaq: VBLT) (VBL), a late-clinical stage biotechnology company focused on developing first-in-class therapeutics for difficult-to-treat malignant solid tumors and immune or inflammatory indications, reported that it will host a key opinion leader (KOL) luncheon and seminar on ovarian cancer on Monday, April 11, 2022 at 12pm Eastern Time at the St. Regis Hotel in New York, NY (Press release, VBL Therapeutics, MAR 31, 2022, View Source [SID1234611247]).

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The seminar will feature presentations and a panel discussion with KOL’s Bradley J. Monk, MD, FACS, FACOG, of the University of Arizona College of Medicine and Creighton University School of Medicine, Richard Penson, MBBS, of Massachusetts General Hospital (Mass General), and Kathleen Moore, MD, of OU College of Medicine, who will discuss the current treatment landscape and unmet medical need in treating patients with ovarian cancer. The live event will be hosted by Dror Harats, MD, chief executive officer of VBL Therapeutics. A live question and answer session will follow.

VBL’s lead product candidate, ofra-vec (ofranergene obadenovec; VB-111), will be discussed as a potential treatment solution for platinum resistant ovarian cancer. Ofra-vec utilizes VBL’s novel VTS platform and is being evaluated in VBL’s registration enabling OVAL Phase 3 clinical trial. Ofra-vec’s unique mechanism of action is designed to combine the blockade of tumor microvasculature (the blood vessels required for tumor growth) with an anti-tumor immune response. OVAL is now fully enrolled with 409 patients globally, and topline data on the progression free survival primary endpoint are expected in the second half of 2022.

To register for the event, please click here. If you would like to attend in person, please indicate so when registering, and you will receive an email confirming your attendance closer to the event. The event will be webcasted for those who are unable to attend in person.

Bradley J. Monk, MD, FACS, FACOG is currently a Professor of Gynecologic Oncology at the University of Arizona College of Medicine, Phoenix and a Professor of Obsterics & Gynecology at the Creighton University School of Medicine, Phoenix. He is board certified in both Obstetrics & Gynecology and Gynecologic Oncology and practices at Virginia G. Piper Cancer Center. He is the Fellow of the American College of Surgeons (ACS) and the American College of Obstetricians and Gynecologists (ACOG). Prof. Monk also serves as a Co-Director for the Gynecologic Oncology Group (GOG) Research Consortium. Among his many professional contributions, Prof. Monk was the first to report the activity of anti-vascular growth factor (VEGF) therapy in gynecologic cancers and his papers in the New England Journal of Medicine have let to the global approvals of anti-VEGF therapy, PARP inhibitors and immunotherapy in ovarian and cervical cancers. He has published more than 350 peer-review manuscripts, written more than 30 book chapters and led countless successful clinical trials.

Richard Penson, MBBS came to Mass General from St Bartholomew’s Hospital, London, in 1997, and is the Clinical Director of Medical Gynecologic Oncology at Mass General. His practice is devoted almost exclusively to gynecologic oncology with the majority of patients having ovarian cancer. Dr. Penson attends on the Bigelow General Medical Service at Mass General, sits on the national Gynecologic Oncology Group (NRG GOG) committees for ovarian cancer and quality of life research, and the National Comprehensive Cancer Network (NCCN) Ovarian Committee. Dr. Penson serves as the chairman for panels C and F of the Institutional Review Board of Dana-Farber/Mass General Brigham CancerCare.

Kathleen N. Moore, MD, is an Associate Professor in the Section of Gynecologic Oncology; the Jim and Christy Everest Endowed Chair in Cancer Research; and the Director of the Oklahoma TSET Phase I Program for the Stephenson Cancer Center at the University of Oklahoma College of Medicine. She attended medical school at the University of Washington School of Medicine and completed her residency in obstetrics and gynecology at the University Health Center of Pittsburgh. Dr Moore completed a fellowship in gynecologic oncology at the University of Oklahoma Health Sciences Center while simultaneously earning a master’s degree in epidemiology. She is board certified in obstetrics and gynecology as well as gynecologic oncology and hospice and palliative care. She serves as the Associate Director of Clinical Research and Medical Director of the Clinical Trials Office for the Stephenson Cancer Center. She has published over 200 peer-reviewed publications and serves on the editorial board for four academic publications. She has a clinical research interest in drug development and Phase 1 trials.

On March 31, 2022 Selvita S.A. – [ticker: WSE: SLV] – one of the largest preclinical contract research organizations in Europe, reported that continues its dynamic development in Poland and abroad (Press release, Selvita, MAR 31, 2022, View Source [SID1234611246]). Following the acquisition of Fidelta, Selvita Group has more than doubled its sales revenues in 2021, as compared to the year before.

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Dynamic growth in all business segments

Selvita Group continued its dynamic development in every segment of its business activity. Commercial revenues from services executed in Poland reached EUR 32.3 million and were 30% higher compared to 2020, when they amounted to EUR 25.5 million. In the fourth quarter of 2021 alone, these revenues increased by as much as 50% y/y, to the level of EUR 9.5 million. In 2021, Fidelta, representing the segment of services executed in Croatia, recorded EUR 27.8 million in commercial revenues with EBITDA of EUR 8.6 million (30.8% margin). In the fourth quarter of 2021 alone, the Company achieved EUR 7.8 million in sales revenues, and EBITDA of EUR 2.5 million with a margin of 31.6%. The bioinformatics segment (Ardigen, a subsidiary company) closed 2021 with EUR 6.9 million of commercial revenues, compared to EUR 4.0 million in 2020 (an increase of 77% y/y). EBITDA was at the level of EUR 2.1 million (27.5% margin) and was 91% higher than in 2020.

Selvita Group continued its development on the key geographic markets. In 2021, revenues from the United States, the largest global market for CROs, increased by over 95% and amounted to EUR 18.9 million. The Group recorded also significant sales revenues from the clients in the United Kingdom, amounting in 2021 to EUR 8.3 million, as compared to EUR 3.1 million a year earlier, which indicates an increase of 171% y/y.

– The past year was a breakthrough one for us. Joining forces with Fidelta and continued dynamic organic growth allowed us to more than double our revenues while maintaining high profitability. Considering this, and the equally strong year 2020, we managed to implement the development strategy planned for four years, in just two. Along with such a dynamic development and a significant increase in the scale of operations, we are invariably able to generate high margins, and we enter the new year with a contract portfolio of over EUR 48 million that will ensure our further development in all segments.

We are not planning to slow down which is why we have already set ourselves new ambitious goals for the coming years – comments Bogusław Sieczkowski, co-founder, significant shareholder and Chief Executive Officer at Selvita.

Development Strategy for 2022-2025

The former Group’s development strategy, announced in April 2020, aimed at an increase in sales revenues up to app. EUR 70million, an increase in the scale of operations through acquisitions as well as over EUR 230 million in market capitalization. Since Selvita Group had achieved these goals by the end of 2021, the Company’s Management Board decided to present a new strategy for 2022-2025.

During the aforementioned period, Selvita Group plans to triple its sales revenues (up to EUR 200 million), while maintaining high profitability. The Group will work to implement its strategy through organic growth and acquisitions. Execution of the planned investments will allow Selvita to become the leading global preclinical CRO.

Selvita Group Development Strategy for 2022-2025 is based on three key principles:

Comprehensive services offer in the field of drug discovery and development – supplementing the drug discovery offer and building the drug development segment
Focusing on high-value services for the clients – specialization in selected therapeutic areas and development of unique competences
Development of the Group’s operations in the largest markets in the United States and United Kingdom – growing teams and potentially establishing new research locations

In the area of acquisitions, in 2020-2025, Selvita plans to acquire at least two preclinical CROs in Europe or North America providing services complementary to the Company’s offer or enabling expansion of the scale of its operations. The Company will allocate a total of EUR 110 million for this purpose, from the cash generated and the debt raised.

One of the basic assumptions of the new strategy is a consistent expansion of the services portfolio in the field of drug discovery and development, which will allow us to offer our clients support at every stage of the drug development process, from the early stage of discovery to the selection of a clinical candidate. Selvita also plans to develop further competences in selected therapeutic areas, attractive from a clients’ perspective, in order to strengthen its competitive advantage on the global CRO market. Moreover, the Company plans to continue development in the area of ​​drug development and contract testing studies.

In order to efficiently implement the assumptions of the new business development strategy, from March 31, 2022, Fidelta will fully migrate under Selvita brand. This will allow Selvita not only to benefit from the decades-long history of drug discovery experience held by the Croatian team, but also will facilitate communication with customers and strengthen business development activities.

As far as our further business development is considered, we are planning to continue strengthening our presence and position on the largest global markets, i.e. the U.S. and U.K. markets. For this purpose, we intend to hire new specialists in order to strengthen the local teams – comments Milosz Gruca, Ph.D., Chief Commercial Officer and Executive Vicepresident at Selvita.

The planned development of the Group will be supported by significant investments in the infrastructure. Selvita has already made the first step in this direction, commencing in 2021, the construction of its own research center. By 2025, the Company plans to complete the second stage of this investment, i.e. to build another laboratory building. To secure the possibility of further organic growth after 2025, Selvita acquired an additional, adjacent building plot in early March this year. In addition to investing in its own laboratories in Krakow, the Company plans to simultaneously increase the research space leased in Zagreb and Poznan.

Financing of the new Development Strategy

Selvita Group plans to allocate a total sum of approximately EUR 210 million for the implementation of the development strategy. The Group plans to spend EUR 40m on financing organic growth, another EUR 60m on laboratory infrastructure expansion and EUR 110m on acquisitions.

– We are a company with a stable and very good profitability, which, given the low level of debt we currently have, will allow us to finance the entirety of the planned investments. We consider the possible acquisition of additional capital as something extraordinary that could happen only in the event of financing major acquisitions – adds Sieczkowski.

– From the very beginning of Selvita, our aim was to build a strong brand with a solid position on the market. Years of effort and the commitment of the entire team are bringing us closer to our goal which is to become a large, global player. Organic growth will continue to be the major factor driving our growth, and to make it possible we will be investing in infrastructure expansion and strengthening our scientific team. Moreover, in the coming years, we intend to continue our development through acquisitions. The recent acquisition of Fidelta has shown us clearly what a great impact a well-selected partner can make on both the scale of operations and the scope of competences.

We firmly believe that thanks to the accomplishment of the goals of our development strategy, Selvita will become a leading global preclinical CRO company – sums up Boguslaw Sieczkowski.

*excluding the impact of the non-cash incentive program