On March 23, 2022 Recursion (Nasdaq: RXRX), the clinical-stage biotechnology company industrializing drug discovery by decoding biology, reported business updates and financial results for its fourth quarter and fiscal year ending December 31, 2021 (Press release, Recursion Pharmaceuticals, MAR 23, 2022, View Source [SID1234610767]).

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Recursion Pipeline Programs
"2021 was an exciting year for Recursion, in which we closed one of the largest biotechnology initial public offerings in history; expanded our partnership with Bayer; entered into a transformational partnership with Roche and Genentech; received Fast Track and Orphan Drug Designations from the FDA for our NF2 and FAP programs, respectively; readied several programs to initiate clinical trials; expanded our therapeutics pipeline with numerous programs in oncology; and built and began to utilize our supercomputer, BioHive1," said Recursion Co-Founder & CEO Chris Gibson, Ph.D. "As we applied our mapping and navigating capabilities to explore complex biology, we discovered and advanced many new scientific and business opportunities. We are excited for 2022 as we work to transition more biology and chemistry from maps to medicines."

Summary of Business Highlights

Clinical Programs
Cerebral cavernous malformation (CCM) (REC-994): In March 2022, we enrolled the first patient in our Phase 2 SYCAMORE clinical trial, which is a double-blind, placebo-controlled safety, tolerability and exploratory efficacy study of this drug candidate in 60 subjects with CCM.
Neurofibromatosis type 2 (NF2) (REC-2282): We plan to initiate our Phase 2/3 POPLAR-NF2 clinical trial, which is a parallel group, two stage, randomized, multicenter study of this drug candidate in the second quarter of 2022.
Familial adenomatous polyposis (FAP) (REC-4881): We plan to initiate a Phase 2, randomized, double-blind, placebo-controlled study to evaluate safety, pharmacokinetics and efficacy of this drug candidate in the third quarter of 2022.
Preclinical and Discovery Programs
Clostridium difficile colitis (REC-3964): We made progress in IND-enabling studies for REC-3964 and plan to initiate a Phase 1 study in the second half of 2022.
Small molecule inhibitor of a target with a novel link to CDK12 biology: A small molecule inhibitor of a novel target not otherwise known to be related to CDK12, discovered using our next generation mapping and navigating technology, has demonstrated robust single-agent and combination activity with olaparib in an HRD-negative ovarian cancer PDX model, achieving 100% complete and durable response.
Cancer immunotherapy target ‘alpha’: We expanded the in vivo dataset of target alpha, where a small molecule inhibitor of target alpha, discovered using our next generation mapping and navigating technology, demonstrated robust combination activity with an anti-PD1 therapy in an EMT6 mouse model and achieved 80% complete response.
Oncology pipeline: We continued to make progress expanding and advancing numerous oncology programs, discovered using our next generation mapping and navigating technology, through scientific milestones including the programs mentioned above as well as programs related to immune checkpoint resistance in STK11-mutant non-small cell lung cancer, small molecule MYC inhibition, cancer immunotherapy target ‘beta,’ hepatocellular carcinoma, ovarian cancer, and other indications.
Roche-Genentech Collaboration: In early December 2021, we announced a transformational collaboration with Roche and Genentech to advance novel potential medicines in neuroscience and an indication in gastrointestinal oncology by mapping complex biology using the Recursion OS. In this collaboration, Recursion received an upfront payment of $150 million in January 2022, is eligible for milestones for map-building and data-sharing that could exceed $500M, as well as research and development, commercialization and net sales milestones on up to 40 programs that could exceed $300M per program and mid- to high-single digit tiered royalties on net sales for products commercialized from this work together.
Bayer AG Collaboration: In early December 2021, we announced the expansion of our collaboration with Bayer to include the use of Recursion’s biological mapping and navigating capabilities to discover small molecule drug candidates with the potential to treat fibrotic diseases. In this expanded collaboration, Recursion and Bayer may now work on more than a dozen programs of relevance to fibrotic diseases.
Recursion OS
Closed Loop Automated Synthesis Suite (CLASS): We began designing CLASS, our automated chemical microsynthesis system, which will further enable novel chemical formulation and profiling across our maps of biology and chemistry.
Total Observations: In the fourth quarter of 2021, we surpassed the milestone of executing 100 million total phenotypic experiments and producing 1 billion proprietary biological images.
Fourth Quarter and Fiscal Year 2021 Financial Results

Cash Position: Cash, cash equivalents, and investments were $516.6 million as of December 31, 2021, compared to $262.1 million as of December 31, 2020. This cash balance does not include the upfront payment of $150 million from entering into the Roche-Genentech collaboration in December 2021, which was received in January 2022.
Revenue: Total revenue, consisting primarily of revenue from collaborative agreements, was $2.5 million for the fourth quarter of 2021, compared to $2.7 million for the fourth quarter of 2020. Total revenue, consisting primarily of revenue from collaboration agreements, was $10.2 million for the year ended December 31, 2021, compared to $4.0 million for the year ended December 31, 2020. The increase in 2021 was due to revenue recognized from our collaboration with Bayer.
Research and Development Expenses: Research and development expenses were $48.3 million for the fourth quarter of 2021, compared to $20.7 million for the fourth quarter of 2020. Research and development expenses were $135.3 million for the year ended December 31, 2021, compared to $63.3 million for the year ended December 31, 2020. The increases in both periods in 2021 were primarily due to an increased number of experiments run on the Recursion OS, an increased number of assets being validated, and increased clinical costs of studies to progress our drug candidates.
General and Administrative Expenses: General and administrative expenses were $19.2 million for the fourth quarter of 2021, compared to $7.6 million for the fourth quarter of 2020. General and administrative expenses were $57.7 million for the year ended December 31, 2021, compared to $25.3 million for the year ended December 31, 2020. The increases in both periods in 2021 were due to the growth in size of the company’s operations, including an increase in salaries and wages of $16.4 million during the year ended December 31, 2021, equipment costs, human resources-related costs, facilities costs, and other administrative costs associated with operating as a high-growth company.
Net Loss: Net loss was $64.9 million for the fourth quarter of 2021, compared to a net loss of $25.8 million for the fourth quarter of 2020. Net loss was $186.5 million for the year ended December 31, 2021, compared to a net loss of $87.0 million for the year ended December 31, 2020.
Additional Corporate Updates

Letter to Shareholders: Recursion Co-Founder & CEO Chris Gibson, Ph.D. wrote an annual letter to shareholders which may be found in our 10-K report filed with the SEC.
Environmental, Social, and Governance (ESG) Report: Recursion has prepared a report which describes our operations in relation to a number of ESG metrics. A copy of this report may be found on the Recursion website at www.Recursion.com.
Neuroscience: Tim Ahfeldt, Ph.D. joined Recursion as Fellow, Neuroscience; Irit Rappley, Ph.D. joined Recursion as Vice President, Neuroscience and Translational Research; and Glenn Morrison, Ph.D. joined Recursion as Vice President, Clinical Development.
Clinical Development: Rogelio Mosqueda-Garcia, M.D., Ph.D. joined Recursion as Vice President, Clinical Development & Head of Human Pharmacology and Translational Medicine and Lisa Boyette, M.D., Ph.D. was promoted to Vice President, Medical Affairs.
Chemical Technology & Manufacturing: David Northrup joined Recursion as Vice President, Manufacturing & Supply Chain and Thierry Masquelin, Ph.D. joined Recursion as Senior Director, Chemical Technology.
Intellectual Property: Rich Person, J.D. joined Recursion as Vice President, Intellectual Property.
Annual Shareholder Meeting: The Recursion Annual Meeting of Shareholders will be held on June 14, 2022.

On March 23, 2022 Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, reported its financial results for the fourth quarter and year-to-date for the period ended December 31, 2021 (Press release, Navidea Biopharmaceuticals, MAR 23, 2022, View Source [SID1234610840]).

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Alexander L. Cappello, Chair of Navidea’s Board of Directors, said, "We remain focused on our mission of developing precision immunodiagnostic agents and immunotherapeutics to enhance patient care. We are confident that our strong management team, supported by our experienced and active Board of Directors, can continue to execute on our business plan and fulfill the vision we have for Navidea."

Fourth Quarter 2021 Highlights and Subsequent Events

●Continued to work on financing for the Company. We have engaged with an investment bank and options are being pursued.

●Initiated and enrolled into the Company’s NAV3-33 Phase 3 trial in rheumatoid arthritis ("RA") titled "Evaluation of Tc 99m Tilmanocept Imaging for the Early Prediction of Anti-TNFα Therapy Response in Patients with Moderate to Severe Active Rheumatoid Arthritis."

●Continued enrollment into the Company’s NAV3-32 Phase 2b trial comparing Tc99m tilmanocept imaging to histopathology of joints of patients with active RA. Eleven patients out of an originally estimated maximum of 24 based on subject pathotype are now enrolled with both imaging and biopsy performed.

●Completed enrollment in the Company’s NAV3-35 Phase 2b study, "Development of a Normative Database for Rheumatoid Arthritis (RA) Imaging with Tc99m Tilmanocept."

●Completed the investigator-initiated Phase 2 trial being run at the Massachusetts General Hospital evaluating Tc99m tilmanocept uptake in atherosclerotic plaques of HIV-infected individuals. An abstract was presented at the Conference on Retroviruses and Opportunistic Infections in February 2022.

●Signed research agreement with the University of Pennsylvania evaluating Tc99m tilmanocept as a prognostic marker for glioblastoma.

●Signed a Letter of Intent with the image analysis company MIM Software, Inc., to be the Company’s commercial partner for image quantification of Tc99m tilmanocept imaging in RA.

●Filed two new provisional patent applications. The first is related to new methods of attaching chemotherapeutics to the Manocept platform, and the second relates to maximizing target-tissue uptake and off-target competitive blocking. These have important implications for pipeline applications.

Michael Rosol, Ph.D., Chief Medical Officer for Navidea, said, "The clinical research team continues to work diligently to advance the technology in key disease areas, with an emphasis on our RA program. The NAV3-33 Phase 3 trial is enrolling, we continue to enroll into the NAV3-32 Phase 2b trial comparing tilmanocept imaging to synovial tissue biopsy samples of RA patients, and we have completed our normative database trial enrollment. Concurrent with all of this, we continue to make progress in our therapeutics pipeline, and we expect to keep advancing these towards the clinic."

Financial Results

●Total net revenues for the fourth quarter of 2021 were $50,000, compared to $219,000 for the same period in 2020. Total net revenues for the full year of 2021 were $532,000, compared to $914,000 in 2020. The decrease was primarily due to decreased grant revenue related to Small Business Innovation Research grants from the National Institutes of Health supporting Manocept development and decreased royalty and license revenue from sales of Tc99m tilmanocept in Europe, offset by the partial recovery of debts previously written off in 2015 and receipt of reimbursement from Cardinal Health 414, LLC of certain R&D costs.

●Research and development ("R&D") expenses for the fourth quarter of 2021 were $1.4 million, compared to $1.3 million in the same period in 2020. R&D expenses for the full year of 2021 were $5.1 million, compared to $4.9 million in 2020. The net increase during the year to date was primarily due to increased regulatory consulting, employee compensation, travel, recruiting and general office expenses, coupled with net increases in drug project expenses, including increased Manocept therapeutic and Tc99m tilmanocept development costs, offset by decreased Manocept diagnostic development costs.

●Selling, general and administrative ("SG&A") expenses for the fourth quarter of 2021 were $2.3 million, compared to $1.7 million in the same period in 2020. SG&A expenses for the full year of 2021 were $7.5 million, compared to $6.7 million in 2020. The net increase during the year to date was primarily due to separation expenses related to the resignation of our former Chief Executive Officer, coupled with increased consulting services related to European distribution of Tc99m tilmanocept, director compensation related to additional board members and increased board compensation rates, insurance costs, losses on the abandonment of certain intellectual property, recruiting fees, travel and general office expenses, offset by decreases in legal and professional services, employee compensation, investor relations costs, European annual registration fees, facilities costs and franchise taxes.

●Navidea’s net loss attributable to common stockholders for the fourth quarter of 2021 was $3.7 million, or $0.12 per share, compared to $3.0 million, or $0.11 per share, for the same period in 2020. Navidea’s net loss attributable to common stockholders for the full year of 2021 was $11.7 million, or $0.40 per share, compared to $11.4 million, or $0.48 per share, in 2020.

●Navidea ended the fourth quarter of 2021 with $4.2 million in cash and cash equivalents.

Conference Call Details

Investors and the public are invited to dial into the earnings call through the information listed below, or participate via the audio webcast on the company website. Dr. Michael Rosol, Chief Medical Officer, and Erika Eves, Vice President of Finance and Administration, will host the call and webcast to discuss the financial results and provide an update on recent developments and clinical progress. Management will be available to answer questions live immediately following the earnings announcement and prepared remarks portion of the call.

A live audio webcast of the conference call will also be available on the investor relations page of Navidea’s corporate website at www.navidea.com. In addition, the recorded conference call can be replayed and will be available for 90 days following the call on Navidea’s website.

On March 23, 2022 DURECT Corporation (Nasdaq: DRRX) reported that Dr. James E. Brown, President and CEO, will be participating in a panel discussion at the Cantor Virtual Rare Orphan Disease Summit hosted by Kristen Kluska, Managing Director, Biotechnology Research Analyst of Cantor Fitzgerald (Press release, DURECT, MAR 23, 2022, https://investors.durect.com/news-releases/news-release-details/durect-corporation-present-2022-cantor-fitzgerald-virtual-rare [SID1234610912]). The title of the panel is "Small but Mighty: Innovative Strategies in Tackling Some of the Larger Rare Orphan Disease Markets" and will take place at 1:00 pm ET on Wednesday, March 30, 2022.

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If you have interest in participating in the Cantor Virtual Rare Orphan Disease Summit, please reach out to your Cantor Fitzgerald representative.

On March 23, 2022 4D pharma plc (AIM: DDDD, NASDAQ: LBPS), a pharmaceutical company leading the development of Live Biotherapeutic products (LBPs), a novel class of drug derived from the microbiome, reported that in Part B of its signal finding study of MRx0518 in combination with MSD’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab) in patients with solid tumors that have progressed on a prior immune checkpoint inhibitor (ICI), the renal cell carcinoma (RCC) group has met its primary efficacy endpoint ahead of enrollment completion (Press release, 4d Pharma, MAR 23, 2022, View Source [SID1234610651]).

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The ongoing study is being conducted in heavily pre-treated metastatic patients with solid tumors who have previously experienced clinical benefit on prior ICI therapy and subsequently developed progressive disease. The study is being conducted in collaboration with MSD (Merck & Co., Inc., Kenilworth, NJ, USA). The primary efficacy endpoint for Part B of the study is more than three out of 30 patients per tumor group achieving clinical benefit, defined as complete response, partial response, or stable disease for at least six months.

Part B of the study has to date enrolled 20 patients with RCC, of which four out of the first 16 evaluable patients have achieved clinical benefit, each having achieved at least 6 months of stable disease. To date, Part B of the study has enrolled 47 patients of up to a total of 120 patients with RCC, non-small cell lung cancer, bladder cancer, and head and neck squamous cell carcinoma. MRx0518 continues to be safe and well tolerated.

"Today’s results in renal cell carcinoma, meeting the predefined primary efficacy endpoint early in this difficult to treat population, marks another important step forward for MRx0518 and the increasing importance of the microbiome in cancer treatment," commented Dr. Alex Stevenson, Chief Scientific Officer, 4D pharma. "Meeting the primary efficacy endpoint for this group is crucial for the future development of MRx0518, and these data are highly informative for our strategy going forward as we determine next steps in RCC."
4D pharma intends to discuss next steps with partners and its Genitourinary Cancers Advisory Board regarding the development path of MRx0518 and a potentially pivotal study in patients with ICI-refractory RCC. 4D pharma will continue to recruit patients into the ongoing study of MRx0518 and Keytruda in RCC and the three tumor groups, with potential expansion into other types of ICI resistance.

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

Conference Call & Webcast Information

4D pharma will host a conference call and live webcast on Wednesday, March 23, 2022, at 10:00 am ET (2:00 pm GMT) to discuss the interim results of the Phase I/II study of the combination of MRx0518 and Keytruda for the treatment of renal cell carcinoma.

4D pharma management will be joined by key opinion leaders (KOLs) Dr. Petros Grivas, Associate Professor Clinical Research Division at the Fred Hutchinson Cancer Research Center, and Dr. Scott T. Tagawa, Professor of Medicine and Urology at Weill Cornell Medicine, both members of the 4D pharma’s Genitourinary Cancers Advisory Board.

To access the live webcast, please visit the ‘Events’ section of the 4D pharma website. To access audio only, please dial (866) 939-3921 (United States) and (678) 302-3550 (International) and reference Confirmation Number 50287940. A replay of the webcast and accompanying slides will be available on the 4D pharma website following the event.

On March 23, 2022 Medigene reported that results for fiscal year 2021 and outlook Martinsried/Munich, 23 March 2022. Medigene AG ( View Source) (Medigene, FSE: MDG1, Prime Standard), an immuno-oncology company focusing on the development of T-cell-based cancer therapies, today published its financial results and Annual Report for the 2021 fiscal year and its outlook for 2022 (Press release, MediGene, MAR 23, 2022, View Source [SID1234610751]). The full version of the Annual Report 2021 can be downloaded here: View Source/investors-media/reports-presentations/

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Business review and outlook

The Company has been repositioned with the aim of fully focusing its future development programs on T cell receptor-modified T cell immunotherapy (TCR-T immunotherapy) of solid cancer, based on scientific, clinical and commercial considerations. Medigene believes that this direction optimally leverages its unique technologies and opens the greatest commercial opportunities for the Company now and in the future. It remains Medigene’s mission to offer seriously ill cancer patients new, effective and well-tolerated therapies developed internally or through partnerships.

Validating, comprehensive TCR-T and technology partnership with BioNTech SE (BioNTech)

BioNTech recently acquired Medigene’s TCR-4 from the MDG10XX program and has an exclusive option to acquire additional existing TCRs in Medigene’s discovery pipeline. Medigene will develop a number of new TCRs under a development partnership agreement with BioNTech lasting initially for three years and has granted BioNTech licenses to its PD1-41BB switch receptor and precision pairing library. These are technologies that could make TCR-T therapies more efficient and safer.

Under the agreement, Medigene has received an upfront payment of EUR 26 million and will be reimbursed for research and development costs incurred during the period of the collaboration. Medigene will be eligible for development, regulatory and commercial milestone payments up to a triple-digit million Euro amount per program. In addition, the Company will be eligible for tiered deferred option payments on global net sales for products based on TCRs arising from the collaboration and royalties on products utilizing at least one of the licensed technologies.

MDG1011 – clinically validated TCR-T therapy in blood cancers

In June 2021, the last patient was enrolled in the third dose cohort of the Phase-I part of the Phase I/II trial of MDG1011 in blood cancer. Medigene reported on safety, tolerability and feasibility in December 2021. In February 2022, first efficacy and immune monitoring data were published. MDG1011 was successfully produced for 12 of the 13 heavily pretreated patients (92.3%) and proved to be safe and well tolerated. MDG1011 showed signs of both biological and clinical activity and one patient is currently still under observation, over nine months after treatment. In line with Medigene’s focus on solid cancers, the Company has decided that, contingent on the final results from the Phase I part, the Phase II part of the trial would only be conducted with or by a partner.

Unique tumor-specific antigens – the "dark matter" of our genome

Under the Company’s collaboration with the University of Montréal, Medigene gained access to 47 potential new tumor-specific antigens (TSAs) common to solid tumors of different origin, such as ovarian, breast, and lung cancer. Medigene’s high-throughput screening technology identified ten peptides that were immunogenic and able to induce specific T cell responses. To date, Medigene has isolated more than 20 TCRs of T cell clones that recognize these novel TSAs. Their further functional and safety characterization is ongoing.

Development partnerships

Medigene continues its successful collaborations with 2seventy bio, Inc. (formerly: bluebird bio, Inc.) and Cytovant Sciences HK Limited, a biopharmaceutical company founded by Roivant Sciences (Roivant/Cytovant) and initiates operations within a new partnership with BioNTech. To maximize the Company’s value, Medigene continues to evaluate new partnering opportunities related to its suite of technologies and portfolio of product candidates.

Prof. Dolores Schendel, Chief Executive Officer (CEO) and Chief Scientific Officer (CSO) at Medigene: "Our steadfast focus on TCR-T therapies against solid cancers, has led, most recently, to the comprehensive new partnership with BioNTech and the sound financial basis it provides for the Company.

This partnership validates Medigene’s investment in T-cell-based immunotherapy of cancer. This was clearly appreciated and valued by BioNTech in the lengthy due diligence process leading to the deal. We look forward to executing on this partnership.

Medigene is very well positioned to sustainably increase value through partnerships and our internal projects, discovering novel TCRs and developing and improving new technologies to make TCR-T therapies safer, more efficient and cost effective."

Change in the Executive Management Board

Axel Malkomes, Medigene’s Chief Financial and Business Development Officer, will leave the Company at the end of March 2022 by mutual consent at the expiry of his contract. Prof. Dolores Schendel will remain as CEO and CSO.

Dr. Gerd Zettlmeissl, Chairman of Medigene’s Supervisory Board: "Axel was a valued member of the Executive Management Board, making a significant contribution to the restructuring and improvement of Medigene’s financial outlook. We would like to thank Axel and wish him the best in his future endeavors.

We are very pleased that Dr. Birger Kohlert, Vice President Finance, Controlling, Procurement and IT at Medigene since January 2020, will act as CFO. Birger looks back on years of international experience in finance and was previously CFO at S + P Samson, Kissing, Germany, EvoBus Sweden and EvoBus Denmark. Prior to that, he had several positions in the finance department of the Daimler Group in Germany and the USA and in the audit department of KPMG in Germany. He holds a doctorate in the field of international accounting."

Financial development and guidance

In fiscal 2021, the financial forecast that was initially issued was adjusted to reflect the more favorable revenue and cost situation. Thereby, the expected range for total revenues was increased from previously EUR 7 – 9 million to EUR 10 – 11 million and the forecast for research and development expenses (R&D expenses) was reduced from EUR 14 – 20 million to EUR 11 – 12 million. The reason for this was, among other things, the efficiency measures of the previous year and active cost management, which were ultimately also reflected in the EBITDA loss, the range of which also shifted from EUR 10 – 17 million to EUR 7 – 9 million. The total revenues of EUR 10.5 million (2020: EUR 8.0 million) and EBITDA loss incurred in fiscal year 2021 of EUR -6.6 million (2020: EUR -22.2 million) were therefore within the specified forecast range, while R&D expenses of EUR 12.8 million (2020: EUR 22.3 million) were slightly higher.

The financial forecast for 2022 reflects the Company’s focus on and progress in the core business of immunotherapies and does not include potential future milestone payments from existing or future partnerships or transactions, as the timing and extent of such events depends to a large extent on external parties and therefore cannot be reliably predicted by Medigene. In 2022, Medigene expects to achieve revenues of EUR 23 – 28 million, R&D expenses of EUR 11 – 15 million and a positive EBITDA in the amount of EUR 3 – 5 million.

Cash and cash equivalents amounted to EUR 22.4 million at the end of 2021 (31 December 2020: EUR 30.0 million). Including the upfront payment of EUR 26 million received under the new partnership with BioNTech signed in February 2022, Medigene is financed into Q4 2024 based on current planning.

Conference call

The Management Board will hold a conference call in English today at 3 pm CET (10 am ET). Please register beforehand and latest 2 hours prior to the event through this link in order to get your personal access information (phone number, passcode + individual PIN):