On March 24, 2022 Yumanity Therapeutics (Nasdaq: YMTX), a clinical-stage biopharmaceutical company focused on the discovery and development of innovative, disease-modifying therapies for neurodegenerative diseases, reported financial results for full-year ended December 31, 2021 and provided an overview of the Company’s recent corporate developments (Press release, Yumanity Therapeutics, MAR 24, 2022, View Source [SID1234615744]).

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"We continue to believe in the potential of YTX-7739, which may represent a major advancement in the treatment paradigm for Parkinson’s patients," said Richard Peters, M.D., Ph.D., President, Chief Executive Officer and Director of Yumanity. "As previously announced, to preserve capital and optimize shareholder value, we took several rapid steps recently including engaging H.C. Wainwright to evaluate strategic alternatives for the Company; implementing an aggressive restructuring of our workforce; retiring our venture debt with Hercules; and reducing our lease expenses."

Recent Corporate Developments

In February 2022, the Company announced its exploration of strategic alternatives to enhance shareholder value and engaged H.C. Wainwright as its exclusive financial advisor to assist in this process. The Company also announced a restructuring of the Company to preserve capital.
In February 2022, the Company collected a $5 million milestone payment from Merck & Co. for its ongoing research collaboration in ALS and frontotemporal lobar dementia. Yumanity is eligible to receive more than $500 million in future milestones and royalties under this research agreement.
In January 2022, the U.S. Food and Drug Administration (FDA) placed a partial clinical hold on our multidose clinical trials of YTX-7739. The partial clinical hold suspends initiation of multiple dose clinical trials in the U.S. until the FDA’s concerns have been addressed. The FDA has not halted all clinical programming and is permitting our planned single dose formulation clinical trial to proceed. We anticipate working closely with the FDA to adequately address their concerns.
Announced successful Phase 1b clinical trial results for YTX-7739 in patients with Parkinson’s disease. YTX-7739 demonstrated target engagement in patients with mild-to-moderate disease, and was found to be generally well tolerated, demonstrating favorable pharmacokinetic/ pharmacodynamic (PK/PD) profiles and a safety profile with no serious adverse events. In a subset of patients studied, YTX-7739 demonstrated a statistically significant change compared to baseline in an exploratory measurement of quantitative electroencephalogram, suggestive of a potential improvement in synaptic function that may benefit Parkinson’s patients.
2021 Financial Highlights

Cash position: As of December 31, 2021, cash, cash equivalents and investments were $36.5 million, compared to $85.3 million as of December 31, 2020. The decrease was primarily due to spending on the clinical development of YTX-7739 and costs related to being a public company. The Company believes its cash, cash equivalents and marketable securities, including the $5 million milestone payment from Merck & Co., will not be sufficient to fund operating expenses and capital expenditure requirements for a period of twelve months.
Research and development expense (R&D): Research and development expense was $26.4 million compared to $22.3 million for the prior year. The increase in R&D expense was due to the costs associated with the YTX-7739 clinical program, the YTX-9184 preclinical program, and increased spending on early-stage discovery efforts.
General and administrative expense: General and administrative expense was $20.4 million compared to $11.9 million for the prior year. The increase was primarily attributable to increased professional services fees associated with operating as a public company.
Net loss: The Company reported a net loss of $39.5 million, or $3.84 per basic and diluted share, compared to a net loss of $50.8 million, or $21.57 per basic and diluted share for the prior year. The decrease was due to increased research and development expenses and increased general and administrative expenses offset by costs associated with a one-time in-process research and development assets acquired expense in 2020.

About YTX-7739
YTX-7739 is Yumanity Therapeutics’ proprietary lead small molecule investigational therapy designed to penetrate the blood-brain barrier and inhibit the activity of a novel target, stearoyl-CoA desaturase (SCD). SCD appears to play an important and previously unrecognized role in mitigating neurotoxicity arising from the effects of pathogenic alpha-synuclein protein aggregation and accumulation, which ultimately results in the death of neurons and the subsequent dysregulation of movement and cognition that afflicts patients living with these diseases. Through inhibition of SCD, YTX-7739 modulates an upstream process in the alpha-synuclein pathological cascade and has been shown to rescue or prevent toxicity in preclinical cellular and animal models. The company is assessing the potential utility of YTX-7739 as a disease modifying therapy for Parkinson’s disease.

About SCD
SCD is an enzyme that catalyzes fatty acid desaturation, the products of which are incorporated into phospholipids, triglycerides, or cholesterol esters. These classes of lipid molecules regulate multiple diverse cellular properties and processes, including membrane structure and function, vesicle and organelle trafficking, intracellular signaling and inflammation. SCD expression is regulated by a transcription factor known as SREBF1, which has been identified in human genome-wide association studies as a risk factor for Parkinson’s disease. In preclinical models, SCD inhibition appears to normalize the dynamic interaction of pathological alpha-synuclein with membranes, which improves neuronal function and reduces toxicity, leading to enhanced neuronal survival. Following the initial discovery of SCD’s role in synucleinopathy by Yumanity’s unbiased discovery engine, several prominent academic labs have independently focused on SCD as a promising upstream target for mitigating alpha-synuclein mediated neurodegeneration. Alpha-synuclein-dependent disruption of membrane-related biological pathways, such as vesicle trafficking, is closely linked to the formation of Lewy body protein/membrane aggregations a hallmark pathological feature of Parkinson’s disease, Lewy body dementia and other neurodegenerative diseases.

On March 24, 2022 LAVA Therapeutics N.V. (Nasdaq: LVTX), an immuno-oncology company focused on developing its proprietary Gammabody platform of bispecific gamma delta T cell engagers to transform the treatment of cancer, reported recent corporate highlights and financial results for the fourth quarter and year ended December 31, 2021 (Press release, Lava Therapeutics, MAR 24, 2022, View Source [SID1234611048]).

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"I am incredibly proud of our LAVA team and the steady advancements we’ve made in the continued development of our Gammabody pipeline, despite the challenging times of the last year," said Stephen Hurly, president and chief executive officer. "With the encouraging LAVA-051 initial safety and pharmacodynamic observations and the LAVA-1207 study now actively recruiting patients, we are focused on execution and delivering potential product and platform-validating milestones this year and preparing our early-stage Gammabody pipeline for the clinic. We remain focused on our mission to efficiently develop transformative treatments for those suffering from cancer."

Recent Business and Pipeline Highlights

LAVA-051 Shows Encouraging Initial Safety and Pharmacodynamic Observations: In March 2022, LAVA announced interim data from the first three single patient cohorts of the Phase 1 dose escalation portion of its Phase 1/2a clinical trial, which we believe demonstrated that the doses of LAVA-051 used in these initial cohorts were safe and well-tolerated with no dose limiting toxicities or cytokine release syndrome observed. Per the study protocol, the cohort three dose was 33-times that of the cohort one dose. Vg9Vd2 (Vgamma9 Vdelta2) T cell receptor occupancy of LAVA-051 increased with LAVA-051 dose increases and peripheral blood Vg9Vd2 T cells also expressed higher levels of activation markers after LAVA-051 dosing. One patient with chronic lymphocytic leukemia (CLL) experienced multiple enlarged tender diseased lymph nodes one week after first dosing that subsequently regressed, reminiscent of tumor flare. Dosing in the study is continuing, with subsequent cohorts planned to enroll at least three patients per cohort. Additional data from the Phase 1 dose escalation phase of the trial is expected in the second

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quarter of 2022 and data from the Phase 2a expansion cohorts are expected in the second half of 2022.

The Phase 1/2a clinical trial (NCT04887259) is currently evaluating LAVA-051 in patients with relapsed or refractory chronic lymphocytic leukemia (CLL) and multiple myeloma (MM). Later in the trial, LAVA will also include patients with acute myeloid leukemia (AML). The trial is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity and preliminary antitumor activity of LAVA-051. In October 2021, the company announced that the U.S. Food and Drug Administration (FDA) granted orphan drug designation to LAVA-051 for the treatment of CLL.

Enrollment in LAVA-1207 Phase 1/2a Trial Underway: In February 2022, LAVA announced it had initiated dosing in the Company’s open-label, multi-center, Phase 1/2a clinical trial evaluating LAVA-1207 in patients with metastatic castration-resistant prostate cancer (mCRPC) and enrollment is ongoing. LAVA-1207 is a Gammabody that conditionally activates Vg9Vd2 T cells upon crosslinking to prostate-specific membrane antigen (PSMA) to trigger the potent and preferential killing of PSMA-positive tumor cells. The trial is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity and preliminary antitumor activity of LAVA-1207 in patients with mCRPC. The Phase 1 dose-escalation phase of the study will determine the recommended Phase 2 dose/schedule to be used in the subsequent Phase 2a expansion cohort to confirm safety and tolerability of LAVA-1207 in mCRPC patients. Data from the Phase 1 dose escalation phase of the trial are expected in the second half of 2022 and data from the Phase 2a expansion cohort are expected in the first half of 2023.

Early-Stage Pipeline Development: In addition to LAVA’s two lead programs, the Company is developing a portfolio of earlier stage GammabodyTM programs including LAVA-1223, a GammabodyTM directed at the epidermal growth factor receptor (EGFR) for the treatment of solid tumors, for which a clinical trial application (CTA) is planned for late 2022. There is potential for targeting several EGFR-expressing tumors with LAVA-1223, including: colorectal cancer, head and neck squamous cell carcinoma, non-small cell lung cancer and pancreatic cancer.

LAVA today announces the addition of LAVA-1266, a CD123 GammabodyTM, to its pipeline for the treatment of hematological malignancies. A CTA is planned for late 2023. CD123 is overexpressed in a wide range of hematological malignancies, including AML, B-cell acute lymphoblastic leukemia, hairy cell leukemia, Hodgkin lymphoma, blastic plasmacytoid dendritic cell neoplasm, B-cell chronic lymphoproliferative disorders and myelodysplastic syndrome.

Fourth Quarter and Annual Financial Results

●As of December 31, 2021, LAVA had cash, cash equivalents and investments totaling $133.2 million compared to cash and cash equivalents of $15.8 million as of December 31,

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2020. The increase was primarily attributable to proceeds from the Series C financing and subsequent IPO during the first quarter of 2021, partially offset by operating expenses.
●Research and license revenue was solely attributable to the company’s collaboration with Janssen Biotech, Inc. which was entered into in May 2020.
●Research and development expenses were $6.9 million and $37.2 million for the quarter and year ended December 31, 2021, respectively, compared to $5.2 million and $15.7 million for the quarter and year ended December 31, 2020. The increase for the quarter was primarily due to increases in clinical trial, headcount and other costs incurred in connection with advancing our lead GammabodyTM clinical candidates, LAVA-051 and LAVA-1207, into human clinical trials. The increase for the year also includes $14.4 million in license fees triggered by the IPO, most of which will be paid on the first and second anniversaries of our IPO and may be paid in either cash or common stock of the Company.

●General and administrative expenses were $3.9 million and $12.2 million for the quarter and year ended December 31, 2021, compared to general administrative expenses of $0.4 million and $2.7 million for the quarter and year ended December 31, 2020. The increases for the quarter and year were primarily due to increases in personnel-related costs, non-cash share-based compensation expense and additional insurance, professional and consultant fees incurred in connection with being a publicly traded company in the United States.
●Net losses were $9.9 million and $3.7 million, or $0.38 and $12.97 loss per share for the quarters ended December 31, 2021 and 2020, respectively and were $45.3 million and $15.5 million, or $2.30 and $38.85 loss per share for the years ended December 31, 2021 and 2020, respectively.

On March 24, 2022 IntelGenx Technologies Corp. (TSX:IGX)(OTCQB:IGXT) (the "Company" or "IntelGenx") reported financial results for the three- and twelve-month periods ended December 31, 2021 (Press release, IntelGenx, MAR 24, 2022, View Source [SID1234610996]). All dollar amounts are expressed in U.S. currency, unless otherwise indicated, and results are reported in accordance with United States generally accepted accounting principles except where noted otherwise.

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"2021 was a transformational year for IntelGenx, during which we achieved multiple corporate milestones, entered into important strategic partnerships and made significant progress across our various development programs," commented Dr. Horst G. Zerbe, CEO of IntelGenx. "We transitioned from a development-stage to a commercial-stage leader in pharmaceutical films with our first shipment of CBD Filmstrips to Heritage Cannabis; and graduated to the TSX, Canada’s most senior exchange. We entered into a strategic partnership and signed a second feasibility agreement with atai, solidifying our position in the burgeoning psychedelics space; established a commercial partnership for Tadalafil oral films in the U.S.; and partnered with an animal healthcare company to evaluate our VetaFilmTM platform. Further, our commercialization partner, Exeltis Healthcare S.L., launched our migraine treatment, RIZAPORT in Spain. On the heels of all of that, we were pleased to start 2022 with the resumption of our Phase 2a ‘BUENA’ clinical trial. I am thrilled with our team’s progress, which positions us for continued success this year and beyond."

2021 Fourth Quarter Financial Highlights:

Revenue was $494,000, compared to $790,000 in the 2020 fourth quarter.
Net comprehensive loss was $2.9 million, compared to $1.3 million in the 2020 fourth quarter.
Adjusted EBITDA loss was $2.3 million, compared to $0.8 million in Q4-2020.
2021 Full-Year Financial Highlights:

Revenue was $1.5 million, essentially unchanged from 2020.
Net comprehensive loss was $9.8 million, compared to $7.1 million in 2020.
Adjusted EBITDA loss was $7.1 million, compared to $5.3 million in 2020.
Recent Developments:

The Company’s wholly owned subsidiary, IntelGenx Corp., received a third term loan in the amount of $3.0 million pursuant to its amended and restated secured loan agreement with atai Life Sciences ("atai").
Resumed patient dosing in the ongoing Phase 2a ‘BUENA’ clinical trial in patients with mild to moderate Alzheimer’s Disease under a previously amended protocol using higher doses of Montelukast VersaFilm.
Initiated an arbitration proceeding against Tilray, Inc. related to an alleged breach of the parties’ 2018 license, development and supply agreement, as amended, for the co-development and commercialization of cannabis-infused VersaFilm products.
Graduated to the Toronto Stock Exchange.
Financial Results:

Total revenues for the three-month period ended December 31, 2021 amounted to $494,000, a decrease of $296,000, or 37%, compared to $790,000 for the three-month period ended December 31, 2020. The change is mainly attributable to a $425,000 decrease in revenues from licensing agreements, partially offset by increases in and R&D revenues of $94,000 and product revenues of $35,000. Operating costs and expenses were $3.0 million for the fourth quarter of 2021, versus $1.8 million for the corresponding three-month period of 2020. For Q4-2021, the Company had an operating loss of $2.5 million, compared to operating loss of $1.0 million for the comparable period of 2020. Net comprehensive loss was $2.9 million, or $0.02 per basic and diluted share, for the fourth quarter of 2021, compared to net comprehensive loss of $1.3 million, or $0.01 per basic and diluted share, for the comparable period of 2020.

Total revenues for the twelve-month period ended December 31, 2021 amounted to $1.5 million, essentially unchanged from the year ended December 31, 2020. Operating costs and expenses were $9.5 million for the full year 2021, versus $7.8 million for the corresponding twelve-month period of 2020. For the twelve-month period of 2021, the Company had an operating loss of $8.0 million, compared to an operating loss of $6.3 million for the comparable period of 2020. Net comprehensive loss was $9.9 million, or $0.07 per basic and diluted share, for the twelve-month period of 2021, compared to net comprehensive loss of $7.1 million, or $0.07 per basic and diluted share, for the comparable period of 2020.

As at December 31, 2021, the Company’s cash and short-term investments totalled $9.9 million, which did not include the $3.0 million secured loan granted to IntelGenx Corp. by atai in February 2022.

Annual Filings:

The Company’s annual report on Form 10-K and financial statements for the year ended December 31, 2021, as well as the 2022 Proxy Statement, will be filed with the United States Securities and Exchange Commission and the Canadian Securities regulatory authorities today, March 24, 2022.

Conference Call Details:

IntelGenx will host a conference call to discuss these 2021 fourth quarter and full year financial results today at 4:30 p.m. ET. The dial-in number for the conference call is (888) 506-0058 (Canada and the United States) or (973) 528-0135 (International); access code 503612. The call will be also be webcast live and archived on the Company’s website at www.intelgenx.com under "Webcasts" in the Investors section.

On March 24, 2022 Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, reported its audited consolidated financial results for the year ending December 31, 2021 and provided corporate updates (Press release, Valneva, MAR 24, 2022, View Source [SID1234610990]). The 2021 audited consolidated financial statements are available on the Company’s website (Financial Reports – Valneva).

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Valneva will provide a live webcast of its full-year 2021 results conference call beginning at 3 p.m. CET today. This webcast will also be available on the Company’s website. Please refer to this link: View Source

Peter Bühler, Valneva’s Chief Financial Officer, commented, "2021 was an exceptional year for Valneva, marked by unprecedented R&D progress and our successful Nasdaq listing. We reported positive Phase 3 results for two vaccine candidates (COVID-19 and chikungunya) and we expect both vaccines, if approved, to make a positive change to people’s lives. With close to €350 million in cash, we entered 2022 in a strong position and will continue to focus on gaining regulatory approvals and preparing market entry for our key late-stage programs."

Clinical Stage Vaccine Candidates

LYME DISEASE VACCINE CANDIDATE – VLA15
Further positive Phase 2 results reported

Valneva and Pfizer2 are developing VLA15, a Lyme disease vaccine candidate that targets the outer surface protein A (OspA) of Borrelia burgdorferi, the bacteria that cause Lyme disease. The vaccine candidate covers the six OspA serotypes expressed by Borrelia burgdorferi sensu lato species that are prevalent in North America and Europe.

In February 2022, Valneva and Pfizer reported further positive Phase 2 data for VLA153 confirming the robust immunogenicity profile observed for adults (18-65 years) in previous Phase 2 studies. The companies are also evaluating VLA15 in pediatric participants aged 5 to 17 years, with first data expected in the second quarter of 2022. Based on the latest Phase 2 results, Valneva and Pfizer plan to proceed with a three-dose primary series vaccination schedule for adults (18-65 years) in a planned Phase 3 clinical trial, which they expect to initiate in the third quarter of 2022, subject to regulatory approval.

SARS-CoV-2 VACCINE CANDIDATE – VLA2001
First Emergency Use Authorization granted

VLA2001 is currently the only whole virus, inactivated, adjuvanted vaccine candidate in clinical trials against COVID-19 in Europe. It is produced using Valneva’s established Vero-cell platform, leveraging the manufacturing technology for the Company’s commercial Japanese encephalitis vaccine, IXIARO.

Valneva remains focused on achieving regulatory approvals of VLA2001. In March 2022, VLA2001 was granted emergency use authorization from the Kingdom of Bahrain4. Valneva now expects to deliver the first VLA2001 shipments to Bahrain at the end of March 2022 as per the purchase agreement signed in December 20215.

VLA2001 is in advanced review processes with the EMA and UK MHRA, as recently communicated6. Subject to acceptance of Valneva’s responses by the EMA’s Committee for Medicinal Products for Human Use (CHMP), Valneva anticipates receiving a positive CHMP recommendation for conditional approval of VLA2001 for primary immunization in adults 18 to 55 years of age in April 2022. Following such conditional approval, the Company would expect to start delivering planned doses of VLA2001 to European countries in the second quarter of 2022. Valneva signed an agreement with the European Commission (EC) in November 2021 to supply up to 60 million doses of VLA2001 over two years, including 24.3 million doses in 20227 and the remainder via options in 2023.

In order to gradually expand the label and indications of VLA2001 to further age groups, Valneva is currently conducting additional clinical studies, including for potential use as a homologous and heterologous booster vaccine in the course of 2022.

CHIKUNGUNYA VACCINE CANDIDATE – VLA1553
Final Positive Phase 3 Results reported

Valneva is developing a single-dose vaccine candidate against the chikungunya virus, a mosquito-borne virus that has spread to over 120 countries.

In March 2022, Valneva announced successful completion of the Phase 3 pivotal trial of VLA15538. The final six-month analysis confirmed the very high level of seroprotection reported in August 2021. Six months after receiving a single vaccination, 96.3% of participants showed protective CHIKV neutralizing antibody titers. VLA1553’s good safety and tolerability profile was also consistent with topline Phase 3 data. Valneva now expects to commence the pre-submission process with the U.S. Food and Drug Administration (FDA) in the second quarter of 2022.

The Company also previously reported positive topline lot-to-lot manufacturing consistency results for VLA15539. This is one of the standard requirements for vaccine licensure, and final lot-to-lot results are expected in the second quarter of 2022.

Valneva also initiated a Phase 3 trial in adolescents in January 2022. The trial, conducted in Brazil by Instituto Butantan, is designed to support label extension to this age group following a potential initial regulatory approval in adults in the U.S10. Funded by the Coalition for Epidemic Preparedness Innovations (CEPI), the trial is also expected to support licensure of the vaccine in Brazil, which would be the first potential approval for use in an endemic region.

Commercial Vaccines

JAPANESE ENCEPHALITIS VACCINE (IXIARO/JESPECT)
IXIARO is the only Japanese encephalitis vaccine licensed and available in the U.S., Canada and Europe.

Sales of IXIARO were €45.1 million in 2021 compared to €48.5 million in 2020. While the COVID-19 pandemic continued to adversely impact the travel industry and vaccine sales to the private market, the impact on IXIARO sales was mitigated by the Company’s contract with the U.S. Government’s Department of Defense (DoD).

CHOLERA / ETEC11-DIARRHEA VACCINE (DUKORAL)

DUKORAL is an oral vaccine for the prevention of diarrhea caused by Vibrio cholerae and/or heat-labile toxin producing ETEC, the leading cause of travelers’ diarrhea. DUKORAL is authorized for use in the European Union and Australia to protect against cholera and in Canada, Switzerland, New Zealand and Thailand to protect against cholera and ETEC.

DUKORAL recorded sales of €2.4 million in 2021 compared to €13.3 million in 2020. 2021 sales continued to be significantly affected by the COVID-19 pandemic’s impact on the travel industry.

Full Year 2021 Financial Review
(Audited, consolidated under IFRS)

Revenues
Valneva’s total revenues were €348.1 million in 2021 compared to €110.3 million in 2020, an increase of 216%.

Product sales decreased by 4.5% to €63.0 million in 2021 compared to €65.9 million in 2020 as the travel industry continued to be impacted by the COVID-19 pandemic. On a constant exchange rate (CER) basis, product sales also decreased by 4.5% in 2021 as compared to 2020.

IXIARO/JESPECT product sales decreased by 6.9% (5.7% at CER) to €45.1 million in 2021 compared to €48.5 million in 2020. The impact of the COVID-19 pandemic was mitigated by sales to the U.S. Government’s Department of Defense (DoD) during the period. DUKORAL product sales declined by 81.7% (82.4% at CER) to €2.4 million in 2021 compared to €13.3 million in 2020. Third Party product sales grew by 271.0% to €15.4 million in 2021 from €4.2 million in 2020. The increase in Third Party product sales was driven by incremental sales related to Valneva’s distribution agreement with Bavarian Nordic for the sales of Rabipur/RabAvert and Encepur, which commenced in certain territories in 2021.

Other Revenues amounted to €285.1 million in 2021 compared to €44.4 million in 2020. This increase was attributable to revenues recognized in relation to the terminated UK COVID-19 vaccine supply agreement for non-refundable payments received up to December 31st, 2021.

Operating Result and EBITDA
Costs of goods and services sold (COGS) were €187.9 million in 2021. Gross margin on product sales was 36.5% compared to 36.6% in 2020. COGS of €22.6 million were related to IXIARO/JESPECT product sales, yielding a product gross margin of 50.0%. COGS of €7.6 million were related to DUKORAL product sales, causing a negative product gross margin. Of the remaining 2021 COGS, €9.9 million were related to the Third-Party product distribution business, €122.8 million to the COVID-19 business and €25.1 million to cost of services. COGS for the COVID-19 business in 2021 included write-offs of materials and onerous purchase agreements resulting from the termination of the UK VLA2001 supply agreement. In 2020, overall COGS were €54.3 million, of which €41.8 million related to cost of goods and €12.5 million related to cost of services.

Research and development investments continued to increase in 2021, growing to €173.3 million compared to €84.5 million in 2020. This was mainly driven by investments in Valneva’s COVID-19 vaccine candidate, VLA2001, as well as Phase 3 clinical study costs for Valneva’s chikungunya vaccine program, VLA1553. Excluding COVID-19, research and development investments amounted to €59.4 million in 2021 compared to €65.5 million in 2020. Marketing and distribution expenses in 2021 amounted to €23.6 million compared to €18.3 million in 2020. Marketing and distribution expenses in 2021 notably included €3.8 million of expenses (compared to €0.6 million in 2020) related to the launch preparation costs of the chikungunya vaccine candidate, VLA1553, and also included higher expenses related to the Company’s employee share-based compensation programs, which offset cost containment measures taken as a result of the pandemic’s impact on the travel vaccine business. General and administrative expenses increased to €47.6 million in 2021 from €27.5 million in 2020, mainly driven by increased costs to support corporate transactions such as the Company’s initial public offering on Nasdaq, increased resources in support of incremental COVID-19 activities, and higher costs related to the Company’s employee share-based compensation programs.

Other income, net of other expenses, increased to €23.0 million in 2021 from €19.1 million in 2020. This increase was mainly driven by increased R&D tax credits directly resulting from increased R&D spending.
Valneva recorded an operating loss of €61.4 million in 2021 compared to an operating loss of €55.1 million in 2020. EBITDA loss in 2021 was €47.1 million compared to an EBITDA loss of €45.2 million in 2020.

Net Result
In 2021, Valneva generated a net loss of €73.4 million compared to a net loss of €64.4 million in 2020.

Finance expense and currency effects in 2021 resulted in a net finance expense of €8.6 million, compared to a net finance expense of €10.0 million in 2020. This was mainly a result of foreign exchange gains amounting to €8.1 million in 2021, primarily driven by revaluation gains of non-Euro denominated balance sheet positions, compared to a net foreign exchange gain (including gains on derivative financial instruments) of €0.6 million in 2020. Interest charges increased to €17.0 million in 2021 compared to €10.7 million in 2020. This growth was mainly driven by increased interest charges related to refund liabilities.

Cash Flow and Liquidity
Net cash generated by operating activities amounted to €76.9 million in 2021 compared to €137.7 million in 2020, mainly driven by pre-payments related to the vaccine supply agreement signed with the EC. Net cash generated by operating activities in 2020 was mainly derived from the $130 million upfront payment received from Pfizer related to the Lyme R&D collaboration agreement, as well as payments received from the UK government in relation to the UK VLA2001 supply agreement.

Cash outflows from investing activities amounted to €93.1 million in 2021 compared to €19.3 million in 2020, mainly as a result of COVID manufacturing related construction activities across production sites in Scotland and Sweden, as well as equipment purchases.

Net cash generated from financing activities amounted to €154.5 million in 2021, which was mainly a result of proceeds from the issuance of new shares in the U.S. initial public offering and European private placement (Global Offering). Cash inflows in 2020 amounted to €21.7 million and mainly consisted of net proceeds from the financing arrangement with U.S. healthcare funds Deerfield and OrbiMed, offset by €20.0 million of repayments of borrowings to the European Investment Bank.
Liquid funds increased to €346.7 million as of December 31, 2021, compared to €204.4 million as of December 31, 2020. The cash increase resulted from significant cash in-flows most notably COVID related payments received from UK government and EC member states as well as net proceeds from the Global Offering in May and October 2021.

Non-IFRS Financial Measures
Management uses and presents IFRS results as well as the non-IFRS measure of EBITDA to evaluate and communicate its performance. While non-IFRS measures should not be construed as alternatives to IFRS measures, management believes non-IFRS measures are useful to further understand Valneva’s current performance, performance trends, and financial condition.

EBITDA is a common supplemental measure of performance used by investors and financial analysts. Management believes this measure provides additional analytical tools. EBITDA is defined as earnings (loss) from continuing operations before interest expense, income taxes, depreciation and amortization.

On March 24, 2022 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a biotechnology company developing novel LAG-3 related immunotherapy treatments for cancer and autoimmune diseases, reported that new interim data from 2nd line NSCLC patients (Part B) of its phase II TACTI-002 trial has been published in an abstract today in advance of ESMO (Free ESMO Whitepaper)’s European Lung Cancer Congress (ELCC) 2022. ELCC 2022 will now be taking place in a virtual only format from 30 March 2022 to 2 April 2022 (Press release, Immutep, MAR 24, 2022, View Source [SID1234610980]).

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Title: Results of a phase II study investigating eftilagimod alpha (soluble LAG-3 protein) and pembrolizumab in 2nd line PD-1/PD-L1 refractory metastatic non-small cell lung carcinoma pts
Abstract: Available at
View Source conference/ELCC 2022_TACTI-002 Part B_Abstract_Final.pdf
The related poster presentation with new and updated data that are not part of the abstract will now be released by ELCC on 29 March 2022 at 12:00 noon, CEST and will subsequently be made available on Immutep’s website at www.immutep.com.

About the TACTI-002 Trial

TACTI-002 (Two ACTive Immunotherapies) is being conducted in collaboration with Merck & Co., Inc., Kenilworth, NJ, USA (known as "MSD" outside the United States and Canada). The study is evaluating the combination of eftilagimod alpha (efti) with MSD’s KEYTRUDA (pembrolizumab) in patients with second line head and neck squamous cell carcinoma or non-small cell lung cancer in first and second line.

The trial is a Phase II, Simon’s two-stage, non-comparative, open-label, single-arm, multicentre clinical study that is taking place in study centres across Australia, Europe, and the US.

Patients participate in one of the following:

Part A – first line Non-Small Cell Lung Cancer (NSCLC), PD-X naïve – given the promising results of the first two stages of Part A, an expansion stage with additional patients was commenced in November 2020 to assist with trial design in subsequent late-stage settings

Part B – second line NSCLC, PD-X refractory

Part C – second line Head and Neck Squamous Cell Carcinoma (HNSCC), PD-X naïve

TACTI-002 is an all-comer study in terms of PD-L1 status, a well-known predictive marker for response to pembrolizumab monotherapy especially in NSCLC and HNSCC.