On May 11, 2022 Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company developing a novel class of injectable biologics to selectively engage and modulate targeted T cells directly within the patient’s body, reported that the U.S. Food and Drug Administration (FDA) has accepted the Company’s Investigational New Drug (IND) application for the evaluation of CUE-102, its second interleukin 2 (IL-2)-based CUE-100 series biologic, in a dose escalation and expansion monotherapy Phase 1 trial, which will have a starting dose of 1 mg/kg for the treatment of Wilms’ Tumor 1 (WT1)-positive recurrent/metastatic cancers, with initial focus on gastric, pancreatic, ovarian and colon cancers (Press release, Cue Biopharma, MAY 11, 2022, View Source [SID1234614235]).

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CUE-102 supports the modularity of the IL-2 based CUE-100 series as the core biologic framework is largely conserved with the primary difference being the incorporation of the WT1 T cell epitope. The IND acceptance allowing the dose escalation trial to begin dosing at 1 mg/kg was supported by the safety and tolerability data from the CUE-101 trial. CUE-101, the first biologic from the CUE-100 series, had a starting dose of 0.06 mg/kg and required approximately 9 months to dose escalate from 0.06 mg/kg to 1 mg/kg. As such, the starting dose of CUE-102 (targeting WT1 expressing cancers) may provide substantive time and cost savings for potentially demonstrating tolerability at therapeutically effective doses.

"The ability to start our dose escalation trial at 1 mg/kg, is significant as it allows us to initiate the trial at a dose level that demonstrated signs of clinical activity in our CUE-101 trial. At this dose level, we can potentially determine tolerability and therapeutically effective doses much more efficiently by truncating the dose escalation process," stated Ken Pienta, M.D., acting chief medical officer of Cue Biopharma. "We believe CUE-102 provides a significant opportunity to address a high unmet medical need in a wide variety of WT1-positive malignancies including colorectal, pancreatic and lung, and potentially offers a tolerable and more effective treatment option to patients in need. We believe CUE-102 has the potential to change the treatment landscape for WT1-positive patients and are very pleased to now begin evaluating its potential benefit in the clinic."

Anish Suri, Ph.D., president and chief scientific officer of Cue Biopharma said, "The IND acceptance of CUE-102 is a step forward in support of our strategic vision for pipeline expansion of assets emerging from our IL-2-based CUE-100 series of Immuno-STATs. Since the core framework and the IL-2 components are conserved, the clinical de-risking achieved with CUE-101 should in principle allow us to develop subsequent therapeutic molecules in a significantly expedited and cost-effective manner. To that end, we believe that FDA clearance to initiate the CUE-102 clinical trial at 1 mg/kg dose is an important step forward to the platform de-risking achieved with our current clinical candidate, CUE-101."

FDA acceptance of the IND application for CUE-102 is another important milestone for Cue Biopharma in their multi-target strategic collaboration with LG Chem Life Sciences, the life sciences division of LG Chem Ltd., to develop multiple Immuno-STAT biologics focused in the field of oncology.

About CUE-102
Leveraging the Immuno-STAT (Selective Targeting and Alteration of T cells) platform of targeted interleukin 2 (IL-2) therapies and the ongoing development of CUE-101, CUE-102 is being developed as a novel therapeutic fusion protein to selectively activate tumor antigen-specific T cells to treat Wilms’ Tumor 1 (WT1)-expressing cancers. CUE-102 consists of two human leukocyte antigen (HLA) molecules presenting a WT1 peptide, four affinity-attenuated IL-2 molecules, and an effector attenuated human immunoglobulin G (IgG1) Fc domain. WT1 is a well-recognized onco-fetal protein known to be over-expressed in a number of cancers, including solid tumors and hematologic malignancies.

Cue Biopharma’s presentation at the 2021 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting, demonstrating CUE-102’s ability to selectively activate and expand WT1-specific T cells for the treatment of WT1-expressing cancers, can be accessed in the investor section of the Cue Biopharma website here.

About the CUE-100 Series
The CUE-100 series consists of Fc-fusion biologics that incorporate peptide-major histocompatibility complex (pMHC) molecules along with rationally engineered interleukin 2 (IL-2) molecules. These singular biologics are anticipated to selectively target, activate and expand a robust repertoire of tumor-specific T cells directly in the patient’s body. The binding affinity of IL-2 for its receptor has been deliberately attenuated to achieve preferential selective activation of tumor-specific effector T cells while reducing potential for effects on regulatory T cells (Tregs) or broad systemic activation, potentially mitigating the dose-limiting toxicities associated with current IL-2-based therapies.

About Immuno-STAT
The company’s Immuno-STAT (Selective Targeting and Alteration of T cells) platform biologics are designed for targeted modulation of disease-associated T cells in the areas of immuno-oncology and autoimmune disease. Each of our biologic drugs is designed using our proprietary scaffold comprising: 1) a peptide-major histocompatibility complex (pMHC) to provide selectivity through interaction with the T cell receptor (TCR), and 2) a unique co-stimulatory signaling molecule to modulate the activity of the target T cells.

The simultaneous engagement of co-regulatory molecules and pMHC binding mimics the signals delivered by antigen presenting cells (APCs) to T cells during a natural immune response. This design enables Immuno-STAT biologics to engage with the T cell population of interest, resulting in selective T cell modulation. Because our drug candidates are delivered directly in the patient’s body (in vivo), they are fundamentally different from other T cell therapeutic approaches that require the patients’ T cells to be extracted, modified outside the body (ex vivo) and reinfused.

On May 11, 2022 IceCure Medical Ltd. (NASDAQ: ICCM) (TASE: ICCM) ("IceCure" or the "Company"), developer of minimally-invasive cryoablation technology, the ProSense System, that destroys tumors by freezing as an alternative to surgical tumor removal ("ProSense"), reported it will report its business and financial results for the first quarter ended March 31, 2022 on Wednesday, May 18, 2022 with a press release issued at 7:00 am ET (Press release, IceCure Medical, MAY 11, 2022, https://www.prnewswire.com/news-releases/icecure-medical-to-report-q1-2022-results-and-conduct-conference-call-may-18-2022-301545359.html [SID1234614249]). IceCure’s management team, joined by Dr. Richard Fine, will host a conference call that morning at 8:30 am ET.

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Dr. Richard E. Fine, MD, past President of the American Society of Breast Surgeons, an ICE3 trial investigator, Program Director of the Breast Surgical Oncology Fellowship, and Director of Research and Education at the West Comprehensive Breast Center in Germantown, Tennessee, will be on the call to discuss ProSense as a potential treatment for early stage breast cancer and will be available for Q&A with investors.

On May 11, 2022 Epigenomics AG (FSE: ECX, OTCQX: EPGNY, the "Company") reported financial results (IFRS, unaudited) for the first three months of 2022 (Press release, Epigenomics, MAY 11, 2022, View Source [SID1234614174]).

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Financial key figures

Revenues in the first quarter 2022 increased slightly from EUR 106 thousand to EUR 115 thousand compared to the prior-year period.
R&D costs increased from EUR 737 thousand in the first quarter 2021 to EUR 1,401 thousand in Q1 2022 to support the advancement of Epi proColon "Next-Gen". Additionally, short-time work at the Berlin site was terminated in mid-September 2021 and additional personnel were recruited in the U.S.A. for the "Next-Gen" development and study.
Selling and administrative expenses increased from EUR 1,601 thousand to EUR 2,015 thousand, mainly due to U.S. market studies.
EBITDA (before share-based payment expenses) amounted to EUR -2,574 thousand in the reporting period, compared with EUR -985 thousand in the same period of the previous year.
The net loss for the period was EUR -2,657 thousand (Q1 2021: EUR -1,201 thousand); the loss per share decreased from EUR 0.20 to EUR 0.17 compared to the same period of the previous year.
Cash consumption increased to EUR 3,408 thousand in the first quarter of 2022 (Q1 2021: EUR 2,386 thousand).
As of March 31, 2022, the Company had cash and cash equivalents of EUR 20,039 thousand (December 31, 2021: EUR 23,049 thousand).
Operational developments

During the 2022 conversion windows for the mandatory convertible bonds issued in January 2021 and September 2021, bonds were converted into 817,564 new shares (ISIN DE000A3H2184). Accordingly, the number of shares outstanding increased from 15,539,737 to 16,357,301 no-par value registered shares of the Company. The Company’s share capital increased accordingly to EUR 16,357,301.00.
The Company continues to make progress on the "Next-Gen" development and clinical trial. The Company is on-track to initiate the trial this summer and publish preliminary assay performance data this year.
"We are very pleased with our progress on Epi proColon "Next-Gen" and remain on-track to achieve our development and trial goals for this year", said Greg Hamilton, CEO of Epigenomics. "We are optimistic that the performance of "Next-Gen" will result in a significant market opportunity in the years to come."

Outlook 2022

Revenue

The Company confirms its outlook for fiscal year 2022 and continues to expect revenue within the range of EUR 0.3 million to EUR 0.8 million. If Medicare reimbursement is indeed achieved via legislation in 2022, the Company is likely to amend the revenue forecast.
EBITDA / cash consumption

For EBITDA (before share-based payment expenses), Epigenomics forecasts a range of EUR -15.0 million to EUR -17.0 million. This assumes that the Company initiates the Epi proColon "Next-Gen" trial in the summer of 2022. If this trial is delayed or enrollment is slower than anticipated then the forecast for the adjusted EBITDA is likely to improve. The anticipated spend for the clinical trial in 2022 will be aligned with the Company’s ability to raise funds for the remainder of the trial in 2023 and 2024.
Further information

The interim statement for the first three months 2022 (unaudited) can be found on Epigenomics’ website at: View Source." target="_blank" title="View Source." rel="nofollow">View Source

Conference call for analysts and investors

Epigenomics AG will host a conference call for analysts and investors today at 4.00 pm (CET) / 10.00 am (EDT). The webcast can be accessed on the Company’s website View Source

Participants are asked to dial in 10 minutes prior to the start of the conference call and to register using the link above.

An audio replay of the conference call will be provided on the Epigenomics’ website subsequently.

On May 11, 2022 Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP; "Cyclacel" or the "Company"), a biopharmaceutical company developing innovative medicines based on cancer cell biology, reported first quarter 2022 financial results and provided a business update (Press release, Cyclacel, MAY 11, 2022, View Source [SID1234614218]).

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"We are pleased to report another productive quarter for Cyclacel, which included continued expansion of our three, registration-directed, clinical trials and publication of research findings supporting our drug development strategy," said Spiro Rombotis, Chief Executive Officer of Cyclacel. "Oral fadraciclib, our CDK2/9 drug candidate, is proving to be well tolerated in 065-101, our Phase 1/2 solid tumor and lymphoma study, having reached dose level 5 in the dose escalation stage which provides for daily dosing over 4 out of 4 weeks. In our PLK1 program, we have dosed the first patients in the streamlined Phase 1/2 trial of CYC140 for the treatment of solid tumors and lymphomas. We have optimized the properties of CYC140 to fit its apoptosis-driven mechanism, including short half-life and differentiated structural and biological properties, compared to other PLK1 inhibitors in development. We therefore believe CYC140 has the potential to demonstrate activity across a wide range of solid tumors, as a single agent and in combinations."

"A growing body of preclinical research supports the clinical development plan of fadraciclib. In April, we announced publication of research from The University of Texas MD Anderson Cancer Center highlighting fadraciclib’s antileukemic activity in CLL. Fadraciclib treatment resulted in suppression of MCL1, a key target protein. In addition, synergy of fadraciclib in combination with venetoclax was observed against primary CLL cell lines, including those with 17p deletion. With funding estimated through mid-2023, we are continuing to execute on our clinical development plan. We look forward to presenting initial fadraciclib clinical data in solid tumors and lymphomas, in the coming weeks, determining the recommended Phase 2 dose and entering proof of concept stage in the second half of 2022."

Key Highlights

·Fadraciclib 065-101 Phase 1/2 study in advanced solid tumors: Phase 1 dose escalation has reached dose level 5 (100mg given twice a day for 5 days for 4 weeks in a 4-week cycle) with a favorable patient safety profile and appropriate pharmacokinetic data observed thus far. The study is enrolling at four sites with several additional sites planning to join the proof-of-concept stage of this registration-directed study in 2H 2022. The Phase 2 part includes seven histologically defined cohorts thought to be sensitive to the drug’s mechanism: breast, colorectal (including KRAS mutant), endometrial/uterine, hepatobiliary, ovarian cancers and lymphomas. The study also includes an eighth basket cohort which will enroll patients regardless of histology with biomarkers relevant to the drug’s mechanism, including MCL1, MYC and/or cyclin E amplified.

·Fadraciclib 065-102 Phase 1/2 study in patients with leukemias or myelodysplastic syndromes. This study is now enrolling at City of Hope and MD Anderson Cancer Center and is treating patients at dose level one. Once the recommended Phase 2 dose (RP2D) for single-agent, oral fadraciclib is determined, the study will enter into proof-of-concept, cohort stage, where fadraciclib will be administered, both as a single agent and in combinations, to patients in up to seven cohorts relevant to the drug’s mechanism of action and informed by the clinical activity of fadraciclib in previous studies. Single-agent cohorts will include patients with acute myeloid leukemia (AML) or myelodysplastic syndromes (MDS) who have an inadequate response or have progressed on venetoclax combinations with hypomethylating agent (HMA) or low dose Ara C and relapsed/refractory AML or MDS patients with FLT3, KIT or MAPK pathways (including N and K RAS, BRAF, PTPN11, NF1). The trial will also include patients with CLL who have progressed after at least two lines of therapy including a BTK inhibitor and/or venetoclax.

Announced publication confirming fadraciclib suppresses MCL1 and synergizes with venetoclax in chronic lymphocytic leukemia. Results from the study confirmed that fadraciclib inhibited CDK9 mediated transcription, reduced levels of the short-lived, anti-apoptotic protein MCL1, and induced apoptosis in primary CLL cells. The data highlighted the importance of continuous treatment to prevent recovery of MCL1 protein levels. Furthermore, fadraciclib was shown to combine synergistically with the BCL2 antagonist, venetoclax, and demonstrated even greater synergy when targeted against 17p deleted CLL cells which were not sensitive to either agent alone.

·CYC140 140-101 Phase 1/2 study in solid tumors and lymphomas. This registration-directed study opened in April at City of Hope and MD Anderson Cancer Center and is enrolling patients in the Phase 1 dose escalation stage. The study uses a streamlined design and will initially determine RP2D for single-agent oral CYC140. Following RP2D, the trial will immediately enter into proof-of-concept, cohort stage, using a Simon 2-stage design. In this stage CYC140 will be administered to patients in up to seven mechanistically relevant cohorts including patients with bladder, breast, colorectal (including KRAS mutant), hepatocellular and biliary tract, and lung cancers (both small cell and non-small cell), as well as lymphomas plus an eighth basket cohort which will enroll patients with biomarkers relevant to the drug’s mechanism.

More information on our clinical trials can be found here.

Financial Highlights

As of March 31, 2022, cash and cash equivalents totaled $29.6 million, compared to $36.6 million as of December 31, 2021. Subsequent to the end of the first quarter, the Company received $3.6 million of United Kingdom research & development tax credits and $1.3 million in royalty receipts providing pro forma March 31, 2022, cash and cash equivalents of $34.5 million. The Company estimates that its available cash will fund currently planned programs through June 2023.

Research and development (R&D) expenses were $5.0 million for the three months ended March 31, 2022, as compared to $2.6 million for the same period in 2021. R&D expenses relating to fadraciclib were $3.6 million for the three months ended March 31, 2022, as compared to $1.7 million for the same period in 2021 due to increase in clinical trial costs associated with ongoing clinical trials evaluating fadraciclib in Phase 1/2 studies along with an increase in non-clinical expenditures. R&D expenses related to CYC140 were $1.1 million for the three months ended March 31, 2022, as compared to $0.7 million for the same period in 2021 due to clinical trial costs associated with the opening of clinical sites for CYC140 Phase 1/2 studies.

General and administrative expenses for the three months ended March 31, 2022, were $1.6 million, compared to $1.7 million for the same period of the previous year due to a decrease in professional and recruitment costs.

Total other income, net, for the three months ended March 31, 2022, was $1.3 million, compared to $0.1 million for the same period of the previous year. The increase of $1.2 million for the three months ended March 31, 2022, is primarily related to royalty income received from Thermo Fisher Scientific Corporation.

United Kingdom research & development tax credits were $1.1 million for the three months ended March 31, 2022, as compared to $0.7 million for the same period in 2021 as a direct consequence of increased qualifying research and development expenditure. Tax credit receipts of $3.6 million in respect of the financial year ended December 31, 2021, were received in May 2022.

Net loss for the three months ended March 31, 2022, was $4.1 million, compared to $3.5 million for the same period in 2021.

For the live and archived webcast, please visit the Corporate Presentations page on the Cyclacel website at www.cyclacel.com. The webcast will be archived for 90 days and the audio replay for 7 days.

On May 11, 2022 Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZS) ("Aeterna" or the "Company"), a specialty biopharmaceutical company developing and commercializing a diversified portfolio of pharmaceutical and diagnostic products, reported its financial and operating results for the first quarter ended March 31, 2022 (Press release, AEterna Zentaris, MAY 11, 2022, View Source;b=2533&ID=108323&m=rl&g=1592 [SID1234614236]). The Company also provided an update on its pre-clinical and clinical development programs.

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"We are beginning to see tangible progress related to the development programs we in-licensed throughout 2021. In particular, we are very pleased to report data with our pre-clinical program for AIM biologicals, which have recently been accepted for presentation at two scientific conferences. We remain focused advancing our pipeline, executing on our strategic priorities and unlocking the full potential of our pipeline and value for all stakeholders," commented Dr. Klaus Paulini, Chief Executive Officer of Aeterna.

Recent Highlights

Presented results from pre-clinical studies of Aeterna’s AIM Biologicals (Autoimmunity Modifying Biologicals) for the potential treatment of Parkinson’s Disease ("PD") at IMMUNOLOGY2022, the Annual Event of the American Association of Immunologists, held May 6-10, 2022.
Secured new European patent providing intellectual property protection of macimorelin in 27 countries within the European Union as well as additional European non-EU countries, such as the UK and Turkey, for macimorelin (Ghryvelin; Macrilen) for use to diagnose growth hormone deficiency (GHD) in adults.
Announced that results from pre-clinical studies of Aeterna’s AIM Biologicals for the potential treatment of neuromyelitis optica spectrum disorder ("NMOSD") were accepted for presentation at the 13th International Congress on Autoimmunity to be held June 10-13, 2022 in Athens, Greece.
Pre-Clinical and Clinical Programs Update:

Therapeutics Development Pipeline

AIM Biologicals: Targeted, highly specific autoimmunity modifying therapeutics for the potential treatment of neuromyelitis optica spectrum disorder ("NMOSD") and Parkinson’s disease (PD)

AIM Biologicals utilize a novel mechanism which is believed to demonstrate that peptide antigens presented on immunosuppressive MHC class I molecules can selectively and efficiently induce antigen-specific tolerance. Based on this mechanism, the targeted immunomodulating therapeutics are being designed as optimized soluble molecules with the goal that they may be adapted to selectively induce tolerance to various autoantigens. With AIM Biologicals, the Company aims to restore the tolerance against such proteins to treat autoimmune diseases.

Pre-clinical studies conducted by the University of Wuerzburg, Germany thus far indicate that tolerance induction appears to be achieved via selective elimination of antigen-specific immune effector cells and via induction of antigen-specific regulatory T cells from naïve T cells. AIM Biologicals thus have the potential to become highly specific and effective yet not personalized treatments of NMOSD. Data from the pre-clinical studies will be presented at the 13th International Congress on Autoimmunity to be held June 10-13, 2022 in Athens, Greece.

For the treatment of NMOSD, it is believed that the AIM Biologicals will present a specific antigen derived from the water channel protein aquaporin-4 (AQP4) loaded to soluble immunoregulatory HLA-G protein to selectively induce immunological tolerance in the central nervous system.

For the development of AIM Biologicals as potential PD therapeutics, Aeterna plans to utilize, among others, an innovative animal model on neurodegeneration by α-synuclein-specific T cells in AAV-A53T-α-synuclein Parkinson’s disease mice, which has recently been published by University of Wuerzburg researchers. Additionally, the Company recently presented pre-clinical data demonstrating that corresponding AIM Biologicals prevented mobility impairments and postmortem histopathological assessment confirmed the induction of favorable in-situ immune cell composition and the rescue of substantia nigra neurons. The pre-clinical data confirmed that the translation potential of the approach deserves further exploration.

The University of Wuerzburg continues to bolster its intellectual property (IP) protection and has filed new IP on AIM-Biologicals related to both NMOSD and PD.

Next Steps – NMOSD

Conduct in-vitro and in-vivo assessments to select an AIM Biologicals-based development candidate.
Manufacturing process development for a selected candidate.
Next Steps – Parkinson’s Disease

Design and produce antigen-specific AIM Biologics molecules for the potential treatment of Parkinson’s disease.
Conduct in-vitro and in-vivo assessments in relevant Parkinson’s disease models.
Delayed Clearance Parathyroid Hormone ("DC-PTH") Fusion Polypeptides: Potential treatment for primary hypoparathyroidism

In March 2021, Aeterna entered into an exclusive patent and know-how license agreement and research agreement with The University of Sheffield, United Kingdom, for the intellectual property relating to DC-PTH fusion polypeptides with delayed clearance for all human uses. In consultation with The University of Sheffield, Aeterna has selected AEZS-150 as the lead candidate in its DC-PTH program. AEZS-150 is being developed with the goal of providing a potential new treatment option for primary hypoparathyroidism in adults.

The Company has selected a contract manufacturing organization for the development of its manufacturing for AEZS-150.

Next Steps

Work with The University of Sheffield to conduct in depth characterization of development candidate (in-vitro and in-vivo).
Ongoing development of manufacturing process.
Formalize pre-clinical development of AEZS-150 in preparation for a potential IND filing for conducting the first in-human clinical study.
Macimorelin Therapeutic: Ghrelin agonist in development for the treatment of ALS (Lou Gehrig’s disease)

In January 2021, the Company entered into a material transfer agreement with the University of Queensland, Australia, to provide macimorelin for the conduct of pre-clinical and subsequent clinical studies evaluating macimorelin as a potential therapeutic for the treatment of ALS (Lou Gehrig’s disease). The University of Queensland researchers have filed for supportive grants and aim to conduct pre-clinical studies in multiple pre-clinical models to demonstrate the therapeutic potential of macimorelin to slow disease progression and disease-specific pathology.

Macimorelin, a potent ghrelin agonist, is an orally active small molecule that stimulates the secretion of growth hormone from the pituitary gland. Acting via this mechanism, which was established during the development as a diagnostic test for growth hormone deficiency, it is believed that macimorelin may slow the progression of certain neurodegenerative diseases like ALS.

Apart from already available pre-clinical and clinical data on macimorelin for the development as a diagnostic, Aeterna may utilize the established supply chain to support this development. Alternative formulations are currently also under development, as a further option in addition to the existing oral solution already approved for the diagnostic use in adult growth hormone deficiency (AGHD).

Next Steps

Continue investigating macimorelin efficacy in an ALS specific SOD1 mouse model.
Assess alternative formulations.
Formalize pre-clinical development plan.
Diagnostics Development Pipeline

Macimorelin Diagnostic: Ghrelin agonist in development for diagnostic use in childhood-onset growth hormone deficiency ("CGHD")

Aeterna is currently conducting its pivotal Phase 3 safety and efficacy study AEZS-130-P02 (the "DETECT-trial") evaluating macimorelin for the diagnosis of CGHD.

Children and adolescents from two to less than 18 years of age with suspected growth hormone deficiency are to be included. The study is expected to include approximately 100 subjects in Europe and North America, with at least 40 subjects in pre-pubertal and 40 subjects in pubertal status. Macimorelin growth hormone stimulation test ("GHST") will be performed twice for repeatability data and two standard GHSTs will be used as controls: arginine (i.v.) and clonidine (p.o.).

On April 22, 2021, the U.S. FDA Investigational New Drug Application associated with this clinical trial became active.

The first clinical sites in the U.S. and in Europe are open for patient recruitment. In Europe, national clinical trial approval procedures and site initiation activities are ongoing. Site activation and patient enrollment continues to be impacted by the ongoing COVID-19 pandemic. The Company is actively monitoring delays to mitigate potential impact of COVID-19 on estimated trial completion dates. Additionally, clinical trial sites originally planned in the Ukraine and Russia are being halted due to the conflict in Ukraine intensifying following the Russian invasion. As a result, further delays with enrollment are expected as the DETECT-trial planned to recruit at least 25% (25 subjects) within those countries. Due to these circumstances and the resulting feasibility data from the Company’s CRO on potential options, Aeterna believes recruitment for the DETECT-trial may now continue until later into 2023.

The Company continues to advance its ongoing business development discussions to secure commercialization partners for macimorelin in additional markets. In addition to its previously established agreements, Aeterna recently entered into a license agreement with NK Meditech Ltd., for the development and commercialization of macimorelin in the Republic of Korea, and a distribution agreement with Er-Kim Pharmaceuticals Bulgaria EOOD for the commercialization of macimorelin in Turkey and some Balkan countries.

Vaccine Development Pipeline

Bacterial Vaccine Platform: Orally active, live-attenuated bacterial vaccine platform with potential application against viruses and bacteria, such as coronavirus types, including COVID-19 (SARS-CoV-2) and Chlamydia

In February 2021, Aeterna entered into an exclusive option agreement with the University of Wuerzburg to evaluate a pre-clinical, potential COVID-19 vaccine developed at the University of Wuerzburg. In March 2021, the Company exercised its option and entered into a license agreement where the Company was granted an exclusive, world-wide, license to certain patent applications and know-how owned by the University of Wuerzburg to research and develop, manufacture, and sell a potential COVID-19 vaccine. The Company’s vaccine platform is currently undergoing pre-clinical studies for the prevention of coronavirus diseases, including COVID-19 (SARS-CoV-2) with the planned start of clinical development targeted for H1 2023.

In September 2021, the Company exercised its option under the agreement with the University of Wuerzburg on a then undisclosed field, now known to be Chlamydia. Chlamydia trachomatis is a sexually transmitted bacterium infecting over 130 million subjects annually. Asymptomatic disease can spread to the reproductive tract eventually inducing infertility, miscarriage, or ectopic pregnancy, which is a life-threatening condition. Ocular infections can lead to inclusion conjunctivitis or trachoma, which is the primary source of visual impairment or infectious blindness. Additionally, Prof. Dr. Thomas Rudel of the University of Wuerzburg was engaged by the Company in September 2021 as a scientific consultant to support development of the salmonella-based vaccine platform for the coronavirus and Chlamydia vaccines.

Recently, the Company expanded its research agreement with the University of Wuerzburg to conduct supplementary research activities and pre-clinical development studies on the potential vaccines, the results of which are covered within the scope of the license agreements. Under the expanded research program, the University of Wuerzburg will validate and utilize innovative human 3D intestinal tissue models to study the infection biology of Salmonella strains towards clinical development.

Next Steps – Coronavirus Vaccine

Evaluate administration route, dose and immunization scheme.
Initiate in-vivo immunology experiments with antigen variant candidates in relevant mice models.
Conduct virus challenge experiments in immunized transgenic animals.
Start manufacturing process assessment / development.
Conduct pre-clinical safety and toxicology assessment.
Next Steps – Chlamydia Vaccine

Design and prepare candidate vaccine strains.
Evaluate administration route, dose and immunization scheme.
Conduct In-vivo immunology experiments with candidate strains in relevant mouse models.
Summary of First Quarter 2022 Financial Results

All amounts in this press release are in U.S. dollars unless otherwise noted.

Results of operations for the three-month period ended March 31, 2022

For the three-month period ended March 31, 2022, we reported a consolidated net loss of ($2.6 million), or ($0.02) net loss per common share (basic), as compared with a consolidated net loss of ($1.5) million, or ($0.02) net income per common share (basic) for the three-month period ended March 31, 2021. The $1.1 million increase in net loss is primarily due to an increase of $1.3 million in total operating costs, $0.2 million decline in total revenues and offset by favorable foreign currency exchange rates of $0.4 million

Revenues

Our total revenue for the three-month period ended March 31, 2022 was $1.5 million as compared with $1.7 million for the same period in 2021, representing a decline of $0.2 million. The 2022 revenue was comprised of $0.43 million in licensing revenue (2021 – $0.52 million), $1.0 million in development revenue (2021 – $1.1), $0.04 million in supply chain revenue (2021 – $0.04 million), $0.02 million in royalty income (2021 – $0.01 million). and $0.06 in product sales (2021 – $nil)
Operating expenses

Our total operating expense for the three-month period ended March 31, 2022 was $4.3 million as compared with $3.0 million for the same period in 2021, representing an increase of $1.3 million. This increase arose primarily from a $0.9 increase research and development, $0.3 million increase in general and administrative expenses and an increase of $0.1 million in selling expenses.
Net finance (costs) income

Our net finance (costs) for the three-month period ended March 31, 2022 was $0.2 million as compared with net finance cost of $(0.3) million for the same period in 2021, representing an increase in net finance income of $0.5 million.
The Company had $63.6 million cash and cash equivalents at March 31, 2022 (December 31, 2021 – 65.3 million).

Consolidated Financial Statements and Management’s Discussion and Analysis

For reference, the Management’s Discussion and Analysis of Financial Condition and Results of Operations for the fourth quarter and full year 2021, as well as the Company’s unaudited consolidated interim financial statements as of December 31, 2021, will be available on the Company’s website (www.zentaris.com) in the Investors section or at the Company’s profile at www.sedar.com and www.sec.gov.