On March 28, 2024 Omega Therapeutics, Inc. (Nasdaq: OMGA) ("Omega"), a clinical-stage biotechnology company pioneering the development of a new class of programmable epigenomic mRNA medicines, reported financial results for the fourth quarter and full year ended December 31, 2023, and a strategic prioritization initiative to focus resources on near-term milestones to support long-term shareholder value (Press release, Omega Therapeutics, MAR 28, 2024, View Source [SID1234641574]).

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"2023 was an important year for Omega where we executed to plan and demonstrated clinical validation of an epigenomic controller to regulate c-MYC in humans for the first time. These proof-of-platform clinical data, coupled with our research collaboration with Novo Nordisk in obesity, support the ability of the OMEGA platform to potentially address epigenomic regulation of almost all human genes across broad therapeutic areas including cancer, cardiometabolic conditions and liver regeneration," said Mahesh Karande, President and Chief Executive Officer of Omega Therapeutics. "Initial clinical data from our ongoing Phase 1/2 MYCHELANGELO I trial of OTX-2002 demonstrated controlled modulation of MYC expression levels, one of the most challenging gene targets in oncology, and an encouraging disease control rate and stable disease in heavily pre-treated, late-stage HCC patients. We are within what we believe is a clinically meaningful dose range and, as we continue to see a promising safety profile for OTX-2002, have recently opened enrollment of Cohort 5. We look forward to sharing additional updates from this program throughout 2024."

"Today we also announced a strategic prioritization, implemented to ensure we have sufficient resources to advance our lead program and maximize near- and long-term value creation from our platform. As part of this initiative, we are taking difficult but necessary actions to streamline our team and optimize our R&D efforts and cost structure to extend our cash runway into the first quarter of 2025. These changes will unfortunately affect a number of our colleagues, and we are grateful for their dedication and contributions to our mission," continued Mr. Karande. "As we sharpen our focus, we look forward to the opportunities ahead to generate meaningful clinical data for OTX-2002, continue to demonstrate the broad potential of our platform, and establish additional partnerships. We remain steadfast in our mission to pioneer a new class of programmable epigenomic mRNA medicines to transform the treatment of a broad range of diseases."

Recent Highlights and Key Anticipated Milestones

Development Pipeline and Platform

•
Advanced the Phase 1/2 MYCHELANGELO I clinical trial evaluating OTX-2002 in patients with hepatocellular carcinoma (HCC):
o
OTX-2002 continues to advance in monotherapy dose escalation.
o
As of March 24, 2024, data from the first three cohorts (0.02 mg/kg – 0.06 mg/kg) showed:
▪
OTX-2002 continued to be generally well tolerated, with no dose-limiting toxicities observed.
▪
Consistent dose-dependent pharmacokinetics with no drug accumulation observed following repeat doses.
▪
All patients demonstrated controlled modulation and downregulation of MYC mRNA expression, an important oncogene regulating cell function and cell death.
▪
The interim disease control rate (DCR) for the target population of HCC patients was 80%, reflecting 4 out of 5 efficacy-evaluable patients having a best overall response of stable disease. These patients had an average of three or more previous therapies and entered the trial with a life expectancy of less than 12 weeks. The DCR for patients with non-HCC solid tumors in the trial (n=5) was 40%, indicating the potential specificity of OTX-2002 for HCC.
o
The Company continues to evaluate patients with HCC in Cohort 4 at the 0.12 mg/kg dose level, which recently cleared the 28-day dose limiting toxicity (DLT) window. Based on preclinical experience and modeling, Omega believes this dose level is within the expected active dose range. In March 2024, the Company opened enrollment for Cohort 5 at a dose level of 0.3 mg/kg.
o
Omega expects to report additional updated clinical data from monotherapy dose escalation in mid-2024.
o
The Company plans for expansion into monotherapy and combination settings in mid-2024.
•
Announced research collaboration with Novo Nordisk to develop a novel therapeutic for obesity management:
o
The collaboration will leverage Novo Nordisk’s expertise in research and development within cardiometabolic diseases and Omega’s proprietary platform technology to develop an epigenomic controller designed to enhance metabolic activity.
o
Unlike traditional approaches focused on appetite suppression, the program aims to leverage precision epigenomic control to enhance thermogenesis, a naturally occurring metabolic process that burns calories.
o
Under the terms of the agreement, Novo Nordisk will reimburse all R&D costs and has the right to select one target to advance for clinical development.

Omega and Flagship’s Pioneering Medicines are eligible to receive up to $532 million in upfront, development and commercial milestone payments, as well as tiered royalties on annual net sales of a licensed product, which will be split equally between the parties.
•
Continued to advance and expand OMEGA platform capabilities:
o
Presented new preclinical data supporting the breadth of Omega’s platform capabilities, including bidirectional and multiplexed epigenomic control of gene expression in liver inflammation and fibrosis at the American Association for the Study of Liver Diseases’ (AASLD) The Liver Meeting 2023.
▪
A HNF4A-targeting epigenomic controller led to a durable increase in HNF4α expression, preferential upregulation of HNF4α P1 promoter isoforms, and reduced key measures of fibrosis both in vitro and in vivo, supporting this development candidate’s potential for the treatment of fibrotic liver disease.
▪
In preclinical models, liver-specific multiplexed targeting of CXCL9, CXCL10 and CXCL11 via an epigenomic controller led to a significant reduction in T-cell migration, a critical driver of inflammation-induced liver injury, supporting the potential of this approach as a novel treatment for inflammatory liver diseases.

Corporate

•
Announced cost reduction and strategic prioritization initiative to maximize near- and long-term value creation opportunities:
o
Following a strategic review, the Company has focused its pipeline and reduced overall headcount by approximately 35%. These fiscally disciplined actions are expected to extend the Company’s cash runway into Q1 2025.
o
Positions the Company to achieve key clinical data readouts from the monotherapy dose escalation and dose expansion stages of the MYCHELANGELO I clinical trial.
o
The Company will prioritize certain preclinical programs and platform efforts:
▪
Prioritized preclinical programs include OTX-2101 for non-small cell lung cancer (NSCLC), the HNF4A program in liver regeneration, and development of an epigenomic controller for obesity in collaboration with Novo Nordisk.
▪
Core work on platform biology, epigenomic controllers, and characterization of LNP delivery to the lung and other tissues will continue.
o
An updated corporate presentation is available on the Investors section of the Company’s website at View Source

Fourth Quarter and Full Year 2023 Financial Results

As of December 31, 2023, the Company had cash, cash equivalents and marketable securities totaling $73.4 million, which is expected to fund operations into Q1 2025.

Research and development (R&D) expenses for the fourth quarter of 2023 were $15.5 million, compared to $26.0 million for the fourth quarter of 2022. R&D expenses for 2023 were $77.2 million compared to $81.2 million in 2022. The $4.0 million decrease in R&D expenses in 2023 compared to 2022 was primarily due to lower external research and manufacturing costs, consulting and professional fees, and lab expenses, partially offset by an increase in personnel-related expenses, including stock-based compensation to support business growth, and facilities and other costs.

General and administrative (G&A) expenses for the fourth quarter of 2023 were $6.2 million, compared to $5.7 million for the fourth quarter of 2022. G&A expenses for 2023 were $26.2 million, compared to $23.7 million in 2022. The $2.5 million increase in G&A expenses in 2023 compared to 2022 was primarily due to higher professional and consulting fees, and facilities and other administrative costs.

Net loss for the fourth quarter of 2023 was $20.2 million, compared to $30.8 million for the fourth quarter of 2022. Net loss for the year ended December 31, 2023, was $97.4 million, compared to a net loss of $102.7 million for the year ended December 31, 2022. The decrease in net loss for 2023 compared to 2022 was primarily due to decreases in R&D expenses.

On March 28, 2024 Moleculin Biotech, Inc., (Nasdaq: MBRX) (Moleculin or the Company), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat tumors and viruses, reported Walter Klemp, President and Chief Executive Officer of Moleculin will present at the MedInvest Biotech & Pharma Investor Conference behind held in New York City, NY on Thursday, April 4, 2024 at 4:10 PM ET (Press release, Moleculin, MAR 28, 2024, View Source [SID1234641573]).

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In addition to the presentation, management will be available to participate in one-on-one meetings with qualified members of the investor community who are registered to attend the conference. For more information about the event, please visit the conference website.

A live webcast of the event will be available on the Events page in the Investors section of the Company’s website (moleculin.com).

On March 28, 2024 Molecular Templates, Inc. (Nasdaq: MTEM, "Molecular Templates," or "MTEM"), a clinical-stage biopharmaceutical company focused on the discovery and development of proprietary targeted biologic therapeutics, known as engineered toxin bodies, to create novel therapies with potent and differentiated mechanisms of action for cancer, reported that it has entered into a definitive amended and restated securities purchase agreement with certain healthcare investors that will provide $9.5 million in gross proceeds to MTEM through the closing of the second tranche of its previously announced July 2023 private placement and purchase agreement on amended terms (Press release, Molecular Templates, MAR 28, 2024, View Source [SID1234641572]). The financing is being led by existing investor BVF Partners L.P. and includes existing investors BB Biotech AG and Santé, and other leading institutional investors.

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At the closing of the second tranche, MTEM expects to issue an aggregate of 1,209,612 shares of its common stock (and, in lieu thereof, prefunded warrants to purchase 2,460,559 shares of common stock) and accompanying warrants to purchase up to an aggregate of 7,340,342 shares of its common stock (or prefunded warrants in lieu thereof) at a combined purchase price of $2.60 per share and accompanying warrants, in accordance with the "Minimum Price" requirement as defined in the Nasdaq rules. The closing of the second tranche is subject to the satisfaction of customary closing conditions.

Stifel is acting as the sole placement agent in connection with the financing.

MTEM intends to use the net proceeds from the proceeds of the second tranche to fund its ongoing clinical studies, working capital and for general corporate purposes.

The securities sold in the second tranche, including the shares of common stock underlying the warrants, are being made in a transaction not involving a public offering and have not been registered under the Securities Act of 1933, as amended, or applicable state securities laws and may not be reoffered or resold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and applicable state securities laws. MTEM has agreed to file a resale registration statement with the Securities and Exchange Commission registering the resale of the securities issued in the second tranche.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

On March 28, 2024 Merck (NYSE: MRK), known as MSD outside of the United States and Canada, reported that the European Commission (EC) has approved KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with platinum-containing chemotherapy as neoadjuvant treatment, then continued as monotherapy as adjuvant treatment, for resectable non-small cell lung cancer (NSCLC) at high risk of recurrence in adults (Press release, Merck & Co, MAR 28, 2024, View Source [SID1234641571]).

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This approval by the EC follows the positive recommendation from the Committee for Medicinal Products for Human Use received in February 2024 and was based on results from the Phase 3 KEYNOTE-671 trial. At a median follow-up of 29.8 months (range, 0.4 to 62.0 months), KEYTRUDA plus chemotherapy in the neoadjuvant setting followed by KEYTRUDA as monotherapy after surgical resection significantly improved overall survival (OS), reducing the risk of death by 28% (HR=0.72 [95% CI, 0.56-0.93]; one-sided p=0.00517) in patients with resectable stage II, IIIA or IIIB NSCLC versus placebo plus chemotherapy in the neoadjuvant setting followed by placebo after surgical resection, regardless of PD-L1 expression. For patients who received the KEYTRUDA-based regimen, median OS was not reached (95% CI, NR-NR) versus 52.4 months (95% CI, 45.7-NR) for patients who received the chemotherapy-placebo regimen. The KEYTRUDA-based regimen also improved event-free survival (EFS), reducing the risk of disease recurrence, progression or death by 41% (HR=0.59 [95% CI, 0.48-0.72]) compared to the chemotherapy-placebo regimen. For patients who received the KEYTRUDA-based regimen, median EFS was improved by nearly two and a half years compared to the chemotherapy-placebo regimen (47.2 months [95% CI, 32.9-NR] versus 18.3 months [95% CI, 14.8-22.1], respectively).

"Despite the clinical advances for patients with metastatic lung cancer, lung cancer continues to be the leading cause of cancer death in Europe, reinforcing the need to treat these patients in earlier stages of their disease, where we may have the most impact," said Dr. Solange Peters, chair of the medical oncology and thoracic malignancies department, Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland. "The approval of this KEYTRUDA-based regimen is an important milestone for patients diagnosed with resectable non-small cell lung cancer at high risk of recurrence, regardless of PD-L1 expression, providing a new option for these patients that has shown, through the results of the Phase 3 KEYNOTE-671 trial, the potential to help extend their lives."

This approval allows marketing of this KEYTRUDA regimen for this indication in all 27 EU member states, as well as Iceland, Liechtenstein, Norway and Northern Ireland. KEYTRUDA is now approved for six indications in NSCLC, and for 27 indications overall in the EU. In October 2023, KEYTRUDA was approved in the U.S. for the treatment of patients with resectable (tumors ≥4 cm or node positive) NSCLC in combination with platinum-containing chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery.

"Today’s approval of the first anti-PD-1/L1 therapy as part of a treatment regimen in Europe for the neoadjuvant followed by adjuvant treatment of resectable NSCLC based on positive overall survival results demonstrates our continued progress to advance treatments in earlier stages of lung cancer," said Marjorie Green, senior vice president and head of oncology, global clinical development, Merck Research Laboratories. "We are eager to build on this momentum as we plan to seek additional approvals of this regimen around the world, and to work together with the cancer community to help drive earlier diagnoses of lung cancer, an urgent need."

About the KEYNOTE-671 study design

KEYNOTE-671 is a randomized, double-blind Phase 3 trial (ClinicalTrials.gov, NCT03425643) evaluating KEYTRUDA in combination with neoadjuvant chemotherapy, followed by surgery and continued adjuvant treatment with KEYTRUDA as a single agent, versus placebo plus neoadjuvant chemotherapy, followed by resection and adjuvant placebo, in patients with resectable stage II, IIIA or IIIB (T3-4N2) NSCLC (per the eight edition of the American Joint Committee on Cancer [AJCC] Cancer Staging Manual). The trial’s dual primary endpoints are EFS, per RECIST v1.1 by investigator assessment, and OS. Key secondary endpoints include pathologic complete response (pCR) and major pathological response (mPR). The study enrolled 797 patients who were randomly assigned (1:1) to receive either:

KEYTRUDA (200 mg intravenously [IV] every three weeks [Q3W]) plus chemotherapy (cisplatin [75 mg/m2, IV; given on Day 1 of each cycle] and either gemcitabine [1,000 mg/m2, IV; given on Days 1 and 8 of each cycle] or pemetrexed [500 mg/m2, IV; given on Day 1 of each cycle]) for up to four cycles as neoadjuvant therapy prior to surgery. Within 4-12 weeks following surgery, KEYTRUDA (200 mg) was administered every three weeks for up to 13 cycles, or;
Placebo (saline IV Q3W) plus chemotherapy (cisplatin [75 mg/m2, IV; given on Day 1 of each cycle] and either gemcitabine [1,000 mg/m2, IV; given on Days 1 and 8 of each cycle] or pemetrexed [500 mg/m2, IV; given on Day 1 of each cycle]) for up to four cycles as neoadjuvant therapy prior to surgery. Within 4‑12 weeks following surgery, placebo was administered every three weeks for up to 13 cycles.
About lung cancer

Lung cancer is the leading cause of cancer death worldwide. In 2022 alone, there were approximately 2.4 million new cases and 1.8 million deaths from lung cancer globally. Non-small cell lung cancer is the most common type of lung cancer, accounting for about 80% of all cases. In recent decades, the overall five-year survival rate for patients diagnosed with lung cancer increased from 11% to 15% on average across EU countries. Improved survival rates are due, in part, to earlier detection and screening, reduction in smoking, advances in diagnostic and surgical procedures, as well as the introduction of new therapies. Early detection and screening remain an important unmet need, as 44% of lung cancer cases are not found until they are advanced.

On March 28, 2024 MaaT Pharma (EURONEXT: MAAT – the "Company"), a clinical-stage biotech company and a leader in the development of Microbiome Ecosystem TherapiesTM (MET) dedicated to improving survival outcomes for patients with cancer, reported the full-year 2023 annual results and provided a business overview (Press release, MaaT Pharma, MAR 28, 2024, View Source [SID1234641570]).

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"As we reflect on the achievements of 2023, I am proud to announce that we have successfully delivered on milestones across our entire pipeline, while being cash conscious. This past year has been pivotal, laying the foundations for the next phase of development for our lead asset MaaT013 with completion of the Phase 3 and readiness for commercialization. We look forward to reaching new milestones in 2024 and anticipate a major inflection point with the publication of the primary endpoint of our Phase 3. By relying on our team and our network of physicians, and continuing to work closely with regulators, we anticipate continuing to create value for our shareholders and make significant progress in bringing new therapeutic options for patients with cancer," states Hervé Affagard, CEO and co-founder of MaaT Pharma.

Pipeline highlights

MET-N

MaaT013

In hemato-oncology:

In April 2023, the U.S. Food and Drug Administration (FDA) lifted the clinical hold and cleared the Investigational New Drug (IND) application for MaaT013 in patients with aGvHD[4]. The Company has engaged active discussions with prominent US clinicians in the field of stem cell transplantation to explore the most efficient path forward to introduce MaaT013 to patients in the United States.
In July 2023, the Company announced that clinical data from its Phase 2 study assessing MaaT013 as a treatment for aGvHD was published in eClinicalMedicine, one of the Lancet Discovery Science suite of journals.
In October 2023, the Company announced that the DSMB[5] unanimously recommended that the open-label, single arm pivotal Phase 3 ARES clinical trial (NCT04769895), evaluating MaaT013 in aGvHD, continue without modification. The Overall Response Rate (ORR) was superior to pre-defined protocol assumptions. Therefore, the DSMB concluded that the benefit/risk ratio with "high efficacy and low toxicity" was favorable in this patient population. Primary endpoint, gastrointestinal overall response rate (GI-ORR), is now expected mid Q4 2024.
In December 2023, the Company presented positive results from the Early Access Program (EAP) in Europe involving 111 patients with aGvHD treated with MaaT013, at the 2023 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting. The GI-ORR was 54% at day 28, positively and significantly impacting overall survival (OS) with 47% OS at 12 months for all patients with aGvHD and 52% for a patient subgroup from the EAP with a similar profile to those in the ARES trial with GI-ORR of 61% and 58% of complete responses observed at day 28.
As a post period event, in March 2024, the Company announced that it will present for the first time extended results that include OS data after 12 months in more aGvHD patients from its EAP that were treated with MaaT013. The data will be shared during an oral presentation at the 50th Annual Meeting of the European Society for Blood and Marrow Transplantation held in Glasgow, UK, from April 14-17, 2024.
As a post period event, the Company announces the launch of a retrospective multicenter trial called CHRONOS in Europe. Its objective is to provide the Company efficacy data for 3rd-line therapies for patients not receiving MaaT013 or any Microbiome intervention. This retrospective study does not impact cash projections as funding is already secured.
In immuno-oncology:

As a post period event, in March 2024, the Company informed on the completion of patient recruitment for the Phase 2a clinical trial (NCT04988841) sponsored by AP-HP and in collaboration with INRAe[6] and Institut Gustave Roussy[7], evaluating MaaT013, the Company’s lead product candidate, in combination with immune checkpoint inhibitors (ICI), ipilimumab (Yervoy) and nivolumab (Opdivo) in ICI naïve patients with metastatic melanoma. Having reached this key recruitment milestone, the first publication will be submitted at the end of 2024 or in the first quarter of 2025.
MaaT033

In hemato-oncology:

In April 2023, data from the Phase 1b study (CIMON) with MaaT033, previously communicated during the 64th annual ASH (Free ASH Whitepaper) meeting, were also presented at the EBMT 2023 conference.
In September 2023, the Company announced that the European Medicines Agency (EMA) had granted orphan drug designation (ODD) to MaaT033, which is aimed at improving overall survival in patients undergoing allo-HSCT[8]. The EMA recognized the significant benefit that MaaT033 could therefore bring to this patient population. The status offers key benefits including market exclusivity, clinical protocol assistance, waivers or reductions in regulatory fees.
In November 2023, the Company announced that the first patient was treated in the Phase 2b trial (PHOEBUS) investigating the efficacy of MaaT033 in improving OS at 12 months in patients with blood cancer that are receiving allo-HSCT. The international, multi-center, randomized, double-blind, placebo-control study (NCT05762211), will be conducted in up to 56 clinical investigation sites and is expected to enroll 387 patients. It is, to date, the largest randomized controlled trial assessing a microbiome therapy in oncology.
In November 2023, the Company announced that its ongoing Phase 2b trial, PHOEBUS has been selected for funding of 7.4 million EUR as part of the France 2030 Health Innovation plan, in response to the ‘Innovation in Biotherapy and Bioproduction’ call for projects from the ‘Biotherapies and Bioproduction of Innovative Therapies’ acceleration strategy, operated by Bpifrance (project code: METALLO). Post period the first tranche of 1.8 million EUR was received.

In neurodegenerative diseases:

In September 2023, the Company announced that the first patient was dosed in the IASO Phase 1b pilot study (NCT05889572) in Amyotrophic Lateral Sclerosis (ALS), also known as Lou Gehrig’s disease in the U.S. and Charcot’s disease in French-speaking countries. As a post period event, in February 2024, the Company announced that the DSMB reviewed safety data in the IASO trial in the first 8 patients with ALS treated with MaaT033. The DSMB recommended that the trial continue without modifications.
MET-C

MaaT034

In immuno-oncology:

In November 2023, the Company had two presentations at the 38th Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting highlighting in vitro results for its new Artificial Intelligence (AI)-generated lead product, MaaT034, designed to improve responses to immunotherapy for patients with solid tumors. MaaT034 is the first member of the
MET-C platform. Data presented at SITC (Free SITC Whitepaper) 2023 shows that MaaT034 replicates, at large industrial scale, the richness, and diversity of healthy native-based microbiome ecosystems. The first clinical batches are expected to be produced in 2024 and the first-in-human study is planned for 2025.
As a post period event, in March 2024, the Company announced that it will present new in vitro data at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2024, taking place on April 5-10 in San Diego, California.
Corporate update

In February 2023, the Company completed a successful capital increase of approximately €12.7 million with the support of current shareholders.
In July 2023, MaaT Pharma joined the Microbiome Therapeutics Innovation Group (MTIG). MTIG is a coalition of companies focused on developing FDA-approved microbiome therapeutics and products to improve medical care, outcomes, and cost-effectiveness.
In September 2023, the Company and Skyepharma announced completion of the cGMP manufacturing facility and the transfer of MaaT Pharma’s Production and Development teams to the new site.
During 2023 and Q1 2024, MaaT Pharma reinforced its board of directors, executive team, and key functions:
Karim Dabbagh as Chairman and Nadia Kamal as Director, both independent.
Jonathan Chriqui, as Chief Business Officer and member of the executive management team.
Guilhaume Debroas, as Head of Investor Relations.
Financial highlights

The key financial results for the 2023 full year are as follows:

Income Statement

In thousands of euros 31 December 2023 31 December 2022
Revenue 2 228 1 430
Cost of Goods Sold (573) (339)
Gross Margin 1 655 1 091
Other Income 4 667 4 122
Sales and distribution costs (449) (347)
General and administrative costs (4 965) (4 111)
Research and development costs (20 851) (14 311)
Operating income (expense) (19 943) (13 557)
Financial Income 639 45
Financial Expense (413) (201)
Net financial income (expense) 226 (156)
Income (loss) before income tax (19 717) (13 713)

Income tax expense – –
Net Income (loss) for the period (19 717) (13 713)
Prepared in accordance with international standards, IFRS.
Revenues totaled €2.2 million for the year ended December 31, 2023, the highest revenues generated thus far by the Company, which includes compensation invoiced from the Early Access Program in France and for which data was presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December 2023. The gross margin generated by the compassionate access program amounts to €1.7 million.

Operating expense amounted to €19.9 million compared with €13.6 million for 2022, an increase of €6.3 million. This increase reflects the growth of research and development costs which have risen from €14.3 million in 2022 to €21.2 million in 2023, representing an overall increase of €6.9 million and consistent with the advancement of clinical and operational activities as detailed in the pipeline highlights’ section above.

Other income of €4.7 million includes the R&D tax credit of €3.6 million, an increase of €0.4 million compared with prior year, which amounted to €3.2 million and in line with the growth of research and development activities and eligible expenses.

General and administrative expenses amounted to €5.0 million compared with €4.1 million in 2022 reflecting the increase in regulatory advisory costs and expenses to support the early access program.

The net loss amounts to €19.7 million for the year ended December 31, 2023, compared with €13.7 million for the year ended December 31, 2022.

Average annual employees evolved from 43 in 2022 to 53 in 2023 following the strengthening of the clinical and production and supply chain and to a lesser extent administrative teams.

Cash Position

As of December 31, 2023, total cash and cash equivalents were €24.3 million, as compared to €31.7 million as of September 30, 2023, and €35.2 million as of December 31, 2022.

The net decrease in cash position of €11.0 million between December 31, 2022, and December 31, 2023, is due to the financing of operations for a total of €18.7 million, offset by cash inflows from financing of €8.1 million. Cash inflows from financing reflects the share capital increase in February 2023 of approximately €12.7 million, offset by debt repayments over 2023 €4.2 million. Total financial debt totaled €14.1 million as of December 31, 2023, of which €0.4 million relates to state-backed loans ("PGE") and €6.1 million of lease liabilities, which includes future contractual payments due to Skyepharma for the use of the manufacturing facility completed in 2023.

Based on the development plans and corresponding cash needs, the Company believes it has sufficient cash to finance operations to the end of Q3.2024 extending the cash runway by three months compared to prior communications as a result of a voluntary slowdown in headcount growth, optimization of its manufacturing plan and prioritizing expenses to support on the roll out of the Phase 2b trial PHOEBUS in France and Germany (approved countries) and finalizing recruitment into the Phase 3 ARES trial in Europe. The Company has active discussions ongoing to finance operations beyond the end of Q3.2024 and remains confident in extending its cash runway.

Note: This press release contains financial data approved by the Board of Directors on March 27, 2024, based on the financial statements for the year ended December 31, 2023. The audit is in progress at the date of this communication.

Upcoming financial communication*

May 14, 2024: Publication of revenues for Q1 2024
May 28, 2024: Annual General Shareholders Meeting
September 19, 2024: Publication of half year financial results H1
November 5, 2024: Publication of revenues for Q3 2024
*Indicative calendar that may be subject to change.

Upcoming investor conferences participation

April 15-17, 2024 – Kempen Life Sciences Conference, Amsterdam
June 11-12, 2024 – Portzamparc Mid & Small Caps 2024 Conference
June 25-27, 2024 – Stifel European Healthcare Summit Lyon
Upcoming investor conferences participation

April 5-10, 2024 – American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2024, San Diego
April 14-17, 2024 – 50th Annual meeting of the European Bone Marrow Transplant (EBMT), Glasgow
The Company’s universal registration document, which includes the annual financial report, will be available on MaaT Pharma’s website on 02/04/2024: www.maatpharma.com