On March 22, 2023 InflaRx N.V. (Nasdaq: IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, reported financial and operating results for the year ended December 31, 2022 (Press release, InflaRx, MAR 22, 2023, View Source [SID1234629158]).

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Prof. Niels C. Riedemann, CEO and Founder of InflaRx, commented: "We are very pleased with the exceptional progress we have made in the past year with our lead drug candidate, vilobelimab, in several areas, as well as in advancing our pipeline with a new clinical asset, INF904, an orally available small molecule inhibitor of the C5a receptor. Upon detailed feedback from the FDA related to our development of vilobelimab for the treatment of PG, a rare debilitating and neutrophil driven skin disease, we have designed and submitted a Phase III protocol to the FDA while we are currently initiating the trial. We also submitted an EUA application to treat critically ill, mechanically ventilated patients with COVID-19, who today are still facing poor outcomes, and shortly await a decision from the FDA. Further, we expect first results from our ongoing Phase I clinical trial with INF904 and interim results from our Phase II clinical trial in cutaneous squamous cell carcinoma later this year. With these important milestones anticipated, 2023 promises to be an exciting year

Recent Highlights and R&D Update

InflaRx reported on key recent highlights and provided an update on its research and development activities.

Vilobelimab in Pyoderma Gangrenosum (PG)

Final data from an open-label, multi-center Phase IIa exploratory study evaluating the safety and efficacy of vilobelimab in patients with moderate to severe PG were presented in March 2022. The results showed a dose-dependent treatment effect. In the highest dose cohort of 2,400 mg, six out of seven patients demonstrated a clinical remission (Physician Global Assessment (PGA) score ≤ 1) and closure of the target ulcer.

Based on these compelling results and a productive End-of-Phase II meeting with the FDA in Q3 2022, InflaRx is moving forward with a pivotal Phase III clinical development program in this indication. In January 2023, the Company announced details related to the design of its planned Phase III study, a multi-national, randomized, double-blind, placebo-controlled trial. The Company has submitted the clinical trial protocol to the FDA and plans to begin patient enrollment around mid-2023.

Vilobelimab was granted Orphan Drug designation by both the FDA and the European Medicines Agency (EMA) for the treatment of ulcerative PG in June 2022, and in July was granted Fast Track designation for this indication by the FDA.

Vilobelimab for the Treatment of Critically ill COVID-19 Patients

InflaRx submitted an EUA application to the FDA for vilobelimab for the treatment of critically ill, intubated, mechanically ventilated COVID-19 patients in September 2022. The Company continues to be in active dialogue with and has addressed several requests for information that it received from the FDA. There is no set timeline for a decision from the FDA related to the EUA. The Company will continue to interact closely with the FDA and will provide a timely update when appropriate. If EUA is granted, InflaRx plans to seek full marketing authorization in major markets, including the United States and Europe and, in parallel, intends to seek partners to support commercialization efforts.

InflaRx also previously received Fast Track designation from the FDA for vilobelimab for the treatment of critically ill, intubated, mechanically ventilated COVID-19 patients.

In September 2022, results from the PANAMO Phase III study, an international, double-blind, placebo-controlled, randomized clinical trial investigating vilobelimab in invasively mechanically ventilated COVID-19 patients, were published in the peer-reviewed journal, The Lancet Respiratory Medicine, which included an in-depth statistical analysis supporting the robustness of the observed clinical survival benefit in the study.

Based on current COVID-19 trends, the U.S. Department of Health and Human Services (HHS) expects the COVID-19 federal public health emergency to expire on May 11, 2023. However, HHS has stated that it expects that the FDA will provide continued access to pathways for EUAs for medical products. See View Source

In 2021, InflaRx was awarded a grant from the German Ministry of Education and Research and the German Ministry of Health to support the development of vilobelimab for the treatment of COVID-19. As of December 31, 2022, the Company had received €25.6 million in grant funds and still has a maximum amount of €15.9 million available for claiming under the grant throughout the end of the grant term in June 2023.

Vilobelimab in Cutaneous Squamous Cell Carcinoma (cSCC)

InflaRx is conducting an open-label, multicenter Phase II study, evaluating vilobelimab alone and in combination with pembrolizumab in patients with programmed cell death protein-1 (PD-1) or programmed cell death ligand-1 (PD-L1) inhibitor resistant/refractory, locally advanced or metastatic cSCC. Patients are being recruited into two independent arms – vilobelimab as monotherapy (Arm A) and in combination with pembrolizumab (Arm B). The main objectives of the trial are to assess the safety and antitumor activity of vilobelimab monotherapy and to determine the maximum tolerated or recommended dose, safety and antitumor activity in the combination arm in this patient population.

So far, 10 patients have been recruited into Arm A of the study. First data from an interim analysis in patients in Arm A is expected to be available in the first half of 2023. In Arm B of the study, as of today, 14 patients have been recruited into three dose cohorts (3+6+5). Data from an interim analysis in Arm B are expected to be available in the first half of 2024.

C5aR Inhibitor INF904

In November 2022, the company announced that the first healthy volunteer had been dosed in a randomized, double-blind, placebo-controlled Phase I trial. This single and multiple ascending dose Phase I trial aims to evaluate the safety, tolerability and pharmacokinetics of INF904 in healthy volunteers. The effect of INF904 on C5a-induced downstream activity will also be explored. Results are expected in the second half of 2023. In the future, InflaRx plans to develop INF904 for complement-mediated, chronic autoimmune and inflammatory diseases where oral administration is the preferred choice for patients.

Staidson Agreements

In December 2022, InflaRx amended its existing co-development agreement with Staidson (Beijing) BioPharmaceuticals Co., Ltd. (Staidson) from 2015 to support Staidson in its regulatory approval efforts for its proprietary drug candidate BDB-001 in China. InflaRx will receive royalties of 10% on net sales of BDB-001 for the treatment of COVID-19 in China. InflaRx has granted Staidson an exclusive license for use in China to certain of InflaRx’s clinical, manufacturing and regulatory documentation regarding vilobelimab in order to support and facilitate the planned regulatory filing for BDB-001 for the treatment of severely ill COVID-19 patients with the Chinese National Medical Products Administration (NMPA).

In parallel, InflaRx entered into a share purchase agreement with Staidson Hong Kong Investment Company Limited (Staidson HK), an affiliate of Staidson, pursuant to which Staidson HK purchased ordinary shares of InflaRx for an aggregate amount of $2.5 million at a price of $5.00 per share. The share purchase agreement also includes an option pursuant to which Staidson HK may in the future purchase, at InflaRx’s discretion, additional ordinary shares for an aggregate amount of $7.5 million.

2022 Financial Highlights

Dr. Thomas Taapken, CFO of InflaRx, said: "We are well financed to bring vilobelimab to patients, should we receive EUA, as well as to continue our development programs, including initiating a Phase III study in PG later this year. The grant money we have received from the German government for our COVID-19 development work as well as the investment by Staidson further strengthen our financial position, and we have sufficient cash to fund operations into H2 2025."

Research and Development (R&D) Expenses

InflaRx’s R&D expenses increased by €1.8 million to €37.5 million in 2022, from €35.7 million in 2021. R&D expenses are predominantly comprised of costs for external contract research organizations (CROs) for pre-clinical activities and the conduct of clinical trials, costs for external contract manufacturing organizations (CMOs) for product manufacturing-related activities, costs for professional consultants primarily in the areas of regulatory affairs and intellectual property, as well as personnel expenses.

General and Administrative (G&A) Expenses

InflaRx’s G&A expenses increased by €2.9 million to €14.9 million in 2022, from €12.0 million in 2021. The increase is partly attributable to higher consulting and legal costs incurred in enhancing InflaRx’s internal control environment as it is complying with the auditor attestation requirement of Section 404(b) of the Sarbanes-Oxley Act of 2002 for the first time due to the loss of its "emerging growth company" status. G&A expenses are predominantly comprised of professional fees for auditors, consulting expenses not related to R&D activities, professional fees for lawyers, cost of facilities, travel, communication and office expenses as well as personnel related expenses.

Other Income

In 2022, InflaRx recognized other income of €20.1 million from grant payments received from the German federal government for the development of vilobelimab in COVID-19, including expenses related to clinical development and manufacturing process development.

Net Financial Result

InflaRx’s net financial result increased by €0.7 million to €2.7 million in 2022, from €2.0 million in 2021. This is mainly attributable to a net increase of €0.5 million in foreign exchange income and expense and an increase of €0.5 million in interest income from marketable securities.

Net Loss

InflaRx incurred a net loss of €29.5 million, or €0.67 per common share, in 2022 compared to €45.6 million, or €1.10 per common share, in 2021.

Liquidity and Capital Resources

As of December 31, 2022, InflaRx’s total funds available amounted to approximately €83.7 million, comprised of €16.3 million of cash and cash equivalents and €67.4 million of marketable securities.

Net Cash Used in Operating Activities

InflaRx’s net cash used in operating activities decreased to €33.7 million in 2022, from €39.9 million in 2021, mainly due to the decrease of loss before income tax resulting mainly from income recognized from the grant received from the German federal government.

Additional Financial Information

Additional information regarding these results and other relevant information is included in the notes to the financial statements in "Item 18. Financial Statements," which are included in InflaRx’s most recent annual report on Form 20-F as filed with the U.S. Securities and Exchange Commission.

InflaRx N.V. and subsidiaries

Consolidated Statements of Operations and Comprehensive Loss for the Years Ended December 31, 2022, 2021 and 2020

in €, except for share information 2022 2021 2020

Operating Expenses
Research and development expenses (37,526,090 ) (35,697,935 ) (25,684,140 )
General and administrative expenses (14,869,564 ) (11,984,722 ) (8,467,203 )
Total Operating Expenses (52,395,654 ) (47,682,657 ) (34,151,343 )
Other income 20,159,169 54,221 221,748
Other expenses (1,381 ) (6,381 ) (13,209 )
Operating Result (32,237,866 ) (47,634,817 ) (33,942,804 )
Finance income 608,679 109,391 887,702
Finance expenses (45,250 ) (24,769 ) (26,000 )
Foreign exchange result 2,442,298 1,964,135 (776,512 )
Other financial result (252,471 ) (44,000 ) (126,000 )
Income Taxes — — —
Loss for the Period (29,484,611 ) (45,630,059 ) (33,983,614 )

Share Information
Weighted average number of shares outstanding 44,207,873 41,629,974 27,064,902
Loss per share (basic/diluted) (0.67 ) (1.10 ) (1.26 )

Loss for the Period (29,484,611 ) (45,630,059 ) (33,983,614 )
Other comprehensive income (loss) that may be re-classified to profit or loss in subsequent periods:
Exchange differences on translation of foreign currency 4,206,810 6,777,061 (5,954,019 )
Total Comprehensive Loss (25,277,801 ) (38,852,998 ) (39,937,633 )

InflaRx N.V. and subsidiaries

Consolidated Statements of Financial Position as December 31, 2022 and 2021

in €

2022 2021

ASSETS
Non-current assets
Property and equipment 328,920 274,373
Right-of-use assets 1,311,809 1,408,078
Intangible assets 138,905 235,216
Other assets 308,066 336,566
Financial assets 2,900,902 27,206,990
Total non-current assets 4,988,602 29,461,223
Current assets
Current other assets 14,170,510 10,983,458
Income tax receivable 1,432,087 1,282,177
Financial assets from government grants 732,971 —
Other Financial assets 64,810,135 57,162,266
Cash and cash equivalents 16,265,355 26,249,995
Total current assets 97,411,058 95,677,896
TOTAL ASSETS 102,399,660 125,139,120

EQUITY AND LIABILITIES
Equity
Issued capital 5,364,452 5,304,452
Share premium 282,552,633 280,310,744
Other capital reserves 36,635,564 30,591,209
Accumulated deficit (243,460,290 ) (213,975,679 )
Other components of equity 7,257,081 3,050,270
Total equity 88,349,440 105,280,996
Non-current liabilities
Lease liabilities 987,307 1,066,354
Other liabilities 36,877 35,019
Total non-current liabilities 1,024,184 1,101,373
Current liabilities
Trade and other payables 4,987,538 8,574,244
Liabilities from government grants received 6,209,266 8,300,000
Lease liabilities 369,376 366,171
Employee benefits 1,312,248 1,378,130
Other liabilities 147,608 138,206
Total current liabilities 13,026,036 18,756,751
Total Liabilities 14,050,220 19,858,124
TOTAL EQUITY AND LIABILITIES 102,399,660 125,139,120

InflaRx N.V. and subsidiaries

Consolidated Statements of Changes in Shareholders’ Equity for the Years Ended December 31, 2022, 2021 and 2020

in € Issued capital Share premium Other capital reserves Accumulated deficit Other
components of equity Total equity

Balance as of January 1, 2020 3,132,631 211,006,606 25,142,213 (134,362,006 ) 2,227,228 107,146,673
Loss for the Period — — — (33,983,614 ) — (33,983,614 )
Exchange differences on
translation of foreign currency — — — — (5,954,019 ) (5,954,019 )
Total Comprehensive Loss — — — (33,983,614 ) (5,954,019 ) (39,937,633 )
Issuance of common shares 234,982 9,535,961 — — — 9,770,943
Transaction costs — (729,840 ) — — — (729,840 )
Equity-settled share-based payments — — 1,116,791 — — 1,116,791
Share options exercised 19,797 477,149 — — — 496,946
Balance as of December 31, 2020 3,387,410 220,289,876 26,259,004 (168,345,620 ) (3,726,791 ) 77,863,880
Loss for the Period — — — (45,630,059 ) — (45,630,059 )
Exchange differences on
translation of foreign currency — — — — 6,777,061 6,777,061
Total Comprehensive Loss — — — (45,630,059 ) 6,777,061 (38,852,998 )
Issuance of common shares 1,873,203 63,269,346 — — — 65,142,549
Transaction costs — (4,219,222 ) — — — (4,219,222 )
Equity-settled share-based payments — — 4,332,205 — — 4,332,205
Share options exercised 43,839 970,744 — — — 1,014,583
Balance as of December 31, 2021 5,304,452 280,310,744 30,591,209 (213,975,679 ) 3,050,270 105,280,996
Loss for the Period — — — (29,484,611 ) — (29,484,611 )
Exchange differences on
translation of foreign currency — — — — 4,206,810 4,206,810
Total Comprehensive Loss — — — (29,484,611 ) 4,206,810 (25,277,801 )
Issuance of common shares 60,000 2,289,624 — — — 2,349,624
Transaction costs — (47,735 ) — — — (47,735 )
Equity-settled share-based payments — — 6,044,356 — — 6,044,356
Balance as of December 31, 2022 5,364,452 282,552,633 36,635,564 (243,460,290 ) 7,257,080 88,349,440

InflaRx N.V. and subsidiaries

Consolidated Statements of Cash Flows for the Years ended December 31, 2022, 2021 and 2020

in € 2022 2021 2020

Operating activities
Loss for the Period (29,484,611 ) (45,630,059 ) (33,983,614 )
Adjustments for:
Depreciation & amortization of property and equipment, right-of-use assets and intangible assets 596,597 669,434 712,713
Net finance income (2,753,255 ) (2,004,757 ) 40,810
Share-based payment expense 6,044,356 4,332,205 1,116,791
Net foreign exchange differences 385,359 111,606 (247,322 )
Other non-cash adjustments — — 3,436
Changes in:
Financial assets from government grants (732,971 ) — —
Other assets (3,308,485 ) (7,094,467 ) (1,554,611 )
Employee benefits (64,024 ) (3,290 ) 355,545
Other liabilities 9,403 19,863 8,960
Liabilities from government grants received (2,090,734 ) 8,300,000 —
Trade and other payables (3,586,706 ) 316,112 (4,155,529 )
Interest received 1,287,200 1,070,235 1,201,547
Interest paid (44,946 ) (23,633 ) (26,387 )
Net cash used in operating activities (33,742,817 ) (39,936,751 ) (36,527,661 )
Investing activities
Purchase of intangible assets and property and equipment (162,391 ) (37,778 ) (94,189 )
Purchase of non-current other financial assets — — —
Purchase of current and non-current financial assets (64,474,543 ) (97,516,417 ) (101,600,176 )
Proceeds from the maturity of current financial assets 83,995,029 71,603,310 123,056,347
Net cash from/ (used in) investing activities 19,358,095 (25,950,885 ) 21,361,982
Financing activities
Proceeds from issuance of common shares 2,349,624 65,142,549 9,770,944
Transaction costs from issuance of common shares (47,735 ) (4,219,222 ) (729,841 )
Proceeds from exercise of share options — 1,014,583 496,946
Repayment of lease liabilities (364,429 ) (360,644 ) (366,156 )
Net cash from/ (used in) financing activities 1,937,459 61,577,266 9,171,893
Net increase/(decrease) in cash and cash equivalents (12,447,262 ) (4,310,369 ) (5,993,786 )
Effect of exchange rate changes on cash and cash equivalents 2,462,622 4,591,683 (1,168,813 )
Cash and cash equivalents at beginning of period 26,249,995 25,968,681 33,131,280
Cash and cash equivalents at end of period 16,265,355 26,249,995 25,968,681

About Vilobelimab:

Vilobelimab is a first-in-class monoclonal anti-human complement factor C5a antibody, which highly and effectively blocks the biological activity of C5a and demonstrates high selectivity towards its target in human blood. Thus, vilobelimab leaves the formation of the membrane attack complex (C5b-9) intact as an important defense mechanism of the innate immune system, which is not the case for molecules blocking C5. In pre-clinical studies, vilobelimab has controlled the inflammatory response driven tissue and organ damage by specifically blocking C5a as a key "amplifier" of this response. Vilobelimab has been shown to be well tolerated within clinical trials in different disease settings. Vilobelimab is being developed for various debilitating or life-threatening inflammatory indications, including pyoderma gangrenosum (PG), severe COVID-19 and cutaneous squamous cell carcinoma (cSCC).

The COVID-19 related work described herein is partly funded by the German Federal Government through grant number 16LW0113 (VILO-COVID). All responsibility for the content of this work lies with InflaRx.

On March 22, 2023 ERYTECH Pharma (Nasdaq & Euronext: ERYP), a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating therapeutic drug substances inside red blood cells, reported a business and financial update for the fourth quarter and full year of 2022 (Press release, ERYtech Pharma, MAR 22, 2023, View Source [SID1234629157]).

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"After the disappointing results of our Phase 3 trial in pancreatic cancer, we have pursued during 2022 a consistent strategy to maximize the remaining value for our shareholders through strategic partnering. We sold our US manufacturing site, sharply reduced our cash burn, focused on our most promising preclinical programs, and relentlessly pursued partnering options", said Gil Beyen, Chief Executive Officer of ERYTECH. "We are very pleased this resulted in the recently announced strategic combination with Pherecydes to build on complementary expertise and capabilities of both companies and create a global leader in phage therapy to address the increasingly alarming health context caused by antimicrobial-resistant bacteria."

Business Highlights

U.S. cell therapy manufacturing facility sold to Catalent for a total consideration of USD 44.5 million

Following the disappointing results of the Company’s Phase 3 trial in pancreatic cancer, ERYTECH in April 2022 sold its state-of-the-art commercial-scale cell therapy manufacturing facility in Princeton, New Jersey, to Catalent for a total consideration of $44.5 million. ERYTECH’s staff at the site of approximately 40 people has been transferred to Catalent.

Graspa program halted and focused shifted to preclinical RBC vesicles program

After FDA feedback on the envisaged BLA submission for Graspa in hypersensitive ALL setback, and a non-conclusive early readout of first patients in a Phase 2 trial in TNBC, with the same product candidate, ERYTECH decided in September 2022 to halt further development of Graspa, L-asparaginase encapsulated in donor red blood cells. Erytech decided to focus its development efforts on its most promising preclinical programs, the vesiculation of red blood cells that have already been loaded with active therapeutics to produce cargo-loaded RBC-derived extracellular vesicles, for the development of novel therapeutic approaches.

Deep restructuring implemented

Linked to the halt of the Company’s lead program Graspa, a restructuring program was initiated in May 2022. Combined with the approximately 40 people who transferred to Catalent after the sale of the Company’s manufacturing facility in Princeton, the global team size will be less than 25% compared to the start of this year. The Company has retained its R&D team and its expertise in key functional areas to keep the ability to restart a pipeline of partnered development programs and maintain a fully operational dual-listed company.

Combination with Pherecydes announced

On February 15, 2023, the Company announced the strategic combination with Pherecydes, a biotechnology company specializing in precision phage therapy to treat resistant and/or complicated bacterial infections, with the ambition to create a global leader in extended phage therapy and accelerate the development of a portfolio of phage candidates targeting pathogenic bacteria.

The proposed transaction seeks to leverage ERYTECH’s financial resources and teams to both accelerate and expand PHERECYDES’ existing phage development programs and reinforce efforts to advance novel phage candidates.

ERYTECH and PHERECYDES intend to merge their operations and relocate all teams to ERYTECH’s premises in Lyon, where they will benefit from presence in a major European hub for infectious diseases.

The combined company’s cash runway would extend into Q3 2024, with a consolidated cash position of approximately €41 million as of December 31, 2022, and would enable funding of existing and novel programs through multiple clinical milestones.

The proposed transaction is structured as a merger of PHERECYDES into ERYTECH, pursuant to which the shareholders of PHERECYDES would receive newly issued ERYTECH ordinary shares in consideration of the contribution of the assets and liabilities of PHERECYDES. The extraordinary general meetings of ERYTECH and PHERECYDES will be called upon to vote on the proposed merger, currently expected to be convened at the end of June of 2023. The proposed transaction is expected to close shortly after the approval by the EGM.

Full Year 2022 Financial Results

Key financial figures for the twelve months of 2022 compared with the same period of the previous year are summarized below:

In thousands of euros Q4 2022
(12 months) Q4 2021
(12 months)
Revenues — —
Other income 6,647 4,180
Net gain on asset sale 24,351 —
Operating income 30,998 4,180
Research and development (19,907) (45,100)
General and administrative (13,887) (15,595)
Operating expenses (33,793) (60,696)
Operating income (loss) (2,796) (56,517)
Financial income 4,453 5,422
Financial expenses (1,364) (2,702)
Financial income (loss) 3,089 2,720
Income tax (521) (2)
Net loss (227) (53,798)
Net loss for the full year of 2022 was €0.2 million, a €53.7 million improvement year-over-year, reflecting the €24.4 million net gain on the sale of the Princeton facility, and the further decrease in operating expenses, which, at €33.8 million of expenses at the end of 2022, were also showing an accelerated decrease of €26.9 million (-44%) year-over-year, with a €25.2 million decrease in R&D expenses (-56%), related to the termination of clinical programs, and a €1.7 million decrease (-11%) in G&A.
Other income included the €4.9 million debt extinguishment related to the conditional advance on the Tedac R&D program, owing to the termination of developments on the Graspa platform, and €1.5M for the R&D tax credit.
Total operating expenses of €33.8 million included an impairment charge of €2.4 million on the Lyon production facility, related to the end of eryaspase operations, and a one-off €1.8 million cost of restructuring, related to the resizing of French operations and staff.

Income tax expense in 2022 was €0.5 million, reflecting the expected tax impacts of the capital gain from the sale of the Princeton facility.

As of December 31, 2022, ERYTECH had cash and cash equivalents totaling €38.8 million (approximately $41.5 million), compared with €33.7 million as of December 31, 2021. The €5.1 million net increase in cash position during the twelve months of 2022 was the result of the net cash of €37.6 million received from the sale of the Princeton facility, a €31.3 million net cash utilization in operating activities and investing activities (excluding the sale of the Princeton facility) and €1.8 million used in financing activities, while the variation of the U.S. dollar against the euro led to a €0.5 million positive currency exchange impact.

Earlier this year, the company initiated a deep restructuring and cost reduction program, then further intensified with the halt of the Graspa program and BLA process. Considering this ongoing reduction in operating expenses, the Company believes that its current cash position can fund its current activities and planned operating expenses to the second half of 2024.

Filing of 2022 Universal Registration Document and 2022 Annual Report on Form 20-F

The Company’s 2022 Universal Registration Document for the year ended December 31, 2022, including the management report and the annual financial report, and its Annual Report on Form 20-F for the year ended December 31, 2022, will be filed with the "Autorité des Marchés Financiers" (AMF) and with the U.S. Securities and Exchange Commission (SEC), respectively, on March 27, 2023.

These documents will be accessible on the Investors section of the Company’s corporate website (www.erytech.com). In addition, the Universal Registration Document will be available on the website of the AMF (www.amf-france.org) and the Annual Report on Form 20-F will also be available on the website of the SEC (www.sec.gov). Printed copies of these documents will also be available free of charge, by sending a postal request to the registered offices of ERYTECH Pharma, Bâtiment Bioserra, 60 Avenue Rockefeller, 69008 in Lyon (France).

2023 Financial Calendar*

Business Update and Financial Highlights for the First Quarter of 2023: May 9, 2023 (after U.S. market close), followed by a conference call & webcast on May 10, 2023 (2:30pm CET/8:30am ET)

Shareholders’ Meeting: June 23, 2023 at 9.30am CET – Paris

Business Update and Financial Highlights for the Second Quarter & First Half of 2023: September 11, 2023 (after U.S. market close), followed by a conference call & webcast on September 12, 2023 (2:30pm CET/8:30am ET)

Business Update and Financial Highlights for the Third Quarter of 2023: November 6, 2023 (after U.S. market close), followed by a conference call & webcast on November 7, 2023 (2:30pm CET/8:30am ET)

On March 22, 2023 ArcticZymes Technologies ASA (OSE: AZT) reported that the Board of Directors has today accepted the voluntary resignation of Jethro Holter as Chief Executive Officer, due to personal reasons (Press release, ArcticZymes Technologies, MAR 22, 2023, View Source [SID1234629155]).

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The resignation will take effect on 30th September 2023 after the required 6 months notice period.

"On behalf of the Board, I want to thank Jethro very much for his outstanding contributions to ArcticZymes over the past 3 years that he has served as our CEO. During that time, Jethro has been instrumental in transforming ArcticZymes into a successful and highly profitable business," said Marie Roskrow. "All of the employees of ArcticZymes send their good wishes and thanks to Jethro."

The Board of Directors will immediately initiate a search for a new CEO. In the meantime, Chairman of the Board, Marie Roskrow, will act as Executive Chairman to lead and support the Company through this transition period.

ArcticZymes also anticipates expanding the Board of Directors in the near future.

On March 22, 2023 BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a pre-commercial-stage biopharmaceutical company focused on oncology, reported its audited 2022 annual financial results for the year ended December 31, 2022, and provided recent corporate and portfolio updates (Press release, BioLineRx, MAR 22, 2023, https://ir.biolinerx.com/news-releases/news-release-details/biolinerx-reports-2022-financial-results-and-recent-corporate [SID1234629154]).

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"Over the last quarter and into this year, we continue to proceed with activities to advance the NDA review process of APHEXDA, while in parallel progressing with pre-launch activities in anticipation of potential approval later this year," said Philip Serlin, Chief Executive Officer of BioLineRx. "Importantly, we recently announced the appointment of our new chief medical officer and completed the formation of our U.S. commercialization team that includes industry veterans with significant and very relevant drug launch and sales experience. Additionally, we announced a new collaboration to evaluate motixafortide for stem cell mobilization for gene therapies in sickle cell disease, which continues our goal of fully maximizing its clinical potential for patients. This is an extremely exciting year for the Company, with the potential commercial approval of our first product, anticipated pancreatic cancer clinical trial data, as well as the planned initiation of two new clinical trials that may further our growth."

Recent Corporate Updates

Appointed Tami Rachmilewitz, M.D. as Chief Medical Officer
Finalized formation of the U.S. commercial leadership team, which collectively has significant drug launch and sales experience, with particular expertise in stem cell mobilization and transplantation
Portfolio Execution

Motixafortide (selective inhibitor of CXCR4 chemokine receptor)

Multiple Myeloma

Announced FDA acceptance of the APHEXDA (motixafortide) NDA in stem cell mobilization for autologous transplantation in multiple myeloma patients. PDUFA target action date set for September 9, 2023
Presented a cost-effectiveness analysis of APHEXDA (motixafortide) versus plerixafor in stem cell mobilization for autologous transplantation in patients with multiple myeloma at the American Society of Hematology (ASH) (Free ASH Whitepaper) 64th Annual Meeting, which was held December 10-13, 2022, in New Orleans, Louisiana. The analysis demonstrated significant net cost savings with APHEXADA (motixafortide)
Pancreatic Ductal Adenocarcinoma (PDAC)

Continued to advance preparation activities for a Phase 2b randomized clinical trial with 200 patients assessing motixafortide in combination with a PD-1 inhibitor and standard-of-care chemotherapy as a first line metastatic PDAC (mPDAC) therapy with collaboration partner GenFleet. Anticipate clinical trial initiation in 2023
Continued collaboration progress with Columbia University investigator-initiated Phase 2 study assessing motixafortide in combination with the PD-1 inhibitor cemiplimab and standard-of-care chemotherapy in first line mPDAC patients. Anticipate initial patient data in 2023
Sickle Cell Disease & Gene Therapy

Announced clinical trial collaboration with Washington University School of Medicine in St. Louis to evaluate motixafortide as monotherapy and in combination with natalizumab for CD34+ hematopoietic stem cell mobilization for gene therapies in sickle cell disease. Anticipate clinical trial initiation in 2023. Clinical trial design was presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) 64th Annual Meeting, which was held December 10-13, 2022, in New Orleans, Louisiana
AGI-134 (synthetic alpha-Gal glycolipid)

Solid Tumor Immunotherapy

Announced results from Phase 1/2a study of investigational anti-tumor vaccine AGI-134 in metastatic solid tumors. First-in-human, single-agent study met primary endpoint for safety and tolerability and demonstrated immune activity across multiple biomarkers. The Company is evaluating potential development program pathways in consultation with its scientific advisory board
Financial Results for Year Ended December 31, 2022

Research and development expenses for the year ended December 31, 2022, were $17.6 million compared to $19.5 million for the year ended December 31, 2021. The decrease resulted primarily from lower expenses related to NDA supporting activities related to motixafortide, as well as lower expenses associated with the completed motixafortide GENESIS clinical trial, offset by an increase in expenses associated with the AGI-134 study and an increase in payroll and related expenses
Sales and marketing expenses for the year ended December 31, 2022, were $6.5 million compared to $1.0 million the year ended December 31, 2021. The increase resulted primarily from initiation of pre-commercialization activities related to motixafortide, as well as an increase in market research
General and administrative expenses for the year ended December 31, 2022, were $5.1 million compared to $4.3 million for the year ended December 31, 2021. The increase resulted primarily from an increase in share-based compensation and small increases in a number of general and administrative expenses
Net loss for the year ended December 31, 2022, was $25.0 million, compared to $27.1 million for the year ended December 31, 2021
As of December 31, 2022, the Company had cash, cash equivalents, and short-term bank deposits of $51.1 million and anticipates this will be sufficient to fund operations, as currently planned, into the first half of 2024
A copy of the Company’s annual report on Form 20-F for the year ended December 31, 2022 has been filed with the U.S. Securities and Exchange Commission at View Source and posted on the Company’s investor relations website at View Source Company will deliver a hard copy of its annual report, including its complete audited consolidated financial statements, free of charge, to its shareholders upon request at [email protected].

Conference Call and Webcast Information

BioLineRx will hold a conference call today, Wednesday, March 22 at 10:00 a.m. EDT.

To access the conference call, please dial +1-888-281-1167 from the U.S. or +972-3-918-0685 internationally. A live webcast and a replay of the call can be accessed through the event page on the Company’s website. Please allow extra time prior to the call to visit the site and download any necessary software to listen to the live broadcast. The call replay will be available approximately two hours after completion of the live conference call. A dial-in replay of the call will be available until March 24, 2023; please dial +1-888-295-2634 from the US or +972-3-925-5904 internationally.

On March 22, 2023 Applied DNA Sciences, Inc. (NASDAQ: APDN) (the "Company"), a leader in PCR-based DNA technologies, reported that its wholly-owned clinical laboratory subsidiary, Applied DNA Clinical Labs, LLC (ADCL), has submitted a validation package to the New York State Department of Health (NYSDOH) in support of approval for a pharmacogenomics (PGx) assay as a NYSDOH laboratory-developed test (LDT) (Press release, Applied DNA Sciences, MAR 22, 2023, View Source [SID1234629153]). If approved by NYSDOH, the LDT test will be used by ADCL to power its population-scale PGx testing services.

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ADCL’s PGx testing will focus on population-scale testing that is expected to be accretive to ADCL’s margin profile. ADCL’s commercial strategy is centered on the direct-to-enterprise and self-insured health markets that do not require ADCL to seek third-party reimbursement or engage in individual patient billing. In advance of initiating its PGx testing services, the Company’s sales outreach has targeted regional health systems and large, self-insured entities in its New York operating area and in States that recognize New York’s CLEP/CLIA certification.

PGx testing is a data-driven approach that relates an individual’s genetic factors to variable responses to prescription drugs. ADCL’s PGx assay interrogates 120 targets across 37 genes relevant to a broad range of common drugs, including cardiac, pain management, cancer, and mental health therapies. PGx testing yields actionable information to empower healthcare providers to deliver precision medicine to their patients through personalized drug prescribing and dosing.

Recently published studies have shown that population-scale PGx testing can significantly reduce overall population healthcare costs, reduce adverse drug events, and increase population wellbeing1,2. These benefits can result in significant cost savings to large entities and self-insured employers, the latter accounting for approximately 65% of all U.S. employers in 20223.

"PGx testing is a logical first step into the promising field of personalized medicine that brings together ADCL’s demonstrated capacity for population-scale testing and PGx’s proven benefits to the individual. When applied to large populations, we believe that the combination will generate significant healthcare cost reductions for enterprises and overall wellness benefits to employees," stated Dr. James A. Hayward, president and CEO of Applied DNA Sciences. "Given PGx testing’s attractive margin profile and ongoing conversations with prospective customers, we view this first genetic assay as the basis for a long-term, profitable testing service."

Footnotes:
1 Jarvis, J. P., Peter, A. P., Keogh, M., Baldasare, V., Beanland, G. M., Wilkerson, Z. T., Kradel, S., & Shaman, J. A. (2022). Real-world impact of a pharmacogenomics-enriched comprehensive medication management program. Journal of Personalized Medicine, 12(3), 421. View Source
2 Jesse J Swen, Cathelijne H van der Wouden, et al., A 12-gene pharmacogenetic panel to prevent adverse drug reactions: an open-label, multicentre, controlled, cluster-randomised crossover implementation study, The Lancet, Volume 401, Issue 10374, 2023, pages 247-356. View Source(22)01841-4. https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(22)01841-4/fulltext
3 View Source