On February 28, 2022 Astellas Pharma Inc. (TSE:4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") and Seagen Inc. (Nasdaq:SGEN) reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has confirmed its previously adopted positive opinion, recommending approval of PADCEV (enfortumab vedotin) as monotherapy for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received platinum-containing chemotherapy and a PD-1/L1 inhibitor (Press release, Seagen, FEB 28, 2022, View Source [SID1234609093]).

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The CHMP initially adopted a positive opinion of enfortumab vedotin on December 16, 2021, providing its recommendation to the European Commission (EC) for a final decision. During the EC’s decision-making process, further safety information was brought to the attention of the CHMP. Following a request from the EC and taking into account the latest information, the CHMP re-adopted its positive opinion.1 If approved by the EC, enfortumab vedotin will be the first antibody-drug conjugate authorized in the European Union for people living with advanced urothelial cancer.

The positive opinion from the CHMP will now be reviewed by the EC. EC decisions are valid in the European Union Member States, as well as Iceland, Norway and Liechtenstein.2

About Urothelial Cancer

Urothelial cancer is the most common type of bladder cancer (90 percent of cases) and can also be found in the renal pelvis (where urine collects inside the kidney), ureter (tube that connects the kidneys to the bladder) and urethra.3 Globally, approximately 573,000 new cases of bladder cancer and 212,000 deaths are reported annually.4

About Enfortumab Vedotin

Enfortumab vedotin is an antibody-drug conjugate (ADC) that is directed against Nectin-4, a protein located on the surface of cells and highly expressed in bladder cancer.5,6 Nonclinical data suggest the anticancer activity of enfortumab vedotin is due to its binding to Nectin-4 expressing cells followed by the internalization and release of the anti-tumor agent monomethyl auristatin E (MMAE) into the cell, which result in the cell not reproducing (cell cycle arrest) and in programmed cell death (apoptosis).6

PADCEV (enfortumab vedotin-ejfv) U.S. Indication & Important Safety Information

BOXED WARNING: SERIOUS SKIN REACTIONS

PADCEV can cause severe and fatal cutaneous adverse reactions including Stevens-Johnson syndrome (SJS) and Toxic Epidermal Necrolysis (TEN), which occurred predominantly during the first cycle of treatment, but may occur later.
Closely monitor patients for skin reactions.
Immediately withhold PADCEV and consider referral for specialized care for suspected SJS or TEN or severe skin reactions.
Permanently discontinue PADCEV in patients with confirmed SJS or TEN; or Grade 4 or recurrent Grade 3 skin reactions.
U.S. Indication

PADCEV is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer (mUC) who:

have previously received a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor and platinum-containing chemotherapy, or
are ineligible for cisplatin-containing chemotherapy and have previously received one or more prior lines of therapy.5
Important Safety Information

Warnings and Precautions

Skin reactions Severe cutaneous adverse reactions, including fatal cases of SJS or TEN, occurred in patients treated with PADCEV. SJS and TEN occurred predominantly during the first cycle of treatment but may occur later. Skin reactions occurred in 55% of the 680 patients treated with PADCEV in clinical trials. Twenty-three percent (23%) of patients had maculo-papular rash and 33% had pruritus. Grade 3-4 skin reactions occurred in 13% of patients, including maculo-papular rash, rash erythematous, rash or drug eruption, symmetrical drug-related intertriginous and flexural exanthema (SDRIFE), dermatitis bullous, dermatitis exfoliative, and palmar-plantar erythrodysesthesia. In clinical trials, the median time to onset of severe skin reactions was 0.6 months (range: 0.1 to 6.4). Among patients experiencing a skin reaction leading to dose interruption who then restarted PADCEV (n=59), 24% of patients restarting at the same dose and 16% of patients restarting at a reduced dose experienced recurrent severe skin reactions. Skin reactions led to discontinuation of PADCEV in 2.6% of patients. Monitor patients closely throughout treatment for skin reactions. Consider topical corticosteroids and antihistamines, as clinically indicated. Withhold PADCEV and refer for specialized care for suspected SJS or TEN or for severe (Grade 3) skin reactions. Permanently discontinue PADCEV in patients with confirmed SJS or TEN, or for Grade 4 or recurrent Grade 3 skin reactions.

Hyperglycemia and diabetic ketoacidosis (DKA), including fatal events, occurred in patients with and without pre-existing diabetes mellitus, treated with PADCEV. Patients with baseline hemoglobin A1C ≥8% were excluded from clinical trials. In clinical trials, 14% of the 680 patients treated with PADCEV developed hyperglycemia; 7% of patients developed Grade 3-4 hyperglycemia. The incidence of Grade 3-4 hyperglycemia increased consistently in patients with higher body mass index and in patients with higher baseline A1C. Five percent (5%) of patients required initiation of insulin therapy for treatment of hyperglycemia. The median time to onset of hyperglycemia was 0.6 months (range: 0.1 to 20.3). Hyperglycemia led to discontinuation of PADCEV in 0.6% of patients. Closely monitor blood glucose levels in patients with, or at risk for, diabetes mellitus or hyperglycemia. If blood glucose is elevated (>250 mg/dL), withhold PADCEV.

Pneumonitis Severe, life-threatening or fatal pneumonitis occurred in patients treated with PADCEV. In clinical trials, 3.1% of the 680 patients treated with PADCEV had pneumonitis of any grade and 0.7% had Grade 3-4. In clinical trials, the median time to onset of pneumonitis was 2.9 months (range: 0.6 to 6). Monitor patients for signs and symptoms indicative of pneumonitis, such as hypoxia, cough, dyspnea or interstitial infiltrates on radiologic exams. Evaluate and exclude infectious, neoplastic and other causes for such signs and symptoms through appropriate investigations. Withhold PADCEV for patients who develop persistent or recurrent Grade 2 pneumonitis and consider dose reduction. Permanently discontinue PADCEV in all patients with Grade 3 or 4 pneumonitis.

Peripheral neuropathy (PN) occurred in 52% of the 680 patients treated with PADCEV in clinical trials, including 39% with sensory neuropathy, 7% with muscular weakness and 6% with motor neuropathy; 4% experienced Grade 3-4 reactions. PN occurred in patients treated with PADCEV with or without preexisting PN. The median time to onset of Grade ≥2 PN was 4.6 months (range: 0.1 to 15.8 months). Neuropathy led to treatment discontinuation in 5% of patients. Monitor patients for symptoms of new or worsening peripheral neuropathy and consider dose interruption or dose reduction of PADCEV when PN occurs. Permanently discontinue PADCEV in patients who develop Grade ≥3 PN.

Ocular disorders were reported in 40% of the 384 patients treated with PADCEV in clinical trials in which ophthalmologic exams were scheduled. The majority of these events involved the cornea and included events associated with dry eye such as keratitis, blurred vision, increased lacrimation, conjunctivitis, limbal stem cell deficiency, and keratopathy. Dry eye symptoms occurred in 34% of patients, and blurred vision occurred in 13% of patients, during treatment with PADCEV. The median time to onset to symptomatic ocular disorder was 1.6 months (range: 0 to 19.1 months). Monitor patients for ocular disorders. Consider artificial tears for prophylaxis of dry eyes and ophthalmologic evaluation if ocular symptoms occur or do not resolve. Consider treatment with ophthalmic topical steroids, if indicated after an ophthalmic exam. Consider dose interruption or dose reduction of PADCEV for symptomatic ocular disorders.

Infusion site extravasation Skin and soft tissue reactions secondary to extravasation have been observed after administration of PADCEV. Of the 680 patients, 1.6% of patients experienced skin and soft tissue reactions, including 0.3% who experienced Grade 3-4 reactions. Reactions may be delayed. Erythema, swelling, increased temperature, and pain worsened until 2-7 days after extravasation and resolved within 1-4 weeks of peak. Two patients (0.3%) developed extravasation reactions with secondary cellulitis, bullae, or exfoliation. Ensure adequate venous access prior to starting PADCEV and monitor for possible extravasation during administration. If extravasation occurs, stop the infusion and monitor for adverse reactions.

Embryo-fetal toxicity PADCEV can cause fetal harm when administered to a pregnant woman. Advise patients of the potential risk to the fetus. Advise female patients of reproductive potential to use effective contraception during PADCEV treatment and for 2 months after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with PADCEV and for 4 months after the last dose.

Adverse Reactions

Most Common Adverse Reactions, Including Laboratory Abnormalities (≥20%)

Rash, aspartate aminotransferase (AST) increased, glucose increased, creatinine increased, fatigue, PN, lymphocytes decreased, alopecia, decreased appetite, hemoglobin decreased, diarrhea, sodium decreased, nausea, pruritus, phosphate decreased, dysgeusia, alanine aminotransferase (ALT) increased, anemia, albumin decreased, neutrophils decreased, urate increased, lipase increased, platelets decreased, weight decreased and dry skin.

EV-301 Study: 296 patients previously treated with a PD-1/L1 inhibitor and platinum-based chemotherapy.

Serious adverse reactions occurred in 47% of patients treated with PADCEV; the most common (≥2%) were urinary tract infection, acute kidney injury (7% each) and pneumonia (5%). Fatal adverse reactions occurred in 3% of patients, including multiorgan dysfunction (1.0%), hepatic dysfunction, septic shock, hyperglycemia, pneumonitis and pelvic abscess (0.3% each). Adverse reactions leading to discontinuation occurred in 17% of patients; the most common (≥2%) were PN (5%) and rash (4%). Adverse reactions leading to dose interruption occurred in 61% of patients; the most common (≥4%) were PN (23%), rash (11%) and fatigue (9%). Adverse reactions leading to dose reduction occurred in 34% of patients; the most common (≥2%) were PN (10%), rash (8%), decreased appetite and fatigue (3% each). Clinically relevant adverse reactions (<15%) include vomiting (14%), AST increased (12%), hyperglycemia (10%), ALT increased (9%), pneumonitis (3%) and infusion site extravasation (0.7%).

EV-201, Cohort 2 Study: 89 patients previously treated with a PD-1/L1 inhibitor and not eligible for platinum-based chemotherapy.

Serious adverse reactions occurred in 39% of patients treated with PADCEV; the most common (≥3%) were pneumonia, sepsis and diarrhea (5% each). Fatal adverse reactions occurred in 8% of patients, including acute kidney injury (2.2%), metabolic acidosis, sepsis, multiorgan dysfunction, pneumonia and pneumonitis (1.1% each). Adverse reactions leading to discontinuation occurred in 20% of patients; the most common (≥2%) was PN (7%). Adverse reactions leading to dose interruption occurred in 60% of patients; the most common (≥3%) were PN (19%), rash (9%), fatigue (8%), diarrhea (5%), AST increased and hyperglycemia (3% each). Adverse reactions leading to dose reduction occurred in 49% of patients; the most common (≥3%) were PN (19%), rash (11%) and fatigue (7%). Clinically relevant adverse reactions (<15%) include vomiting (13%), AST increased (12%), lipase increased (11%), ALT increased (10%), pneumonitis (4%) and infusion site extravasation (1%).

Drug Interactions

Effects of other drugs on PADCEV (Dual P-gp and Strong CYP3A4 Inhibitors)

Concomitant use with a dual P-gp and strong CYP3A4 inhibitors may increase unconjugated monomethyl auristatin E exposure, which may increase the incidence or severity of PADCEV toxicities. Closely monitor patients for signs of toxicity when PADCEV is given concomitantly with dual P-gp and strong CYP3A4 inhibitors.

Specific Populations

Lactation Advise lactating women not to breastfeed during treatment with PADCEV and for at least 3 weeks after the last dose.

Hepatic impairment Avoid the use of PADCEV in patients with moderate or severe hepatic impairment.

On February 28, 2022 CRISPR Therapeutics (Nasdaq: CRSP), a biopharmaceutical company focused on creating transformative gene-based medicines for serious diseases, reported that members of its senior management team are scheduled to participate in the following investor conferences in March (Press release, CRISPR Therapeutics, FEB 28, 2022, View Source [SID1234609092]):

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Cowen 42nd Annual Health Care Conference
Date: Monday, March 7, 2022
Time: 10:30 a.m. ET.

Barclays Global Healthcare Conference
Date: Thursday, March 17, 2022
Time: 10:15 a.m. ET.

Oppenheimer 32nd Annual Healthcare Conference
Date: Thursday, March 24, 2022
Time: 11:00 a.m. ET.

A live webcast of the events will be available on the "Events & Presentations" page in the Investors section of the Company’s website at View Source A replay of the webcasts will be archived on the Company’s website for 14 days following each presentation.

On February 28, 2022 Celsion Corporation (NASDAQ: CLSN), a clinical-stage company focused on DNA-based immunotherapy and next-generation vaccines, reported that, as previously authorized by its shareholders, the Company is implementing a consolidation (reverse stock split) of its outstanding Common Shares on the basis of one (1) new Common Share for every fifteen (15) currently outstanding Common Shares (Press release, Celsion, FEB 28, 2022, View Source [SID1234609091]).

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The new Common Shares will be effective for trading purposes as of the commencement of trading on Tuesday, March 1, 2022, and will trade under a new CUSIP number 15117N 602. The Company’s ticker symbol, CLSN, will remain unchanged. The Company has filed a Certificate of Amendment to its Certificate of Incorporation to effect the stock consolidation.

The new number of outstanding common shares will be approximately 5.8 million shares. The number of authorized shares and the par value per share will remain unchanged. No fractional shares will be issued in connection with the reverse stock split. Holders of fractional shares will be paid out in cash for the fractional portion. The number of outstanding options and warrants will be adjusted accordingly, with outstanding options being approximately 437,500 and outstanding warrants being approximately 168,500.

Celsion stockholders will receive instructions from the Company’s transfer agent, American Stock Transfer and Trust Company, relating to procedures for exchanging existing stock certificates for new certificates or book-entry shares and for the receipt of cash proceeds in lieu of fractional shares.

On February 28, 2022 ALX Oncology Holdings Inc., ("ALX Oncology") (Nasdaq: ALXO) a clinical-stage immuno-oncology company developing therapies that block the CD47 checkpoint pathway, reported financial results for the fourth quarter and year ended December 31, 2021 and provided clinical development and operational highlights (Press release, ALX Oncology, FEB 28, 2022, View Source [SID1234609090]).

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"ALX Oncology achieved key milestones in 2021 to advance our lead program, evorpacept, a next-generation CD47 blocker, through multiple clinical trials," said Jaume Pons, Ph.D., Founder, President and Chief Executive Officer of ALX Oncology. "Notable accomplishments included initiating two Phase 2 trials in head and neck squamous cell carcinoma ("HNSCC") and presenting encouraging Phase 1b data from the ASPEN-01 trial in gastric/gastroesophageal junction ("GEJ") cancer and HNSCC, along with early Phase 1a data from the ASPEN-02 trial in myelodysplastic syndromes ("MDS"). Data from these trials also showed evorpacept to be well tolerated when combined with anti-cancer antibodies and multi-agent chemotherapy regimens in solid tumors and with azacitidine in MDS."

Dr. Pons added: "2022 is expected to be another productive year with the anticipated initiation of a randomized Phase 2/3 clinical trial of evorpacept in combination with trastuzumab, ramucirumab and paclitaxel in patients with 2nd line or greater gastric/GEJ cancer and the expected completion of enrollment and dose optimization data readout from our Phase 1b clinical trial of evorpacept in combination with azacitidine in patients with MDS. The design of evorpacept, with an inactive Fc, continues to set us apart from competing CD47 blockers to date. Our data suggest that evorpacept’s inactive Fc approach shows greater tolerability than CD47 blocking approaches using an active Fc domain, several of which have shown significant cytopenias in the clinic. Additionally, our initial clinical data show anti-tumor activity on par or better than other such agents."

Anticipated Key Clinical Milestones for 2022

Initiation of a randomized Phase 2/3 clinical trial of evorpacept in combination with Herceptin (trastuzumab), Cyramza (ramucirumab) and paclitaxel in patients with 2nd line or greater gastric/GEJ cancer (ASPEN-06).
Dose optimization readout of a Phase 1b clinical trial of evorpacept in combination with azacitidine in patients with MDS (ASPEN-02).
Initiate and provide updates on investigator sponsored clinical trials with evorpacept.
Provide updates on ongoing collaboration with Zymeworks in HER2-expressing breast cancer and other solid tumors.
Select development candidate(s) from preclinical pipeline.
Recent Clinical Developments for Evorpacept (ALX148)

U.S. Food and Drug Administration ("FDA") Granted Orphan Drug Designation ("ODD") for Evorpacept for the Treatment of Patients with Gastric/GEJ Cancer
In January 2022, ALX announced that the U.S. FDA granted ODD to evorpacept, a next-generation CD47 blocker, for the treatment of patients with gastric/GEJ cancer.
Presented Initial Phase 1a Clinical Data in Combination with Azacitidine in Patients with MDS (ASPEN-02) at ASH (Free ASH Whitepaper)
In December 2021, the Company presented initial clinical data from its ongoing trial evaluating evorpacept in combination with azacitidine for the treatment of patients with previously untreated higher-risk or relapsed or refractory MDS. The new data, shared in a poster at the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) ("ASH") Annual Meeting [Abstract #2601], show that the combination of evorpacept and azacitidine is active and well-tolerated. Patient accrual is ongoing in the Phase 1b dose optimization part of the study.
Presented Updated Phase 1b Clinical Trial Data in Combination with Pembrolizumab with and without Chemotherapy in Patients with HNSCC and in Combination with Trastuzumab, Ramucirumab, and Paclitaxel in Patients with Gastric/GEJ Cancer (ASPEN-01) at SITC (Free SITC Whitepaper)
In November 2021, updated results from Phase 1b study (ASPEN-01) evaluating patients with solid tumor malignancies were presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s 36th Anniversary Annual Meeting [Abstract #498]. ALX Oncology reported updated results from the gastric/GEJ cancer patient cohort receiving evorpacept plus trastuzumab plus chemotherapy, and from the head and neck squamous cell carcinoma patient cohort receiving evorpacept plus pembrolizumab with and without chemotherapy. Data showed robust and durable responses with emerging signs of clinical benefit in survival-based endpoints in patients with advanced solid tumors. All data reflected response evaluable patients as of September 1, 2021.
Initiation of a Phase 1a Clinical Trial in Combination with Venetoclax and Azacitidine in Acute Myeloid Leukemia (ASPEN-05)
In October 2021, the first patient was dosed in the Phase 1/2 ASPEN-05 study evaluating the combination of evorpacept with venetoclax and azacitidine for the treatment of patients with acute myeloid leukemia ("AML"). The Phase 1 portion will characterize the safety of evorpacept in combination with venetoclax and azacitidine for the treatment of patients with relapsed/refractory AML and previously untreated AML who are not candidates for intensive induction therapy.
Initiation of a Phase 1b/2 Clinical Trial in Combination with Zanidatamab in Patients with Advanced HER2-Expressing Breast Cancer and Other Solid Tumors
In October 2021, Zymeworks and ALX Oncology dosed the first patient in an open-label, multi-center Phase 1b/2 clinical trial to evaluate the safety and efficacy of zanidatamab, Zymeworks’ lead HER2-targeted bispecific antibody, in combination with evorpacept in patients with advanced HER2-positive breast cancer, HER2-low breast cancer and additional non-breast HER2-expressing solid tumors.
Recent Corporate Updates

Acquired Privately Held ScalmiBio Inc.: In October 2021, ALX Oncology acquired ScalmiBio which further expanded its pipeline with plans to develop novel antibody-drug conjugates ("ADCs") based on ScalmiBio’s SHIELD platform.
Full Year and Fourth Quarter 2021 Financial Results:

Cash and Cash Equivalents: Cash and cash equivalents as of December 31, 2021 were $363.7 million. ALX Oncology believes its cash and cash equivalents is sufficient to fund planned operations through mid-2024.
Related-party Revenue: There was no related-party revenue for the three months ended December 31, 2021 and 2020. There was no related-party revenue for the year ended December 31, 2021, compared to $1.2 million for the prior-year period. The decrease in related-party revenue relates to the termination of the research and development agreement with Tallac Therapeutics, Inc. in July 2020.
Research and Development ("R&D") Expenses: R&D expenses consist primarily of pre-clinical, clinical and manufacturing expenses related to the development of the Company’s current lead product candidate, evorpacept, and R&D employee-related expenses. These expenses for the three months ended December 31, 2021, were $20.9 million, compared to $12.1 million for the prior-year period. Expenses for the three months ended December 31, 2021 included $4.7 million of acquired in-process research and development expenses related to the acquisition of ScalmiBio. R&D expenses for the year ended December 31, 2021, were $60.2 million, compared to $29.0 million for the prior-year period.
General and Administrative ("G&A") Expenses: G&A expenses consist primarily of administrative employee-related expenses, legal and other professional fees, patent filing and maintenance fees, and insurance. These expenses for the three months ended December 31, 2021, were $7.6 million, compared to $5.7 million for the prior-year period. G&A expenses for the year ended December 31, 2021, were $23.4 million, compared to $14.8 million for the prior-year period.
Net loss: GAAP net loss attributable to common stockholders was $28.4 million for the fourth quarter ended December 31, 2021, or $0.70 per basic and diluted share, as compared to a net loss of $18.8 million for the fourth quarter ended December 31, 2020, or $0.50 per basic and diluted share. GAAP net loss for the year ended December 31, 2021 was $83.5 million, or $2.07 per basic and diluted share, as compared to $50.9 million, or $2.76 per basic and diluted share, for the year ended December 31, 2020. Non-GAAP net loss was $22.8 million for the fourth quarter ended December 31, 2021, as compared to a net loss of $16.3 million for the fourth quarter ended December 31, 2020. Non-GAAP net loss for the year ended December 31, 2021 was $69.5 million, as compared to $43.8 million for the year ended December 31, 2020. A reconciliation of GAAP to non-GAAP financial results can be found at the end of this news release.

On February 28, 2022 AB Science S.A. (the "Company" or "AB Science", Euronext – FR0010557264 – AB) reported that it reached an agreement with a historical investor on a financing of USD 8.5 million through the issuance of bonds convertible into new ordinary shares (the "OCA") with attached warrants (the "Warrants" and, with the OCA, the "OCABSA") (Press release, AB Science, FEB 28, 2022, View Source [SID1234609089]).

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50,000 OCABSA will be issued, representing a nominal value of USD 8.5 million. It will reinforce the cash position of AB Science for the development of its clinical research program.

Terms of the issuance
The settlement delivery of the OCABSA will happen at the latest on March 7, 2022. The board of AB Science authorized, on February 27, 2022, this issuance based on the 20th resolution of the June 20, 2021 shareholders’ meeting. The OCABSA will be issued through a private placement (withing the meaning of article L. 411-2 of the French Financial and Monetary Code) without preferential subscription right for existing shareholders.

The issuance of the OCABSA, the conversion of the OCA into ordinary shares of AB Science and the exercise of the Warrants, as the case may be, will not be subject to any prospectus to be filed with the French Autorité des marchés financiers.

Main terms and conditions of the OCA
50,000 OCA will be issued at their par value of USD 170,0 each (the "PV"), representing a total par value of USD 8.5 million.

The OCA will not be listed on Euronext Paris.

The OCA will be freely tradable. They will mature withing three years from their issuance date (the "Maturity Date") and they will bear an interest based on the one-month Bloomberg Short Term Bank Yield (1M BSBY) + 350 basis points per year, payable on a monthly basis.

Each OCA will be convertible at any time, at the option of its holder only, into a number of ordinary shares equals to the result of the following formula: "PV / 14" (the "Conversion Basis"). Each OCA will be convertible, at the option of AB Science (during 10 trading days), on the same Conversion Basis, (i) if the AB Science closing market price, during a trading session, is above EUR 18.0, and (ii) the average daily trading volume (during a minimum of 10 consecutive trading days before the conversion) is above EUR 1,0 million.

The OCA that will not be converted before the Maturity Date will be redeemed by AB Science at their par value.

In any case, the number of ordinary shares that could be issued following the conversion of the OCA will be caped so that AB Science will not break the 20% threshold of article 1st§5 a) and b) of the EU Regulation 2017/1129. The OCA that will not be converted pursuant to this cap will be redeemed in cash.

Main terms of the Warrants
One Warrant will be attached to each OCA. It will be detached from the OCABSA immediately after the issuance.

The Warrants will not be listed on Euronext Paris.

The Warrants will be freely tradable and will be exercisable from their issuance until December 31, 2030 (the "Exercise Period"). The Warrants not exercised at the end of the Exercise Period will be null and void.

Each Warrant will give the right to its holder, during the Exercise Period, to subscribe to one ordinary share of AB Science. The subscription price of one ordinary share upon exercise of a Warrant will be equal to 12.65 euros.

Ordinary shares issued following the conversion of the OCABSA or exercise of the Warrants
The ordinary shares to be issued upon conversion of the OCA or following the exercise of the Warrants will be fungible in all respects with AB Science existing ordinary shares. They will be admitted to trade on the regulated market of Euronext Paris under the existing ISIN securities identification code for AB Science’s ordinary shares (code ISIN FR0010557264).

Impacts of the issuance in term of cash management
AB Science expects that, based on its gross cash position on December 31, 2021, its financial option with the EBI and the amount of research tax credit to be collected, the issuance of the OCA and the potential exercise of the Warrants will allow AB Science to finance its activities for the coming 12 months at least.

AB Science shareholding structure after issuance of the OCABSA, conversion of the OCA and exercise of Warrants (based on the euro/dollar conversion rate on February 25, 2022, i.e. 1/1.1272)
Following the issuance of the OCABSA, AB Science share capital will be EUR 537,078.85 (with 47,399,948 ordinary shares) and EUR 537,578.85 (with 47,449,948 ordinary shares) in the event of exercise of all the Warrants, representing 101.01% of the total current share capital of AB Science (or 101.11% in the event of exercise of all the Warrants).

On an illustrative basis, a shareholder holding 1% of AB Science’s share capital before the conversion of the OCA and who did not participate in will hold 0.9900% of the AB Science’s shares after the conversion of the OCA and 0.9891% if all the Warrants are exercised.

Shareholder

Before issuance of the OCABSA After conversion of the OCA After exercise of the BSA
Ordinary shares % Ordinary shares % Ordinary shares %
A. Moussy 1,255,362 2.68% 1,255,362 2.65% 1,255,362 2.65%
AMY SAS 12,273,000 26.19% 12,273,000 25.89% 12,273,000 25.87%
Concert (A. Moussy and AMY SAS excluded) 5,257,931 11.22% 5,257,931 11.09% 5,257,931 11.08%
Other investors 28,075,036 59.91% 28,613,665 60.37% 28,663,665 60.41%
Total 46,861,329 100.00% 47.399.958 100.00% 47.449.958 100.00%
Disclaimer
In France, the offer of AB Science securities described above will take place solely as a private placement, in accordance with Article L. 411-2 of the of the French Monetary and Financial Code and applicable regulations. The offering does not constitute a public offering in France, as defined in Article L. 411-1 of the French Monetary and Financial Code.

With regard to the Member States of the European Economic Area which have transposed Directive 2003/71/CE of the European Parliament and of the Council of November 4, 2003 (as amended in particular by Directive 2010/73/EU, insofar as this directive has been transposed in each of the Member States of the European Economic Area), no action has been taken and will not be taken to allow a public offer of the securities subject of this press release making necessary to publish a prospectus in either of the Member States.

This press release and the information it contains does not, and will not, constitute a public offering to subscribe for or sell, nor the solicitation of an offer to subscribe for or buy, securities of AB Science in the United States or any other jurisdiction where restrictions may apply. Securities may not be offered or sold in the United States absent registration or an exemption from registration under the US Securities Act of 1933, as amended and applicable State securities laws. AB Science does not intend to register securities or conduct a public offering in the United States.

This distribution of this press release may be subject to legal or regulatory restrictions in certain jurisdictions. Any person who comes into possession of this press release must inform him or herself of and comply with any such restrictions.