On February 28, 2022 Turning Point Therapeutics, Inc. (NASDAQ: TPTX), a precision oncology company developing next-generation therapies that target genetic drivers of cancer, reported financial results for the fourth quarter and year ended December 31, 2021, and provided operational updates (Press release, Turning Point Therapeutics, FEB 28, 2022, View Source [SID1234609241]).

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"We are encouraged by the progress made during 2021 and into the first two months of 2022," said Athena Countouriotis, M.D., President and CEO. "We look forward to sharing topline ORR and DOR data for our lead investigational therapy repotrectinib in patients with ROS1-positive NSCLC and completing a pre-NDA meeting with the FDA in the second quarter. Supported by our strong financial position, with approximately $1 billion in cash at the end of 2021, we continue to invest in our clinical programs and our research engine, while we also consider opportunities to bring in external innovation where there’s a strategic fit."

Fourth quarter and recent operational highlights include:

REPOTRECTINIB, ROS1/TRK INHIBITOR

Remain on track to report topline blinded independent central review (BICR) data from all of the ROS1-positive non-small cell lung cancer (NSCLC) cohorts from TRIDENT-1 and discuss the BICR data with the FDA at a pre-NDA meeting, as well as share topline ORR and DOR BICR data prior to the pre-NDA meeting, in the second quarter of 2022.
The Chinese Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) granted the company’s Greater China partner, Zai Lab, Breakthrough Therapy Designation for repotrectinib for the treatment of patients with ROS1-positive metastatic NSCLC who have not been treated with a ROS1 tyrosine kinase inhibitor (TKI).
Strong enrollment progress in the Phase 2 registration enabling TRIDENT-1 study across all cohorts during the fourth quarter of 2021 with expansion cohort 4 (EXP-4 — ROS1-positive advanced NSCLC population pretreated with one prior TKI without chemotherapy) now fully enrolled with the targeted 60 patients. Enrollment across all six cohorts of the study remains open and continues to progress steadily.
Updated durability data from ROS1-positive TKI-naïve NSCLC patients in the Phase 1 portion of the TRIDENT-1 trial continues to demonstrate best-in-class potential. Among a total of 7 patients treated at or above the recommended Phase 2 dose (RP2D), 3 patients had a DOR of greater than 30 months, using blinded independent central review (BICR) assessments as of the data cut-off date of July 22, 2019 followed by physician assessments as of the data cut-off date of November 29, 2021. 4 out of 7 patients remained on treatment for greater than 3 years.
Held a Type B meeting with the FDA to discuss potential next steps for repotrectinib in NTRK-positive TKI-pretreated advanced solid tumor patients treated within expansion cohort 6 (EXP-6) of the registrational TRIDENT-1 study.
The FDA guided that a pre-NDA meeting should be requested to discuss the topline BICR results from the Phase 2 TKI-pretreated EXP-6 and TKI-naïve EXP-5 patients, when responders have been followed for at least six months past onset of response.
The FDA noted that data from EXP-5 may be used to support the efficacy data for EXP-6, or potentially could be pooled with data from EXP-6 to support a broader indication.
The company plans to provide guidance on the timing of the pre-NDA meeting for repotrectinib in patients with NTRK-positive advanced solid tumors after completion of enrollment of the targeted 40 EXP-6 patients is achieved.
ELZOVANTINIB (TPX-0022), MET/SRC/CSF1R INHIBITOR

Patient enrollment continues in the SHIELD-1 study at 40 mg QD to 40 mg BID in Phase 1 dose expansion and in parallel elzovantinib is being studied at an intermediate dose level (60 mg QD to 60 mg BID) in Phase 1 dose escalation.
FDA clearance of the Investigational New Drug (IND) Application for the combination of elzovantinib and aumolertinib in EGFR mutant MET-amplified NSCLC. The combination of elzovantinib and aumolertinib will be studied in the SHIELD-2 Phase 1b/2 trial in patients with EGFR mutant MET-amplified advanced NSCLC who have progressed following treatment with osimertinib.
TPX-0046, RET INHIBITOR

Ongoing evaluation of multiple doses and schedules to further characterize the pharmacokinetics, safety, and efficacy profile before determining the RP2D.
TPX-0131, ALK INHIBITOR

Ongoing patient dosing in the Phase 1/2 FORGE-1 study of TPX-0131 in locally advanced or metastatic TKI-pretreated ALK-positive NSCLC. The study endpoints include safety and tolerability, determination of the RP2D, pharmacokinetics, and any early signals of efficacy.
DISCOVERY

Continued advancement of internal discovery programs targeting aberrant GTPase signaling known to drive genomically defined cancers with significant unmet medical need. The most advanced programs target KRAS G12D and the p21 activated kinase, or "PAK" family. The company is targeting nomination of two development candidates in the second half of 2022 with a goal to achieve at least one new IND per year beginning in 2023.
Upcoming Milestones
Key milestones anticipated in 2022 include:

Repotrectinib

Provide topline BICR data from all the ROS1-positive NSCLC cohorts from TRIDENT-1 and discuss the BICR data with the FDA at a pre-NDA meeting in the second quarter of 2022
Provide a clinical data update from the NTRK+ advanced solid tumor cohorts from TRIDENT-1 in the second half of 2022
Elzovantinib

Initiate the Phase 1b/2 SHIELD-2 study of elzovantinib in combination with aumolertinib in mid-2022
Initiate the Phase 2 portion of the SHIELD-1 study in the second half of 2022, pending FDA feedback on data from the intermediate dose level
Provide a clinical data update from the Phase 1 SHIELD-1 study in the second half of 2022
TPX-0131

Provide early interim data from initial patients treated in the dose-finding portion of the FORGE-1 study in the fourth quarter of 2022 or early 2023
Discovery

Nominate 2 development candidates in the second half of 2022
Provide details on the other 2 GTPase signaling discovery programs in the second half of 2022
Fourth Quarter and Full-Year 2021 Financial Results

Revenue: Revenue of $30.8 million for the year was attributable to the company’s licensing agreements with Zai Lab for repotrectinib and elzovantinib in Greater China.

R&D Expenses: Research and development expenses were $58.2 million for the fourth quarter compared to $34.3 million for the fourth quarter of 2020, and $193.0 million for the year compared to $113.4 million for the year ended December 31, 2020. Primary drivers of the year-over-year increase were investments made to develop repotrectinib, elzovantinib, TPX-0046, TPX-0131, discovery efforts and personnel expenses.

G&A Expenses: General and administrative expenses were $20.5 million for the fourth quarter compared to $13.7 million for the fourth quarter of 2020, and $75.9 million for the year compared to $73.4 million for the year ended December 31, 2020. G&A expenses in 2020 included a one-time non-cash stock-based compensation charge of $31.4 million associated with the modification of the vesting and expected term of the outstanding stock options pursuant to a transition agreement with our scientific founder.

Net Loss: Net loss was $78.4 million for the fourth quarter compared to net loss of $47.4 million for the fourth quarter of 2020, and $236.6 million for the year compared to $157.3 million for the year ended December 31, 2020.

Cash position: Cash, cash equivalents and marketable securities at December 31 totaled $981.6 million, reflecting a net decrease of $140.9 million from December 31, 2020. Turning Point projects its cash position is sufficient to fund current operations into the second half of 2024.

On February 28, 2022, Rocket Pharmaceuticals, Inc. (the "Company") reported that it entered into a sales agreement (the "Sales Agreement"), with Cowen and Company, LLC ("Cowen"), with respect to an at-the-market offering program pursuant to which the Company may offer and sell, from time to time at its sole discretion, shares of its common stock, par value $0.01 per share, having an aggregate offering price of up to $200,000,000 (the "Shares") through Cowen as its sales agent (Filing, 8-K, Rocket Pharmaceuticals, FEB 28, 2022, View Source [SID1234609212]). The Shares to be offered and sold under the Sales Agreement, if any, will be offered and sold pursuant to the Company’s shelf registration statement on Form S-3 (File No. 333-253756), which was filed with the Securities and Exchange Commission ("SEC") on March 2, 2021 and which became effective on September 10, 2021. The Company filed a prospectus supplement with the SEC on February 28, 2022 in connection with the offer and sale of the Shares pursuant to the Sales Agreement.

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Under the Sales Agreement, the Company will set the parameters for the sale of Shares, including the number of Shares to be issued, the time period during which sales of Shares are requested to be made, limitations on the number or dollar value of Shares that may be sold in any one trading day and any minimum price below which sales may not be made. Subject to the terms of the Sales Agreement, Cowen may sell the Shares by any method that is deemed to be an "at-the-market offering" as defined in Rule 415(a)(4) promulgated under the Securities Act of 1933, as amended (the "Securities Act"), including sales made directly on The Nasdaq Global Market ("Nasdaq") or any other trading market for the Shares.

The Company or Cowen may suspend or terminate the offering of Shares upon notice to the other party and subject to other conditions. The offering of Shares pursuant to the Sales Agreement will terminate upon the earlier of (i) the sale of all Shares subject to the Sales Agreement or (ii) termination of the Sales Agreement in accordance with the terms and conditions set forth therein. Cowen will act as sales agent on a commercially reasonable efforts basis consistent with its normal trading and sales practices and applicable state and federal law, rules and regulations and the rules of Nasdaq.

The Company will pay Cowen a cash commission of up to 3.0% of gross proceeds from the sale of the Shares pursuant to the Sales Agreement. The Company has also agreed to provide Cowen with customary indemnification and contribution rights. The Company will also reimburse Cowen for certain expenses incurred in connection with the Sales Agreement.

The foregoing description of the Sales Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of the Sales Agreement, a copy of which is attached as Exhibit 10.1 hereto and is incorporated herein by reference.

Goodwin Procter LLP, counsel to the Company, has issued a legal opinion relating to the Shares. A copy of such legal opinion, including the consent included therein, is attached as Exhibit 5.1 hereto.

This Current Report on Form 8-K shall not constitute an offer to sell or solicitation of an offer to buy any Shares, nor shall there be any sale of the Shares in any state in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities law of such state or jurisdiction.

On February 28, 2022 Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX), a clinical stage pharmaceutical company focused on the discovery, development, and commercialization of novel therapeutics for rare endocrine diseases and endocrine-related tumors, and Sanwa Kagaku Kenkyusho Co., Ltd. ("Sanwa"), an established, fully integrated pharmaceutical company headquartered in Nagoya, Japan, reported that the parties have entered into a strategic partnership to exclusively develop and commercialize paltusotine in Japan (Press release, Crinetics Pharmaceuticals, FEB 28, 2022, View Source [SID1234609209]). Paltusotine is Crinetics’ investigational, orally available nonpeptide somatostatin receptor type 2 (SST2) agonist being evaluated as a treatment for acromegaly and neuroendocrine tumors (NETs), including NETs complicated by carcinoid syndrome.

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Under the terms of this agreement, Crinetics will receive $13.0 million upfront and will be eligible to receive milestone payments related to the achievement of certain development, regulatory and commercial goals. In addition, upon market approval of paltusotine in Japan, Crinetics will be eligible to receive tiered royalties based on net product sales. Sanwa will have an exclusive right to develop and commercialize the product in Japan and will be responsible for leading the development and commercialization of paltusotine for acromegaly and NETs in Japan. Also, Sanwa will assume all costs associated with clinical trials and regulatory applications associated with these processes. Crinetics retains all rights to develop and commercialize paltusotine outside Japan.

There are approximately 10,000 acromegaly patients and 11,000 NETs patients in Japan and, as in the United States, somatostatin analogues are the first-line medical therapy for individuals for whom surgery is either not prescribed or is not curative. Shusaku Isono, President and Chief Executive Officer of Sanwa Kagaku Kenkyusho Co., Ltd. said "Through this license agreement, we will make our best effort with Crinetics to provide a new oral treatment option for acromegaly and NETs patients in Japan."

"In Sanwa, we met a company that shares our vision of developing, as the first indication for paltusotine, a once-daily oral therapy for acromegaly that will establish a new class of medicine to allow patients to live full lives free of the burden of painful monthly injections," added Scott Struthers, Ph.D., founder and Chief Executive Officer of Crinetics. "With the promise of additional indications for NETs, we look forward to a long and productive relationship with our colleagues at Sanwa and are pleased to have the external validation that such a high-quality partnership provides."

Crinetics is currently enrolling patients in its Phase 3 PATHFNDR program, which is evaluating the safety and efficacy of once-daily oral paltusotine in a wide cross section of acromegaly patients in the United States and Europe. In Japan, Sanwa expects to initiate Phase 1 development with paltusotine in 2022.

ABOUT ACROMEGALY
Acromegaly is a serious disease generally caused by a pituitary adenoma, a benign tumor in the pituitary that secretes growth hormone. Excess GH secretion causes excess secretion of IGF-1 from the liver. Together, excess of these hormones leads to the symptoms and physical manifestations of acromegaly, including abnormal growth of hands and feet, alteration of facial features, arthritis, carpal tunnel syndrome, joint aches, deepening of voice due to enlarged vocal cords, fatigue, sleep apnea, enlargement of heart, liver and other organs, and changes in glucose and lipid metabolism. Surgical removal of pituitary adenomas, if possible, is the preferred initial treatment for most acromegaly patients. Pharmacological treatments are used for patients that are not candidates for surgery, or when surgery is unsuccessful in achieving treatment goals. Approximately 50% of patients with acromegaly prove to be candidates for pharmacological treatment. Long-acting somatostatin-receptor ligands (SRLs) are the most common initial pharmacologic treatment; however, these drugs require monthly depot injections with large gauge needles that are commonly associated with pain, injection site reactions, and increased burden of therapy on the lives of patients.

ABOUT NEUROENDOCRINE TUMORS AND CARCINOID SYNDROME
Carcinoid syndrome is a group of symptoms that presents in some individuals with neuroendocrine tumors (NETs). NETs are a rare, slow-growing type of cancer that arises most often in the digestive tract. Carcinoid syndrome is most common in patients with NETs that develop in the lung and gastrointestinal tract and metastasize to the liver. In these cases, the liver is unable to filter the hormones secreted by the NETs, causing them to be circulated systemically and inducing the symptoms of carcinoid syndrome which commonly include diarrhea and flushing.

ABOUT PALTUSOTINE
Paltusotine is an investigational, orally available nonpeptide agonist that is designed to be highly selective for the somatostatin receptor type 2 (SST2). It was designed by the Crinetics discovery team to provide a once-daily option for patients with acromegaly and neuroendocrine tumors. A previously completed Phase 1 trial of paltusotine showed clinical proof of concept by providing evidence of potent suppression of the growth hormone axis in healthy volunteers. In Phase 2 trials, paltusotine maintained IGF-1 levels in acromegaly patients who switched from injectable depot medications to once-daily oral paltusotine. IGF-1 is the primary biomarker endocrinologists use to manage their acromegaly patients.

On February 28, 2022 Olema Pharmaceuticals, Inc. ("Olema" or "Olema Oncology," Nasdaq: OLMA), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of targeted therapies for women’s cancers, reported financial results for the fourth quarter and full year ended December 31, 2021 and provided a business update (Press release, Olema Oncology, FEB 28, 2022, View Source [SID1234609200]).

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"2021 was a transformative year for Olema. Our team made important progress against our strategic goals, culminating in the presentation of strong proof-of-concept data for OP-1250 in ER+ / HER2- breast cancer. The initial data, demonstrating OP-1250’s attractive pharmacokinetics, favorable tolerability and encouraging anti-tumor activity in a heavily pretreated patient population, validate OP-1250’s potential to become the endocrine therapy of choice for ER+ breast cancer. We are now actively expanding our clinical study enrollment and expect to be in a position to present more data later this year," said Sean P. Bohen, M.D., Ph.D., President and Chief Executive Officer of Olema Oncology. "Importantly, we entered 2022 with a strong balance sheet, and as we continue to build our team and grow our capabilities, we are well positioned to advance our clinical development program and discovery efforts."

Recent Corporate Highlights

●Presented interim Phase 1a dose escalation data for OP-1250 from the ongoing Phase 1/2 clinical study. The initial data provide strong proof-of-concept supporting OP-1250’s potential as a once-daily oral monotherapy in women with recurrent, locally advanced, or metastatic ER+ / HER2- breast cancer, with OP-1250
Image result for olema logo

demonstrating highly attractive pharmacokinetics, favorable tolerability, and clear efficacy signals in a heavily pretreated patient population.
●Initiated monotherapy dose expansion at 60 mg and 120 mg dose levels. Each cohort will enroll approximately 15 patients with measurable disease, and findings will help inform the selection of a recommended Phase 2 dose (RP2D). Enrollment remains on track to complete in the first quarter of 2022.
●Initiated Phase 1b combination study with palbociclib, a CDK4/6 inhibitor. The dose escalation portion of the combination trial includes a starting dose of 30 mg OP-1250 once-daily and follows a standard 3+3 design.
●Presented nonclinical data on OP-1250 in a poster session at the San Antonio Breast Cancer Symposium (SABCS), held December 7-10, 2021. Data presented showed that the addition of OP-1250 to anti-HER2 agents, trastuzumab and tucatinib, improved the inhibition of tumor growth in nonclinical models of ER+ / HER2+ breast cancer.
●Appointed Naseem Zojwalla, M.D., as Olema’s new Chief Medical Officer. Dr. Zojwalla joins Olema from Turning Point Therapeutics and brings significant leadership in clinical development, operations and regulatory experience. Former CMO Pamela Klein, M.D., continues to work with Olema in a strategic advisory capacity and as a newly appointed member of the company’s Scientific Advisory Board.
●In December 2021, Olema was added to the NASDAQ Biotechnology Index (Nasdaq: NBI).
Anticipated Milestones

●Select the Recommended Phase 2 Dose (RP2D) for OP-1250 and initiate Phase 2 in the first half of 2022. The Phase 2 study includes enrollment across three cohorts: patients with measurable disease (N=50), patients with non-measurable disease (N=15) and patients with CNS metastasis (N=15).
●Initiate additional Phase 1b combination studies with CDK4/6 and PI3Kα inhibitors in 2022.
●Initiate Phase 1b study of OP-1250 in patients with ER+/HER2+ breast cancer and CNS metastases in the second half of 2022.
●Present updated monotherapy and initial combination data for OP-1250 in 2022.
●Sean Bohen, M.D., Ph.D., President and CEO of Olema Oncology, is scheduled to present at the 42nd Annual Cowen Healthcare Conference on Monday, March 7, 2022 at 2:50 PM ET.
Fourth Quarter and Full Year 2021 Financial Results

●Cash, cash equivalents and marketable securities as of December 31, 2021 were $287.3 million. Olema anticipates that this balance of cash will be sufficient to fund operations into 2024.
Image result for olema logo

●Net loss was $21.6 million and $71.1 million for the quarter and year ended December 31, 2021, respectively, as compared to $10.1 million and $22.1 million for the quarter and year ended December 31, 2020, respectively. The increase in net loss related primarily to Olema’s continued investment in OP-1250, and an increase in general and administrative (G&A) infrastructure costs.
●GAAP research and development (R&D) expenses were $16.0 million and $51.1 million for the quarter and year ended December 31, 2021, respectively, as compared to $6.3 million and $13.7 million for the quarter and year ended December 31, 2020, respectively. The increase in R&D expenses was primarily related to the advancement of the ongoing Phase 1/2 clinical trial of OP-1250, increase in nonclinical development activities, higher personnel-related expenses and higher non-cash stock-based compensation expenses. Non-GAAP R&D expenses were $13.1 million and $41.8 million for the quarter and year ended December 31, 2021, respectively, excluding $2.9 million and $9.3 million non-cash stock-based compensation expense respectively. Non-GAAP R&D expenses were $4.8 million and $11.7 million for the quarter and year ended December 31, 2020, respectively, excluding $1.5 million and $2.0 million non-cash stock-based compensation expense respectively. The increase in R&D expenses was primarily related to the advancement of the ongoing Phase 1/2 clinical trial of OP-1250, increase in nonclinical development activities, higher personnel-related expenses and higher non-cash stock-based compensation expenses. A reconciliation of GAAP to non-GAAP financial measures used in this press release can be found at the end of this news release.
●GAAP G&A expenses were $5.8 million and $20.4 million for the quarter and year ended December 31, 2021, respectively, as compared to $3.8 million and $7.8 million for the quarter and year ended December 31, 2020, respectively. Non-GAAP G&A expenses were $4.1 million and $13.8 million for the quarter and year ended December 31, 2021, respectively, excluding $1.7 million and $6.6 million non-cash stock-based compensation expense respectively. The increase in G&A expenses was primarily related to an increase in personnel, public company-related expenses, other corporate costs and higher non-cash stock-based compensation expenses. Non-GAAP G&A expenses were $3.0 million and $6.7 million for the quarter and year ended December 31, 2020, excluding $0.9 million and $1.1 million non-cash stock-based compensation expense respectively. The increase in G&A expenses was primarily related to an increase in personnel, public company-related expenses, other corporate costs and higher non-cash stock-based compensation expenses.

On February 28, 2022 GENFIT (Nasdaq and Euronext: GNFT), a late-stage biopharmaceutical company dedicated to improving the lives of patients with severe chronic liver diseases, reported its cash position as of December 31, 2021 and revenues for 2021[1] (Press release, Genfit, FEB 28, 2022, https://ir.genfit.com/news-releases/news-release-details/genfit-announces-solid-revenues-and-cash-position-december-31 [SID1234609199]).

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Financials

As of December 31, 2021, the Company’s cash and cash equivalents amounted to €258.8 million compared with €171.0 million, as of December 31, 2020. This amount includes:

A €120 million non-refundable upfront payment from Ipsen received in December 2021, as well as €24 million in VAT collected on that amount
A €28 million equity investment from Ipsen in December 2021
A €7.9 million Research Tax Credit 2020 reimbursement received in October 2021
A €2.25 million subsidized loan from Bpifrance in November 2021 in addition to the State Guaranteed Loans received in June and July 2021

As of June 30, 2021, cash and cash equivalents amounted to €104.4 million.

The solid cash position as of December 31, 2021 takes into account the collaboration and license agreement signed with Ipsen in December 2021 which gives Ipsen exclusive worldwide[2] license to develop, manufacture and commercialize GENFIT’s investigational treatment elafibranor for people living with Primary Biliary Cholangitis (PBC), in return for a €120 million upfront payment. In addition to the upfront payment GENFIT is eligible to receive up to €360 million in milestone payments as well as tiered double-digit royalties of up to 20%. To underscore the long-term commitment represented by this partnership, Ipsen also purchased newly issued GENFIT equity representing 8% post-issuance through a €28 million investment in GENFIT, becoming one of the largest shareholders.

Pascal Prigent, CEO of GENFIT, commented: "This breakthrough strategic partnership with Ipsen marks the beginning of a new chapter for GENFIT. With a considerably improved financial situation, we’re now in a good position to accelerate our development."

Revenues [3]

Revenues for 2021 were €80.06 million compared to €0.76 million for 2020. This mainly results from the receipt of the €120 million upfront payment from Ipsen, out of which €80 million is recognized as 2021 revenue, after deduction of €40 million deferred revenue, which will gradually be recognized as revenue following the completion of the ELATIVE double-blind study, in accordance with the IFRS 15 norms.

As a comparison, revenues for 2020 mainly resulted from the licensing agreements with Labcorp to roll out the NIS4 diagnostic technology in NASH and the sale of goods and services provided pursuant to the collaboration and license agreement with Terns Pharmaceuticals.

A note about the COVID-19 pandemic and its potential consequences on our business

During this evolving crisis, our priorities continue to be to ensure the safety and well-being of our employees, of the patients and healthcare professionals involved in our clinical trials, as well as the integrity of our ongoing clinical trials. We remain committed to ensuring business continuity and have been monitoring the situation closely.

We have worked with our contract research organizations (CRO), trial sites and investigators to regularly revise our program execution estimations to take into account the evolution of the pandemic situation and its impact on our activities.

As a result of measures implemented in consultation with our CRO we were able to minimize disruption to our ELATIVE Phase 3 clinical trial of elafibranor in PBC, which enrolled its first patient in September 2020. At the start of the trial, and considering the pandemic situation, we had estimated that enrollment in the ELATIVE study would take approximately 18 months and so far, we have been broadly in-line with this estimate. However, the recent rapid expansion of the highly contagious Omicron strain of COVID has created additional complications for us in enrolling patients and in clinical trial operations generally. The rate of infection, as well as the containment measures put in place to control its growth have led to patients postponing site visits or having to be re-screened because they had fallen outside the screening window. This recent worsening of the COVID pandemic has also created significant additional administrative backlogs at sites and regulatory agencies, due to the combination of continued high volume of trials and staffing shortages. This has disproportionately impacted regions where there were already significant delays, such as Latin America. Although we currently do not anticipate these recent complexities to substantially change the guidance related to availability of the ELATIVE top line results, we are currently assessing with our CRO the extent of impact on enrollment timelines. We will provide an update during our next webcast scheduled for April 7, 2022.

Upcoming Financial Communications

The Company will release its full-year 2021 financial results on April 7, 2022. The 2021 Universal Registration Document, the 2021 Annual Financial Report (included in the 2021 Universal Registration Document), and the Annual Report on Form 20-F will be published by the end of April 2022.