Entry into a Material Definitive Agreement

On March 3, 2022, X4 Pharmaceuticals, Inc. (the "Company"), reported that it entered into a securities purchase agreement (the "Securities Purchase Agreement") with BCLS II Investco, LP (the "Investor"), an affiliate of Bain Capital Life Sciences, pursuant to which the Company agreed to issue and sell to the Investor in a private placement (the "Private Placement") (i) 900,000 shares (the "Shares") of the Company’s common stock, par value $0.001 per share (the "Common Stock"), at a purchase price of $1.80 per share, which represents the volume weighted average price per share of the Common Stock as quoted on the Nasdaq Stock Market for the thirty (30) consecutive-day trading day period ending on March 2, 2022, and (ii) pre-funded warrants (the "Pre-Funded Warrants") to purchase 766,666 shares of Common Stock at a price of $0.01 per share, at a purchase price of $1.79 per Pre-Funded Warrant (Filing, 8-K, X4 Pharmaceuticals, MAR 3, 2022, View Source [SID1234609507]). The price per Pre-Funded Warrant represents the price of $1.80 per share to be sold in the Private Placement, minus the $0.01 per share exercise price of each such Pre-Funded Warrant. The Pre-Funded Warrants are exercisable at any time after their original issuance and will not expire.

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The Pre-Funded Warrants to be issued in the Private Placement will provide that the holder of the Pre-Funded Warrants will not have the right to exercise any portion of its Pre-Funded Warrants if such holder, together with its affiliates, would beneficially own in excess of 9.99% of the number of shares of the Company’s Common Stock outstanding immediately after giving effect to such exercise (the "Beneficial Ownership Limitation"); provided, however, that the holder may increase or decrease the Beneficial Ownership Limitation by giving 61 days’ notice to the Company, but not to any percentage in excess of 19.99%.

The Private Placement is expected to close on or about March 7, 2022 (the "Closing Date"), subject to the satisfaction of certain customary closing conditions. The Company expects to receive aggregate gross proceeds from the Private Placement of approximately $3.0 million, before deducting estimated offering expenses payable by the Company. The Company expects the net proceeds from the Private Placement to be used for advancement of the Company’s clinical development pipeline, business development activities, working capital and general corporate purposes.

The foregoing descriptions of the Securities Purchase Agreement and the Pre-Funded Warrants do not purport to be complete and are qualified in their entirety by reference to such agreements, copies of which are filed as Exhibits 10.1 and 4.1 hereto, respectively, and incorporated by reference herein.

Registration Rights Agreement
Also, on March 3, 2022, the Company entered into a registration rights agreement (the "Registration Rights Agreement") with the Investor, pursuant to which the Company agreed to register for resale the Shares and the shares of Common Stock underlying the Pre-Funded Warrants held by the Investor (the "Registrable Securities"). Under the Registration Rights Agreement, the Company has agreed to file a registration statement covering the resale of the Registrable Securities by no later than April 30, 2022 (the "Filing Deadline"). The Company has agreed to use commercially reasonable efforts to cause such registration statement to become effective as soon as practicable and to keep such registration statement effective until the date the Shares and the shares of Common Stock underlying the Pre-Funded Warrants covered by such registration statement have been sold or may be resold pursuant to Rule 144 without restriction. The Company has agreed to be responsible for all fees and expenses incurred in connection with the registration of the Registrable Securities.

In the event (i) the registration statement has not been filed by the Filing Deadline, (ii) the registration statement has not been declared effective prior to the earlier of (A) five business days after the date which the Company is notified by the U.S. Securities and Exchange Commission (the "SEC") that the registration statement will not be reviewed by the SEC staff or is not subject to further comment by the SEC staff, or (B) 60 days following the Filing Deadline (or, in the event the SEC reviews and has written comments to the registration statement, 120 days following the Filing Deadline) or (iii) after the registration statement has been declared effective by the SEC, sales cannot be made pursuant to the registration statement for any reason including by reason of a stop order or the Company’s failure to update such registration statement, subject to certain limited exceptions, then the Company has agreed to make pro rata payments to the Investor as liquidated damages in an amount equal to 1% of the aggregate amount invested by the Investor in the Registrable Securities per 30-day period or pro rata for any portion thereof for each such month during which such event continues, subject to certain caps set forth in the Registration Rights Agreement.
The Company has granted the Investor customary indemnification rights in connection with the registration statement. The Investor has also granted the Company customary indemnification rights in connection with the registration statement.

The foregoing description of the Registration Rights Agreement does not purport to be complete and is qualified in its entirety by reference to the Registration Rights Agreement, a copy of which is filed as Exhibit 10.2 hereto and incorporated by reference herein.

DBV Technologies Reports Full Year 2021 Financial Results and Recent Business Updates

On March 3, 2022 DBV Technologies S.A. (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT), a clinical-stage specialty biopharmaceutical company, reported financial results for the full year of 2021 (Press release, DBV Technologies, MAR 3, 2022, View Source [SID1234609506]). The audit procedures have been substantially completed by the Company’s statutory auditors and financials were approved by the Board of Directors on March 3, 2022. The audit report will be issued by the Company’s auditors in March 2022.

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DBV has extended its cash runway into the first quarter of 2023 as a result of continued financial diligence and cost containment measures. These targeted efforts adequately support the critical research and development work underway to advance the Viaskin platform. The protocol for the new Phase 3 pivotal study of the modified Viaskin Peanut ("mVP") patch was completed at the end of February 2022 and has been prepared for FDA submission. The Company is currently engaged in fruitful discussions with FDA in preparation for protocol submission and review. DBV expects to complete protocol submission following further alignment with FDA.

"Initiating our new Phase 3 trial with the mVP is our top priority. We are pleased with our ongoing exchanges with FDA. In parallel to these discussions, DBV continues to maximize the efficiency of its spend. Based on our current assumptions, we have extended our cash runway into the first quarter of 2023," said Daniel Tasse, Chief Executive Officer, DBV Technologies. "We expect that this cash position, combined with our continued discipline to reduce general and administrative expenses without sacrificing research and development, will give DBV sufficient time to gain alignment with FDA on the protocol for the mVP pivotal trial. DBV has been strategic in advancing its EPIT pipeline, and through these efforts, we aim to realize the full potential of the Viaskin technology for patients and families.

As of December 31, 2021, cash and cash equivalents were $77.3 million, compared to $196.4 million as of December 31, 2020. In 2021, cash used in operating activities was $(108.2) million under U.S. GAAP and $(104.1) million under IFRS compared to $(165.6) million under U.S. GAAP and $(160.9) million under IFRS in 2020.

The 35% decrease in net cash used in operating activities between the years ended December 31, 2021 and 2020 reflects the Company’s continued implementation of budget discipline measures.

Over the past 2 years, DBV reduced its net cash used in operating activities by 54%.

Net cash used in operating activities, including restructuring amounts paid as part of the global restructuring plan launched in June 2020 (in millions of $)

Cash flows used in investment activities were $(0.4) million in 2021, compared to $(2.9) million in 2020.

Cash from financing activities were $0.3 million under U.S. GAAP and $(3.9) million under IFRS compared to net cash flows provided by financing activities of $149.5 million under U.S. GAAP and $144.8 million under IFRS in 2020, including $150.0 million received in connection with DBV’s follow-on public offering of its securities in the first quarter of 2020.

DBV has continued to practice financial diligence and implemented further cost containment strategies. Based on its current operations, as well as its plans and assumptions as revised pursuant to its change of strategy announced in December 2021, DBV expects that its current cash and cash equivalents will support its operations into the first quarter of 2023.

Operating Income is primarily generated from DBV’s Research Tax Credit (French Crédit Impôt Recherche, or CIR) and from revenue recognized by DBV under its collaboration agreement with Nestlé Health Science. Operating income was $5.7 million, for the year ended December 31, 2021, compared to $11.3 million the year ended December 31, 2020. The decrease in operating income is primarily attributable to the revision of the revenue recognized under Nestlé’s collaboration agreement, as the Company updated its measurement of progress of its Phase II clinical study conducted as part of the contract due to recruitments’ delays.

Operating Expenses for the year ended December 31, 2021, were $104.3 million under U.S. GAAP and $104.0 million under IFRS, compared to $170.1 million under U.S. GAAP and $169.2 million under IFRS for the year ended December 31, 2020. The decrease in operating expenses for both periods is mainly attributable to the decrease in external clinical-related expenses and professional fees due to the budget discipline measures taken by DBV, as well as the decrease in employee-related costs, which is directly related to the workforce reduction DBV implemented as part of its 2020 global restructuring plan.

Excluding restructuring and share-based payments expenses, employee-related costs decreased by $19.2 million, from $42.0 million for the year ended December 31, 2020 to $22.7 million for the year ended December 31, 2021, under U.S. GAAP. Under IFRS, excluding share-based payments expenses, employee-related costs decreased by $19.5 million, from $42.3 million for the year ended December 31, 2020 to $22.8 million for the year ended December 31, 2021.

The average headcount decreased by 63% between the two periods, from 270 full-time equivalent employees for the year ended December 31, 2020 to 101 for the year ended December 31, 2021. As of December 31, 2021, DBV had 92 employees.

For the year ended December 31, 2021, net loss was $(97.8) million under U.S. GAAP and $(98.1) million under IFRS, compared to a net loss of $(159.6) million and $(159.7) million, respectively, for the year ended December 31, 2020.

On a per share basis, net loss (based on the weighted average number of shares outstanding over the period) was $(1.78) under U.S. GAAP and $(1.79) under IFRS for the year ended December 31, 2021.

Conference Call Information:

DBV will host a conference call and live audio webcast on Thursday, March 3, 2022, at 5:00 p.m. ET to report fourth quarter and full year 2021 financial results and review recent business updates.

This call is accessible via the below teleconferencing numbers, followed by the reference ID: 50283860

A live webcast of the call will be available on the Investors & Media section of the Company’s website: View Source A replay of the presentation will also be available on DBV’s website after the event.

Corvus Pharmaceuticals to Provide Business Update and Report Fourth Quarter and Full Year 2021 Financial Results on March 10, 2022

On March 3, 2022 Corvus Pharmaceuticals, Inc. (Nasdaq: CRVS), a clinical-stage biopharmaceutical company, reported that the Company will host a conference call and webcast on March 10, 2022 at 4:30 pm ET (1:30 pm PT) to provide a business update and report fourth quarter and full year 2021 financial results (Press release, Corvus Pharmaceuticals, MAR 3, 2022, View Source [SID1234609505]).

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The conference call can be accessed by dialing 1-877-407-0784 (toll-free domestic) or 1-201-689-8560 (international) and using the conference ID 13727689. The live webcast may be accessed via the investor relations section of the Corvus website. A replay of the webcast will be available on Corvus’ website for 90 days.

Aurinia Pharmaceuticals to Present at Upcoming Investor Conferences

On March 3, 2022 Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) (the "Company") reported that members of the executive management team will give corporate presentations at two upcoming investor conferences including (Press release, Aurinia Pharmaceuticals, MAR 3, 2022, View Source [SID1234609504]):

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Cowen 42nd Annual Virtual Healthcare Conference corporate presentation on Wednesday, March 9, 2022 at 2:50 p.m. ET. Link here
Oppenheimer’s 32nd Annual Healthcare Conference corporate presentation on Wed, March 16, 2022 at 1:20 p.m. ET. Link here
To participate in the audio webcast, interested parties can access the live webcast under "News/Events" through the "Investors" section of the Aurinia corporate website at www.auriniapharma.com.

Priothera – FDA and EMA Grant Orphan Drug Designation to mocravimod for the treatment of Acute Myeloid Leukemia (AML) in patients undergoing allogeneic hematopoietic stem cell transplantation (HSCT)

On March 3, 2022 Priothera, a late-clinical stage biotechnology company pioneering the development of its S1P receptor modulator drug, mocravimod, reported that the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have both granted orphan drug designation (ODD) to mocravimod for the treatment of Acute Myeloid Leukemia (AML) in patients undergoing allogeneic hematopoietic stem cell transplantation (HSCT) (Press release, Priothera, MAR 3, 2022, View Source;fda-and-ema-grant-orphan-drug-designation-to-mocravimod-for-the-treatment-of-acute-myeloid-leukemia-aml-in-patients-undergoing-allogeneic-hematopoietic-stem-cell-transplantation-hsct-301494655.html [SID1234609500]). EMA’s ODD follows a recommendation from the Committee for Orphan Medicinal Products (COMP).

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Florent Gros, Co-Founder and CEO of Priothera, commented: "The orphan drug designations we received for mocravimod from both the FDA and EMA are important milestones towards addressing the urgent, unmet needs of AML patients. Allogenic stem cell transplantation is the only potentially curative approach for AML patients but has unacceptably high mortality rates with current treatments. We are looking forward to initiating the global Phase 2b clinical trial with mocravimod in multiple centers in the US, Europe and Asia in the coming months."

Mocravimod, a sphingosine 1 phosphate (S1P) receptor modulator which has been previously tested in multiple autoimmune indications, is being developed to enhance the curative potential of HSCT. Moreover, it has shown a clinically relevant benefit in an early clinical study in patients with hematologic malignancies undergoing HSCT.

A multicenter Phase 2b study evaluating the efficacy and safety of mocravimod as an adjunctive and maintenance therapy to HSCT in adult AML patients is planned for the second half of 2022. The study will include approximately 250 patients in several countries in Europe, the US and Asia, upon approvals from respective health authorities.

Orphan drug designation is reserved for medicines treating rare, life-threatening or chronically debilitating diseases.

About mocravimod

Mocravimod (also known as KRP203), is a novel, synthetic, sphingosine 1-phosphate receptor (S1PR) modulator with a long duration in the body. Phase 1 and Phase 2 trials successfully assessed mocravimod for safety and tolerability in several autoimmune indications. Promising data from a Phase 1b/2a clinical study in patients with hematological malignancies led Priothera to further develop mocravimod for the treatment of blood cancers.

Mocravimod will be investigated in a Phase 2b/3 study as a potential treatment for patients with Acute Myeloid Leukemia (AML) receiving allogeneic hematopoietic stem cell transplantation (HSCT). Allogenic HSCT is the only potentially curative approach for AML patients, but current treatments have unacceptably high mortality and morbidity rates.

Priothera leverages S1PR’s unique mode of action to maintain anti-leukemia activity – graft-versus leukemia (GVL) – while reducing tissue damage resulting from graft-versus-host disease (GVHD), a consequence of allogenic HSCT. This novel treatment approach – the only S1PR modulator treating blood cancers – tackles a high unmet medical need and intends to add quality life to patients.