Cellectis Announces Dosing of the First Patient in Europe with its In-house Manufactured Product Candidate UCART22

On April 11, 2023 Cellectis (the "Company") (Euronext Growth: ALCLS – NASDAQ: CLLS), a clinical-stage biotechnology company using its pioneering gene-editing platform to develop life-saving cell and gene therapies, reported that the first patient in Europe has been dosed in France with its in-house manufactured product candidate UCART22 and completed the 28-day Dose Limiting Toxicity period (Press release, Cellectis, APR 11, 2023, View Source [SID1234629937]).

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"Our team has worked tirelessly to expand our BALLI-01 clinical study (evaluating UCART22) to Europe. Dosing our first patient in France with our UCART22 product candidate manufactured in-house is an important advancement for Cellectis" said Mark Frattini, M.D., Ph.D., Chief Medical Officer at Cellectis. "By targeting the CD22 antigen, we aim at offering a novel therapeutic alternative to patients living with relapsed/refractory B-cell ALL, including those patients who have relapsed or did not respond to CD19-directed therapy. "

UCART22 is an allogeneic CAR T-cell product candidate that targets CD22 and is evaluated in the BALLI-01 clinical study, a Phase 1/2a open-label study designed to evaluate the safety and clinical activity of the product candidate in patients with r/r B-cell ALL. UCART22 is currently the most advanced allogeneic CAR T-cell product in development for r/r B-cell ALL.

With its proprietary GMP manufacturing facilities in both Raleigh (North Carolina) and Paris (France), Cellectis has taken full control of UCART production and manufacturing timelines. Cellectis believes that its off-the-shelf treatment approach, coupled with its ability to manufacture UCART product candidates completely in-house, gives the Company a main advantage on the market: it potentially maximizes the chances for eligible patients to be treated without delay.

In December 2022, Cellectis presented positive preliminary clinical data for UCART22 in a Live Webcast, that support the continued administration of UCART22 after fludarabine, cyclophosphamide and alemtuzumab (FCA) lymphodepletion in patients with r/r B-cell ALL. The BALLI-01 study (evaluating UCART22) is actively enrolling patients with r/r B-cell ALL after FCA lymphodepletion. For more information, eligibility criteria and trial locations, please visit www.clinicaltrials.gov (NCT04150497) or contact [email protected]

Entry into a Material Definitive Agreement

On April 5, 2023, Eterna Therapeutics Inc., a Delaware corporation (the "Company"), entered into a purchase agreement (the "Purchase Agreement") and a registration rights agreement (the "Registration Rights Agreement") with Lincoln Park Capital Fund, LLC ("Lincoln Park"), pursuant to which Lincoln Park has committed to purchase up to $10.0 million of the Company’s common stock, par value $0.005 per share (the "Common Stock"), subject to certain limitations and satisfaction of the conditions set forth in the Purchase Agreement (Filing, 8-K, Brooklyn ImmunoTherapeutics, APR 11, 2023, View Source [SID1234629936]).

Upon the terms and subject to the satisfaction of the conditions set forth in the Purchase Agreement, the Company has the right, but not the obligation, to sell to Lincoln Park, and Lincoln Park is obligated to purchase, up to $10.0 million of Common Stock. Such sales of Common Stock by the Company, if any, are subject to certain limitations set forth in the Purchase Agreement, and may occur from time to time, at the Company’s sole discretion, over a period of up to 24-months, commencing on the date on which each of the conditions to Lincoln Park’s purchase obligations set forth in the Purchase Agreement have initially been satisfied (such date, the "Commencement Date"), including the effectiveness of a registration statement registering under the Securities Act of 1933, as amended (the "Securities Act"), the resale by Lincoln Park of shares of Common Stock that have been and may be issued by the Company to Lincoln Park under the Purchase Agreement. The Company has agreed to file such registration statement with the Securities and Exchange Commission (the "SEC") not later than 10 business days after the date of execution of the Purchase Agreement and the Registration Rights Agreement.

From and after the Commencement Date, the Company may from time to time, on any business day selected by the Company on which the closing sale price per share of Common Stock as reported on The Nasdaq Capital Market is not less than the "floor price" threshold set forth in the Purchase Agreement (each such business day, a "purchase date"), by written notice delivered by the Company to Lincoln Park, direct Lincoln Park to purchase up to 30,000 shares of Common Stock on such purchase date, at a purchase price per share that will be determined and fixed in accordance with the Purchase Agreement at the time the Company delivers such written notice to Lincoln Park (each, a "regular purchase"). The maximum number of shares the Company may sell to Lincoln Park in a regular purchase may be increased by certain amounts to up to 90,000 shares, with the applicable maximum share limit determined by whether the closing sale price per share of Common Stock as reported on The Nasdaq Capital Market on the applicable purchase date for such regular purchase equals or exceeds certain minimum price thresholds set forth in the Purchase Agreement, in each case, subject to adjustment for any recapitalization, non-cash dividend, forward or reverse stock split or other similar transactions as provided in the Purchase Agreement; however, Lincoln Park’s maximum purchase commitment in any single regular purchase may not exceed $1,000,000.

In addition to regular purchases, provided that the Company has directed Lincoln Park to purchase the maximum amount of shares that the Company is then able to sell to Lincoln Park in a regular purchase, the Company may, in its sole discretion, direct Lincoln Park to purchase additional shares of Common Stock in "accelerated purchases" and "additional accelerated purchases," as set forth in the Purchase Agreement. The purchase price per share of Common Stock sold in each such accelerated purchase and additional accelerated purchase, if any, will calculated in accordance with the pricing terms for an accelerated purchase and an additional accelerated purchase, as applicable, set forth in the Purchase Agreement. There are no upper limits on the price per share that Lincoln Park must pay for shares of Common Stock in any purchase under the Purchase Agreement.

Under the Purchase Agreement, the Company will control the timing and amount of sales of Common Stock to Lincoln Park, if any. Lincoln Park has no right to require the Company to sell any shares of Common Stock to Lincoln Park, but Lincoln Park is obligated to make purchases as the Company directs, subject to certain conditions set forth in the Purchase Agreement. Actual sales of shares of Common Stock to Lincoln Park, if any, will depend on a variety of factors to be determined by the Company from time to time, including, among others, general market conditions, the trading prices for the Common Stock, and determinations by the Company as to the appropriate sources of funding for the Company and its operations.

Under applicable Nasdaq listing rules, the aggregate number of shares of Common Stock that the Company may issue to Lincoln Park under the Purchase Agreement cannot exceed 19.99% of the shares of Common Stock issued and outstanding immediately prior to the execution of the Purchase Agreement (the "Exchange Cap"), unless (i) the Company first obtains stockholder approval to issue shares of Common Stock in excess of the Exchange Cap in accordance with applicable Nasdaq listing rules, or (ii) at the time the Company has issued shares of Common Stock equal to the Exchange Cap and at all times thereafter, the average price per share of Common Stock for all shares of Common Stock sold by the Company to Lincoln Park under the Purchase Agreement equals or exceeds $3.6094 per share (representing the lower of the official closing price of the Common Stock on Nasdaq on the trading day immediately preceding the date of the Purchase Agreement and the average official closing price of the Common Stock on Nasdaq for the five consecutive trading days ending on the trading day immediately preceding the date of the Purchase Agreement, as adjusted under applicable Nasdaq rules to take into account the issuance of shares of Common Stock to Lincoln Park for non-cash consideration as payment of the commitment fee described below), such that the Exchange Cap limitation would no longer apply to issuances and sales of Common Stock by the Company to Lincoln Park under the Purchase Agreement under applicable Nasdaq listing rules.

Additionally, Company may not direct Lincoln Park to purchase any shares of Common Stock under the Purchase Agreement if such purchase would result in Lincoln Park beneficially owning more than 4.99% of the issued and outstanding shares of Common Stock.

There are no restrictions on future financings, rights of first refusal, participation rights, penalties or liquidated damages in the Purchase Agreement or Registration Rights Agreement, except the Company is prohibited, subject to certain exceptions, during the term of the Purchase Agreement or 90 days following the effective date of the termination of the Purchase Agreement, whichever concludes earlier, from entering into an agreement to effect an "equity line of credit" or other similar offering in which the Company may issue and sell Common Stock, from time to time over a certain period of time, at future determined prices based on the market prices of the Common Stock at the time of each such issuance and sale. Lincoln Park has agreed not to engage in any short sales of the Common Stock or hedging transaction that establishes a net short position in the Common Stock during the term of the Purchase Agreement.

As consideration for Lincoln Park’s commitment to purchase shares of Common Stock in accordance with the Purchase Agreement, the Company has issued 73,659 shares of Common Stock to Lincoln Park as a commitment fee.

The Purchase Agreement and the Registration Rights Agreement contain customary representations, warranties, conditions and indemnification obligations of the parties. The Company has the right to terminate the Purchase Agreement at any time with one business day’s prior written notice to Lincoln Park, at no cost or penalty.

The foregoing description of the Purchase Agreement and the Registration Rights Agreement is only a summary and is qualified in its entirety by reference to the full text of the Purchase Agreement and the Registration Rights Agreement, copies of which are attached hereto as Exhibit 10.1 and Exhibit 10.2, respectively, and incorporated herein by reference. The representations, warranties and covenants contained in such agreements were made only for purposes of such agreements and as of specific dates, were solely for the benefit of the parties to such agreements and may be subject to limitations agreed upon by the contracting parties.

The offer and sale of the Common Stock pursuant to the Purchase Agreement have not been registered under the Securities Act or any state securities laws. The Common Stock may not be offered or sold in the United States absent registration or an applicable exemption from registration requirements. Neither this Current Report on Form 8-K, nor the exhibits attached hereto, is an offer to sell or the solicitation of an offer to buy the Common Stock described herein or therein.

In the Purchase Agreement, Lincoln Park represented to the Company that it is an "accredited investor", as defined in Rule 501 promulgated under the Securities Act, and the Company’s offer and sale of the Common Stock under the Purchase Agreement are being made in reliance upon the exemptions from the registration requirements of the Securities Act pursuant to Section 4(a)(2) thereof and Rule 506(b) of Regulation D promulgated thereunder.

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BridgeBio Pharma Reports Inducement Grants under Nasdaq Listing Rule 5635(c)(4)

On April 11, 2023 BridgeBio Pharma, Inc. (Nasdaq: BBIO) ("BridgeBio" or the "Company"), a commercial-stage biopharmaceutical company focused on genetic diseases and cancers, reported that on April 7, 2023, the compensation committee of BridgeBio’s board of directors granted 11 new employees restricted stock units for an aggregate of 134,300 shares of the Company’s common stock (Press release, BridgeBio, APR 11, 2023, View Source [SID1234629935]). All of the above-described awards were made under BridgeBio’s 2019 Inducement Equity Plan (the Plan).

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The above-described awards were each granted as an inducement material to the employees entering into employment with the Company in accordance with Nasdaq Listing Rule 5635(c)(4) and were granted pursuant to the terms of the Plan. The Plan was adopted by BridgeBio’s board of directors in November 2019 and has been amended and restated from time to time.

Bexion Pharmaceuticals, Inc. to Present at the 22nd Annual Needham Virtual Healthcare Conference

On April 11, 2023 Bexion Pharmaceuticals, Inc., a mid-stage clinical biopharmaceutical company developing a new generation of biologic immunotherapy to treat solid tumor cancers and Chemotherapy Induced Peripheral Neuropathy (CIPN), reported that Bexion Pharmaceuticals will be presenting at the Needham Healthcare Conference. The conference will be held virtually from April 17-20, 2023 (Press release, Bexion, APR 11, 2023, View Source [SID1234629934]).

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Scott Shively, Bexion’s CEO and President, and Joyce LaViscount, Bexion’s CFO, will be jointly presenting a company overview on Wednesday, April 19 from 4:30-5:10 pm in Track 3.

Update to contractual arrangements between AstraZeneca, Swedish Orphan Biovitrum AB and Sanofi

On April 11, 2023 AstraZeneca, Swedish Orphan Biovitrum AB (publ) (Sobi) and Sanofi have updated and simplified their contractual arrangements relating to the development and commercialisation of nirsevimab in the US (Press release, AstraZeneca, APR 11, 2023, View Source [SID1234629933]). Given the upcoming launch of nirsevimab in the US and other markets, simplification of the prior arrangements clarifies the roles and responsibilities of relevant parties.

Under the updated arrangements, Sobi has entered into a direct relationship with Sanofi, replacing the previous participation agreement with AstraZeneca entered into in November 2018. Under the previous agreement, from the day of the transaction with Sobi, AstraZeneca had to provision the risk adjusted value of the discounted cash flow of future payments to be made to Sobi as a liability. As a result of this simplification agreement, Sanofi will pay royalties to Sobi as US nirsevimab sales arise, and the liability related to future obligations is eliminated. AstraZeneca will record a gain of $0.7 billion, to be recognised in Core Other operating income in 2023. This does not impact AstraZeneca’s financial guidance for 2023.

Notes
About nirsevimab
Nirsevimab is a single dose long-acting antibody, developed and commercialised in partnership by AstraZeneca and Sanofi using AstraZeneca’s YTE technology. It is designed to protect infants entering or during their first respiratory syncytial virus (RSV) season and for children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season. Nirsevimab has been developed to offer newborns and infants direct RSV protection via an antibody to help prevent lower respiratory tract disease (LRTD) caused by RSV. Monoclonal antibodies do not require the activation of the immune system to help offer timely, rapid and direct protection against disease.1

In November 2022, Beyfortus was approved by the European Commission and by the UK Medicines and Healthcare products Regulatory Agency (MHRA).2-3

Sanofi Alliance
In March 2017, AstraZeneca and Sanofi announced an agreement to develop and commercialise nirsevimab. Under the terms of the agreement, AstraZeneca leads development and manufacturing activities, and Sanofi leads commercialisation activities and records revenue. Under the terms of the global agreement, Sanofi made an upfront payment of €120m, has paid a development milestone of €30m and will pay further milestones subject to achievement of certain development and sales-related milestones. The two companies share costs and profits. Revenue from the agreement is reported as Alliance Revenue and Collaboration Revenue in the Company’s financial statements.

Sobi Transaction
In November 2018, AstraZeneca announced that it had agreed to sell the US commercial rights for Synagis (palivizumab), and the right to participate in the US profits or losses for nirsevimab, to Sobi (the 2018 announcement).

Today’s announcement is made pursuant to LR10.4.2 R in respect of the November 2018 announcement. Except as set out in this announcement, there has been no significant change affecting any matter contained in the 2018 announcement and no other significant new matter has arisen which would have been required to be mentioned in the 2018 announcement if it had arisen at the time of the preparation of the 2018 announcement.

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