BioMarin to Present at 41st Annual J.P. Morgan Healthcare Conference on Monday, January 9, at 10:30 am PT /1:30 pm ET, in San Francisco, CA

On January 4, 2023 BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) reported that Jean-Jacques Bienaimé, Chairman and Chief Executive Officer, will present at the 41st Annual J.P. Morgan Healthcare Conference on Monday, January 9, 2023, at 10:30 am PT / 1:30 pm ET, in San Francisco, California (Press release, BioMarin, JAN 4, 2023, View Source,-January-9,-at-10-30-am-PT-1-30-pm-ET,-in-San-Francisco,-CA [SID1234625791]). To access the live webcast, please visit the investor section of the BioMarin website, www.biomarin.com. A replay will also be archived on the site for at least one week following the event.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!


Cellectis Establishes an At-The-Market (ATM) Program on Nasdaq

On January 4, 2023 Cellectis S.A. ("Cellectis" or 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 it has filed a prospectus supplement with the Securities and Exchange Commission ("SEC"), pursuant to which it may offer and sell to eligible investors a maximum gross amount of up to $60.0 million of American Depositary Shares ("ADS"), each representing one ordinary share of Cellectis, nominal value €0.05 per share, from time to time in sales deemed to be an "at the market offering" pursuant to the terms of a sales agreement with Jefferies LLC ("Jefferies"), acting as sales agent (Press release, Cellectis, JAN 4, 2023, View Source [SID1234625795]). The timing of any sales will depend on a variety of factors. The at-the-market ("ATM") program is presently intended to be effective through the expiration of the existing registration statement, i.e. July 6, 2025, unless terminated prior to such date in accordance with the sales agreement or the maximum amount of the program has been reached.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The ADSs are listed on the Nasdaq Global Market under the symbol "CLLS", and the Company’s ordinary shares are listed on Euronext Growth in Paris under the symbol "ALCLS".

The Company plans to use the net proceeds, if any, of sales of ADSs issued under the ATM program to fund the continued clinical development of UCART 123, UCART22, UCART20x22, and UCARTCS1, and any remainder for working capital and other general corporate purposes.

Jefferies, as sales agent, will use commercially reasonable efforts to arrange on the Company’s behalf for the sale of all ADSs requested to be sold by the Company, consistent with Jefferies’ normal sales and trading practices. Sales prices may vary based on market prices and other factors. Only eligible investors (as described in greater detail below) may purchase ADSs under the ATM program. In any case, the corresponding sales price of the new ordinary shares underlying the ADSs will not be less than the volume weighted-average of the trading prices of the Company’s ordinary shares on Euronext Growth in Paris over the three trading days prior to the relevant pricing date, subject to a maximum discount to such volume weighted-average price of 15%.

The ADSs and the underlying ordinary shares will be issued through a capital increase without shareholders’ preferential subscription rights under the provisions of Article L. 225-138 of the French Commercial Code (Code de commerce) as decided by the board of directors (the "Board") of Cellectis on December 15, 2022 pursuant to the 11th and/or 13th resolutions adopted by the Combined General Meeting of Shareholders held on June 28, 2022 (or any substitute resolutions, adopted from time to time), within the limit of a maximum number of 13,645,293 ordinary shares (being the maximum authorized by the shareholders for each such resolution), representing a maximum potential dilution of approximately 23.04% based on the share capital of the Company as of September 30, 2022.

The ATM program may only be issued to the categories of investors defined in the 11th and/or 13th resolutions (or any similar resolutions that may be substituted to them in the future), comprising (i) any person or legal entity, whether French or foreign (i.e., non-French), that invests on a regular basis or has invested at least €5 million over the preceding 36 months in the health or biotechnology sector and/or (ii) any industrial company, institution or entity, whether French or foreign (i.e., non-French), active in the health or biotechnology sectors or any affiliate thereof. The new ordinary shares will be admitted to trading on the market of Euronext Growth in Paris and the issued ADSs will trade on Nasdaq.

During the term of the ATM program, the Company will include, in the publication of its quarterly results, information about its use of the program during the preceding quarter and will also provide an update after each capital increase on a dedicated location on its corporate website in order to inform investors about the main features of each issue that may be completed under the ATM program from time to time and, as the case may be, will publish a press release if required by applicable law or regulation.

A shelf registration statement on Form F-3 (including a prospectus) relating to Cellectis’ ADSs was filed with the SEC and was declared effective on July 7, 2022. Before purchasing ADSs in the ATM program, prospective investors should read the prospectus supplement and the accompanying prospectus, together with the documents incorporated by reference therein. Prospective investors may obtain these documents for free by visiting EDGAR on the SEC’s website at www.sec.gov. Alternatively, a copy of the prospectus supplement (and accompanying prospectus) relating to the ATM program may be obtained from Jefferies LLC, 520 Madison Avenue, New York, NY 10022 or by telephone at +1 (877) 821-7388 or by email at [email protected]. There will be no prospectus subject to the approval of the Autorité des Marchés Financiers. The Company disclosed in a press release on December 28, 2022 that it entered into a finance contract with the European Investment Bank ("EIB") on December 28, 2022, which is further described, in particular with respect to the warrants to be issued to the EIB, if any, in a report on Form 6-K dated January 4, 2023 and incorporated by reference in the prospectus supplement, and which is available on the Company’s website at View Source Further, the prospectus supplement also incorporates by reference a report on Form 6-K dated January 4, 2022 that on December 31, 2022, Alain Godard informed the Board of his resignation as a member of the Board, effective immediately. Mr. Godard’s resignation from the Board did not result from any disagreement with Cellectis.

BioCryst to Present at 41st Annual J.P. Morgan Healthcare Conference

On January 4, 2023 BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) reported that the company will present at the 41st Annual J.P. Morgan Healthcare Conference in San Francisco, California on Tuesday, January 10, 2023, at 6:00 p.m. ET (Press release, BioCryst Pharmaceuticals, JAN 4, 2023, View Source [SID1234625790]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Links to the live audio webcast and replay of the presentation may be accessed in the Investors & Media section of BioCryst’s website at http://www.biocryst.com.

Bicycle Therapeutics Announces FDA Fast Track Designation Granted to BT8009 for the Treatment of Adult Patients with Previously Treated Locally Advanced or Metastatic Urothelial Cancer

On January 4, 2023 Bicycle Therapeutics plc (NASDAQ:BCYC), a biotechnology company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle) technology, reported that the United States Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to Bicycle’s BT8009 monotherapy for the treatment of adult patients with previously treated locally advanced or metastatic urothelial cancer (Press release, Bicycle Therapeutics, JAN 4, 2023, View Source [SID1234625788]). BT8009 is a potential first in class Bicycle Toxin Conjugate (BTC) targeting Nectin-4, a protein that is highly expressed in urothelial cancer (UC) and other solid tumors.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"FTD represents another positive step in the development of BT8009 and reflects the pressing need for a clinically meaningful, differentiated therapy compared to what is available for patients," said Kevin Lee, Ph.D., Chief Executive Officer. "We believe this designation is a valuable component of our future clinical and regulatory strategy as we work to align with the FDA to address the pressing unmet needs of people living with urothelial cancer."

FTD is intended to facilitate and expedite development and review of new drugs to address unmet medical need in the treatment of a serious or life-threatening condition. This unmet medical need is defined as providing a therapy where either none exists or providing a therapy which may prove superior to existing therapy. A clinical program that receives FTD may benefit from more frequent meetings and communications with the FDA to discuss development plans and ensure the collection of appropriate data needed to support approval. Clinical programs conducted under FTD may be eligible for Accelerated Approval and Priority Review if relevant criteria are met. More information on the Fast Track process is available here.

Bicara Therapeutics to Present at 41st Annual J.P. Morgan Healthcare Conference

On January 4, 2023 Bicara Therapeutics, a clinical-stage biotechnology company developing dual-action biologics designed to modulate the tumor microenvironment to elicit a potent and durable anti-tumor response, reported that Claire Mazumdar, Ph.D., MBA, Chief Executive Officer of Bicara Therapeutics, will present a corporate overview at the 41st Annual J.P. Morgan Healthcare Conference being held in San Francisco, CA, on Wednesday, January 11, 2023 at 9:30 am PST (Press release, Bicara Therapeutics, JAN 4, 2023, View Source;utm_medium=rss&utm_campaign=bicara-therapeutics-to-present-at-41st-annual-j-p-morgan-healthcare-conference [SID1234625787]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!