BridgeBio Pharma Announces Proposed Public Offering of Common Stock

On March 4, 2024 BridgeBio Pharma, Inc. (Nasdaq: BBIO) ("BridgeBio"), a commercial-stage biopharmaceutical company focused on genetic diseases and cancers, reported that it has commenced an underwritten public offering of $250 million of shares of its common stock (Press release, BridgeBio, MAR 4, 2024, View Source [SID1234640726]). BridgeBio also intends to grant the underwriters a 30-day option to purchase up to an additional $37.5 million of shares of its common stock. All of the shares in the proposed offering are to be sold by BridgeBio.

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!

J.P. Morgan, Cantor Fitzgerald & Co. and Mizuho are acting as joint book-running managers for the proposed offering. Raymond James is acting as lead manager. The proposed offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the proposed offering.

The shares of common stock are being offered by BridgeBio pursuant to an effective shelf registration statement on Form S-3ASR that was previously filed with the U.S. Securities and Exchange Commission (SEC) on May 4, 2023 and automatically became effective upon filing. The offering is being made only by means of a prospectus supplement and the accompanying prospectus that will form a part of the registration statement. A preliminary prospectus supplement and accompanying prospectus relating to and describing the terms of the offering will be filed with the SEC and may be obtained, when available, from J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, by telephone at (866) 803-9204, or by email at [email protected]; Cantor Fitzgerald & Co., Attention: Capital Markets, 110 East 59th Street, 6th Floor, New York, NY 10022, or by email at [email protected]; Mizuho Securities USA LLC, Attention: Equity Capital Markets, 1271 Avenue of the Americas, 3rd Floor, New York, New York 10020, by telephone at 1-212-205-7602 or by email at [email protected]; or by accessing the SEC’s website at www.sec.gov. The final terms of the proposed offering will be disclosed in a final prospectus supplement to be filed with the SEC.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

BioLineRx Strengthens Intellectual Property Estate with Notice of Allowance for U.S. Patent Covering Method of Manufacturing Motixafortide (BL-8040) Suitable for Large Scale Production

On March 4, 2024 BioLineRx Ltd. (NASDAQ/TASE: BLRX), a commercial stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases, reported that it has received a Notice of Allowance from the U.S. Patent and Trademark Office (USPTO) for a patent, "Process for Manufacturing Peptide," covering a method of manufacturing motixafortide (BL-8040) that is suitable for large scale production (Press release, BioLineRx, MAR 4, 2024, View Source [SID1234640725]).

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!

In addition to a broad range of U.S. and international patents covering various aspects of motixafortide, including composition of matter, methods of synthesis, methods of use and combinations, BioLineRx was granted seven years of Orphan Drug market exclusivity beginning on September 8, 2023, the day APHEXDA (motixafortide) was approved by the FDA, in combination with G-CSF, for use by multiple myeloma patients undergoing autologous stem cell transplantation. Additionally, motixafortide was granted five years of market exclusivity across all indications as a New Chemical Entity (NCE). The NCE exclusivity also commenced on September 8, 2023.

"This is a very meaningful addition to our IP portfolio as we look to scale up the production of motixafortide to support both the commercial demand for APHEXDA for stem cell mobilization in multiple myeloma patients as well as the numerous ongoing clinical trials underway in other indications, including metastatic pancreatic cancer and for gene therapies in sickle cell disease," stated Philip Serlin, Chief Executive Officer of BioLineRx. "When combined with the seven years of Orphan Drug Designation market exclusivity that we were granted upon FDA approval of APHEXDA beginning last September, and five years of exclusivity across all indications as a New Chemical Entity, we have a broad set of IP protections that we believe will allow us to maximize the value of this important molecule for our company and shareholders for years to come."

Motixafortide has also been granted Orphan Drug Designation in the U.S. and Europe for the treatment of pancreatic cancer, as well as in the U.S. for the treatment of acute myeloid leukemia (AML).

Ascendis Pharma to Participate in the Leerink Partners Global Biopharma Conference 2024

On March 4, 2024 Ascendis Pharma A/S (Nasdaq: ASND) reported that company executives will participate in a fireside chat at the Leerink Partners Global Biopharma Conference 2024 on Monday, March 11, 2024 at 2:00 p.m. ET in Miami, Florida (Press release, Ascendis Pharma, MAR 4, 2024, View Source [SID1234640724]).

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!

A live webcast of the fireside chat will be available via the Investors & News section of the Ascendis Pharma website at investors.ascendispharma.com. A webcast replay will also be available on this website shortly after conclusion of the event for 30 days.

Arvinas to Participate in Upcoming Investor Conferences

On March 4, 2024 Arvinas, Inc. (Nasdaq: ARVN), a clinical-stage biotechnology company creating a new class of drugs based on targeted protein degradation, reported that management will participate in three upcoming investor conferences (Press release, Arvinas, MAR 4, 2024, View Source [SID1234640723]):

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!

Leerink Partners Global Biopharma Conference on Tuesday, March 12.
Ron Peck, M.D., chief medical officer, and Randy Teel, Ph.D., interim chief financial officer, will participate in a fireside chat. A live audio webcast of the presentation will be available here and on the Events + Presentations section of the Company’s website.

Jefferies Biotech on the Bay Summit on Wednesday, March 13.
Ron Peck, M.D., chief medical officer, and Randy Teel, Ph.D., interim chief financial officer, will participate in investor 1×1 meetings.

UBS Virtual CNS Day 2024 on Monday, March 18.
Ian Taylor, Ph.D., chief scientific officer, and Angela Cacace, Ph.D., senior vice president of neuroscience and platform biology, will participate in a fireside chat. A live audio webcast of the presentation will be available here and on the Events + Presentations section of the Company’s website.

Akoya Reports Record Revenue in the Fourth Quarter of 2023 and Provides Full Year 2024 Financial Outlook

On March 4, 2024 Akoya Biosciences, Inc. (Nasdaq: AKYA) ("Akoya"), The Spatial Biology Company, reported its financial results for the fourth quarter and full year ending December 31, 2023 (Press release, Akoya Biosciences, MAR 4, 2024, View Source [SID1234640722]).

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!

"Akoya’s successful 2023 performance reflects the high demand for our leading spatial biology solutions and effective execution of our financial and strategic plan," said Brian McKelligon, CEO of Akoya Biosciences. "We expanded our installed base to nearly 1,200 instruments, improved platform speeds, and simplified workflows with new offerings of reagents and analysis tools. We anticipate strong topline growth in 2024 and operating cash flow breakeven by year end."

Fourth Quarter 2023 Financial Highlights

Revenue was $26.5 million in the fourth quarter of 2023, compared to $21.2 million in the prior year period; an increase of 25.0%. This increase was primarily due to higher reagents and services revenue.
Gross margin was 62.7% in the fourth quarter of 2023, compared to 56.8% in the prior year period. The increase in gross margin was primarily driven by product mix and improved margin on the product business.
Operating expense was $26.1 million for the fourth quarter of 2023, compared to $29.6 million in the prior year period; a decrease of 11.8%. The decrease was primarily driven by further realized operating leverage and efficiencies.
Operating loss was $9.4 million for the fourth quarter of 2023, compared to an operating loss of $17.6 million in the prior year period; a decrease of 46.6%.
$83.1 million of cash and cash equivalents as of December 31, 2023.
Fourth Quarter 2023 Business Highlights

Announced a license and distribution agreement with Thermo Fisher Scientific to deliver spatial multiomic workflow by combining Akoya’s market leading spatial biology solutions with ViewRNA technology to enable rapid, whole-slide imaging of RNA and protein biomarkers.
Announced the formation of a new Scientific Advisory Board with initial members consisting of global experts in immunobiology: James Allison, Ph.D., former Akoya director Garry Nolan, Ph.D., and Padmanee Sharma, M.D., Ph.D.
Announced deployment of the MaxFuse algorithm co-developed by Dr. Garry Nolan and his laboratory at Stanford University for multiomic integration of spatial and single-cell data on the Enable Medicine platform.
Full Year 2023 Financial and Business Highlights

Revenue was $96.6 million for the year ended December 31, 2023, compared to $74.9 million in the prior year; an increase of 29.0%.
Gross margin was 58.3% for the year ended December 31, 2023, compared to 58.0% in the prior year period.
Operating expense was $114.0 million for the year ended December 31, 2023, compared to $109.5 million in the prior year period; an increase of 4.1%.
Operating loss was $57.7 million for the year ended December 31, 2023, compared to an operating loss of $66.1 million in the prior year period; a decrease of 12.7%.
Instrument installed base of 1,183 as of December 31, 2023 (342 PhenoCyclers, 841 PhenoImagers), compared to an installed base of 934 in the prior year period (254 PhenoCyclers, 680 PhenoImagers); an increase of 26.7%.
1,160 total publications citing Akoya’s technology as of December 31, 2023, compared to 772 total publications in the prior year period: an increase of 50.3%.
2024 Financial Outlook

The Company, based on its current plans and initiatives, expects full year 2024 revenue guidance range of $114.0-118.0 million and projects operating cash flow breakeven by year end.

Webcast and Conference Call Details

Akoya will host a conference call today, March 4, 2024, at 5:00 p.m. Eastern Time to discuss its fourth quarter and full year 2023 financial results. Investors interested in listening to the conference call are required to register online. A live webcast of the conference call will be available on the "Investors" section of the Company’s website at View Source The webcast will be archived on the website following the completion of the call for three months.