On May 12, 2022 Pacira BioSciences, Inc. (Nasdaq: PCRX), the industry leader in its commitment to non-opioid pain management and regenerative health solutions, reported preliminary unaudited net product sales for EXPAREL (bupivacaine liposome injectable suspension) and iovera° for the month of April 2022 (Press release, Pacira Pharmaceuticals, MAY 12, 2022, View Source [SID1234614393]). EXPAREL net product sales were $44.8 million, compared with $43.1 million for April 2021. EXPAREL average daily sales for the month of April 2022 were 109 percent of April 2021. The company reports average daily growth rates for EXPAREL to account for differences in the number of selling days per reporting period. The number of EXPAREL selling days were 21 in April 2022 and 22 in April 2021. Net product sales of iovera° were $1.1 million for the month of April 2022, compared with $1.5 million for April 2021.

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"We are pleased to report solid EXPAREL growth as we support the market transition to outpatient sites of care, with utilization expanding and significantly outperforming the elective surgery market amidst pockets of persistent operating disruptions and healthcare labor shortages," said Dave Stack, chairman and chief executive officer of Pacira BioSciences. "ZILRETTA and iovera° are gaining traction and we expect improving sales trends for both products as the year progresses and we build awareness around their value as both complementary and standalone non-opioid solutions for managing osteoarthritis. Importantly, we continue to execute from a position of financial strength having recently reported adjusted EBITDA of $53.8 million in the first quarter of 2022 and having ended the first quarter with a significant cash position. As such, we remain highly confident in our outlook for robust revenue and earnings growth as we cement our leadership position and deliver patients innovative, non-opioid solutions along the neural pain pathway."

Since early 2020, the company’s revenues have been impacted by COVID-19 and pandemic-related challenges that included the significant postponement or suspension in the scheduling of elective surgical procedures due to public health guidance and government directives. While the degree of impact has diminished during the course of the pandemic due to the introduction of vaccines and the lessening of elective surgery restrictions, certain pandemic-related operational challenges persist. It remains unclear how long it will take the elective surgery market to normalize or if restrictions on elective procedures will recur due to future COVID-19 variants or otherwise.

The company is not providing 2022 financial guidance at this time given the continued uncertainty around COVID-19 and the pace of recovery for the elective surgery market. To provide greater transparency, the company is reporting monthly intra-quarter unaudited net product sales for EXPAREL and iovera° until it has gained enough visibility around the impacts of COVID-19.

The company is also providing weekly EXPAREL utilization and elective surgery data within its investor presentation, which is accessible at investor.pacira.com. Pacira is currently not reporting preliminary monthly ZILRETTA net product sales as the required adjustments for certain product rebate programs are calculated after the end of the quarter. Pacira completed its acquisition of Flexion Therapeutics on November 19, 2021, which added ZILRETTA (triamcinolone acetonide extended-release injectable suspension) to its commercial offering.

The financial information included in this press release is preliminary, unaudited, and subject to adjustment. It does not present all information necessary for an understanding of the company’s financial results for the second quarter or full year 2022.

On May 12, 2022 Imago BioSciences, Inc. ("Imago") (Nasdaq: IMGO), a clinical stage biopharmaceutical company discovering and developing new medicines for the treatment of myeloproliferative neoplasms (MPNs) and other bone marrow diseases, reported that updated Phase 2 data from its two clinical programs for bomedemstat (IMG-7289) have been accepted for poster presentation at the 27th Congress of the European Hematology Association (EHA) (Free EHA Whitepaper) for 2022, to be held on June 9-12, 2022 in Vienna, Austria and virtually (Press release, Imago BioSciences, MAY 12, 2022, View Source [SID1234614392]).

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Details on Imago’s EHA (Free EHA Whitepaper) 2022 Presentations:

Poster Presentation Title: A Phase 2 Study of IMG-7289 (Bomedemstat) in Patients with Advanced Myelofibrosis
Abstract Number: EHA (Free EHA Whitepaper)-2824
Final Abstract Code: P1051
Presentation Date & Time: Friday, June 10, 2022 – 16:30 – 17:45 CEST
Presenting Author: Harinder Gill

Poster Presentation Title: A Phase 2 Study of the LSD1 Inhibitor IMG-7289 (Bomedemstat) for the Treatment of Essential Thrombocythemia (ET)
Abstract Number: EHA (Free EHA Whitepaper)-2792
Final Abstract Code: P1033
Presentation Date & Time: Friday, June 10, 2022 – 16:30 – 17:45 CEST
Presenting Author: Francesca Palandri

The abstracts are available on the EHA (Free EHA Whitepaper) 2022 Annual Congress meeting website at the EHA (Free EHA Whitepaper) web library.

On May 12, 2022 X4 Pharmaceuticals, (Nasdaq: XFOR), a leader in the discovery and development of novel oral CXCR4-targeted small molecule therapeutics to benefit people with rare immune system disorders, reported financial results for the first quarter ended March 31, 2022 (Press release, X4 Pharmaceuticals, MAY 12, 2022, View Source [SID1234614391]).

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"As we quickly approach top-line results from our 4WHIM pivotal Phase 3 trial for WHIM syndrome by the end of this year, the X4 team continues to identify and expand the breadth of individuals diagnosed with this rare disease. Initiatives aimed at supporting diagnosis and driving disease awareness, such as our PATH4WARD program offering free genetic sequencing to patients, and publishing peer-reviewed research to help define novel pathogenic genetic variants, are adding to the population of those known to be affected by WHIM and chronic neutropenia," said Paula Ragan, Ph.D., President and Chief Executive Officer of X4 Pharmaceuticals. "Specifically, to support those affected by chronic neutropenia, we are expanding the availability of genetic testing through PATH4WARD and evaluating patients with congenital, idiopathic, and cyclic chronic neutropenia in our ongoing Phase 1b study. We look forward to providing both clinical data and regulatory updates over the coming months on this important initiative."

Recent Highlights

Presented posters at the CIS 2022 Annual Meeting that detailed the PATH4WARD genetic testing program to aid in the diagnosis of WHIM syndrome and chronic neutropenia, and the characterization of a novel pathogenic CXCR4 variant (S341Y).
Presented preclinical data on mavorixafor’s ability to significantly enhance the tumor-cell killing activity of the leading commercial and clinical stage Bruton Tyrosine Kinase Inhibitors (BTKi) including ibrutinib, zanubrutinib, pirtobrutinib (LOXO-305) and nemtabrutinib (ARQ-531), at the 2022 AACR (Free AACR Whitepaper) Annual Meeting.
Completed enrollment in the ongoing Phase 1b study of mavorixafor in combination with ibrutinib in patients with Waldenström’s Macroglobulinemia (WM) whose tumors express mutations in MYD88 and CXCR4. A total of 16 patients were enrolled and dose escalation to the 600 mg dose of mavorixafor has been completed. Results from this study are expected to be reported during the second half of 2022.

First Quarter 2022 Financial Results

Cash, Cash Equivalents & Restricted Cash: X4 had $67.7 million in cash, cash equivalents, and restricted cash as of March 31, 2022. The company expects that its cash and cash equivalents will fund company operations into the fourth quarter of 2022.
Research and Development (R&D) Expenses were $14.1 million for the first quarter of 2022 as compared to $12.1 million for the comparable period in 2021. R&D expenses include $0.7 million and $0.6 million of certain non-cash expenses for the first quarter of 2022 and 2021, respectively.
Selling, General and Administrative Expenses (SG&A) were $7.7 million for the first quarter of 2022 as compared to $5.8 million for the comparable period in 2021. SG&A expenses include $0.8 million and $0.7 million of certain non-cash expenses for the first quarter of 2022 and 2021, respectively.
Net Loss: X4 reported a net loss of $22.0 million for the first quarter of 2022, as compared to $18.7 million for the comparable period in 2021. Net losses include $1.5 million and $1.3 million of certain non-cash expenses for the first quarter of 2022 and 2021, respectively.
Conference Call and Webcast
X4 will host a conference call and webcast today at 8:30 am EDT to discuss financial results and business highlights. The conference call can be accessed by dialing (866) 721-7655 from the United States or (409) 216-0009 internationally, followed by the conference ID: 4382059. The live webcast can be accessed on the investor relations section of X4 Pharmaceuticals’ website at www.x4pharma.com. Following the completion of the call, a webcast replay of the conference call will be available on the website.

On May 12, 2022 GT Biopharma, Inc. (NASDAQ: GTBP), an immuno-oncology company focused on developing innovative therapeutics based on the Company’s proprietary tri-specific natural killer (NK) cell engager, TriKE protein biologic technology platform, reported that management will present at H.C. Wainwright’s Hybrid Global Investment Conference (Press release, GT Biopharma, MAY 12, 2022, https://ir.gtbiopharma.com/news/detail/252/gt-biopharma-to-participate-at-h-c-wainwright-hybrid-global-investment-conference [SID1234614389]). The conference will take place May 23-26, 2022 at the Fontainebleau, Miami Beach Hotel, Miami Beach, Florida.

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H.C. Wainwright Global Investment Conference – May 23-26, 2022

If you are interested in arranging a 1×1 meeting request with management, please contact your bank conference representative. To access the archived recording for replay, please see the Presentations section of GT Biopharma’s corporate website.

On May 12, 2022 BridgeBio Pharma, Inc. (Nasdaq: BBIO) (BridgeBio), a commercial-stage biopharmaceutical company focused on genetic diseases and cancers, reported an exclusive license with Bristol Myers Squibb to develop and commercialize BBP-398, a potentially best-in-class SHP2 inhibitor, in oncology (Press release, BridgeBio, MAY 12, 2022, View Source [SID1234614388]).

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Under the terms of the agreement, BridgeBio will receive an upfront payment of $90 million, up to $815 million in development, regulatory and sales milestone payments, and tiered royalties in the low- to mid-teens. BridgeBio will retain the option to acquire higher royalties in the United States in connection with funding a portion of development costs upon the initiation of registrational studies.

Based on the terms of the agreement, BridgeBio will continue to lead its ongoing Phase 1 monotherapy and combination therapy trials. Bristol Myers Squibb will lead and fund all other development and commercial activities.

"We are grateful to be expanding our collaboration with Bristol Myers Squibb, a leader in oncology, and we believe this agreement will allow us to reach even more patients with difficult-to-treat cancers. We believe our SHP2 inhibitor has the potential to be a best-in-class agent given the data we have seen, and we are eager to see our monotherapy and combination trials progress in collaboration with our partners at Bristol Myers Squibb," said Neil Kumar, Ph.D., founder and CEO of BridgeBio.

SHP2 is a protein-tyrosine phosphatase that links growth factor, cytokine and integrin signaling with the downstream RAS/MAPK pathway to regulate cellular proliferation and survival. Overactivity of SHP2 is a critical contributor to many forms of cancer, is a mechanism of resistance to several targeted therapies, and can suppress antitumor immunity.

"We have seen the potential role SHP2 inhibition could play in unlocking possible combination therapies to treat patients suffering from a range of cancers. We are hopeful this collaboration with BridgeBio will help us maximize the possibilities SHP2 inhibition with BBP-398 will hold for patients," said Rupert Vessey, M.A., B.M., B.Ch., FRCP, D.Phil., Executive Vice President, Research & Early Development, Bristol Myers Squibb.

In July 2021, BridgeBio initially announced a non-exclusive, co-funded clinical collaboration with Bristol Myers Squibb to evaluate the combination of BBP-398 with OPDIVO (nivolumab) in patients with advanced solid tumors with KRAS mutations. BridgeBio is currently advancing its Phase 1 clinical trial in patients with solid tumors driven by mutations in the MAPK signaling pathway, including RAS and receptor tyrosine kinase genes.

OPDIVO is a trademark of Bristol-Myers Squibb Company.

About BBP-398
BBP-398 is a SHP2 inhibitor that is being developed for difficult-to-treat cancers and was founded through a collaboration with The University of Texas MD Anderson Cancer Center’s Therapeutics Discovery division. BridgeBio has a strategic collaboration with LianBio for clinical development and commercialization of BBP-398 in combination with various agents in solid tumors such as non-small cell lung cancer, colorectal and pancreatic cancer, in mainland China and other major Asian markets and clinical collaborations; with Bristol Myers Squibb for combination with OPDIVO (nivolumab) in patients with advanced solid tumors with KRAS mutations; and with Amgen for combination with LUMAKRAS (sotorasib), Amgen’s KRASG12C inhibitor, in patients with advanced solid tumors with KRASG12C mutations.