On May 9, 2024 CRISPR Therapeutics (Nasdaq: CRSP), a biopharmaceutical company focused on creating transformative gene-based medicines for serious diseases, reported that members of its senior management team will present at the Bank of America Securities Health Care Conference on Wednesday, May 15, 2024, at 12:20 p.m. ET (Press release, CRISPR Therapeutics, MAY 9, 2024, View Source [SID1234642987]).

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 on the "Events & Presentations" page in the Investors section of the Company’s website at View Source A replay of the webcast will be archived on the Company’s website for 14 days following the presentation.

On May 9, 2024 Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX), a clinical stage pharmaceutical company focused on the discovery, development and commercialization of novel therapeutics for endocrine diseases and endocrine-related tumors, reported financial results for the first quarter ended March 31, 2024 (Press release, Crinetics Pharmaceuticals, MAY 9, 2024, View Source [SID1234642986]).

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!

"Building on the positive momentum from the first PATHFNDR readout in 2023, Crinetics began 2024 with continued strong performance. Our lead investigational compound, paltusotine, delivered positive data from two consecutive late-stage clinical trials in acromegaly and carcinoid syndrome. With our pivotal PATHFNDR Phase 3 program in acromegaly now complete, we are working diligently to submit an NDA in the second half of 2024. We also intend to discuss the positive results from our Phase 2 study in carcinoid syndrome with the FDA in preparation for the Phase 3 program, which is expected to be initiated by the end of this year," said Scott Struthers, Ph.D., founder and chief executive officer of Crinetics.

"The clinical trials for the second compound in our pipeline, atumelnant, which is being developed for the treatment of CAH and Cushing’s disease, continue to enroll patients. We plan to report initial results from a subset of patients from these trials in the second quarter," continued Dr. Struthers. "In the first quarter, we strengthened our balance sheet to support commercial readiness for a potential paltusotine launch in acromegaly, as well as to fund the development of our deep clinical and preclinical pipeline. The progress made across our pipeline positions the Company for long-term success and towards achieving our objective to become a fully integrated pharmaceutical company."

First Quarter 2024 and Recent Highlights:

Phase 3 PATHFNDR-2 study achieved primary and all secondary endpoints. In March, Crinetics reported positive topline results from its placebo-controlled Phase 3 study of paltusotine in non-pharmacologically treated participants with acromegaly. PATHFNDR-2 was designed to support a treatment indication in those with uncontrolled acromegaly.
Phase 2 study of paltusotine in carcinoid syndrome reported positive results. In March, Crinetics reported positive topline results from its open-label Phase 2 study of paltusotine in participants with carcinoid syndrome. Paltusotine was shown to result in rapid and sustained reductions in frequency and severity of flushing episodes and bowel movements.
Strengthened balance sheet with $350 million private placement financing. In February, Crinetics announced a private placement equity financing for gross proceeds of approximately $350 million.
Key Upcoming Milestones

Initial results from the ongoing Phase 2 studies of atumelnant* in congenital adrenal hyperplasia (CAH) and ACTH-dependent Cushing’s syndrome will be presented at the Endocrine Society’s annual meeting, ENDO 2024, being held June 1-4, 2024 in Boston. The Phase 2 studies are evaluating the safety, efficacy and pharmacokinetics of different doses of atumelnant in participants with CAH and Cushing’s disease.
Submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking regulatory approval of paltusotine for the treatment of acromegaly is anticipated in the second half of 2024.
Initiation of a Phase 3 program of paltusotine for carcinoid syndrome by the end of 2024, pending discussions with the FDA.
First Quarter 2024 Financial Results

Research and development expenses were $53.3 million for the three months ended March 31, 2024, compared to $38.5 million for the same period in 2023. The increases were primarily attributable to an increase in personnel costs of $9.4 million, increased outside services and facilities costs of $3.8 million, and increased spending on manufacturing and development activities of $1.4 million.
General and administrative expenses were $20.8 million for the three months March 31, 2024, compared to $12.2 million for the same period in 2023. The increases were primarily attributable to an increase in personnel costs of $5.6 million.
Net loss for the three months ended March 31, 2024, was $66.9 million, compared to a net loss of $46.0 million for the same period in 2023.Revenues were $0.6 million for the three months ended March 31, 2024, compared to $2.7 million for the same period in 2023.
Revenues were derived from licensing arrangements for our paltusotine product candidate in 2024 and for paltusotine and CRN01941 product candidates in 2023.
Unrestricted cash, cash equivalents, and investments totaled $901.0 million as of March 31, 2024, compared to $558.6 million as of December 31, 2023. On February 28, 2024, the company announced a private placement equity financing for gross proceeds of approximately $350 million. Based on its current projections, the company now expects that its cash, cash equivalents and short-term investments will be sufficient to fund its current operating plan into 2028.
*Proposed international nonproprietary name under review.

Conference Call and Webcast Details
Management will hold a live conference call and webcast today, Thursday, May 9, 2024 at 4:30 p.m. ET. To participate, please dial 1-888-886-7786 (domestic) or 1-416-764-8658 (international) and refer to Conference ID 71864759. To access the webcast, click here. For instant telephone access, click the Call me link here. Following the live event, a replay will be available on the Investors section of the Company’s website.

On May 9, 2024 CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for life-threatening diseases and conditions, reported financial results for the first quarter ended March 31, 2024 and provided an update on its business (Press release, CorMedix, MAY 9, 2024, View Source [SID1234642985]).

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!

Recent Corporate Highlights:

On April 2, 2024, CMS published its HCPCS coding decision for DefenCath, establishing a new HCPCS Level II code for the product. CMS subsequently notified the Company on April 18th of its determination that DefenCath meets the criteria for a Transitional Drug Add-On Payment (TDAPA) and will be effective July 1, 2024. The TDAPA program currently provides for five years of additional payment reimbursement beyond the ESRD bundled rate to outpatient providers.
On April 15, 2024, the Company commenced commercial launch of DefenCath in the inpatient setting, and remains on schedule to commence outpatient launch in July.
The Company announced in April that it entered into a 5-year commercial supply contract with ARC Dialysis, LLC, a Florida-based dialysis provider, for the supply of DefenCath.
The FDA granted the Company’s Type C meeting request to discuss an updated development plan for DefenCath in Total Parenteral Nutrition (TPN) and pediatric study requirements. The Company expects to receive feedback from the FDA by the end of the second quarter of 2024.
The Company submitted to FDA earlier this week a supplement to the CorMedix NDA adding Siegfried Hameln as an alternate finished dosage manufacturing site for DefenCath. Pending FDA review and approval, the Company anticipates approval of the supplement by the end of 2024.
Cash and short-term investments, excluding restricted cash, at March 31, 2024, amounted to $58.6 million.
Joe Todisco, CorMedix CEO, commented, "I am excited about the Company’s recent progress as we have officially transitioned to a commercial stage organization. In only a few weeks of inpatient deployment we have received meaningful interest in scheduling DefenCath for formulary review at various institutions, and we look forward to additional progress in the coming months. We are also focusing simultaneously on our upcoming outpatient launch and actively engaging with customers regarding the potential to implement DefenCath as a preventative measure to reduce the risk of CRBSI in their respective hemodialysis patients with CVCs."

First Quarter 2024 Financial Highlights

For the first quarter of 2024, CorMedix recorded a net loss of $14.5 million, or $0.25 per share, compared with a net loss of $10.6 million, or $0.24 per share, in the first quarter of 2023, an increase of $3.9 million, driven primarily by an increase in operating expenses, partially offset by the sale of New Jersey NOLs for $1.4 million.

Operating expenses in the first quarter 2024 were $15.9 million, compared with $11.0 million in the first quarter of 2023, an increase of approximately 44%.  The increase was driven by higher SG&A expenses which increased approximately 98% to $15.0 million, partially offset by a decrease in research and development expenses of approximately 75%. The increase in SG&A was primarily driven by the hiring of sales force, medical affairs and marketing personnel. Additionally, as a result of the post FDA approval commercial operations, costs related to medical affairs and certain personnel expenses that supported R&D efforts prior to the FDA approval of DefenCath have been recognized in selling, general and administrative expense during the three months ended March 31, 2024, as compared to the same period last year during which these items were recognized in R&D, which drove the decrease in R&D expenses for this period compared to the same period last year.

The Company reported cash and short-term investments of $58.6 million at March 31, 2024, excluding restricted cash. The Company believes that it has sufficient resources to fund operations for at least twelve months from the issuance of the Company’s Quarterly Report on Form 10-Q.

Conference Call Information

The management team of CorMedix will host a conference call and webcast today, May 9, 2024, at 8:30am Eastern Time, to discuss recent corporate developments and financial results. Call details and dial-in information are as follows:

Thursday, May 9th @ 8:30am ET

Domestic: 1-888-886-7786

International: 1-416-764-8658

Conference ID: 32817785

Webcast: Webcast Link

On May 9, 2024 Coherus BioSciences, Inc. (Coherus, Nasdaq: CHRS), reported financial results for the quarter ended March 31, 2024 and recent business highlights (Press release, Coherus Biosciences, MAY 9, 2024, View Source [SID1234642984]):

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!

RECENT BUSINESS HIGHLIGHTS

UDENYCA RESULTS and ONBODY LAUNCH UPDATE

UDENYCA net product sales were $42.7 million in Q1 2024, an increase of 18% compared to $36.2 million in Q4 2023 and a 63% increase compared to the $26.2 million in Q1 2023. Total unit demand grew 36% in Q1 2024 compared to Q4 2023 and represented a 108% increase compared to Q1 2023.
UDENYCA Autoinjector presentation unit demand grew 158% in Q1 2024 compared to Q4 2023.
UDENYCA ONBODY, a novel and proprietary state-of-the-art delivery system for pegfilgrastim-cbqv, was launched in February 2024. High customer demand and confirmed payer coverage drove early robust uptake.
Based on data from IQVIA, UDENYCA franchise market share for Q1 2024 was 25%, an increase of 10 market share points in Q1 2024 compared to Q4 2023.
LOQTORZI LAUNCH UPDATE

LOQTORZI, the first and only FDA-approved treatment for recurrent, locally advanced or metastatic NPC, commercially launched on January 2, 2024.
Academic research hospital formulary position achieved on 55% of the 33 NCCN institutions, with the remaining institutional reviews scheduled or in process. Formulary position is expected to be achieved with all NCCN institutions by the end of Q2 2024.
Payer coverage has been confirmed on >85% of medical benefit lives in health plans including Medicare Fee for Service, Medicare Advantage, and national and regional commercial plans respectively.
LOQTORZI net sales in Q1 of $2.0 million, tracking to early launch stage expectations, with patient accrual momentum building.
Product-specific, permanent J Code has been granted by the Centers for Medicare and Medicaid Services and will take effect July 1, 2024.
NOVEL IMMUNO-ONCOLOGY PIPELINE ADVANCES

Coherus entered into an agreement with the Cancer Research Institute (CRI) to supply LOQTORZI for a combination study with ENB-003, a first-in-class small molecule inhibitor of endothelin B receptor. Endothelin B receptor is implicated in tumorigenesis and tumor immune suppression for several solid tumors including ovarian cancer. CRI is overseeing the iPROC study.
Clinical data from the dose escalation stage of the Phase 1 study of CHS-114, a highly selective antibody-dependent cellular cytotoxicity (ADCC)-enhanced anti-CCR8 antibody, will be presented at the 2024 ASCO (Free ASCO Whitepaper) Annual Meeting in June.
"The strength of our company’s first-quarter performance reflects our ongoing commitment to driving top-line revenues, controlling operating expenses, advancing our pipeline, and improving our capital structure," said Denny Lanfear, Coherus’ Chairman and Chief Executive Officer. "The progress we reported today aligns with these objectives, consistent with our overarching mission to become a sustainable and growing oncology company improving outcomes for cancer patients."

FIRST QUARTER 2024 FINANCIAL RESULTS

Net revenue was $77.1 million during the three months ended March 31, 2024, and included $42.7 million of net sales of UDENYCA, $2.0 million of net sales of LOQTORZI, which was launched on January 2, 2024, $3.9 million of net sales of YUSIMRY, and $28.2 million of net sales of CIMERLI, which was divested to Sandoz on March 1, 2024. Net revenue was $32.4 million during the three months ended March 31, 2023.

Cost of goods sold (COGS) was $34.6 million and $16.9 million during the three months ended March 31, 2024 and 2023, respectively. CIMERLI COGS included a low to mid 50% royalty on gross profits and UDENYCA COGS includes a mid-single digit royalty on net sales payable through the first half of 2024. The increase in COGS was primarily driven by higher royalty costs and an increase in product costs from the mix of products sold and the launch of new products.

Research and development (R&D) expense was $28.5 million and $34.2 million during the three months ended March 31, 2024 and 2023, respectively. The decrease was primarily due to savings from reduced headcount and lower costs related to biosimilar products, partially offset by increased costs related to moving LOQTORZI production from China to the United States.

Selling, general and administrative (SG&A) expense for the three months ended March 31, 2024 was $56.5 million compared to $49.2 million for the same period in 2023. The increase was primarily due to the net $6.8 million charge in Q1 2024 associated with the full write-off of the outlicense intangible asset and associated release of the CVR liability related to NZV930, obtained in the Surface Oncology acquisition, and higher third-party processing fees from multiple products being commercialized, partially offset by savings from reduced headcount.

Gain on Sale, net for the divestiture of the ophthalmology franchise, which closed during the three months ended March 31, 2024, was $153.6 million, and reflects total cash proceeds of $187.8 million, net of assets transferred to Sandoz, assets derecognized, transactions costs of $7.2 million and other employee transition related expenses.

Net income for the first quarter of 2024 was $102.9 million, or $0.83 per share on a diluted basis, compared to a net loss of $75.7 million, or $(0.96) per share on a diluted basis for the same period in 2023.

Non-GAAP net loss for the first quarter of 2024 was $35.8 million, or $(0.32) per share on a diluted basis, compared to non-GAAP net loss of $59.5 million, or $(0.75) per share on a diluted basis for the same period in 2023. See "Non-GAAP Financial Measures" below for a discussion on how Coherus calculates non-GAAP net loss and a reconciliation to the most directly comparable GAAP measures.

Cash, cash equivalents and investments in marketable securities were $259.8 million as of March 31, 2024, compared to $117.7 million as of December 31, 2023. Proceeds from the divestiture of our ophthalmology franchise received in March 2024 were used to pay down $175.0 million of the total $250.0 in principal on Coherus’ 2027 Term Loans in April 2024.

2024 R&D and SG&A Expense Guidance
Coherus projects combined R&D and SG&A expenses for 2024 to be in the range of $250 to $265 million. This guidance includes approximately $40 million of stock-based compensation expense and excludes the effects of acquisitions, collaborations, investments, divestitures including expenses incurred on behalf of and reimbursed by Sandoz to satisfy Coherus’ obligations under the Transition Services Agreement (TSA), restructuring, the exercise of rights or options related to collaboration programs, and any other transactions or circumstances not yet identified or quantified. This guidance is subject to a number of risks and uncertainties. See Forward-Looking Statements described in the section below.

Conference Call Information

When: Thursday, May 9, 2024, starting at 5:00 p.m. Eastern Daylight Time

To access the conference call:
Dial: (800) 715-9871 (toll-free USA and Canada); (646) 307-1963 (international)

Conference ID: 4442005

Webcast: View Source

An archived webcast will be available on the "Investors" section of the Coherus website at View Source

On May 9, 2024 Cimeio Therapeutics, a biotechnology company leading the field of epitope shielding, reported data for its CD52 program during this week’s Annual Meeting of the American Society of Cell & Gene Therapy (ASGCT) (Free ASGCT Whitepaper) in Baltimore (Press release, Cimeio Therapeutics, MAY 9, 2024, View Source [SID1234642983]). The abstract is titled "Molecular Shielding of CD52 Retains Expression, Anti-Phagocytic Don’t Eat Me Function and Protects from Alemtuzumab-Mediated Depletion."

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 study is the first showing that T cells expressing an engineered CD52 can be effectively shielded from Alemtuzumab-mediated depletion, while maintaining the general features of this receptor. Cimeio’s research team also showed for the first time that CD52 mediates an anti-phagocytotic ‘Don’t Eat Me’ signal, which is retained by the engineering. This program can serve as the basis for a novel approach to treating patients with T cell malignancies, non-genotoxic conditioning, and aiding in improving the persistence of allogeneic CAR T cells.

"Exhaustive screening as well as comprehensive expression, glycan and functional analyses allowed us to identify a base editable point mutation that protected T cells from Alemtuzumab, while allowing CD52 to maintain its cell surface expression, processing and function," said Stefanie Urlinger, Ph.D., Chief Scientific Officer at Cimeio. "We are excited to explore the full potential of our engineered CD52 receptor in the future. This can represent a viable alternative to CD52 knock-out on allogeneic CAR T cells, mediating resistance to lymphodepletion using Alemtuzumab and perhaps also contributing to a prolonged in vivo persistence."