Biodesix: Test Reduced Unnecessary Invasive Procedures on Benign Lung Nodules

New publication in PLOS ONE, a journal of the Public Library of Science, reaffirms clinical utility of the Nodify XL2® proteomic test in a real-world setting

Biodesix, Inc. (Nasdaq: BDSX), a leading data-driven diagnostic solutions company with a focus in lung disease, announced today that the prospective, real-world ORACLE study (An Observational Registry Study to Evaluate the Performance of the Nodify XL2® Test [NCT03766958]) achieved the primary endpoint of a statistically significant change in the proportion of benign lung nodules managed by Nodify XL2® experiencing invasive procedures. The data was published in PLOS ONE this week.

Lung nodules are a common clinical finding with the increased use of medical imaging for general diagnostic purposes and the expansion of lung cancer screening eligibility. Lung nodules represent an opportunity for early detection of lung cancer but pose a diagnostic dilemma because up to 95% of lung nodules are benign. In this patient population, high rates of invasive procedures, such as biopsies or surgeries, on benign nodules have been documented in the pursuit of lung cancer diagnosis and an analysis of Medicare claims has showed that greater than 40% of the total cost of lung cancer diagnosis was accounted for by biopsied patients without a lung cancer diagnosis.

https://finance.yahoo.com/news/biodesix-announces-publication-oracle-clinical-100000984.html

T2 Biosystems Prelim Second Quarter 2023 Financial Results, Outlook

 T2 Biosystems Inc. (NASDAQ:TTOO), a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes, today announced preliminary unaudited financial and operational results for the second quarter 2023.

Recent Financial and Operational Highlights (unaudited)

• Achieved second quarter total revenue of $2.0 million, comprised entirely of product revenue.
• Achieved sepsis test panel revenue of $1.3 million, representing an increase of 7% compared to the prior year period, despite ending the second quarter with a $0.4 million sepsis test backorder.
• Executed contracts for 11 T2Dx^® Instruments during the second quarter, including 4 in the U.S. and 7 internationally.
• Secured multi-year contract with a European distributor for 7 T2Dx Instruments and sepsis test panels for Poland – including T2Bacteria^® Panel, T2Candida^® Panel, and T2Resistance^® Panel.
• Implemented a restructuring program in May 2023, including a workforce reduction of nearly 30%.
• Strengthened balance sheet by converting $10.0 million, or approximately 20%, of term loan debt with CRG Servicing LLC (“CRG”) in exchange for 48,345,798 shares of T2 Biosystems common stock and Series B Convertible Preferred Stock convertible into 93,297,259 shares of common stock.
• Completed Nasdaq listing compliance hearing and a response is expected within 30 days.
• Cash and cash equivalents totaled $16.1 million as of June 30, 2023, including $18.5 million of net proceeds from the sale of shares through the ATM facility in the second quarter.

Recent Pipeline and Clinical Highlights

• Completed patient enrollment in the U.S. clinical trial for the T2Resistance Panel.
• Filed FDA submission for T2Biothreat™ Panel, a direct-from-blood diagnostic test that runs on the FDA-cleared T2Dx Instrument and detects six biothreat pathogens identified as threats by CDC.
• Submitted for FDA Breakthrough Device Designation for a direct-from-blood diagnostic test to detect Candida auris, a multidrug-resistant fungal pathogen identified by CDC as an urgent threat.
• Established a clinical collaboration with Vanderbilt University Medical Center to implement the T2Bacteria Panel and assess its impact on antibiotic usage and clinical interventions.

“We achieved a number of significant milestones during the second quarter, including record demand for our sepsis test panels, the second largest sepsis-driven instrument order in company history, the FDA 510(k) submission for the T2Biothreat Panel, and the FDA Breakthrough Device Designation application for our Candida auris test,” stated John Sperzel, Chairman and CEO of T2 Biosystems. “In addition, we recently strengthened our balance sheet through sales of common stock and the conversion of $10 million of debt to equity, extending our cash runway to pursue strategic initiatives.”

The Company’s second quarter 2023 financial results are preliminary and are subject to the completion of the audit of the Company’s second quarter 2023 financial statements. Complete second quarter 2023 financial results will be announced in August.

2023 Financial Outlook

The Company now expects full year 2023 total sepsis and related product revenue of $9.5 million to $10.5 million, representing growth of 13% to 25%, compared to $8.4 million in 2022.

https://www.biospace.com/article/releases/t2-biosystems-announces-preliminary-second-quarter-2023-financial-resultsreceived-record-quarterly-sepsis-test-panel-orders-and-strengthened-balance-sheet/

7 Life Science IPOs in 2023

 Despite a chilling economy, at least six biotechs and biopharmas have posted sizable IPOs in 2023. Compared with last year, however, it’s clear that the industry is still in an IPO drought.

In 2022, 47 biotech IPOs raised a total of about $4 billion. That was already a steep dropoff from 2021, when 152 offerings raised more than $25 billion, according to Reuters.

This may well be a low point for biopharma IPOs, said biotech analyst Chris Dokomajilar, founder and CEO of DealForma Database. Going forward, he predicted, the recent slowdown in interest rate hikes could spell a positive change for the industry, with more IPOs coming in the second half of the year.

Here are 2023’s IPOs in biopharma and biotech thus far.

 Intensity Therapeutics

• IPO date: June 30
• IPO share price: $5
• Total: $18.9 million**
• Current share price: $5.80*

Connecticut-based Intensity Therapeutics is initiating a Phase III study of its drug, named INT230-6, targeting sarcoma, as well as a Phase II/III study for early-stage breast cancer using the same therapeutic approach, according to the company.

Acelyrin

• IPO date: May 4
• IPO share price: $18
• Total: $540 million
• Current share price: $19.50

Acelyrin is a California-based late-stage clinical biopharmaceutical company focused on developing immunology drugs. The company’s pipeline includes Phase III izokibep for psoriatic arthritis and lonigutamab for thyroid eye disease in Phase II.

CytoMed Therapeutics

• IPO date: April 13
• IPO share price: $4
• Total: $9.6 million
• Current share price: $5.64

CytoMed Therapeutics, based in Singapore, is an R&D company specializing in cell-based immunotherapy for cancer treatment. The company’s chimeric antigen receptor (CAR) T cell technology has supported the development of a pipeline of therapies, particularly in the treatment of hematological malignancies. Its leading CAR T cell technology, called CTM-N2D therapy, is poised to enter a Phase I clinical trial for various advanced cancers.

Mineralys Therapeutics

• IPO date: February 9
• IPO share price: $16
• Total: $192 million
• Current share price: $15.25

Mineralys Therapeutics is a Pennsylvania-based biopharma focused on developing targeted drugs for diseases driven by elevated aldosterone levels. Its lead candidate, lorundrostat, has shown promising results in clinical trials for the treatment of uncontrolled hypertension.

Structure Therapeutics

•  IPO date: February 2
•  IPO share price: $15
• Total: $161 million
• Current share price: $33.27

Structure Therapeutics, a clinical-stage biopharma headquartered in California, specializes in developing oral therapeutics for chronic diseases. The company’s IPO can be attributed to positive outcomes from GSBR-1290, an orally available small molecule agonist for treating type 2 diabetes and obesity.

Genelux

• IPO date: January 25
• IPO share price: $6
• Total: $15 million
• Current share price: $33.35

Among California-based Genelux’s candidates is Olvi-Vec (olvimulogene nanivacirepvec), a proprietary oncolytic vaccinia virus tailored to combat ovarian cancer. Through multiple early- and mid-phase clinical trials involving approximately 150 patients, Olvi-Vec has showcased positive efficacy and safety results, according to Cancer Network.

Cadrenal Therapeutics

• IPO date: January 20
• IPO share price: $5
• Total: $7 million
• Current share price: $1.74

Cadrenal Therapeutics, based in Florida, is focused on a cardiorenal therapy called tecarfarin. It’s designed to prevent systemic thromboembolism originating from the heart in patients with end-stage renal disease and atrial fibrillation. This drug is an oral anticoagulant and a vitamin K antagonist, exhibiting a mechanism of action similar to warfarin, which is prescribed for systemic thromboembolism prevention. The FDA granted Fast Track designation to the drug on Jan. 23, three days after the company went public.

*Reflects IPO totals before deducting underwriting discounts and commissions and other offering expenses payable

**Current prices from Market Watch as of market close, Tuesday, June 11. 

https://www.biospace.com/article/6-life-science-ipos-in-2023/

Incyte’s Opzelura Clears Phase III Trial in Pediatric Atopic Dermatitis

 Top-line data from the Phase III TRuE-AD3 trial showed that Incyte’s Opzelura (ruxolitinib cream) met the study’s primary endpoint and induced treatment success in a higher proportion of children with atopic dermatitis than a control cream, the company announced Tuesday.

Incyte did not provide specific data in its news release but said that significantly more patients achieved the Investigator’s Global Assessment Treatment Success (IGA-TS) after eight weeks of treatment with Opzelura than with a non-medicated cream. Both of Opzelura’s 0.75% and 1.5% doses were statistically better than the control at achieving treatment success.

The IGA-TS defines treatment success as having a score of zero or one, corresponding to clear or almost clear skin, respectively. In addition, patients should demonstrate at least a two-point improvement in the IGA-TS score over eight weeks of treatment. 

Tuesday’s data reinforce “the potential of ruxolitinib cream to offer children a much-needed effective, non-steroidal topical therapy,” Jim Lee, Incyte’s group vice president for inflammation and autoimmunity, said in a statement. 

Incyte will engage regulators to determine the next steps for Opzelura in this indication. The company will also submit TRuE-AD3 data to be presented at an upcoming medical conference.

TRuE-AD3 is a randomized, double-blinded and vehicle-controlled study with more than 300 patients enrolled, all of whom were between the ages of two and 11 years and had been diagnosed with atopic dermatitis (AD) for at least three months.Participants also had IGA scores of two to three and had 3% to 20% of their body surface area covered with AD.

Besides efficacy, TRuE-AD3 also assessed the safety of Opzelura in this indication and found a safety profile consistent with prior published data for ruxolitinib cream. There were no new signals of concern, according to the company. 

Incyte will conduct a long-term safety analysis of Opzelura,which will run for 44 weeks and be open to all patients who successfully complete the initial eight-week efficacy phase.

Opzelura is already approved for mild-to-moderate AD in patients aged 12 years and older, as well as for nonsegmental vitiligo. Its label carries a boxed warning for serious infections, malignancy, major adverse cardiovascular events, thrombosis, and death.

Sanofi also announced a recent win in the AD space. Last month, the company posted promising Phase IIb data for amlitelimab. After 16 weeks of treatment, the investigational antibody met the primary outcome measure of the STREAM-AD study, inducing significant improvements in average Eczema Area and Severity Index (EASI) scores compared with placebo in patients with moderate-to-severe AD.

The French drugmaker won rights to amlitelimab, which targets the OX40-ligand to modulate the inflammatory response, in its January 2021 acquisition of UK biotech Kymab for $1.1 billion.

https://www.biospace.com/article/incyte-s-opzelura-clears-phase-iii-trial-in-pediatric-atopic-dermatitis/

Kamada: Two-Year Extension of KEDRAB® Distribution Agreement in the U.S.

  Kamada Ltd. (NASDAQ: KMDA; TASE: KMDA.TA) (“Kamada” or the “Company”), a commercial stage global biopharmaceutical company with a portfolio of marketed products indicated for rare and serious conditions and a leader in the specialty plasma-derived field, today announced that Kedrion has exercised its option to extend the distribution agreement between the parties in the U.S. for KEDRAB® (Rabies Immune Globulin [Human]), which is indicated for passive, transient post-exposure prophylaxis (PEP) of rabies infection to persons of all ages when given immediately after contact with a rabid or possibly rabid animal. The current agreement now extends through March 2026, and the companies are in discussions to potentially further expand the scope of the collaboration.

https://www.biospace.com/article/releases/kamada-announces-kedrion-exercised-its-option-for-two-year-extension-of-kedrab-distribution-agreement-in-the-u-s-/

Bellevue Life Sciences Acquisition, OSR in Exclusive Letter of Intent for Business Combination

 Bellevue Life Sciences Acquisition Corp. (Nasdaq: BLAC), a publicly traded special purpose acquisition company ("BLAC"), and OSR Holdings, Ltd. ("OSR Holdings"), a global healthcare holding company, announced today that they have entered into an exclusive, non-binding letter of intent, with the goal of completing a business combination in the fourth quarter of 2023, resulting in OSR Holdings becoming a publicly traded company.

BLAC and OSR Holdings expect to finalize their definitive agreement with respect to the proposed business combination in the coming weeks and plan to announce additional details at that time. Upon completion of the business combination, the surviving company will be renamed as OSR Biosciences, Inc.

About OSR Holdings

OSR Holdings is a global healthcare company that leverages its international network of partners in the US, Europe, and South Korea to develop and license its pipeline of innovative biomedical therapies based on proprietary platform technologies, with the ultimate goal of addressing unmet medical needs. OSR Holdings currently wholly-owns three operating subsidiaries in Switzerland and South Korea, two of which are focused on developing therapeutic drugs in the areas of oncology and osteoarthritis, and the third is a distributor of medical devices for the treatment of neurovascular and other diseases. Additionally, OSR Holdings signed a Letter of Intent on July 7, 2023 to acquire Landmark BioVentures AG, a Swiss company which operates through four different biotech ventures in France with therapeutic focuses on oncology and immunology. For more information, visit www.osr-holdings.com.

https://finance.yahoo.com/news/bellevue-life-sciences-acquisition-corp-204500866.html

'GoodRx, CVS join forces to lower customers' out-of-pocket costs'

 GoodRx (GDRX) announced another big pharmacy benefits manager (PBM) partner Wednesday — CVS's (CVS) Caremark — potentially lowering out-of-pocket costs to a huge swath consumers in the prescription drug market.

The duo is launching a new product, Caremark Cost Saver, that is an automatic offering to help commercially insured customers save on generic drugs at all eligible pharmacies. The new plan goes into effect in January 2024, giving ample time for plan sponsors and employers to opt in.

CVS Caremark is a part of the CVS Health company, but separate from the retail pharmacy chain.

GoodRx co-founder Doug Hirsch told Yahoo Finance the new relationship gives the company access to 70% of those commercially insured, adding to last year's similar partnership with Cigna's (CI) ExpressScripts.

GoodRx currently receives about 200 billion price points per day with its wide variety of PBM and pharmacy relationships.

"Everyone likes to think we're like (only serving) low-income people who are just cash pay. The reality is 75% of people who come to GoodRx have insurance," Hirsch said.

"And we're also looking to get into the Medicare market...and there's more complexity there," Hirsch added, noting it would add yet another large portion of the American population to the database for the company.

The growth in business — and the plug-in from bigger PBMs — means the company significantly increases its bottom line. GoodRx makes money from a fee for every prescription filled originating from its discounted price, in addition to its limited telehealth offerings.

But Hirsch said its a win-win for both consumers and PBMs alike.

"When (customers) show up at the pharmacy counter, they don't have to do anything. They present their insurance, like they normally do, they get a great price, and it counts toward their deductible," he said.

The price paid at the counter counts toward the deductible or out-of-pocket obligations, according to a statement from CVS and GoodRx.

“We work every day to provide a more affordable drug benefit for our CVS Caremark clients and their plan members, and this collaborative prescription discount solution enables us to dynamically shop for the best price on their behalf,” said David Joyner, executive vice president at CVS Health and president of CVS Caremark, in a statement.

“By lowering out-of-pocket costs for our clients’ members, Caremark Cost Saver will help patients afford to take their medicine as directed," Joyner said.

https://finance.yahoo.com/news/goodrx-cvs-join-forces-to-lower-customers-out-of-pocket-costs-100037919.html