On February 1, 2024 RS Oncology (RSO), a clinical stage biotechnology company developing innovative therapies to eradicate mesothelioma and other diseases, reported the successful dosing of the first patient in the Phase 2 dose expansion portion of its United Kingdom multicenter study (MITOPE; NCT05278975) (Press release, RS Oncology, FEB 1, 2024, View Source [SID1234639791]).

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Malignant pleural effusion (MPE) is the build up of fluid in the lining membrane (pleura) of the lungs. MPE is a common clinical symptom in patients with various malignancies (~15% of end-stage cancer patients) and produces significant morbidity in the majority of affected patients. RSO’s novel, investigational anti-cancer treatment, RSO-021, is administered weekly directly into the pleural space following MPE drainage via an indwelling pleural catheter. RSO recently (4Q 2023) completed the Phase 1 dose escalation portion of its MITOPE trial and established a recommended Phase 2 dose and safety/tolerability profile of RSO-021 in a relapse setting.

Recently, RSO has expanded the Phase 2 portion of MITOPE and is now investigating RSO-021 anticancer activity in patients:

First presenting with MPE due to malignant pleural mesothelioma (MPM) and before standard-of-care (SOC) treatment (a window of opportunity arm).

With MPE who have failed first line SOC treatment and have relapsed disease.

With local metastatic lung disease and MPE.

With MPE due to advanced metastatic breast, ovarian and non-small cell lung cancers (in combination with systemic paclitaxel).

"Mesothelioma has notoriously been a difficult cancer to treat, especially since patients are often diagnosed in the more advanced stages," said Prof. Dean Fennell, Director of the Mesothelioma Research Programme at Leicester University Hospitals. "RSO-021 exhibits a unique mechanism of action that we believe could provide new hope to patients with this disease."

"RSO-021 is an exciting novel anti-cancer treatment that can potentially help a global population of cancer patients who are left with little to no options," said Jarrett Duncan, CEO of RS Oncology. "Commencing the Phase 2 portion of our trial presents a major milestone for patients and their caregivers."

About RSO-021

RSO-021 is a novel small molecule treatment that irreversibly binds mitochondrial peroxiredoxin 3 (PRX3). Preclinical studies with RSO-021 have shown that inhibition of the antioxidant signaling network results in selective killing of malignant cells by upregulating oxidative stress; in contrast, healthy cells are spared.

On February 1, 2024 Revolution Medicines, Inc. (Nasdaq: RVMD), a clinical-stage oncology company developing targeted therapies for RAS-addicted cancers, reported that Mark A. Goldsmith, M.D., Ph.D., the company’s chief executive officer and chairman, will be a featured speaker at the Guggenheim Healthcare Talks 6th Annual Biotechnology Conference and the TD Cowen 44th Annual Health Care Conference (Press release, Revolution Medicines, FEB 1, 2024, View Source [SID1234639790]).

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Details of the company’s participation are as follows:

Guggenheim Healthcare Talks 6th Annual Biotechnology Conference
Conference Dates: February 7-8, 2024
Fireside Chat Time/Date: 3:00 p.m. Eastern on Wednesday, February 7, 2024
Location: New York, NY; webcast available
TD Cowen 44th Annual Health Care Conference
Conference Dates: March 4-6, 2024
Fireside Chat Time/Date: 2:10 p.m. Eastern on Wednesday, March 6, 2024
Location: Boston, MA; webcast available

To access the live webcasts of the presentations, please visit the "Events & Presentations" page of Revolution Medicines’ website at View Source Additionally, replays of the webcasts will be available on the "Events & Presentations" page of the Revolution Medicines website for at least 14 days following each conference.

On February 1, 2024 Quest Diagnostics Incorporated (NYSE: DGX), the world’s leading provider of diagnostic information services, reported financial results for the fourth quarter and full year ended December 31, 2023 (Press release, Quest Diagnostics, FEB 1, 2024, View Source [SID1234639789]).

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"We delivered strong revenue growth in our base business of 7% for the full year 2023 and delivered on our earnings commitment as we transitioned away from COVID testing," said Jim Davis, Chairman, CEO, and President. "We made progress during the year advancing our growth strategy with innovative testing solutions, new and expanded relationships with health systems, and a robust pipeline of M&A and professional lab services opportunities. We also delivered double-digit revenue growth in several clinical areas, including in advanced cardiometabolic, prenatal and hereditary genetics, and neurology, as well as strengthened our oncology offering with a strategic investment in higher growth minimal residual disease testing."

Mr. Davis continued: "Our guidance for 2024 reflects a return to overall revenue growth while balancing the earnings tailwinds and headwinds we see for the year. Looking beyond 2024, we are well positioned to deliver our long-term financial outlook to drive mid-single digit revenue growth and high-single digit earnings growth. Finally, I’m grateful to our dedicated Quest colleagues who bring our purpose to life every day, working together to create a healthier world, one life at a time."

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Three Months Ended December 31,

Twelve Months Ended December 31,

2023

2022

Change

2023

2022

Change

(dollars in millions, except per share data)

Reported:

Net revenues

$ 2,288

$ 2,333

(1.9) %

$ 9,252

$ 9,883

(6.4) %

Base business revenues (a)

$ 2,251

$ 2,149

4.7 %

$ 9,029

$ 8,429

7.1 %

COVID-19 testing revenues

$ 37

$ 184

(79.8) %

$ 223

$ 1,454

(84.7) %

Diagnostic information services revenues

$ 2,221

$ 2,265

(2.0) %

$ 8,976

$ 9,609

(6.6) %

Revenue per requisition

(3.5) %

(5.9) %

Requisition volume

1.9 %

(0.6) %

Organic requisition volume

1.4 %

(1.0) %

Operating income (b)

$ 267

$ 135

98.2 %

$ 1,262

$ 1,428

(11.6) %

Operating income as a percentage of net revenues (b)

11.7 %

5.8 %

5.9 %

13.6 %

14.5 %

(0.9) %

Net income attributable to Quest Diagnostics (b)

$ 192

$ 101

91.3 %

$ 854

$ 946

(9.7) %

Diluted EPS (b)

$ 1.70

$ 0.87

95.4 %

$ 7.49

$ 7.97

(6.0) %

Cash provided by operations

$ 527

$ 334

58.0 %

$ 1,272

$ 1,718

(25.9) %

Capital expenditures

$ 72

$ 147

(51.6) %

$ 408

$ 404

0.9 %

Adjusted (b):

Operating income

$ 338

$ 330

2.1 %

$ 1,457

$ 1,742

(16.3) %

Operating income as a percentage of net revenues

14.8 %

14.2 %

0.6 %

15.8 %

17.6 %

(1.8) %

Net income attributable to Quest Diagnostics

$ 245

$ 229

6.9 %

$ 994

$ 1,181

(15.9) %

Diluted EPS

$ 2.15

$ 1.98

8.6 %

$ 8.71

$ 9.95

(12.5) %

(a)

Excludes COVID-19 testing.

(b)

For further details impacting the year-over-year comparisons related to operating income, operating income as a percentage of net revenues, net income attributable to Quest Diagnostics, and diluted EPS, see note 2 of the financial tables attached below.

Dividend Increased

Quest Diagnostics’ Board of Directors has authorized a 5.6% increase in its quarterly dividend from $0.71 to $0.75 per share, or $3.00 per share annually, effective with the dividend payable on April 22, 2024 to shareholders of record of Quest Diagnostics common stock on April 8, 2024. The company has raised its dividend annually since 2011.

Guidance for Full Year 2024

We estimate full year 2024 guidance as follows:

Low

High

Net revenues

$9.35 billion

$9.45 billion

Net revenues increase

1.1 %

2.1 %

Reported diluted EPS

$7.69

$7.99

Adjusted diluted EPS

$8.60

$8.90

Cash provided by operations

Approximately $1.3 billion

Capital expenditures

Approximately $420 million

Note on Non-GAAP Financial Measures

As used in this press release the term "reported" refers to measures under accounting principles generally accepted in the United States ("GAAP"). The term "adjusted" refers to non-GAAP operating performance measures that exclude special items such as restructuring and integration charges, amortization expense, excess tax benefits ("ETB") associated with stock-based compensation, costs associated with donations, contributions, and other financial support through Quest for Health Equity (our initiative with the Quest Diagnostics Foundation to reduce health disparities in underserved communities), gains and losses associated with changes in the carrying value of our strategic investments, impairment charges, and other items.

Non-GAAP adjusted measures are presented because management believes those measures are useful adjuncts to GAAP results. Non-GAAP adjusted measures should not be considered as an alternative to the corresponding measures determined under GAAP. Management may use these non-GAAP measures to evaluate our performance period over period and relative to competitors, to analyze the underlying trends in our business, to establish operational budgets and forecasts and for incentive compensation purposes. We believe that these non-GAAP measures are useful to investors and analysts to evaluate our performance period over period and relative to competitors, as well as to analyze the underlying trends in our business and to assess our performance. The additional tables attached below include reconciliations of non-GAAP adjusted measures to GAAP measures.

Conference Call Information

Quest Diagnostics will hold its quarterly conference call to discuss financial results beginning at 8:30 a.m. Eastern Time today. The conference call can be accessed by dialing 888-455-0391 within the U.S. and Canada, or 773-756-0467 internationally, passcode: 7895081; or via live webcast on our website at www.QuestDiagnostics.com/investor. We suggest participants dial in approximately 10 minutes before the call.

A replay of the call may be accessed online at www.QuestDiagnostics.com/investor or, from approximately 10:30 a.m. Eastern Time on February 1, 2024 until midnight Eastern Time on February 15, 2024, by phone at 800-934-9421 for domestic callers and 203-369-3391 for international callers. Anyone listening to the call is encouraged to read our periodic reports, on file with the Securities and Exchange Commission, including the discussion of risk factors and historical results of operations and financial condition in those reports.

On February 1, 2024 Purple Biotech Ltd. ("Purple Biotech" or "the Company") (NASDAQ/TASE: PPBT), a clinical-stage company developing first-in-class therapies that harness the power of the tumor microenvironment to overcome tumor immune evasion and drug resistance, reported that it has determined 100mg/kg is the recommended Phase 2 dose (RP2D) for NT219 in combination with cetuximab in the treatment of head and neck cancer based on its Phase 1/2 dose escalation study (NCT04474470) (Press release, Purple Biotech, FEB 1, 2024, View Source [SID1234639787]). NT219 is a first-in-class small molecule dual inhibitor of IRS1/2 and STAT3.

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The RP2D was determined based on data from the open-label dose escalation study designed to assess the safety, pharmacokinetics, pharmacodynamics and efficacy of NT219 in combination with Erbitux (cetuximab), in previously treated recurrent and/or metastatic (R/M) squamous cell carcinoma of the head and neck (SCCHN) patients. The Company recently reported that NT219, in combination with cetuximab, demonstrated a dose dependent anti-tumor activity with confirmed partial responses. No dose-limiting toxicities were reported. The additional supporting data used for this determination was pharmacokinetics of NT219 across all dose levels. Further dose optimization is planned for future studies.

The Phase 1 dose escalation study is being concluded and the remaining patients’ data are expected to be reported during the first half of 2024. The Company is now advancing its upcoming Phase 2 Proof of Concept study of NT219 for the treatment of R/M SCCHN.

Detailed clinical results from the dose escalation portion of the study are intended to be presented at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Targeted Anticancer Therapies (ESMO TAT) Congress 2024 in Paris on February 26, 2024, in an Oral Presentation titled "Interim results of a Phase 1/2 trial of NT219 in combination with cetuximab in patients with advanced/metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)."

"This is a major milestone for the development of NT219 for an indication in need of more effective therapies. As we progress into a Phase 2 study, our goal is to establish NT219 as standard of care for squamous cell carcinoma of the head and neck for patients who have not responded to first line treatments," stated Gil Efron, Chief Executive Officer of Purple Biotech. "We look forward to treating more patients with NT219 in a Phase 2 study."

About NT219

NT219 is a first-in-class, small molecule that promotes Insulin Receptor Substrates 1/2 (IRS) degradation and inhibits Signal Transducer and Activator of Transcription 3 (STAT3) phosphorylation, two major complementary signalling pathways that play a key role in the tumor and its microenvironment. IRS1/2 acts as scaffolds, organizing signalling complexes that mediate mitogenic, metastatic, angiogenic, and anti-apoptotic signals from IGF1R and other oncogenes, consisting of an important driver in multiple cancers and is highly involved in triggering drug resistance. STAT3 is a transcription factor that is broadly hyperactivated in many cancers, promoting proliferation, survival, angiogenesis, metastasis, and tumor immune evasion. Feedback activation of STAT3 plays a prominent role in mediating drug resistance to various anti-cancer therapies. As an inhibitor of both IRS1/2 and STAT3, NT219 has the potential to prevent the development of resistance to multiple approved therapies.

On February 1, 2024-Panbela Therapeutics, Inc. (Nasdaq: PBLA), a clinical stage company developing disruptive therapeutics for the treatment of patients with urgent unmet medical needs, reported the closing of its previously announced public offering of (i) 4,375,000 shares of its common stock or pre-funded warrants in lieu thereof and (ii) two classes of warrants to purchase up to an aggregate of 8,750,000 shares of its common stock (the "Public Warrants") at a purchase price of $2.06 per share and associated Public Warrants and $2.059 per pre-funded warrant and associated Public Warrants (Press release, Panbela Therapeutics, FEB 1, 2024, View Source [SID1234639786]). The prefunded warrants have an exercise price of $0.001 per share. The Public Warrants have an exercise price of $2.06 per share, are exercisable upon issuance, and will expire five years following the date of issuance. The Public Warrants do not have any alternative cashless exercise or other provisions to adjust their exercise price beyond customary proportionate adjustments for recapitalizations and similar events.

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Roth Capital Partners acted as sole placement agent of the offering.

Gross proceeds, before deducting placement agent fees and commissions and offering expenses, were approximately $9.0 million. The Company intends to use the net proceeds from the proposed offering for the continued clinical development of its product candidates, working capital, business development and other general corporate purposes, which may include repayment of debt.

The securities described above were offered pursuant to a registration statement on Form S-1 (File No. 333-276367), as amended, that was declared effective by the U.S. Securities and Exchange Commission ("SEC"), on January 26, 2024. The offering was made solely by means of a prospectus. Copies of the accompanying prospectus relating to and describing the terms of the offering may be obtained at the SEC’s website at www.sec.gov or by contacting Roth Capital Partners, LLC, 888 San Clemente Drive, Suite 400, Newport Beach, CA 92660 or by email at [email protected].