On October 20, 2022 Erasca, Inc. (Nasdaq: ERAS), a clinical-stage precision oncology company singularly focused on discovering, developing, and commercializing therapies for patients with RAS/MAPK pathway-driven cancers, reported a clinical trial collaboration and supply agreement (CTCSA) with Pfizer Inc. (NYSE: PFE) for the CDK4/6 inhibitor palbociclib (IBRANCE) (Press release, Erasca, OCT 20, 2022, View Source [SID1234622228]).

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This agreement will support a clinical proof-of-concept study evaluating ERAS-007, an oral ERK1/2 inhibitor, in combination with palbociclib for the treatment of patients with KRAS- and NRAS-mutant colorectal cancer (CRC) and KRAS-mutant pancreatic ductal adenocarcinoma (PDAC). The combination is currently being investigated as part of the ongoing Phase 1b/2 HERKULES-3 master protocol clinical trial in patients with gastrointestinal (GI) malignancies. Erasca is sponsoring the study, and Pfizer is supplying palbociclib at no cost.

"We are excited to expand our existing relationship with Pfizer to explore ERAS-007 in combination with palbociclib in RAS-mutated GI malignancies as part of our HERKULES-3 program," said Jonathan E. Lim, M.D., Erasca’s chairman, CEO, and co-founder. "Preclinical evidence supports synergistic anti-tumor effects when downstream RAS/MAPK pathway inhibition is combined with cell cycle inhibition in CRC and PDAC. ERAS-007 blocks RAS/MAPK pathway signaling at the terminal node with robust inhibitory activity across RAS mutations, while data support palbociclib inhibition of CDK4/6 leading to cell cycle arrest. Based on their respective mechanisms of action, ERAS-007 and palbociclib offer a promising combination to overcome adaptive resistance in patients with these highly prevalent oncogenic drivers."

Worldwide, approximately 1.8 million cases of CRC are diagnosed annually, with about 50% of patients harboring KRAS or NRAS mutations. PDAC accounts for an estimated 0.5 million new cases diagnosed annually, with over 90% harboring a KRAS mutation. Lack of effective treatment availability and emergence of compensatory mechanisms of resistance continue to challenge the ability to achieve and maintain responses in these GI malignancies. Erasca is exploring whether inhibiting ERK1/2, the terminal node of the RAS/MAPK signaling pathway, in combination with palbociclib can limit the development of treatment resistance and further improve therapeutic benefits.

About ERAS-007
ERAS-007 is a potential best-in-class ERK1/2 inhibitor being investigated alone or in combination with different inhibitors targeting upstream nodes of the RAS/MAPK pathway as part of Erasca’s MAPKlamp strategy. The extracellular signal-regulated kinases (ERK), ERK1 and ERK2, belong to a family of serine-threonine kinases that regulate cellular signaling and comprise the terminal node of the RAS/MAPK pathway. ERAS-007 is being investigated across a series of HERKULES clinical trials that span multiple tumor types and include both monotherapy and combinations with approved and investigational agents, such as RTK, SHP2, RAS, RAF, and/or cell cycle inhibitors. HERKULES-1 is a Phase 1b/2 clinical trial for ERAS-007 as a single agent and in combination with the SHP2 inhibitor ERAS-601 (together, Erasca’s first MAPKlamp) in advanced solid tumors. HERKULES-2 is a Phase 1b/2 master protocol clinical trial for ERAS-007 in combination with various agents in patients with non-small cell lung cancer (NSCLC). HERKULES-3 is a Phase 1b/2 master protocol clinical trial for ERAS-007 in combination with various agents in patients with GI cancers.

On October 20, 2022 Agios Pharmaceuticals, Inc. (NASDAQ: AGIO), a leader in the field of cellular metabolism pioneering therapies for rare and genetically defined diseases, reported the company will host a conference call and live webcast on Thursday, November 3, 2022, at 8:00 a.m. ET to report its third quarter 2022 financial results and other business highlights (Press release, Agios Pharmaceuticals, OCT 20, 2022, https://investor.agios.com/news-releases/news-release-details/agios-webcast-conference-call-third-quarter-2022-financial [SID1234622227]).

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A live webcast can be accessed under "Events & Presentations" in the Investors section of the company’s website at www.agios.com. The webcast will be archived and made available for replay on the company’s website beginning approximately two hours after the event.

On October 20, 2022 Quest Diagnostics Incorporated (NYSE: DGX), the world’s leading provider of diagnostic information services, reported that financial results for the third quarter ended September 30, 2022 (Press release, Quest Diagnostics, OCT 20, 2022, View Source [SID1234622226]).

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"We accelerated growth in the base business in the third quarter, with a strong performance across much of the country," said Jim Davis, CEO-elect. "Our base business revenue grew five percent year-over-year in the third quarter, with performance rebounding in August and September from the softer volume trends we saw earlier in the year. At the same time, we continued to invest in advanced diagnostics and consumer initiated testing while managing our cost structure to help offset inflationary pressures and declining COVID-19 volumes."

Steve Rusckowski, Chairman, CEO and President said: "Our strong performance in the base business occurred despite the impact of Hurricane Ian. I’m proud of the efforts of our colleagues in the Southeast to quickly restore services to our customers. Based on our performance in the quarter we have raised our outlook for the remainder of 2022."

Mr. Davis will assume the responsibilities of CEO and President on November 1, 2022. Mr. Rusckowski will remain as Executive Chairman through March 2023.

"On behalf of our 50,000 Quest colleagues I would like to thank Steve for his leadership of Quest Diagnostics over the last 10 years," said Mr. Davis. "We are grateful for his efforts, and excited about what lies ahead for the future of this company."

(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.

(c) 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, certain financial impacts resulting from the COVID-19 pandemic, 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, a gain on sale of an ownership interest in a joint venture, 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 October 20, 2022 until midnight Eastern Time on November 3, 2022, by phone at 888-566-0462 for domestic callers or 203-369-3609 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.

The sum of reported and adjusted diluted EPS for the first three quarters of 2021 did not equal the totals for the nine months ended September 30, 2021 due to both quarterly fluctuations in the company’s earnings and in the weighted average common shares outstanding throughout the period as a result of the impact of accelerated share repurchase agreements that the company entered into during April 2021.

On October 20, 2022 PDX Pharma reported to be among seven companies that won a matching grant for phase II small business innovative research (SBIR) from Oregon State Lottery funds administered by Oregon Business Development Department (Press release, PDX Pharmaceuticals, OCT 20, 2022, View Source [SID1234622225]). The award will be used for our IP protection, financing a new facility, and fundraising activities.

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On October 20, 2022 Plus Therapeutics, Inc. (Nasdaq: PSTV) (the "Company"), a clinical-stage pharmaceutical company developing innovative, targeted radiotherapeutics for rare and difficult-to-treat cancers, reported financial results for the third quarter ended September 30, 2022, and provided an overview of recent business highlights (Press release, Cytori Therapeutics, OCT 20, 2022, View Source [SID1234622224]).

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"The third quarter of 2022 was another period of significant progress for Plus Therapeutics, highlighted by the achievement of three key milestones," said Marc H. Hedrick M.D., President and Chief Executive Officer of Plus Therapeutics. "First, our CPRIT award of $17.6 million substantially funds the LM program through Phase 2 for our lead investigational drug, Rhenium-186 Nanoliposome (186RNL). Second, we moved 186RNL toward a Phase 2 trial for recurrent GBM, which we expect to initiate in the fourth quarter of 2022. Third, we met our timeline for cGMP 186RNL drug availability for all future trials. In addition, the combination of current cash, committed grant funding in conjunction with existing discretionary capital sources, secures our cash runway through 2025."

RECENT HIGHLIGHTS

On September 9, 2022, Dr. Andrew Brenner, ReSPECT-GBM trial principal investigator, presented Phase 1 results from the ReSPECT-GBM Phase 1/2a dose escalation trial evaluating 186RNL in patients with recurrent GBM at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2022. The Phase 1 results demonstrated safety and a potential efficacy signal in heavily pretreated patients with recurrent GBM.
On August 17, 2022, Plus Therapeutics announced the award of a three-year, $17.6 million Product Development Research grant by the Cancer Prevention & Research Institute of Texas (CPRIT) to fund 186RNL for the treatment of patients with LM.
On August 29, 2022, Plus announced a summary of its Type C meeting with the U.S. Food and Drug Administration (FDA) regarding the CMC program for 186RNL. The Company determined that it may proceed in utilizing its 186RNL in its planned Phase 2 programs.
On September 6, 2022, Plus announced a summary of its Type C meeting with the FDA regarding its clinical development program for 186RNL for recurrent GBM. Based on that meeting, the Company plans to begin a Phase 2 trial of 186RNL in patients with recurrent GBM, with a focus on small and medium-sized tumors. The Company will also continue exploration of both higher and multiple doses of 186RNL.
The Company initiated enrollment of Cohort 2 of the ReSPECT-LM Phase 1/2a dose escalation trial of 186RNL in patients with LM.
On October 18, 2022, at the 35th Annual Congress of the European Association of Nuclear Medicine (EANM), the Company presented data from two ongoing clinical trials evaluating 186RNL in recurrent GBM and LM. The findings presented at EANM indicate the potential for 186RNL as a safe, well-tolerated and promising radiotherapeutic for both GBM and LM.
THIRD QUARTER 2022 FINANCIAL RESULTS

The Company’s cash balance was $20.3 million at September 30, 2022, compared to $18.4 million at December 31, 2021. The Company believes that the current cash on hand, anticipated funding from the National Institutes of Health (NIH) and CPRIT and existing discretionary capital sources are sufficient to fund both its currently planned overhead and development expenses through 2025.
Grant revenue of $73,000 was recognized in the third quarter of 2022, which represents CPRIT’s initial share of the costs incurred for development of 186RNL for the treatment of patients with LM. The Company expects the first CPRIT grant funds of approximately $1.9 million to be disbursed to the Company by October 31, 2022.
Total operating expenses for the third quarter of 2022 were $5.2 million, compared to total operating expenses of $3.5 million for the third quarter of 2021. The increase is due primarily to incremental CMC spend, now winding down, related to the development of GMP 186RNL drug and key regulatory consulting activities. In addition, to a lesser extent, the Company had a forecasted increase in litigation, legal, professional fees and other general corporate expenses.
Net loss for the third quarter of 2022 was $5.2 million, or $(0.19) per share, compared to a net loss of $3.7 million, or $(0.28) per share, for the third quarter of 2021.
UPCOMING EVENTS AND MILESTONES

During the remainder of 2022, the Company expects to accomplish the following key business objectives:

ReSPECT-GBM Phase 2 clinical trial initiation
Present updated data from the ReSPECT-GBM and ReSPECT-LM trials at the Society for Neuro-Oncology (SNO) Annual Meeting and Education Day, November 17-20, 2022
Complete Cohort 2 of ReSPECT-LM Phase 1/2a dose escalation trial
Submit an Investigational New Drug (IND) application to the FDA for the study of 186RNL in patients with pediatric brain cancer (ReSPECT-PBC), ependymoma and high-grade glioma
Complete certain key CMC and IND-enabling studies for 188RNL-BAM
Third Quarter 2022 Results Conference Call

The Company will hold a conference call and live audio webcast at 5:00 p.m. Eastern Time today to discuss its financial results and provide a general business update.

A live webcast will be available at ir.plustherapeutics.com/events.

Participants may also pre-register any time before the call here. Once registration is completed, participants will be provided a dial-in number with a personalized conference code to access the call. Please dial in 15 minutes prior to the start time.

Following the live call, a replay will be available on the Company’s website under the ‘For Investor’ section. The webcast will be available on the Company’s website for 90 days following the live call.