On August 2, 2022 4SC AG (4SC, FSE Prime Standard: VSC) reported that it will publish its half-year report 2022 on 9 August 2022 (Press release, 4SC, AUG 2, 2022, View Source [SID1234617290]). On this day, the Management of 4SC AG will host a conference call at 2 pm CEDT (8 am EDT) to inform about important developments in the reporting period and beyond .

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Investors, financial analysts, and journalists interested in participating in the conference call can access via the telephone numbers stated below. Please join the event conference 5-10 minutes prior to the start time. You will be asked to provide the confirmation code.

A presentation document supporting the conference call will be available on 9 August 2022, at 4SC’s website. After the event, a replay can be accessed from there as well.

On August 2, 2022 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for cancer, reported that it filed a lawsuit against Foresight Diagnostics Inc. for infringement of Personalis’ U.S. Patent Nos. 10,450,611, 11,299,783, and 11,384,394 (Press release, Personalis, AUG 2, 2022, View Source [SID1234617306]). These patents are part of Personalis’ intellectual property portfolio in the field of whole genome-enabled, tumor-informed molecular residual disease (MRD) testing.

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Personalis’ patent portfolio protects its pioneering work in whole genome sequencing to identify mutations that indicate the continued presence or recurrence of cancer with part-per-million sensitivity. Personalis is seeking both injunctive relief and monetary damages based upon Foresight’s infringement of these patents.

"Personalis has been active in whole human genome sequencing from very early on. By 2013, when we first began filing the applications that led to the patents we are asserting against Foresight, Personalis had already received customer orders to sequence and analyze over 1,000 human genomes and had realized the power of utilizing whole genome sequencing alongside our advanced targeted sequencing methods," said Personalis CEO, John West.

Personalis launched its ultra-sensitive MRD solution, NeXT Personal, in late 2021. NeXT Personal leverages many elements of the asserted patents, including the use of whole genome sequencing to identify up to 1,800 variants that are specific to a patient’s cancer, thereby achieving superior signal-to-noise in the detection of ctDNA in plasma samples. NeXT Personal is purpose-built to accurately detect MRD in patient samples with low overall ctDNA, which is particularly important for cancers that have low shedding or low mutational burden, such as breast and prostate cancers, or soon after resection.

"Personalis has invested hundreds of millions of dollars in research and development across a broad array of disciplines for over a decade, and we stand firm in our resolve to protect that investment and our leadership position in the field. NeXT Personal is our most recent product leveraging our pioneering work. We believe that it represents the most sensitive MRD approach for solid tumors and can be transformational in cancer, detecting residual disease and recurrence, and in actively fighting cancer after recurrence has been detected," Mr. West added.

About NeXT Personal

NeXT Personal is a next-generation, tumor-informed liquid biopsy assay designed to detect and quantify MRD and recurrence in patients previously diagnosed with cancer. The assay is designed to deliver industry-leading MRD sensitivity down to the 1 part-per-million range, an approximately 10- to 100-fold improvement over other available technologies. It leverages whole genome sequencing of a patient’s tumor to identify up to 1,800 specially selected somatic variants that are subsequently used to create a personalized liquid biopsy panel for each patient. This may enable earlier detection across a broader variety of cancers and stages, including typically challenging early-stage, low mutational burden, and low-shedding cancers. NeXT Personal is also designed to simultaneously detect and quantify clinically relevant mutations in ctDNA that may be used in the future to help guide therapy when cancer is detected. These include known targetable cancer mutations, drug resistance mutations, and new variants that can emerge and change over time, especially under therapeutic pressure.

On August 2, 2022 Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), reported financial results for the three months ended June 30, 2022 and provided an update on key milestones (Press release, Lexicon Pharmaceuticals, AUG 2, 2022, View Source [SID1234617327]).

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"We received acceptance last week of our New Drug Application (NDA) for sotagliflozin for the treatment of heart failure with a standard review assigned by the FDA and a PDUFA action date anticipated in May 2023," said Lonnel Coats, Lexicon’s chief executive officer. "As we mentioned in the announcement of the acceptance, we are seeking a broad heart failure label in the NDA, informed by our regulatory discussions, that encompasses heart failure patients with and without diabetes. We believe that the results of SOLOIST-WHF in patients admitted for recent worsening heart failure will be an important element distinguishing our proposed label."

"In another major accomplishment this quarter, we announced positive top-line results from our Phase 2 RELIEF-DPN-1 study of LX9211 in painful diabetic neuropathy at the end of June, achieving proof-of-concept for LX9211 with its novel mechanism of action in a historically difficult to treat indication," Mr. Coats continued. "We expect to report top-line results in the fourth quarter of this year from a second proof-of-concept study of LX9211 in post-herpetic neuralgia. We believe that our recent achievements for both sotagliflozin and LX9211 have the potential to be transformative for our organization, our stakeholders, and most importantly, patients."

Second Quarter Highlights

Sotagliflozin

A poster was presented at the 6th Annual HEART IN DIABETES Conference evaluating the effect of sotagliflozin on major adverse cardiovascular events (MACE: cardiovascular [CV] death, non-fatal myocardial infarction [MI] and non-fatal stroke) across the sotagliflozin clinical program of over 20,000 patients with type 1 or type 2 diabetes. The results showed that treatment with sotagliflozin was associated with a statistically significant and clinically meaningful reduction in MACE in patients with T1D and T2D.
A new analysis of data from the SCORED Phase 3 clinical trial of sotagliflozin was presented at the 82nd Scientific Sessions of the American Diabetes Association. The analysis showed that treatment with sotagliflozin significantly reduced HbA1c overall and across prespecified subgroups, including those with stage 4 chronic kidney disease with a severe decrease in glomerular filtration rate (eGFR <30mL/min/1.73m2), possibly reflecting the dual SGLT-1/2 mechanism of action of sotagliflozin.
LX9211

Positive top-line results for the Phase 2 proof-of-concept study of LX9211 for the treatment of painful diabetic neuropathy (RELIEF-DPN-1) were achieved at the end of the second quarter of 2022. Full results from the complete RELIEF-DPN-1 study are expected to be presented at a medical meeting in the fourth quarter of 2022.
Patient enrollment continued in the Phase 2 proof-of-concept study of LX9211 for the treatment of post-herpetic neuralgia (RELIEF-PHN-1), from which top-line results are expected in the fourth quarter of 2022.
Second Quarter 2022 Financial Highlights

Research and Development (R&D) Expenses: Research and development expenses for the second quarter of 2022 increased to $13.4 million from $10.3 million for the corresponding period in 2021, primarily due to increases in salaries and benefits and higher professional and consulting costs related to the resubmission of our NDA for sotagliflozin.

Selling, General and Administrative (SG&A) Expenses: Selling, general and administrative expenses for the second quarter of 2022 increased to $10.7 million from $7.9 million for the corresponding period in 2021, primarily due to increases in salaries and benefits, professional and consulting costs and marketing costs relating to preparations for the commercial launch of sotagliflozin.

Net Loss: Net loss for the second quarter of 2022 was $24.6 million, or $0.16 per share, as compared to a net loss of $18.1 million, or $0.13 per share, in the corresponding period in 2021. For the second quarters of 2022 and 2021, net loss included non-cash, stock-based compensation expense of $2.8 million for both quarters.

Cash and Investments: As of June 30, 2022, Lexicon had $62.0 million in cash and investments, as compared to $86.7 million as of December 31, 2021. This amount does not include $82.2 million in approximate net proceeds received from the company’s July 27, 2022 public offering and concurrent private placement of its common stock.

Conference Call and Webcast Information

Lexicon management will hold a live conference call and webcast today at 5:00 pm ET / 4:00 pm CT to review its financial and operating results and to provide a general business update. The dial-in number for the conference call is 888-886-7786 and the conference ID for all callers is 78319165. The live webcast and replay may be accessed by visiting Lexicon’s website at www.lexpharma.com/events. An archived version of the webcast will be available on the website for 14 days.

On August 2, 2022 Blueprint Medicines Corporation (NASDAQ: BPMC) reported that financial results and provided a business update for the second quarter ended June 30, 2022 (Press release, Blueprint Medicines, AUG 2, 2022, View Source [SID1234617259]).

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"We are now one year into the AYVAKIT launch in advanced systemic mastocytosis (SM) and continue to see a significant expansion of our prescriber base as well as strong patient demand, reinforcing our conviction in the growth opportunity in SM," said Kate Haviland, Chief Executive Officer of Blueprint Medicines. "We are on track to announce topline data from our registration-enabling PIONEER trial in August, which will catalyze our ability to bring AYVAKIT’s transformative potential to patients living with non-advanced SM. In addition, we continue to make significant progress across our pipeline of innovative investigational medicines in EGFR-mutant and CDK2-vulnerable cancers. We look forward to sharing more about our strategic vision, including the opportunities we see in SM, EGFR-mutant lung cancer, and CDK2-vulnerable cancers, and how our expanding research platform will continue to drive innovation at an Investor Day on November 1, 2022 in New York, NY. With our strong revenue performance, a clinical-stage pipeline of five significant assets, and well over $1 billion in cash on our balance sheet as of today, we are uniquely positioned to drive near- and long-term value for all of our stakeholders by delivering transformative precision medicines to patients around the world."

Second Quarter 2022 Highlights and Recent Progress

AYVAKIT/AYVAKYT (avapritinib): systemic mastocytosis (SM) and PDGFRA gastrointestinal stromal tumor (GIST)

Reported global net product revenues of $28.5 million for the second quarter of 2022.
Presented new retrospective analyses at the European Hematology Association (EHA) (Free EHA Whitepaper) 2022 Congress, showing that AYVAKIT significantly improved overall survival in patients with advanced SM when compared to real-world data for prior best available therapies, including midostaurin and cladribine. Read the press release here.
Upon request by the FDA, changed the primary endpoint for the registrational PIONEER Part 2 trial of AYVAKIT in patients with non-advanced SM to the mean change in total symptom score (TSS).
GAVRETO (pralsetinib): RET-altered cancers

As previously recorded and reported by Roche, GAVRETO global product sales were 7 million CHF, which excludes sales in the Greater China territory driven by CStone Pharmaceuticals.
Received approval in Hong Kong, China, via the collaboration with CStone Pharmaceuticals, for the treatment of RET fusion-positive non-small cell lung cancer (NSCLC).
Corporate

Announced strategic financing collaborations with Sixth Street Partners (Sixth Street) and Royalty Pharma plc (Royalty Pharma) (NASDAQ: RPRX) for up to $1.25 billion, of which $175 million was funded as of June 30, 2022, and an additional $400 million funded in July 2022. Read the press release here.
Licensed a development candidate-stage KIT exon 13 inhibitor, and licensed the compound to IDRx, Inc., a recently launched clinical-stage biopharmaceutical company, in exchange for a 15 percent Series A preferred equity investment and up to $217.5 million in future milestone payments and tiered percentage royalty payments.
Published an inaugural Corporate Responsibility Report, highlighting the company’s long-standing commitment to delivering sustainable value to patients with cancer and blood disorders, as well as the communities in which Blueprint Medicines operates. Read the press release here and access the report here.
Announced the appointment of Habib Dable, former Chief Executive Officer of Acceleron Pharma, Inc., to the company’s Board of Directors. Read the press release here.
Key Upcoming Milestones

The company plans to achieve the following near-term milestones:

Present topline data from the registrational PIONEER Part 2 trial for avapritinib in non-advanced SM in August 2022 and submit a supplemental new drug application to the FDA for AYVAKIT in non-advanced SM in the second half of 2022.
Share the strategic vision for Blueprint, including opportunities in SM, EGFR-mutant lung cancer, and CDK2-vulnerable cancers, and how our expanding research platform has the potential to deliver the promise of precision medicine to more patients at an Investor Day on November 1, 2022 in New York, NY.
Present updated BLU-945 monotherapy data and initial dose escalation data for BLU-945 in combination with osimertinib from the Phase 1/2 SYMPHONY trial in EGFR-mutant NSCLC in the second half of 2022.
Present initial clinical data from the Phase 1/2 HARMONY trial of BLU-701 in EGFR-mutant NSCLC in the second half of 2022.
Present initial data from the HARBOR trial of BLU-263 in non-advanced SM in the second half of 2022.
Present initial clinical data from the Phase 1/2 CONCERTO trial of BLU-451 in EGFR-mutant NSCLC in the first half of 2023.
Present initial clinical data from the Phase 1/2 VELA trial of BLU-222 in CDK2-vulnerable cancers in the first half of 2023.
Second Quarter 2022 Results

Revenues: Revenues were $36.5 million for the second quarter of 2022, including $28.5 million of net product revenues from sales of AYVAKIT/AYVAKYT and $8.0 million in collaboration revenues. Blueprint Medicines recorded revenues of $27.3 million in the second quarter of 2021, including $8.5 million of net product revenues from sales of AYVAKIT/AYVAKIT, $2.9 million of net product revenues from sales of GAVRETO and $15.9 million in collaboration revenues.
Cost of Sales: Cost of sales was $4.9 million for the second quarter of 2022, as compared to $6.5 million for the second quarter of 2021.
R&D Expenses: Research and development expenses were $128.5 million for the second quarter of 2022, as compared to $80.0 million for the second quarter of 2021. This increase was primarily due to increased costs associated with the progression of our clinical trials and increased costs related to early discovery effort. Research and development expenses included $10.5 million in stock-based compensation expenses for the second quarter of 2022.
SG&A Expenses: Selling, general and administrative expenses were $58.7 million for the second quarter of 2022, as compared to $49.3 million for the second quarter of 2021. This increase was primarily due to increased costs associated with expanding our commercial infrastructure for commercialization of AYVAKIT/AYVAKYT. General and administrative expenses included $14.9 million in stock-based compensation expenses for the second quarter of 2022.
Net Loss: Net loss was $159.7 million for the second quarter of 2022, or a net loss per share of $2.68, as compared to a net loss of $108.4 million for the second quarter of 2021, or a net loss per share of $1.86.
Cash Position: As of June 30, 2022, cash, cash equivalents and investments were $947.2 million, as compared to $1,034.6 million as of December 31, 2021. Cash as of June 30, 2022, does not include $400 million gross proceeds received from our strategic non-dilutive financing agreements with Sixth Street, which closed and were funded in July 2022.
Financial Guidance

Blueprint Medicines anticipates approximately $180M to $200M in total revenues in 2022, including approximately $115M to $130M in AYVAKIT net product revenues. The company continues to expect that its existing cash, cash equivalents and investments, together with anticipated future product revenues, will provide sufficient capital to enable the company to achieve a self-sustainable financial profile.

Conference Call Information

Blueprint Medicines will host a live conference call and webcast at 8:00 a.m. ET today to discuss second quarter 2022 financial results and recent business activities. The conference call may be accessed by dialing 844-200-6205 (domestic) or 929-526-1599 (international), and referring to conference ID 694684. A webcast of the call will also be available under "Events and Presentations" in the Investors & Media section of the Blueprint Medicines website at View Source The archived webcast will be available on Blueprint Medicines’ website approximately two hours after the conference call and will be available for 30 days following the call.

On August 2, 2022 Nuvo Pharmaceuticals Inc. (TSX:MRV; OTCQX:MRVFF) d/b/a Miravo Healthcare (Miravo or the Company), a Canadian focused, healthcare company with global reach and a diversified portfolio of commercial products, reported it expects to release its second quarter 2022 financial results before markets open on Monday, August 15, 2022 (Press release, Nuvo Pharmaceuticals, AUG 2, 2022, View Source [SID1234617275]).

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The Company will subsequently hold a conference call the same day, Monday, August 15, 2022 at 11:00 a.m. ET, hosted by Jesse Ledger, Miravo’s President & Chief Executive Officer and other senior management. A question-and-answer session will follow the corporate update.