On August 4, 2022 BioVaxys Technology Corp. (CSE: BIOV) (FRA: 5LB) (OTCQB: BVAXF) ("BioVaxys" or the "Company") reported a non-brokered private placement (the "Private Placement") consisting of up to 10,000,000 units ("Units") at a price of $0.10 per Unit for total gross proceeds of up to approximately $1,000,000 (Press release, BioVaxys Technology, AUG 4, 2022, View Source [SID1234617578]). Each Unit consists of one common share (a "Common Share") and one whole Common Share purchase warrant (a "Warrant") . Each Warrant is exercisable for one additional Common Share at an exercise price of $0.20 for a period of 48 months.

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All securities issued pursuant to the Private Placement are subject to a statutory hold period of four months and one day from the date of issuance. The Company may pay cash finder’s fees on all or a portion of the Private Placement.

The Company intends to use the net proceeds of the Private Placement for working capital purposes. Closing of the Private Placement is subject customary conditions of closing, including the approval of the Canadian Securities Exchange, and is expected to complete on or about August 19th, 2022.

On August 4, 2022 Myriad Genetics, Inc. (NASDAQ: MYGN), a leader in genetic testing and precision medicine, reported financial results for its second quarter ended June 30, 2022 and provided an update on business performance (Press release, Myriad Genetics, AUG 4, 2022, View Source [SID1234617577]).

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"We are pleased with our progress this quarter as we advance our strategic operating plan to drive long term growth and profitability. Our team continues to execute on a disciplined approach to growing our business while managing gross margins and operating expenses despite significant wage and supply chain inflationary pressures. We are particularly excited about the progress of our Mental Health business, as Myriad’s GeneSight Psychotropic test quarterly volumes grew 39% year-over-year and 13% sequentially. We believe this momentum can be sustained as providers and payers digest the positive results of the PRIME Care study where both co-primary endpoints were achieved and remission rates for major depressive disorders showed significant improvement when clinicians had access to GeneSight test results," said Paul J. Diaz, president and CEO, Myriad Genetics.

Mr. Diaz went on to comment, "We also see continued stabilization and opportunities in the marketplace to grow our hereditary cancer and prenatal businesses and are excited about the growth we continue to see in our companion diagnostic business and our prostate cancer prognostic test – Prolaris. I want to thank the entire Myriad Genetics team and our provider partners for their continued efforts to serve our patients and execute on our transformation plan to enhance our product offerings, the experience of our customers and access for our patients."

Financial and Operational Highlights:

Diagnostic test volumes of 260,000 in the second quarter of 2022 increased 9% year-over-year and 7% sequentially from the first quarter of 2022, excluding divested businesses. During the second quarter of 2022, the company’s hereditary cancer volumes stabilized, down 4% year-over-year as compared to the first quarter of 2022 when volumes were down 12% year-over-year.
The following table summarizes sequential and year-over-year quarterly volume changes in the company’s core product categories:

Overall, average selling price (ASP)1 in the second quarter of 2022 decreased 2% year-over-year and increased 2% sequentially, excluding divested businesses.
Total revenue in the second quarter of 2022 was $179.3 million, an increase of 7% year-over-year and 9% sequentially, excluding the divested business revenue from Myriad RBM, Autoimmune and myPath Melanoma. Total revenue was negatively impacted by approximately $2.0 million in the quarter and $3.0 million year-to-date as a result of fluctuations in foreign exchange rates compared to the the prior year. Excluding divestitures, revenue for the six months ended June 30, 2022, increased 9% to $343.9 million compared to revenue for the six months ended June 30, 2021, which is in line with the company’s long term revenue guidance of 9 to 12%.
The following table summarizes year-over-year quarterly revenue changes in the company’s core businesses by product category:
GAAP gross margin in the second quarter of 2022 was 72.3%; adjusted gross margin in the quarter was 72.4%, which improved 30 basis points year-over-year.
GAAP total operating expenses in the second quarter of 2022 were $147.4 million, decreasing $9.1 million year-over-year; adjusted operating expenses in the quarter increased $2.2 million year-over-year to $125.3 million.
GAAP operating loss in the second quarter of 2022 was $17.8 million, improving $3.0 million year-over-year; adjusted operating income was $4.5 million, down $9.0 million year-over-year from $13.5 million.
Diluted GAAP EPS in the second quarter of 2022 were $(0.18), decreasing $0.12 year-over-year; adjusted EPS were $0.04, decreasing $0.08 year-over-year from $0.12.
Ended the second quarter of 2022 with $283.6 million in cash, cash equivalents and investments as compared to $339.2 million at the beginning of the quarter. The decrease of $55.6 million was driven primarily by a $48.0 million payment in connection with the settlement of the qui tam lawsuit filed in 2016. The company ended the quarter with no debt outstanding.
Business Performance and Highlights:

Oncology
The Myriad Genetics Oncology business provides hereditary cancer testing, including the MyRisk hereditary cancer test for patients who have cancer. It also provides tumor profiling products such as the myChoice CDx companion diagnostic test, the Prolaris prostate cancer test, and the EndoPredict breast cancer prognostic test. The Oncology business delivered revenue of $76.1 million in the second quarter of 2022, a decrease of 3% year-over-year and an increase of 9% sequentially from the first quarter of 2022.

Myriad Genetics recently launched Precise Oncology Solutions, which combines the company’s MyRisk germline cancer testing technology and its myChoice CDx companion diagnostic test with Precise Tumor, a tumor profiling test powered by Illumina, Inc.’s TruSight Oncology 500 (TSO500) assay and processed by Intermountain Precision Genomics.
MyChoice CDx reported its highest quarterly volume level in the United States ever in the second quarter of 2022 with quarterly volumes up 63% year-over-year and 10% sequentially from the first quarter of 2022.
Prolaris is a prostate cancer prognostic test designed to assess prostate cancer aggressiveness. The Oncology business achieved its highest quarterly Prolaris volumes in the second quarter of 2022, beating its previous quarterly volume record by 6%.
Women’s Health
The Myriad Genetics Women’s Health business serves women of all ancestries by assessing their risk of cancer and offers prenatal testing solutions for those who are pregnant or planning a family. The Women’s Health business delivered revenue of $70.1 million in the second quarter of 2022, an increase of 4% year-over-year and 7% sequentially from the first quarter of 2022.

Hereditary Cancer
Myriad Genetics continues to address the health inequities and accessibility challenges that exist within the hereditary cancer testing market. Myriad Genetics’ MyRisk hereditary cancer test with RiskScore for all ancestries offers the first and only personalized 5-year and lifetime breast cancer risk assessment for all women, including those of non-European ancestry. RiskScore is available at no additional cost to women who take the MyRisk test.
Prenatal
Myriad Genetics offers its Prequel noninvasive prenatal screen (NIPS), including proprietary AMPLIFY technology, which significantly enhances the test’s performance and works to reduce test failure rates so that patients may avoid unnecessary invasive procedures.
The company also offers its Foresight carrier screen to provide critical genetic insights for patients of all ethnicities.
Mental Health
The Myriad Genetics Mental Health business consists of the GeneSight psychotropic test that covers 64 medications commonly prescribed for depression, anxiety, attention deficit hyperactivity disorder, and other psychiatric conditions. GeneSight helps physicians understand how genetic alterations impact patient response to antidepressants and other drugs. In the pharmacogenomics category, GeneSight recorded revenue of $33.1 million in the second quarter of 2022, an increase of 46% year-over-year and 13% sequentially from the first quarter of 2022.

For the second quarter of 2022, the Mental Health business achieved its highest quarterly GeneSight volumes, beating its previous quarterly volume record by more than 10%.
In July of 2022, the Journal of the American Medical Association published results from the PRIME Care study — the largest pharmacogenomics randomized controlled trial ever conducted in mental health. The study, funded and conducted by the U.S. Department of Veterans Affairs, achieved both of its co-primary endpoints and found that major depressive disorder remission rates were significantly improved when clinicians had access to GeneSight Psychotropic test results. The PRIME Care study further reinforces the body of evidence supporting the clinical utility of pharmacogenomics testing and the GeneSight test as important tools for medication selection in the treatment of major depressive disorder and other mental illnesses.
Key Accomplishments in the Quarter
Myriad Genetics saw additional developments in the second quarter of 2022 including:

Myriad Genetics announced a partnership with Epic Systems Corporation (Epic), the industry leading healthcare software company, to integrate the company’s full line of genetic testing solutions with Epic’s expansive network of 600,000 physicians and more than 250 million patients. We believe the partnership bolsters Myriad Genetics’ growth plans of scaling customer-centric, tech-enabled commercial capabilities with over 600 electronic health record integrations this year.
The company presented multiple studies and showcased Precise Oncology Solutions at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting, demonstrating the value of genetic testing in guiding and clarifying cancer treatment and risk assessment.
Myriad Genetics was selected to participate in United Healthcare’s Preferred Laboratory Network (PLN), effective July 1, 2022. The PLN consists of currently contracted independent, freestanding laboratory care providers that have met higher standards for access, cost, data, quality and service, based on a rigorous application and review process.
The company announced an expansion of its strategic partnership with Intermountain Precision Genomics to add a new liquid biopsy therapy selection test to its growing oncology portfolio. The liquid biopsy test will use Illumina’s TSO500 ctDNA assay and be processed by Intermountain Precision Genomics. The new Precise liquid biopsy offering is expected to be available in 2023.
Myriad Genetics released its first environmental, social and governance report outlining actions taken to expand access to genetic testing, advance social justice, and increase environmental sustainability.
Myriad Genetics’ fiscal year 2022 non-GAAP guidance begins with the comparable GAAP financial measure and excludes the estimated impact of stock-based compensation expense of approximately $40.0 million, non-cash amortization associated with acquisitions of approximately $40.0 million and special items such as costs related to transformation initiatives of approximately $15.0 million. These projections are forward-looking statements and are subject to the risks summarized in the safe harbor statement at the end of this press release.

The company reiterates its fiscal year 2022 revenue and gross margin guidance and updates its guidance for total operating expense and earnings per share. The company is increasing its fiscal year 2022 operating expense guidance by approximately $20.0 million. As a result of current market conditions, the company plans to make opportunistic incremental investments in research and development, technology and sales and marketing programs to access available market share and support its growth initiatives. Inclusive of these additional investments, Myriad’s updated fiscal year 2022 total operating expense guidance reflects a 6% — 8% year-over-year increase from fiscal year 2021 total operating expense, excluding divested businesses. This increase remains in line with current inflationary trends and demonstrates strong cost management even as the company invests in additional commercial and innovation initiatives.
Myriad Genetics will host its 2022 Investor Day at the NASDAQ MarketSite in New York City on August 11, 2022. Investor Day presentations and Q&A will take place from 10:00 a.m. to 12:00 p.m. EDT. For those unable to attend in person, a webcast will be available at the investor site on www.myriad.com.

Conference Call and Webcast
A conference call will be held today, Thursday, August 4, 2022, at 4:30 p.m. EDT to discuss Myriad Genetics’ financial results and business developments for the second quarter 2022. The dial-in number for domestic callers is 1-800-918-9482. International callers may dial 1-212-231-2929. All callers will be asked to reference reservation number 22019815. An archived replay of the call will be available for seven days by dialing 1-800-633-8284 and entering the reservation number above. The conference call and slide presentation will be available through a live webcast at www.myriad.com.

On August 4, 2022 Omega Therapeutics, Inc. (Nasdaq: OMGA) ("Omega"), a clinical-stage biotechnology company pioneering the first systematic approach to use mRNA therapeutics as a new class of programmable epigenetic medicines by leveraging its OMEGA Epigenomic Programming platform, reported financial results for the second quarter ended June 30, 2022, and highlighted recent Company progress (Press release, Omega Therapeutics, AUG 4, 2022, View Source [SID1234617576]).

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"This has been an exciting second quarter for Omega, in which we were thrilled to receive FDA clearance of our first IND application for OTX-2002, representing the first ever Omega Epigenomic ControllerTM, a new class of programmable mRNA therapeutics. This is a critical milestone for Omega as we enter our next phase of growth and reflects our pioneering work to realize the potential of epigenomic programming," said Mahesh Karande, President and Chief Executive Officer of Omega Therapeutics. "Additionally, we were also pleased to share exciting, new supportive preclinical data, both from our lead program OTX-2002 in hepatocellular carcinoma, as well as from another program in our pipeline focused on non-small cell lung cancer, a potential future indication. We look forward to continuing this momentum as we enter the clinic in the second half of this year and further exploring the broad ranging capabilities of our novel platform in additional therapeutic areas."

Recent Business Highlights

Development Pipeline and Platform

Received FDA Clearance of Investigational New Drug (IND) application for OTX-2002, the First Omega Epigenomic ControllerTM (OEC), for MYC driven Hepatocellular Carcinoma (HCC): OTX-2002 is a novel, engineered, and programmable mRNA therapeutic designed to downregulate c-Myc (MYC) expression pre-transcriptionally through epigenetic modulation while potentially overcoming MYC autoregulation. This represents the first ever epigenomic controller, a new class of programmable mRNA therapeutics, to receive IND clearance.
On Track to Launch a Phase 1/2 Clinical Trial Under the MYCHELANGELOTM Clinical Trial Program in HCC patients in the 2H’22: The study consists of Part 1 (OTX-2002 as monotherapy) and Part 2 (OTX-2002 combined with standards of care in HCC). The Phase 1/2 trial will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of OTX-2002 as a monotherapy and in combination with standard of care therapies in patients with relapsed or refractory HCC and other solid tumor types known for association with the MYC oncogene. The study is expected to enroll approximately 190 patients at clinical trial sites in the United States, Asia, and Europe and the Company expects to dose the first patient during the fourth quarter of 2022.
Part 1: This dose escalation portion of the trial will evaluate OTX-2002 monotherapy in patients with relapsed or refractory HCC and other solid tumors. Investigators will utilize a 3+3 design to identify the following primary endpoints of any dose limiting toxicities (DLTs), maximum tolerated dose (MTD), incidence of treatment emergent adverse events (TEAEs), and the recommended dose for expansion (RDE). There will then be a monotherapy expansion for patients with relapsed or refractory HCC who have received at least 1 prior line of systemic anticancer treatment and are without available subsequent standards of care. These patients will receive the RDE of OTX-2002. The primary endpoints of the monotherapy expansion will be overall response rate (ORR) and duration of response (DOR).
Part 2: This portion of the trial will evaluate OTX-2002 in combination with standard of care therapies and will consist of safety run-in and expansion cohorts. During the safety run-in, patients with relapsed or refractory HCC will receive OTX-2002 at the selected dose in combination with one of three current standard of care therapies. These combination partners will be one of two types of tyrosine kinase inhibitors (TKIs) or an immune checkpoint inhibitor (ICI). The primary endpoints of the safety run-in will be DLT, MTD, and incidence of TEAEs. Once the combination therapies have been determined to be tolerable in the safety run-in, patients with relapsed or refractory HCC will be enrolled into the expansion cohorts for each of the combination therapies, with the primary endpoints of ORR and DOR.
New OTX-2002 Preclinical Data Presented at Three Major Medical Meetings Show Robust In Vivo Efficacy and In Vitro Loss of Cancer Cell Viability:
Non-Human Primate (NHP) Data for OTX-2002 in HCC Presented at ESMO (Free ESMO Whitepaper)-GI 2022: Results showed that treatment with OTX-2002 resulted in robust in vivo efficacy in xenograft tumor models and successfully achieved pre-transcriptional downregulation of hepatocyte MYC gene expression in NHPs. These data support the clinical potential of OTX-2002 in combination with existing standard of care therapies for HCC, including ICIs. The ESMO (Free ESMO Whitepaper)-GI poster presentation is available here.
In Vivo Data for OTX-2002 in HCC Presented at AACR (Free AACR Whitepaper) 2022: Results demonstrated that OTX-2002 suppresses MYC gene expression resulting in a loss of cancer cell viability in vitro and a reduction in tumor growth in in vivo xenograft models. These data support the potential of Omega’s platform to engineer programmable mRNA therapeutics that successfully regulate gene expression. The AACR (Free AACR Whitepaper) poster presentation is available here.
In Vivo OEC Data in Models of Non-Small Cell Lung Cancer (NSCLC) Presented at ASGCT (Free ASGCT Whitepaper) 2022: Results demonstrated that regulation of MYC gene expression via epigenomic programming resulted in decreased viability of cancer cells in vitro and reduced tumor burden in in vivo xenograft models. These data support the potential of OECs to precisely and durably regulate gene expression and their potential as a future treatment for NSCLC. The ASGCT (Free ASGCT Whitepaper) poster presentation is available here.
Additional OEC Development: Beyond HCC and NSCLC, the Company is advancing multiple programs through preclinical studies spanning oncology, multigenic diseases including immunology, regenerative medicine, and select monogenic diseases.
OMEGA Epigenomic ProgrammingTM Platform: Omega is creating a new generation of programmable mRNA medicines that are designed to control the fundamental epigenetic processes to correct the root cause of disease by restoring aberrant gene expression to normal levels without altering native nucleic acid sequences. Omega has developed a highly rational and deterministic approach to drug design that enables the Company to rapidly develop and optimize novel OECs with high target specificity to durably tune the expression of single or multiple genes. Omega is advancing multiple preclinical development programs spanning oncology, multigenic diseases including immunology, regenerative medicine, and select monogenic diseases.
Corporate

Joshua Reed Appointed Chief Financial Officer. Mr. Reed brings over 25 years of successful and diverse corporate and financial operations experience including capital raising, business development, and investor relations.
Second Quarter 2022 Financial Results

As of June 30, 2022, the Company had cash, cash equivalents and marketable securities totaling $173.7 million.

Research and development (R&D) expenses for the second quarter of 2022 were $19.4 million, compared to $11.2 million for the second quarter of 2021. The $8.2 million increase in R&D expense was primarily driven by an increase in personnel-related expenses, external manufacturing costs, and study costs in support of the advancement of our programs

General and administrative (G&A) expenses for the second quarter of 2022 were $6.2 million, compared to $3.6 million for the second quarter of 2021. The $2.6 million increase in G&A expense was primarily driven by an increase in personnel-related expenses to support business growth.

Net loss for the second quarter of 2022 was $25.9 million, compared to $15.4 million for the second quarter of 2021, driven predominantly by increased R&D and G&A expenses to support the Company’s growth and operations as a public company.

On August 4, 2022 BioCryst Pharmaceuticals, Inc. (Nasdaq:BCRX) reported financial results for the second quarter ended June 30, 2022, and provided a corporate update (Press release, BioCryst Pharmaceuticals, AUG 4, 2022, View Source [SID1234617575]).

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"With ORLADEYO firmly established in the marketplace as it steadily grows each quarter towards $1 billion in peak sales, our pipeline of other oral drugs for rare diseases and a balance sheet of nearly $500 million alongside our product revenues, BioCryst is uniquely positioned to bring multiple oral medicines for rare diseases to patients," said Jon Stonehouse, president and chief executive officer of BioCryst.

Program Updates and Key Milestones

ORLADEYO (berotralstat): Oral, Once-daily Treatment for Prevention of Hereditary Angioedema (HAE) Attacks

U.S. Launch

ORLADEYO net revenue in the second quarter of 2022 was $65.2 million.

In the second quarter, more new physicians prescribed ORLADEYO than any quarter since the third quarter of 2021.

Prescribing from the top 500 HAE treaters increased in the second quarter with 60 percent of those physicians now having prescribed ORLADEYO. These top 500 physicians accounted for two-thirds of new patient prescriptions in the quarter.

The majority of patients continue to be well controlled on ORLADEYO. Even as the patient base has continued to grow steadily, discontinuations in the second quarter declined to their smallest number since the third quarter of 2021.

Patients continue to have broad and rapid access to ORLADEYO with the median time for a patient to receive reimbursed product following a prescription now under three weeks.

Based on the strong performance of ORLADEYO in the first half of 2022, and the steady quarterly ORLADEYO net revenue growth the company expects in the second half of 2022, the company now expects full year 2022 ORLADEYO net revenue to be between $255 million and $265 million. The company expects peak global net ORLADEYO sales of $1 billion.
"More than a year and a half into the launch of ORLADEYO, we see steady growth and strong momentum, which we expect to continue. The majority of HAE patients are very satisfied with their experience using oral, once-daily ORLADEYO and physicians continue to consistently express their strong intent for future prescribing, which we see translating directly to our growing patient numbers quarter after quarter," said Charlie Gayer, chief commercial officer of BioCryst.

ORLADEYO: Global Updates

In the second quarter, ORLADEYO was approved in Canada and Switzerland. The company expects approvals and launches in additional countries throughout the year.

Also in the second quarter, pricing was finalized in Germany, France and Switzerland.

On June 9, 2022, the company announced it had selected Pint Pharma as its commercial partner for ORLADEYO in Latin America.
Complement Oral Factor D Inhibitor Program – BCX9930

On August 4, 2022, the company announced that the U.S. Food and Drug Administration (FDA) has lifted its partial clinical hold on the BCX9930 program. The company will resume enrollment in global clinical trials under revised protocols at a reduced dose of 400 mg twice daily of BCX9930. This includes the REDEEM-1 and REDEEM-2 pivotal trials in patients with paroxysmal nocturnal hemoglobinuria (PNH) and the RENEW proof-of-concept trial in patients with C3 glomerulopathy (C3G), immunoglobulin A nephropathy (IgAN) and primary membranous nephropathy (PMN).

Clinical evidence and recent laboratory studies have informed the company’s hypothesis that crystals form in the kidneys of some patients. The company believes that lowering the dose to 400 mg and ensuring adequate hydration will dilute the concentration of drug in the urine below the threshold where crystals can form.

The company’s goal is to find a safe and effective dose for BCX9930. The company expects this can be accomplished in a reasonable time frame after resuming enrollment, in a relatively small number of patients given the rate and timing of the serum creatinine rises in patients prior to the enrollment pause.

If successful, the company plans to invest more significantly in BCX9930 to tap the full potential of reaching many patients suffering from a number of alternative pathway diseases, and, if not successful, the company will stop investment in BCX9930 and move on to other molecules in the pipeline.
Additional Updates

On April 27, 2022, the company announced the European Medicines Agency (EMA) had granted PRIME designation to BioCryst’s ALK-2 inhibitor, BCX9250, for the treatment of fibrodysplasia ossificans progressiva.

The EMA also has recently granted orphan drug designation and the FDA has granted fast track status for BCX9250.
Second Quarter 2022 Financial Results

For the three months ended June 30, 2022, total revenues were $65.5 million, compared to $50.0 million in the second quarter of 2021 (+31 percent year-over-year (y-o-y)). The increase was primarily due to $65.2 million in ORLADEYO net revenue in the second quarter of 2022, compared to $28.5 million in ORLADEYO net revenue in the second quarter of 2021 (+129 percent y-o-y). The $65.2 million of ORLADEYO net revenue in the second quarter of 2022 included approximately $2.2 million of non-repeating reimbursement related accrual releases.

Research and development expenses for the second quarter of 2022 increased to $62.0 million from $52.9 million in the second quarter of 2021 (+17 percent y-o-y), primarily due to increased investment in the development of our Factor D program, including BCX9930, as well as other research, preclinical and development costs.

Selling, general and administrative expenses for the second quarter of 2022 increased to $38.0 million, compared to $26.3 million in the second quarter of 2021 (+44 percent y-o-y). The increase was primarily due to increased investment to support the commercial launch of ORLADEYO and expanded international operations.

Interest expense was $24.0 million in the second quarter of 2022, compared to $13.5 million in the second quarter of 2021 (+78 percent y-o-y). The increase was due to service on the royalty financings, which were completed in November 2021.

Net loss for the second quarter of 2022 was $58.9 million, or $0.32 per share, compared to a net loss of $43.2 million, or $0.24 per share, for the second quarter of 2021.

Cash, cash equivalents, restricted cash and investments totaled $418.9 million at June 30, 2022, compared to $222.8 million at June 30, 2021. Operating cash use for the second quarter of 2022 was $27.9 million.

Additionally, on July 29, 2022, having achieved all required revenue-based milestones, the company drew the available $75 million tranche under its existing credit facility from Athyrium Capital Management. On a pro-forma basis, net of fees, this results in pro-forma cash of approximately $492 million.

Financial Outlook for 2022

Based on the strength of the ORLADEYO launch through the first half of 2022, and the continued steady growth from new patient demand the company expects for the remainder of the year, the company expects full year 2022 net ORLADEYO revenue to be between $255 million and $265 million.

Based on the reduced spending on the BCX9930 program in the first half of the year, and lower than projected spending on the program for the remainder of the year, the company now expects operating expenses for full year 2022, not including non-cash stock compensation, to be between $390 million and $400 million.

Conference Call and Webcast

BioCryst management will host a conference call and webcast at 8:30 a.m. ET today to discuss the financial results and provide a corporate update. The live call may be accessed by dialing 866-374-5140 for domestic callers and 404-400-0571 for international callers and using conference ID 68509725#. A live webcast of the call and any slides will be available online at the investors section of the company website at www.biocryst.com. A replay of the call will be available on the company website.

On August 4, 2022 Jounce Therapeutics, Inc. (NASDAQ: JNCE), a clinical-stage company focused on the discovery and development of novel cancer immunotherapies and predictive biomarkers, reported financial results for the second quarter ended June 30, 2022 and provided a corporate update (Press release, Jounce Therapeutics, AUG 4, 2022, View Source [SID1234617574]).

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"Jounce has made significant progress advancing our pipeline, and we look forward to sharing more details on our two ongoing clinical trials, INNATE and SELECT, later this year. Today, we are pleased to announce that we’ve completed enrollment in our randomized Phase 2 biomarker-selected trial SELECT, and plan to submit a clinical data abstract later this year to ESMO (Free ESMO Whitepaper)-IO being held in December. In addition, we expect to provide preliminary clinical and biomarker data across multiple cohorts from the Phase 2 portion of INNATE with an abstract submission to ESMO (Free ESMO Whitepaper)-IO in December. Our current financial position enables our continued growth and execution beyond the proof-of-concept inflection points of INNATE and SELECT, while continuing our robust, novel discovery efforts," said Richard Murray, Ph.D., chief executive officer and president of Jounce Therapeutics. "We continue to focus on our mission of delivering meaningful and long-lasting benefit to cancer patients through the discovery and pursuit of therapies that target new mechanisms of immune suppression across different types of immune cells, and bringing the right immunotherapies to the right patients."

Pipeline Update & Highlights:

JTX-8064 (LILRB2/ILT4)

Continued to advance INNATE Phase 2 trial across 7 indications. Jounce is evaluating JTX-8064 in the ongoing Phase 2 portion of the INNATE clinical trial, which is comprised of indication specific expansion cohorts, including one monotherapy cohort and seven cohorts in combination with pimivalimab. Each combination cohort is a Simon’s 2-stage design, enrolling 10 patients for an initial analysis of response data, and then further expansion to a total of 29 patients if prespecified response criteria are met. Last quarter, Jounce announced the expansion of the first two combination cohorts. The expanded indications are 3rd/4th line PD-(L)1 inhibitor naive platinum-resistant ovarian cancer and 2nd/3rd line PD-(L)1 inhibitor resistant clear cell renal cell carcinoma. Having met the response criteria for expansion, both indications are continuing enrollment to 29 patients each. Jounce has seen an acceptable safety profile for both the monotherapy and combination therapy to date.

On track to report preliminary clinical data before year end. Jounce plans to submit a clinical abstract on preliminary clinical data including all 31 Phase 1 dose escalation patients and at least 80 Phase 2 combination treatment patients from INNATE, to the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Immuno-Oncology Congress 2022 being held from December 7-9 in Geneva, Switzerland. Phase 2 data will include safety, preliminary efficacy based on RECIST 1.1, pharmacodynamics, and potential predictive biomarker correlation with efficacy within each cohort, by prior PD-(L)1 inhibitor history, and in a cross-cohort analysis.
Vopratelimab (ICOS) and Pimivalimab (PD-1)

Patient enrollment complete in Phase 2 SELECT trial of vopratelimab. Patient enrollment is complete in the SELECT trial, a randomized Phase 2 trial evaluating vopratelimab, Jounce’s inducible costimulator (ICOS) agonist, in combination with pimivalimab versus pimivalimab alone in immunotherapy naïve, TISvopra biomarker-selected, second line non-small cell lung cancer (NSCLC) patients.

On track to report clinical data before year end. Jounce plans to submit a clinical data abstract on the SELECT trial, including additional single agent data for pimivalimab, to the ESMO (Free ESMO Whitepaper) Immuno-Oncology Congress 2022.

First-in-human manuscript from the ICONIC trial in Clinical Cancer Research. A manuscript was recently published in the journal Clinical Cancer Research from the Phase 1/2 ICONIC trial of vopratelimab alone and in combination with nivolumab in patients with advanced solid tumors. Data from ICONIC identified TISvopra as a potential predictive biomarker currently being investigated in SELECT.
JTX-1484 (LILRB4/ILT3)

Continued advancement of JTX-1484. JTX-1484 is the most recent product to emerge from Jounce’s Translational Science Platform and is a monoclonal antibody designed to block human LILRB4 (ILT3) expressed on myeloid cells in the tumor microenvironment with the potential to reduce immune suppression and enhance T cell functionality. JTX-1484 is currently in investigational new drug (IND) enabling activities, with the goal of filing an IND application in 2023. Jounce has submitted a preclinical abstract on JTX-1484 for consideration at this year’s annual Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) meeting being held from November 9-11 in Boston, MA.
Discovery Pipeline

LILRB family preclinical data abstract submitted to SITC (Free SITC Whitepaper). Jounce has submitted a LILRB family preclinical data abstract for consideration at this year’s SITC (Free SITC Whitepaper) annual meeting.

Productive discovery engine with the goal of an IND every 12 to 18 months. Jounce continues to invest in and advance its growing immuno-oncology pipeline. Its discovery engine is built upon the capability to thoroughly interrogate different cell types in the tumor microenvironment, including T cells and myeloid cells. This approach has resulted in four clinical stage programs, with a fifth in IND enabling studies, over the last 6 years.
Corporate Update:

Updates regarding the Board of Directors. Jigar Raythatha has become the Chair of the Board, replacing Perry Karsen who has served as the Chair since April of 2016. Perry Karsen will remain as a member of the board.

Key promotions across leadership team. Jounce is announcing that Hugh Cole is being promoted from Chief Business Officer to Chief Operating Officer, and Dr. Haley Laken is being promoted from Senior Vice President of Program and Portfolio Strategy to Chief Development Officer. Both Mr. Cole and Dr. Laken are impactful leaders within Jounce and Jounce congratulates them on their respective promotions.
Second Quarter 2022 Financial Results:

Cash position: As of June 30, 2022, cash, cash equivalents and investments decreased to $162.3 million, compared to $220.2 million as of December 31, 2021. The decrease was due to operating expenses incurred during the period.

License and collaboration revenue: Jounce did not recognize any revenue during the second quarter of 2022. License and collaboration revenue of $25.4 million was recognized during the second quarter of 2021 and was comprised of a $25.0 million clinical development and regulatory milestone for FDA clearance of the IND for GS-1811 and $0.4 million related to non-cash revenue for the performance of research and transition services, both under the Gilead License Agreement.

Research and development expenses: Research and development expenses were $26.2 million for the second quarter of 2022, compared to $22.1 million for the same period in 2021. The increase in research and development expenses was primarily due to increased manufacturing activities performed for Jounce’s development programs, increased clinical and regulatory costs for INNATE, and increased payroll and lab supplies.

General and administrative expenses: General and administrative expenses were relatively flat at $7.5 million for the second quarter of 2022, compared to $7.3 million for the same period in 2021.

Net loss: Net loss was $33.5 million for the second quarter of 2022, resulting in basic and diluted net loss per share of $0.65. Net loss was $4.0 million for the same period in 2021, resulting in a basic and diluted net loss per share of $0.08. The increase in net loss is attributable to increased operating expenses and no revenue recognized under the Gilead License Agreement in the second quarter of 2022.
Financial Guidance:

Based on its current operating and development plans and cost containment efforts, Jounce is updating its financial guidance for 2022. Gross cash burn on operating expenses and capital expenditures for the full year 2022 is now expected to be at the lower end of the range of $115.0 million to $130.0 million. Jounce now expects its existing cash, cash equivalents and investments to be sufficient to enable the funding of its operating expenses and capital expenditure requirements into the first quarter of 2024.

Conference Call and Webcast Information:

Jounce Therapeutics will host a live conference call and webcast today at 8:00 a.m. ET. To access the conference call, participants may register here1.It is advised to register at least 10 minutes prior to joining the call. The live webcast can be accessed under "Events & Presentations" in the Investors and Media section of the company’s website at www.jouncetx.com. The webcast will be archived and made available for replay on the company’s website approximately two hours after the call and will be available for 30 days thereafter.