On August 8, 2022 Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, reported its financial results for the second quarter and six months ended June 30, 2022 (Press release, Castle Biosciences, AUG 8, 2022, View Source [SID1234617788]).

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"In the second quarter, we saw strong execution across the Castle team, which produced another quarter of record test report volume," said Derek Maetzold, president and chief executive officer of Castle Biosciences. "In our core dermatology business, we delivered a 44% increase in test report volume over the second quarter of 2021 and a 16% increase over the first quarter of 2022. We believe our continued momentum is directly linked to the clinical value our tests provide to clinicians and their patients, coupled with the focused investments we have made and continue to make in our business.

"We are excited about the Company’s ongoing collaboration with the National Cancer Institute (NCI) to link DecisionDx-Melanoma testing data with data from the Surveillance, Epidemiology and End Results (SEER) program registries on cutaneous melanoma cases. Data from this real-world cohort showed that patients diagnosed with melanoma and tested with DecisionDx-Melanoma had improved survival—27% improvement in melanoma-specific survival—compared to untested patients. We expect to generate data from this collaboration, as we expand our matched data beyond the initial cohort.

"Turning to our newest franchises, gastroenterology and mental health, we are making great progress with our integration efforts, and the initial reception from clinicians for both tests is strong. We made these acquisitions to contribute meaningfully to our top-line growth in the mid-to long-term, and along with focused investments, we believe they will contribute to our anticipated operating cash-flow neutrality by 2025.

"Our progress is the direct result of our dedicated team of professionals at Castle, who are committed to improving health through the innovative tests we offer. Thanks to their efforts, we believe Castle will continue with the current momentum we have seen and continue creating value for stockholders."

Second Quarter Ended June 30, 2022, Financial and Operational Highlights

Revenues were $34.8 million, a 53% increase compared to $22.8 million during the same period in 2021. Included in revenue for the current year was $0.6 million related to tests delivered in prior periods. Revenue for the same quarter last year included $(0.2) million related to tests delivered in prior periods.
Adjusted revenues, which exclude the effects of revenue adjustments related to tests delivered in prior periods, were $34.3 million, a 49% increase compared to $22.9 million for the same period in 2021.
Delivered 11,034 total test reports in the second quarter of 2022, an increase of 57% compared to 7,007 in the same period of 2021:
DecisionDx-Melanoma test reports delivered in the quarter were 7,125, compared to 5,128 in the second quarter of 2021, an increase of 39%.
DecisionDx-SCC test reports delivered in the quarter were 1,344, compared to 784 in the second quarter of 2021, an increase of 71%.
MyPath Melanoma and DiffDx-Melanoma diagnostic gene expression profile (GEP) aggregate test reports delivered in the quarter were 955, compared to 627 in the second quarter of 2021, an increase of 52%.
DecisionDx-UM test reports delivered in the quarter were 431, compared to 468 in the second quarter of 2021, a decrease of 8%.
TissueCypher Barrett’s Esophagus test reports delivered in the quarter were 352.
IDgenetix test reports delivered in the quarter were 827 (April 26, 2022–June 30, 2022).
Gross margin for the quarter ended June 30, 2022, was 72%, and adjusted gross margin was 78%.
Operating cash flow was $(9.0) million, compared to $(6.4) million for the same period in 2021, and adjusted operating cash flow was $(9.0) million, compared to $(4.3) million for the same period in 2021.
Net loss for the second quarter was $(1.6) million, compared to $(8.8) million for the same period in 2021.
Adjusted EBITDA for the second quarter was $(10.9) million, compared to $(3.4) million for the same period in 2021.
Six Months Ended June 30, 2022, Financial and Operational Highlights

Revenues were $61.7 million, a 35% increase compared to $45.6 million during the same period in 2021. Included in revenue for the for the period was $(0.3) million related to tests delivered in prior periods. Revenue for the same period last year included $5.1 million related to tests delivered in prior periods.
Adjusted revenues were $62.0 million, a 53% increase, which exclude the effects of revenue adjustments related to tests delivered in prior periods, compared to $40.5 million for the same period in 2021.
Total test reports delivered in the six months ended June 30, 2022, were 19,661, compared to 12,149 in the same period of 2021, an increase of 62%:
DecisionDx-Melanoma test reports delivered in the six months ended June 30, 2022, were 13,148, compared to 9,188 during the same period of 2021, an increase of 43%.
DecisionDx-SCC test reports delivered in the six months ended June 30, 2022, were 2,486, compared to 1,311 during the same period in 2021, an increase of 90%.
MyPath Melanoma and DiffDx-Melanoma aggregate diagnostic GEP test reports delivered in the six months ended June 30, 2022, were 1,905, compared to 845 during the same period in 2021, an increase of 125%.
DecisionDx-UM test reports delivered in the six months ended June 30, 2022, were 887, compared to 805 during the same period in 2021, an increase of 10%.
TissueCypher Barrett’s Esophagus test reports delivered in the six months ended June 30, 2022, were 408.
IDgenetix test reports delivered in the six months ended June 30, 2022, were 827 (April 26, 2022–June 30, 2022).
Gross margin for the six months ended June 30, 2022, was 72%, and adjusted gross margin was 78%.
Operating cash flow was $(30.4) million, compared to $(10.1) million for the same period in 2021.
Adjusted operating cash flow was $(30.4) million, compared to $(9.8) million for the same period in 2021.
Net loss for the six months ended June 30, 2022, was $(26.3) million, compared to $(13.1) million for the same period in 2021.
Adjusted EBITDA for the six months ended June 30, 2022, was $(22.2) million, compared to $(2.5) million for the same period in 2021.
Cash and Cash Equivalents

As of June 30, 2022, the Company’s cash and cash equivalents totaled $273 million.

2022 Revenue Guidance

Castle Biosciences is increasing its previously issued guidance for anticipated total revenue in 2022. The Company now anticipates generating $130–135 million in total revenue in 2022, compared to the previously provided guidance of $118–123 million.
Second Quarter and Recent Accomplishments and Highlights

Dermatology

In April, the Company announced new real-world data from its ongoing collaboration with the National Cancer Institute (NCI). In a recent study, patients who received DecisionDx-Melanoma test results in addition to traditional clinicopathologic factors, as part of their clinical care, had improved survival compared to patients who were not tested (that is, their clinician could only rely upon available traditional clinicopathologic factors), with a 27% (hazard ratio (HR)=0.73, p=0.028) and 21% (HR=0.79, p=0.006) MSS (melanoma-specific survival) and OS (overall survival) survival benefit compared to matched patients who were not tested, respectively. The data was shared in a poster presentation at the 18th European Association of Dermato-Oncology (EADO) Congress. See the Company’s news release from April 21, 2022, for more information.
In May, the Company announced new data showing that DecisionDx-SCC can independently risk-stratify patients with cutaneous squamous cell carcinoma (SCC) and one or more risk factors according to their biologic risk of metastasis, consistent with findings in previous development and validation studies. The poster was presented at the 2022 American College of Mohs Surgery (ACMS) Annual Meeting. Overall, the study data confirm what previous development and validation studies have substantiated: DecisionDx-SCC can accurately classify risk for metastasis in SCC patients with one or more risk factors and provides significant prognostic information independent from current risk prediction methods. Additionally, the study data further support the use of DecisionDx-SCC test results in combination with other risk-assessment and staging systems to guide more refined and risk-aligned patient care. See the Company’s news release from May 19, 2022, for more information.
In May, the Company announced that it had been selected as the winner of the "Best New Technology Solution – Dermatology" award in the sixth annual MedTech Breakthrough Awards program for its innovative DecisionDx-Melanoma gene expression profile (GEP) test. The mission of the MedTech Breakthrough Awards is to honor excellence and recognize the innovation, hard work and success in a range of health and medical technology categories. This year’s program attracted more than 3,900 nominations from over 15 different countries throughout the world. See the Company’s news release from May 27, 2022, for more information.
In June, the Company announced a poster presentation on DecisionDx-Melanoma at the 2022 Fall Clinical Dermatology Conference for PAs & NPs. The poster, titled "Attitudes of Patients with Cutaneous Melanoma Towards Prognostic Testing Using Gene Expression Profiling," shares results from a survey of 120 melanoma patients regarding prognostic testing with DecisionDx-Melanoma. In the survey, a significant majority of patients desired testing with DecisionDx-Melanoma after receiving a melanoma diagnosis and appreciated the in-depth information provided by the results, regardless of whether they received low or high-risk scores. See the Company’s news release from June 14, 2022, for more information.
In June, the Company announced a new collaboration with the Oregon Health & Science University’s (OHSU) War on Melanoma. The War on Melanoma is a multi-faceted public health campaign with a focus on early detection and prevention of melanoma through various education, activism and research programs. The collaboration includes support of various aspects of the War on Melanoma program, including the Start Seeing Melanoma campaign and the Skin Crew. See the Company’s news release from June 20, 2022, for more information.
Uveal Melanoma

In May, the Company announced a partnership with Research to Prevent Blindness (RPB), the leading nonprofit organization supporting eye research directed at the prevention, treatment or eradication of all diseases that damage and destroy sight, to provide funding for the RPB/Castle Biosciences Medical Student Eye Research Fellowship in Ocular Cancer, which allows medical students to take a year off from medical school to devote time to the pursuit of a research project within an RPB-supported department of ophthalmology. See the Company’s news release from May 20, 2022, for more information.
In June, the Company announced findings from a study that evaluated uveal melanoma (UM) patients’ attitudes toward prognostic testing and specifically with respect to DecisionDx-UM. Highlights from the study were shared in a poster presentation at the 20th congress of the International Society of Ocular Oncology (ISOO), recently held in Leiden, The Netherlands. Of the 177 survey participants, 90% reported wanting prognostic information at diagnosis. And of the patients who received prognostic testing with DecisionDx-UM, there was no significant difference in decision regret levels among those receiving a low- (Class 1A), intermediate- (Class 1B) or high-risk (Class 2) test result (Kruskal-Wallis rank sum test, X2=4.1, p=0.13). Patients tested with DecisionDx-UM reported gaining value from their test result, including increased knowledge and understanding of their disease, more personalized treatment options, information relevant to life planning, and relief from uncertainty about the future. See the Company’s news release from June 23, 2022, for more information.
Gastroenterology

In April, the Company announced an independent, peer-reviewed article published in Clinical Gastroenterology and Hepatology. The authors performed a pooled analysis, and the data demonstrated the ability of TissueCypher to significantly improve predictions of progression to esophageal cancer in patients with Barrett’s Esophagus (BE), compared to predictions based on traditional clinicopathologic variables alone, allowing for more informed disease management decisions. See the Company’s news release from April 27, 2022, for more information.
In May, the Company announced new study data demonstrating the ability of its TissueCypher Barrett’s Esophagus test to independently predict malignant progression to high-grade dysplasia (HGD) and esophageal adenocarcinoma (EAC) in patients with non-dysplastic (ND), indefinite or low-grade dysplasia (LGD) (BE). Overall, the study demonstrated that TissueCypher can accurately predict progression to HGD or EAC in BE patients who are initially diagnosed with LGD, outperforming the majority of pathologist diagnoses evaluated in the study. Further, TissueCypher test results may provide an objective solution to observer variability, identifying more progressors early and helping to inform management decisions and standardize care plans for patients with BE. See the Company’s news release from May 24, 2022, for more information.
In August, the Company announced that the American Gastroenterological Association (AGA) recently published a best practice advice article stating that the TissueCypher Barrett’s Esophagus test may be beneficial for risk-stratification of patients with non-dysplastic BE. The best practice advice article from the AGA, titled "AGA Clinical Practice Update on New Technology and Innovation for Surveillance and Screening in Barrett’s Esophagus: Expert Review," was recently published online in Clinical Gastroenterology and Hepatology and can be viewed here. See the Company’s news release from Aug. 4, 2022, for more information.
Mental Health

In May, the Company announced a collaboration with Camille Schrier, Miss America 2020, as part of Mental Health Awareness Month, to promote the potential of genetic testing and the IDgenetix test to help improve treatment for mental health conditions. See the Company’s news release from May 6, 2022, for more information.
Conference Call and Webcast Details

Castle Biosciences will hold a conference call on Monday, Aug. 8, 2022, at 4:30 p.m. Eastern time to discuss its second quarter 2022 results and provide a corporate update.

A live webcast of the conference call can be accessed here: View Source or via the webcast link on the Investor Relations page of the Company’s website, View Source Please access the webcast at least 10 minutes before the conference call start time. An archive of the webcast will be available on the Company’s website until Aug. 31, 2022.

To access the live conference call via phone, please dial 844 200 6205 from the United States, or +1 929 526 1599 internationally, at least 10 minutes prior to the start of the call, using the conference ID 705869.

There will be a brief Question & Answer session following management commentary.

Use of Non-GAAP Financial Measures (UNAUDITED)

In this release, we use the metrics of Adjusted Revenue, Adjusted Gross Margin, Adjusted Operating Cash Flow and Adjusted EBITDA, which are non-GAAP financial measures and are not calculated in accordance with generally accepted accounting principles in the United States (GAAP). Adjusted Revenue and Adjusted Gross Margin reflect adjustments to net revenues to exclude changes in variable consideration related to test reports delivered in previous periods. Adjusted Gross Margin further excludes acquisition-related intangible asset amortization. Adjusted Operating Cash Flow excludes the effects of repayments to Medicare of COVID-19 government relief advancements to healthcare providers. Adjusted EBITDA excludes from net loss interest expense, depreciation and amortization expense, income tax (benefit) expense, stock compensation expense, acquisition-related transaction costs and change in fair value of contingent consideration.

We use Adjusted Revenue, Adjusted Gross Margin, Adjusted Operating Cash Flow and Adjusted EBTIDA internally because we believe these metrics provide useful supplemental information in assessing our revenue and cash flow performance reported in accordance with GAAP, respectively. We believe Adjusted Revenue and Adjusted Gross Margin are also useful to investors because they provide additional information on current-period performance by removing the effects of revenue adjustments related to tests delivered in previous periods and, with respect to Adjusted Gross Margin, acquisition-related intangible asset amortization, which we believe may facilitate revenue and gross margin comparisons to historical periods. We believe Adjusted Operating Cash Flow is also useful to investors as a supplement to GAAP measures in the assessment of our cash flow performance by removing the effects of COVID-19 government relief payments, which we believe are not indicative of our ongoing operations. We believe Adjusted EBITDA may enhance an evaluation of our operating performance based on recent revenue generation and product/overhead cost control because it excludes the impact of prior decisions made about capital investment, financing and other expenses. However, these non-GAAP financial measures may be different from non-GAAP financial measures used by other companies, even when the same or similarly titled terms are used to identify such measures, limiting their usefulness for comparative purposes.

These non-GAAP financial measures are not meant to be considered in isolation or used as substitutes for net revenues, gross margin, net cash (used in) provided by operating activities or net loss reported in accordance with GAAP; should be considered in conjunction with our financial information presented in accordance with GAAP; have no standardized meaning prescribed by GAAP; and are not prepared under any comprehensive set of accounting rules or principles. In addition, from time to time in the future, there may be other items that we may exclude for purposes of these non-GAAP financial measures, and we may in the future cease to exclude items that we have historically excluded for purposes of these non-GAAP financial measures. Likewise, we may determine to modify the nature of adjustments to arrive at these non-GAAP financial measures. Because of the non-standardized definitions of non-GAAP financial measures, the non-GAAP financial measure as used by us in this press release and the accompanying reconciliation tables have limits in their usefulness to investors and may be calculated differently from, and therefore may not be directly comparable to, similarly titled measures used by other companies. Accordingly, investors should not place undue reliance on non-GAAP financial measures. Reconciliations of these non-GAAP financial measures to the most directly comparable GAAP financial measures are presented in the tables at the end of this release.

1Centers for Medicare & Medicaid Services: View Source

On August 8, 2022 Mersana Therapeutics, Inc. (NASDAQ: MRSN), a clinical-stage biopharmaceutical company focused on discovering and developing a pipeline of antibody-drug conjugates (ADCs) targeting cancers in areas of high unmet medical need, reported financial results for the second quarter ended June 30, 2022 (Press release, Mersana Therapeutics, AUG 8, 2022, View Source [SID1234617787]).

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"We are incredibly pleased by all of the progress Mersana has made thus far in 2022, as we have continued to build UpRi as a potential foundational medicine in ovarian cancer, achieved key regulatory goals with XMT-1660 and XMT-2056 and entered into two exciting new strategic partnerships," said Anna Protopapas, President and Chief Executive Officer of Mersana Therapeutics. "UpRi’s advancement remains a primary focus for the organization, and we are excited to be approaching enrollment completion in UPLIFT, our potential registrational trial, and to have patient screening in UP-NEXT underway. At the same time, Mersana’s proprietary ADC platforms are allowing us to advance new candidates into the clinic while also enabling significant collaborations with Janssen and GSK. We believe these recent accomplishments have strengthened both our balance sheet and our position as an ADC leader."

Strategic Goals, Recent Developments and Anticipated Milestones

Build Upifitamab Rilsodotin (UpRi), a first-in-class NaPi2b-targeting ADC, into a Foundational Medicine in Ovarian Cancer
Approaching Enrollment Completion in UPLIFT Registration Trial: Mersana expects to complete the enrollment of patients with platinum-resistant ovarian cancer in UPLIFT, the company’s potential registrational clinical trial, around the end of Q3 2022. The trial’s primary endpoint is the confirmed overall response rate (ORR) in approximately 100 NaPi2b high patients.
Initiated Patient Screening in UP-NEXT Trial: Patient screening is now underway in UP-NEXT, a Phase 3 clinical trial of UpRi as monotherapy maintenance following treatment with platinum doublets in recurrent platinum-sensitive ovarian cancer. If successful, UP-NEXT could serve as a post-approval confirmatory trial in the United States, support potential approvals outside of the United States and support UpRi’s expansion into earlier lines of therapy.
Dose Escalating in UPGRADE Combination Trial: UPGRADE, the company’s Phase 1/2 umbrella trial of UpRi in combination with other agents, is currently dose escalating UpRi in combination with carboplatin. Mersana expects to disclose initial interim dose escalation data in Q4 2022, with a primary focus on safety and tolerability.
Build Pipeline of Highly Impactful Cancer Medicines
Cleared IND for XMT-1660: XMT-1660 is a B7-H4-directed Dolasynthen ADC with a precise, target-optimized drug-to-antibody ratio (DAR 6) and Mersana’s clinically validated DolaLock microtubule inhibitor payload with controlled bystander effect. The U.S. Food and Drug Administration (FDA) has cleared Mersana’s Investigational New Drug (IND) application for XMT-1660, and the company plans to initiate a Phase 1 clinical trial of this candidate imminently. This trial will investigate XMT-1660 in a range of B7-H4-expressing tumors with high unmet need, including breast, endometrial and ovarian cancers.
Cleared IND and Announced Orphan Designation for XMT-2056: XMT-2056 is a systemically administered Immunosynthen STING agonist ADC (DAR 8) that is designed to target a novel HER2 epitope and locally activate STING signaling in both tumor-resident immune cells and in tumor cells (a "one-two punch"), providing the potential to treat patients with HER2-high or -low tumors as monotherapy or in combination with standard-of-care agents. The FDA recently cleared Mersana’s IND application for XMT-2056, and the company plans to initiate a Phase 1 clinical trial of this candidate in patients with a range of HER2 expressing tumors, such as breast, gastric and non-small cell lung cancer, in the second half of 2022. The FDA also recently granted orphan drug designation to XMT-2056 for the treatment of gastric cancer.
Build Mersana with Strategic Partners
Announced New Option Agreement with GSK: In a separate press release today, Mersana announced a global collaboration that provides GSK plc (LSE/NYSE: GSK) an exclusive option to co-develop and commercialize XMT-2056. Under the terms of the agreement, Mersana will receive an upfront option purchase fee of $100 million. Mersana also is eligible to receive up to $1.36 billion in the form of an option exercise payment and development, regulatory and commercial milestone payments if GSK exercises its option. Mersana has retained options to profit-share and to co-promote in the United States. If it exercises its profit-share option, Mersana will be eligible to receive tiered royalties on net sales outside of the United States. If Mersana does not elect to profit-share, it is eligible to receive double-digit tiered royalties on global net sales.
Second Quarter 2022 Financial Results

Net cash used in operating activities in the second quarter of 2022 was $44.7 million.
Cash, cash equivalents and marketable securities as of June 30, 2022, were $225.1 million, compared to cash and cash equivalents of $177.9 million as of December 31, 2021. Mersana expects that its available funds, together with the $100 million option payment due from GSK, will be sufficient to support its operating plan commitments into the first half of 2024.
Collaboration revenue for the second quarter of 2022 was $4.3 million, compared to an immaterial amount for the same period in 2021. The year-over-year increase was related to the company’s recent collaboration agreement with Janssen.
Research and development (R&D) expenses for the second quarter of 2022 were $41.2 million, compared to $32.0 million for the same period in 2021. Included in second quarter 2022 R&D expenses was $2.7 million in non-cash stock-based compensation. The year-over-year increase in R&D expenses was primarily related to XMT-1660- and Dolasynthen-related clinical and manufacturing costs, higher UpRi manufacturing and clinical costs and an increase in headcount.
General and administrative (G&A) expenses for the second quarter of 2022 were $14.8 million, compared to $8.9 million during the same period in 2021. Included in second quarter 2022 G&A expenses was $2.6 million in non-cash stock-based compensation. The year-over-year increase in G&A expenses was primarily related to an increase in consulting, professional fees, and increased headcount.
Net loss for the second quarter of 2022 was $52.2 million, or $0.55 per share, compared to a net loss of $40.9 million, or $0.59 per share, for the same period in 2021.
Conference Call Reminder
Mersana will host a conference call today at 4:30 p.m. ET to discuss business updates and its financial results for the second quarter of 2022. To access the call, please dial 646-307-1963 (domestic) or 800-715-9871 (international) and provide the Conference ID 4656534. A live webcast of the presentation will be available on the Investors & Media section of the Mersana website at www.mersana.com, and a replay of the webcast will be available in the same location following the conference call for at least 90 days.

On August 8, 2022 Precigen, Inc. (Nasdaq: PGEN), a biopharmaceutical company specializing in the development of innovative gene and cell therapies to improve the lives of patients, reported second quarter and first half 2022 financial results (Press release, Precigen, AUG 8, 2022, View Source [SID1234617786]).

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"Precigen is laser focused on maximizing the value of our highest priority assets and prioritizing our capital allocation to enable us to reach critical inflection points in our clinical trials. We have been able to expedite our prioritized programs, rapidly progressing from Phase 1 dose escalations to 1b expansions and have already initiated Phase 2 studies for several programs," said Helen Sabzevari, PhD, President and CEO of Precigen. "We continue to demonstrate the potential of these assets and their associated therapeutic platforms, and are actively pursuing rapid regulatory strategies for licensure to bring these potential investigational therapies to patients as quickly as possible. We expect additional data this year and early next for our prioritized programs, and are particularly excited for the Phase 1 data presentation for the PRGN-2012 AdenoVerse study in Q4 2022."

"The transaction to sell Trans Ova Genetics, which is expected to close in Q3 2022, will provide Precigen with $170 million in cash up-front and up to a $10 million earn-out over the next two years. The proceeds from this sale will fortify our balance sheet and provide non-dilutive funds to pay our convertible notes, which we intend to do when due," said Harry Thomasian Jr., CFO of Precigen. "We believe that our cash on hand and cost reduction initiatives, taking into account our plan for our convertible notes, give us enough runway to advance our clinical priorities into Q4 2023."

Key Business Highlights

Agreement to Divest Non-Healthcare Subsidiary Trans Ova Genetics
Precigen entered into an agreement to sell its wholly-owned subsidiary Trans Ova Genetics to URUS for $170 million in upfront cash and up to a $10 million earn-out based on the performance of Trans Ova Genetics in 2022 and 2023. The close, subject to customary closing conditions including clearance under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, is expected in Q3 2022.
Transaction will solidify the Company’s balance sheet and provide the ability to pay off the outstanding convertible notes utilizing a non-dilutive funding source.
PRGN-3006 UltraCAR-T in AML
The US Food and Drug Administration (FDA) Fast Track designation for PRGN-3006 UltraCAR-T, received in the first half of 2022, is important for patients with relapsed or refractory (r/r) AML, a serious condition with high unmet medical need, as it may facilitate development and expedite the review process for this promising investigational therapy.
Enrollment is ongoing in the Phase 1b expansion study of PRGN-3006 UltraCAR-T at Dose Level 3 with lymphodepletion (clinical trial identifier: NCT03927261).
The Phase 1b study of PRGN-3006 UltraCAR-T has been expanded to Mayo Clinic in Rochester, Minnesota as the first of several new sites expected as part of the multicenter expansion of the study. Additionally, technology transfer was successfully completed and FDA clearance was received to initiate PRGN-3006 UltraCAR-T manufacturing and patient treatment at Mayo Clinic.
Multicenter expansion demonstrates proof of concept for the technology transfer and scale-up for decentralized manufacturing of UltraCAR-T using UltraPorator at multiple medical centers. Technology transfer and site activation activities are in progress at several major cancer centers across the US and additional expansion sites are anticipated to be activated in 2022 and 2023.
The Company received FDA clearance to incorporate repeat dosing in the Phase 1b expansion phase of the study and plans to initiate in 2022.
Additional data for the Phase 1/1b study is expected at a major scientific conference in Q4 2022.
PRGN-3005 UltraCAR-T in Ovarian Cancer
Enrollment was completed in the dose escalation phase of both the intraperitoneal (IP) and intravenous (IV) arms of the Phase 1 study without lymphodepletion (clinical trial identifier: NCT03907527). The FDA cleared moving directly to Dose Level 3 after dosing one patient at Dose Level 1 in the IV arm, enabling rapid progression in the IV arm. Patient follow up is ongoing and the Company expects Phase 1 data to be presented in the first half of 2023.
FDA approval was received to incorporate lymphodepletion in the IV arm and enrollment (N=3) was completed at Dose Level 3 with lymphodepletion. Patient follow up is ongoing.
The Company initiated the Phase 1b expansion study of PRGN-3005 UltraCAR-T at Dose Level 3 with lymphodepletion prior to IV infusion.
The Company plans multicenter expansion of the Phase 1b study and site activation activities are in progress at major cancer centers in the US.
The Company received FDA clearance to incorporate repeat dosing in the Phase 1b expansion study and plans to initiate in 2022.
PRGN-3007 UltraCAR-T in Advanced ROR1+ Hematological and Solid Tumors
PRGN-3007, based on the next generation UltraCAR-T, incorporates intrinsic PD-1 checkpoint inhibition in addition to the three effector genes (chimeric antigen receptor (CAR), membrane-bound interleukin 15 (mbIL15) and kill switch), is being readied for the clinic.
The Phase 1/1b umbrella study of PRGN-3007 in advanced receptor tyrosine kinase-like orphan receptor 1-positive (ROR1+) hematological tumors, including chronic lymphocytic leukemia (CLL), mantle cell leukemia (MCL), acute lymphoblastic leukemia (ALL) and diffuse large B-cell lymphoma (DLBCL) and solid tumors, including triple negative breast cancer (TNBC) is on track to initiate dosing in the second half of 2022.
PRGN-2012 AdenoVerse Immunotherapy in RRP
Enrollment was completed in the Phase 1 study (N=15) and patient follow up is ongoing. The Company is planning an investigator-led Phase 1 data presentation to be held in Q4 2022.
The Company initiated a Phase 2 study of PRGN-2012 in adult patients with RRP (clinical trial identifier: NCT04724980). Enrollment is ongoing in the Phase 2 study with 11 patients enrolled to date.
Discussions with the FDA are ongoing to evaluate various regulatory paths given the high unmet medical need for this patient population.
PRGN 2009 AdenoVerse Immunotherapy in HPV-associated Cancers
Enrollment was completed in the Phase 1 monotherapy (N=6) and combination therapy (N=11) arms in patients with recurrent or metastatic HPV-associated cancers (clinical trial identifier: NCT04432597). Patient follow up is ongoing. The Company expects Phase 1 data to be presented in the first half of 2023.
Enrollment is ongoing in the Phase 2 monotherapy arm in newly diagnosed oropharyngeal squamous cell carcinoma (OPSCC) patients with 17 patients enrolled to date.
Second Quarter and First Half 2022 Financial Highlights

Net cash used in operating activities of $25.8 million during the six months ended June 30, 2022 compared to $24.2 million during the six months ended June 30, 2021;
Cash, cash equivalents, short-term and long-term investments totaled $132.8 million as of June 30, 2022;
Selling, general and administrative (SG&A) costs decreased for both the three and six months ended June 30, 2022 compared to the prior year periods; and
As a result of the anticipated Trans Ova Genetics sale, the Trans Ova Genetics business is now classified as a discontinued operation with its assets, liabilities and operations in prior periods reclassified to conform to the current presentation.
Second Quarter 2022 Financial Results Compared to Prior Year Period

Total revenues decreased $0.9 million, or 24%, from the quarter ended June 30, 2021. Product and service revenues generated by Exemplar decreased $0.5 million and collaboration and license revenue decreased $0.3 million from the quarter ended June 30, 2021. Gross margin on products and services declined as a result of the decreased revenues, and increased costs for supplies, drugs, and personnel costs.
Research and development expenses decreased by $1.2 million, or 9%, from the quarter ended June 30, 2021. Contract research organization costs and lab supplies decreased $1.9 million due to timing differences, the completion of the Phase 1b/2a clinical trial of AG019 in the fourth quarter of the prior year, as well as a continued prioritization of clinical product candidates with less expense incurred related to preclinical research programs for the comparable period. This decrease was partially offset with an increase in salaries, benefits, and other personnel costs of $0.7 million primarily due to an increase in the hiring of employees to support the growth in the Company’s development activities.
SG&A expenses decreased $2.3 million, or 15%, from the quarter ended June 30, 2021. Salaries, benefits, and other personnel costs decreased $1.5 million primarily due to reduced stock compensation in 2022 and reduced head count. Professional fees decreased $0.4 million, primarily due to decreased legal fees associated with certain matters.
Loss from continuing operations was $26.1 million, or $(0.13) per basic and diluted share, compared to loss from continuing operations of $30.9 million, or $(0.16) per basic and diluted share, in 2021.
First Half 2022 Financial Results Compared to Prior Year Period

Total revenues increased $1.2 million, or 16%, from six months ended June 30, 2021. Product and service revenues generated by Exemplar increased $1.6 million, which was offset by a $0.3 million reduction in collaboration and license revenue from the six months ended June 30, 2021. Gross margin on services remained comparable to the prior year as increased revenues were offset by increased costs for supplies, drugs, and personnel costs.
Research and development expenses increased $0.4 million, or 2%, from the six months ended June 30, 2022. Salaries, benefits, and other personnel costs increased $1.2 million due to an increase in the hiring of employees to support the growth in the Company’s development activities. This increase was partially offset with a decrease of contract research organization costs and lab supplies of $0.9 million, primarily due to timing differences, the completion of the Phase 1b/2a clinical trial of AG019 in the fourth quarter of the prior year, and a continued prioritization of clinical product candidates with less expense incurred related preclinical research programs for the comparable period.
SG&A expenses decreased $2.9 million, or 10%, from the six months ended June 30, 2021. Salaries, benefits, and other personnel costs decreased $3.5 million primarily due to reduced stock compensation in 2022 and reduced head count. This decrease was partially offset with an increase in legal and professional fees of $1.1 million, primarily due to increased consulting fees and legal fees associated with certain matters.
Loss from continuing operations was $50.0 million, or $(0.25) per basic and diluted share, compared to loss from continuing operations of $57.8 million, or $(0.29) per basic and diluted share, in 2021.

On August 8, 2022 IGM Biosciences, Inc. (Nasdaq: IGMS), a clinical-stage biotechnology company focused on creating and developing IgM antibodies, reported its financial results for the second quarter ended June 30, 2022 and provided an update on recent developments (Press release, IGM Biosciences, AUG 8, 2022, View Source [SID1234617785]).

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"We continued to make good progress in the second quarter in our two Phase 2 clinical trials of our IgM T cell bispecific antibody, imvotamab, and in our Phase 1 clinical trial of our IgM Death Receptor 5 (DR5) agonist, IGM-8444, in multiple combination treatment regimens. We also made good progress across our preclinical pipeline in the second quarter, and we continue to expect to file INDs for our targeted IL-15 IgM antibody, IGM-7354, and our CD38 x CD3 bispecific IgM antibody, IGM-2644, this year," said Fred Schwarzer, Chief Executive Officer of IGM Biosciences. "In the second quarter, we also initiated our research collaboration with Sanofi for the development of agonist IgM antibodies against three oncology targets and three autoimmune/inflammation targets."

Pipeline Updates

Imvotamab (CD20 x CD3)

Clinical development of imvotamab (IGM-2323) advances. IGM continues to advance the clinical development of imvotamab, the Company’s novel IgM T cell engaging bispecific antibody, and continues to enroll patients in two Phase 2 clinical trials to assess the safety and efficacy of two doses, 100 mg and 300 mg, in patients with relapsed and/or refractory diffuse large B cell lymphoma and follicular lymphoma. IGM expects to provide an initial Phase 2 efficacy and safety update later this year or in the first quarter of 2023.
IGM-8444 (DR5)

Clinical development of IGM-8444. IGM continues to advance the clinical development of IGM-8444, the Company’s IgM DR5 agonist, in an open-label, multicenter, Phase 1 clinical trial in multiple combination treatment regimens in subjects with relapsed and/or refractory solid and hematologic cancers.

Three initial patients dosed in the fourth FOLFIRI dose cohort. IGM announced that it has successfully dosed the initial three patients in the fourth and final planned FOLFIRI combination dose escalation cohort (10 mg/kg Q2W) with no dose limiting toxicities (DLTs) and no clinically significant liver toxicity observed to date. IGM plans to continue to enroll patients in the fourth FOLFIRI dose cohort and expects to provide an initial efficacy and safety update on the FOLFIRI combination later this year or in the first quarter of 2023.

Third birinapant dose cohort successfully completed. IGM also announced that it has cleared the third of four planned birinapant combination dose escalation cohorts with no DLTs and no clinically significant liver toxicity observed to date. IGM is currently enrolling patients in the fourth planned birinapant combination dose escalation cohort.
IGM-7354 (IL-15 x PD-L1)

IND application expected to be filed this year. IGM expects to file an Investigational New Drug Application (IND) for IGM-7354, the Company’s targeted IL-15 IgM antibody, in solid tumors this year.
IGM-2644 (CD38 x CD3)

IND application expected to be filed this year. IGM expects to file an IND for IGM-2644, the Company’s CD38 x CD3 bispecific IgM antibody, in multiple myeloma this year.
Corporate Updates

Collaboration agreement with Sanofi. In connection with the closing of the previously-announced collaboration agreement, IGM received a $150 million upfront payment from Sanofi in the second quarter. The agreement is for the creation, development, manufacture, and commercialization of IgM antibody agonists against three oncology targets and three immunology/inflammation targets. In addition to the $150 million upfront payment, IGM is eligible to receive potentially over $6 billion in aggregate development, regulatory and commercial milestones, a 50:50 profit share in certain major market countries and tiered royalties on net sales in the rest of world for oncology targets, and tiered royalties on global net sales for autoimmune/inflammation targets.

Umesh Muchhal, Ph.D., appointed Senior Vice President of Antibody Sciences. Dr. Muchhal brings over 24 years of biotech experience to IGM and is an industry leader in the design and development of novel antibody-based therapeutics. He has co-authored 24 publications and is an inventor on more than 15 granted U.S. patents. Prior to joining IGM, he led the Protein Sciences and Technology teams at Xencor. Dr. Muchhal received a Ph.D. in Molecular Biology from the University of Nebraska-Lincoln and an M.S. in Microbiology from the Maharaja Sayajirao University of Baroda.

Steven Weber appointed Senior Vice President, Corporate Controller and Principal Accounting Officer. Mr. Weber has over 20 years of experience leading financial operations. Most recently, Mr. Weber served as Vice President and Principal Accounting Officer at Aeglea BioTherapeutics, where he held several positions of increasing responsibility. Mr. Weber received an M.P.A. and a B.B.A. in Accounting from the University of Texas at Austin.
Second Quarter 2022 Financial Results

Cash and Investments: Cash and investments as of June 30, 2022 were $513.2 million, compared to $229.5 million as of December 31, 2021.
Collaboration Revenue: For the second quarter of 2022, collaboration revenue was $0.4 million, compared to no revenue for the same period in 2021.
Research and Development (R&D) Expenses: For the second quarter of 2022, R&D expenses were $47.2 million, compared to $30.1 million for the same period in 2021.
General and Administrative (G&A) Expenses: For the second quarter of 2022, G&A expenses were $12.4 million, compared to $8.6 million for the same period in 2021.
Net Loss: For the second quarter of 2022, net loss was $58.6 million, or a loss of $1.33 per share, compared to a net loss of $38.7 million, or a loss of $1.16 per share, for the same period in 2021. The net loss included non-cash stock-based compensation expense of $11.3 million and $5.6 million for the second quarter of 2022 and 2021, respectively.
2022 Financial Guidance
IGM expects to end 2022 with a balance of approximately $400 million in cash and investments. IGM estimates full year collaboration revenue of approximately $1 million related to the Sanofi agreement. IGM reiterates its previously issued financial guidance expecting full year GAAP operating expenses of $250 million to $260 million including estimated non-cash stock-based compensation expense of approximately $50 million.

On August 8, 2022 Pliant Therapeutics, Inc. (Nasdaq: PLRX), a clinical stage biotechnology company focused on discovering and developing novel therapeutics for the treatment of fibrosis, reported second quarter 2022 financial results (Press release, Pliant Therapeutics, AUG 8, 2022, View Source [SID1234617784]).

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"A highlight to our team’s progress in 2022 is the positive safety and efficacy data from the INTEGRIS-IPF Phase 2a trial. The trial met its primary endpoint demonstrating that PLN-74809 was well tolerated over a 12-week treatment period, and delivered compelling efficacy results demonstrating a clear dose dependent treatment effect in patients with IPF," said Bernard Coulie, M.D., Ph.D., President and Chief Executive Officer of Pliant Therapeutics. "These data reflect the significant preclinical and clinical derisking conducted that allows for PLN-74809’s late-stage development and moves this program closer to potentially assisting patients in need."

Second Quarter and Recent Highlights

PLN-74809 Highlights

INTEGRIS-IPF Phase 2a trial results showed PLN-74809 was well tolerated with dose-dependent treatment effects on forced vital capacity (FVC) and quantitative lung fibrosis (QLF) in patients with idiopathic pulmonary fibrosis (IPF). Exploratory endpoints a showed a dose-dependent treatment effect on FVC and QLF versus placebo in all PLN-74809 dose groups, both with and without standard of care therapy. In addition, a dose-dependent reduction in the proportion of patients with percent-predicted FVC (FVCpp) decline of ≥ 10%, a risk factor associated with increased mortality in IPF patients, was observed across all treatment groups.
INTEGRIS-IPF Phase 2a trial of PLN-74809 at 320 mg completed enrollment in patients with IPF. Enrollment is complete in the randomized, double-blind, placebo-controlled trial evaluating PLN-74809 at a once daily dose of 320 mg administered for at least six months and up to 48 weeks in approximately 28 patients with IPF. The trial will evaluate primary and secondary endpoints of safety, tolerability, and pharmacokinetics. Exploratory efficacy endpoints will include effect on FVC and QLF imaging as well as biomarkers. Interim 12-week data is anticipated in early 2023.
INTEGRIS-PSC Phase 2a data anticipated in the first half of 2023. This 12-week randomized, dose-ranging, double-blind, placebo-controlled trial is evaluating the safety, tolerability, and pharmacokinetics of PLN-74809 in primary sclerosing cholangitis (PSC) patients. The trial is also evaluating exploratory endpoints including fibrosis biomarkers such as PRO-C3 and ELF, changes in ALP, and liver imaging. Topline data from this trial is expected in the first half of 2023.
FDA Fast Track designation received for PLN-74809 for the treatment of PSC. FDA’s Fast Track designation is intended to facilitate and expedite the development and review of new drugs to treat serious or life-threatening conditions. The benefits of Fast Track designation include opportunities for frequent meetings with the FDA to discuss trial design, development plans, and data needed to support drug approval, as well as the ability to submit a New Drug Application (NDA) on a rolling basis, and eligibility for priority review, if relevant criteria are met.
Early-Stage Development Programs

Advancement of integrin target in fibrosis under strategic collaboration. A fibrosis-directed integrin target moved into development as part of Pliant’s 2019 research and development collaboration with Novartis. Pliant earned a $4.0 million milestone payment and research funding in support of the development work.
Oncology and muscular dystrophy programs progressing through Investigational New Drug (IND) enabling studies. IND application submissions for both programs expected by the end of 2022.
Corporate Highlights

Underwritten public offering raised approximately $215.7 million in net proceeds. In July 2022, the Company closed a public offering of $230.0 million of common stock including the underwriter’s exercise in full of their overallotment option to support development of ongoing and future preclinical and clinical programs including PLN-74809.
Loan facility agreement with Oxford Finance LLC provides up to $100 million of non-dilutive financing. The agreement provides support for the continued clinical development of PLN-74809 in the lead indications of IPF and PSC. The Company drew $10.0 million at closing of an initial $25.0 million tranche. Following the achievement of a development milestone, the Company now has access to the second $25.0 million tranche.
Second Quarter 2022 Financial Results

Research and development expenses were $26.3 million, as compared to $19.2 million for the prior-year quarter. The increase was due primarily to employee related expenses and higher costs related to the advancement of preclinical programs and ongoing Phase 1/2 clinical trials.
General and administrative expenses were $8.3 million, as compared to $5.5 million for the prior-year quarter. The increase was due to higher personnel-related and professional services expenses.
Net loss of $29.5 million as compared to $22.8 million for the prior-year quarter due to an increase in operating expenses partially offset by an increase in collaboration revenue resulting from a $4.0 million target validation fee earned under the Novartis collaboration during the quarter.
As of June 30, 2022, the Company had cash, cash equivalents and short-term investments of $163.6 million. With the aggregate net proceeds from the public offering of approximately $215.7 million, the Company had pro-forma cash, cash equivalents and short-term investments of $379.8 million as of June 30, 2022. With current cash and full utilization of our loan facility, the Company expects to be able to fund operations to mid-2025.