On May 9, 2022 Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company developing a first-in-class telomerase inhibitor, imetelstat, to treat hematologic malignancies, reported financial results for the first quarter of 2022, including current and projected financial resources (Press release, Geron, MAY 9, 2022, View Source [SID1234613917]).

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"This quarter, we continued to build on the momentum from our clinical execution throughout 2021, with our first Phase 3 data readout expected in just eight months. We believe that if the Phase 3 IMerge trial in lower risk MDS confirms similar depth, breadth and durability of transfusion independence, and safety, observed in our Phase 2 study, imetelstat could represent a significant treatment advance for these heavily transfusion-burdened patients," said John A. Scarlett, M.D., Geron’s Chairman and Chief Executive Officer. "Separately, we are advancing our IMpactMF Phase 3 refractory MF trial by continuing to open clinical sites around the world, which we expect to enable a potential interim analysis in 2024. We are also executing on our IMproveMF Phase 1 study, which has recently started. This study will allow us to potentially demonstrate safety and efficacy of combination therapy with imetelstat and ruxolitinib in the frontline MF setting."

Dr. Scarlett continued: "The successful financing in April adds to our current financial resources, as well as provides access to additional capital upon the potential exercise of warrants in the future. We expect these current and projected financial resources will be sufficient for our projected operations through the end of 2023, including planned key regulatory milestones and pre-commercial activities. In addition, this extended cash runway provides us the opportunity to thoughtfully and broadly explore multiple business strategies, including partnering and financing options, to optimize the value of imetelstat for patients and shareholders."

Current and Projected Financial Resources

As of March 31, 2022, the Company had $178.0 million in cash and marketable securities. In April 2022, the Company completed an underwritten public offering of 53,333,334 shares of Geron common stock and a pre-funded warrant to purchase 18,095,238 shares of Geron common stock (pre-funded warrant), together with accompanying warrants to purchase 35,714,286 shares of Geron common stock (stock purchase warrants). The combined public offering price of the common stock and accompanying stock purchase warrants was $1.05 per share. The combined public offering price of the pre-funded warrant and accompanying stock purchase warrant was $1.049 per share. The net cash proceeds from this offering are approximately $70 million, after deducting the underwriting discount and other offering expenses payable by the Company and excludes any future proceeds from the exercise of the pre-funded warrant or the stock purchase warrants. The stock purchase warrants have an exercise price of $1.45 per share and expire five years from the date of issuance; however, such term will be shortened upon achievement of a regulatory milestone.

Under current planning assumptions, the Company projects its existing capital resources, including the net proceeds from the public offering completed in April 2022, and projected future proceeds of up to $124.3 million from the exercise of currently outstanding warrants will be sufficient to fund Geron’s projected level of operations, which includes preparatory activities for potential U.S. commercial launch of imetelstat in lower risk MDS, until the end of 2023.

First Quarter 2022 Results

For the first quarter of 2022, the Company reported a net loss of $30.1 million, or $0.09 per share, compared to $27.8 million, or $0.09 per share, for the same period in 2021.

Revenues for the first quarter of 2022 were $123,000 compared to $137,000 for the same period in 2021. Royalty revenues in 2022 and 2021 primarily reflect estimated royalties from sales of cell-based research products from the Company’s divested stem cell assets.

Total operating expenses for the first quarter of 2022 were $28.8 million compared to $28.6 million for the same period in 2021. Research and development expenses for the first quarter of 2022 were $22.1 million compared to $21.1 million for the same period in 2021. The increase in research and development expenses in the first quarter of 2022, compared to the same period in 2021, primarily reflects higher personnel-related costs for additional headcount. General and administrative expenses for the first quarter of 2022 were $6.7 million compared to $7.5 million for the same period in 2021. The decrease in general and administrative expenses in the first quarter of 2022, compared to the same period in 2021, primarily reflects the net result of reduced costs related to modernizing the internal infrastructure to support commercial launch and lower legal fees, partially offset by higher personnel-related expenses for additional headcount.

Interest income for the first quarter of 2022 was $112,000 compared to $173,000 for the same period in 2021. The decrease in interest income in the first quarter of 2022, compared to the same period in 2021, primarily reflects lower yields on the Company’s reduced marketable securities portfolio.

Interest expense for the first quarter of 2022 was $1.5 million compared to $743,000 for the same period in 2021. Currently, the Company has $50.0 million in principal debt outstanding.

Net other expense for the first quarter of 2022 was $56,000 compared to net other income of $1.2 million for the same period in 2021. During the first quarter of 2021, the Company sold all of its holdings in an equity investment resulting in a net realized gain of $1.2 million, including foreign currency translation adjustments.

Projected 2022 Financial Guidance Reaffirmed

For fiscal year 2022, under generally accepted accounting principles (GAAP), the Company continues to expect total operating expenses in the range of approximately $155 million to $165 million, which includes non-cash items such as: stock-based compensation expense, amortization of debt discounts and issuance costs and depreciation and amortization. The Company continues to expect non-GAAP total operating expenses for fiscal year 2022, which excludes estimated non-cash items such as: stock-based compensation expense, amortization of debt discounts and issuance costs and depreciation and amortization, in the range of approximately $140 million to $150 million.

The fiscal year 2022 financial guidance reflects costs to support: (a) preparatory activities for top-line results from the IMerge Phase 3 clinical trial and readiness for potential regulatory filings and commercialization of imetelstat in lower risk MDS; (b) continued conduct of IMerge and IMpactMF and commencement of new clinical studies associated with the imetelstat pipeline expansion strategy; (c) finalizing validation batches of imetelstat at contract manufacturers to enable future production of imetelstat for clinical and commercial purposes; (d) projected increases in headcount and (e) interest payments on outstanding debt.

As of March 31, 2022, the Company had 79 employees. The Company plans to grow to a total of approximately 90 to 100 employees by year-end 2022.

Conference Call

Geron will host a conference call at 4:30 p.m. ET on Monday, May 9, 2022 to review recent events and first quarter 2022 financial results.

A live webcast of the conference call and related presentation will be available on the Company’s website at www.geron.com/investors/events. An archive of the webcast will be available on the Company’s website for 30 days.

Participants may access the webcast by registering online using the following link: View Source Participants that are unable to register online can access the conference call via telephone by dialing domestically +1 (888) 330-2434 or internationally +1 (240) 789-2725. The conference ID is 67335.

About Imetelstat

Imetelstat is a novel, first-in-class telomerase inhibitor exclusively owned by Geron and being developed in hematologic malignancies. Data from Phase 2 clinical trials provide strong evidence that imetelstat targets telomerase to inhibit the uncontrolled proliferation of malignant stem and progenitor cells in myeloid hematologic malignancies resulting in malignant cell apoptosis and potential disease-modifying activity. Imetelstat has been granted Fast Track designation by the United States Food and Drug Administration for both the treatment of patients with non-del(5q) lower risk MDS who are refractory or resistant to an erythropoiesis stimulating agent and for patients with Intermediate-2 or High-risk MF whose disease has relapsed after or is refractory to janus associated kinase (JAK) inhibitor treatment.

About IMerge Phase 3

IMerge Phase 3 is a double-blind, randomized, placebo-controlled Phase 3 clinical trial with registrational intent. The trial is designed to enroll approximately 170 transfusion dependent patients with Low or Intermediate-1 risk myelodysplastic syndromes (MDS), also referred to as lower risk MDS, who have relapsed after or are refractory to prior treatment with an erythropoiesis stimulating agent (ESA). The primary endpoint is the rate of red blood cell (RBC) transfusion independence (TI) for any consecutive period of eight weeks or longer, or 8-week RBC-TI rate. Key secondary endpoints include the rate of RBC-TI lasting at least 24 weeks, or 24-week RBC-TI rate, duration of TI and the rate of hematologic improvement-erythroid (HI-E), defined as a reduction of at least four units of RBC transfusions over eight weeks compared with the prior RBC transfusion burden.

IMerge Phase 3 is fully enrolled and patient enrollment has been closed. For additional information about IMerge Phase 3, visit ClinicalTrials.gov/NCT02598661.

About IMpactMF

IMpactMF is an open label, randomized, controlled Phase 3 clinical trial with registrational intent. The trial is designed to enroll approximately 320 patients with Intermediate-2 or High-risk myelofibrosis (MF) who are refractory to prior treatment with a JAK inhibitor, also referred to as refractory MF. Patients will be randomized to receive either imetelstat or best available therapy. The primary endpoint is overall survival (OS). Key secondary endpoints include symptom response, spleen response, progression free survival, complete remission, partial remission, clinical improvement, duration of response, safety, pharmacokinetics, and patient reported outcomes.

IMpactMF is currently enrolling patients. For further information about IMpactMF, including enrollment criteria, locations and current status, visit ClinicalTrials.gov/NCT04576156.

About IMproveMF

IMproveMF is a single arm, open label Phase 1 study to evaluate the safety, pharmacokinetics, pharmacodynamics and clinical activity of imetelstat in combination with ruxolitinib in patients with frontline myelofibrosis (MF), consisting of two parts. Part one will enroll up to 20 patients and is designed to identify a safe dose for the combination of imetelstat and ruxolitinib. Part two will also enroll approximately 20 patients and is designed to confirm the dose identified in part one.

On May 9, 2022 Olema Pharmaceuticals, Inc. ("Olema" or "Olema Oncology," Nasdaq: OLMA), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of targeted therapies for women’s cancers, reported first quarter financial results for the period ended March 31, 2022 and provided a business update (Press release, Olema Oncology, MAY 9, 2022, View Source [SID1234613933]).

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"Following the successful completion of the Phase 1a dose escalation portion of our trial for OP-1250 late last year, we are pleased with the continued robust enrollment we are achieving across our development program. Both our Phase 1/2 monotherapy expansion study and the Phase 1b combination trial with palbociclib are advancing, and we expect to initiate additional combination trials later this year. In parallel, we plan to evaluate OP-1250’s potential in the treatment of patients with ER+/HER2+ breast cancer and CNS metastases, an important and underserved patient population with limited treatment options," said Sean P. Bohen, M.D., Ph.D., President and Chief Executive Officer of Olema Oncology. "Our knowledge and clinical experience with OP-1250 is rapidly expanding. We are fortunate to be supported by both a strong team and balance sheet as we approach potential near-term value drivers for our business. We look forward to presenting updated clinical data later this year."

Recent Corporate Highlights

Achieved target enrollment of 30 patients in Phase 1b monotherapy dose expansion at 60 mg and 120 mg dose levels (N=15 per cohort).

Enrolled initial dose cohorts in the dose escalation portion of the Phase 1b combination study with palbociclib and dose escalation of OP-1250 continues.

Presented two posters at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, held April 8-13, 2022. Data presented showed that 10 mg/kg OP-1250, a complete estrogen receptor (ER) antagonist (CERAN), alone or in combination with palbociclib, substantially inhibits primary tumor growth in an endocrine-resistant breast cancer model with ERα Y537S mutation. A second poster showed that OP-1250 is able to effectively reverse estradiol-induced transcriptional changes associated with the activated estrogen receptor in two ER+ cell lines, MCF7 and CAMA-1.
Anticipated Milestones

Select the Recommended Phase 2 Dose (RP2D) for OP-1250 in the second quarter of 2022, followed by initiation of the Phase 2 portion of the trial. Phase 2 will include enrollment across three cohorts: patients with measurable disease (N=50), patients with non-measurable disease (N=15) and patients with CNS metastasis (N=15).

Initiate additional Phase 1b combination studies with CDK4/6 and PI3Kα inhibitors in 2022.

Initiate Phase 1b study of OP-1250 in patients with ER+/HER2+ breast cancer and CNS metastases in the second half of 2022.

Present updated monotherapy and initial combination data for OP-1250.
Financial Results

Cash, cash equivalents and marketable securities as of March 31, 2022, were $267.9 million. Olema anticipates that this balance will be sufficient to fund operations into 2024.

Net loss for the quarter ended March 31, 2022, was $23.0 million, compared to $15.3 million for the same period of the prior year. The increase in net loss related primarily to Olema’s continued investment in OP-1250, and an increase in general and administrative (G&A) costs.

GAAP research and development (R&D) expenses were $16.0 million for the quarter ended March 31, 2022, compared to $10.7 million for the same period of the prior year. The increase in R&D expenses was primarily related to the advancement of the development program for OP-1250, increase in nonclinical development activities, and higher personnel-related expenses, including non-cash stock-based compensation expenses. Non-GAAP R&D expenses were $12.9 million for the quarter ended March 31, 2022, excluding $3.1 million non-cash stock-based compensation expense. Non-GAAP R&D expenses were $9.0 million for the quarter ended March 31, 2021, excluding $1.7 million non-cash stock-based compensation expense. A reconciliation of GAAP to non-GAAP financial measures used in this press release can be found at the end of this news release.

GAAP G&A expenses were $7.2 million for the quarter ended March 31, 2022, as compared to $4.8 million for the same period of the prior year. The increase in G&A expenses was primarily related to higher personnel-related expenses, including non-cash stock-based compensation expenses, and other corporate costs. Non-GAAP G&A expenses were $5.3 million for the quarter ended March 31, 2022, excluding $1.9 million non-cash stock-based compensation expense. Non-GAAP G&A expenses were $3.3 million for the quarter ended March 31, 2021, excluding $1.5 million non-cash stock-based compensation expense.

On May 9, 2022 Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), a biopharmaceutical company focused on the development and commercialization of novel products for rare and ultra-rare diseases, reported that clinical, preclinical and manufacturing data from its investigational gene therapy programs will be presented at the American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) 25th Annual Meeting, which will be held both in person and virtually May 16-19, 2022 (Press release, Ultragenyx Pharmaceutical, MAY 9, 2022, View Source [SID1234613949]). The company will present new data supporting its gene therapy portfolio and discuss critical topics during a scientific symposium on Accelerated Approval and at the pre-meeting workshops.

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Clinical and pre-clinical presentations include:

Oral presentation: Safety and Efficacy of DTX301 in Adults with Late-Onset Ornithine Transcarbamylase (OTC) Deficiency: A Phase 1/2 Trial (Abstract #463)
Date/Time: Tuesday, May 17, 4:15-4:30 PM ET
Presenter: Cary Harding, M.D., Oregon Health & Science University

Oral presentation: Sustained Efficacy and Safety at Week 52 and up to Three Years in Adults with Glycogen Storage Disease Type Ia (GSDIa): Results from a Phase 1/2 Clinical Trial of DTX401, an AAV8-mediated, Liver-directed Gene Therapy (Abstract #1212)
Date/Time: Thursday, May 19, 11:00-11:15 AM ET
Presenter: Rebecca Riba-Wolman, M.D., University of Connecticut

Poster presentation: Improving Neuronal Gene Transfer to the Brain After CSF Administration of AAV9 in Juvenile Non-Human Primates (Board No. Tu-143)
Date/Time: Tuesday, May 17, 5:30-6:30 PM ET
Presenter: Maggie Wright, Ph.D, Ultragenyx

Poster presentation: Understanding the Educational Needs of United States Physicians Related to Gene Therapy (Board No. Tu-67)
Date/Time: Tuesday, May 17, 5:30-6:30 PM ET
Presenter: Emily Belcher, CE Outcomes
Manufacturing presentations covering the company’s Pinnacle PCL (AAV vector Producer Cell Line) platform and technology include:

Oral presentation: Development and Characterization of Highly Optimized Monoclonal Producer Cell Lines (PCLs) for the Treatment of CDKL5 Deficiency Disorder (CDD) (Abstract #863)
Date/Time: Wednesday, May 18, 4:15-4:30 PM ET
Presenter: Laurie Tran, MSc, Ultragenyx

Poster presentation: Development of High Density & High Purity AAV Production Processes (Board No. M-293)
Date/Time: Monday, May 16, 5:30-6:30 PM ET
Presenter: Jan Panteli, Ph.D, Ultragenyx

Poster presentation: Development of an In Vitro Model for the Evaluation of Adeno-Associated Virus Delivered Microdystrophin Transgenes (Board No. W-56)
Date/Time: Wednesday, May 18, 5:30-6:30 PM ET
Presenters: Eric Himelman, Ph.D, and Hwan June Kang, Ph.D, both Ultragenyx
In addition to the data presentations, Emil D. Kakkis, M.D., Ph.D., Chief Executive Officer and President of Ultragenyx will deliver a presentation at ASGCT (Free ASGCT Whitepaper)’s session on "Accelerated Approval for Gene Therapies," taking place on Monday, May 16 from 8:00-9:45 AM ET.

Separately, several members of the team will present during the following pre-meeting workshops on Sunday, May 15:

Newborn Screening: Toward a System That Keeps Pace with Gene Therapy Advances
Time: 8:55-9:45 AM ET
Presenter: Erin Frey, Director, State Government Affairs, Ultragenyx
AAV Vector Integration
Time: 2:50-4:50 PM ET
Presenter: Sam Wadsworth, Ph.D., Chief Scientific Officer of Ultragenyx Gene Therapy
What to Expect as a Participant in a Gene Therapy Clinical Trial
Time: 1:00-3:00 PM ET
Presenter: Heather Lau, M.D., Executive Director, Global Clinical Development, Ultragenyx

On May 9, 2022 Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, reported its financial results for the first quarter ended March 31, 2022 (Press release, Castle Biosciences, MAY 9, 2022, View Source [SID1234613966]).

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"We saw significant progress and execution on our growth initiatives in the first quarter, with record test report volume," said Derek Maetzold, president and chief executive officer of Castle Biosciences. "We remain laser-focused on the execution of our three operational growth pillars — our strong core dermatology business, pipeline initiatives and strategic opportunities — and are pleased with our results.

"In 2021, we made commercial investments, including a significant sales team expansion, in our proprietary skin cancer test business to further our position of strength in 2022 and beyond. We believe these investments, coupled with the demonstrated utility of our tests, are the drivers behind the nearly 70% increase in total test volume during the first quarter.

"We reported initial proof of concept data on our sample collection method for our pipeline test for inflammatory skin diseases, and we remain on track to launch this test in 2025, which would add an additional $1.9 billion to our estimated U.S. total addressable market (TAM), if successful.

"We are encouraged with the initial progress on our gastroenterology franchise and TissueCypher Barrett’s Esophagus (BE) test. We successfully hired and trained our commercial team for this test, who were in the field in February 2022, and received new Advanced Diagnostic Laboratory Test (ADLT) status from the Centers for Medicare & Medicaid Services (CMS) in March 2022. Further, the recent acquisition of AltheaDx and the IDgenetix pharmacogenomic test (PGx), in alignment with our M&A strategy to diversify our portfolio and create near- and long-term revenue growth opportunity, adds approximately $5.0 billion to our estimated U.S. TAM. IDgenetix now has expanded Medicare coverage, from depression only to seven additional mental health conditions. We are entering the remainder of 2022 with an estimated in-market U.S. TAM of just under $8 billion, for all our franchises combined.

"We believe our progress is only possible through the dedication of our Castle team, who allows us to execute at a high level, further our impact on patient care and position ourselves for continued value creation."

First Quarter Ended March 31, 2022, Financial and Operational Highlights

Revenues were $26.9 million, an 18% 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 $5.3 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 $26.3 million, an 50% increase, compared to $17.5 million for the same period in 2021.
Delivered 8,627 total test reports in the first quarter of 2022, an increase of 68% compared to 5,142 in the same period of 2021:
DecisionDx-Melanoma test reports delivered in the quarter were 6,023, compared to 4,060 in the first quarter of 2021, an increase of 48%.
DecisionDx-SCC test reports delivered in the quarter were 1,142, compared to 527 in the first quarter of 2021, an increase of 117%.
myPath Melanoma and DecisionDx DiffDx-Melanoma (Castle’s comprehensive diagnostic offering) aggregate test reports delivered in the quarter were 950, compared to 218 in the first quarter of 2021, an increase of 336%.
DecisionDx-UM test reports delivered in the quarter were 456, compared to 337 in the first quarter of 2021, an increase of 35%.
TissueCypher Barrett’s Esophagus test reports delivered in the quarter were 56.
Gross margin for the quarter ended March 31, 2022, was 72%, and adjusted gross margin was 77%.
Operating cash flow was $(21.4) million, compared to $(3.6) million for the same period in 2021, and adjusted operating cash flow was $(21.4) million, compared to $(5.5) million for the same period in 2021.
Net loss for the first quarter, inclusive of non-cash stock-based compensation expense of $8.4 million, was $(24.6) million, compared to $(4.3) million for the same period in 2021.
Adjusted EBITDA for the first quarter was $(11.4) million, compared to $0.9 million for the same period in 2021.
Cash and Cash Equivalents

As of March 31, 2022, the Company’s cash and cash equivalents totaled $309 million.

2022 Revenue Guidance

Castle Biosciences is increasing its previously issued guidance for anticipated total revenue in 2022. The Company now anticipates generating $118-123 million in total revenue in 2022, compared to the previously provided guidance of $115-120 million. This includes expected revenue from the TissueCypher Barrett’s Esophagus test, acquired in December 2021, and the IDgenetix pharmacogenomics test for mental health conditions, acquired in April 2022.

First Quarter and Recent Accomplishments and Highlights

Dermatology

In April, the Company announced new real-world data from its ongoing collaborative study with the National Cancer Institute (NCI). This new data showed that 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.
Castle’s U.S. Federal Supply Schedule (FSS) contract with the Veterans Health Administration (VHA) was expanded to include coverage for the Company’s entire skin cancer test portfolio, effective April 15, 2022. Castle’s expanded U.S. FSS contract now includes DecisionDx-SCC, DecisionDx DiffDx-Melanoma, myPath Melanoma and DecisionDx-CMSeq, in addition to DecisionDx-Melanoma. Castle was awarded its first U.S. FSS contract in August 2021 for DecisionDx-Melanoma. See the Company’s news release from April 29, 2022, for more information.
In April, the Company gave a poster presentation highlighting data and concluding that its non-invasive skin scraping technique produces sufficient ribonucleic acid (RNA) to assess reproducible gene expression for its inflammatory skin disease pipeline test. The poster was presented at the 4th Annual Revolutionizing Atopic Dermatitis Conference. The Company expects to launch this pipeline test by the end of 2025. See the Company’s news release from April 18, 2022, for more information.
In March, the Company announced new data further demonstrating the performance of DecisionDx-Melanoma and i31-SLNB to provide improved risk prediction of sentinel lymph node (SLN) positivity, compared to using T-stage factors alone, in patients with cutaneous melanoma. In the study, the DecisionDx-Melanoma test outperformed T-stage in identifying patients with low-risk tumors who could forgo SLN biopsy, with an Area Under the Curve of 0.89 versus 0.78 for T-stage in patients with T1-T2 tumors, indicating that DecisionDx-Melanoma provides improved predictions compared to those of the T-stage system. See the Company’s news release from March 11, 2022, for more information.
Uveal Melanoma

In January, the Company announced the publication of a study in Ocular Oncology and Pathology demonstrating that the combined application of DecisionDx-UM, DecisionDx-PRAME and DecisionDx-UMSeq allows for highly accurate analysis of RNA and DNA from a single biopsy sample for patients with uveal melanoma (UM). DecisionDx-UMSeq is Castle’s 7-gene test that uses next-generation sequencing to identify somatic mutations relevant to UM. This information, together with results from the DecisionDx-UM gene expression profile test, is designed to help build a comprehensive genomic profile of an individual UM tumor from a single biopsy, which can then be used to inform patient care. See the Company’s news release from Jan. 12, 2022, for more information.
Gastroenterology

In March, the Company announced that CMS granted ADLT status for the TissueCypher Barrett’s Esophagus test, effective March 24, 2022. TissueCypher is Castle’s prognostic test designed to predict future development of high-grade dysplasia and/or esophageal cancer in patients with BE. ADLT status requires that a clinical diagnostic laboratory test provide new clinical diagnostic information that cannot be obtained from any other test or combination of tests, among other criteria.1 The announcement of ADLT status for TissueCypher confirms that the test meets these criteria established by CMS for laboratory tests under the Protecting Access to Medicare Act of 2014 (PAMA). See the Company’s news release from March 29, 2022, for more information.
In April, the company announced an independent, peer-reviewed article published in Clinical Gastroenterology and Hepatology. The study reinforces the ability of TissueCypher to significantly improve predictions of progression to esophageal cancer in patients with 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.
Mental Health

In April, the Company diversified and expanded its portfolio into the mental health market with the acquisition of AltheaDx and the IDgenetix PGx test for mental health conditions. IDgenetix has been reimbursed by Medicare for depression since the fall of 2020, and in a randomized, controlled clinical-use trial demonstrated clinical utility over standard of care, when physicians used the test prior to prescribing a medication. The acquisition adds approximately $5.0 billion to the Company’s estimated U.S. TAM. See the Company’s news release from April 26, 2022, for more information.
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, May 9, 2022, at 4:30 p.m. Eastern time to discuss its first quarter 2022 results and provide a corporate update.

A live webcast of the conference call can be accessed here: 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 May 30, 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 355837.

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 expense, stock compensation expense, 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 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 on GAAP basis; 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 May 9, 2022 IGM Biosciences, Inc. (Nasdaq: IGMS), a clinical-stage biotechnology company focused on creating and developing IgM antibodies, reported its financial results for the first quarter ended March 31, 2022 and provided an update on recent developments (Press release, IGM Biosciences, MAY 9, 2022, View Source [SID1234614001]).

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"IGM took a major step in expanding the scope and support of our research pipeline of IgM antibodies with the recent closing of an exclusive worldwide collaboration agreement with Sanofi for the creation, research and development of agonist IgM antibodies against three oncology targets and three autoimmune/inflammation targets," said Fred Schwarzer, Chief Executive Officer of IGM Biosciences. "We have also made significant progress in the clinical development of our wholly-owned pipeline of IgM antibodies with the start of our two Phase 2 studies for our T cell bispecific antibody, IGM-2323, and the continuation of our Phase 1 trial of IGM-8444. In addition to continued progress in these ongoing clinical trials, we also 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."

Corporate Updates

Closing of collaboration agreement with Sanofi. IGM announced that the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended (the HSR Act), has expired in connection with the Company’s previously announced exclusive worldwide collaboration agreement with Sanofi. In connection with the closing of the collaboration agreement, Sanofi will pay IGM a $150 million upfront payment. The agreement is for the creation, development, manufacture, and commercialization of IgM antibody agonists against three oncology targets and three autoimmune/inflammation targets. In addition to the $150 million upfront payment, IGM is eligible for over $6 billion in aggregate development, regulatory and commercial milestones, a 50:50 profit share in certain major market countries and tiered royalties in the rest of world for oncology targets, and tiered royalties for autoimmune/inflammation targets.

Completed underwritten public offering of common stock. In April 2022, IGM closed a public offering of its common stock with gross proceeds of $230 million, before deducting the underwriting discounts and commissions and estimated offering expenses payable by IGM.
Pipeline Updates

IGM-2323 (CD20 x CD3)

Phase 2 studies. IGM previously announced the initiation of two Phase 2 studies to assess the safety and efficacy of two doses of IGM-2323, 100 mg and 300 mg, in patients with diffuse large B cell lymphoma (DLBCL) and follicular lymphoma (FL).
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 I study of IGM-8444 in multiple combinations in subjects with relapsed and/or refractory solid and hematologic cancers.
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.
First Quarter 2022 Financial Results

Cash and Investments: Cash and investments as of March 31, 2022 were $187.5 million, compared to $229.5 million as of December 31, 2021.
The March 31, 2022 cash and investments balance does not include the $230.0 million in gross proceeds, before deducting the underwriting discounts and commissions and other offering expenses payable by IGM, received in connection with IGM’s 2022 public offering, which closed in April.
The March 31, 2022 cash and investments balance also does not include the $150.0 million upfront payment that IGM is expected to receive from Sanofi during the second quarter of 2022 under the terms of the collaboration agreement announced in March 2022.
Research and Development (R&D) Expenses: For the first quarter of 2022, R&D expenses were $38.9 million, compared to $23.6 million for the same period in 2021.
General and Administrative (G&A) Expenses: For the first quarter of 2022, G&A expenses were $13.1 million, compared to $8.1 million for the same period in 2021.
Net Loss: For the first quarter of 2022, net loss was $51.9 million, or a loss of $1.53 per share, compared to a net loss of $31.6 million, or a loss of $0.95 per share, for the same period in 2021. The net loss included non-cash stock-based compensation expense of $11.5 million and $5.5 million for the first quarter of 2022 and 2021, respectively.
2022 Financial Guidance

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. IGM expects to end 2022 with a balance of over $390 million in cash and investments.