Market Newsdesk

MENLO PARK, Calif., March 28, 2023 (GLOBE NEWSWIRE) — Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of medications to treat severe endocrine, oncologic, metabolic and neurological disorders by modulating the effects of the hormone cortisol, today announced that it has initiated CATALYST, a 1,000-patient, Phase 4 trial examining the prevalence of hypercortisolism in patients with difficult to control type 2 diabetes. Those patients with hypercortisolism will be offered entry into a randomized, double-blind, placebo-controlled study of Korlym^®.

“We are excited that our CATALYST trial is now open,” said Bill Guyer, PharmD, Corcept’s Chief Development Officer. “Many smaller studies conducted over the last fifteen years have found that the prevalence of hypercortisolism in patients with type 2 diabetes is substantially higher than in the general population. The most prominent diabetologists in the United States helped us design and are participating in CATALYST, which will be the largest study of its kind ever to be conducted. Data from CATALYST will enable physicians to better identify and care for these patients. We expect to complete enrollment by the end of this year.”

Hypercortisolism

Hypercortisolism, often referred to as Cushing’s syndrome, is caused by excessive activity of the hormone cortisol. Endogenous Cushing’s syndrome is an orphan disease that most often affects adults aged 20-50. In the United States, an estimated 20,000 patients have Cushing’s syndrome, with about 3,000 new patients diagnosed each year. Symptoms vary, but most patients experience one or more of the following manifestations: high blood sugar, diabetes, high blood pressure, upper-body obesity, rounded face, increased fat around the neck, thinning arms and legs, severe fatigue and weak muscles. Irritability, anxiety, cognitive disturbances and depression are also common. Hypercortisolism can affect every organ system and can be lethal if not treated effectively. Corcept holds patents directed to the composition of relacorilant and the use of cortisol modulators, including Korlym, in the treatment of patients with hypercortisolism.

About Corcept Therapeutics

Corcept has discovered a large portfolio of proprietary compounds that selectively modulate the effects of cortisol and owns extensive United States and foreign intellectual property covering both their composition and their use to treat a variety of serious disorders. Clinical trials are being conducted with the company’s leading selective cortisol modulators as potential treatments for patients with serious disorders – Cushing’s syndrome, ovarian, prostate and adrenal cancer, ALS, post-traumatic stress disorder and liver disease. Corcept’s drug Korlym^® was the first medication approved by the U.S. Food and Drug Administration for the treatment of patients with Cushing’s syndrome.

Forward Looking Statements

Statements in this press release, other than statements of historical fact, are forward-looking statements based on our current plans and expectations that are subject to risks and uncertainties that might cause our actual results to differ materially from those such statements express or imply. These risks and uncertainties include, but are not limited to, our ability to operate our business, conduct our clinical trials and achieve our other goals during the COVID-19 pandemic and generate sufficient revenue to fund our activities; the availability of competing treatments for hypercortisolism, including generic versions of Korlym; our ability to obtain acceptable prices and adequate insurance coverage and reimbursement for Korlym; risks related to the development of our product candidates, including their clinical attributes, regulatory approvals, mandates, oversight and other requirements; the timing, cost and outcome of legal disputes and investigations; and the scope and protective power of our intellectual property. These and other risks are set forth in our SEC filings, which are available at our website and the SEC’s website.

In this press release, forward-looking statements include, among others: the design, timing and expectations regarding our CATALYST trial. We disclaim any intention or duty to update forward-looking statements made in this press release.

CONTACT:

Corcept Therapeutics
Investor Relations
[email protected]
www.corcept.com

• Expanded clinical development footprint of BMF-219, the company’s lead investigational, orally administered, covalent menin inhibitor, to eight liquid and solid tumor indications and type 2 diabetes across three ongoing clinical trials
  • COVALENT-101 (Phase I study) enrolling four liquid tumor cohorts, each focused on distinct patient subsets of acute lymphocytic and myeloid leukemias (ALL/AML) including patients with MLL rearrangements (MLLr) and NPM1 mutations, diffuse large B-cell lymphoma (DLBCL), multiple myeloma (MM) and most recently, chronic lymphocytic leukemia (CLL)
  • COVALENT-102 (Phase I/Ib study) enrolling patients with KRAS-mutated solid tumors, including non-small cell lung cancer (NSCLC), colorectal cancer (CRC) and pancreatic ductal adenocarcinoma (PDAC)
  • COVALENT-111 (Phase I/II study) advanced BMF-219 to the clinic for type 2 diabetes; completed the Phase I healthy volunteer portion of the study in Canada, initiated dosing of type 2 diabetic patients in the Phase II portion in the U.S. and Canada and reported initial clinical data from the first two cohorts of diabetic patients
• Continued to advance the second product candidate, BMF-500, a highly selective and potent covalent third generation FLT3 inhibitor, toward the clinic with IND filing on track for the first half of 2023
• Cash position of $113.4 million at the end of the fourth quarter of 2022

REDWOOD CITY, Calif., March 28, 2023 (GLOBE NEWSWIRE) — Biomea Fusion, Inc. (“Biomea” or “the Company”) (Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to discovering and developing novel covalent small molecules to treat and improve the lives of patients with genetically defined cancers and metabolic diseases, reported fourth quarter and full year 2022 financial results and business highlights.

“During 2022 we transformed Biomea from a preclinical company to a fully integrated clinical-stage company, pursuing ten indications, with two distinct molecules in three different trials. I am incredibly proud of our team’s performance and dedication, which has enabled our rapid clinical progress,” said Thomas Butler, CEO and Chairman of Biomea. “In 2023, we will significantly advance all three programs and plan to deliver on multiple data readouts, beginning with initial data reported this quarter from our COVALENT-111 study in patients with type 2 diabetes. Loss of mass and function of beta cells is an underlying cause of type 2 diabetes. There is biological precedent, reinforced by our preclinical data for BMF-219, that suggests inhibiting menin may enable the proliferation, preservation, and reactivation of healthy, functional beta cells capable of producing insulin, thereby leading to long-term glycemic control in patients with type 2 diabetes. None of the currently approved therapies for diabetes are effectively addressing the loss and function of beta cells. We believe the data from COVALENT-111 of our oral agent BMF-219, which we have started to report this quarter, could represent a monumental event for the treatment of patients with diabetes and a transformative milestone for our company.”

2022 and Recent Clinical and Regulatory Highlights

ONCOLOGY

• COVALENT-101 (BMF-219 for Genetically Defined Liquid Tumors)
  • Presented robust anti-tumor activity of covalent, small molecule menin inhibitor, BMF-219, as a single agent and mechanistic evidence for novel inhibition of the menin protein in preclinical models of DLBCL, MM, and CLL. BMF-219 displayed significant single agent activity, surpassing greater than 90% cell killing at clinically relevant exposures in DLBCL, MM and CLL cell lines and patient-derived samples.
  • BMF-219 is the first investigational menin inhibitor in clinical development to show potential as a therapeutic agent in hematologic malignancies outside of MLLr and NPM1 mutated AML/ALL patients, specifically in subsets of DLBCL, MM and CLL patients.
  • Continued site activation and patient enrollment across four liquid tumor cohorts including patients with AML/ALL, DLBCL, MM and CLL.
  • Anticipated Milestone in 2023:
    • On track to present initial clinical data of AML/ALL patients (including those with MLLr rearrangement and NPM1 mutations) dosed in the COVALENT-101 study in the first half of 2023.
• COVALENT-102 (BMF-219 for KRAS-Mutant Solid Tumors)
  • Presented strong and highly specific pan-KRAS anti-cancer activity of BMF-219 as a single agent across KRAS G12C, G12D, G12V and G13D mutant cell lines including in NSCLC, CRC and PDAC.
  • BMF-219 is the first investigational menin inhibitor in development to enter clinical trials for the treatment of solid tumors. A targeted pan-KRAS inhibitor could have the potential to treat 25-35% of NSCLC, 35-45% of CRC, and approximately 90% of PDAC patients.
  • Dosed first patient in January 2023 in COVALENT-102, a study of BMF-219 as a monotherapy in patients with unresectable, locally advanced, or metastatic NSCLC, CRC or PDAC with an activating KRAS mutation.
• COVALENT-103 (BMF-500 for Acute Leukemias)
  • Announced second Investigational New Drug (IND) candidate, BMF-500, a potential best-in-class oral covalent inhibitor of FLT3, designed and developed in-house, from target to IND candidate, utilizing Biomea’s proprietary FUSION™ System.
  • Presented data showing multi-fold higher potency and increased cytotoxicity of Biomea’s covalent FLT3 small molecule inhibitor BMF-500 compared to the commercially available reversible, non-covalent FLT3 inhibitor gilteritinib, and complete, sustained tumor regression in mouse models of FLT3-ITD AML with maintenance of effect after cessation of therapy.
  • Anticipated Milestone in 2023:
    • On track to file IND for BMF-500 in the first half of 2023 to initiate COVALENT-103 study in patients with acute leukemias.

DIABETES

• COVALENT-111 (BMF-219 for Type 2 Diabetes)
  • Presented preclinical data highlighting the ability of BMF-219 in a type 2 diabetes rat model to restore normal HOMA-B, a measure of pancreatic beta cell function, following only four weeks of treatment and to significantly lower HbA1c compared to active control, liraglutide, -3.5% vs -1.7%, respectively.
  • BMF-219 is the first investigational menin inhibitor in development to enter clinical trials for the improvement of glycemic control and insulin sensitivity in type 2 diabetes patients.
  • Completed the Phase I healthy volunteer portion of Phase I/II (COVALENT-111) study of BMF-219 in Canada. BMF-219 was well tolerated with a favorable pharmacokinetic and pharmacodynamic profile in healthy volunteers and with no safety signals detected.
  • Received FDA clearance in December 2022 to expand the Phase II portion of COVALENT-111 to sites in the U.S. and dosed the first diabetic patient in the U.S. in January 2023. Biomea continues to enroll type 2 diabetes patients in the Phase II portion of the study in the U.S. and Canada.
  • In March 2023, Biomea reported initial clinical data from the first two cohorts of the Phase II portion of COVALENT-111, with initial data in its Cohort 3 (n=10 patients at 100 mg without food) showing 89% patients achieving a reduction in HbA1c, 78% of subjects achieving a ≥ 0.5% reduction in HbA1c and 56% achieving a >1.0% reduction in HbA1c (median and mean reduction over the cohort: -1.0% and -0.81%, respectively). BMF-219 demonstrated a well-tolerated safety profile with no dose discontinuations.
  • Anticipated Milestone in 2023:
    • Further clinical updates at higher treatment doses expected including follow up on the initial dosing cohorts reported in the first quarter of 2023.

FUSION™
 SYSTEM DISCOVERY PLATFORM

• Developed two covalently binding small molecules (BMF-219 and BMF-500), each within 18 months from target identification to IND candidate, leveraging the proprietary FUSION™ System Discovery Platform and showing promising preclinical profiles.
• Anticipated Milestone in 2023:
  • On track to announce a third development candidate from the FUSION™ platform in the first half of 2023.

FOURTH QUARTER AND FULL YEAR 2022 FINANCIAL RESULTS

• Cash, Cash Equivalents, Restricted Cash, and Investments: As of December 31, 2022, the Company had cash, cash equivalents, restricted cash, and investments of $113.4 million, compared to $175.7 million as of December 31, 2021.
• Net Income/Loss: Biomea reported a net loss attributable to common stockholders of $25.3 million for the three months ended December 31, 2022, compared to a net loss of $14.7 million for the same period in 2021. Net loss attributable to common stockholders was $81.8 million for the year ended December 31, 2022, compared to a net loss of $41.6 million for the same period in 2021.
• Research and Development (R&D) Expenses: R&D expenses were $20.5 million for the three months ended December 31, 2022, compared to $11.1 million for the same period in 2021. The increase of $9.5 million was primarily due to an increase in clinical and preclinical development costs as well as an increase in personnel-related expenses. R&D expenses were $62.7 million for the year ended December 31, 2022, compared to $28.0 million for the same period in 2021. The increase of $34.7 million was primarily due to an increase in personnel-related expenses, as well as an increase in clinical and preclinical development costs, including manufacturing and external consulting, related to the Company’s product candidates, BMF-219 and BMF-500.
• General and Administrative (G&A) Expenses: G&A expenses were $5.7 million for the three months ended December 31, 2022, compared to $3.6 million for the same period in 2021. The increase of $2.1 million was primarily due to higher personnel-related expenses and other corporate costs to support the Company’s expanding operations as well as additional costs incurred as a public company. G&A expenses were $20.9 million for the year ended December 31, 2022, compared to $13.7 million for the same period in 2021. The increase of $7.3 million was primarily due to higher personnel-related expenses and other corporate costs to support the Company’s expanding operations as well as additional costs incurred as a public company.

About COVALENT-101

COVALENT-101 is a Phase I, open-label, multi-center, dose escalation and dose expansion study originally designed to assess the safety, tolerability, and pharmacokinetics/pharmacodynamics of oral dosing of BMF-219 in patients with R/R acute leukemias —including subpopulations where menin inhibition is expected to provide maximal therapeutic benefit (e.g., patients with MLL1/KMT2A gene rearrangements or NPM1 mutations), multiple myeloma (MM) and diffuse large B-cell lymphoma (DLBCL). The study design has now been expanded to include a cohort for patients with R/R CLL. Additional information about the Phase I clinical trial of BMF-219 in genetically defined liquid tumors can be found at ClinicalTrials.gov using the identifier NCT05153330.

About COVALENT-102

COVALENT-102 is an open-label, multi-cohort, multicenter, Phase I/Ib dose finding study evaluating the safety, tolerability, and clinical activity of escalating doses of oral BMF-219 administered to patients with unresectable, locally advanced, or metastatic NSCLC, CRC, and PDAC with a KRAS mutation. Additional information about the Phase I/Ib clinical trial of BMF-219 in KRAS-mutant solid tumors can be found at ClinicalTrials.gov using the identifier NCT05631574.

About COVALENT-111

COVALENT-111 is a multi-site, randomized, double-blind, placebo-controlled Phase I/II study. In the completed Phase I portion of the trial, healthy subjects were enrolled in single ascending dose cohorts to ensure safety at the prospective dosing levels for type 2 diabetic patients. Phase II consists of multiple ascending dose cohorts and includes adult patients with type 2 diabetes uncontrolled by current therapies. Additional information about the Phase I/II clinical trial of BMF-219 in type 2 diabetes can be found at ClinicalTrials.gov using the identifier NCT05731544.

About Biomea Fusion

Biomea Fusion is a biopharmaceutical company focused on the discovery and development of covalent small molecules to treat patients with genetically defined cancers and metabolic diseases. A covalent small molecule is a synthetic compound that forms a permanent bond to its target protein and offers a number of potential advantages over conventional non-covalent drugs, including greater target selectivity, lower drug exposure, and the ability to drive a deeper, more durable response. The company is utilizing its proprietary FUSION™ System to advance a pipeline of covalent-binding therapeutic agents against key oncogenic drivers of cancer and metabolic diseases. Biomea Fusion’s goal is to utilize its capabilities and platform to become a leader in developing covalent small molecules in order to maximize the clinical benefit when treating various cancers and metabolic diseases.

Forward-Looking Statements

Statements we make in this press release may include statements which are not historical facts and are considered forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). These statements may be identified by words such as “aims,” “anticipates,” “believes,” “could,” “estimates,” “expects,” “forecasts,” “goal,” “intends,” “may,” “plans,” “possible,” “potential,” “seeks,” “will,” and variations of these words or similar expressions that are intended to identify forward-looking statements. Any such statements in this press release that are not statements of historical fact, including statements regarding our cash runway, the clinical and therapeutic potential of our product candidates and development programs, including BMF-219 and BMF-500, the potential of BMF-500 as an FLT3 inhibitor, the potential of BMF-219 as a treatment for various types of cancer and diabetes, our research, development and regulatory plans, the progress of our ongoing clinical trials, including COVALENT-101, COVALENT-102 and our Phase I/II COVALENT-111 study of BMF-219 in type 2 diabetes, our plans to submit IND applications for BMF-500 in patients with FLT3 mutations, our plans to provide clinical updates on the healthy volunteer section of our Phase I/II type 2 diabetes study of BMF-219, BMF-219 in type 2 diabetes patients, and patients in the COVALENT-101 study, our plans to announce a third development candidate from the FUSION platform, and the timing of such events, may be deemed to be forward-looking statements. We intend these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act and are making this statement for purposes of complying with those safe harbor provisions.

Any forward-looking statements in this press release are based on our current expectations, estimates and projections only as of the date of this release and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements, including the risk that we may encounter delays in preclinical or clinical development, the preparation, filing and clearance of INDs, patient enrollment and in the initiation, conduct and completion of our ongoing and planned clinical trials and other research and development activities. These risks concerning Biomea Fusion’s business and operations are described in additional detail in its periodic filings with the U.S. Securities and Exchange Commission (the “SEC”), including its most recent periodic report filed with the SEC and subsequent filings thereafter. Biomea Fusion explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law.

BIOMEA FUSION, INC.

Condensed Statement of Operations

(Unaudited)

(in thousands, except share and per share amounts)

⁽¹⁾ Includes stock-based compensation as follows:

BIOMEA FUSION, INC.

Condensed Balance Sheet Data

(Unaudited)

(in thousands)

New CPI-818 Predictive Biomarker Enables Selection of Lymphoma Patients Most Likely to Benefit from Treatment

Conference Call Today at 4:30 p.m. ET / 1:30 p.m. PT

BURLINGAME, Calif., March 28, 2023 (GLOBE NEWSWIRE) — Corvus Pharmaceuticals, Inc. (Corvus or the Company) (Nasdaq: CRVS), a clinical-stage biopharmaceutical company, today provided a business update and reported financial results for the fourth quarter and year ended December 31, 2022.

“Heading into 2023, we are building momentum for CPI-818, our ITK inhibitor, which we believe is well positioned to provide a platform opportunity across cancer and immune diseases,” said Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus. “This includes a growing body of clinical and preclinical data supporting ITK inhibition across a range of indications. The most encouraging data is in oncology, where enrollment in our Phase 1/1b trial in T cell lymphoma has accelerated and has enabled us both to increase the number of patients treated at the optimum dose and to identify a predictive biomarker that we believe will enrich for patients most likely to benefit from treatment with CPI-818. Looking forward, we are focused on achieving value driving milestones for CPI-818 including interim T cell lymphoma clinical data at upcoming medical meetings and additional preclinical data with CPI-818 in solid tumors at the upcoming AACR meeting in April. In addition, we have upside potential from ciforadenant and mupadolimab, the clinical development of which are primarily being advanced and funded by partners.”

Business Update and Strategy

Prioritized Program: CPI-818 (selective ITK inhibitor)

CPI-818 for T Cell Lymphoma

• CPI-818 Phase 1/1b clinical trial results presented at the 64^th American Society of Hematology (ASH) Annual Meeting & Exposition in December 2022 provided clinical data and in vivo evidence supporting its ongoing development as a therapy for T cell lymphoma and its potential in autoimmune and allergic diseases. Key data from the presentation include:
  • As of September 2, 2022, there were 1 complete response (CR), 1 nodal CR and 2 partial responses (PR) in 11 evaluable patients in the 200 mg twice per day cohort (identified optimal dose). An additional PR was seen in a patient receiving the 600 mg twice per day dose. No dose limiting toxicities were observed in 43 patients enrolled across four dosing cohorts, and a maximally tolerated dose was not reached at doses as high as 600 mg twice per day.
  • The 200 mg dose was shown to induce Th1 skewing and both Th2 and Th17 blockade based on findings in peripheral blood samples from several patients and in vitro data demonstrated that it did so in a dose-dependent manner that supported the selection of the 200 mg twice per day optimum dose. The findings of the human and preclinical studies suggest that CPI-818 enhances anti-tumor immunity representing a potentially novel approach to immunotherapy.
• Enrollment in the 200 mg cohort has accelerated and is ongoing. As of February 23, 2023, 20 patients were enrolled, including 13 evaluable for tumor response. There have been 1 CR of 24 months duration, 1 equivocal CR awaiting confirmatory PET scan of 13+ months duration (a previous PR), 1 nodal CR of 21 months duration and 1 PR of 7 months duration. Ten patients continue on therapy, including seven that have not yet been evaluated for tumor response. The swimmer and waterfall tumor plots for these patients are shown below.
• New CPI-818 predictive biomarker: Corvus has identified a biomarker associated with response to CPI-818. CPI-818 induces a host anti-tumor cell mediated immune response that requires normal functioning T cells. Data from the 200 mg cohort in the Phase 1/1b clinical trial indicates that a minimum absolute lymphocyte count (ALC) above 900 per cubic milliliter of blood is required for tumor response and disease control. Four of eight patients with ALC above 900 have objective responses (those four patients are described above), all eight have disease control (stable disease, PR, CR) and the median progression free survival (PFS) is 28.1 months. No objective responses were seen in five patients (0 of 5) with ALC below 900 and the PFS is 2.1 months. The ALC biomarker is routinely measured, is consistent with CPI-818’s presumed mechanism of action and is present in about 70% of patients based on the Company’s experience to-date. This biomarker has been incorporated as an eligibility criterion in the ongoing Phase 1/1b clinical trial.

Figure 1: Swimmer Plot for Patients in the 200 mg Dose Cohort of the CPI-818 Phase 1/1b Clinical Trial for T Cell Lymphoma. The plot shows the tumor response and duration (months) for patients with various tumor histologies, which are shown on the chart and defined as follows: PTCL-NOS, peripheral T cell lymphoma not otherwise specified; CTCL-SS, cutaneous T cell lymphoma Sezary; CTCL-MF, cutaneous T cell lymphoma mycosis fungoides; AITL, angioimmunoblastic T cell lymphoma; ALCL, anaplastic T cell lymphoma and NKTCL, natural killer T cell lymphoma. The tumor response evaluation are labeled on the chart and are defined as follows: CR, complete response; equivocal CR; PR, partial response; SD, stable disease; PD, progressive disease. Arrows indicate that treatment with CPI-818 is continuing as of the February 23, 2023 data cut-off.

Figure 2: Waterfall Plot for Patients in the 200 mg Dose Cohort of the CPI-818 Phase 1/1b Clinical Trial for T Cell Lymphoma. The plot shows the best percent change in tumor volume in the evaluable patients from the same group shown in Figure 1.

• Corvus recently received a communication from the U.S. Food and Drug Administration (FDA) regarding its clinical development plans for CPI-818. Based on the current enrollment rate of its ongoing Phase 1/1b clinical trial, the Company believes that the number of patients treated in this clinical trial would provide adequate safety and preliminary efficacy data to inform the design of a registration Phase 3 randomized clinical trial. As recommended by the FDA, the Company plans to meet with the FDA to discuss such a clinical trial; it is anticipated that this meeting will take place later this year.

Reprioritization of CPI -818 for Atopic Dermatitis

• Based on recent progress and data supporting the ongoing development of CPI-818 for T cell lymphoma and other cancers, Corvus has decided to delay its plans to initiate a Phase 1 clinical trial in atopic dermatitis. This decision allows the Company to conserve cash and intensify its focus on T cell lymphoma, which could include conducting a potentially registrational, randomized Phase 3 trial. While Corvus is pausing development of CPI-818 for the treatment of atopic dermatitis, the Company will continue to investigate the potential role of CPI-818 in immune diseases through its ongoing and planned preclinical research and external collaborations.

CPI-818 for HIV

• In February 2023, researchers from The University of California San Francisco-Bay Area Center for AIDS Research (UCSF) presented new data at the 30th Annual Conference on Retroviruses and Opportunistic Infections demonstrating the potential of CPI-818 to reduce the need for chronic human immunodeficiency virus (HIV) therapy. The data further highlights the broad therapeutic opportunity for ITK inhibition with CPI-818. Based on this positive data, the UCSF team plans to continue studying the potential for ITK inhibition to be developed within antiproliferative and “block-and-lock” HIV cure strategies.

Partner Led Programs: Ciforadenant (adenosine 2a receptor inhibitor) and Mupadolimab (anti-CD73)

• The Kidney Cancer Research Consortium (KCRC) is enrolling a Phase 1b/2 clinical trial evaluating ciforadenant as a potential first line therapy for metastatic renal cell cancer (RCC) in combination with ipilimumab (anti-CTLA-4) and nivolumab (anti-PD-1). The clinical trial is expected to enroll up to 60 patients and initial data is anticipated before the end of 2023.
• Angel Pharmaceuticals, Corvus’ partner in China, is enrolling patients in a Phase 1/1b clinical trial of mupadolimab in patients with non-small cell lung cancer (NSCLC) and head and neck squamous cell cancers. In this clinical trial, patients will receive mupadolimab monotherapy or in combination with pembrolizumab.

Financial Results

As of December 31, 2022, Corvus had cash, cash equivalents and marketable securities totaling $42.3 million. This compared to cash, cash equivalents and marketable securities of $69.5 million as of December 31, 2021. Corvus expects full year 2023 net cash used in operating activities to be between approximately $19 million and $22 million, resulting in a projected cash balance of between $20 million and $23 million as of December 31, 2023. Based on its current plans, Corvus expects its cash to fund operations into 2024.

Research and development expenses for the three months and full year ended December 31, 2022 totaled $4.1 million and $24.5 million, respectively, compared to $4.8 million and $29.1 million for the same periods in 2021. In the fourth quarter of 2022, the decrease of $0.7 million was primarily related to a decrease in personnel costs.

The net loss for the three months ended December 31, 2022 was $9.8 million compared to a net loss of $9.2 million for the same period in 2021. Total stock compensation expense for the three months ended December 31, 2022 was $0.6 million compared to $0.7 million for the same period in 2021 and the non-cash loss from the Company’s equity method investment in Angel Pharmaceuticals was $4.6 million for the three months ended December 31, 2022 compared to $2.6 million for the same period in 2021.

Conference Call Details

Corvus will host a conference call and webcast today, Tuesday, March 28, 2023, at 4:30 p.m. ET (1:30 p.m. PT), during which time management will provide a business update and discuss the fourth quarter and full year 2022 financial results. The conference call can be accessed by dialing 1-844-825-9789 (toll-free domestic) or 1-412-317-5180 (international) or by clicking on this link and requesting a return call and using the conference passcode 3154152. The live webcast may be accessed via the investor relations section of the Corvus website. A replay of the webcast will be available on Corvus’ website for 90 days.

About Corvus Pharmaceuticals

Corvus Pharmaceuticals is a clinical-stage biopharmaceutical company. Corvus’ lead product candidate is CPI-818, an investigational, oral, small molecule drug that selectively inhibited ITK in preclinical studies and is in a multicenter Phase 1/1b clinical trial in patients with several types of T cell lymphomas. The Company’s second clinical program, ciforadenant (CPI-444), is an oral, small molecule inhibitor of the A2A receptor that is in an open-label Phase 1b/2 clinical trial. Its third clinical program, mupadolimab (CPI-006), is a humanized monoclonal antibody directed against CD73 that has exhibited immunomodulatory activity and activation of immune cells in preclinical and clinical studies. For more information, visit www.corvuspharma.com.

About CPI-818

CPI-818 is an investigational small molecule drug given orally that has selectively inhibited ITK (interleukin-2-inducible T cell kinase) in preclinical studies. It was designed to block malignant T cell growth and to modulate immune responses. ITK, an enzyme, is expressed predominantly in T cells and plays a role in T cell and natural killer (NK) cell lymphomas and leukemias, as well as in normal immune function. Recent clinical data in T cell lymphomas suggests that CPI-818 has the potential to control differentiation of T helper cells and enhance immune responses to tumors. Interference with ITK signaling also can modulate immune responses to various antigens. Optimal doses of CPI-818 have been shown to affect T cell differentiation and induce the generation of Th1 helper cells while blocking the development of both Th2 and Th17 cells and production of Th2 related cytokines. Th1 T cells are required for immunity to tumors, viral infections and other infectious diseases. Th2 and Th17 helper T cells are involved in the pathogenesis of many autoimmune and allergic diseases. The immunologic effects of CPI-818 lead to what is known as Th1 skewing and is made possible by the high selectivity of CPI-818 for ITK. The Company believes the inhibition of specific molecular targets in T cells may be of therapeutic benefit for patients with T cell lymphomas, solid tumors, and in patients with autoimmune and allergic diseases. The Company is conducting a Phase 1/1b trial in patients with refractory T cell lymphomas that was designed to select the optimal dose of CPI-818 and evaluate its safety, PK, target occupancy, immunologic effects, biomarkers and efficacy. Interim data from the Phase 1/1b clinical trial of CPI-818 for T cell lymphoma demonstrated tumor responses in very advanced, refractory, difficult to treat T cell malignancies, and identified a dose that maximally affects T helper cell differentiation.

About Ciforadenant

Ciforadenant (CPI-444) is an investigational small molecule, oral, checkpoint inhibitor designed to disable a tumor’s ability to subvert attack by the immune system by blocking the binding of adenosine in the tumor microenvironment to the A2A receptor. Adenosine, a metabolite of ATP (adenosine triphosphate), is produced within the tumor microenvironment where it may bind to the adenosine A2A receptor present on immune cells and block their activity.   

About Mupadolimab

Mupadolimab (CPI-006) is an investigational, potent humanized monoclonal antibody that is designed to react with a specific site on CD73. In preclinical studies, it has demonstrated immunomodulatory activity resulting in activation of lymphocytes, induction of antibody production from B cells and effects on lymphocyte trafficking. While there are other anti-CD73 antibodies and small molecules in development for treatment of cancer, such agents react with a different region of CD73. Mupadolimab is designed to react with a region of the molecule that acts to stimulate B cells and block production of immunosuppressive adenosine. Mupadolimab is being studied in combination with pembrolizumab in a Phase 1b/2 clinical trial in patients with advanced head and neck cancers and in patients with NSCLC that have failed chemotherapy and anti-PD(L)1 therapy. It is postulated that the activation of B cells will enhance immunity within the tumors of these patients, leading to improved clinical outcomes.

About Angel Pharmaceuticals

Angel Pharmaceuticals is a privately held biopharmaceutical company developing a pipeline of precisely targeted investigational medicines for cancer, autoimmune, infectious and other serious diseases in China. Angel Pharmaceuticals was launched through a collaboration with U.S.-based Corvus and investments from investors in China. Angel Pharmaceuticals licensed the rights to develop and commercialize Corvus’ three clinical-stage candidates – CPI-818, ciforadenant and mupadolimab – in greater China and obtained global rights to Corvus’ BTK inhibitor preclinical programs. Under the collaboration, Corvus currently has a 49.7% equity stake in Angel Pharmaceuticals excluding 7% of Angel’s equity reserved for issuance under the Angel ESOP, and Corvus has designated three individuals on Angel’s five-person Board of Directors. For more information, visit www.angelpharma.com.

Forward-Looking Statements

This press release contains forward-looking statements, including statements related to the potential safety and efficacy of CPI-818, ciforadenant and mupadolimab; the Company’s ability and its partners’ ability, as well as the timing thereof, to develop and advance product candidates into and successfully complete preclinical studies and clinical trials, including the Company and Angel’s Phase 1/1b clinical trial of CPI-818 and the Company’s planned meeting with the FDA to discuss a registration clinical trial with CPI-818 for T cell lymphoma later this year; the design of clinical trials, including the target number of patients to be enrolled; the timing of the availability and announcement of clinical data and certain other product development milestones; the estimated amount of net cash used in operating activities for 2023 and its ability to fund operations into 2024. All statements other than statements of historical fact contained in this press release are forward-looking statements. These statements often include words such as “believe,” “expect,” “anticipate,” “intend,” “plan,” “estimate,” “seek,” “will,” “may” or similar expressions. Forward-looking statements are subject to a number of risks and uncertainties, many of which involve factors or circumstances that are beyond the Company’s control. The Company’s actual results could differ materially from those stated or implied in forward-looking statements due to a number of factors, including but not limited to, risks detailed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022, filed with the Securities and Exchange Commission on or about the date hereof, as well as other documents that may be filed by the Company from time to time with the Securities and Exchange Commission. In particular, the following factors, among others, could cause results to differ materially from those expressed or implied by such forward-looking statements: the Company’s ability to demonstrate sufficient evidence of efficacy and safety in its clinical trials of CPI-818, ciforadenant and mupadolimab; the accuracy of the Company’s estimates relating to its ability to initiate and/or complete preclinical studies and clinical trials; the results of preclinical studies and interim data from clinical trials not being predictive of future results; the unpredictability of the regulatory process; regulatory developments in the United States, and other foreign countries; the costs of clinical trials may exceed expectations; the Company’s ability to accurately estimate the amount of net cash used in operating activities for 2023 and cash on hand providing funding into 2024 and the Company’s ability to raise additional capital. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, it cannot guarantee that the events and circumstances reflected in the forward-looking statements will be achieved or occur, and the timing of events and circumstances and actual results could differ materially from those projected in the forward-looking statements. Accordingly, you should not place undue reliance on these forward-looking statements. All such statements speak only as of the date made, and the Company undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise. The Company’s results for the quarter and year ended December 31, 2022 are not necessarily indicative of its operating results for any future periods.

CORVUS PHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(in thousands, except share and per share data)

CORVUS PHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands)

INVESTOR CONTACT:

Leiv Lea
Chief Financial Officer
Corvus Pharmaceuticals, Inc.
+1-650-900-4522
[email protected]

MEDIA CONTACT:

Sheryl Seapy
Real Chemistry
+1-949-903-4750
[email protected]

Photos accompanying this announcement are available at:

https://www.globenewswire.com/NewsRoom/AttachmentNg/8cad1fa6-2452-4d29-9270-3ea844f7facf

https://www.globenewswire.com/NewsRoom/AttachmentNg/9fecd0a2-f763-48d1-b034-c75a997c6396

• Company has initiated pre-IND discussions with the FDA for its first AIM INJ indication
  
• NEXI-001 completed enrollment in its final safety cohorts and all patients have been dosed; Company continues to follow patients and will announce data at or around an upcoming scientific conference
• Company announces executive management changes as part of resource reallocation
  

GAITHERSBURG, Md., March 28, 2023 (GLOBE NEWSWIRE) — NexImmune, Inc. (Nasdaq: NEXI), a biotechnology company developing a novel approach to immunotherapy designed to orchestrate a targeted immune response by directing the function of antigen-specific T cells for liquid and solid malignancies, today reported financial results for the fourth quarter and full year 2022.

“We remain confident in the potential therapeutic benefit of our AIM platform-based products and their ability to significantly impact the emerging field of antigen specific immuno-oncology therapies, novel IO combinations, autoimmune treatments and potential approaches for viral-driven diseases. While we are still observing patients in our ongoing cell therapy program, we are focused on advancing our AIM INJ ‘off-the-shelf’ modality,” said Kristi Jones, Chief Executive Officer. “The combined data from our clinical cell therapy programs and INJ preclinical experiments are consistent, and we believe validate the AIM nanoparticles MOA regardless of modality. In addition, recent preclinical data combining AIM nanoparticle expanded multi-antigen specific T cells with a T cell bispecific engager demonstrated superior potency as well as enhanced persistence and durability, supporting novel antigen specific IO combinations. We believe that the AIM INJ therapeutic modality offers the most disruptive potential to benefit patients, as well as the greatest potential to create long-term value for our shareholders. The unique benefits of our “off-the-shelf” T cell targeted therapies include scalability and access to broader patient populations to address unmet needs. We will provide an update on these programs over the coming months.”

Jones continued, “Our AIM ACT cell therapy product candidates currently in clinical trials continue to show clinical activity in early dose escalation and are well-tolerated in patients. While paused, these clinical programs have demonstrated reduction in tumor burden and a tolerability profile to support potential novel IO combinations and to shift into patients with lower tumor burden. We are exploring external opportunities, including with academic centers and corporate collaborators, to advance these programs.”

Select Fourth Quarter and Full Year 2022 Clinical and Business Highlights

Business and Strategy Update

Jerry Zeldis, MD, PhD, will retire from his position of Executive Vice President, R&D, effective March 31, 2023. Also, as part of the Company’s previous announced realignment of resources to focus on the AIM INJ platform and pause our cell therapy clinical programs, Bob Knight, MD, will step down from the position of Chief Medical Officer. Dr. Knight and Dr. Zeldis will transition to advisory roles and continue to provide both strategic counsel and fulfill operating responsibilities at NexImmune. Dr. Zeldis will also continue to be an active member on NexImmune’s Scientific Advisory Board.

“On behalf of the BOD, I want to thank Jerry and Bob for their leadership and contribution in bringing NexImmune’s revolutionary technology to the clinic and into patients. We are grateful for the continued support we will receive as both will remain involved with NexImmune in an active advisory capacity,” said Sol Barer, NexImmune’s Chairman of the Board.

Clinical and Preclinical Updates

AIM INJ, Injectable “Off-the-shelf” Antigen-Specific Immunotherapy, and Other Preclinical Research

• Initiated multiple preclinical studies to evaluate monotherapy and in combination with a checkpoint inhibitor to support our oncology program
• Continued to evaluate AIM INJ nanoparticles as a therapeutic for type 1 diabetes as well as other autoimmune diseases with Yale University Professor Kevan Harold in partnership with JDRF
• Poster presented at 2023 Tandem Meetings: Transplantation & Cellular Therapy Meetings of ASTCT and CIBMTR demonstrated evidence that AIM multi-antigen specific cells combined with a BCMA bispecific results in superior potency, enhanced persistence and durability in multiple myeloma models
• Publication in Frontiers in Medicine highlighting the ability of NexImmune’s AIM Platform to treat viral diseases
• Announced research collaboration with National Institute of Neurological Disorders and Stroke of the National Institutes of Health with initial focus on multiple sclerosis
• Announced neo-antigen melanoma research collaboration with NYU Langone’s Perlmutter Cancer Center

NEXI-001 Relapsed Refractory AML Post Allo-HSCT

• Full enrollment and dosing in the final safety cohort of NEXI-001 completed
• Plan to announce data for currently enrolled patients at or around an upcoming conference in mid-2023
• Continue to explore opportunities to advance NEXI-001 with potential collaborators and investigators

NEXI-003 HPV-Related Cancers

• Announced clearance of IND by the FDA for NEXI-003 for treatment of HPV-related cancers
• Continue to explore opportunities to develop this adoptive cell therapy with external partners and collaborators and develop a corporate HPV strategy that utilizes the AIM INJ modality

Select 4Q and Full 2022 Financial Highlights

Cash, cash equivalents and marketable securities for the Company as of December 31, 2022 were $34.6 million compared to $81.8 million at December 31, 2021. Based upon current operating plans, NexImmune expects that its existing cash, cash equivalents and marketable securities will enable the Company to fund its operating and capital expenditure requirements into the fourth quarter of 2023.

Research and development expenses were $13.7 million in the fourth quarter ended December 31, 2022, compared to $12.0 million for the same period in the prior year. Research and development expenses were $47.1 million for the full year period ended December 31, 2022, an increase of $9.6 million compared to $37.5 million for the full year ended December 31, 2021. The increase in R&D expenses was mainly attributable to costs for research related to preclinical manufacturing and the two clinical trials, as well as personnel-related expenses driven by increased headcount.

General and administrative expenses were $3.5 million for the fourth quarter ended December 31, 2022, which represent effectively no change for the same period in the prior year. General and administrative expenses were $15.9 million for the full year period ended December 31, 2022, an increase of $0.1 million compared to $15.8 million for the full year ended December 31, 2021. The increase was due primarily to an increase in fees related to professional and consulting services offset by decrease in headcount and stock compensation expense.

Net loss, according to generally accepted accounting principles in the U.S. (GAAP), was $16.9 million for the quarter and $62.5 million for the full year 2022, or a basic and diluted GAAP loss per share of $0.65 and $2.60 respectively. This compared to a net loss of $50.9 million, or a basic and diluted GAAP loss per share of $2.54, for the same period the prior year.

About NexImmune

NexImmune is a clinical-stage biotechnology company developing a novel approach to immunotherapy designed to employ the body’s own T cells to generate a specific, potent, and durable immune response. The backbone of NexImmune’s approach is a proprietary Artificial Immune Modulation (AIM™) nanoparticle technology platform. The AIM technology enables NexImmune to construct nanoparticles that function as synthetic dendritic cells capable of directing a specific T cell-mediated immune response. AIM constructed nanoparticles employ natural biology to engage, activate and expand endogenous T cells in ways that combine anti-tumor attributes of antigen-specific precision, potency and long-term persistence with reduced potential for off-target toxicities. NexImmune is focused on developing injectable AIM nanoparticle constructs and modalities for potential clinical evaluation in oncology, autoimmune disorders and infectious diseases.

For more information, visit www.neximmune.com.

Forward Looking Statements

This press release may contain “forward-looking” statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are based on the beliefs and assumptions and on information currently available to management of NexImmune, Inc. (the “Company”). All statements other than statements of historical fact contained in this press release are forward-looking statements, including statements concerning our results of operations for the full year ended December 31, 2022; the sufficiency of the Company’s current cash, cash equivalents and marketable securities to fund its planned operations into the fourth quarter of 2023;the enrollment, timing, progress, release of data from and results of the Company’s paused clinical trials and the expectations with respect to potential AIM INJ product candidates; the timing, progress and release of preclinical data from our AIM INJ platform programs and other preclinical research programs; and the utility of prior preclinical and clinical data in determining future clinical results. In some cases, you can identify forward-looking statements by terminology such as “may,” “will,” “should,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “potential” or “continue” or the negative of these terms or other comparable terminology. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the Company’s actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. These risks and uncertainties include, but are not limited to, the risks and uncertainties set forth in the “Risk Factors” section of our Annual Report on Form 10-K for the year ended December 31, 2022 filed with the Securities and Exchange Commission (“SEC”) on March 28, 2023, and subsequent reports that we file with the SEC. Forward-looking statements represent the Company’s beliefs and assumptions only as of the date of this press release. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, it cannot guarantee future results, levels of activity, performance or achievements. Except as required by law, the Company assumes no obligation to publicly update any forward-looking statements for any reason after the date of this press release to conform any of the forward-looking statements to actual results or to changes in its expectations.

Contacts

Investors and Media:

Chad Rubin, SVP Corporate Affairs and Investor Relations
NexImmune, Inc.
[email protected]

NEXIMMUNE, INC.

BALANCE SHEETS

NEXIMMUNE, INC.

STATEMENTS OF OPERATIONS

STATEMENTS OF COMPREHENSIVE LOSS

Strategy focused on profitability by end of 2024, using current cash on hand

New leadership to host conference call and webcast today at 4:30 PM ET

NASHUA, N.H., March 28, 2023 (GLOBE NEWSWIRE) — iCAD, Inc. (NASDAQ: ICAD), a global medical technology leader providing innovative cancer detection and therapy solutions, today reported its financial and operating results for the twelve months ended December 31, 2022.

Highlights:

• Company continues to invest in Detection business, driving commercial growth through global adoption of Breast AI Suite while exploring strategic options for Therapy segment
• Several strategic partnership agreements signed in Q4, including Google Health and Solis Mammography, positioning the Company for growth
• Promising clinical research reaffirms clinical value and utility of Breast AI Suite
• Company reduces annualized expenses by $4.3 to $4.6 million and decreases annualized cash burn by $4.9 to $5.2 million

“In the battle against cancer, we see early detection and diagnosis as a key part in transforming the patient journey and quality of care. Breast cancer is the most common cancer in women worldwide and the second leading cause of cancer death among women in the U.S. With iCAD’s early detection technology, we have the ability to detect cancers early, giving individuals the opportunity for more positive outcomes and more lives saved. The body of evidence supporting our Breast AI suite continues to grow, and we are committed to upholding our vision to be the world’s most pervasive and personalized suite of AI cancer detection solutions. We look forward to strengthening our focus to rapidly advance our progress in this area,” said Dana Brown, President and CEO of iCAD, Inc.

“We are amidst an exciting period of transition across many aspects of the Company, including the shift to a partnership approach for both select elements of our business as well as our go-to-market strategy. Several key partnerships and agreements were signed in Q4, including a strategic development and commercialization agreement with Google Health, which is positioned to improve our market-leading AI solutions for mammography, expand access to our technology to millions of women and providers worldwide, and accelerate time to market for our own cloud-based SaaS solution planned for 2024. We are also continuing to strengthen our partnership with Solis Mammography, the largest independent provider of breast screening and diagnostic services in the U.S. We remain enthusiastic about the potential these partnerships present in 2023 and beyond,” said Ms. Brown.

“While both the Therapy and Detection lines of business have significant market opportunity and potential, we believe our core competencies and focus need to be solely on Detection and our strategy around AI. We remain confident that the Xoft technology has the potential to positively impact the lives of cancer patients and the providers who care for them on a global scale. As we move through this time of transition, we want to explore strategic options that could accelerate the accessibility of this technology and provide more focus and synergies to its growth. As we explore these opportunities, we are projecting to be cash flow positive and reach profitability before the end of 2024. We believe these changes give us the runway needed to successfully navigate this business model transition without needing to raise additional capital,” said Ms. Brown.

Three Months Ended December 31, 2022 Financial Results

Total Detection and Therapy revenue for the fourth quarter of 2022 was $6.5 million, a decrease of $1.3 million, or 17%, as compared to the fourth quarter of 2021.

Revenue: Cancer Detection revenue for the fourth quarter of 2022, which includes the Company’s mammography and breast density products, and the associated service and supplies revenue, was $4.6 million, a decrease of 16%, as compared to the fourth quarter of 2021. Therapy revenue for the fourth quarter of 2022, which includes Xoft® Axxent® eBx® System® sales, as well as the associated service and supplies revenue, was $1.9 million, a decrease of 20%, as compared to the fourth quarter of 2021.

Gross Profit: Gross profit for the fourth quarter of 2022 was $4.6 million, or 71% of revenue, as compared to $5.7 million, or 73% of revenue, in the fourth quarter of 2021.

Operating Expenses: Total operating expenses for the fourth quarter of 2022 were $8.0 million, a 19% decrease from $9.9 million in the fourth quarter of 2021.

GAAP Net Loss: Net loss for the fourth quarter of 2022 was ($3.1) million, or ($0.12) per diluted share, as compared to a net loss of ($4.1) million, or ($0.17) per diluted share, for the fourth quarter of 2021.

Non-GAAP Adjusted Net Loss: Non-GAAP Adjusted Net Loss, a non-GAAP financial measure as defined below, for the fourth quarter of 2022 was ($3.0) million, or ($0.12) per diluted share, as compared to a Non-GAAP Adjusted Net Loss of ($4.1) million, or ($0.17) per diluted share, for the fourth quarter of 2021. Please refer to the section entitled “Reconciliation of Non-GAAP Financial Measures to Comparable GAAP Measures” and the accompanying financial table included at the end of this release for a reconciliation of GAAP Net Loss to Non-GAAP Adjusted Net Loss results for the three-month periods ended December 31, 2022 and 2021, respectively.

Non-GAAP Adjusted EBITDA: Non-GAAP Adjusted EBITDA, a non-GAAP financial measure as defined below, for the fourth quarter of 2022 was a loss of ($2.8) million, a $0.5 million increase as compared to the fourth quarter 2021 Non-GAAP Adjusted EBITDA loss of ($3.3) million. Please refer to the section entitled “Reconciliation of Non-GAAP Financial Measures to Comparable GAAP Measures” and the accompanying financial table included at the end of this release for a reconciliation of GAAP Net Loss to Non-GAAP Adjusted EBITDA results for the three-month periods ended December 31, 2022 and 2021, respectively.

Twelve Months Ended December 31, 2022 Financial Results

Revenues for the year ended December 31, 2022, were $27.9 million, a decrease of $5.7 million or 17% over $33.6 million in Fiscal 2021.

Revenue: Cancer Detection revenue for the Twelve months ended December 31, 2022, which includes the Company’s mammography and breast density products, and the associated service and supplies revenue, was $19.8 million, a decrease of 10%, as compared to the Twelve months ended December 31, months ended December 31, 2021. Therapy revenue for the Twelve months ended December 31, months ended December 31, 2022, which includes Xoft® Axxent® eBx® System® sales, as well as the associated service and supplies revenue, was $8.1 million, a decrease of 30%, as compared to Twelve months ended December 31, months ended December 31, 2021.

Gross Profit: Gross profit for the Twelve months ended December 31, months ended December 31, 2022 was $19.8 million, or 71% of revenue, as compared to $24.2 million, or 72% of revenue, in the Twelve months ended December 31, months ended December 31, 2021.

Operating Expenses: Total operating expenses for the Twelve months ended December 31, months ended December 31, 2022 were $33.7 million, as compared to $35.0 million in the Twelve months ended December 31, months ended December 31, 2021.

GAAP Net Loss: Net loss for the Twelve months ended December 31, months ended December 31, 2022 was ($13.7) million, or ($0.54) per diluted share, as compared to a net loss of ($11.21) million, or ($0.45) per diluted share, for the Twelve months ended December 31, months ended December 31, 2021.

Non-GAAP Adjusted Net Loss: Non-GAAP Adjusted Net Loss, a non-GAAP financial measure as defined below, for the Twelve months ended December 31, months ended December 31, 2022 was ($13.6) million, or ($0.54) per diluted share, as compared to a Non-GAAP Adjusted Net Loss of ($10.7) million, or ($0.43) per diluted share, for the Twelve months ended December 31, months ended December 31, 2021. Please refer to the section entitled “Reconciliation of Non-GAAP Financial Measures to Comparable GAAP Measures” and the accompanying financial table included at the end of this release for a reconciliation of GAAP Net Loss to Non-GAAP Adjusted Net Loss results for the twelve-month periods ended December 31, 2022 and 2021, respectively.

Non-GAAP Adjusted EBITDA: Non-GAAP Adjusted EBITDA, a non-GAAP financial measure as defined below, for the Twelve months ended December 31, months ended December 31, 2022 was a loss of ($11.7) million, a $4.4 million increase as compared to the Twelve months ended December 31, months ended December 31, 2021 Non-GAAP Adjusted EBITDA loss of ($7.3) million. Please refer to the section entitled “Reconciliation of Non-GAAP Financial Measures to Comparable GAAP Measures” and the accompanying financial table included at the end of this release for a reconciliation of GAAP Net Loss to Non-GAAP Adjusted EBITDA results for the twelve-month periods ended December 31, 2022 and 2021, respectively.

Conference Call




Tuesday, March 28, 2023 at 4:30 PM ET

Use of Non-GAAP Financial Measures

In its quarterly news releases, conference calls, slide presentations or webcasts, the Company may use or discuss non-GAAP financial measures as defined by SEC Regulation G. The GAAP financial measures most directly comparable to each non-GAAP financial measure used or discussed, and a reconciliation of the differences between each non-GAAP financial measure and the comparable GAAP financial measure, are included in this press release after the condensed consolidated financial statements. When analyzing the Company’s operating performance, investors should not consider these non-GAAP measures as a substitute for the comparable financial measures prepared in accordance with GAAP. The Company’s quarterly news releases containing such non-GAAP reconciliations can be found on the Investors section of the Company’s website at www.icadmed.com. 

About iCAD, Inc.

Headquartered in Nashua, NH, iCAD® is a global medical technology leader providing innovative cancer detection and therapy solutions. For more information, visit www.icadmed.com. 

Forward-Looking Statements

Certain statements contained in this News Release constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements about the expansion of access to the Company’s products, improvement of performance, acceleration of adoption, expected benefits of ProFound AI®, the benefits of the Company’s products, and future prospects for the Company’s technology platforms and products. Such forward-looking statements involve a number of known and unknown risks, uncertainties and other factors which may cause the actual results, performance, or achievements of the Company to be materially different from any future results, performance, or achievements expressed or implied by such forward-looking statements. Such factors include, but are not limited, to the Company’s ability to achieve business and strategic objectives, the willingness of patients to undergo mammography screening in light of risks of potential exposure to Covid-19, whether mammography screening will be treated as an essential procedure, whether ProFound AI will improve reading efficiency, improve specificity and sensitivity, reduce false positives and otherwise prove to be more beneficial for patients and clinicians, the impact of supply and manufacturing constraints or difficulties on our ability to fulfill our orders, uncertainty of future sales levels, to defend itself in litigation matters, protection of patents and other proprietary rights, product market acceptance, possible technological obsolescence of products, increased competition, government regulation, changes in Medicare or other reimbursement policies, risks relating to our existing and future debt obligations, competitive factors, the effects of a decline in the economy or markets served by the Company; and other risks detailed in the Company’s filings with the Securities and Exchange Commission. The words “believe,” “demonstrate,” “intend,” “expect,” “estimate,” “will,” “continue,” “anticipate,” “likely,” “seek,” and similar expressions identify forward-looking statements. Readers are cautioned not to place undue reliance on those forward-looking statements, which speak only as of the date the statement was made. The Company is under no obligation to provide any updates to any information contained in this release. For additional disclosure regarding these and other risks faced by iCAD, please see the disclosure contained in our public filings with the Securities and Exchange Commission, available on the Investors section of our website at http://www.icadmed.com and on the SEC’s website at http://www.sec.gov.

Contact:

Media Inquiries:
Jessica Burns, iCAD
+1-201-423-4492
[email protected] 

Investor Inquiries:
iCAD Investor Relations
[email protected] 

Reconciliation of Non-GAAP Financial Measures to Comparable GAAP Measures

The Company reports its financial results in accordance with United States generally accepted accounting principles, or GAAP. However, management believes that in order to understand the Company’s short-term and long-term financial and operational trends, investors may wish to consider the impact of certain non-cash or non-recurring items, when used as a supplement to financial performance measures in accordance with GAAP. These items result from facts and circumstances that vary in frequency and/or impact on continuing operations. Management also uses results of operations before such items to evaluate the operating performance of the Company and compare it against past periods, make operating decisions, and serve as a basis for strategic planning. These non-GAAP financial measures provide management with additional means to understand and evaluate the operating results and trends in the Company’s ongoing business by eliminating certain non-cash expenses and other items that management believes might otherwise make comparisons of the Company’s ongoing business with prior periods more difficult, obscure trends in ongoing operations or reduce management’s ability to make useful forecasts. Management believes that these non-GAAP financial measures provide additional means of evaluating period-over-period operating performance. In addition, management understands that some investors and financial analysts find this information helpful in analyzing the Company’s financial and operational performance and comparing this performance to its peers and competitors.

Management defines “Non-GAAP Adjusted EBITDA” as the sum of GAAP Net Loss before provisions for interest expense, other income, stock-based compensation expense, depreciation and amortization, tax expense, severance, gain on sale of assets, loss on disposal of assets, acquisition and litigation related expenses. Management considers this non-GAAP financial measure to be an indicator of the Company’s operational strength and performance of its business and a good measure of its historical operating trends, in particular the extent to which ongoing operations impact the Company’s overall financial performance.

The non-GAAP financial measures do not replace the presentation of the Company’s GAAP financial results and should only be used as a supplement to, not as a substitute for, the Company’s financial results presented in accordance with GAAP. The Company has provided a reconciliation of each non-GAAP financial measure used in its financial reporting and investor presentations to the most directly comparable GAAP financial measure.

Management excludes each of the items identified below from the applicable non-GAAP financial measure referenced above for the reasons set forth with respect to that excluded item:

• Interest expense: The Company excludes interest expense which includes interest from the facility agreement, interest on capital leases and interest on the convertible debentures from its non-GAAP Adjusted EBITDA calculation.
• Stock-based compensation expense: excluded as these are non-cash expenses that management does not consider part of ongoing operating results when assessing the performance of the Company’s business, and also because the total amount of expense is partially outside of the Company’s control as it is based on factors such as stock price volatility and interest rates, which may be unrelated to our performance during the period in which the expense is incurred.
• Amortization and depreciation: Purchased assets and intangibles are amortized over a period of several years and generally cannot be changed or influenced by management after they are acquired. Accordingly, these non-cash items are not considered by management in making operating decisions, and management believes that such expenses do not have a direct correlation to future business operations. Thus, including such charges does not accurately reflect the performance of the Company’s ongoing operations for the period in which such charges are incurred.
• Loss on fair value of convertible debentures. The Company excludes this non-cash item as it is not considered by management in making operating decisions, and management believes that such item does not have a direct correlation to future business operations.
• Litigation related: These expenses consist primarily of settlement, legal and other professional fees related to litigation. The Company excludes these costs from its non-GAAP measures primarily because the Company believes that these costs have no direct correlation to the core operations of the Company.
• Loss on extinguishment of debt: The Company excludes this non-cash item as it is not considered by management in making operating decisions, and management believes that such item does not have a direct correlation to future business operations.

On occasion in the future, there may be other items, such as loss on extinguishment of debt, significant asset impairments, restructuring charges or significant gains or losses from contingencies that the Company may exclude if it believes that doing so is consistent with the goal of providing useful information to investors and management.