On May 12, 2022 Aadi Bioscience, Inc. (NASDAQ: AADI), a biopharmaceutical company focused on developing and commercializing precision therapies for genetically-defined cancers with alterations in mTOR pathway genes, reported financial results for the first quarter of 2022 and provided a corporate update (Press release, Aadi Bioscience, MAY 12, 2022, View Source [SID1234614334]).

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"We are very pleased and encouraged by the strong demand for FYARRO since its February 22nd launch despite the ultra-rare nature of advanced malignant PEComa," commented Neil Desai, Ph.D., Founder, President and Chief Executive Officer of Aadi. "A number of factors are believed to have contributed to the sales in Q1 including pent up demand since FYARRO’s approval on November 22, 2021, transition of expanded access and clinical trial patients to the commercial drug, significant physician awareness and favorable reimbursement," he added.

Dr. Desai continued, "Our clinical team has been focused on advancing nab-sirolimus and the first patient was dosed in our PRECISION 1 tumor-agnostic registration-directed trial in March. Based on data recently presented at AACR (Free AACR Whitepaper), TSC1 and TSC2 genetic alterations within tumors represent one of the larger opportunities within targeted oncology. We have also partnered with large community oncology center networks and next generation sequencing (NGS) providers to identify these patient candidates for our trial, which we believe will augment the pace of enrollment in the PRECISION 1 trial. We anticipate initial clinical data to be available in the first half of next year."

Recent and First Quarter 2022 Corporate Highlights

In May, Aadi was granted a product-specific permanent J-code (J9331) for FYARRO that will become effective on July 1, 2022. This code is expected to further facilitate reimbursement for the drug.
Also in May, Aadi announced a partnership with NGS providers and leaders in genomic testing and profiling, including Foundation Medicine, Tempus and others, to assist with identifying patients for its PRECISION 1 trial. Aadi plans to leverage these partnerships and others to expedite patient recruitment and increase physician familiarity with FYARRO.
Aadi announced a poster presentation at the Annual Meeting of the American Association for Cancer Research (AACR) (Free AACR Whitepaper), held April 8-13, 2022 in New Orleans, LA. The project determined the incidence of advanced cancer patients on an annual basis carrying TSC1 or TSC2 alterations and characterized approximately 12,000 patients who may carry "definite impact" mutations (frameshift, nonsense, splice-site mutations and deep deletions). These data confirmed Aadi’s initial projections on the size of the patient population that could be addressed by a potential nab-sirolimus tumor-agnostic therapy. The study also found that TSC1 alterations were most frequent in bladder, kidney, and lung squamous cell cancers, while TSC2 alterations were most frequent in hepatobiliary, ovarian cancers, and soft tissue sarcomas.
In April, Aadi opened an additional office location in Morristown, New Jersey.
In March, Aadi dosed its first patient in its Phase 2 tumor-agnostic registration-directed trial, PRECISION 1, to evaluate nab-sirolimus in adult and adolescent patients 12 years and older with solid tumors harboring pathogenic inactivating alterations in TSC1 or TSC2 genes. The trial consists of two separate arms of 60 patients each for TSC1 or TSC2 alterations. Initial clinical data from PRECISION 1 are expected in the first half of 2023.
In February, Aadi announced the launch and commercial availability of FYARRO (sirolimus protein-bound particles for injectable suspension) (albumin-bound) for intravenous use for the treatment of adult patients with locally advanced unresectable or metastatic malignant PEComa.
Also in February, FYARRO was added to the National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology (NCCN Guidelines) as the only preferred treatment regimen for malignant PEComa.
First Quarter 2022 Financial Highlights

As of March 31, 2022, cash and cash equivalents totaled $129.8 million, compared to $149.0 million as of December 31, 2021. Based on our current plans, we expect cash and cash equivalents to fund operations into 2024.

For the three months ended March 31, 2022, net product sales were $2.3 million resulting from the launch of FYARRO in February. This compares to $0.1 million of grant revenue during the three months ended March 31, 2021. No grant revenue was recognized during the three months ended March 31, 2022.

Operating expenses for the three months ended March 31, 2022 were $16.1 million compared to $4.2 million for the same period last year.

Selling, general and administrative expenses for the three months ended March 31, 2022 were $9.1 million, an $8.5 million increase over the same period last year. This increase was primarily the result of increased personnel expenses related to the buildout of our commercial operations and infrastructure, as well as increased marketing expenses related to the commercial launch of FYARRO in February 2022.

Research and development expenses for the three months ended March 31, 2022 were $6.8 million, a $3.2 million increase over the same period last year. This increase was primarily the result of increased clinical trial expenses and costs related to the buildout of the organization.

Net loss for the three months ended March 31, 2022 was $13.9 million compared to $5.5 million for the three months ended March 31, 2021.

Conference Call Information:
Individuals may join the webcast online by clicking here or may participate in the live call via telephone by dialing (877) 407-9716 (domestic) or (201) 493-6779 (international) and using conference ID 13729259. A replay of the call will also be available through Aadi’s website within the "Investors & News/Event Calendar" section.

About FYARRO

FYARRO is an mTOR inhibitor indicated for the treatment of adult patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PEComa).

Important Safety Information

Contraindication

FYARRO is contraindicated in patients with a history of severe hypersensitivity to sirolimus, other rapamycin derivatives, or albumin.

Warnings and Precautions

Stomatitis

Stomatitis, including mouth ulcers and oral mucositis, occurred in 79% of patients treated with FYARRO, including 18% Grade 3. Stomatitis was most often first reported within 8 weeks of treatment. Based on the severity of the adverse reaction, withhold, resume at reduced dose, or permanently discontinue FYARRO.

Myelosuppression

FYARRO can cause myelosuppression including anemia, thrombocytopenia and neutropenia. Anemia occurred in 68% of patients; 6% were Grade 3. Thrombocytopenia and neutropenia occurred in 35% of patients each. Obtain blood counts at baseline and every 2 months for the first year of treatment and every 3 months thereafter, or more frequently if clinically indicated. Based on the severity of the adverse reaction, withhold, resume at reduced dose, or permanently discontinue FYARRO.

Infections

FYARRO can cause infections. Infections such as urinary tract infections (UTI), upper respiratory tract infections and sinusitis occurred in 59% of patients. Grade 3 infections occurred in 12% of patients, including a single case each of a UTI, pneumonia, skin, and abdominal infections. Monitor patients for infections, including opportunistic infections. Based on the severity of the adverse reaction, withhold, resume at reduced dose, or permanently discontinue FYARRO.

Hypokalemia

FYARRO can cause hypokalemia. Hypokalemia occurred in 44% of patients including 12% Grade 3 events. Monitor potassium levels prior to starting FYARRO and implement potassium supplementation as medically indicated. Based on the severity of the adverse reaction, withhold, resume at reduced dose, or permanently discontinue FYARRO.

Hyperglycemia

FYARRO can cause hyperglycemia. Hyperglycemia occurred in 12% of patients treated with FYARRO, all of which were Grade 3 events. Monitor fasting serum glucose prior to starting FYARRO. During treatment, monitor serum glucose every 3 months in non-diabetic patients, or as clinically indicated. Monitor serum glucose more frequently in diabetic patients. Based on the severity of the adverse reaction, withhold, resume at reduced dose, or permanently discontinue FYARRO.

Interstitial Lung Disease / Non-Infectious Pneumonitis

FYARRO can cause interstitial lung disease (ILD) / non-infectious pneumonitis. ILD / non-infectious pneumonitis occurred in 18% of patients treated with FYARRO, of which all were Grades 1 and 2. Based on the severity of the adverse reaction, withhold, reduce the dose, or permanently discontinue FYARRO.

Hemorrhage

FYARRO can cause serious and sometimes fatal hemorrhage. Hemorrhage occurred in 24% of patients treated with FYARRO, including Grade 3 and Grade 5 events in 2.9% of patients each. Monitor patients for signs and symptoms of hemorrhage. Based on the severity of adverse reaction, withhold, resume at reduced dose, or permanently discontinue FYARRO.

Hypersensitivity Reactions

FYARRO can cause hypersensitivity reactions. Hypersensitivity reactions, including anaphylaxis, angioedema, exfoliative dermatitis, and hypersensitivity vasculitis have been observed with administration of the oral formulation of sirolimus. Hypersensitivity reactions including anaphylaxis have been observed with human albumin administration. Monitor patients closely for signs and symptoms of infusion reactions during and following each FYARRO infusion in a setting where cardiopulmonary resuscitation medication and equipment are available. Monitor patients for at least 2 hours after the first infusion and as clinically needed for each subsequent infusion. Reduce the rate, interrupt infusion, or permanently discontinue FYARRO based on severity and institute appropriate medical management as needed.

Embryo-Fetal Toxicity

Based on animal studies and the mechanism of action, FYARRO can cause fetal harm when administered to a pregnant woman. In animal studies, mTOR inhibitors caused embryo-fetal toxicity when administered during the period of organogenesis at maternal exposures that were equal to or less than human exposures at the recommended lowest starting dose. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to avoid becoming pregnant and to use effective contraception while using FYARRO and for 12 weeks after the last dose.

Male Infertility

Azoospermia or oligospermia may be observed in patients treated with FYARRO. FYARRO is an anti-proliferative drug and affects rapidly dividing cells such as germ cells.

Immunizations and Risks Associated with Live Vaccines

No studies in conjunction with immunization have been conducted with FYARRO. Immunization during FYARRO treatment may be ineffective. Update immunizations according to immunization guidelines prior to initiating FYARRO, if possible. Immunization with live vaccines is not recommended during treatment and avoid close contact with those who have received live vaccines while on FYARRO. The interval between live vaccinations and initiation of FYARRO should be in accordance with current vaccination guidelines for patients on immunosuppressive therapies.

Risk of Transmission of Infectious Agents with Human Albumin

FYARRO contains human albumin, a derivative of human blood. Human albumin carries only a remote risk of transmission of viral diseases because of effective donor screening and product manufacturing processes. A theoretical risk for transmission of Creutzfeldt-Jakob Disease (CJD) also is considered extremely remote. No cases of transmission of viral diseases or CJD have ever been associated with albumin.

Adverse Reactions

Adverse Reactions in PEComa

The most common adverse reactions (≥30%) were stomatitis in 27 (79%) patients; fatigue and rash in 23 (68%) patients each; infection in 20 (59%) patients; nausea and edema in 17 (50%) patients each; diarrhea, musculoskeletal pain and decreased weight in 16 (47%) patients each; decreased appetite in 15 (44%) patients; cough in 12 (35%) patients; and vomiting and dysgeusia in 11 (32%) patients each.

Laboratory Abnormalities in PEComa

The most common Grade 3 to 4 laboratory abnormalities (≥6%) were decreased lymphocytes in 7 (21%) patients; increased glucose and decreased potassium in 4 (12%) patients each; decreased phosphate in 3 (9%) patients; and decreased hemoglobin and increased lipase in 2 (6%) patients each.

Dosage interruptions

Dose interruptions of FYARRO due to an adverse reaction occurred in 22 (65%) patients. Adverse reactions which required dosage interruption in >5% of patients included stomatitis in 6 (18%) patients, pneumonitis in 5 (15%) patients, anemia in 3 (9%) patients, and dehydration, dermatitis acneiform, and thrombocytopenia in 2 (6%) patients each.

Dose reduction

Dose reductions of FYARRO due to an adverse reaction occurred in 12 (35%) patients. Adverse reactions which required dose reductions in > 5% of patients included stomatitis and pneumonitis in 3 (9%) patients each.

Drug Interactions

Reduce the dosage of FYARRO to 56 mg/m2 when used concomitantly with a moderate or weak cytochrome P-450 3A4 (CYP3A4) inhibitor. Avoid concomitant use with drugs that are strong CYP3A4 and/or P-glycoprotein (P-gp) inhibitors and inducers and with grapefruit and grapefruit juice.

Use in Specific Populations

Pregnancy

Based on the mechanism of action and findings in animals, FYARRO can cause fetal harm when administered to a pregnant woman. Advise females of the potential risk to a fetus and to avoid becoming pregnant while receiving FYARRO.

Lactation

Sirolimus is present in the milk of lactating rats. There is potential for serious adverse effects from sirolimus in breastfed infants based on mechanism of action. Because of the potential for serious adverse reactions in breastfed infants from FYARRO, advise women not to breastfeed during treatment with FYARRO and for 2 weeks after the last dose.

Females and Males of Reproductive Potential

FYARRO can cause fetal harm when administered to a pregnant woman. Verify the pregnancy status of females of reproductive potential prior to starting treatment with FYARRO. Advise females of reproductive potential to use effective contraception and avoid becoming pregnant during treatment with and for at least twelve weeks after the last dose of FYARRO. Advise males with female partners of reproductive potential to use effective contraception and avoid fathering a child during treatment with FYARRO and for at least twelve weeks after the last dose of FYARRO. Although there are no data on the impact of FYARRO on fertility, based on available clinical findings with oral formulation of sirolimus and findings in animals, male and female fertility may be compromised by the treatment with FYARRO.

Pediatric

The safety and effectiveness of FYARRO in pediatric patients have not been established.

Geriatric Use

Of the 34 patients treated with FYARRO, 44% were 65 years of age and older, and 6% were 75 years of age and older. Clinical studies of FYARRO did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients.

Hepatic Impairment

FYARRO is not recommended for use in patients with severe hepatic impairment. Reduce FYARRO dosage in patients with mild or moderate hepatic impairment.

Full prescribing information can be found here.

About Malignant PEComa

Advanced malignant PEComa, defined by the World Health Organization as ‘mesenchymal tumors composed of distinctive cells that show a focal association with blood-vessel walls and usually express both melanocytic and smooth muscle markers,’ are a rare subset of soft-tissue sarcomas, with an undefined cell of origin. While there is no formal epidemiology for malignant PEComa, it is estimated that there are about 100-300 new patients per year in the United States. Malignant PEComas may arise in almost any body site (typically the uterus, retroperitoneum, lung, kidney, liver, genitourinary, and gastrointestinal tract with a female predominance) and can have an aggressive clinical course including distant metastases and ultimately death. The estimated prognosis based on retrospective reports is 12-16 months. Cytotoxic chemotherapies typically used for sarcoma show minimal benefit. Malignant PEComas have been shown to frequently harbor mutations in the TSC1 and/or TSC2 genes that result in the activation of mTOR pathway making it a rational therapeutic target for this disease.

About the PRECISION 1 Trial

The PRECISION 1 trial is a multi-center, open-label, tumor-agnostic pivotal study, of nab-sirolimus designed as a basket trial that will evaluate approximately 120 adult and adolescent patients with solid tumors harboring pathogenic inactivating alterations in TSC1 or TSC2 genes. The trial will have two independent arms of 60 patients each to separately evaluate patients with either TSC1 or TSC2 inactivating alterations. Aadi has received Fast Track designation to evaluate nab-sirolimus in this indication from the FDA. The first patient in the PRECISION 1 trial was dosed in March 2022.

About the National Comprehensive Cancer Network (NCCN)
The NCCN is a not-for-profit alliance of 27 leading U.S. cancer centers devoted to patient care, research and education, is dedicated to improving the quality, effectiveness and efficiency of cancer care. The intent of the NCCN Guidelines is to assist in the decision-making process of individuals involved in cancer care – including physicians, nurses, pharmacists, payers, patients and their families – with the ultimate goal of improving patient care and outcomes. For more information about the National Comprehensive Cancer Network go to: View Source

On May 12, 2022 Silverback Therapeutics, Inc. (Nasdaq: SBTX) ("Silverback"), a biopharmaceutical company leveraging its proprietary ImmunoTAC technology platform to develop systemically delivered, tissue targeted therapeutics for the treatment of chronic viral infections, cancer, and other serious diseases, reported financial results for the first quarter ended March 31, 2022 and provided a business update (Press release, Silverback Therapeutics, MAY 12, 2022, View Source [SID1234614333]).

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"In the first quarter of 2022, we have made significant progress in advancing the preclinical development of SBT8230, a first-in-class antibody-drug conjugate that we believe has the potential to drive functional cure in patients with chronic hepatitis B (cHBV) by eliciting a liver-localized anti-viral response," said Laura Shawver, Ph.D., chief executive officer of Silverback. "We believe that activating the immune response is an important component of a functional cure and may be combined with treatments that target the HBV life cycle to improve durability. Our team is on track to complete a regulatory submission in the fourth quarter of 2022, enabling the planned initiation of the single ascending dose healthy volunteer cohort of the Phase 1 study in the first quarter of 2023. We plan to report data from this cohort in the second half of 2023."

SBT8230 (ASGR1-TLR8 ImmunoTAC conjugate for chronic HBV)

Initiated Phase 1-enabling toxicology study for SBT8230 in the first quarter of 2022 and on track to complete Phase 1 regulatory submission in the fourth quarter of 2022. Silverback expects to open enrollment for the single ascending dose healthy volunteer cohort of the Phase 1 study in the first quarter of 2023 and anticipates reporting data from this portion of the study in the second half of 2023. SBT8230 is comprised of an ASGR1 monoclonal antibody conjugated to a TLR8 linker-payload. ASGR1 is highly expressed in liver and is restricted in its expression to this organ. SBT8230 is designed to elicit a liver-localized anti-viral immune response and has the potential to improve the therapeutic window observed with untargeted, orally administered TLR8 agonists in cHBV, which have shown promise preclinically, but have been limited by toxicities in the clinic associated with immune activation in the gastrointestinal tract.
ImmunoTAC Discovery Programs

Silverback continues to advance discovery programs, with an update anticipated in the fourth quarter of 2022. Discovery efforts are focused on evaluating and developing new antigen binding domains specific for targets of interest (including antibodies), next-generation linker technologies, and both agonist and antagonist small molecule payloads, that may be combined to create novel tissue-targeted antibody conjugates.
First Quarter Financial Results

For the first quarter ended March 31, 2022, Silverback reported a net loss of $24.6 million, compared to a net loss of $18.9 million for the comparable period in 2021.

Research and development expenses for the first quarter ended March 31, 2022 were $16.9 million, compared to $12.2 million for the same period in 2021. The increase in the Company’s research and development expenses in 2022 were primarily attributable to an increase in direct costs related to preclinical research efforts, including the Company’s SBT8230 program, and increases in personnel-related expenses as operations grew in support of program advances.

General and administrative expenses for the first quarter ended March 31, 2022 were $7.8 million, compared to $6.6 million for the same period in 2021. The increase in general and administrative expenses in 2022 were primarily attributable to an increase in personnel-related expenses, including increases in salaries, bonuses, and stock-based compensation. The increase in general and administrative expenses in 2022 was also due to an increase in legal fees, professional fees, and other various general and administrative expenses as we now operate as a public company.

As of March 31, 2022, Silverback reported cash, cash equivalents, and investments of $298.1 million, compared to $319.1 million at December 31, 2021, which is expected to fund operating expenses and capital expenditure requirements into the second half of 2026. As of March 31, 2022, Silverback had 35,145,281 shares of common stock outstanding.

On May 12, 2022 Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, reported that financial results for the three-month period ended March 31, 2022 and provided a corporate update (Press release, Spectrum Pharmaceuticals, MAY 12, 2022, View Source [SID1234614332]).

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"We anticipate FDA approvals later this year for poziotinib and eflapegrastim. In the first quarter, we initiated a confirmatory study and presented additional positive scientific data for poziotinib. The resubmitted BLA for eflapegrastim was also accepted for review by the FDA," said Tom Riga, President and Chief Executive Officer of Spectrum Pharmaceuticals. "We are proud of the progress we’ve made toward our core business objectives and we remain dedicated to making a meaningful difference in the lives of cancer patients."

Pipeline Updates

Eflapegrastim, a novel long-acting G-CSF

The U.S. Food and Drug Administration (FDA) has accepted Spectrum’s resubmitted Biologics License Application (BLA) for eflapegrastim with a Prescription Drug User Fee Act (PDUFA) date of September 9, 2022. The company is working with its partner, Hanmi Pharmaceutical, to support the FDA regulatory review process.
Poziotinib, a Pan ErbB inhibitor targeting HER2 exon20 mutations

The New Drug Application (NDA) for poziotinib is under active review at the FDA with Fast Track designation. The NDA is based on the positive results of Cohort 2 in patients with previously treated locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring HER2 exon 20 insertion mutations. The agency has set a PDUFA date of November 24, 2022. There is currently no FDA approved therapy for patients with NSCLC harboring HER2 exon 20 insertion mutations.
A study for poziotinib has been initiated to confirm the clinical benefit seen in Cohort 2, as required for an accelerated approval. The trial, Study SPI-POZ-301 (PINNACLE), is designed to enroll 268 patients with previously treated NSCLC harboring HER2 exon 20 mutations. Patients are being randomized 2-to-1 into one of two treatment arms using 8mg of poziotinib orally administered BID (twice daily) versus 75mg/m2 of docetaxel administered intravenously every three weeks. The primary endpoint will be Progression Free Survival.
FDA’s Oncologic Drugs Advisory Committee (ODAC) is scheduled to review poziotinib for the treatment of patients with previously treated locally advanced or metastatic NSCLC harboring HER2 exon 20 insertion mutations. The fall ODAC meeting is being held September 22-23, 2022. ODAC is an independent panel of experts that evaluates data concerning the efficacy and safety of marketed and investigational products for use in the treatment of cancer and makes appropriate recommendations to the FDA. As usual, the final decision regarding the approval of the product is made by the FDA solely, and the recommendations by the panel are non-binding.
Data from Cohort 4 of the ZENITH20 study in patients with treatment-naïve NSCLC harboring HER2 exon 20 insertion mutations were presented in an oral session at the European Society for Medical Oncology Targeted Anticancer Therapies (ESMO TAT) Congress 2022. The results showed a confirmed objective response rate (ORR) of 41%, as evaluated centrally by an independent image review committee using RECIST 1.1 criteria. The evaluable patient population showed an ORR of 50%. The study met its primary endpoint as the observed lower bound of 30% exceeded the pre-specified lower bound of 20%. The safety profile was consistent with the tyrosine kinase inhibitor (TKI) class. Notably, on-target adverse events (AEs) were meaningfully reduced with BID dosing.
The company presented a poster on the predictive ability of circulating tumor DNA (ctDNA) in poziotinib-treated patients with NSCLC harboring HER2 exon 20 insertion mutations at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. Preliminary results suggest that decreases in plasma ctDNA during poziotinib therapy correlate with clinical response in patients with advanced NSCLC with HER2 exon 20 insertion mutations. Additional data from this study will be presented at the 2022 ASCO (Free ASCO Whitepaper) Annual Meeting in early June.
Corporate Updates

Nora E. Brennan was named Chief Financial Officer effective May 25, 2022. Ms. Brennan has served on Spectrum’s Board of Directors since December 2020 and as Chair of the Audit Committee. She will relinquish her board duties to assume her new senior leadership role. Most recently, Ms. Brennan served as Chief Financial Officer of Fore Biotherapeutics, a developer of cancer therapies driven by functional genomics. Prior to Fore, she served as Chief Financial Officer at TELA Bio, Inc. and as Senior Vice President of Treasury and Investor Relations at Integra Life Sciences Holdings Corporation.
Hanmi Pharmaceutical completed a $20 million strategic equity investment in Spectrum in January 2022, which included revisions to the licensing and supply agreements for eflapegrastim and poziotinib.
Two new members of the Board of Directors have been named. In March, Juhyun Lim was appointed to the Board. Ms. Lim currently serves as President, Global Strategy and Planning at Hanmi Science and Hanmi Pharmaceutical, where she leads the execution of corporate strategy and investment. In May, Spectrum named Brittany Bradrick to the Board and she will succeed Ms. Brennan as Chair of the Audit Committee. Ms. Bradrick currently serves as Chief Financial Officer of Neurelis, Inc. Ms. Bradrick is a seasoned executive with 25 years of experience in the life sciences sector including in the areas of mergers and acquisitions, investment banking, finance, strategy and corporate development.
A strategic restructuring with a ~30% staff reduction and ~20-25% reduction in operating cash burn was initiated in January 2022 to focus the company’s development activities on its late-stage assets, poziotinib and eflapegrastim. Development activities for the early-stage pipeline has been deprioritized.
Three-Month Period Ended March 31, 2022 (All numbers are from Continuing Operations and are approximate)

GAAP Results

Spectrum recorded a net loss of $15.4 million, or a $0.09 loss per basic and diluted share, in the three-month period ended March 31, 2022, compared to a net loss of $35.7 million, or a $0.25 loss per basic and diluted share, in the comparable period in 2021. Total research and development expenses were $4.2 million in the quarter, as compared to $19.4 million in the same period in 2021. Selling, general and administrative expenses were $9.9 million in the quarter, compared to $14.3 million in the same period in 2021.

Non-GAAP Results

Spectrum recorded a non-GAAP net loss of $9.6 million, or a $0.06 non-GAAP loss per basic and diluted share, in the three-month period ended March 31, 2022, compared to a non-GAAP net loss of $29.4 million, or a $0.20 non-GAAP loss per basic and diluted share, in the comparable period in 2021. Non-GAAP research and development expenses were $2.1 million, as compared to $18.0 million in the same period of 2021. Non-GAAP selling, general and administrative expenses were $7.5 million, as compared to $11.5 million in the same period in 2021.

Cash Position and Guidance

In January, the company received a $20 million strategic equity investment from Hanmi Pharmaceutical. Together with this strategic investment, Spectrum ended the quarter with cash, cash equivalents, and marketable securities of approximately $89.2 million. The additional cash, combined with the restructuring, is expected to extend the company’s cash runway into 2023.

This conference call will also be webcast. Listeners may access the webcast, which will be available on the investor relations page of Spectrum Pharmaceuticals’ website: View Source on May 12, 2022 at 4:30 p.m. Eastern/1:30 p.m. Pacific.

On May 12, 2022 Wugen, Inc., a clinical-stage biotechnology company developing a pipeline of off-the-shelf cell therapies to treat a broad range of hematological and solid tumor malignancies, reported it will present new preclinical data highlighting the anti-tumor activity of Wugen’s lead memory natural killer (NK) product candidate WU-NK-101 at the European Hematology Association (EHA) (Free EHA Whitepaper) 2022 Hybrid Congress being held June 9-12, 2022, virtually and in-person in Vienna, Austria (Press release, Wugen, MAY 12, 2022, View Source [SID1234614331]).

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The data highlight preclinical activity of WU-NK-101 supporting its clinical development for acute myeloid leukemia (AML). WU-NK-101 displayed activity against AML cell lines both in vitro and in vivo, and improved homing to the bone marrow. Further, the functional characteristics of WU-NK-101 support the potential development of WU-NK-101 for solid tumors, with data showing resistance to an adverse and immunosuppressive tumor microenvironment (TME).

The details of Wugen’s poster presentation at EHA (Free EHA Whitepaper) are as follows:

Title: WU-NK-101, An Allogeneic Memory NK Cell, for the Treatment of Relapse or Refractory (R/R) Acute Myeloid Leukemia (AML)
Session date and time: Friday, June 10, 2022, from 4:30 – 5:45 p.m. CEST
Abstract Number: P1426
Presenting Author: Jan Davidson-Moncada, M.D., Ph.D., Chief Medical Officer, Wugen

Additional meeting information can be found at www.ehaweb.org/congress

About WU-NK-101

WU-NK-101 is a novel immunotherapy harnessing the power of memory natural killer (NK) cells to treat liquid and solid tumors. Memory NK cells are hyper-functional, long-lasting immune cells that exhibit enhanced anti-tumor activity. This rare cell population has a superior phenotype, proliferation capacity, and metabolic fitness that makes it better suited for cancer therapy than other NK cell therapies. Wugen is applying its proprietary MonetaTM platform to advance WU-NK-101 as a commercially scalable, off-the-shelf cell therapy for cancer. WU-NK-101 is currently in development for acute myelogenous leukemia (AML) and solid tumors.

On May 12, 2022 ADC Therapeutics SA (NYSE: ADCT), reported that results from the pivotal Phase 2 clinical trial of camidanlumab tesirine (Cami) in patients with relapsed or refractory Hodgkin lymphoma have been accepted for an oral presentation at the European Hematology Association (EHA) (Free EHA Whitepaper) 2022 Hybrid Congress (EHA2022), which will be held virtually and in Vienna, Austria from June 9-12, 2022 (Press release, ADC Therapeutics, MAY 12, 2022, View Source [SID1234614330]).

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"We continue to be encouraged by the data from our ongoing pivotal Phase 2 trial demonstrating the efficacy and safety of Cami as a single agent for patients with relapsed or refractory Hodgkin lymphoma," said Joseph Camardo, MD, Chief Medical Officer of ADC Therapeutics. "As we advance Cami toward a potential BLA submission, we look forward to sharing these data with the hematology community at EHA (Free EHA Whitepaper)2022."

Details of ADC Therapeutics’ oral presentation are as follows:

Camidanlumab Tesirine: Updated Efficacy And Safety In An Open-Label, Multicenter, Phase 2 Study Of Patients With Relapsed Or Refractory Classical Hodgkin Lymphoma (R/R CHL)Presentation Date and Time: Friday, June 10, 2022, 11:45 am – 12:00 pm CEST // 5:45 am – 6 am EDT

Presentation Date and Time: Friday, June 10, 2022, 11:45 am – 12:00 pm CEST // 5:45 am – 6 am EDT

Session Title: Hodgkin lymphoma – Clinical

Session Room: Hall A8

Abstract Code: S201

Presenter: Carmelo Carlo-Stella, MD, Department of Biomedical Sciences, Humanitas University, and Department of Oncology and Hematology, IRCCS Humanitas Research Hospital, Milan, Italy

Details of ADC Therapeutics’ poster presentations are as follows:

Health-Related Quality Of Life And Tolerability Of Loncastuximab Tesirine In High-Risk Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma Treated In A Phase 2 Clinical Trial (LOTIS 2)

Session Date and Time: Friday, June 10, 2022, 16:30 – 17:45 CEST // 10:30 am – 11:45 am EDT

Location: Hall D

Abstract Code: P1717

Real-World Characteristics And Clinical Outcomes In Relapse/Refractory Diffuse Large B-Cell Lymphoma Patients Who Received Car-T Therapy

Session Date and Time: Friday, June 10, 2022, 16:30 – 17:45 CEST // 10:30 am – 11:45 am EDT

Location: Hall D

Abstract Code: 1182

Real-World Characteristics And Clinical Outcomes In Relapse/Refractory Diffuse Large B-Cell Lymphoma Post Car-T Failure

Session Date and Time: Friday, June 10, 2022, 16:30 – 17:45 CEST – 10:30 am – 11:45 am EDT

Location: Hall D

Abstract Code: 1181

Titles of ADC Therapeutics’ abstracts accepted for publication only are as follows:

·A Phase 2, Open-Label Study Of Loncastuximab Tesirine In Combination With Rituximab (LONCA-R) In Previously Untreated Unfit/Frail Patients With Diffuse Large B-Cell Lymphoma (DLBCL) (LOTIS-9) [Trials in progress]

·Long-term survival projections of loncastuximab tesirine-treated patients in relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL)

·Phase 3 Randomized Study of Loncastuximab Tesirine in Combination With Rituximab (Lonca-R) Versus Immunochemotherapy in Patients With R/R DLBCL (LOTIS-5) [Trials in progress]

Please note: times and locations are tentative and subject to change.

About Camidanlumab Tesirine (Cami)

Camidanlumab tesirine (Cami) is an antibody drug conjugate (ADC) comprised of a monoclonal antibody that binds to CD25 (HuMax-TAC, licensed from Genmab A/S), conjugated to the pyrrolobenzodiazepine (PBD) dimer payload, tesirine. Once bound to a CD25-expressing cell, Cami is internalized into the cell where enzymes release the PBD-based payload, killing the cell. This applies to CD25-expressing tumor cells and also to CD25-expressing Tregs. The intra-tumoral release of its PBD payload may also cause bystander killing of neighboring tumor cells, and PBDs have also been shown to induce immunogenic cell death. All of these properties of Cami may enhance immune-mediated anti-tumor activity.

Cami is being evaluated in a pivotal Phase 2 clinical trial in patients with relapsed or refractory Hodgkin lymphoma and a Phase 1b clinical trial as monotherapy and in combination with pembrolizumab in solid tumors.

About ZYNLONTA (loncastuximab tesirine-lpyl)

ZYNLONTA is a CD19-directed antibody drug conjugate (ADC). Once bound to a CD19-expressing cell, ZYNLONTA is internalized by the cell, where enzymes release a pyrrolobenzodiazepine (PBD) payload. The potent payload binds to DNA minor groove with little distortion, remaining less visible to DNA repair mechanisms. This ultimately results in cell cycle arrest and tumor cell death.

The U.S. Food and Drug Administration (FDA) has approved ZYNLONTA (loncastuximab tesirine-lpyl) for the treatment of adult patients with relapsed or refractory (r/r) large B-cell lymphoma after two or more lines of systemic therapy, including DLBCL not otherwise specified, DLBCL arising from low-grade lymphoma and also high-grade B-cell lymphoma. The trial included a broad spectrum of heavily pre-treated patients (median three prior lines of therapy) with difficult-to-treat disease, including patients who did not respond to first-line therapy, patients refractory to all prior lines of therapy, patients with double/triple hit genetics and patients who had stem cell transplant and CAR-T therapy prior to their treatment with ZYNLONTA. This indication is approved by the FDA under accelerated approval based on overall response rate and continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

ZYNLONTA is also being evaluated as a therapeutic option in combination studies in other B-cell malignancies and earlier lines of therapy.