Olema Oncology Reports First Quarter 2022 Financial Results and Provides Corporate Update

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

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

Recent Corporate Highlights

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

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

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

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

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

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

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

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

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

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

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

Sutro Biopharma Reports First Quarter 2022 Financial Results, Business Highlights, and Anticipated Milestones

On May 9, 2022 Sutro Biopharma, Inc. ("Sutro" or the "Company") (NASDAQ: STRO), a clinical-stage drug discovery, development and manufacturing company focused on the application ofprecise protein engineering and rational design to create next-generation cancer therapeutics, reported its financial results for the quarter ended March 31, 2022, its recent business highlights, and a preview of anticipatedselect milestones (Press release, Sutro Biopharma, MAY 9, 2022, View Source [SID1234613932]).

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"Sutro remains steadfastly dedicated to advancing next generation cancer therapeutics by leveraging the advantages of our proprietary platform," said Bill Newell, Sutro’s Chief Executive Officer. "We are pleased with the progress of our lead program, STRO-002, a FolRα-targeting antibody-drug conjugate. Our top priority is charting the course for a potential registrational trial for patients with advanced ovarian cancer. We are also expanding our clinical studies into endometrial cancer and have plans for non-gynecological indications, including NSCLC, to explore the possibility of treatment with STRO-002 for people who suffer from these debilitating cancers and have limited available treatment options."

Recent Business Highlights and Anticipated Select Milestones
STRO-002, FolRα-Targeting Antibody-Drug Conjugate (ADC): STRO-002 is being studied in the clinic, in both the United States and Europe, for patients with ovarian and endometrial cancers.

The Phase 1 dose-expansion cohort for patients with advanced ovarian cancer has completed enrollment and is ongoing. Sutro expects to report additional data on efficacy, safety, and durability from the dose-expansion cohort in the second half of 2022.
Regulatory discussions on a potential registrational study for patients with advanced ovarian cancer are planned for mid-year 2022.
The STRO-002 study in combination with bevacizumab for patients with advanced ovarian cancer is ongoing and the first patient was dosed in March 2022. A dose-expansion study of STRO-002 for patients with endometrial cancer continues to enroll patients.
Nonclinical data presented at the AACR (Free AACR Whitepaper) Annual Meeting 2022 in April demonstrated STRO-002’s ability to induce immunogenic cell death. Additionally, studies showed robust STRO-002 activity in endometrial and non-small cell lung cancer (NSCLC) patient-derived xenograft models with diverse levels of folate receptor alpha (FolRα) expression.
Sutro expects to initiate clinical trials for STRO-002 in NSCLC and other non-gynecologic solid tumors in the second half of 2022.
STRO-001, CD74-Targeting ADC: The Phase 1 study for patients with B‑cell malignancies, including patients withnon-Hodgkin’s lymphoma and multiple myeloma, continues in dose escalation.

Dose escalation is ongoing to achieve a recommended phase 2 dose (RP2D), with the last reported doses of 5.0 mg/kg in the multiple myeloma (MM) cohort and 5.0 mg/kg in the non-Hodgkin’s lymphoma (NHL) cohort.

Additional Pipeline Programs: Research and preclinical development are underway for several internal candidates.

Discovery and preclinical work on multiple programs are underway to determine Sutro’s next product candidates to advance to the clinic.
Sutro presented preclinical data for a novel immunostimulatory antibody-drug conjugate (iADC) at the 12th Annual World ADC Conference in March 2022. The iADC modality provides for dual mechanisms to attack the tumor, through cytotoxic killing as well as potentially building a protective immune response.
Corporate Updates: Sutro expands the strength of its leadership team with several appointments and promotions.

Venkatesh Srinivasan joined Sutro in April 2022 as Senior Vice President, Process and Analytical Development and part of the senior management team. Dr. Srinivasan brings more than 25 years of experience in bioprocess development, biologics manufacturing and tech transfer in the biopharmaceutical industry. He was most recently Vice President, Global Manufacturing Sciences & Technology at Bayer.
Kristin Bedard, Vice President of Discovery, who joined Sutro in February 2020, recently became part of the senior management team. Recent promotions within the senior management team include Brunilda Shtylla to Senior Vice President of Business Development and Annie Chang to Vice President of Investor Relations.
Collaboration Updates: Sutro continues to seek to maximize the value of its proprietary cell-free platform by working with partners on programs in multiple disease spaces and geographies and has received from collaborators an aggregate of approximately $456 million in payments, including equity investments, through March 31, 2022.

Sutro is manufacturing initial drug supply for the potential clinical development of the first molecule in the Merck cytokine derivative collaboration; clinical trial materials for Bristol Myers Squibb’s (BMS) CC-99712, a BCMA‑targeting ADC, for treatment of multiple myeloma, in Phase 1 studies; and clinical trial materials for M1231, a MUC1-EGFR-targeting bispecific ADC, for Merck KGaA, Darmstadt, Germany, known as EMD Serono in the U.S. and Canada (EMD Serono), in Phase 1 studies.
Sutro supplies cell-free extract to Vaxcyte for the manufacture of clinical trial materials for VAX-24, which is designed to prevent invasive pneumococcal disease. Vaxcyte announced in April 2022 that the first participants were dosed in the Phase 2 portion of the clinical study of VAX-24.
Sutro plans to support BioNova Pharmaceuticals (BioNova) in clinical trial initiations for STRO-001 in the Greater China market and provide clinical drug supply as needed.
In April 2022, Sutro and Tasly Biopharmaceuticals (Tasly) amended Tasly’s exclusive license to develop and commercialize STRO-002 in Greater China. Pursuant to the amended agreement, the upfront payment due from Tasly was changed to $25.0 million and $15.0 million will become payable to Sutro based on certain regulatory milestones. The amended agreement provides for additional potential payments to Sutro totaling up to $350.0 million related to development, regulatory and commercialization milestones. Sutro plans to support Tasly for initiation of clinical development activities in Greater China and provide clinical drug supply as needed.
First Quarter 2022 Financial Highlights
Cash, Cash Equivalents and Marketable Securities

As of March 31, 2022, Sutro had cash, cash equivalents and marketable securities of $192.1 million, as compared to $229.5 million as of December 31, 2021, with projected cash runway into the second half of 2023, based on current business plans and assumptions. The above balances do not include the value associated with Sutro’s holdings of Vaxcyte common stock.

Unrealized Gain from Increase in Value of Vaxcyte Common Stock

As of March 31, 2022, Sutro held approximately 1.6 million shares of Vaxcyte common stock, with a fair value of $37.7 million. The non-operating, unrealized gain of $0.6 million in the first quarter of 2022 was due to the increase since December 31, 2021 in the estimated fair value of Sutro’s holdings of Vaxcyte common stock. Vaxcyte common stock held by Sutro will be remeasured at fair value based on the closing price of Vaxcyte’s common stock on the last trading day of each reporting period, with any non-operating, unrealized gains and losses recorded in Sutro’sstatements of operations.

Revenue

Revenue was $5.9 million for the quarter ended March 31, 2022, as compared to $14.7 million for the same period in 2021, related principally to the Merck, BMS, and EMD Serono collaborations. Future collaboration revenue from Merck, BMS, and EMD Serono, and from any additional collaboration partners, will fluctuate as a result of the amountand timing of revenue recognition of upfront, milestones, and other collaboration agreement payments.

Operating Expenses

Total operating expenses for the quarter ended March 31, 2022 were $45.0 million, as compared to $33.7 million for the same period in 2021. The first quarter of 2022 includes non-cash expenses for stock-based compensation of $7.0 million and depreciation and amortization of $1.3 million, as compared to $4.0 million and $1.3 million, respectively, in the comparable 2021 period. Total operating expenses for the quarter ended March 31, 2022 were comprised of research and development expenses of $30.0 million and general and administrative expenses of $15.0 million, which are expected to increase in 2022 as Sutro’s internal product candidates advance in clinical development and additional general and administrative expenses are incurred as a public company.

Aptose Reports Results for the First Quarter 2022

On May 9, 2022 Aptose Biosciences Inc. ("Aptose" or the "Company") (NASDAQ: APTO, TSX: APS), a clinical-stage precision oncology company developing highly differentiated oral kinase inhibitors to treat hematologic malignancies, reported financial results for the three months ended March 31, 2022 and provided a corporate update (Press release, Aptose Biosciences, MAY 9, 2022, View Source [SID1234613931]).

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The net loss for the quarter ended March 31, 2022 was $11.5 million ($0.12 per share) compared with $16.2 million ($0.18 per share) for the quarter ended March 31, 2021. Total cash and cash equivalents and investments as of March 31, 2022 were $69.5 million. Based on current operations, Aptose expects that cash on hand and available capital provide the Company with sufficient resources to fund all planned Company operations including research and development into the fourth quarter of 2023.

"Aptose has two meaningful clinical-stage kinome inhibitors in HM43239 and luxeptinib, and we continue to advance their development in distinct patient populations," said William G. Rice, Ph.D., Chairman, President and Chief Executive Officer. "To date, both have demonstrated clear activity and have been well-tolerated. As we define the next steps in the development program with our lead compound HM43239, we are encouraged by the clinical remissions we are seeing in AML patients, particularly in those with highly adverse mutations that typically are difficult to treat but respond to HM43239. We look forward to reporting all available data on our programs at an upcoming corporate event."

Key Corporate Highlights

Aptose Receives Fast Track Designation for HM43239 – The U.S. Food and Drug Administration (FDA) granted Fast Track designation to HM43239 (239), an oral, myeloid kinome inhibitor, for the treatment of patients with relapsed, refractory (R/R) acute myeloid leukemia (AML) who have FLT3 mutations. Fast Track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need.The purpose is to get important new drugs to patients earlier.

HM43239 Expansion at 160 mg in Diverse AML Patient Population – HM43239, an oral, myeloid kinome inhibitor in an international Phase 1/2 trial in patients with relapsed or refractory acute myeloid leukemia (AML), thus far has delivered six composite complete remissions (CR) and a PR at the 80 mg and 120 mg doses. Aptose is now expanding at the 160 mg dose level, with the goal of understanding the breadth of activity of 239 in diverse mutations and identifying the best efficacious and safe doses to treat relapsed and refractory AML. HM43239 thus far has demonstrated a favorable safety profile with no DLTs and no drug discontinuations from drug related toxicity at doses up to 160 mg per day.

Headway with Luxeptinib "G3" Formulation in Patients – Luxeptinib , a dual lymphoid and myeloid kinome inhibitor, currently is being evaluated in a Phase 1 a/b study in patients with relapsed or refractory AML and higher risk MDS, and in a separate Phase 1 a/b study in patients with relapsed or refractory B-cell malignancies. Aptose has made significant progress with the clinical evaluation of a new formulation of luxeptinib (Lux), that may enable greater exposures across patients. In the ongoing studies in AML and B-cell malignancies, a dose of the G3 formulation has been safely administered to three patients at the 50 mg dose level and is now being dosed at the 100 mg dose level. After patients receive the single G3 dose, samples are collected for PK evaluation and patients then go onto the original formulation of Lux for comparison.

Aptose Appoints Chief Commercial Officer – Aptose recently appointed Dr. Philippe Ledru to the position of Chief Commercial Officer, responsible for providing executive leadership and vision for commercial development and marketing strategies for the future commercial launches of HM43239 and luxeptinib and to consolidate responsibilities over business development and licensing. Dr. Ledru most recently served as Associate Vice President and Head of Oncology New Products at Merck & Co., over 25 assets from discovery to mid-stage clinical development, across major solid tumors and hematological malignancies At Merck, he also provided leadership on all licensing and M&A activities, including the Peloton Therapeutics and Arqule acquisitions in 2019. Earlier, at Novartis, he had early commercial development and global marketing responsibilities for several new compounds, including FLT3 inhibitor midostaurin, and at Novartis Oncologie he helped lead launches of several oncology products, including imatinib (Gleevec).

RESULTS OF OPERATIONS

A summary of the results of operations for the three-month periods ended March 31, 2022 and 2021 is presented below:

The net loss for the three-month period ended March 31, 2022, decreased by $4.7 million to $11.5 million as compared with $16.2 million for the comparable period in 2021. Components of the net loss are presented below:

Research and Development

Research and development expenses consist primarily of costs incurred related to the research and development of our product candidates. Costs include the following:

External research and development expenses incurred under agreements with third parties, such as CROs, consultants, members of our scientific advisory boards, external labs and CMOs; and

Employee-related expenses, including salaries, benefits, travel, and stock-based compensation for personnel directly supporting our clinical trials and manufacturing, and development activities.
We have ongoing Phase 1 clinical trials for our product candidates HM43239 and Luxeptinib. HM43239 was licensed into Aptose in Q4, 2021 and we have assumed sponsorship, and the related costs, of the HM43239 study effective January 1, 2022. In Q4, 2021, we discontinued the APTO-253 program and are exploring strategic alternatives for this compound.

We expect our research and development expenses to be higher for the foreseeable future as we continue to advance HM43239 and luxeptinib into larger clinical trials.

The research and development expenses for the three-month periods ended March 31, 2022, and 2021 were as follows:

Research and development expenses decreased by $835 thousand to $7.4 million for the three-month period ended March 31, 2022 as compared with $8.2 million for the comparative period in 2021. Changes to the components of our research and development expenses presented in the table above are primarily as a result of the following events:

Program costs for HM43239 increased by approximately $1.2 million as the Company in-licensed the development rights of HM43239 in the fourth quarter of 2021 and assumed sponsorship, and the related costs, of the study effective January 1, 2022.

Program costs for luxeptinib decreased by approximately $1.1 million, primarily due to lower manufacturing costs as a result of the current formulation requiring less API than the prior formulation and also from lower clinical trial costs, mostly related to fewer contractors needed to support the trials.

Program costs for APTO-253 decreased by approximately $1.0 million, due to the Company’s decision on December 20, 2021 to discontinue further clinical development of APTO-253.

Personnel-related expenses increased by $546 thousand, mostly related to new positions hired in 2021 to support our clinical trials and manufacturing activities.

Stock-based compensation decreased by approximately $432 thousand in the three months ended March 31, 2022, compared with the three months ended March 31, 2021, primarily due to lower grant date fair value of options which were granted in the current period.
General and Administrative

General and administrative expenses consist primarily of salaries, benefits and travel, including stock-based compensation for our executive, finance, business development, human resource, and support functions. Other general and administrative expenses are professional fees for auditing, and legal services, investor relations and other consultants, insurance and facility related expenses.

We expect that our general and administrative expenses will increase for the foreseeable future as we incur additional costs to support the expansion of our pipeline of activities. We also expect our intellectual property related legal expenses to increase as our intellectual property portfolio expands.

The general and administrative expenses for the three-month periods ended March 31, 2022 and 2021 were as follows:

General and administrative expenses for the three-month period ended March 31, 2022 were $4.1 million as compared with $8.0 million for the comparative period in 2021, a decrease of approximately $3.9 million. The decrease was primarily as a result of the following:

General and administrative expenses, other than stock-based compensation and depreciation of equipment, decreased by approximately $204 thousand in the three months ended March 31, 2022 primarily as a result lower professional fees.

Stock-based compensation decreased by approximately $3.7 million in the three months ended March 31, 2022, compared with the three months ended March 31, 2021, primarily due to lower grant date fair value of options which were granted in the current period, and additional compensation recognized in the comparative period for modifications made to then vested and unvested stock options for one officer, as part of a separation and release agreement.
COVID-19 did not have a significant impact on our results of operations for the three-month period ended March 31, 2022. We have not experienced and do not foresee material delays to the enrollment of patients or timelines for the HM43239 Phase 1/2 trial or the luxeptinib Phase 1a/b trials due to the variety of clinical sites that we have actively recruited for these trials. As of the date of this report, we have not experienced material delays in the manufacturing of HM43239 or luxeptinib related to COVID-19. Should our manufacturers be required to shut down their facilities due to COVID-19 for an extended period of time, our trials may be negatively impacted.

Conference Call and Webcast

Aptose will host a conference call to discuss results for the quarter ended March 31, 2022 today, Monday, May 9, 2022 at 5:00 PM ET. Participants can access the conference call by dialing 1-866-374-5140 (North American toll-free number) and 1-404-400-0571 (international/toll number) and using conference ID 38238231#. The conference call can be accessed here and will also be available through a link on the Investor Relations section of Aptose’s website at View Source An archived version of the webcast will be available on the Company’s website for 30 days.

The press release, the financial statements and the management’s discussion and analysis for the quarter ended March 31, 2021 will be available on SEDAR at www.sedar.com and EDGAR at www.sec.gov/edgar.shtml.

Biomea Fusion to Participate in Bank of America Securities 2022 Healthcare Conference

On May 9, 2022 Biomea Fusion, Inc. (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 that Thomas Butler, Chief Executive Officer and Chairman of the Board, will participate in a fireside chat at the live Bank of America Securities 2022 Healthcare Conference (Press release, Biomea Fusion, MAY 9, 2022, View Sourcenews-releases/news-release-details/biomea-fusion-participate-bank-america-securities-2022" target="_blank" title="View Sourcenews-releases/news-release-details/biomea-fusion-participate-bank-america-securities-2022" rel="nofollow">View Source [SID1234613930]). The fireside chat will take place on Wednesday, May 11th at 4:00pm Pacific Time.

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A live webcast of the fireside chat can be accessed at View Source and will be available for 90 days following the presentation.

Y-mAbs Announces First Quarter Financial Results and Recent Corporate Developments

On May 9, 2022 Y-mAbs Therapeutics, Inc. (the "Company" or "Y-mAbs") (Nasdaq: YMAB) a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, reported financial results for the first quarter 2022 (Press release, Y-mAbs Therapeutics, MAY 9, 2022, View Source [SID1234613929]).

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"Y-mAbs had a successful first quarter. We resubmitted the omburtamab BLA, bringing us one step closer to the potential approval and achieving our goal of delivering omburtamab to children suffering from high-risk neuroblastoma brain tumors," said Thomas Gad, Interim Chief Executive Officer. "We are very encouraged by our first quarter financial results, driven by our continued execution of the DANYELZA launch which generated revenues of $10.5 million. Based on the steady progress and a strong first quarter we anticipate full-year 2022 DANYELZA revenues in the range of $45-50 million. Our strong balance sheet with $156.7 million in cash, and anticipated revenues from product sales, is expected to support us through multiple potentially value-creating catalysts and into mid-2024."

First Quarter 2021 and Recent Corporate Developments

On April 27, 2022, Y-mAbs announced a management change. Dr. Claus Moller has stepped down as Chief Executive Officer and Board Member, and Thomas Gad, the Company’s Founder, Chairman, and President has assumed the role of Interim CEO. The Board, under the newly appointed Chairman Dr. Jim Healy, has begun a search for Dr. Moller’s successor.
On April 8, 2022, Y-mAbs presented pre-clinical data from the GD2-SADA construct at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2022 Annual Meeting. Pre-clinical models indicated that treatment with GD2-SADA increased tumor antigen binding, uptake, and persistence in tumor tissue in-vivo with activity lasting over 100 days after the treatment.
On April 1, 2022, Y-mAbs announced that on March 31, 2022, the Company completed the resubmission of its Biologics License Application for omburtamab to the FDA. The FDA has a 60-day review period to determine whether the BLA is complete and acceptable for filing.
Financial Results

Revenues

Y-mAbs reported net revenues of $10.5 million for the quarter ended March 31, 2022, which was a 94% increase over $5.4 million in the comparable quarter of 2021. Additionally, net revenues were up 9% from the fourth quarter 2021. The Company has now delivered DANYELZA to 34 centers across the nation, corresponding to an increase of more than 20% since the end of the fourth quarter of 2021. Approximately 50% of the vials sold in the U.S. are now sold outside Memorial Sloan Kettering ("MSK"), a notable increase over the approximately 40% of the vials sold outside MSK in prior quarters.

Operating Expenses

Research and Development

Research and development expenses were $22.9 million for the three months ended March 31, 2022, compared to $21.6 million for the three months ended March 31, 2021. The $1.3 million increase reflects our increased clinical trial activity and employee-related costs, partially offset by decreased outsourced manufacturing expenses. Having completed the resubmission of the BLA for omburtamab on March 31, 2022, Y-mAbs is focusing pipeline development on DANYELZA label expansion, omburtamab, and advancing the SADA constructs into the clinic.

Selling, General, and Administration

Selling, general, and administrative expenses were $13.4 million for the three months ended March 31, 2022, which was a $1.4 million increase compared to $12.0 million for the three months ended March 31, 2021. The increase in selling, general, and administrative expenses was primarily due to costs related to the launch and commercialization of DANYELZA; which includes a $0.7 million increase in personnel costs due to the expansion of our commercial team that is poised to drive further adoption of DANYELZA in 2022 and beyond.

Net Result

Y-mAbs reported a net loss for the quarter ended March 31, 2022, of $28.1 million, or $0.64 per basic and diluted share, compared to net income of $33.4 million, or $0.80 per basic share and $0.75 per diluted share, for the quarter ended March 31, 2021. The decrease in earnings was primarily driven by a one-time $62.0 million net gain from the sale of our DANYELZA Priority Review Voucher in the quarter ended March 31, 2021, partially offset by the favorable impact of increasing DANYELZA revenues.

Cash and Cash Equivalents

The Company had approximately $156.7 million in cash and cash equivalents as of March 31, 2022, which, when combined with anticipated revenues from product sales, is expected to be sufficient to fund the current operations to mid-2024.

Webcast and Conference Call

Y-mAbs will host a conference call on Tuesday, May 10, 2022, at 9 a.m. Eastern Time. To participate in the call, please dial 877-407-0792 (domestic) or 201-689-8263 (international) and reference the conference ID 13729248.

A webcast will be available at: View Source