On May 5, 2022 Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, reported financial results for the first quarter of 2022 (Press release, Oncternal Therapeutics, MAY 5, 2022, View Source [SID1234613650]).

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"In the first quarter, we continued to advance our robust pipeline towards important inflection points, including the planned initiation of our zilovertamab registrational Phase 3 study in patients with MCL in Q3 2022, the submission of an IND for our ROR1-targeting CAR-T cell therapy candidate ONCT-808 in mid-2022, and the execution of IND-enabling studies for ONCT-534, our DAARI product candidate that may address key resistance mechanisms in metastatic prostate cancer," said James Breitmeyer, M.D., Ph.D., Oncternal’s President and CEO. "Substantial progress of our pipeline has been supported by solid collaborations with our partners and execution by our team, and is being carried out with a focus on prudent cash management. Very importantly, we narrowed our focus on hematological malignancies and prostate cancer, and deprioritized our ONCT-216 program, which helped extend our cash runway well into Q3 2023. We will continue to explore and evaluate all potential sources of capital to enable us to reach our milestones."

Recent Highlights

In January 2022, we announced that we reached consensus with the FDA on the design and major study details of the Phase 3 Study, ZILO-301, to treat patients with relapsed or refractory mantle cell lymphoma (MCL) with zilovertamab, an investigational anti-ROR1 monoclonal antibody, in combination with ibrutinib. The agency also provided positive feedback on the proposed key clinical and regulatory requirements of our development program for zilovertamab in patients with MCL.
In April 2022, we established a clinical manufacturing agreement with the Dana-Farber Cancer Institute to conduct cGMP cell preparation and manufacturing activities for use in first-in-human studies of our ROR1-targeting CAR-T cell therapy candidate ONCT-808.
In April 2022, we announced the deprioritization of further development of ONCT-216 and the discontinuation of enrollment in the Phase 1/2 study evaluating ONCT-216 in patients with relapsed or refractory Ewing sarcoma.
Expected Upcoming Milestones

Zilovertamab, our ROR1 antibody program
Initiation of global registrational Phase 3 Study, ZILO-301, in the third quarter of 2022
Interim clinical data update for patients with MCL and CLL treated with zilovertamab plus ibrutinib in ongoing Phase 1/2 clinical study will be presented at the ASCO (Free ASCO Whitepaper) 2022 Annual Meeting
Initiation of Phase 1b investigator sponsored trial of zilovertamab plus docetaxel for patients with metastatic castration-resistant prostate cancer (mCRPC) in mid-2022
ONCT-808, lead candidate in our autologous ROR1-targeted CAR-T cell therapy program
Investigational New Drug (IND) application submission in mid-2022
ONCT-534, lead candidate in our DAARI program
IND-enabling GLP toxicology studies and GMP manufacturing initiated in the second quarter of 2022
First Quarter 2022 Financial Results
Our grant revenue was $0.7 million for the first quarter ended March 31, 2022. Our grant revenue is derived from a subaward under a grant from the California Institute for Regenerative Medicine (CIRM) to the University of California, San Diego and two research and development grant awards from the National Institutes of Health (NIH).

Our total operating expenses for the first quarter ended March 31, 2022 were $10.7 million, including $2.0 million in non-cash stock-based compensation expense. Research and development expenses for the quarter totaled $7.0 million, and general and administrative expenses for the quarter totaled $3.7 million. Net loss for the first quarter was $9.9 million, or a loss of $0.20 per share, basic and diluted.

As of March 31, 2022, we had approximately 49.4 million shares of common stock outstanding, $82.2 million in cash and cash equivalents and no debt. We believe these funds will be sufficient to fund our operations well into Q3 2023. Our cash guidance is subject to a number of assumptions, including those related to the severity and duration of the COVID-19 pandemic, and the pace of our research and clinical development programs, among other aspects of our business and the geopolitical environment.

On May 5, 2022 SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a clinical-stage biopharmaceutical company focused on developing life-changing medicines for patients with severe rare diseases and cancer, reported first quarter financial results for the period ended March 31, 2022 and provided an update on recent company developments (Press release, SpringWorks Therapeutics, MAY 5, 2022, View Source [SID1234613665]).

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"In the first quarter of 2022 we continued to advance our diversified targeted oncology pipeline, which now includes 18 development programs across rare oncology, BCMA combinations in multiple myeloma, and biomarker-defined metastatic solid tumors," said Saqib Islam, Chief Executive Officer of SpringWorks. "The second quarter of 2022 will be a meaningful period for SpringWorks and the patients we are working to serve as we expect to announce topline data from our Phase 3 DeFi study, share initial clinical data from our collaboration with GSK evaluating nirogacestat in combination with low-dose BLENREP in patients with multiple myeloma at ASCO (Free ASCO Whitepaper), and host our first R&D Day, which will include initial clinical data from our biomarker-defined metastatic solid tumor programs with BeiGene, our preparations for serving patients with desmoid tumors, as well as broader developments across our pipeline."

Recent Business Highlights and Upcoming Milestones

Rare Oncology

SpringWorks is conducting the Phase 3 DeFi trial evaluating nirogacestat in adult patients with progressing desmoid tumors. DeFi is an event-driven trial with a primary endpoint of progression-free survival. The Company has commenced the activities to enable the topline analysis from the Phase 3 DeFi trial and expects to report topline data in the second quarter of 2022.
A poster entitled, "Extended progression free survival and long-term safety of nirogacestat in patients with desmoid tumors" will be presented at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. The poster will include updated data from the NCI-sponsored Phase 2 study of nirogacestat in patients with progressing desmoid tumors.
Recruitment is ongoing in a Phase 2 study sponsored by the Children’s Oncology Group evaluating nirogacestat in pediatric patients with desmoid tumors.
The Phase 2b ReNeu trial evaluating mirdametinib in adult and pediatric patients with NF1-associated plexiform neurofibromas (NF1-PN) is fully enrolled.
Recruitment is ongoing in a Phase 1/2 clinical trial evaluating mirdametinib in children and young adults with low-grade glioma.
B-cell Maturation Antigen (BCMA) Combinations in Multiple Myeloma

SpringWorks continues to advance nirogacestat as a potential cornerstone of BCMA combination therapy across modalities in collaboration with eight industry leaders. Five studies are currently ongoing: nirogacestat + GSK’s BLENREP (belantamab mafodotin-blmf), nirogacestat + Allogene’s ALLO-715, nirogacestat + Janssen’s teclistamab, nirogacestat + Precision Biosciences’ PBCAR269A, and nirogacestat + Pfizer’s elrantamab; three additional studies are planned: nirogacestat + Seagen’s SEA-BCMA, nirogacestat + AbbVie’s ABBV-383, and nirogacestat + Regeneron’s REGN5458.
A poster entitled, "Synergistic effects of low-dose belantamab mafodotin in combination with a gamma-secretase inhibitor (nirogacestat) in patients with relapsed/refractory multiple myeloma (RRMM): DREAMM-5 study" will be presented in a poster discussion session at the 2022 ASCO (Free ASCO Whitepaper) Annual Meeting.
In April 2022, SpringWorks entered into a clinical trial collaboration and supply agreement with Regeneron Pharmaceuticals, Inc. to evaluate nirogacestat in combination with Regeneron’s investigational bispecific antibody targeting BCMA and CD3, REGN5458, in patients with relapsed or refractory multiple myeloma.
Biomarker-Defined Metastatic Solid Tumors

Enrollment is ongoing in a Phase 1b/2 trial evaluating mirdametinib with BeiGene’s RAF dimer inhibitor, lifirafenib, in adult patients with RAS/RAF mutant and other MAPK pathway aberrant solid tumors. Initial clinical data from the BeiGene-sponsored trial are expected to be presented at an upcoming SpringWorks-sponsored R&D Day.
Enrollment is ongoing in a Phase 1 trial of BGB-3245 in adult patients with RAF mutant solid tumors. BGB-3245 is a selective RAF dimer inhibitor being developed by MapKure, LLC, a joint venture between SpringWorks and BeiGene. Initial clinical data from the MapKure-sponsored trial are expected to be presented at an upcoming SpringWorks-sponsored R&D Day.
Enrollment is ongoing in a Phase 1b/2a platform study sponsored by Memorial Sloan Kettering Cancer Center evaluating mirdametinib both as a monotherapy and as a combination therapy in advanced solid tumors harboring selected MAPK-activating mutations.
Preclinical data from the TEAD inhibitor program were presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in April 2022. SpringWorks expects to nominate a drug candidate from the TEAD inhibitor portfolio in the second half of 2022.
First Quarter 2022 Financial Results

Research and Development (R&D) Expenses: R&D expenses were $34.1 million for the first quarter of 2022, compared to $17.4 million for the comparable period of 2021. The increase in R&D expense was primarily attributable to an increase in internal costs driven by the growth in employee costs associated with increases in the number of personnel, including an increase in stock-based compensation expense, and an increase in external costs related to drug manufacturing and trial costs.
General and Administrative (G&A) Expenses: G&A expenses were $27.4 million for the first quarter of 2022, compared to $12.4 million for the comparable period of 2021. The increase in G&A expense was primarily attributable to an increase in internal costs driven by the growth in employee costs associated with increases in the number of personnel, including an increase in stock-based compensation expense as we continued to expand our operations to support the organization, and an increase in professional fees, as we continue to build new capabilities, including commercial.
Net Loss Attributable to Common Stockholders: SpringWorks reported net loss of $61.8 million, or $1.26 per share, for the first quarter of 2022. This compares to a net loss of $29.8 million, or $0.62 per share, for the comparable period of 2021.
Cash Position: Cash, cash equivalents and marketable securities were $380.7 million as of March 31, 2022.
COVID-19 Update

To date, the COVID-19 pandemic has had a relatively modest impact on SpringWorks’ business operations, in particular on SpringWorks’ clinical trial programs, and SpringWorks is undertaking considerable efforts to mitigate the various challenges presented by this crisis. For further details and descriptions of the risks associated with the COVID-19 pandemic, please see the Risk Factors in SpringWorks’ periodic filings with the Securities and Exchange Commission and refer to the Forward-Looking Statements section in this press release.

On May 5, 2022 Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, reported that it will report its first quarter 2022 financial and operating results on Thursday, May 12, 2022, following the close of the U.S. financial markets (Press release, Lineage Cell Therapeutics, MAY 5, 2022, View Source [SID1234613681]). Lineage management will also host a conference call and webcast on Thursday, May 12, 2022, at 4:30 p.m. Eastern Time/1:30 p.m. Pacific Time to discuss its first quarter 2022 financial and operating results and to provide a business update.

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Interested parties may access the conference call by dialing (866) 888-8633 from the U.S. and Canada and (636) 812-6629 from elsewhere outside the U.S. and Canada and should request the "Lineage Cell Therapeutics Call". A live webcast of the conference call will be available online in the Investors section of Lineage’s website. A replay of the webcast will be available on Lineage’s website for 30 days and a telephone replay will be available through May 20, 2022, by dialing (855) 859-2056 from the U.S. and Canada and (404) 537-3406 from elsewhere outside the U.S. and Canada and entering conference ID number 1875641.

On May 5, 2022 SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant infections, reported it will host a conference call and live webcast at 8:30 a.m. ET on Thursday, May 12, 2022 to provide a corporate update and discuss the Company’s financial results for the first quarter ended March 31, 2022 (Press release, Scynexis, MAY 5, 2022, View Source [SID1234613697]).

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A live audio webcast can be accessed by visiting the Investor Relations section of the Company’s website, www.scynexis.com. A replay of the webcast will be archived on the SCYNEXIS website for 90 days following the event.

On May 5, 2022 Merrimack Pharmaceuticals, Inc. (Nasdaq: MACK) [("Merrimack" or the "Company")] reported its first quarter 2022 financial results for the period ended March 31, 2022 (Press release, Merrimack, MAY 5, 2022, View Source [SID1234613712]).

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"During the first quarter of 2022 we continued to see reductions in our operating expenses and were able to close the sale of an additional preclinical asset" said Gary Crocker, Chairman of Merrimack’s Board of Directors. "We continue to be focused on maintaining cash balances that will allow us to be in a position to receive milestone payments from Ipsen and Elevation if the programs that we have licensed to them continue to progress."

First Quarter 2022 Financial Results

Merrimack reported a net loss of $132 thousand for the first quarter ended March 31, 2022, or $0.01 per basic and diluted share on a fully diluted basis, compared to a net loss of $696 thousand, or $0.05 per basic and diluted share on a fully diluted basis, for the same period in 2021.

Merrimack reported a gain on the sale of assets for the first quarter ended March 31, 2022, of $445 thousand, attributable to the sale of certain of our preclinical programs, compared to $50 thousand for the same period in 2021.

General and administrative expenses for the first quarter ended March 31, 2022, were $577 thousand, compared to $746 thousand for the same period in 2021.

As of March 31, 2022, Merrimack had cash and cash equivalents and investments of $14.3 million, compared to $14.2 million as of December 31, 2021.

As of March 31, 2022, Merrimack had 13.4 million shares of common stock outstanding.

Updates on Programs Underlying Potential Milestone Payments

Ipsen

– On April 27, 2022, Ipsen released to the public an update on its sales performance for the first quarter of 2022. At the same time, Ipsen publicly indicated that a data readout from its ongoing Phase 3 trial of ONIVYDE as a treatment of second line small cell lung cancer would be provided in the second half of 2022. In addition, Ipsen reported that it is continuing to study ONIVYDE in Phase III clinical trials in first line pancreatic ductal adenocarcinoma, with a data readout expected in 2023.

Elevation Oncology

– On April 27, 2022 Elevation Oncology announced that initial data from its Phase 2 CRESTONE Study of Seribantumab has been selected for oral presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) on June 7, 2022.