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 iBio, Inc. (NYSEA:IBIO) ("iBio" or the "Company"), a developer of next-generation biopharmaceuticals and pioneer of the sustainable, plant-based FastPharming Manufacturing System, reported that it will report its fiscal 2022 third quarter financial results after market close on Thursday, May 12, 2022 (Press release, iBioPharma, MAY 5, 2022, View Source [SID1234613664]). iBio management will host a webcast and conference call at 4:30 p.m. Eastern Time to discuss the results and provide a corporate update.

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The live and archived webcast may be accessed on the Company’s website at www.ibioinc.com under "News and Events" in the Investors section. The live call can be accessed by dialing (833) 672-0651 (domestic) or (929) 517-0227 (international) and referencing conference ID: 2392536.

On May 5, 2022 Aileron Therapeutics (Nasdaq: ALRN), a chemoprotection oncology company that aspires to make chemotherapy safer and thereby more effective to save more patients’ lives today, reported financial results and business highlights for the first quarter ended March 31, 2022 (Press release, Aileron Therapeutics, MAY 5, 2022, View Source [SID1234613663]).

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"Building on our positive proof-of-concept trial last year in patients with small cell lung cancer treated with topotecan, we view 2022 as a year of validation and execution for Aileron as we seek to bring selective chemoprotection to all patients with p53-mutated cancers regardless of the type of cancer or chemotherapy. Our ongoing NSCLC clinical trial and upcoming breast cancer clinical trial are designed to help us further understand ALRN-6924’s chemoprotective effect against chemotherapy-induced hematologic toxicities as well as other toxicities," said Manuel Aivado, M.D., Ph.D., President and Chief Executive Officer of Aileron. "We believe that evaluating ALRN-6924 across these two major cancer types treated with different chemotherapies that carry distinct toxicity profiles may provide us with an expanded regulatory opportunity based on established precedent for other supportive care drug approvals."

Nearly 1 million patients are diagnosed with a p53-mutated cancer in the US each year. Aileron is pioneering a precision medicine-based approach known as selective chemoprotection to exclusively treat patients with p53-mutated cancers receiving chemotherapy. ALRN-6924 is designed to selectively protect these patients’ healthy cells from chemotherapy without interfering with chemotherapy’s effects on cancer cells. Aileron’s vision is to bring chemoprotection to all patients with p53-mutated cancers regardless of the type of cancer or chemotherapy.

First Quarter 2022 Highlights and Recent Updates

On track to report interim results from ongoing randomized, double-blind, placebo-controlled Phase 1b clinical trial of ALRN-6924 in advanced p53-mutated NSCLC in June 2022. Aileron plans to enroll 60 patients with advanced p53-mutated NSCLC undergoing treatment with first-line carboplatin plus pemetrexed with or without immune checkpoint inhibitors. Patients are randomized 1:1 to receive carboplatin/pemetrexed plus 0.3 mg/kg ALRN-6924 or placebo for four 21-day treatment cycles.

The company anticipates reporting interim results on the first 20 patients enrolled in June 2022 and topline results on 60 patients in 4Q 2022. The interim readout will include an initial evaluation of the trial’s composite endpoint, composed of the proportion of treatment cycles free of severe toxicities, blood transfusions, and the use of growth factors, as well as dose reductions or dose delays, in patients treated with ALRN-6924 versus placebo.
Completed blinded safety evaluation of NSCLC clinical trial. In 1Q 2022, Aileron conducted a blinded safety evaluation of the first ten patients enrolled in the NSCLC clinical trial who completed the first cycle of treatment with ALRN-6924 and carboplatin plus pemetrexed. The evaluation did not identify any safety concerns, consistent with ALRN-6924’s previously demonstrated safety and tolerability profile.
On track to initiate Phase 1b randomized trial of ALRN-6924 in patients with p53-mutated ER+/HER2- neoadjuvant breast cancer in 2Q 2022. The planned breast cancer trial will evaluate ALRN-6924’s protection against chemotherapy-induced bone marrow toxicities, as well as other toxicities, including alopecia, in patients with p53-mutated ER+/HER2- breast cancer treated with a doxorubicin + cyclophosphamide and docetaxel chemotherapy regimen. The Phase 1b trial is anticipated to enroll up to 30 patients in a parallel group design trial with a dose expansion cohort.
Announced management team updates. In April 2022, Aileron announced the appointment of Christopher Zergebel as Vice President, Program Management and Clinical Operations. Mr. Zergebel previously served as Vice President, R&D Services at Taiho Oncology, Inc., overseeing clinical project management, clinical operations, data management, medical writing, and clinical supplies through all phases of clinical development and through regulatory approvals. Aileron also recently announced the pending departure of Richard Wanstall, Chief Financial Officer. Mr. Wanstall joined Aileron in July 2018 and has been instrumental in Aileron’s successful evolution to a chemoprotection oncology company and helped expand Aileron’s finance, operations, and human resources infrastructure. Prior to joining Aileron, Mr. Wanstall served for four years as Vice President, Finance at Moderna. Aileron has launched a formal search process to identify Mr. Wanstall’s successor.
Upcoming virtual investor event on Thursday, May 19th. Aileron’s management team, joined by guest speakers, will host an investor event to discuss ALRN-6924’s revolutionary potential as the first precision medicine-based supportive care drug, the landscape of chemotherapy-induced toxicities, and the company’s clinical trials and planned 2022 data readouts. To register, visit View Source
First Quarter 2022 Financial Results

Cash Position: Cash, cash equivalents, and investments on March 31, 2022, were $38.1 million, compared to $45.9 million on December 31, 2021. Based on its current operating plan, the company expects its existing cash, cash equivalents, and investments will fund operations into the fourth quarter of 2023.
Research and Development (R&D) Expenses: R&D expenses for the quarter ended March 31, 2022, were $5.9 million, compared to $4.3 million for the quarter ended March 31, 2021. The $1.6 million increase in R&D spending primarily resulted from $0.4 million of increased spending for clinical development of ALRN-6924 related to the Phase 1b clinical trial in patients with advanced p-53 mutated NSCLC and startup activities related to the Phase 1b randomized trial of ALRN-6924 in patients with p53-mutated ER+/HER2- neoadjuvant breast cancer, partially offset by lower spending for the ongoing Phase 1 trial in healthy human volunteers and the completion of the Phase 1b trial in small cell lung cancer in 2021. R&D expenses also increased in the first quarter of 2022 compared to the first quarter of 2021 resulting from increased ALRN-6924 manufacturing activities.
General and Administrative (G&A) Expenses: G&A expenses for the quarter ended March 31, 2022, were $2.5 million compared to $2.7 million for the quarter ended March 31, 2021. The decrease in general and administrative expenses was the result of lower professional services fees during the first quarter of 2022 as compared to the first quarter of 2021.
Net Loss: Net loss for the quarter ended March 31, 2022, was $8.4 million, compared to $7.0 million for the corresponding quarter in 2021. The basic and diluted net loss per share for the first quarter of 2022 was $0.09 compared to $0.08 for the first quarter of 2021.

On May 5, 2022 CytomX Therapeutics, Inc. (Nasdaq: CTMX), a leader in the field of conditionally activated oncology therapeutics, reported first quarter 2022 financial results and provided a business update (Press release, CytomX Therapeutics, MAY 5, 2022, View Source [SID1234613662]).

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"The CytomX team continued to execute across our portfolio during the first quarter of 2022, including significant progress with patient enrollment in our most advanced clinical studies. Initial data readouts for both Arms A and B for praluzatamab ravtansine and a data update for CX-2029 remain on track for the second half of this year. Beyond these important milestones, we are also advancing many new experimental therapeutics, including our conditionally activated version of interferon alpha-2b, which was detailed in a presentation at the recent American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. The breadth of our clinical and preclinical pipeline continues to demonstrate the multi-modality potential of our technology platform to deliver important new treatments for cancer," said Sean McCarthy, D.Phil., chief executive officer and chairman at CytomX Therapeutics.

First Quarter Business Highlights and Recent Developments

Praluzatamab ravtansine – Praluzatamab ravtansine is a CD166-directed conditionally activated antibody-drug conjugate (ADC) wholly-owned by CytomX. The three-arm Phase 2 study is evaluating praluzatamab ravtansine as monotherapy in patients with hormone receptor-positive, human epidermal growth factor receptor 2-non-amplified breast cancer (Arm A) and in patients with triple-negative breast cancer (TNBC, Arm B), and in combination with pacmilimab, our PD-L1 directed Probody therapeutic, in patients with TNBC (Arm C). Enrollment to Arm A is complete.
CX-2029 – CX-2029 is a CD71-directed conditionally activated ADC being co-developed by CytomX and AbbVie. In addition to head and neck squamous cell carcinoma, the Phase 2 expansion study has now also completed patient enrollment in the squamous non-small cell lung cancer cohort. The study remained open for enrollment in the esophageal and gastro-esophageal junction cancers cohort, and the diffuse large B-cell lymphoma cohort.
CX-904 – CX-904 is a conditionally activated T-cell-engaging bispecific antibody targeting the epidermal growth factor receptor (EGFR) on tumor cells and the CD3 receptor on T cells, and is partnered with Amgen. The investigational new drug application for a first-in-human Phase 1 study of CX-904 in patients with advanced solid tumors was allowed to proceed by the U.S. Food and Drug Administration and study start-up activities were initiated.
Ipilimumab Probody Program – BMS-986249 and BMS-986288 are Probody versions of the anti-CTLA4 antibody, ipilimumab and non-fucosylated ipilimumab, respectively. BMS-986249 is currently being evaluated by CytomX’s collaboration partner, Bristol Myers Squibb, in a randomized Phase 2 study in combination with nivolumab, the anti-PD-1 antibody, versus ipilimumab plus nivolumab in patients newly diagnosed with advanced melanoma. This novel combination is also being studied in advanced hepatocellular carcinoma, castration-resistant prostate cancer, and TNBC. Bristol Myers Squibb also continued to evaluate BMS-986288, as monotherapy and in combination with nivolumab, in a Phase 1 study in advanced solid tumors.
Preclinical Programs – CytomX continued to work on broadening the potential application of its multi-modality Probody platform to other product candidates, including a broad initiative towards enhancing the therapeutic window of cytokines. At the 2022 AACR (Free AACR Whitepaper) Annual Meeting, CytomX presented encouraging preclinical data that highlighted a conditionally activated interferon alpha-2b therapeutic candidate as a promising addition to current immunotherapy regimens, potentially expanding benefit to patients with typically unresponsive tumors.
Priorities for 2022

Continue enrolling patients with TNBC in Arms B and C in the Phase 2 study of praluzatamab ravtansine and report initial data from Arms A and B in the second half of 2022
Continue advancing the expansion phase of the Phase 2 study of CX-2029 in collaboration with our partner AbbVie and provide a data update in the second half of 2022
Advance the Phase 1 study of CX-904 in solid tumors
First Quarter 2022 Financial Results
Cash, cash equivalents and investments totaled $263 million as of March 31, 2022, compared to $305 million as of December 31, 2021.

Total revenue was $17.1 million for the three months ended March 31, 2022 compared to $16.0 million for the corresponding period in 2021. The increase in total revenue was largely related to the CD71 collaboration with AbbVie.

Research and development expenses increased by $8.2 million during the three months ended March 31, 2022 to $30.6 million compared to $22.4 million for the first quarter of 2021. The increase was primarily driven by contract and service expenses in manufacturing and development activities in support of our pre-clinical and clinical portfolio.

General and administrative expenses increased by $1.3 million during the first quarter of 2022 to $10.5 million compared to $9.2 million in the same period in 2021. The increase was mainly in personnel and professional expenses.

Conference Call & Webcast Information
CytomX management will host a conference call and a simultaneous webcast today at 5:00 p.m. ET (2:00 p.m. PT) to discuss the financial results and provide a business update. To join the conference call, please dial (877) 809-6037 (domestic) or (615) 247-0221 (international) and reference the conference ID 5241057. A live webcast of the call can be accessed on the Events and Presentations page of CytomX’s website at View Source An archived replay of the webcast will be available on the Company’s website until May 12, 2022.

On May 5, 2022 Idera Pharmaceuticals, Inc. ("Idera," the "Company," "we," "us," or "our") (Nasdaq: IDRA) reported its financial and operational results for the first quarter ended March 31, 2022 (Press release, Idera Pharmaceuticals, MAY 5, 2022, View Source [SID1234613661]).

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"We continue to preserve cash while actively pursuing new development or commercial-stage assets for Idera’s portfolio," stated Vincent Milano, Idera’s Chief Executive Officer. "We also continue to work with JMP Securities, a Citizens Company, our current partner and advisor on business development activities, to explore additional strategic alternatives for the Company."

First Quarter Financial Results
Our cash position as of March 31, 2022 was $28.0 million. Based on our current operating plan, we anticipate that our current cash and cash equivalents will fund our operations through the one-year period subsequent to the May 5, 2022 filing date of the Quarterly Report Form 10-Q.

Research and development expenses for the three months ended March 31, 2022 totaled $1.8 million, compared to $6.9 million for the same period in 2021. General and administrative expense for the three months ended March 31, 2022 totaled $2.4 million, compared to $3.2 million for the same period in 2021.

Additionally, during the three months ended March 31, 2021, we recorded $7.0 million and $118.8 million non-cash warrant revaluation gain and non-cash future tranche right revaluation gain, respectively, related to the change in fair value of securities issued in connection with our December 2019 private placement transaction. No such non-cash gains were recognized in the three months ended March 31, 2022, as the warrants and future tranche rights were terminated in the first quarter of 2021.

As a result of the factors above, net loss applicable to common stockholders for the three months ended March 31, 2022 was $4.2 million or $0.08 per basic and diluted share compared to net income applicable to common stockholders of $109.6 million or $2.66 per basic share for 2021. On a diluted basis, net loss applicable to common stockholders for the three months ended March 31, 2021 was $10.0 million or $0.14 per diluted share.

Excluding the non-cash gain of approximately $125.8 million for the three months ended March 31, 2021 related to the termination of securities issued in connection with the December 2019 private placement transaction, net loss applicable to common stockholders was $10.0 million, or $0.24 per basic and diluted share (calculated based upon the basic weighted-average number of common shares, due to the antidilutive effect of net loss).