On August 11, 2022 Mustang Bio, Inc. ("Mustang") (NASDAQ: MBIO), a clinical-stage biopharmaceutical company focused on translating today’s medical breakthroughs in cell and gene therapies into potential cures for hematologic cancers, solid tumors and rare genetic diseases, reported financial results and recent corporate highlights for the second quarter ended June 30, 2022 (Press release, Mustang Bio, AUG 11, 2022, View Source [SID1234618138]).

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Manuel Litchman, M.D., President and Chief Executive Officer of Mustang, said, "We are very pleased with the significant clinical and regulatory milestones achieved in the first half of 2022 for our portfolio of cell and gene therapies. Interim Phase 1/2 data on MB-106, our CD20-targeted, autologous CAR T cell therapy for patients with relapsed or refractory B-cell non-Hodgkin lymphomas ("B-NHLs") and chronic lymphocytic leukemia ("CLL"), were presented at several prestigious medical meetings. MB-106 continues to demonstrate high efficacy and a favorable safety profile across all patients with a wide range of hematologic malignancies including follicular lymphoma ("FL"), CLL, diffuse large B-cell lymphoma ("DLBCL") and Waldenstrom macroglobulinemia ("WM"), with no cytokine release syndrome or immune effector cell-associated neurotoxicity syndrome greater than grade 2. Additionally, the U.S. Food and Drug Administration ("FDA") granted Orphan Drug Designation to MB-106 for WM, a rare type of B-NHL. We are excited by the continued progress of MB-106 and anticipate dosing the first patient shortly in a multicenter Phase 1/2 clinical trial evaluating the safety and efficacy of MB-106 for relapsed or refractory B-NHL and CLL under Mustang’s Investigational New Drug application ("IND"). Furthermore, we expect to enroll 3 to 6 patients in this trial by the end of 2022 and to disclose data from both the single-center Fred Hutch trial and the multicenter Mustang trial in the fourth quarter of this year. We also continued to advance our recurrent glioblastoma ("rGBM") clinical program. Data presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) ("AACR") Annual Meeting 2022 support the safety of administering our two clinical candidates, MB-108 (Nationwide Children’s herpes simplex virus type 1 oncolytic virus) and MB‐101 (City of Hope’s IL13Rα2‐targeted CAR T cell therapy), sequentially to optimize treatment in a regimen designated as MB-109, for which we plan to file an IND in 2023."

"Mustang is pleased to be a leader in the development of gene therapy treatments for severe combined immunodeficiency ("SCID") patients. Interim Phase 1/2 data on treatment with the same lentiviral vector used in MB-107, our ex vivo lentiviral gene therapy for X-linked SCID ("XSCID") in newly diagnosed infants under the age of two, presented at the American Society of Gene & Cell Therapy ("ASGCT") 25th Annual Meeting showed all 23 treated patients were alive at 2.6-year median follow-up without evidence of malignant transformation, and the treatment established a stable, functioning immune system in patients. We also announced that the first patient successfully received LV-RAG1 ex vivo lentiviral gene therapy to treat recombinase-activating gene-1 ("RAG1") SCID ("RAG1-SCID"), in an ongoing Phase 1/2 multicenter clinical trial taking place in Europe. Mustang has exclusively licensed LV-RAG1 for the development of MB-110, a first-in-class ex vivo lentiviral gene therapy for RAG1-SCID. XSCID and RAG1-SCID make up almost 60% of all SCID cases combined. We look forward to the continued advancement of our SCID clinical program, including our anticipated initiation in 2023 under Mustang’s IND of multicenter pivotal Phase 2 trials for both MB-107 in newborn XSCID patients and MB-207 in previously transplanted XSCID patients."

Recent Corporate Highlights:

In April 2022, Mustang announced that interim Phase 1/2 clinical trial data on MB-106, a CD20-targeted, autologous CAR T cell therapy for patients with relapsed or refractory B-cell NHL and CLL, were presented at the 2022 Tandem Meetings I Transplantation & Cellular Therapy Meetings of the American Society of Transplantation and Cellular Therapy and Center for International Blood & Marrow Transplant Research. Data demonstrated high efficacy and a favorable safety profile in all patients (n=25). Five dose levels were used during the study, and CRs were observed at all dose levels. Durable responses were observed in a wide range of hematologic malignancies including FL, CLL, DLBCL, and WM. An overall response rate ("ORR") of 96% and a complete response rate ("CR") of 72% were observed in all patients across all dose levels. Within the next 60 days, Mustang expects to dose the first patient in a multicenter Phase 1/2 clinical trial evaluating the safety and efficacy of MB-106 for relapsed or refractory B-NHL and CLL, and further expects to enroll 3 to 6 patients in this trial by the end of 2022.
Also in April 2022, MB-106 data focused on CLL were presented at the 4th International Workshop on CAR-T and Immunotherapies.
Additionally, in April 2022, Mustang announced interim data from two ongoing investigator-sponsored Phase 1 clinical trials evaluating two clinical candidates, MB‐101 (IL13Rα2‐targeted CAR T cell therapy licensed from City of Hope) and MB-108 (herpes simplex virus type 1 oncolytic virus licensed from Nationwide Children’s Hospital) for the treatment of recurrent glioblastoma ("rGBM"). The data were from a late-breaking poster presented at the AACR (Free AACR Whitepaper) Annual Meeting 2022. Preclinical data also presented support the safety of administering these two therapies sequentially to optimize treatment in a regimen designated as MB-109. Mustang expects to file an IND in 2023 to initiate an MB-109 Phase 1 clinical trial.
In May 2022, interim Phase 1/2 data on treatment with the same lentiviral vector used in MB-107, Mustang’s lentiviral gene therapy for XSCID, also known as bubble boy disease, in newly diagnosed infants under the age of two, were presented in an oral presentation during the Clinical Trials Spotlight Symposium at the ASGCT (Free ASGCT Whitepaper) 25th Annual Meeting. The presentation included updated data from a multicenter Phase 1/2 clinical trial for XSCID in newly diagnosed infants under the age of two at St. Jude Children’s Research Hospital, UCSF Benioff Children’s Hospital in San Francisco and Seattle Children’s Hospital. All 23 treated patients were alive at 2.6-year median follow-up without evidence of malignant transformation.
In June 2022, MB-106 CD20-targeted autologous CAR T cell therapy data were presented in an oral session at the European Hematology Association (EHA) (Free EHA Whitepaper) 2022 Hybrid Congress. Mazyar Shadman, M.D., M.P.H., Associate Professor and physician at Fred Hutchinson Cancer Center and University of Washington presented updated interim data from the ongoing Phase 1/2 clinical trial for B-NHL and CLL. Data presented included a 94% ORR and 78% CR in 18 patients with FL. Overall, for the 26 patients treated on the trial, there was a 96% ORR and 73% CR, including complete responses in both DLBCL patients, both WM patients, and both patients previously treated with CD19-targeted CAR-T therapy (1 DLBCL patient and 1 FL patient).
Also in June 2022, the FDA granted Orphan Drug Designation to MB-106 CD20-targeted autologous CAR T cell therapy for the treatment of WM, a rare type of B-NHL.
In July 2022, Mustang announced that the first patient successfully received LV-RAG1 ex vivo lentiviral gene therapy to treat RAG1-SCID, in an ongoing Phase 1/2 multicenter clinical trial taking place in Europe. LV-RAG1 is exclusively licensed by Mustang for the development of MB-110, a first-in-class ex vivo lentiviral gene therapy for the treatment of RAG1-SCID.
In 2023, Mustang expects to enroll the first patient in a pivotal multicenter Phase 2 clinical trial under Mustang’s IND to evaluate MB-107, a lentiviral gene therapy for the treatment of infants under the age of two with XSCID.
Mustang filed an IND application in December 2021 for its pivotal multicenter Phase 2 clinical trial of MB-207, a lentiviral gene therapy for the treatment of patients with XSCID who have been previously treated with hematopoietic stem cell transplantation ("HSCT") and for whom re-treatment is indicated. The trial is currently on hold pending CMC clearance from the FDA and, based on feedback from the Agency, Mustang expects to enroll the first patient in a pivotal multicenter Phase 2 clinical trial in 2023.
Financial Results:

As of June 30, 2022, Mustang’s cash and cash equivalents and restricted cash totaled $108.4 million, compared to $123.2 million at March 31, 2022 and $110.6 million as of December 31, 2021, a decrease of $14.8 million for the quarter and a decrease of $2.2 million year-to-date.
Research and development expenses were $15.2 million for the second quarter of 2022, compared to $11.9 million for the second quarter of 2021. Non-cash, stock-based expenses included in research and development were $0.4 million for the second quarter of 2022, compared to $0.3 million for the second quarter of 2021.
General and administrative expenses were $3.1 million for the second quarter of 2022, compared to $2.5 million for the second quarter of 2021. Non-cash, stock-based expenses included in general and administrative expenses were $0.2 million for the second quarter of 2022, compared to $0.2 million for the second quarter of 2021.
Net loss attributable to common stockholders was $19.1 million, or $0.19 per share, for the second quarter of 2022, compared to a net loss attributable to common stockholders of $14.4 million, or $0.16 per share, for the second quarter of 2021.

On August 11, 2022 HTG Molecular Diagnostics, Inc. (Nasdaq: HTGM) (HTG), a life science company advancing precision medicine through its innovative transcriptome-wide profiling technology, reported recent business highlights and financial results for the quarter ended June 30, 2022 (Press release, HTG Molecular Diagnostics, AUG 11, 2022, View Source [SID1234618137]).

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Throughout the quarter ended June 30, 2022, the Company’s technology and strategic development efforts were highlighted in a number of customer and KOL presentations and publications including, but not limited to, the following:

A webinar titled "Integration of the HTG Transcriptome Panel into Preclinical and Clinical Programs to Drive Precision Medicine Research" featuring Pete Ansell, Ph.D., Scientific Director and Research Fellow, Precision Medicine Oncology at AbbVie, addressed how Dr. Ansell and his team at AbbVie have overcome many challenges they have previously faced using FFPE clinical samples by integrating the HTG Transcriptome Panel (HTP) into their biomarker strategies.

In a keynote presentation at the 7th Annual Markets and Markets Biomarker and Companion Diagnostics Conference in San Diego, CA, titled "Implementing Biomarker Strategy in Clinical Trials," Chetan Deshpande, Director, Biomarker Clinical Assay Lead, Global Product Development at Pfizer discussed the challenges that are generally faced in clinical trials and how Pfizer has leveraged HTG’s proprietary gene expression profiling HTG EdgeSeq technology in multiple clinical trials to overcome these challenges.

The first peer-reviewed journal article featuring our HTP was published by one of the participants in our Early Adopter Program in Frontiers in Medicine less than one year after the commercial release of the product.

The Company published a second white paper, further establishing the utility of its transcriptome-informed approach to drug design and discovery utilizing its proprietary HTG EdgeSeq technology.

A webinar addressing "Drug Candidate Attrition – How to Improve Clinical Development Success and Patent Outcomes," including a presentation from key opinion leader, Dr. Robert Spitale, PhD, University of California – Irvine, further outlined the potential uses of RNA-based platform technologies in drug discovery.
In July 2022, the Company entered into an amendment to its June 24, 2020 Loan and Security Agreement ("LSA") with its lender, Silicon Valley Bank. Under the terms of the amendment, Silicon Valley Bank agreed to waive the existing financial covenant through the remaining term of the LSA in exchange for a partial prepayment of outstanding principal. The remaining principal will continue to amortize through December 2023, the original maturity date of the term loan.

Second Quarter 2022 Financial Highlights:

Revenue for the quarter ended June 30, 2022 was $1.5 million, compared with $2.1 million for the same period in 2021, and was comprised entirely of product and product-related services revenue. Sales of the HTP to new and existing customers as consumables and sample processing services represented over 42% of revenue for the quarter ended June 30, 2022.

Net loss from operations for the quarter ended June 30, 2022 was $5.7 million, compared with $4.1 million for the same period in 2021. Net loss per share was $(0.54) for the quarter ended June 30, 2022 compared with $(0.39) for the second quarter of 2021.

Cash, cash equivalents and short-term available-for-sale securities totaled $14.1 million as of June 30, 2022, with current liabilities of approximately $10.2 million and non-current liabilities of $6.5 million.

Conference Call and Webcast:

HTG will host a conference call for the investment community today beginning at 4:30 p.m. Eastern Time.

On August 11, 2022 Applied DNA Sciences, Inc. (NASDAQ: APDN) ("Applied DNA" or the "Company"), a leader in PCR-based DNA technologies, reported consolidated financial results for the third quarter of fiscal 2022, ended June 30, 2022 (Press release, Applied DNA Sciences, AUG 11, 2022, View Source [SID1234618136]). The Company’s results are in line with preliminary selected quarterly results issued in the Company’s Form S-1/A filed on August 1, 2022.

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"We executed well in the fiscal third quarter, managing our financial results through COVID-19 testing seasonality inherent to our academia-heavy client base and the implementation of cost management initiatives to optimize our cost structure and reallocate resources towards our strategic growth pillars to drive long-term growth," stated Dr. James A. Hayward, president and CEO of Applied DNA. "Revenues increased substantially year-over-year driven by continued demand for fast, accurate detection of COVID-19 especially considering the high transmissibility of the new sub-variants. Fiscal management remained a key focus, resulting in a 15% sequential decline in total operating expenses and a halving of our average monthly cash burn rate since the beginning of this fiscal year. These organizational adjustments underscore our commitment to our LinearDNA platform’s value-creation potential and to sustainable long-term growth.

"Our performance during the quarter was notable also for the groundwork laid for multiple inflection points over the balance of the current fiscal year and as we look ahead to fiscal 2023," continued Dr. Hayward. "Notably, we ramped up the positioning of our LinearDNA platform as an alternative to plasmids (pDNA) to service the growing global demand for DNA for genetic medicines. We have determined that the platform’s near-term opportunity lies in its use as a replacement for pDNA in the manufacture of mRNA therapeutics. To that end, we recently presented for the first-time key data demonstrating the numerous advantages of using linearDNA to manufacture mRNA at an industry conference. The industry’s receptivity to linearDNA gives us confidence that we are at the right place and at the right time with a cell-free workflow for mRNA manufacture that is potentially more cost-effective and more scalable than pDNA and, in our view, even outpaces our competition in certain use cases. We are moving to cultivate linearDNA supply contracts across the mRNA production spectrum, from therapy developers to contract development and manufacturing organizations.

"At ADCL, we believe the recent receipt of a 12-month contract extension from the City University of New York (CUNY), our largest client for COVID-19 testing services, serves as a solid foundation for continued revenue. Having established ADCL’s workflow with high-throughput COVID-19 testing and with its access to the Company’s DNA expertise, ADCL can develop molecular diagnostics quickly and, we believe, profitably," continued Dr. Hayward. "Our ongoing development of a monkeypox virus test and pharmacogenomics (PGx) panel offers the excellent potential for uplift in ADCL’s profit margin upon commercialization. We are on track to submit the validation package for the monkeypox test in the coming weeks and anticipate the commercial launch of the PGx panel in early 2023, both contingent on the New York State Department of Health (NYSDOH) approval as Laboratory Developed Tests (LDTs). Armed with an approved LDT, ADCL can serve as a reference lab to hospital systems and larger clinical labs in New York State and clinical labs in many other States that accept clinical labs permitted under the NYSDOH Clinical Laboratory Evaluation Program.

"As for our supply chain integrity business, we believe the implementation of the Uyghur Forced Labor Prevention Act (UFLPA) on June 21 is driving the industry’s conversations around regulatory compliance towards our CertainT authentication platform following the Federal government’s recognition of isotopic testing and DNA traceability as evidence of compliance with the UFLPA. CertainT’s layered, technology-first, and forensic approach, we believe, makes it ideally suited to enable customers to withstand the rigor of a Customs and Border Protection inquiry of goods about to enter the U.S. marketplace that can also serve to secure brands’ supply chains and backstop their product claims. We have begun to onboard new CertainT clients for isotopic testing catalyzed by the UFLPA while concurrently pursuing sales opportunities both domestically and internationally catalyzed by the need to differentiate cottons and production from those under the UFLPA’s scrutiny."

Concluded Dr. Hayward, "Subsequent to the close of the quarter, we closed on an equity offering primarily to fund the further development of our LinearDNA platform and support the expansion of ADCL’s diagnostics offering through commercialization. We are focused on advancing the LinearDNA platform to serve as the common denominator for the next generation of DNA-based therapies – beyond mRNA to DNA vaccines and gene and cell therapies. We believe we are well positioned for future growth with a strengthened balance sheet supporting our pivot towards a growing biotherapeutics opportunity."

Third Quarter Fiscal 2022 Financial Highlights:

Revenues increased 153% for the third quarter of fiscal 2022 to $4.3 million, compared with $1.7 million reported in the same period of the prior fiscal year and decreased 30% from $6.1 million for the second quarter of fiscal 2022. The increase in revenues year-over-year was due primarily to an increase in clinical laboratory service revenues from the safeCircle COVID-19 testing platform of $3.1 million. This increase was offset by a decrease in product revenues of approximately $420 thousand due mainly to a decrease in sales of the Linea 1.0 COVID-19 Assay Kit and supplies.
Gross profit for the three months ended June 30, 2022, was $1.0 million, or 24%, compared with $584 thousand and 34% for the same period in the prior fiscal year. The decline in the gross profit percentage was the result of a significant portion of our clinical laboratory service revenues coming from the testing contracts where we also provide and staff the testing centers, as these contracts have higher costs associated with them as compared to our surveillance testing contracts.
Total operating expenses decreased to $3.9 million for the third quarter of fiscal 2022, compared with $4.0 million in the prior-year quarter and decreased from $4.5 million for the second quarter of fiscal 2022. The year-over-year decrease is primarily attributable to a decrease in research and development expenses of approximately $279 thousand, offset by an increase in selling, general and administrative expenses of approximately $130 thousand.
Net loss applicable to common stockholders for the third quarter of fiscal 2022, was $1.1 million, or $0.13 per share, compared with a net loss of $3.4 million, or $0.48 per share, for the prior-year quarter.
Excluding non-cash expenses, Adjusted EBITDA was negative $2.3 million and negative $2.8 million for the third quarters of fiscal 2022 and 2021, respectively. See below for information regarding non-GAAP measures.
Cash and cash equivalents stood at $4.7 million on June 30, 2022, compared with $6.6 million as of September 30, 2021. Cash and cash equivalents do not include the proceeds from a public offering that closed on August 8, 2022, which raised gross proceeds of $12 million and warrant exercises on August 8, 2022, totaling $3.6 million.
Third Quarter Fiscal 2022 Conference Call Information
The Company will hold a conference call and webcast to discuss its third quarter fiscal 2022 financial results today, Thursday, August 11, 2022, at 4:30 PM ET. To participate in the conference call, please follow the instructions below. While every attempt will be made to answer investors’ questions on the Q&A portion of the call, not all questions may be answered.

To Participate:

Telephonic replay (available 1 hour following the conclusion of the live call through August 18, 2022):

Participant Toll Free: 1-877-344-7529
Participant Toll: 1-412-317-0088
Participant Passcode: 7769802
Presentation slides will also be posted to the "News & Events" section of the Applied DNA website at View Source and embedded into the live webcast.

Information about Non-GAAP Financial Measures
As used herein, "GAAP" refers to accounting principles generally accepted in the United States of America. To supplement our condensed consolidated financial statements prepared and presented in accordance with GAAP, this earnings release includes Adjusted EBITDA, which is a non-GAAP financial measure as defined in Rule 101 of Regulation G promulgated by the Securities and Exchange Commission. Generally, a non-GAAP financial measure is a numerical measure of a company’s historical or future performance, financial position, or cash flows that either excludes or includes amounts that are not normally excluded or included in the most directly comparable measure calculated and presented in accordance with GAAP. The presentation of this non-GAAP financial information is not intended to be considered in isolation or as a substitute for, or superior to, the financial information presented in accordance with GAAP. We use this non-GAAP financial measure for internal financial and operational decision-making purposes and as a means to evaluate period-to-period comparisons of the performance and results of operations of our core business. Our management believes that these non-GAAP financial measures provide meaningful supplemental information regarding the performance of our business by excluding non-cash expenses that may not be indicative of our recurring operating results. We believe this non-GAAP financial measure is useful to investors as they allow for greater transparency with respect to key metrics used by management in its financial and operational decision making.

"EBITDA"- is defined as earnings (loss) before interest expense, income tax expense and depreciation and amortization expense.

"Adjusted EBITDA"- is defined as EBITDA adjusted to exclude (i) stock-based compensation and (ii) other non-cash expenses.

On August 11, 2022 Aprea Therapeutics, Inc. (Nasdaq: APRE), a biopharmaceutical company focused on developing and commercializing novel synthetic lethality-based cancer therapeutics targeting DNA damage response (DDR) pathways reported financial results for the three and six months ended June 30, 2022 and provided a business update (Press release, Aprea, AUG 11, 2022, View Source [SID1234618135]).

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"This is an exciting time for Aprea as we advance our ATR program into clinical development this year, continue to progress our WEE1 program toward IND submission and leverage our unique discovery platform capabilities to build for future success," said Oren Gilad, Ph.D., President and Chief Executive Officer of Aprea. "We believe our current cash resources will last through the end of 2023 and enable us to execute on our development plan to reach near term clinical milestones."

Second Quarter Financial Results

Cash and cash equivalents: As of June 30, 2022, the Company had $39.1 million of cash and cash equivalents compared to $53.1 million of cash and cash equivalents as of December 31, 2021. The Company believes its cash and cash equivalents as of June 30, 2022 will be sufficient to meet its current projected operating requirements through the end of 2023.
Research and Development (R&D) expenses: R&D expenses were $6.8 million for the quarter ended June 30, 2022, compared to $6.7 million for the comparable period in 2021. R&D expenses for the quarter ended June 30, 2022 primarily represented close out costs for (i) the Company’s pivotal Phase 3 clinical trial of eprenetapopt with azacitidine for the frontline treatment of TP53 mutant MDS, (ii) the Company’s Phase 2 post-transplant MDS/AML clinical trial, (iii) the Company’s Phase 1 AML trial, and (iv) the Company’s Phase 1/2 solid tumor trial and the Company’s Phase 1 dose-escalation trial of APR-548.
General and Administrative (G&A) expenses: G&A expenses were $15.6 million for the quarter ended June 30, 2022, compared to $3.3 million for the comparable period in 2021. The increase in G&A expenses was primarily due to an increase in non-cash stock-based compensation expense resulting from the acceleration of vesting of all outstanding stock options and restricted stock units in connection with the acquisition of Atrin in May 2022.
Acquired In-Process Research and Development (IPR&D) expenses: Acquired IPR&D expense was $76.0 million for the quarter ended June 30, 2022. Acquired IPR&D resulted from the Atrin Acquisition in May 2022 which was accounted for as an asset acquisition. The acquisition cost allocated to acquired IPR&D with no alternative future use was recorded as an expense as of the closing date.
Net loss: Net loss was $98.3 million, or $4.34 per share for the quarter ended June 30, 2022, compared to a net loss of $10.3 million, or $0.48 per share for the quarter ended June 30, 2021. The increase in net loss was primarily attributable to the acquired in process research and development of $76.0 million associated with the Atrin acquisition. The Company had 23,401,846 shares of common stock outstanding as of June 30, 2022.
Business Operations Update:

On May 16, 2022 the Company completed the acquisition of Atrin Pharmaceuticals, Inc. ("Atrin"), a privately held biotechnology company focused on the discovery and development of novel therapeutics targeting proteins in the DDR, pathway in oncology through synthetic lethality. Following the Company’s Annual Meeting of Stockholders on July 28, 2022, Christian S. Schade transitioned to the role of Executive Chairman of the Board of Directors and Oren Gilad, Ph.D., assumed the role of Chief Executive Officer.

DDR Programs

ATRN-119 – ATRN-119 is an orally-bioavailable, highly potent and selective macrocyclic small molecule inhibitor of ATR, a protein with key roles in response to DNA damage. ATRN-119 has received FDA IND approval for a first-in-human clinical trial for cancer patients and this trial is expected to begin in the third quarter of 2022.

ATRN-W1051 – ATRN-W1051 is an orally-bioavailable, highly potent and selective small molecule inhibitor of WEE1, a key regulator of multiple phases of the cell cycle. ATRN-W1051 is currently in preclinical development and we anticipate commencing IND-enabling studies in the second half of 2022.

p53 Reactivator Programs

Eprenetapopt – APR-246, or eprenetapopt, is a small molecule p53 reactivator that has been tested in clinical trials for solid tumors and for hematologic malignancies. A manuscript describing the results of a Phase 2 clinical trial of eprenetapopt with azacitidine after allogeneic stem-cell transplantation in TP53 mutant acute myeloid leukemia and myelodyspastic syndromes has recently been published online in the Journal of Clinical Oncology and a manuscript describing results of a Phase 1b clinical trial of eprenetapopt with pembrolizumab in advanced solid tumors has been accepted for publication in ESMO (Free ESMO Whitepaper) Open. We currently have no ongoing clinical trials of eprenetapopt.

APR-548 – APR-548 is a second generation p53 reactivator that is a unique analog of eprenetapopt. APR-548 exhibits high oral bioavailability in preclinical testing and is being developed in an oral dosage form. We initiated a Phase 1 clinical trial testing APR-548 in relapsed/refractory MDS and AML. Enrollment in the first dosing cohort was completed. There are currently no patients receiving APR-548 in this trial and enrollment into the trial has been closed.

On August 11, 2022 Erasca, Inc. (Nasdaq: ERAS), a clinical-stage precision oncology company singularly focused on discovering, developing, and commercializing therapies for patients with RAS/MAPK pathway-driven cancers, reported financial results for the fiscal quarter ended June 30, 2022, and provided business updates (Press release, Erasca, AUG 11, 2022, View Source [SID1234618134]).

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"We continued to advance our development-stage programs this quarter, while also establishing a strong clinical foundation for their future expansion. We also were excited to enter two new clinical partnerships that broaden the clinical potential of ERAS-007 and ERAS-601 and complement our ongoing HERKULES and FLAGSHP-1 trials, respectively," said Jonathan E. Lim, M.D., Erasca’s chairman, CEO, and co-founder. "These partnerships include a second clinical trial collaboration with Eli Lilly to explore cetuximab with our SHP2 inhibitor ERAS-601 in EGFR-driven cancers dependent on RAS/MAPK signaling and a partnership with Dr. Ryan Corcoran at Harvard Medical School and Dr. Scott Kopetz at MD Anderson Cancer Center to evaluate our ERK inhibitor ERAS-007 with a KRAS G12C inhibitor in KRAS G12C-driven non-small cell lung cancer (NSCLC) and colorectal cancer (CRC), which trial is being funded under a grant from Stand Up To Cancer (SU2C)."

Dr. Lim continued, "In the second half of the year, we look forward to providing clinical updates on ERAS-007 and ERAS-601 and expect to file an IND for our central nervous system (CNS)-penetrant KRAS G12C inhibitor ERAS-3490 in KRAS G12C mutant NSCLC. For ERAS-007 and ERAS-601, we expect to report preliminary monotherapy safety and pharmacokinetics data to help inform dose selection and administration for combination regimens, as well as preliminary monotherapy efficacy data for our two lead clinical candidates. With a strong balance sheet and focused therapeutic strategies, we remain on track to execute across our near-term catalysts in the second half of the year and our long-term mission to erase cancer."

Research and Development (R&D) Highlights

Presented Six Poster Presentations at the 2022 AACR (Free AACR Whitepaper) Annual Meeting: In April 2022, Erasca presented six poster presentations supporting the clinical development of programs with best-in-class potential, including ERK1/2 inhibitor ERAS-007, SHP2 inhibitor ERAS-601, and CNS-penetrant KRAS G12C inhibitor ERAS-3490, at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2022 annual meeting
Hosted a Key Opinion Leader (KOL) Investor Webinar on AACR (Free AACR Whitepaper) Data: In April 2022, Erasca hosted an investor webinar highlighting its 2022 AACR (Free AACR Whitepaper) presentations and featuring a presentation by KOL Scott Kopetz, M.D., Ph.D., of MD Anderson Cancer Center
Announced Clinical Trial for ERAS-007 and KRAS G12C Inhibitor Combination: In June 2022, Erasca announced a Phase 1b clinical proof-of-concept trial to evaluate the ERK1/2 inhibitor ERAS-007 in combination with a KRAS G12C inhibitor in KRAS G12C-driven NSCLC and CRC in partnership with Ryan Corcoran, M.D., Ph.D., at Harvard Medical School and Scott Kopetz, M.D., Ph.D., at MD Anderson Cancer Center, which trial is being funded under a grant from SU2C

Corporate Highlights

Expanded Board of Directors: In April 2022, Erasca increased the size of its board of directors (the Board) by one director and appointed Jean I. Liu, J.D., to the Board and the audit committee of the Board
Opened New Corporate Headquarters: In April 2022, Erasca opened its new corporate headquarters in San Diego, CA, to accommodate and unify its expanded employee base
Strengthened Clinical, Operational, and Commercial Leadership: In May 2022, Erasca appointed Shannon Morris, M.D., Ph.D., as senior vice president of clinical development, Amy Grekowicz Parker as vice president of clinical operations, and John Lo, Ph.D., as senior commercial advisor and member of Erasca’s newly expanded Research, Development, and Commercial Advisory Board. In August 2022, Erasca appointed Tim Grammer, Ph.D., as vice president of portfolio, program, and alliance management (PPAM). Dr. Grammer brings 20 years of project and program management, portfolio prioritization and planning, and alliance management experience in the life sciences. Most recently, as vice president of program management at Nektar Therapeutics, Dr. Grammer served as global program management lead for the bempegaldesleukin (NKTR-214) program for multiple solid tumors. He holds a Ph.D. in biochemistry from Harvard University, an M.S. in medicine from Harvard, an MBA from the Wharton School at the University of Pennsylvania, and a B.S. in biochemistry from the University of Illinois. He is a certified project management professional (PMP)
Entered into a Clinical Trial Collaboration and Supply Agreement (CTCSA) with Eli Lilly (Lilly): In July 2022, Erasca announced that it had entered into a CTCSA under which Lilly will supply its EGFR inhibitor cetuximab (ERBITUX) at no cost in connection with a clinical proof-of-concept trial evaluating ERAS-601, an oral SHP2 inhibitor, in various combinations including with cetuximab for the treatment of triple wildtype (KRAS/NRAS/BRAF wildtype) metastatic CRC and human papillomavirus (HPV)-negative advanced head and neck squamous cell carcinoma (HNSCC) as part of the ongoing Phase 1/1b FLAGSHP-1 trial. This CTCSA complements the CTCSA we previously entered into with Lilly and Pfizer, respectively, to evaluate cetuximab and encorafenib (BRAFTOVI) in combination with the ERK1/2 inhibitor ERAS-007 in the HERKULES-3 Phase 1b/2 trial
Key Upcoming Milestones

HERKULES-1: Phase 1b/2 trial for ERAS-007/MAPKlamp in patients with advanced solid tumors
Initial Phase 1b monotherapy data expected in the second half of 2022
HERKULES-3: Phase 1b/2 trial for ERAS-007 in patients with gastrointestinal (GI) malignancies
Initial Phase 1b combination data expected in the first half of 2023
FLAGSHP-1: Phase 1/1b trial for ERAS-601 in patients with advanced solid tumors
Initial Phase 1 monotherapy data expected in the second half of 2022
Initial Phase 1b combination data in triple wildtype (KRAS/NRAS/BRAF wildtype) CRC expected in the first half of 2023
HERKULES-2: Phase 1b/2 trial for ERAS-007 in patients with advanced NSCLC
Initial Phase 1b combination data expected in 2023
ERAS-3490: CNS-penetrant KRAS G12C inhibitor
IND filing expected in the second half of 2022

Second Quarter 2022 Financial Results

Cash Position: Cash, cash equivalents, and marketable securities were $390.8 million as of June 30, 2022, compared to $459.2 million as of December 31, 2021. Erasca expects its current cash, cash equivalents, and marketable securities balance to fund operations into the second half of 2024.

Research and Development Expenses: R&D expenses were $27.5 million for the quarter ended June 30, 2022, compared to $17.6 million for the quarter ended June 30, 2021. The increase was primarily driven by expenses incurred in connection with clinical trials, preclinical studies, discovery activities, personnel costs due to increased headcount to support increased development activities, and stock-based compensation. Erasca also recorded $0 and $5.5 million of in-process R&D expense during the quarters ended June 30, 2022 and 2021, respectively, related to the issuance of shares of its common stock issued in connection with the amendment to its license agreement with The Regents of the University of California, San Francisco.

General and Administrative (G&A) Expenses: G&A expenses were $8.4 million for the quarter ended June 30, 2022, compared to $5.1 million for the quarter ended June 30, 2021. The increase was primarily driven by personnel costs, insurance costs, and stock-based compensation.

Net Loss: Net loss was $35.6 million, or $(0.30) per basic and diluted share, for the quarter ended June 30, 2022, compared to $28.2 million, or $(1.20) per basic and diluted share, for the quarter ended June 30, 2021.