On May 9, 2023 Poseida Therapeutics, Inc. (Nasdaq: PSTX), a clinical-stage cell and gene therapy company advancing a new class of treatments for patients with cancer and rare diseases, reported updates and financial results for the first quarter ended March 31, 2023 (Press release, Poseida Therapeutics, MAY 9, 2023, View Source [SID1234631288]).

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"In the first quarter, we continued to advance our clinical and research stage efforts as well as enhanced our leadership with the recent appointment of Kristin Yarema, Ph.D., as President, Cell Therapy," said Mark Gergen, Chief Executive Officer of the Company. "In our allogeneic CAR-T portfolio, we are actively enrolling patients in the Phase 1 studies for P-MUC1C-ALLO1 and P-BCMA-ALLO1 and remain on track for an IND for P-CD19CD20-ALLO1 mid-year. These initial allogeneic clinical programs are designed to evaluate many aspects of our unique high-TSCM allogeneic platform including dosing strategies, pre-conditioning regimens, potential biomarkers and many other factors. In our gene therapy portfolio, we are in discussions with Takeda about our collaboration following the news that they have made some strategic decisions in their research priorities and will update when appropriate. In the meantime, we remain excited about the strong progress made on all gene therapy programs and look forward to giving six preclinical presentations at the American Society of Gene and Cell Therapy annual meeting next week."

Program Updates

CAR-T Programs

In cell therapy, the Company is focused on three allogeneic CAR-T programs with two programs currently progressing in Phase 1 clinical trials and one expected IND during the year:

MUC1-C Program

P-MUC1C-ALLO1 is an allogeneic CAR-T product candidate targeting solid tumors derived from epithelial cells, including breast and ovarian cancers. The Company is currently evaluating P-MUC1C-ALLO1 in a Phase 1 clinical trial and presented early clinical data in December 2022 at the European Society for Medical Oncology Immuno-Oncology 2022 Annual Congress (ESMO I-O) in Geneva, Switzerland. The Company currently expects to present further clinical updates for the program at a medical meeting in 2023.

BCMA Program

P-BCMA-ALLO1 is an allogeneic CAR-T product candidate being developed to target relapsed/refractory multiple myeloma (R/R MM) in partnership with Roche. The Company is currently evaluating P-BCMA-ALLO1 in a Phase 1 clinical trial and shared early clinical data from the

program at ESMO (Free ESMO Whitepaper) I-O in December 2022. The Company currently expects to present further clinical updates for the program at a medical meeting in 2023, subject to clearance with Roche.

CD19CD20 Program

P-CD19CD20-ALLO1 is a preclinical allogeneic CAR-T product being developed to target B-cell malignancies in partnership with Roche. P-CD19CD20-ALLO1 is the Company’s first dual CAR program and contains two fully functional CAR molecules to target cells that express either CD19 or CD20. The Company believes that by targeting both CD19 and CD20, there is potential to overcome potential antigen escape that has been observed by others. The Company expects to file an IND for P-CD19CD20-ALLO1 in mid-2023.

Gene Therapy Programs

The Company is advancing multiple preclinical gene therapy programs in liver-directed diseases:

OTC Program

P-OTC-101 is an in vivo program for the treatment of urea cycle disease caused by congenital mutations in the ornithine transcarbamylase (OTC) gene. The Company is developing the P-OTC-101 program utilizing a hybrid delivery system and working on an updated timeline for the program. The Company presented data at its R&D Day in February 2023, highlighting continued advancements in preclinical models leading towards a potential functional cure of OTC Deficiency.

FVIII Program

The Company is advancing its P-FVIII-101 preclinical program partnered with Takeda, which is in development for the in vivo treatment of Hemophilia A. P-FVIII-101 utilizes piggyBac gene modification delivered via lipid nanoparticle that has demonstrated stable and sustained Factor VIII expression in animal models. The Company is presenting preclinical data from this program at the upcoming American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) 26th Annual Meeting being held in Los Angeles on May 16-20, 2023.

PAH Program

Announced at the Company’s R&D Day in February 2023, P-PAH-101 is a liver-directed gene therapy partnered with Takeda to treat Phenylketonuria (PKU), an inherited genetic disorder caused by mutations in the phenylalanine hydroxylase (PAH) gene resulting in buildup of phenylalanine in the body. If left untreated, PKU can affect a person’s cognitive development. P-PAH-101 utilizes piggyBac technology combined with its hybrid adeno-associated virus (AAV) and nanoparticle delivery system. The Company’s preclinical data has demonstrated the potential to resolve phenylalanine to normal levels following a single treatment in juvenile and adult mice. P-PAH-101 is currently in preclinical development.

Leadership Updates

Kristin Yarema, Ph.D., Appointed President, Cell Therapy

In April 2023, the Company announced the appointment of Kristin Yarema, Ph.D., as President, Cell Therapy, to lead the Company’s drug development programs in cell therapy, including its collaboration with Roche. She joined the Company after most recently serving as Chief Commercial Officer at Atara Biotherapeutics, where she led the commercialization of EBVALLO, which became the world’s first marketed allogeneic T cell therapy after receiving regulatory approval in Europe for the treatment of a rare lymphoma. Prior to Atara, she held a series of U.S. and global commercial leadership roles at Amgen and Novartis in hematology-oncology among other therapeutic areas.

Rafael G. Amado, M.D., Appointed to Board of Directors

In April 2023, Rafael G. Amado, M.D., was appointed to the Company’s Board of Directors. Dr. Amado is currently President, Head of Global Oncology Research and Development at Zai Lab, a public biopharmaceutical company. Prior to Zai Lab, Dr. Amado served as Executive Vice President, Head of Research and Development and Chief Medical Officer from September 2019 to December 2022 at Allogene Therapeutics, Inc. and President of Research and Development from August 2018 to August 2019 and Chief Medical Officer from March 2015 to August 2018 at Adaptimmune, LLC.

Financial Results for the First Quarter 2023

"We continue to be disciplined on spend and evaluate plans and options to help us further manage our cash burn rate," said Johanna Mylet, Chief Financial Officer at Poseida. "We have been operating at the low end of our guided cash utilization range and our current base plan should allow us to preserve our runway into at least mid-2024, and possibly further depending on other decisions, including business development opportunities."

Revenues

Revenues were $10.3 million for the first quarter ended March 31, 2023, compared to $1.4 million for the same period in 2022. The increase of revenues was primarily due to revenues earned from the collaboration and license agreement with Roche, which became effective in the third quarter of 2022.

Research and Development Expenses

Research and development expenses were $38.1 million for the first quarter ended March 31, 2023, compared to $48.9 million for the same period in 2022. The decrease was primarily driven by the wind-down of the Company’s clinical development activities associated with our autologous programs and related contract termination expense in the prior year and the transition of manufacturing to the Company’s internal pilot plant for P-BCMA-ALLO1, partially offset by increases in the number of ongoing clinical trials, including enrollment and manufacturing for the P-MUC1C-ALLO1 and P-BCMA-ALLO1 Phase 1 clinical trials, and increases related to the Company’s preclinical stage programs due to an increase in research collaboration activity and personnel and facilities expenses as a result of increased headcount.

General and Administrative Expenses

General and administrative expenses for the first quarter ended March 31, 2023 were $11.8 million compared to $9.5 million for the same period in 2022. The increase was primarily related to an increase in stock-based compensation expense due to a one-time modification associated with the retirement of the Company’s former Executive Chairman.

Net Loss

Net loss was $38.8 million for the first quarter ended March 31, 2023, compared to $58.1 million for the same period of 2022.

Cash Position

As of March 31, 2023, the Company’s cash, cash equivalents and short-term investments balance was $247.2 million. The Company expects that its cash, cash equivalents and short-term investments together with the remaining near-term milestones and other payments from Roche will continue to be sufficient to fund operations into at least mid-2024.

On May 9, 2023 Pliant Therapeutics, Inc. (Nasdaq: PLRX), a clinical stage biotechnology company focused on discovering and developing novel therapeutics for the treatment of fibrosis, reported a corporate update and announced first quarter 2023 financial results (Press release, Pliant Therapeutics, MAY 9, 2023, View Source [SID1234631287]).

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"So far in 2023 we have made significant progress in advancing the portfolio including positive 12- and 24-week data readouts from our INTEGRIS-IPF trial and a successful follow-on offering that extended our expected operating runway into the second half of 2026," said Bernard Coulie, M.D., Ph.D., President and Chief Executive Officer of Pliant Therapeutics. "With clinical data and development milestones expected throughout the remainder of 2023, including Phase 2a data from INTEGRIS-PSC and initiation of our BEACON-IPF Phase 2b and our oncology Phase 1 trials, we look forward to building upon an already productive year."

First Quarter and Recent Highlights

Bexotegrast (PLN-74809) Highlights

•INTEGRIS-IPF Phase 2a 24-week 320 mg clinical data showed bexotegrast was well tolerated and demonstrated durable improvements in exploratory endpoints. This 24-week Phase 2a data from the 320 dose group showed bexotegrast was well tolerated up to 40 weeks, displayed a favorable pharmacokinetic profile and in exploratory efficacy endpoints showed improvements in forced vital capacity (FVC), Quantitative Lung Fibrosis (QLF) imaging, patient reported cough severity and biomarkers in patients with idiopathic pulmonary fibrosis (IPF) to Week 24. In January, 12-week data from the 320 mg dose group showed bexotegrast demonstrated statistically significant FVC increases at all time points, was well tolerated with no drug-related severe or serious adverse events and showed dose-proportional increases in plasma concentrations, consistent with prior dose groups.
•Initiation of BEACON-IPF, a Phase 2b trial of bexotegrast in patients with IPF, expected in mid-2023. BEACON-IPF is a 52-week, multinational, randomized, placebo-controlled trial evaluating bexotegrast at doses of 160 mg or 320 mg in approximately 270 patients with IPF.
•INTEGRIS-PSC Phase 2a 12-week clinical data expected in the third quarter of 2023. INTEGRIS-PSC is a 12-week randomized, dose-ranging, double-blind, placebo-controlled trial evaluating safety, tolerability and pharmacokinetics of bexotegrast at doses of 40, 80 or 160 mg in approximately 84 patients with primary sclerosing cholangitis (PSC). Exploratory efficacy endpoints include fibrosis biomarkers such as PRO-C3 and enhanced liver fibrosis (ELF) score, changes in alkaline phosphatase (ALP), and liver imaging. INTEGRIS-PSC is fully enrolled.
•First patient dosed in the INTEGRIS-PSC Phase 2a 320 mg dose cohort, evaluating bexotegrast for at least 24 weeks. This cohort is evaluating the safety, tolerability and pharmacokinetics of bexotegrast at a dose of 320 mg versus placebo over at least 24 weeks of treatment in approximately 28 patients with PSC. The trial is also evaluating exploratory efficacy endpoints including fibrosis biomarkers such as PRO-C3 and ELF score, changes in ALP and liver imaging.

Early-Stage Development Programs

•Initiation of a Phase 1 first-in-human trial of PLN-101095 in oncology expected in the second quarter of 2023. PLN-101095 is an oral, small molecule, dual selective inhibitor of αvβ8 and αvβ1 integrins designed to block TGF-β activation in the tumor microenvironment. Initiation of a Phase 1 trial in patients with solid tumors that are resistant to immune checkpoint inhibitors is expected in the second quarter of 2023.
•Muscular dystrophy program progressing through IND enabling activities. PLN-101325 is a monoclonal antibody designed to act as an allosteric agonist of the integrin α7β1. An IND submission for Duchenne muscular dystrophy (DMD) is expected in 2023.

Corporate Highlights

•Closing of underwritten public offering of $287.5 million in common stock. The Company closed a public offering in January 2023, yielding $269.9 million in net proceeds to the Company, which included the underwriter’s exercise in full of their option to purchase additional shares.

First Quarter 2023 Financial Results

•Research and development expenses were $29.3 million, as compared to $20.9 million for the prior-year quarter. The increase was due primarily to employee related expenses and increased clinical and manufacturing related costs associated with our lead program, bexotegrast, partially offset by a decrease in preclinical manufacturing costs for our pipeline product candidates.
•General and administrative expenses were $14.2 million, as compared to $8.6 million for the prior-year quarter. The increase was due to higher personnel-related and professional services expenses.
•Net loss of $37.5 million as compared to $28.1 million for the prior-year quarter due to an increase in operating expenses coupled with a slight decrease in collaboration revenues under the Novartis collaboration during the quarter.
•As of March 31, 2023, the Company had cash, cash equivalents and short-term investments of $577.3 million, which the Company expects to be sufficient to fund operations into the second half of 2026.

On May 9, 2023 Omeros Corporation (Nasdaq: OMER), a clinical-stage biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market and orphan indications targeting immunologic disorders including complement-mediated diseases, cancers, and addictive and compulsive disorders, reported recent highlights and developments as well as financial results for the first quarter ended March 31, 2023, which include (Press release, Omeros, MAY 9, 2023, View Source [SID1234631286]):

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● Net loss was $33.7 million in the first quarter of 2023, or $0.54 per share, compared to a net loss in the first quarter of 2022 of $33.0 million, or $0.53 per share; our first quarter’s net loss from continuing operations was $39.7 million compared to $39.5 million in the first quarter of 2022, and $0.63 per share for both periods. Cash burn for the first quarter of 2023 was $23.6 million, exclusive of a $200 million milestone payment received in the quarter, a decrease from $26.0 million in the prior quarter.

● In February 2023 we received from Rayner Surgical, Inc. ("Rayner") the $200 million milestone payment due under the Asset Purchase Agreement by which we sold our former ophthalmology product OMIDRIA to Rayner in late 2021. The payment became due upon the achievement of the milestone event in December 2022 and was recorded as a receivable in the fourth quarter of 2022.

● For the quarter ended March 31, 2023, we earned OMIDRIA royalties of $9.2 million on Rayner’s U.S. net sales of $30.7 million. This compares to earned royalties of $13.8 million during the first quarter of the prior year on U.S. net sales of $27.7 million. The above-referenced milestone event triggered a reduction of our U.S. base royalty rate from 50 percent to 30 percent.

● At March 31, 2023, we had $371.4 million of cash, cash equivalents and short-term investments available. In addition, we had $10.0 million of accounts receivable.

● We intend to resubmit our Biologics License Application ("BLA") for narsoplimab in hematopoietic stem cell transplant-associated thrombotic microangiopathy ("TA-TMA") and, consistent with direction from FDA’s Office of New Drugs, have submitted to FDA a proposed plan for assessment of both response rate and survival based on already existing clinical trial data and external data. A meeting with the review division is scheduled for this month to discuss the details of our proposed analyses and to confirm the information required by FDA to support resubmission of the BLA for narsoplimab’s approval.

● In April 2023, we announced positive results from a pre-specified interim analysis of our ongoing Phase 1b clinical trial of OMS906 in treatment-naïve adults with paroxysmal nocturnal hemoglobinuria ("PNH"), and updated interim results are provided later in this release.

● In April 2023, we were awarded a three-year $6.69 million grant from the National Institute on Drug Abuse ("NIDA"), part of the National Institutes of Health, to develop the lead orally administered PDE7 inhibitor compound in our OMS527 program for the treatment of cocaine use disorder ("CUD").

"We are pleased with our progress during the first quarter as our team continues to deliver on important milestones," said Gregory A. Demopulos, M.D., Omeros’ chairman and chief executive officer. "For our MASP-2 inhibitor narsoplimab, we are meeting with FDA this month to discuss our proposed analysis plan and confirm the specifics to be included in a BLA

resubmission for TA-TMA, and our Phase 3 IgA nephropathy trial remains on track for data read-out next quarter. Our long-acting MASP-2 inhibitor is set to begin enrolling its multiple-ascending-dose clinical trial this summer in the U.S. Enrollment is marching ahead in our OMS906 clinical program. The results to date in treatment-naïve PNH patients are impressive, making clear that our MASP-3 inhibitor OMS906 blocks alternative pathway activation and should be effective across AP-related diseases while potentially offering significant safety, efficacy and compliance advantages over other AP-targeting drugs. Now collaborating with and having received a $6.69 million award from NIDA, we are moving forward to assess our PDE7 inhibitor OMS527 in patients with cocaine use disorder. Our immuno-oncology franchise is also rapidly progressing across both our cellular and biologic platforms. Helping to fund the ongoing achievements of these and our other programs is the non-dilutive $200 million milestone payment received in February, forecast to extend our cash runway into 2025. This year has started well for Omeros, and we expect that momentum to continue."

First Quarter and Recent Clinical Developments

● Recent developments regarding narsoplimab, our lead monoclonal antibody targeting mannan-binding lectin-associated serine protease-2 ("MASP-2") in advanced clinical programs for the treatment of TA-TMA and immunoglobulin A ("IgA") nephropathy, include:

o We are preparing to meet with FDA’s Division of Nonmalignant Hematology later this month to confirm the information required by FDA to support resubmission of the BLA for narsoplimab’s approval in TA-TMA. Consistent with direction from FDA’s Office of New Drugs, provided as part of its denial of our appeal of the complete response letter previously issued by FDA, we have proposed a plan to assess already existing clinical trial data and external data on both response rate and survival.

o In our Phase 3 ARTEMIS-IGAN trial evaluating narsoplimab for the treatment of IgA nephropathy, we remain on track to read out 9-month data on the proteinuria endpoint next quarter.

o Narsoplimab is the focus of two recent peer-reviewed publications. One, in Thrombosis Journal, describes a 6-year-old girl with TA-TMA following stem cell transplantation for severe aplastic anemia who had failed treatment with defibrotide. Treated with narsoplimab under compassionate use, her TMA resolved. A recurrence of TMA triggered by parvovirus again was successfully treated with narsoplimab. A second manuscript authored by investigators at Weill Cornell Medicine is in press at Clinical and Experimental Immunology. The manuscript reports a high correlation between elevation of a biomarker of endothelial injury and TA-TMA. Using plasma samples from patients in the narsoplimab pivotal trial, the study also showed that, in those trial patients classified as "responders," narsoplimab restored biomarker levels to those of stem-cell transplant patients without TMA while biomarker levels in narsoplimab "non-responders" remained high.

o The 49th annual meeting of the European Society for Blood and Marrow Transplantation (EBMT), which recently concluded in Paris, featured three presentations regarding narsoplimab in TA-TMA. The first described the design of our ongoing multi-center Phase 2 study evaluating the efficacy and safety of narsoplimab in high-risk pediatric patients with TA-TMA. The second was a case report of a patient treated with narsoplimab under our compassionate use program. The patient had worsening TA-TMA following withdrawal of calcineurin inhibitors, which resolved following narsoplimab treatment. The third was a report of five cases of high-risk pediatric TA-TMA. Three of five failed treatment with the C5 inhibitor eculizumab. Two of these three patients also failed treatment with defibrotide and were then treated with narsoplimab, provided under compassionate use. Following narsoplimab treatment, TA-TMA resolved.

o At the annual meeting of the American Society of Pediatric Hematology/Oncology, being held this week in Fort Worth, Texas, clinical investigators will present the course of a 3-year-old girl with relapsed high-risk neuroblastoma who developed refractory TA-TMA following a second stem cell transplant. After failing treatment with each of eculizumab and defibrotide, the patient’s TA-TMA resolved following treatment with narsoplimab.

o A case report on narsoplimab treatment of a patient with recurrent IgA nephropathy was featured at the recent annual meeting of the Korean Society of Nephrology. Treatment with narsoplimab stabilized both proteinuria and estimated glomerular filtration rate ("eGFR"). Kidney biopsy results confirmed the beneficial effects of narsoplimab in this patient. This was the first report of complement inhibitor treatment of a patient with recurrent IgA nephropathy.

o A manuscript authored by a group of international experts detailing the role of the lectin pathway in the pathophysiology of IgA nephropathy, including glomerular injury, thrombotic microangiopathy, and tubulointerstitial fibrosis, was recently accepted for publication in Kidney International.

● Recent developments regarding OMS1029, our long-acting, next-generation MASP-2 inhibitor, include:

o In April 2023, we announced results from a pre-specified interim analysis of our ongoing Phase 1b clinical trial of OMS906 in treatment-naïve adults with PNH. Updated data from this open label trial continue to show statistically significant and clinically meaningful improvements in all measured markers of hemolysis, including hemoglobin ("Hgb") and lactate dehydrogenase ("LDH"). Despite all patients having received only the lowest of doses planned for the trial, data compare very favorably to those publicly available for marketed and in-development alternative pathway inhibitors. Enrollment is ongoing. Updated data are provided below ("n", or the number of patients, at each time point ranges from 3 to 9 depending on each patient’s respective date of enrollment):

Hemoglobin

• Mean baseline Hgb is 6.78 g/dL (normal: 12.0–15.6 g/dL for women, 13.5–17.2 g/dL for men)
• Mean absolute increase in Hgb is 3.4 g/dL at Day 29, 6.3 g/dL at Day 85, and 9.7 g/dL at Day 113
• After only 1 dose (by Day 29), Hgb increased ≥ 2 g/dL in 67% of patients
• After only 2 doses (by Day 57), Hgb increased ≥ 2g/dL in 100% and by ≥ 4 g/dL in 80% of patients
• By Day 85, 67% of patients had Hgb ≥ 12 g/dL; by Day 113, 100% of patients had Hgb ≥ 15.7 g/dL
• Mean reduction in absolute reticulocyte counts from baseline were ≥ 70,000/µL (range 70,000 – 136,000/µL) at all time points
• No patients have had a clinical breakthrough or thrombotic event, and none have required a transfusion while receiving OMS906

LDH

• Mean baseline LDH is 1931 U/L (~8-fold higher than the upper limit of normal)
• Mean reduction in LDH is 83% at Day 15, 80% at Day 29, and 87% at Day 113
• At Day 113, LDH for all patients is normal or < 1.5 times normal

Both Hgb and LDH improvements are statistically significant at all time points in the trial; OMS906 has been well tolerated and there have been no safety signals of concern.

o Based on PK/PD data from a successful Phase 1 single-ascending-dose study of OMS906 in healthy subjects and the interim data from our Phase 1b clinical trial in treatment-naïve PNH patients, we are planning a dosing frequency of once quarterly, either intravenously or subcutaneously.

o We are also enrolling a Phase 1b clinical trial evaluating OMS906 in PNH patients who have had an unsatisfactory response to the C5 inhibitor ravulizumab. This study has a "switch-over" design and enrolls PNH patients receiving ravulizumab, adds OMS906 to provide combination therapy with ravulizumab for 24 weeks, and then provides OMS906 monotherapy in patients who demonstrate a hemoglobin response with combination therapy. Patient treatment with OMS906 is underway.

o A Phase 1b clinical program evaluating OMS906 in patients with complement 3 glomerulopathy ("C3G") is also ongoing.

o Additional updates on data from our three OMS906 trials in progress are planned for the second half of this year.

o The Annual Meeting of the European Hematology Association (EHA) (Free EHA Whitepaper) to be held this June in Frankfurt, Germany, will feature a presentation on the study design of our two ongoing clinical trials of OMS906 in patients with PNH, along with results from our single-ascending-dose Phase 1 study evaluating both intravenous and subcutaneous administration of OMS906 in healthy subjects.

● Recent developments regarding OMS527, our phosphodiesterase 7 ("PDE7") inhibitor program focused on addiction and movement disorders, include:

o In April 2023, we were awarded a grant from the National Institute on Drug Abuse, part of the National Institutes of Health to develop our lead orally administered PDE7 inhibitor compound for the treatment of cocaine use disorder ("CUD"). The grant – $6.69 million over three years – is intended to support a preclinical cocaine interaction study and a randomized, placebo-controlled, inpatient clinical study evaluating the safety and effectiveness of OMS527 in patients with CUD. A Phase 1 clinical trial of the study drug in healthy subjects was successfully completed.

o OMS527 is also being evaluated by investigators at Emory University as a potential treatment for levodopa-induced dyskinesias ("LID"), which are crippling, involuntary movements reportedly affecting 50 percent or more of levodopa-treated patients with Parkinson’s disease. LID is caused by prolonged treatment with levodopa, the most prescribed treatment for the over 10 million patients with Parkinson’s disease worldwide. Data on OMS527 in LID will be publicly disclosed following the filing of appropriate patent applications.
Financial Results

Net loss for the first quarter of 2023 was $33.7 million, or $0.54 per share. This compares to a net loss in the first quarter of 2022 of $33.0 million, or $0.53 per share. Net loss from continuing operations for the first quarter of 2023 was $39.7 million compared to $39.5 million in the first quarter of 2022, and $0.63 per share for both periods. Cash burn for the first quarter of 2023 was $23.6 million, exclusive of the $200 million milestone payment from Rayner, compared to $26.0 million in the fourth quarter of 2022.

During the first quarter of 2023, we earned royalties of $9.2 million on $30.7 million of Rayner’s U.S. net sales of OMIDRIA. This compares to earned royalties of $13.8 million during the first quarter of the prior year on U.S. net sales of $27.7 million. These royalties were recorded as a reduction of the OMIDRIA contract royalty asset. Omeros received a $200 million milestone payment from Rayner in the first quarter of 2023 in connection with the Asset Purchase Agreement under which Rayner purchased our OMIDRIA business. The achievement of the milestone event in late December 2022 triggered a reduction of our U.S. base royalty rate from 50 percent to 30 percent.

Total costs and expenses for the first quarter of 2023 were $35.7 million compared to $35.0 million for the first quarter of 2022.

Interest expense during the first quarter of 2023 was $7.9 million compared to $4.9 million during the first quarter of 2022. The increase was due to interest on our OMIDRIA contract royalty obligation associated with the sale of a portion of our OMIDRIA royalty receivables, which we entered into during the third quarter of 2022.

During the first quarter of 2023, we earned $4.0 million in interest and other income compared to $0.5 million in the prior year quarter. The increase was due to higher average balances available to invest and higher market interest rates in the current year quarter.

Net income from discontinued operations, net of tax was $6.0 million, or $0.09 per share, in the first quarter of 2023 compared to $6.5 million, or $0.10 per share, in the first quarter of 2022.

As of March 31, 2023, we had $371.4 million of cash and short-term investments, all of which are held in our name, available for operations and debt service. In addition, we had $10.0 million in accounts receivable. Our cash provided by operations during the first quarter of 2023 was $174.5 million and included the $200.0 million collection of the Rayner milestone payment.

Conference Call Details

To access the live conference call via phone, please dial (800) 715-9871 from the United States and Canada or (646) 307-1963 internationally and ask to be placed into the Omeros earnings call. Please dial in approximately 10 minutes prior to the start of the call. A telephone replay will be available for one week following the call and may be accessed by dialing (800) 770-2030 from the United States or Canada or (609) 800-9909 internationally. The replay access code is 8266699.

For online access to the live or subsequently archived webcast of the conference call, go to Omeros’ website at View Source

On May 9, 2023 Olema Pharmaceuticals, Inc. ("Olema", "Olema Oncology", Nasdaq: OLMA), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of targeted therapies for women’s cancers, reported financial results for the first quarter ended March 31, 2023, and provided a corporate update (Press release, Olema Oncology, MAY 9, 2023, View Source [SID1234631285]).

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"We are on track for the initiation of our first pivotal Phase 3 clinical trial in the second half of this year," said Sean P. Bohen, M.D., Ph.D., President and Chief Executive Officer of Olema Oncology. "Our ongoing Phase 2 studies continue to generate data in support of our underlying thesis that OP-1250 has the potential to become a best-in-class complete estrogen receptor antagonist and improve upon the current standard of care in the treatment of ER+/HER2- metastatic breast cancer. We look forward to presenting our next clinical update at the 2023 ESMO (Free ESMO Whitepaper) Breast Cancer Annual Congress in mid-May, and we believe we are well-positioned to achieve our goal to significantly improve endocrine therapy for women living with breast cancer."

Anticipated Upcoming Milestones

● Present interim Phase 2 clinical study results of OP-1250 in combination with CDK4/6 inhibitor (palbociclib) at the 2023 ESMO (Free ESMO Whitepaper) Breast Cancer Annual Congress in Berlin, Germany, in a poster presentation on May 12, 2023.
● Present trials-in-progress clinical study overview of OP-1250 in combination with ribociclib or alpelisib in a poster presentation at the 2023 ASCO (Free ASCO Whitepaper) Annual Meeting, June 2-6, 2023, in Chicago, IL.
● Initiate a pivotal Phase 3 monotherapy clinical trial in the second- and third-line setting of ER+/HER2- advanced or metastatic breast cancer in the second half of 2023.
● Present Phase 2 monotherapy clinical study results in the second half of 2023.
● Present Phase 1b clinical study results of OP-1250 in combination with CDK4/6 inhibitor (ribociclib) in the second half of 2023.

First Quarter 2023 Financial Results

Cash, cash equivalents and marketable securities as of March 31, 2023, were $186.0 million. Olema anticipates that this balance will be sufficient to fund operations into 2025.

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Net loss for the quarter ended March 31, 2023, was $28.3 million, as compared to $23.0 million for same period of the prior year. The increase in net loss related primarily to Olema’s continued investment in OP-1250, increased spending on research and development (R&D) activities, and personnel-related costs, including a one-time restructuring charge of $2.8 million. The increase in R&D spending was partially offset by a decrease in general and administrative (G&A) costs.

GAAP R&D expenses were $22.8 million for the quarter ended March 31, 2023, as compared to $16.0 million for the quarter ended March 31, 2022. The increase in R&D expenses was primarily related to increases in advancing ongoing clinical studies of OP-1250 and associated manufacturing costs, nonclinical research and discovery program activities, and personnel-related expenses, including a one-time restructuring charge of $1.8 million.

Non-GAAP R&D expenses were $19.7 million for the quarter ended March 31, 2023, excluding $3.1 million non-cash stock-based compensation expense. Non-GAAP R&D expenses were $12.9 million for the quarter ended March 31, 2022, respectively, excluding $3.1 million non-cash stock-based compensation expense, respectively. A reconciliation of GAAP to non-GAAP financial measures used in this press release can be found at the end of this press release.

GAAP G&A expenses were $6.8 million for the quarter ended March 31, 2023, as compared to $7.2 million for the quarter ended March 31, 2022. The decrease in G&A expenses was primarily due to lower corporate costs, and personnel-related expenses, including non-cash stock-based compensation expense. The decrease in spending was partially offset by a one-time restructuring charge of $1.0 million.

Non-GAAP G&A expenses were $5.2 million for the quarter ended March 31, 2023, excluding $1.5 million non-cash stock-based compensation expense. 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. A reconciliation of GAAP to non-GAAP financial measures used in this press release can be found at the end of this press release.

On May 9, 2023 Nusano, Inc., a company reshaping the production of cancer-fighting radioisotopes, reported it will participate in a fireside chat at the 2nd Annual Guggenheim Securities Radiopharmaceuticals Day in New York City on Monday, May 15, 2023 (Press release, Nusano, MAY 9, 2023, View Source [SID1234631284]).

Schedule your 30 min Free 1stOncology Demo!
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                  Schedule Your 30 min Free Demo!

WHAT: Guggenheim Securities Fireside Chat
WHO: Chris Lowe, CEO, Nusano
Howard Lewin, COO and Co-Founder, Nusano
WHEN:
May 15, 2023
3:55 – 4:20 p.m. EST
WHERE: New York, NY

Lowe and Lewin will discuss how Nusano’s proprietary ion source and production platform are poised to supply desperately needed medical radioisotopes to support patient care and accelerate cancer therapeutics.