On May 10, 2023 Sonnet BioTherapeutics Holdings, Inc. (NASDAQ:SONN) ("Sonnet" or the "Company"), a biopharmaceutical company developing innovative targeted biologic drugs, reported its financial results for the three months and six months ended March 31, 2023 and provided a business update (Press release, Sonnet BioTherapeutics, MAY 10, 2023, View Source [SID1234631400]).

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"We believe this quarter marked another noteworthy period of execution for Sonnet, where we made important progress with our pipeline, entered into a product development collaboration with Roche, and furthered our cost-cutting plan to extend our cash runway into the 2024 calendar year," said Pankaj Mohan, Ph.D., Sonnet Founder and Chief Executive Officer. "We remain incredibly enthusiastic about the best-in-class potential of our proprietary IL-12 therapeutic candidate, SON-1010, where our recent presentation at the 2023 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting supported the consistency of the compound’s data and reiterated the robustness of its overall profile. Additionally, we are very excited about the non-human primate data that we have generated with SON-1210, our proprietary bifunctional version of human Interleukins 12 (IL-12) and 15 (IL-15), that we believe will help propel the compound into clinical development. We are looking forward to continuing this forward momentum over the balance of 2023."

FY 2023 Second Quarter and Recent Corporate Updates

Sonnet provided the following corporate updates:

● On January 9, 2023, announced a collaboration agreement with Roche for the clinical evaluation of SON-1010 with atezolizumab. The companies have entered into a Master Clinical Trial and Supply Agreement (MCSA), along with ancillary Quality and Safety Agreements, to study the safety and efficacy of the combination of SON-1010 and atezolizumab in a platinum-resistant ovarian cancer (PROC) patient setting. Further, the companies will provide SON-1010 and atezolizumab, respectively, for use in the Phase 1b/Phase 2a combination safety, dose-escalation, and efficacy study (SB221). The SB221 study has been formally submitted for final approval in Australia and preparations are on track to initiate the study during the second calendar quarter of 2023.

● On January 19, 2023, announced that the interim pharmacokinetic (PK) profile simulation of SON-1010 dosing had been completed in the randomized, placebo-controlled Phase 1 clinical trial (SB102) of healthy volunteers. Study SB102 is a single-ascending dose trial that was initiated in July 2022, to address the safety, PK, and PD of SON-1010 in subjects without interference from prior chemotherapy. Data from the first 24 of a total of 31 patients enrolled have been presented to date, most recently at the 2023 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. As an update, the 5th dose cohort was removed, as enough data have now been collected to support the dosing strategy in the cancer trials moving forward. Typical dose-related increases were seen with SON-1010, drug levels peaked at about 11 hours with a geometric mean maximum concentration (Cmax) of 29, 68, and 125 pg/mL for the 50, 100, and 150 ng/kg dose groups, respectively. The mean elimination half-life (t½) after a 150 ng/kg dose of SON-1010 was 112 hours, compared to the published value of 12 hours for rhIL-12. Observed increases in interferon gamma (IFNγ) were most pronounced and were dose-related, controlled, and prolonged. SON-1010 induced IFNγ in all active-drug subjects, which peaked at 24 to 48 hours then returned to baseline after 2 weeks. Low amounts of IL-10 were induced in a dose-dependent manner, which could also be due to the increase in IFNγ. There were small transient increases in IL-6, IL-8, and TNFα after dosing but no consistent pattern was seen with IL-1β, IL-2, or IL-4 and there was no evidence of cytokine release syndrome (CRS). Safety was consistent with what has been reported previously; adverse events have generally been mild/moderate, transient in nature, and have all been tolerable.

● On February 1, 2023, announced the successful completion of two IND-enabling toxicology studies with SON-1210 in non-human primates. SON-1210 is a proprietary, bispecific version of human Interleukins 12 (IL-12) and 15 (IL-15), configured using Sonnet’s Fully Human Albumin Binding (FHAB) platform. The first of two studies, a non-GLP toxicology study, was designed to elucidate the maximum tolerated dose (MTD) of SON-1210 in a dose-escalation format in four cohorts of NHPs. The second study was a GLP repeat-dose toxicology study that employed three dose levels of SON-1210 or a vehicle control, each dosed three times every two weeks. There were no SON-1210-related increases in toxicity, including liver enzymes, in the GLP study apart from the expected, and mild, on-target changes in hematology and clinical chemistry parameters that resolved completely within 14 to 21 days post-dosing. A significant increase in IFNγ, which was transient in nature, was noted as early as one day following administration, with no apparent increase in other proinflammatory cytokines. Sonnet remains on track to initiate the regulatory authorization process for SON-1210 in the first half of calendar 2023.

● On February 8, 2023, announced the pricing of an underwritten public offering of 13,888,888 shares of common stock or common stock equivalents (which includes pre-funded warrants to purchase shares of common stock in lieu of shares of common stock) and investor warrants to purchase up to an aggregate of 27,777,776 shares of common stock. Each share of common stock (or pre-funded warrant in lieu thereof) were sold together with one investor warrant to purchase two shares of common stock at a combined offering price of $1.08, for total gross proceeds of $15.0 million, before underwriting discounts and commissions and offering expenses payable by Sonnet. The investor warrants have an exercise price of $1.08 per share, are exercisable for a period of five years and contain an alternative cashless exercise provision whereby, subject to certain conditions, a warrant may be exercised in a cashless transaction for shares of common stock at the rate of half a share of common stock per full share otherwise issuable upon a cash exercise.

● On April 18, 2023, presented additional data from the SB101 study of SON-1010 at the 2023 AACR (Free AACR Whitepaper) Annual Meeting. SB101 is a single-ascending dose (SAD) trial in adult patients with advanced solid tumors that commenced in the second quarter of 2022 and is currently enrolling the final dose cohort. Of the 15 patients from the first five cohorts of SB101 evaluable for follow-up at this latest cutoff, 9 had stable disease at the first follow-up scan, 4 of which were already progressing at study entry. At the four-month follow-up, 5 of 14 patients remained stable at the second scan, suggesting clinical benefit of SON-1010 in 36% of patients. As an example, the very first patient dosed, with an aggressive endometrial sarcoma, had target tumor shrinkage with complete resolution of ascites at one point and has been clinically stable for nearly a year. SON-1010 has been safe and tolerable at all doses tested to date. Adverse events have generally been mild/moderate and transient in nature, with no study discontinuations for safety reasons. In addition, adverse effects have been less numerous and less intense with subsequent doses. The geomean half-life (t½) of SON-1010 was 113 hours in SB101 and 122 hours in SB102, compared to the published value of 12 hours for recombinant IL-12 observed in prior studies. Comparison of the PK curves between the two studies suggests that SON-1010 may be targeting tumors, as it was designed to do. Cytokine analysis following each dose revealed controlled and prolonged induction of IFNγ that peaked at 24 to 48 hours and returned to baseline after 2 to 4 weeks. A small increase in IL-10 was observed with each dose as expected in response to IFNγ. There was either a minimal or no signal for IL-1β, IL-6, IL-8, and TNFα and no indication of any potential for cytokine release syndrome (CRS) at these doses.

● Sonnet has initiated an ex-U.S. Phase 1b/2a study with SON-080 in CIPN. This study is on track to yield initial clinical safety data during the first half of calendar 2023. Pursuant to a license agreement the Company entered with New Life Therapeutics Pte, Ltd. ("New Life") of Singapore in May 2021, Sonnet and New Life will be jointly responsible for developing SON-080 in DPN. The objective will be to evaluate the data and potentially initiate a Phase 2 study in the second half of calendar 2023, once the CIPN safety data has been evaluated.
● Preclinical development continues for SON-1410 (IL18-FHAB-IL12), Sonnet’s proprietary bispecific combination of Interleukins 18 (IL-18) and 12 (IL-12), with early experimental drug supply suitable for formulation and analytical method development activities, in addition to small quantities for use in early development proof-of-concept in vitro studies. Process development activities will continue through 2023, with the potential to generate a drug suitable for initial in vivo mouse studies by the end of the 2023 calendar year.
● As part of the ongoing cost-cutting evaluations, all antiviral development with SON-1010 has been suspended.

"After initiating human studies just over a year ago, the clinical development program is moving forward rapidly on several fronts with four active trials being conducted in collaboration with two external partners," said Richard Kenney, M.D., Sonnet Chief Medical Officer. "We are very pleased with the team’s progress to date and are on track to meet our projected targets. The dose of SON-1010 was escalated safely in both cancer patients in SB101 and in healthy volunteers in SB102. Comparison of the data from the two trials shows intriguing pharmacokinetic profiles that suggest direct targeting of tumor tissue, as we presented at AACR (Free AACR Whitepaper) last month. The combination of SON-1010 with atezolizumab in SB221 has the potential to induce a synergistic response in platinum-resistant ovarian cancer, and we are excited about the potential added benefit that SON-1010 can bring to these patients with this significant unmet medical need. While the SB211 trial with SON-080 in patients with chemotherapy-induced peripheral neuropathy is still blinded, no serious adverse events have been reported to date."

FY 2023 Second Quarter Ended March 31, 2023 Financial Results

● As of March 31, 2023, Sonnet had $11.4 million cash on hand and no debt. On February 10, 2023, the company closed a public offering for gross proceeds of $15.0 million (net proceeds of $13.6 million), issuing 11,664,888 shares of common stock, pre-funded warrants to purchase 2,224,000 shares of common stock, with an exercise of $0.0001 per share, and common warrants to purchase 27,777,776 shares of common stock, with an exercise price of $1.08 per share.
● Research and development expenses were $3.8 million for the three months ended March 31, 2023, compared to $6.4 million for the three months ended March 31, 2022. The decrease of $2.6 million was primarily due to the establishment of cost savings by transitioning product development activities to cost advantaged locations such as India and Australia and by reducing expenditures on tertiary programs such as SON-3015, which has been placed on a development hold, as well as a decrease in share-based compensation expense.

● General and administrative expenses were $1.9 million for each of the three months ended March 31, 2023 and 2022. There was no significant change in general and administrative expense as we are managing expenses for liquidity purposes.

"Following the successful completion of a $15.0 million financing in February and the cost-cutting objectives that we previewed during the first fiscal quarter of 2023, we have implemented constructive measures to extend our cash runway. These are important initiatives that we have undertaken to deliver on our stated objective of advancing our drug development pipeline, which has progressed considerably over the last 18 months" said Jay Cross, CFO.

On May 10, 2023 Precigen, Inc. (Nasdaq: PGEN), a biopharmaceutical company specializing in the development of innovative gene and cell therapies to improve the lives of patients, reported first quarter 2023 financial results and business updates (Press release, Precigen, MAY 10, 2023, View Source [SID1234631399]).

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"Precigen continues to execute on our strategy to maintain corporate strength while advancing our most promising programs. This quarter, we successfully closed a public offering and more recently announced that Precigen has regained rights to two validated targets (CD19 and BCMA) that will further bolster our already robust UltraCAR-T portfolio and provides an opportunity to advance potential best-in-class UltraCAR-T drug candidates. We continue to advance our vision to transform the personalized cell therapy landscape using Precigen’s library approach to build the most comprehensive clinical and preclinical CAR-T portfolios with antigen-specific targets spanning both hematological and solid tumors where there is high unmet medical need for cancer patients, including CD33, MUC16, ROR1, CD19, BCMA and MSLN," said Helen Sabzevari, PhD, President and CEO of Precigen. "We are pleased with the progress of our programs so far this year. We successfully dosed the first patient with PRGN-3007 and showcased preclinical data for our MSLN next generation UltraCAR-T at the 2023 AACR (Free AACR Whitepaper) annual meeting. We also presented positive Phase 1 data for our PRGN-2012 AdenoVerse immunotherapy in RRP at our R&D day and completed enrollment in the Phase 2 study. Finally, we look forward to sharing additional data at the 2023 ASCO (Free ASCO Whitepaper) annual meeting for our PRGN-3005 UltraCAR-T and PRGN-2009 AdenoVerse immunotherapy."

"We remain focused on strengthening our financial footing while containing costs to support our business objectives," said Harry Thomasian Jr., CFO of Precigen. "Our program of financial discipline, combined with a public offering and early retirement of most of our debt, has provided a solid cash runway to support priorities into late 2024."

Program Highlights

Exclusive Rights to UltraCAR-T Targets, CD19 and BCMA, and IL-12 Gene Therapy

· The Company amended its exclusive license agreement with Alaunos Therapeutics to bolster its portfolio and broaden strategic opportunities.
· The Company regained exclusive rights to CD19 and B-cell maturation antigen (BCMA) targets to enable unencumbered development and commercialization of two validated targets utilizing the UltraCAR-T platform.

· The Company also regained exclusive rights to its interleukin (IL)-12 gene therapy, including application through the off-the-shelf AdenoVerse immunotherapy platform, paving the way for potential future treatments in oncology given the important role of IL-12 cytokines in targeting many types of tumors such as human papillomavirus (HPV)-associated cancers.

PRGN-2012 AdenoVerse Immunotherapy in RRP

· PRGN-2012 is an investigational off-the-shelf (OTS) AdenoVerse immunotherapy designed to elicit immune responses directed against cells infected with HPV 6 or HPV 11 for the treatment of RRP. The US Food and Drug Administration (FDA) granted orphan drug designation for PRGN-2012 for patients with recurrent respiratory papillomatosis (RRP).
· The Company announced positive Phase 1 dose escalation and expansion cohort data (N=15) in January 2023 at its R&D Day virtual event.
· The Company completed enrollment in the Phase 2 portion of the study (N=23) bringing the total number of enrolled patients to 35 at Dose Level 2. Patient follow up is ongoing.
· The Company plans to outline the regulatory strategy as FDA discussions advance.

PRGN 2009 AdenoVerse Immunotherapy in HPV-associated Cancers

· PRGN-2009 is an OTS investigational immunotherapy utilizing the AdenoVerse platform designed to activate the immune system to recognize and target HPV-positive (HPV+) solid tumors.
· The Company completed enrollment in the Phase 1 monotherapy (N=6) and combination therapy (N=11) arms in patients with recurrent or metastatic HPV-associated cancers. An abstract for the clinical data of the PRGN-2009 Phase 1 study (Abstract # 2628) titled, "Phase I evaluation of PRGN-2009 alone and in combination with bintrafusp alfa in patients (pts) with recurrent/metastatic (R/M) HPV-associated cancers (HPV-C)" has been selected for presentation at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting on June 3, 2023 from 8:00 to 11:00 AM CT.
· Enrollment was completed in the Phase 2 monotherapy arm with 20 evaluable patients in newly diagnosed oropharyngeal squamous cell carcinoma (OPSCC) patients. An interim clinical data presentation from the Phase 2 monotherapy arm is expected in the second half of 2023.

PRGN-3006 UltraCAR-T in AML

· PRGN-3006 is an investigational multigenic, autologous chimeric antigen receptor T cell (CAR-T) therapy engineered to simultaneously express a CAR specifically targeting CD33, membrane bound IL-15 (mbIL15), and a kill switch. The FDA granted orphan drug designation and fast track designation for PRGN-3006 UltraCAR-T for patients with relapsed or refractory (r/r) acute myeloid leukemia (AML).
· The Company completed the Phase 1 dose escalation study and announced positive data at the 64th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition. Subsequently, the Company initiated a multicenter Phase 1b dose expansion study of PRGN-3006. The Company received FDA clearance to incorporate repeat dosing in the Phase 1b trial. A Phase 1b clinical data presentation is expected in 2024.

PRGN-3005 UltraCAR-T in Ovarian Cancer

· PRGN-3005 UltraCAR-T is an investigational multigenic, autologous CAR-T cell therapy engineered to express a CAR specifically targeting the unshed portion of MUC16, mbIL15, and a kill switch.
· The Company completed enrollment in the Phase 1 dose escalation cohorts of the intraperitoneal (IP) and intravenous (IV) arms without lymphodepletion as well as in the lymphodepletion cohort in the IV arm. An abstract for the clinical data of the PRGN-3005 Phase 1 dose escalation study (Abstract # 5590) titled, "Phase 1/1b study of PRGN-3005 autologous UltraCAR-T cells manufactured overnight for infusion next day to advanced stage platinum resistant ovarian cancer patients" has been selected for presentation at the 2023 ASCO (Free ASCO Whitepaper) Annual Meeting on June 5, 2023 from 1:15 to 4:15 PM CT.
· The Company initiated a Phase 1b dose expansion trial of PRGN-3005. The Company received FDA clearance to incorporate repeat dosing in the Phase 1b study. A Phase 1b clinical data presentation is expected in 2024.

PRGN-3007 UltraCAR-T in Advanced ROR1+ Hematological and Solid Tumors

· PRGN-3007, based on the next generation of the UltraCAR-T platform, is an investigational multigenic, autologous CAR-T cell therapy engineered to express a CAR targeting receptor tyrosine kinase-like orphan receptor 1 (ROR1), mbIL15, a kill switch, and a novel mechanism for the intrinsic blockade of PD-1 gene expression.
· The Company announced dosing of the first patient in the Phase 1/1b dose escalation/dose expansion study of PRGN-3007 in advanced ROR1-positive (ROR1+) hematological and solid tumors. The target patient population for the Phase 1/1b study includes hematological cancers (chronic lymphocytic leukemia (CLL), mantle cell lymphoma (MCL), acute lymphoblastic leukemia (ALL), and diffuse large B-cell lymphoma (DLBCL)) and solid tumors (triple negative breast cancer (TNBC)).

Next Generation UltraCAR-T Platform

· The Company showcased advances in the UltraCAR-T platform with a preclinical data presentation for the next generation UltraCAR-T platform utilizing mesothelin (MSLN) CAR from Precigen’s library of non-viral plasmids at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2023. Enhancement of efficacy due to incorporation of a novel mechanism for PD-1 blockade in MSLN UltraCAR-T in preclinical models was presented in the abstract titled, "Next Generation UltraCAR-T Cells with Intrinsic Checkpoint Inhibition and Overnight Manufacturing Overcome Suppressive Tumor Microenvironment Leading to Sustained Antitumor Activity."

Financial Highlights

· In January 2023, the Company completed an underwritten public offering of approximately 44 million shares of common stock, including a partial exercise of the underwriters’ option to purchase additional shares, at a price to the public of $1.75 per share, which resulted in net proceeds to the Company of $72.8 million (after deducting underwriting discounts, fees and other expenses).
· During the three months ended March 31, 2023, the Company successfully retired, through open market purchases, $29.5 million of outstanding convertible notes due in July 2023 at a discount to par bringing the total outstanding balance to $13.8 million. Any remaining outstanding convertible notes will be retired using the Company’s restricted cash balance. Early retirements have saved the Company close to $7 million through retirements at discounts to par and reduced interest costs.
· Cash, cash equivalents, short-term and long-term investments and restricted cash totaled $125.4 million as of March 31, 2023.
· Selling, general and administrative (SG&A) costs decreased by 15% for the three months ended March 31, 2023 compared to the prior year period.

First Quarter 2023 Financial Results Compared to Prior Year Period

Research and development expenses increased $0.4 million, or 3%, from the three months ended March 31, 2022. This increase was primarily driven by a continued prioritization of clinical product candidates.

Total other income, net, increased $2.5 million over the three months ended March 31, 2022. This increase was primarily due to reduced interest expense associated with the Company’s Convertible Notes as a significant portion of the original $200 million face value of the Convertible Notes has been retired. In addition, interest income increased due to higher interest rates on the Company’s investments.

SG&A expenses decreased $2.1 million, or 15%, from the three months ended March 31, 2022. This decrease was primarily driven by a reduction in professional fees of $2 million, primarily due to decreased legal fees associated with certain litigation matters.

Total revenues decreased $3.7 million, or 66%, from the three months ended March 31, 2022. This decrease related to the recognition of revenue in the first quarter of 2022 related to agreements for which revenue was previously deferred that did not occur in the first quarter of 2023 of $1.0 million, as well as declines in services performed at Exemplar.

Loss from continuing operations was $22.7 million, or $(0.10) per basic and diluted share, compared to loss from continuing operations of $23.9 million, or $(0.12) per basic and diluted share, in Q1 2022.

On May 10, 2023 PMV Pharmaceuticals, Inc. (Nasdaq: PMVP), a precision oncology company pioneering the discovery and development of small molecule, tumor-agnostic therapies targeting p53, reported financial results for the first quarter ended March 31, 2023, and provided a corporate update (Press release, PMV Pharma, MAY 10, 2023, View Source [SID1234631398]).

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"We are pleased with the ongoing progress in the PYNNACLE study of PC14586, a first-in-class p53 Y220C reactivator, in patients with advanced solid tumors. We look forward to providing the next clinical and regulatory update in the second half of 2023," said David Mack, Ph.D., President and Chief Executive Officer. "Additionally, we are actively enrolling patients in the combination arm of PYNNACLE to explore the potential synergistic effects between PC14586 and KEYTRUDA."

Corporate Highlights:

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The ongoing Phase 1/2 PYNNACLE study is evaluating PC14586 in patients with advanced solid tumors harboring a p53 Y220C mutation. The next clinical and regulatory update is expected in 2H 2023.
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Commenced enrollment in the combination arm of PYNNACLE evaluating PC14586 with KEYTRUDA (pembrolizumab). PMV Pharma and Merck entered into a collaboration in 2022 under the terms of which Merck will supply KEYTRUDA for this study.

First Quarter 2023 Financial Results

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PMV Pharma ended the first quarter with $229.4 million in cash, cash equivalents, and marketable securities, compared to $243.5 million as of December 31, 2022. Net cash used in operations was $15.0 million for the three months ended March 31, 2023, compared to $18.0 million for the three months ended March 31, 2022.
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Net loss for the quarter ended March 31, 2023, was $19.1 million compared to $18.4 million for the quarter ended March 31, 2022.
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Research and development (R&D) expenses were $15.1 million for the quarter ended March 31, 2023, compared to $11.8 million for the quarter ended March 31, 2022. The increase in R&D expenses was primarily related to increased clinical expenses to advance research on PC14586, the Company’s lead drug candidate.
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General and administrative (G&A) expenses were $6.4 million for the quarter ended March 31, 2023, compared to $6.8 million for the quarter ended March 31, 2022. The decrease in G&A expenses was primarily due to reduced spend for insurance and outside services.

KEYTRUDA (pembrolizumab) is a registered trademark of Merck Sharp & Dohme LLC., a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

About PC14586

PC14586 is a first-in-class, small molecule, p53 reactivator designed to selectively bind to the crevice present in the p53 Y220C mutant protein, hence, restoring the wild-type, or normal, p53 protein structure and tumor-suppressing function. The U.S. Food and Drug Administration granted Fast Track designation to PC14586 for the treatment of patients with locally advanced or metastatic solid tumors that have a p53

Y220C mutation. For more information about the Phase 1/2 PYNNACLE trial (PMV-586-101), refer to www.clinicaltrials.gov (NCT study identifier NCT04585750).

On May 10, 2023 Pieris Pharmaceuticals, Inc. (NASDAQ:PIRS), a clinical-stage biotechnology company advancing novel biotherapeutics through its proprietary Anticalin technology platform for respiratory diseases, cancer, and other indications, reported its financial results for the quarter ended March 31, 2023, and provided a business update (Press release, Pieris Pharmaceuticals, MAY 10, 2023, View Source [SID1234631397]).

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"We continue to be excited by the potential of our inhaled biologics pipeline to reshape the treatment paradigm for patients living with uncontrolled asthma and other chronic respiratory diseases. Our top priority remains the study completion and clinical data read out from the elarekibep Phase 2a study in asthma, which is benefitting from increased operational resources from our partner, AstraZeneca," said Stephen S. Yoder, President and CEO of Pieris. "Pieris continues to make measured investments in PRS-220 and PRS-400 while also expecting additional progress across partnered programs through our capital-efficient collaborations with Boston Pharmaceuticals, Genentech, Seagen and Servier."

Respiratory Pipeline:

Elarekibep and AstraZeneca Collaboration: Enrollment is ongoing in the multi-center, placebo-controlled Phase 2a study of dry powder inhaler-formulated elarekibep, an IL-4 receptor alpha (IL-4Rα) inhibitor being developed for the treatment of moderate-to-severe asthma. Topline results measuring placebo-adjusted FEV1 improvement at four weeks, the study’s primary efficacy endpoint, are expected by the middle of 2024. AstraZeneca previously communicated to the Company that completion of the Phase 2a study remains an important priority and that additional resources have been provided to achieve study completion. This includes a commitment to adding several new countries and a significant number of additional clinical sites, bringing the anticipated total number to more than 100 sites. As part of this commitment, AstraZeneca is on track to add three new geographies and related sites in the current quarter. Together with the previously announced protocol amendments, which are positively impacting study screening, we anticipate this will enable the achievement of the enrollment targets and timelines. In addition, the safety review of the 10 mg dose cohort in mild controlled asthmatics was successfully completed, which provides additional data supporting the elarekibep safety profile and enables doses greater than 3 mg to be evaluated in the future, if needed.

Previously reported elarekibep Phase 1 results demonstrated reduced fractional exhaled nitric oxide (FeNO) levels in mild asthma patients, and a favorable safety profile. Elarekibep is further validated by dupilumab, an FDA-approved inhibitor of IL-4Rα that has demonstrated reduced levels of FeNO and clinical efficacy in uncontrolled, moderate-to-severe asthma. Furthermore, dupilumab Phase 3 study results have shown efficacy in chronic obstructive pulmonary disease (COPD).

Pieris retains co-development and U.S. co-commercialization rights for elarekibep, which are exercisable following completion of the ongoing Phase 2a study.
PRS-220: Pieris continues clinical development of PRS-220, a potential best-in-class inhaled Anticalin protein targeting connective tissue growth factor (CTGF) for the treatment of IPF, a disease with a large unmet medical need, and other fibrotic lung diseases. Preclinically, PRS-220 demonstrated superior on-target potency compared to pamrevlumab, an intravenously infused CTGF antagonist in late-stage clinical development. The Company believes inhaled administration will deliver high lung exposure, optimal pulmonary target engagement and superior clinical outcomes, while offering convenience of at-home administration.

The Company is dosing healthy volunteers in a Phase 1 study with PRS-220 and expects to report results in the second half of this year. On May 21, 2023, preclinical data will be presented at the ATS 2023 International Conference, including data demonstrating that inhaled PRS-220 significantly reduced collagen deposition in a silica-induced lung fibrosis mouse model. Pieris continues to benefit from a meaningful grant from the Bavarian government, which supports early-stage development of this program.
PRS-400: Pieris continues its preclinical advancement of PRS-400, an inhaled anti-Jagged-1 Anticalin therapeutic program with transformative potential in a wide range of respiratory diseases driven by mucus hypersecretion. PRS-400 was designed to allow patients to exit the vicious cycle of mucus hypersecretion, infection and airway obstruction, while avoiding inhibition of healthy, normal mucus production outside of the lungs. On May 22, 2023, preclinical data will be presented at the ATS 2023 International Conference demonstrating that PRS-400 reduced inflammation-driven goblet cell metaplasia and mucus hypersecretion in a therapeutic disease model. PRS-400 is advancing toward development candidate nomination in the second half of this year.
Immuno-Oncology Pipeline:
Pieris’ immuno-oncology pipeline continues to progress in a cost-efficient manner with the benefit of its partners. The Company believes that multiple opportunities exist to generate value from this portfolio based on promising data generated to date.

In April, clinical results from the Company’s clinical study of cinrebafusp alfa (PRS-343) in 2L+ HER2-positive gastric cancer were presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting, including an unconfirmed 100% objective response rate and promising emerging durability profile in the five patients enrolled into the study prior to study discontinuation of enrollment for strategic reasons. Pieris is considering a range of transactions to facilitate program continuation, from an immuno-oncology focused spinout to a traditional partnering transaction.
Boston Pharmaceuticals continues to advance BOS-342 (also known as PRS-342), a 4-1BB/GPC3 bispecific Mabcalin (antibody-Anticalin protein) compound, toward the clinic, with Phase 1 expected to begin in the coming months.
Pieris and Servier continue to progress the escalation portion of the Phase 1/2 study of PRS-344/S095012, a 4-1BB/PD-L1 bispecific Mabcalin compound for the treatment of solid tumors, for which Pieris holds full U.S. rights.
As previously announced, Seagen initiated a Phase 1 study for SGN-BB228 (also known as PRS-346), triggering a $5 million milestone payment to Pieris. SGN-BB228 is a first-in-class CD228/4-1BB bispecific antibody-Anticalin compound designed to provide a potent costimulatory bridge between tumor-specific T cells and CD228-expressing tumor cells. Pieris and Seagen continue to collaborate on two other undisclosed bispecific programs.
Fiscal Year End Financial Update:

Cash Position – Cash, cash equivalents, and investments totaled $48.4 million for the quarter ended March 31, 2023, compared to a cash and cash equivalents balance of $59.2 million for the year ended December 31, 2022. The decrease was due to funding operations in the first quarter of 2023. The Company believes operations are sufficiently funded for more than the next 12 months.

R&D Expense – R&D expenses were $13.4 million for the quarter ended March 31, 2023, compared to $14.1 million for the quarter ended March 31, 2022. The decrease was due primarily to lower clinical costs for cinrebafusp alfa and lower personnel costs, license fees and software costs. These lower costs were partially offset by higher overall program costs for PRS-220 and higher preclinical costs for discovery-stage programs, both partnered and proprietary.

G&A Expense – G&A expenses were $4.0 million for the quarter ended March 31, 2023, compared to $4.4 million for the quarter ended March 31, 2022. The period-over-period decrease was driven primarily by lower professional services, consulting and insurance costs.

Other Income – For the quarter ended March 31, 2023, $2.0 million of grant income was recorded with respect to PRS-220, compared to $2.1 million for the quarter ended March 31, 2022, indicating that costs incurred on PRS-220 were comparable for both periods. Interest income was $0.4 million for the quarter ended March 31, 2023, given the impact of rising interest rates compared to a de minimis amount of interest income in the quarter ended March 31, 2022

Net Loss – Net loss was $13.2 million or $(0.45) per share for the quarter ended March 31, 2023, compared to a net loss of $5.1 million or $(0.07) per share for the quarter ended March 31, 2022.

Conference Call:

Pieris management will host a conference call beginning at 8:00 AM EDT on Wednesday, May 10, 2023, to discuss the first quarter 2023 financial results and provide a corporate update. Individuals can join the call by dialing 866-682-6100 (Toll Free US & Canada) or +1 862-298-0702 (International) at least five minutes prior to the start of the call. Alternatively, a listen-only audio webcast of the call can be accessed here.

A replay will be available on the Investors section of the Company’s website, www.pieris.com.

On May 10, 2023 Nuvectis Pharma, Inc (NASDAQ: NVCT) ("Nuvectis" or the "Company"), a clinical-stage biopharmaceutical company focused on the development of innovative precision medicines for the treatment of serious conditions of unmet medical need in oncology, reported its financial results for the first quarter 2023 and provided an update on recent business progress (Press release, Nuvectis Pharma, MAY 10, 2023, View Source [SID1234631395]).

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Ron Bentsur, Chairman and Chief Executive Officer of Nuvectis commented, "In the last few months, the Nuvectis team accomplished several important milestones that significantly advance our NXP800 and NXP900 development programs. For NXP800, we initiated the Phase 1b study, in which the preliminary efficacy of NXP800 in a target population, in this case platinum-resistant, ARID1a-mutated ovarian carcinoma, will be evaluated for the first time. The study is a multicenter, open label, single-arm clinical trial that will be conducted in the United States, United Kingdom and Europe, in collaboration with the GOG Foundation and the European Network of Gynecological Oncological Trial Group ("ENGOT"), two of the world’s premier gynecology oncology clinical trials consortia. The Phase 1b study follows the preliminary safety, tolerability and dosing findings from the Phase 1a in advanced solid tumors." Mr. Bentsur continued, "For NXP900, the Investigational New Drug ("IND") application with the US Food and Drug Administration ("FDA") is pending and we’re preparing to commence the first-in-human clinical trial shortly after the IND becomes effective. Lastly, recent publications for both NXP800 and NXP900 provided substantial scientific evidence for additional clinical development opportunities, including recent data from patient-derived xenograft ("PDX") in vivo models presented at this year’s American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting ("AACR") by investigators from the Mayo Clinic that demonstrated the potential of NXP800 to treat cholangiocarcinoma, a deadly disease for which only limited treatment options exist and new treatment options are greatly needed." Mr. Bentsur concluded, "We expect to continue to make strides in our development programs while effectively managing our cash position and we look forward to providing additional updates in the coming months."

First Quarter 2023 Financial Results

Cash, cash equivalents, and short-term investments were $15.5 million as of March 31, 2023, compared to $20.0 million as of December 31, 2022. The decrease of $4.5 million was primarily a result of the Company’s operations and payment of one-time items. The Company expects that its cash, cash equivalents, and short-term investments will be sufficient to meet its operating expense requirements into the second half of 2024.

The Company’s net loss was $4.0 million for the three months ended March 31, 2023, compared to $2.9 million for the three months ended March 31, 2022, an increase of $1.1 million. Net loss for the first quarter 2023 fiscal three months included $1.4 million in non-cash expenses related to stock-based compensation, $0.2 million in one-time development costs in connection with NXP900 and $0.1 million in interest income.

Research and development expenses were $2.4 million for the three months ended March 31, 2023, compared to $1.8 million for the three months ended March 31, 2022, an increase of $0.6 million. The increase in research and development expenses were primarily attributed to non-cash expenses related stock-based compensation, an increase in preclinical and clinical development costs and an increase in manufacturing costs. Research and development expenses for the first quarter 2023 included $0.7 million in non-cash expenses related to stock-based compensation.

General and administrative expenses were $1.7 million for the three months ended March 31, 2023, compared to $1.1 million for the three months ended March 31, 2022, an increase of $0.6 million. The increase in general and administrative expenses is primarily attributed to costs associated with operating as a public company following our 2022 initial public offering. General and administrative expenses for the first quarter 2023 included $0.7 million in non-cash expenses related to stock-based compensation.