On March 15, 2023 Protagonist Therapeutics (Nasdaq: PTGX) ("Protagonist" or "the Company") reported financial results for the fourth quarter and full year ended December 31, 2022 and provided a corporate update (Press release, Protagonist, MAR 15, 2023, View Source [SID1234628795]).

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"The positive FRONTIER 1 JNJ-2113 (PN-235) data recently reported represents a scientific breakthrough with the potential to transform the treatment landscape for moderate-to-severe plaque psoriasis with oral targeted therapy. We look forward to in-depth presentations of JNJ-2113 pre-clinical and Phase 1 and Phase 2 clinical studies at medical conferences beginning in the second quarter of 2023," said Dinesh V. Patel, Ph.D., President and Chief Executive Officer of Protagonist. "In addition, we are extremely pleased to have announced this morning the positive results from the randomized withdrawal part of the REVIVE study of rusfertide in polycythemia vera (PV). The study met its primary endpoint, with a statistically significant higher number of responders on rusfertide versus placebo (p=0.0003). Improvements in symptoms were observed, and rusfertide was generally well tolerated in the overall study."

Dr. Patel continued, "These positive results from the Phase 2 FRONTIER 1 and REVIVE studies, of JNJ-2113 and rusfertide, respectively, are testaments to the promise of our proprietary platform as well as the expertise, experience and commitment of the Protagonist team. We are focused on enrolling patients globally in the Phase 3 VERIFY study of rusfertide in PV, and we are diligently preparing for the pre-commercial launch-related activities for rusfertide.

"Meanwhile, our discovery engine remains prolific. We are evaluating pre-clinical compounds with the potential to have impact in areas of high unmet medical need, and we are specifically advancing efforts in the oral hepcidin mimetic program. With two assets in late-stage development, Protagonist is now closer than ever to bringing transformative new therapies to patients. As an industry leader in the discovery and development of peptide therapeutics, we hold a unique set of capabilities that position our Company for value creation over the long run," Patel said.

Fourth Quarter 2022 Recent Developments and Upcoming Milestones

Rusfertide: Subcutaneous Injectable Hepcidin Mimetic for Polycythemia Vera (PV) and Other Blood Disorders

· The double-blind, placebo-controlled, 12-week randomized withdrawal portion of the REVIVE study met its primary endpoint, phlebotomy eligibility, with subjects randomized to rusfertide demonstrating a highly statistically significant (p=0.0003) proportion of responders compared to placebo. A study subject was defined as a responder if the subject completed 12 weeks of double-blind treatment while maintaining hematocrit control without phlebotomy eligibility and without phlebotomy. During the 12 weeks of the blinded randomized withdrawal, only 2 of 26 subjects on rusfertide were phlebotomized, keeping 92.3% of patients phlebotomy free in the treatment arm

In patients with moderate or severe Myeloproliferative Neoplasm-Symptom Assessment Form (MPN-SAF) symptom scores at baseline, the change from baseline was statistically significant in fatigue, problems with concentration, inactivity and itching during the 28-week open label Part 1 of the study. Meaningful comparison of symptom assessments in Part 2 are not possible since a majority of subjects randomized to placebo discontinued prior to the 12-week assessment of MPN-SAF symptoms.

· Rusfertide was well tolerated, with localized injection site reactions comprising the majority of reported adverse events. No new safety signals were observed in these data, following presentation of safety data from the REVIVE study at the American Society of Hematology (ASH) (Free ASH Whitepaper) December 2022.

· For PV, Rusfertide has received FDA and EU orphan designation and FDA fast track designation.

JNJ-2113 (formerly PN-235): Oral IL-23 Receptor Antagonist

· The Company announced positive topline results from its collaboration with Janssen Biotech, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, in the FRONTIER 1 Phase 2b clinical trial evaluating the oral Interleukin-23 receptor (IL-23R) antagonist peptide JNJ-2113 in patients with moderate-to-severe plaque psoriasis.

· Data from the 255-patient study showed that JNJ-2113 achieved the study’s primary efficacy endpoint, with a statistically significant greater proportion of patients who received JNJ-2113 achieving PASI-75 (a 75% improvement in skin lesions as measured by the Psoriasis Area and Severity Index) responses compared to placebo at Week 16 in all five treatment groups. A clear dose response was observed across an eight-fold dose range.

· All treatments were well tolerated, with no meaningful difference in frequency of adverse events across treatment groups versus placebo.

· Data from various pre-clinical and clinical studies on JNJ-2113 will be presented at medical conferences beginning in the second quarter of 2023.

· Phase 1 and preclinical data of JNJ-2113 will be presented on May 12, 2023 at the International Societies for Investigative Dermatology Meeting 2023. More information on this presentation, entitled, "First-in-class oral peptide systemically targeting the IL-23 pathway," is available on the ISID 2023 website at isid2023.org.

Fourth Quarter 2022 Financial Results:

· Cash, Cash Equivalents and Marketable Securities: Cash, cash equivalents and marketable securities as of December 31, 2022 were $237.4 million. The Company expects current cash, cash equivalents and marketable securities to be sufficient to fund its planned operating and capital expenditures through the end of 2024.

· License and Collaboration Revenue: License and collaboration revenue for the fourth quarter and full year 2022 were zero and $26.6 million, respectively, as compared to $8.6 million and $27.4 million for the same periods of 2021. The decreases in revenue from prior year periods were primarily due to a decrease in the level of services the Company provided under the Janssen license and collaboration agreement. The Company completed its performance obligation pursuant to the collaboration as of June 30, 2022.

· Research and Development ("R&D") Expenses: R&D expenses for the fourth quarter and full year 2022 were $29.9 million and $126.2 million respectively, as compared to $38.4 million and $126.0 million, respectively, for the same periods of 2021. The decrease in R&D expenses from prior year quarter was primarily due to lower PN-943 expenses related to the suspension of further program expenditures, a decrease in costs related to the completion of JNJ-2113 and PN-232 Phase 1 trials, and a decrease in research and discovery program expenses.

· General and Administrative ("G&A") Expenses: G&A expenses for the fourth quarter and full year 2022 were $6.6 million and $31.7 million, respectively, as compared to $7.3 million and $27.2 million for the same periods of 2021. The decrease in G&A expenses from prior year quarter was primarily due to a decrease in personnel related expenses during the three months ended December 31, 2022. The increase in G&A expenses from prior year was primarily due to increases in personnel related expenses, including stock-based compensation expense, and other expenses to support Company growth.

· Net Loss: Net loss was $34.2 million, or $0.69 per share, for the fourth quarter of 2022 as compared to a net loss of $36.9 million, or $0.77 per share, for the fourth quarter of 2021. Net loss was $127.4 million, or $2.60 per share, for the full year 2022, as compared to a net loss of $125.6 million, or $2.71, for the full year 2021.

3

PROTAGONIST THERAPEUTICS, INC.
Condensed Consolidated Statements of Operations

(Amounts in thousands except share and per share data)

Three Months Ended Twelve Months Ended
December 31, December 31,
2022 2021 2022 2021
License and collaboration revenue – related party $ — $ 8,617 $ 26,581 $ 27,357
Operating expenses:
Research and development (1) 29,884 38,373 126,215 126,006
General and administrative (1) 6,632 7,260 31,739 27,196
Total operating expenses 36,516 45,633 157,954 153,202
Loss from operations (36,516 ) (37,016 ) (131,373 ) (125,845 )
Interest income 2,251 122 4,060 443
Other income (expense), net 71 (13 ) (80 ) (149 )
Net loss $ (34,194 ) $ (36,907 ) $ (127,393 ) $ (125,551 )
Net loss per share, basic and diluted $ (0.69 ) $ (0.77 ) $ (2.60 ) $ (2.71 )
Weighted-average shares used to compute net loss per share, basic and diluted 49,262,643 48,154,171 49,042,232 46,322,910

(1) Amount includes non-cash stock-based compensation expense.

PROTAGONIST THERAPEUTICS, INC.
Stock-based Compensation

(In thousands)

Three Months Ended Twelve Months Ended
December 31, December 31,
2022 2021 2022 2021
Research and development $ 3,429 $ 2,755 $ 14,719 $ 8,996
General and administrative 2,083 2,269 9,483 7,399
Total stock-based compensation expense $ 5,512 $ 5,024 $ 24,202 $ 16,395

PROTAGONIST THERAPEUTICS, INC.
Selected Consolidated Balance Sheet Data
(In thousands)

December 31, December 31,
2022 2021
Cash, cash equivalents and marketable securities $ 237,355 $ 326,900
Working capital 211,198 298,720
Total assets 247,928 347,695
Deferred revenue-related party — 1,601
Accumulated deficit (536,755 ) (409,362 )
Total stockholders’ equity 215,608 300,021

On March 15, 2023 Prescient Therapeutics (ASX: PTX), reported that it has received an expanded Orphan Drug Designation (ODD) from the Food and Drug Administration (FDA) for its targeted cell therapy PTX-100 that now extends to all T-cell lymphomas (TCLs) (Press release, Prescient Therapeutics, MAR 15, 2023, View Source;utm_medium=rss&utm_campaign=ptx-receives-expanded-orphan-drug-designation-for-all-t-cell-lymphomas [SID1234628794]). This is an encouraging signal from the US regulatory agency, who had already awarded the asset ODD for its potential to treat Peripheral T-cell Lymphoma – and aggressive cancer with an average 5-year survival rate of 32%.

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Prescient had applied for ODD due to the asset’s potential to treat Cutaneous T-cell Lymphoma (CTCL). In a pleasant surprise, the FDA granted the designation broader than PTX’s request. There are over 20 different types of TCL, so this significantly broadens the scope of PTX-100’s potential.

The FDA grants ODD status to drugs and biologics that are intended to treat rare diseases or conditions affecting fewer than 200,000 people in the United States. While drugs with ODD designation still have to go through the same rigorous scientific review process that any other drug must complete for approval or licensing, there is a correlation between receiving the designation and approval: between 2010 and 2016, 75% of all novel cancer drugs that received approval in the United States also qualified as orphan products. During the same time period, the average time between receiving ODD and approval was 5.3 years.

Investors tend to place value in the awarding of an ODD on a therapy. Specifically for smaller biotech companies, the average increase in share price or cumulative abnormal return following an ODD announcement has been found to be 8.87% for nano-caps (

An update on the study, which is being expanded to include up to 12 additional patients with TCL, is due imminently.

The focus of the current expansion cohort are patients with relapsed and refractory TCLs. The company has already achieved a partial response in a patient with aggressive PTCL. The response endured for over 32 months before the disease progressed. Importantly, this response was achieved in a patient that had failed five prior lines of therapy.

At the October 2022 update, one of the patients with CTCL, who had failed four prior lines of therapy, had a very good partial response (VGPR) that had endured beyond 6 months. Visually evident reduction in skin abnormalities were recorded and described by the Principle Investigator of the study, haematologist Professor H. Miles Prince, as "impressive responses". The patient remained on therapy. Two other patients with CTCL that failed three prior lines of therapy have experienced stable disease (SD) that had endured for 4 months. PTX-100 is a first in class compound that blocks an important cancer growth enzyme known as geranylgeranyl transferase-1 (GGT-1). This disrupts oncogenic Ras pathways by inhibiting the activation of Rho, Rac and Ral circuits in cancer cells which leads to apoptosis (death) of the cell. More than 30% of all human cancers, including 95% of pancreatic cancers, 45% of colorectal cancers, 35% of lung cancers and 15% of acute myeloid leukaemia – are driven by mutations of the RAS family of genes.

On March 15, 2023 Prelude Therapeutics Incorporated (Nasdaq: PRLD), a clinical-stage precision oncology company, reported its financial results for the fiscal year ended December 31, 2022, and provided a corporate update (Press release, Prelude Therapeutics, MAR 15, 2023, View Source [SID1234628793]).

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"We made considerable progress in 2022, including the filing and acceptance of two new INDs for our next generation CDK4/6 inhibitor and our first-in-class, highly selective SMARCA2 degrader. Our current clinical pipeline consists of four differentiated and internally discovered molecules that effectively target and block key oncogenic pathways in both hematological malignancies and solid tumors. Prelude’s highly productive internal discovery engine continues to deliver novel molecules across multiple therapeutic classes, including significant advances in our research efforts focused on identifying an orally available SMARCA2 degrader," stated Kris Vaddi, Ph.D., Chief Executive Officer of Prelude.

Jane Huang, M.D., President and Chief Medical Officer of Prelude stated, "Prelude’s six preclinical and two clinical abstracts accepted for presentation at the upcoming AACR (Free AACR Whitepaper) Annual Meeting reflect the productivity and success of our research and development efforts. Initial data from PRT2527 and PRT1419 demonstrate encouraging safety, favorable pharmacokinetic and pharmacodynamic profiles in solid tumors, and support continued advancement in hematological cancers. Looking ahead, our top priority for 2023 is to efficiently advance these compounds forward into proof-of-concept clinical studies and determine appropriate next steps for each program."

"Our recently announced collaboration with BeiGene reflects our commitment to maximize the therapeutic value of combining our highly selective and potent CDK9 inhibitor, PRT2527, with BTK inhibitors in hematologic malignancies," added Dr. Huang.

Program Updates and Upcoming Milestones

PRT2527- CDK9 Inhibitor Program
PRT2527 is a potent and selective small molecule that has the potential to avoid off target toxicity and achieve higher clinical activity than other CDK9 programs currently in development. The Company is currently advancing PRT2527 as monotherapy in both solid and hematological indications. The Company also intends to pursue the clinically validated approach of combining PRT2527 with approved BTK inhibitors, beginning with its recently announced clinical collaboration with BeiGene.

Key 2023 objectives for this program include:

Present solid tumor safety dose escalation data at AACR (Free AACR Whitepaper) 2023
Determine RP2D in hematological malignancies in 2H 2023
Present initial clinical results for hematological malignancies at a medical conference in 2H 2023
PRT1419- MCL1 Inhibitor Program
Based on the Phase 1 dose escalation study in solid tumors, and safety measured by troponin levels and changes in ejection fraction, the Company is now advancing PRT1419 in hematologic malignancies as monotherapy. The Company also plans to study PRT1419 in combination with venetoclax and in combination with azacytidine.

Key 2023 objectives for this program include:

Solid tumor safety data to be presented at AACR (Free AACR Whitepaper) 2023
RP2D expected in hematological malignancies in 2H 2023
Hematological malignancy data expected to be presented in 2H 2023
PRT3645-Next Generation CDK4/6 Inhibitor Program
PRT3645 is a highly selective and differentiated CDK4/6 inhibitor. PRT3645 is a CDK4 biased compound with tissue and brain penetration qualities, and has potential in multiple indications including gliomas, head and neck cancers and non-small cell lung cancer, in addition to HR+/HER2- and HR+/HER2+ breast cancers.

Key 2023 objective includes:

Present initial Phase 1 clinical results at a medical conference in 2H 2023
SMARCA2 Targeted Protein Degrader Program
PRT3789 is an IV administered, potent and highly selective SMARCA2 degrader. It is designed to achieve the requisite high selectivity for SMARCA2 over the isoform, SMARCA4, through a targeted protein degrader approach. PRT3789 is a first-in-class SMARCA2 candidate and is currently in Phase 1 clinical development in biomarker selected SMARCA4 mutant patients.

Prelude’s discovery team has also identified orally bioavailable SMARCA2 degraders.

Key objectives include:

Provide Clinical update on PRT3789 2H 2023
Advance an oral SMARCA2 degrader for investigational new drug (IND) submission in 1H 2024
Upcoming presentations

The following clinical abstracts will be presented at AACR (Free AACR Whitepaper) 2023:

Title: A phase 1, open-label, dose-escalation study of PRT1419, a selective induced myeloid leukemia cell differentiation protein (MCL-1) inhibitor, in patients (pts) with advanced/metastatic solid tumors.
Presenter: Gerald Falchook
Session Title: First-in-Human Phase I Clinical Trials 2
Session Date and Time: Tuesday Apr 18, 2023, 9:00 AM – 12:30 PM
Location: Poster Section 45
Poster Board Number: 4
Abstract Presentation Number: CT172
Title: A phase 1, open-label, multicenter, dose-escalation study of PRT2527, a cyclin-dependent kinase 9 (CDK9) inhibitor, in adult patients (pts) with advanced solid tumors.
Presenter: Jason Henry
Session Title: First-in-Human Phase I Clinical Trials 2
Session Date and Time: Tuesday Apr 18, 2023 9:00 AM – 12:30 PM
Location: Poster Section 45
Poster Board Number: 5
Abstract Presentation Number: CT173
The following preclinical abstracts will be presented at AACR (Free AACR Whitepaper) 2023:

Title: SMARCA2 (BRM) degraders promote differentiation and inhibit proliferation in AML models
Presenter: Anjana Agarwal
Session Category: Experimental and Molecular Therapeutics
Session Title: New Therapeutic Targeted Agents
Session Date and Time: Monday Apr 17, 2023 9:00 AM – 12:30 PM
Location: Section 16
Poster Board Number: 17
Abstract Presentation Number: 1594
Title: Development of pharmacodynamic assays for quantifying SMARCA2 protein degradation and target gene expression in response to a SMARCA2 degrader (PRT3789)
Presenter: Andrew Moore
Session Category: Experimental and Molecular Therapeutics
Session Title: Pharmacokinetics, Pharmacodynamics, and Molecular Pharmacology
Session Date and Time: Monday Apr 17, 2023 1:30 PM – 5:00 PM
Location: Section 18
Poster Board Number: 15
Abstract Presentation Number: 2792
Title: Combination therapy with selective SMARCA2 (BRM) degraders for treatment of SMARCA4 (BRG1)-deficient cancers
Presenter: Michael Hulse
Session Category: Experimental and Molecular Therapeutics
Session Title: Epigenetics
Session Date and Time: Wednesday Apr 19, 2023 9:00 AM – 12:30 PM
Location: Section 20
Poster Board Number: 8
Abstract Presentation Number: 6270
Title: The brain penetrant CDK4/6 Inhibitor, PRT3645, is highly effective in combination with other targeted therapies in preclinical models of NSCLC and HER2-positive breast cancer
Presenter: Yue Zou
Session Category: Molecular/Cellular Biology and Genetics
Session Title: Cyclin-dependent Kinases and Cyclin-dependent Kinase Inhibitors
Session Date and Time: Wednesday Apr 19, 2023 9:00 AM – 12:30 PM
Location: Section 9
Poster Board Number: 2
Abstract Presentation Number: 5973
Title: MCL1 inhibitor PRT1419 demonstrates anti-tumor activity in PBRM1-altered clear cell renal cancer and synergizes with standard of care agents
Presenter: Norman Fultang
Session Category: Experimental and Molecular Therapeutics
Session Title: Cell Death Pathways and Treatment / Molecular Classification of Tumors for Diagnostics, Prognostics, and Therapeutic Outcomes
Session Date and Time: Wednesday Apr 19, 2023 9:00 AM – 12:30 PM
Location: Section 16
Poster Board Number: 9
Abstract Presentation Number: 6147
Title: Selective and orally bioavailable SMARCA2 targeted degraders induce synthetic lethality in SMARCA4- deficient solid tumor
Presenter: Koichi Ito
Session Category: Experimental and Molecular Therapeutics
Session Title: Epigenetics
Session Date and Time: Wednesday Apr 19, 2023 9:00 AM – 12:30 PM
Location: Section 20
Poster Board Number: 15
Abstract Presentation Number: 6277
Corporate Update

On February 20, 2023, Bryant D. Lim, Esq., joined Prelude Therapeutics as Chief Legal Officer and Corporate Secretary. He has more than 20 years of experience in pharma and biotech, with expertise in business development, regulatory matters, fundraising and SEC reporting. Kris Vaddi, Ph.D. commented, "We are excited to welcome Bryant to Prelude and expand our leadership team to include his relevant expertise. Bryant is an excellent addition, helping us to move forward in our growth as a Company."

Full Year 2022 Financial Results

Cash and Cash Equivalents: Cash and cash equivalents as of December 31, 2022 were $201.7 million. Following Prelude’s recently announced program prioritization initiatives, the Company has extended its cash guidance and anticipates that its existing cash, cash equivalents and marketable securities will fund Prelude’s operations through the fourth quarter of 2024.
Research and Development (R&D) Expenses: R&D expenses for the year ended December 31, 2022 increased $6.1 million to $92.9 million compared to $86.8 million for the year ended December 31, 2021. Included in research and development expenses for the year ended December 31, 2022, was $11.5 million of non-cash expense related to stock-based compensation expense, including employee stock options, compared to $9.5 million for the year ended December 31, 2021. The increase in research and development expense was primarily due to an increase in discovery-stage program expenses and from the growth and advancement of our clinical pipeline and an increase in non-cash stock-based compensation expense.
General and Administrative (G&A) Expenses: G&A expenses for the year ended December 31, 2022 increased by $3.7 million to $30.7 million compared to $27.0 million for the year ended December 31, 2021. Included in the general and administrative expenses for the year ended December 31, 2022, was $13.6 million of non-cash expense related to stock-based compensation expense, including employee stock options, as compared to $11.5 million for the same period in 2021. The increase in general and administrative expense was primarily due to an increase in non-cash stock-based compensation expense.
Net Loss: Net loss for the year ended December 31, 2022 was $115.4 million or $2.44 per share, compared with a net loss of $111.7 million, or $2.43 per share for the year ended December 31, 2021.

On March 15, 2023 Prelude Therapeutics Incorporated (Prelude) (Nasdaq: PRLD), a clinical-stage precision oncology company, reported a clinical trial collaboration with BeiGene, for future evaluation of its investigational CDK9 inhibitor, PRT2527, in combination with BeiGene’s BTK inhibitor, zanubrutinib, in hematologic malignancies (Press release, Prelude Therapeutics, MAR 15, 2023, View Source [SID1234628792]).

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Inhibition of BTK is an active therapeutic approach in several B cell malignancies and the combination of CDK9 inhibition with BTK inhibition has demonstrated, in recent data publications, synergistic clinical efficacy over BTK inhibition alone; hence, there is a strong rationale for studying the combination in patients with certain hematologic malignancies.

"The opportunity to combine Prelude’s potent, selective and potentially best-in-class CDK9 inhibitor with BeiGene’s next-generation highly efficacious and tolerable BTK inhibitor, zanubrutinib, reflects our commitment to bringing the most promising options to patients," said Jane Huang, MD, President and Chief Medical Officer, Prelude Therapeutics.

Under terms of the clinical trial collaboration agreement, BeiGene will provide zanubrutinib to Prelude, and Prelude will retain all global operational, development and commercialization rights and responsibilities for PRT2527.

About PRT2527

PRT2527 was designed to be a potent and selective Cyclin-dependent kinase 9, or CDK9, inhibitor. In preclinical studies, PRT2527 was shown to reduce MCL1 and MYC protein levels and was highly active in preclinical models at well-tolerated doses. PRT2527 has demonstrated high potency and kinase selectivity which may offer improved efficacy and safety compared to less selective CDK9 inhibitors, allowing for rapid development in combinations. PRT2527 is currently being studied as monotherapy in a Phase 1 dose-escalation study in advanced solid tumors, as well as in relapsed/refractory hematologic malignancies.

On March 15, 2023 Nouscom, a clinical stage immuno-oncology company developing off-the-shelf and personalized viral vector immunotherapies, reported that new translational data obtained from the ongoing Phase 1b trial evaluating NOUS-PEV in patients with metastatic melanoma has been accepted for presentation in a Late-Breaking session at the 2023 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting (Press release, NousCom, MAR 15, 2023, View Source;utm_medium=rss&utm_campaign=nouscom-announces-aacr-2023-late-breaking-presentation-of-translational-phase-1b-data-of-nous-pev-a-personalized-neoantigen-cancer-immunotherapy [SID1234628791]). AACR (Free AACR Whitepaper) will be held in
person in Orlando, FL from 14th to 19th April. Poster Presentation Details:

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• Title: NOUS-PEV, a Personalized Cancer Immunotherapy targeting neoantigens,
induces long lasting, tumor infiltrating memory T cells
• Session Title: Late-Breaking Research: Clinical Research 2
• Date & Time: 18th April 2023, 9:00 AM – 12:30 PM EDT
• Location: Poster Section 35, Poster Board 11
• Poster Number: LB196
• Presenter: Dr. Elisa Scarselli, Chief Scientific Officer at Nouscom
The full abstract will be available on 14th April 2023 at 12pm EDT.