On May 15, 2023 Erasca, Inc. (Nasdaq: ERAS), a clinical-stage precision oncology company singularly focused on discovering, developing, and commercializing therapies for patients with RAS/MAPK pathway-driven cancers, reported financial results for the fiscal quarter ended March 31, 2023, and provided business updates (Press release, Erasca, MAY 15, 2023, View Source [SID1234631718]).

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"In 2023, we plan to further refine the developmental focus of our lead clinical programs and accelerate our transition into a late-stage clinical development company. For ERAS-601, we have identified the maximum tolerated dose for the combination with cetuximab and are pleased by the promising preliminary safety and tolerability data with reversible and manageable treatment-related adverse events (TRAEs) seen with our ‘three weeks on, one week off’ dosing regimen. Continued exploration of this combination will be prioritized in patients with human papillomavirus (HPV)-negative head and neck squamous cell carcinoma (HNSCC), with initial data expected in the first half of 2024," said Jonathan E. Lim, M.D., Erasca’s chairman, CEO, and co-founder. "Coming up at ASCO (Free ASCO Whitepaper), two poster presentations will provide initial combination data for our ERK1/2 inhibitor ERAS-007 from our HERKULES-3 trial in patients with advanced gastrointestinal (GI) malignancies."

Dr. Lim continued, "We are looking forward to dosing the first patient in SEACRAFT-1 expected in the second half of this year and continuing clinical development of naporafenib, the latest addition to our pipeline and our most advanced clinical program. The compelling anti-tumor activity demonstrated in the recent Journal of Clinical Oncology publication of the Phase 1b trial for naporafenib plus trametinib in patients with NRAS-mutant (NRASm) melanoma reinforces the potential benefit of our pivotal Phase 3 SEACRAFT-2 trial, which is expected to initiate in the first half of 2024. With our promotions of two strong leaders, Dr. Shannon Morris to Chief Medical Officer and Ms. Chandra Lovejoy to Chief Regulatory Affairs Officer, we are well-positioned for continued clinical and regulatory execution across our multiple near-term clinical milestones."

Research and Development (R&D) Highlights

•
Granted FDA Fast Track Designation For ERAS-801 in Glioblastoma: In May 2023, Erasca announced that the United States Food and Drug Administration (FDA) granted Fast Track Designation (FTD) to ERAS-801 (CNS-penetrant EGFR inhibitor) for the treatment of adult patients with glioblastoma (GBM) with EGFR gene alterations.
•
Presented Promising Initial Phase 1b Dose Escalation Data for ERAS-601: In April 2023, Erasca presented promising initial Phase 1b dose escalation data from FLAGSHP-1 for ERAS-601 in combination with cetuximab (ERBITUX) in patients with advanced solid tumors as part of a poster presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting.
•
Announced Publication of Phase 1b Data for Naporafenib: In April 2023, Erasca announced the publication of results in the Journal of Clinical Oncology from the expansion arm of a Phase 1b open label trial evaluating pan-RAF inhibitor naporafenib plus MEK inhibitor trametinib (MEKINIST) in patients with NRASm melanoma.
•
Announced Two Poster Presentations at the 2023 ASCO (Free ASCO Whitepaper) Annual Meeting: In April 2023, Erasca announced that preliminary Phase 1b combination data for potential best-in-class ERK1/2 inhibitor ERAS-007 with encorafenib (BRAFTOVI) and cetuximab or with palbociclib (IBRANCE) in patients with advanced GI malignancies will be presented as part of poster presentations at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.

Corporate Highlights

•
Strengthened Clinical and Regulatory Executive Leadership: In April 2023, Erasca promoted Shannon R. Morris, M.D., Ph.D., to Chief Medical Officer, and Chandra D. Lovejoy, M.S., to Chief Regulatory Affairs Officer

Key Upcoming Milestones

•
SEACRAFT-1: Phase 1b trial for naporafenib in patients with RAS Q61X tissue agnostic solid tumors
o
Dosing of the first patient expected in the second half of 2023
o
Initial Phase 1b combination data expected between the second and fourth quarters of 2024
•
SEACRAFT-2: Randomized pivotal Phase 3 trial for naporafenib in patients with NRASm melanoma
o
Dosing of the first patient expected in the first half of 2024
•
HERKULES-1: Phase 1b trial for ERAS-007 plus ERAS-601 in patients with advanced solid tumors
o
Initial Phase 1b combination data expected in the first half of 2024
•
HERKULES-2: Phase 1b trial for ERAS-007 in patients with advanced non-small cell lung cancer (NSCLC)
o
Initial Phase 1b combination data expected in the second quarter of 2023
•
HERKULES-3: Phase 1b trial for ERAS-007 in patients with GI malignancies
o
Initial Phase 1b combination data in patients with RAS- and BRAF-mutated GI malignancies expected in the second quarter of 2023
o
Phase 1b combination expansion data in patients with BRAF-mutated colorectal cancer (CRC) expected between the second half of 2023 and the first half of 2024
•
FLAGSHP-1: Phase 1b trial for ERAS-601 in patients with advanced solid tumors
o
Phase 1b combination data in patients with HPV-negative advanced HNSCC expected in the first half of 2024
•
THUNDERBBOLT-1: Phase 1 trial for ERAS-801 in patients with recurrent glioblastoma (GBM)
o
Initial Phase 1 data in patients with recurrent GBM expected in the second half of 2023
•
AURORAS-1: Phase 1 trial for ERAS-3490 in patients with KRAS G12Cm NSCLC
o
Initial Phase 1 data expected in 2024

First Quarter 2023 Financial Results

Cash Position: Cash, cash equivalents, and marketable securities were $389.7 million as of March 31, 2023, compared to $435.6 million as of December 31, 2022. Erasca expects its current cash, cash equivalents, and marketable securities balance to fund operations into the second half of 2025.

Research and Development (R&D) Expenses: R&D expenses were $27.6 million for the quarter ended March 31, 2023, compared to $27.4 million for the quarter ended March 31, 2022. The quarter ended March 31, 2022 also included $2.0 million of in-process R&D expenses related to a development milestone payment in connection with our license agreement with Katmai Pharmaceuticals, Inc.

General and Administrative (G&A) Expenses: G&A expenses were $9.4 million for the quarter ended March 31, 2023, compared to $7.1 million for the quarter ended March 31, 2022. The increase was primarily driven by personnel costs, including stock-based compensation expense, and facilities and related costs.

Net Loss: Net loss was $33.2 million, or $(0.22) per basic and diluted share, for the quarter ended March 31, 2023, compared to $36.5 million, or $(0.31) per basic and diluted share, for the quarter ended March 31, 2022.

On May 15, 2023 Enveric Biosciences, Inc. (NASDAQ: ENVB) ("Enveric" or the "Company"), a biotechnology company dedicated to the development of novel small-molecule therapeutics for the treatment of anxiety, depression, and addiction disorders, reported a corporate update and reported financial results for the first quarter of 2023 ended March 31, 2023 (Press release, Enveric Biosciences, MAY 15, 2023, View Source [SID1234631717]).

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Enveric announced a cost reduction plan to extend its financial runway into the first quarter of 2024. The operational streamlining entailed an approximately 35 percent reduction in full-time personnel, the cancelation of 7 consulting contracts focused on the cannabinoid programs and a transition from third-party service providers supporting R&D efforts to internal science teams performing this work. Separately, Enveric announced that the proposed spin-off of cannabinoid clinical development pipeline assets to Akos Biosciences, Inc. ("Akos") is not proceeding due to the holders of the Akos Series A Preferred Stock electing to exercise their right to require Enveric to redeem all of the Akos Series A Preferred Stock due to an inability to meet listing requirements on a national exchange. Enveric now plans to engage with strategic advisors to identify and pursue alternative routes to capture value from these assets.

"Underpinning Enveric’s business and development strategy is a continued focus on maximizing the value of our novel drug development programs to produce positive returns for our shareholders. In this pursuit, the Company has been diligently working to develop a robust and differentiated pipeline of small-molecule therapeutics for the treatment of mental health disorders," said Joseph Tucker, Ph.D., Director and CEO of Enveric Biosciences. "Today’s announcement, including the cost reduction plan and reduction in force, reflects the necessary evolution of this strategy, enabling a greater focus of resources towards Enveric’s most valuable assets, EB-373 and our EVM301 Series."

FIRST QUARTER AND RECENT UPDATES

During the quarter, the company has made progress in delivering on the top near-term priorities:

Priority #1 – Progressing Small Molecule Therapeutics Pipeline Targeting Unmet Needs in Mental Health

Advanced product manufacturing and preclinical activities that support initiation of Phase 1 clinical trial for lead asset, EB-373, for the treatment of anxiety disorder
Continued in vitro and in vivo testing of novel chemical entities developed from the EVM301 Series with the goal of identifying lead molecules by year-end 2023
EVM301 Series of novel molecules are specifically designed to promote neuroplasticity and show efficacy in animal models of depression and anxiety without inducing the hallmark hallucinations of other psychedelic or psychedelic-inspired agents
Established Enveric Therapeutics, an Australia-based subsidiary to manage clinical operations for EB-373 and additional clinical-stage candidates from the EVM201 and EVM301 Series of compounds
Priority #2 – Maximizing Operational Efficiency

Announced cost reduction plan designed to extend financial runway into the first quarter of 2024
Operational streamlining includes an approximately 35% reduction in full-time workforce personnel, the cancelation of 7 contracts for consultants focused on the cannabinoid programs, and a transition from third-party service providers supporting R&D efforts to internal science teams performing this work
Update on Proposed Spin-off of Cannabinoid Clinical Pipeline Assets

On May 11, 2022, the Company announced plans to transfer and spin-off its cannabinoid clinical development pipeline assets (the "Spin-Off") to Akos Biosciences, Inc. (formerly known as Acanna Therapeutics, Inc.), a majority-owned subsidiary of the Company. In connection with the Spin-Off, the Company transferred its cannabinoid clinical development pipeline assets to Akos, while retaining its psychedelics and non-hallucinogenic clinical development pipeline assets. The Spin-Off was subject to various conditions, including Akos meeting the qualifications for listing on the Nasdaq Stock Market, and if successful, would result in two standalone public companies. The new company resulting from the Spin-Off was to be referred to as Akos. As of May 5, 2023, since the Spin-Off had not occurred, the holders of the Akos Series A Preferred Stock had the right, but not the obligation, to cause Enveric to redeem all or a portion of the Akos Series A Preferred Stock. As of May 12, 2023, the holders of the Akos Series A Preferred Stock have exercised this right to require Enveric to redeem all of the Akos Series A Preferred Stock for $1,000 per share, plus accrued but unpaid dividends per share of approximately $50,000 for a total of approximately $1,050,000.

Enveric now plans to seek strategic advisors and alternative routes to capture value from these assets.

FIRST QUARTER 2023 FINANCIAL RESULTS

Net loss attributable to shareholders was $4.80 million for the quarter ended March 31, 2023, including $0.56 million in net non-cash expenses, with a basic and diluted loss per share of $2.31, as compared to a net loss of $4.44 with basic and diluted loss per share of $5.34 per share for the quarter ended March 31, 2022.

Net cash used in operations for the quarter ended March 31, 2023, was $5.14 million consisting of a $4.68 million net loss, adjusted by a net of $0.46 million in non-cash expenses and changes in asset and liability balances of $0.92 million.

As of March 31, 2023, the Company had cash and cash equivalents of $12.56 million and working capital of $10.40 million.

On May 15, 2023 Elevation Oncology, Inc. (Nasdaq: ELEV), an innovative oncology company focused on the discovery and development of selective cancer therapies to treat patients across a range of solid tumors with significant unmet medical needs, reported financial results for the quarter ended March 31, 2023, and highlighted recent business achievements (Press release, Ensysce Biosciences, MAY 15, 2023, View Source [SID1234631716]).

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"Throughout the first quarter of 2023, we made significant progress as a company. Most recently, we presented preclinical data for our lead candidate, EO-3021, demonstrating anti-tumor activity in preclinical models expressing varying levels of Claudin 18.2, and highlighted a clinical case study showing EO-3021 induced a confirmed partial response in a patient with metastatic gastric cancer," said Joseph Ferra, Interim Chief Executive Officer of Elevation Oncology. "This is an exciting time for us as we and our partner, CSPC Pharmaceutical Group Limited, embark on sharing initial clinical data from the ongoing Phase 1 study of EO-3021 at ASCO (Free ASCO Whitepaper) 2023. In addition, we remain on track to initiate our Phase 1 trial evaluating EO-3021 in the US in the second half of 2023."

Recent Business Achievements

EO-3021

Presented preclinical proof-of-concept data at AACR (Free AACR Whitepaper) 2023. Key preclinical findings included demonstrating anti-tumor activity in preclinical xenograft models of pancreatic and gastric cancers expressing varying levels of Claudin 18.2. A single-dose of EO-3021 demonstrated tumor regression across low, medium, and high Claudin 18.2-expressing models, with a lower minimal efficacious dose in models with medium and high levels of Claudin 18.2 relative to models with low levels of Claudin 18.2. EO-3021 also outperformed standard of care chemotherapy in gastric and pancreatic cancer preclinical xenograft models.
Highlighted clinical case study of EO-3021 at AACR (Free AACR Whitepaper) 2023. A clinical case study of a patient with metastatic gastric cancer in an ongoing Phase 1 clinical trial of SYSA1801 (EO-3021) in China (NCT05009966) conducted by CSPC Pharmaceutical Group Limited (HKEX: 01093) was also highlighted. The patient was treated with dose level 2, or 1.0mg/kg EO-3021, intravenously, every three weeks (treatment ongoing). The best overall response, as evaluated per RECIST v1.1, was a confirmed partial response (66.7% maximal tumor reduction), while the duration of response was approximately 11 months and ongoing.
SYSA1801 (EO-3021) Phase 1 data selected for presentation at ASCO (Free ASCO Whitepaper) 2023. An abstract featuring SYSA1801 (EO-3021) Phase 1 clinical data has been selected for a poster presentation and poster discussion at the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2023 Annual Meeting, being held June 2-6, 2023, in Chicago, IL. The ongoing Phase 1 dose escalation and dose expansion study is evaluating SYSA1801 in patients with Claudin 18.2-positive advanced solid tumors and is being conducted in China by Elevation Oncology’s partner, CSPC Pharmaceutical Group Limited (CSPC; HKEX: 01093).
Other Pipeline Programs

Continue research and development efforts to advance novel therapeutic drug candidates and targets. Additional pipeline programs include those through its existing partnership with Caris Life Sciences.
Expected Upcoming Milestones and Operational Objectives

Initiate Phase 1 clinical trial of EO-3021 in the US in the second half of 2023
Ongoing target evaluation for future pipeline expansion
First Quarter 2023 Financial Results

As of March 31, 2022, the Company had cash, cash equivalents and marketable securities totaling $73.9 million, compared to $90.3 million as of December 31, 2022.

Research and development expenses for the first quarter 2023 were $7.3 million, compared to $13.6 million for the first quarter 2022. The decrease in R&D expense in the first quarter of 2023 was primarily related to the decrease in costs related to manufacturing clinical supply of seribantumab for use in the CRESTONE clinical trial. The Company prioritized its pipeline and realigned resources to advance its EO-3021 product candidate.

General and administrative expenses for the first quarter 2023 were $4.3 million, compared to $3.8 million for the first quarter 2022. The increase in G&A expense in the first quarter of 2023 was primarily related to increases in personnel costs, professional services and other administrative costs.

Restructuring charges were $5.1 million for the first quarter 2023, and consisted primarily of one-time charges related to the pipeline prioritization and realignment of resources to advance our EO-3021 product candidate, including $1.6 million of termination and contractual termination benefits for severance, healthcare and related benefits.

Net loss for the first quarter 2023 was $17.1 million, compared to $17.3 million for the first quarter 2022.

About EO-3021

EO-3021 (also known as SYSA1801) is a differentiated, clinical-stage antibody drug conjugate (ADC) comprised of an immunoglobulin G1 (IgG1) monoclonal antibody (mAb) that targets Claudin 18.2 and is site-specifically conjugated to the monomethyl auristatin E (MMAE) payload via a cleavable linker with a drug-to-antibody ratio (DAR) of 2. Claudin 18.2 is a specific isoform of Claudin 18 that is only expressed in gastric epithelial cells. During malignant transformation of gastric cancer, the tight junctions may become disrupted, exposing Claudin 18.2 and allowing them to be accessible by Claudin 18.2 targeting agents. Claudin 18.2 can also be expressed in other solids tumors. An Investigational New Drug application for EO-3021 has been cleared by the U.S. Food and Drug Administration.

On May 15, 2023 Elevation Oncology, Inc. (Nasdaq: ELEV), an innovative oncology company focused on the discovery and development of selective cancer therapies to treat patients across a range of solid tumors with significant unmet medical needs, reported financial results for the quarter ended March 31, 2023, and highlighted recent business achievements (Press release, Elevation Oncology, MAY 15, 2023, View Source;utm_medium=rss&utm_campaign=elevation-oncology-reports-first-quarter-2023-financial-results-and-highlights-recent-business-achievements [SID1234631715]).

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"Throughout the first quarter of 2023, we made significant progress as a company. Most recently, we presented preclinical data for our lead candidate, EO-3021, demonstrating anti-tumor activity in preclinical models expressing varying levels of Claudin 18.2, and highlighted a clinical case study showing EO-3021 induced a confirmed partial response in a patient with metastatic gastric cancer," said Joseph Ferra, Interim Chief Executive Officer of Elevation Oncology. "This is an exciting time for us as we and our partner, CSPC Pharmaceutical Group Limited, embark on sharing initial clinical data from the ongoing Phase 1 study of EO-3021 at ASCO (Free ASCO Whitepaper) 2023. In addition, we remain on track to initiate our Phase 1 trial evaluating EO-3021 in the US in the second half of 2023."

Recent Business Achievements

EO-3021

Presented preclinical proof-of-concept data at AACR (Free AACR Whitepaper) 2023. Key preclinical findings included demonstrating anti-tumor activity in preclinical xenograft models of pancreatic and gastric cancers expressing varying levels of Claudin 18.2. A single-dose of EO-3021 demonstrated tumor regression across low, medium, and high Claudin 18.2-expressing models, with a lower minimal efficacious dose in models with medium and high levels of Claudin 18.2 relative to models with low levels of Claudin 18.2. EO-3021 also outperformed standard of care chemotherapy in gastric and pancreatic cancer preclinical xenograft models.
Highlighted clinical case study of EO-3021 at AACR (Free AACR Whitepaper) 2023. A clinical case study of a patient with metastatic gastric cancer in an ongoing Phase 1 clinical trial of SYSA1801 (EO-3021) in China (NCT05009966) conducted by CSPC Pharmaceutical Group Limited (HKEX: 01093) was also highlighted. The patient was treated with dose level 2, or 1.0mg/kg EO-3021, intravenously, every three weeks (treatment ongoing). The best overall response, as evaluated per RECIST v1.1, was a confirmed partial response (66.7% maximal tumor reduction), while the duration of response was approximately 11 months and ongoing.
SYSA1801 (EO-3021) Phase 1 data selected for presentation at ASCO (Free ASCO Whitepaper) 2023. An abstract featuring SYSA1801 (EO-3021) Phase 1 clinical data has been selected for a poster presentation and poster discussion at the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2023 Annual Meeting, being held June 2-6, 2023, in Chicago, IL. The ongoing Phase 1 dose escalation and dose expansion study is evaluating SYSA1801 in patients with Claudin 18.2-positive advanced solid tumors and is being conducted in China by Elevation Oncology’s partner, CSPC Pharmaceutical Group Limited (CSPC; HKEX: 01093).
Other Pipeline Programs

Continue research and development efforts to advance novel therapeutic drug candidates and targets. Additional pipeline programs include those through its existing partnership with Caris Life Sciences.
Expected Upcoming Milestones and Operational Objectives

Initiate Phase 1 clinical trial of EO-3021 in the US in the second half of 2023
Ongoing target evaluation for future pipeline expansion
First Quarter 2023 Financial Results

As of March 31, 2022, the Company had cash, cash equivalents and marketable securities totaling $73.9 million, compared to $90.3 million as of December 31, 2022.

Research and development expenses for the first quarter 2023 were $7.3 million, compared to $13.6 million for the first quarter 2022. The decrease in R&D expense in the first quarter of 2023 was primarily related to the decrease in costs related to manufacturing clinical supply of seribantumab for use in the CRESTONE clinical trial. The Company prioritized its pipeline and realigned resources to advance its EO-3021 product candidate.

General and administrative expenses for the first quarter 2023 were $4.3 million, compared to $3.8 million for the first quarter 2022. The increase in G&A expense in the first quarter of 2023 was primarily related to increases in personnel costs, professional services and other administrative costs.

Restructuring charges were $5.1 million for the first quarter 2023, and consisted primarily of one-time charges related to the pipeline prioritization and realignment of resources to advance our EO-3021 product candidate, including $1.6 million of termination and contractual termination benefits for severance, healthcare and related benefits.

Net loss for the first quarter 2023 was $17.1 million, compared to $17.3 million for the first quarter 2022.

About EO-3021

EO-3021 (also known as SYSA1801) is a differentiated, clinical-stage antibody drug conjugate (ADC) comprised of an immunoglobulin G1 (IgG1) monoclonal antibody (mAb) that targets Claudin 18.2 and is site-specifically conjugated to the monomethyl auristatin E (MMAE) payload via a cleavable linker with a drug-to-antibody ratio (DAR) of 2. Claudin 18.2 is a specific isoform of Claudin 18 that is only expressed in gastric epithelial cells. During malignant transformation of gastric cancer, the tight junctions may become disrupted, exposing Claudin 18.2 and allowing them to be accessible by Claudin 18.2 targeting agents. Claudin 18.2 can also be expressed in other solids tumors. An Investigational New Drug application for EO-3021 has been cleared by the U.S. Food and Drug Administration.

On May 15, 2023 DiaMedica Therapeutics Inc. (Nasdaq: DMAC), a clinical-stage biopharmaceutical company focused on developing novel treatments for neurological disorders and kidney diseases, reported a business update and financial results for the quarter ended March 31, 2023 (Press release, DiaMedica, MAY 15, 2023, View Source [SID1234631714]). Management will host a conference call Tuesday, May 16, 2023, at 7:00AM Central Daylight Time/8:00AM Eastern Daylight Time to discuss its business update and first quarter 2023 financial results.

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Clinical Developments

ReMEDy2 Phase 2/3 Trial for Acute Ischemic Stroke – Clinical Hold Update

DiaMedica plans to file complete response requesting hold lift this week

DiaMedica plans to file a clinical hold response with the U.S. Food and Drug Administration (FDA) by the end of the week. This request for lifting the clinical hold will include the submission of requested additional supporting data to address prior issues that led to the clinical hold in July 2022. DiaMedica has completed supplemental in-use studies as requested by the FDA. These studies, performed at an independent laboratory, were conducted in two parts. Part 1 simulated actual use of DM199 administration in a hospital setting and Part 2 evaluated worst-case scenarios such as varying storage durations, temperature(s) and light exposure to DM199. DiaMedica believes data from Part 1 confirmed its conclusions from prior testing that the intravenous (IV) dose administered in the ReMEDy2 study was higher than planned due to the change in IV bag materials and was the cause of the hypotension. Accordingly, a dose revision in ReMEDy2 from 1.0 µg/kg to 0.5 µg/kg should avoid or minimize the risk of clinically significant hypotension while still reaching what we believe will be a therapeutic blood concentration level. Additionally, results from part 2 of the in-use study were substantially consistent with Part 1 indicating that no special handling instructions should be required. These results are also similar to the Company’s IV bag study completed in the fall of 2022. The Company further notes that there are no proposed changes to the ensuing three weeks of subcutaneous dosing under the study protocol.

As previously announced, the Company provided responses to FDA inquiries on a potential trypsin impurity contributing to hypotension and methods assays to be used to measure results in the in-use study. The FDA responded to the Company indicating that the assays developed for the in-use study appeared appropriate and its assessment of the potential trypsin impurity was also acceptable.

"With the pending submission of our request to lift the clinical hold, we are optimistic that we have fully identified the cause for last year’s unexpected hypotensive events and have provided the FDA with adequate data to support our position and allow the FDA to lift the clinical hold," commented Rick Pauls, DiaMedica’s Chief Executive Officer. "We look forward to receiving the FDA’s response and hope to then be able to resume our work advancing the science of stroke care."

DiaMedica also completed, in healthy volunteers, a Phase 1C open label, single ascending dose (SAD) study of DM199, administered with the polyvinylchloride (PVC) IV bags used in the ReMEDy2 trial. The purpose of the study was to confirm, with human data, that the revised IV dose of DM199, 0.5 µg/kg, was well-tolerated in humans and achieved an appropriate DM199 blood concentration level similar to prior clinical trials and in the desired therapeutic range. The results from this study will be included as additional supporting data in the Company’s clinical hold response package to the FDA.

"Patient safety is paramount for DiaMedica and we’re pleased to go above and beyond to achieve that end," stated Kirsten Gruis, M.D., DiaMedica’s Chief Medical Officer. "Data developed in our Phase 1C study at the 0.5 µg/kg IV dose level has demonstrated similar DM199 exposure with the IV dosing regimen used in our ReMEDy1 AIS trial. These results, in addition to the in-use study, give us further assurance that we have identified the correct DM199 IV dose level and we hope that this will also give confidence to physician investigators once we are able to resume the ReMEDy2 trial."

Balance Sheet and Cash Flow

DiaMedica reported total cash, cash equivalents and investments of $28.7 million, current liabilities of $2.8 million and working capital of $26.9 million as of March 31, 2023, compared to total cash, cash equivalents and investments of $33.5 million, $2.2 million in current liabilities and $31.7 million in working capital as of December 31, 2022. The decreases in cash and investments and in working capital were due primarily to cash used to fund operating activities during the quarter ended March 31, 2023. After the end of the quarter, DiaMedica received $750,000 from a private investment from its newly appointed Chief Business Officer.

Net cash used in operating activities for the three months ended March 31, 2023 was $5.1 million compared to $3.9 million for the three months ended March 31, 2022. The increase in cash usage relates primarily to the increased net loss in the current year period over the prior year period, partially offset by non-cash share-based compensation and the effects of changes in operating assets and liabilities in the current year period.

Financial Results

Research and development (R&D) expenses increased to $3.6 million for the three months ended March 31, 2023, up $1.6 million from $2.0 million for the three months ended March 31, 2022. The increased costs were driven by a number of factors, including primarily increased manufacturing and process development costs, the costs for the in-use study performed to address the clinical hold on the IND for the ReMEDy2 trial, costs incurred for the Phase 1C health volunteer study and increased personnel costs associated with expansion of the clinical team. These increases were partially offset by decreased costs incurred in the Phase 2/3 ReMEDy2 trial due to the clinical hold.

General and administrative (G&A) expenses were $1.9 million for the three months ended March 31, 2023, up from $1.6 million for the three months ended March 31, 2022. The increase was primarily due to recruiting costs incurred in conjunction the expansion of the Company’s team and increased legal fees incurred in connection with the Company’s lawsuit against Pharmaceutical Research Associates Group B.V., which was acquired by and is now a subsidiary of ICON plc.

Conference Call and Webcast Information

DiaMedica Management will host a conference call and webcast to discuss its business update and first quarter 2023 financial results on Tuesday, May 16, 2023, at 8:00 AM Eastern Time / 7:00 AM Central Time:

Date:

Tuesday, May 16, 2023

Time:

7:00 AM CT / 8:00 AM ET

Web access:

View Source

Dial In:

(877) 550-1858

Conference ID:

2125#

Interested parties may access the conference call by dialing in or listening to the simultaneous webcast. Listeners should log on to the website or dial in 15 minutes prior to the call. The webcast will remain available for play back on the Company’s website, under investor relations – events and presentations, following the earnings call and for 12 months thereafter. A telephonic replay of the conference call will be available until May 23, 2023, by dialing (800) 645-7964 (US Toll Free) and entering the replay passcode: 2125#.

About ReMEDy2 Trial

The ReMEDy2 trial is an adaptive design, randomized, double-blind, placebo-controlled trial studying the use of the Company’s product candidate, DM199, to treat acute ischemic stroke (AIS) patients. The trial is intended to enroll approximately 350 patients at 75 sites in the United States. Patients enrolled in the trial will be treated for three weeks with either DM199 or placebo, beginning within 24 hours of the onset of AIS symptoms, with the final follow-up at 90 days. The trial excludes patients treated with tissue plasminogen activator (tPA) and/or mechanical thrombectomy. The study population is representative of the approximately 80% of AIS patients who do not have treatment options today, primarily due to the limitations on treatment with tPA or mechanical thrombectomy. DiaMedica believes that the proposed trial has the potential to serve as a pivotal registration study of DM199 in this patient population.

About DM199

DM199 is a recombinant (synthetic) form of human tissue kallikrein-1 (KLK1). KLK1 is a serine protease (protein) that plays an important role in the regulation of diverse physiological processes including blood flow, inflammation, fibrosis, oxidative stress and neurogenesis via a molecular mechanism that increases production of nitric oxide and prostaglandin. KLK1 deficiency may play a role in multiple vascular and fibrotic diseases such as stroke, chronic kidney disease, retinopathy, vascular dementia, and resistant hypertension where current treatment options are limited or ineffective. DiaMedica is the first company to have developed and clinically studied a recombinant form of the KLK1 protein. The KLK1 protein, produced from the pancreas of pigs and human urine, has been used to treat patients in Japan, China and South Korea for decades. DM199 is currently being studied in patients with acute ischemic stroke (AIS) and patients with chronic kidney disease. In September 2021, the FDA granted Fast Track Designation to DM199 for the treatment of AIS.