On March 15, 2023 Sermonix Pharmaceuticals Inc., a privately held biopharmaceutical company developing innovative therapeutics to specifically treat metastatic breast and gynecological cancers harboring ESR1 mutations, reported an e-poster at the St. Gallen International Breast Cancer Conference detailing its Phase 2 clinical trial evaluating neoadjuvant lasofoxifene in molecularly selected HR+/HER2-, locally advanced breast cancer (Press release, Sermonix Pharmaceuticals, MAR 15, 2023, View Source [SID1234628826]).

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The 18th St. Gallen conference, titled Primary Therapy of Early Breast Cancer. Evidence, Controversies, Consensus, is being held March 15-18 in Vienna.

The open-label, randomized, multicenter trial is a new arm of the Endocrine Optimization Pilot Protocol (EOP), a sub-study of the ongoing I-SPY 2 TRIAL (Investigation of Serial studies to Predict Your Therapeutic Response with Imaging And moLecular analysis 2). The I-SPY family of trials are sponsored and managed by Quantum Leap Healthcare Collaborative (QLHC), which partners with a consortium that includes the U.S. Food and Drug Administration (FDA), industry, patient advocates, philanthropic sponsors, and clinicians from 41 major U.S. cancer research centers.

"Sermonix is pleased to present the I-SPY 2 EOP study protocol during this year’s St. Gallen conference, which is among the most influential and widely attended annual medical congresses solely focused on breast cancer," said Dr. David Portman, founder and chief executive officer of Sermonix. "The EOP arm of the I-SPY 2 trial is an important and valuable addition to our own ongoing clinical development activities, and we look forward to this incremental data as we execute our own registrational ELAINE-3 Phase 3 combination study of lasofoxifene with abemaciclib in the metastatic setting."

"The data generated on lasofoxifene to date is very compelling, particularly as it relates to vaginal and sexual health, areas where the current standard-of-care endocrine therapy, aromatase inhibitors, are known to cause serious side effects," said Dr. Laura Esserman of the University of California San Francisco, founder and leader of the I-SPY Program. "We are pleased to include lasofoxifene in the I-SPY 2 EOP and eager to assess its efficacy in light of its more favorable tolerability profile."

e-Poster Details:

Title: (Trial in Progress) A Phase 2, Open-Label, Randomized Multicenter Trial to Evaluate Neoadjuvant Lasofoxifene in Molecularly Selected HR+/HER2- Clinical Stage 2/3 Breast Cancer
Poster #: P132
Summary: Chemotherapy offers limited benefit for early-stage breast cancer patients with molecular low risk, clinical high risk, hormone receptor positive (HR+)/HER2-negative tumors. Studies have shown neoadjuvant endocrine therapy (NET) can downstage breast tumors and facilitate breast conservation compared to neoadjuvant chemotherapy in women with locally advanced HR+/HER2- breast cancer. Aromatase inhibition (AI) (+/- ovarian function suppression (OFS)) is the standard NET for locally advanced, HR+/HER2- breast cancer. However, the toxicity profile of AI/OFS causes poor tolerance, thus more tolerable and effective treatments are needed.

This Endocrine Optimization Protocol (EOP) is a Phase 2, open-label, randomized multicenter platform sub-study within the ongoing I-SPY 2 clinical trial. Patients will be randomized to receive: 1) lasofoxifene 5 mg daily, 2) AI, or 3) other concurrent experimental arms (if applicable), for six consecutive 28-day periods. The primary endpoint is feasibility (≥80% of enrolled patients completing protocol-defined study therapy). Secondary endpoints include safety and efficacy, as measured by pathological and clinical response and patient reported outcomes, and the identification of potential biomarkers of response for subsequent validation.

Sermonix is supplying lasofoxifene and providing financial support to QLHC for this study. The I-SPY program includes 41 sites, and all I-SPY cancer center sites have the EOP program open.

For more information about the trial: NCT01042379.

All e-posters will be accessible on terminals in the E-Poster Area on Level 1 for the duration of the conference.

About Lasofoxifene

Lasofoxifene is an investigational novel endocrine therapy in clinical development which has demonstrated robust target engagement as an ESR1 antagonist in the breast, particularly in the presence of ESR1 mutations. Lasofoxifene has demonstrated anti-tumor activity as monotherapy and in combination with abemaciclib in Phase 2 studies and has unique tissue selectivity distinguishing it from other current and investigational endocrine therapies, with beneficial effects seen on vagina and bone in previous clinical studies. Lasofoxifene, which Sermonix licensed globally from Ligand Pharmaceuticals Inc. (NASDAQ:LGND), has been studied in previous comprehensive Phase 1-3 non-oncology clinical trials in more than 15,000 postmenopausal women worldwide. Lasofoxifene’s bioavailability and activity in mutations of the estrogen receptor could potentially hold promise for patients who have acquired endocrine resistance due to ESR1 mutations, a common finding in the metastatic setting and an area of high unmet medical need. Lasofoxifene’s novel activity in ESR1 mutations was discovered at Duke University and Sermonix has exclusive rights to develop and commercialize the product in this area. Lasofoxifene, a novel targeted and tissue selective oral endocrine therapy could, if approved, play a critical role in the precision medicine treatment of advanced ER+ breast cancer.

On March 15, 2023 Inhibikase Therapeutics, Inc. (Nasdaq: IKT) ("Inhibikase" or "Company"), a clinical-stage pharmaceutical company developing protein kinase inhibitor therapeutics to modify the course of Parkinson’s disease, Parkinson’s-related disorders and other diseases of the Abelson Tyrosine Kinases, reported an interim update from the dose escalation portion of its ‘501’ bioequivalence study of IkT-001Pro, the Company’s prodrug formulation of imatinib mesylate designed to enhance the safety and efficacy of imatinib (marketed as Gleevec) in patients with Chronic Myelogenous Leukemia (CML) (Press release, Inhibikase Therapeutics, MAR 15, 2023, View Source [SID1234628825]).

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The 501 trial is evaluating IkT-001Pro at four single ascending doses in the dose escalation portion of the study to select the bioequivalent dose, followed by a dose confirmation portion to confirm the bioequivalent dose. The study will enroll a total of 59 male and female healthy volunteers, aged 25 to 55. The study is designed to evaluate the safety profile of IkT-001Pro as well as compare the pharmacokinetic exposure of IkT-001Pro to the standard of care dose of 400 mg imatinib mesylate in order to identify a bioequivalent dose.

As of March 15, 2023, the Company has enrolled 19 of 27 healthy volunteers in the dose calibration portion of the study, completing 3 of 4 planned escalating doses at 300, 400 and 500 mg IkT-001Pro. To date, IkT-001Pro has shown a favorable safety profile, with only 4 mild adverse events observed, none of clinical significance. IkT-001Pro has high oral bioavailability and a pharmacokinetic profile of delivered imatinib that closely matches the exposure of imatinib delivered as 400 mg imatinib mesylate. Upon completion of the dose escalation phase, the Company will conduct a confirmatory analysis of the bioequivalent dose of IkT-001Pro in 32 additional healthy volunteers using a two-period crossover design. The Company remains on track to complete the 501 trial in the second quarter of 2023.

"We have made great progress in our 501 trial, since dosing the first patients in December," stated Dr. Milton Werner, President and Chief Executive Officer. "To date, our observations in the trial have followed expectations and are in line with our previously reported preclinical data, where we demonstrated that delivery of imatinib as IkT-001Pro was well tolerated. With the rapid completion of the first three dose cohorts, we are on track to complete the 501 trial in the second quarter of 2023."

Following the completion of the 501 trial, Inhibikase plans to initiate a discussion with the FDA on the parameters for approval of IkT-001pro under the 505(b)(2) statute.

About IkT-001Pro
IkT-001Pro is a prodrug formulation of imatinib mesylate and has been developed to improve the safety of the first FDA-approved Abelson (Abl) kinase inhibitor, imatinib (marketed as Gleevec). Imatinib is commonly taken for hematological and gastrointestinal cancers that arise from Abl kinase mutations found in the bone marrow or for gastrointestinal cancers that arise from c-Kit and/or PDGFRa/b mutations in the stomach; c-Kit, PDGFRa/b and Abl are all members of the Abelson Tyrosine Kinase protein family. IkT-001Pro has the potential to be a safer alternative for patients and may improve the number of patients that reach and sustain major and/or complete cytogenetic responses in stable-phase CML and/or reduce the relapse rate for these patients. In preclinical studies, IkT-001Pro was shown to be as much as 3.4 times safer than imatinib in non-human primates, reducing burdensome gastrointestinal side effects that occur following oral administration. Imatinib delivered as IkT-001Pro was granted Orphan Drug Designation for stable-phase CML in September 2018.

About Chronic Myelogenous Leukemia
Chronic myeloid leukemia1 is a slowly progressing cancer that affects the blood and bone marrow. In CML, a genetic change takes place in immature myeloid cells — the cells that make most types of white blood cells. This change creates an abnormal gene product called BCR-ABL which transforms the cell into a CML cell. Leukemia cells increasingly grow and divide in an unregulated manner, eventually spilling out of the bone marrow and circulating in the body via the bloodstream. Because they proliferate in an uncontrolled manner, the excessive production of myeloid cells acts like a liquid tumor. In time, the cells can also settle in other parts of the body, including the spleen. CML is a form of slow-growing leukemia that can change into a fast-growing form of acute leukemia that is difficult to treat.

On March 15, 2023 Immunoprecise Antibodies Ltd. (NASDAQ: IPA) ("Immunoprecise" or "IPA" or the "Company"), an AI-driven biotherapeutic research and technology company, reported that Talem Therapeutics LLC, an independently operating subsidiary of IPA, and Libera Bio S.L., have signed a collaboration agreement to jointly address intracellular targets (Press release, ImmunoPrecise Antibodies, MAR 15, 2023, View Source [SID1234628824]). It is estimated that 75% of disease-causing targets are located inside cells1. Some of the most elusive cancer targets are expressed inside tumor cells. Because they are so difficult to address, they have sometimes been deemed "undruggable" and thus represent high unmet medical needs.

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Numerous pathways intersect inside tumor cells, such as the MAPK pathway or the "Hedgehog Pathway", and may generate conditions for tumors to develop, grow and evade the immune system. Disrupting signals at one or more points within these pathways may slow down the growth of the tumors and inhibit their proliferation. Small molecules have been successfully developed to this end, but they often present a significant lack of specificity resulting in toxicity, leading to undesirable side effects for patients. Engineering antibodies to force them inside tumor cells has also been attempted, but it is a complex process, often wrought with failure. The collaboration between Talem and Libera Bio will leverage a nanotechnology that has been proven in vivo to deliver antibodies inside tumor cells and provides a potential solution to this medical challenge.

Libera Bio’s Multifunctional Polymeric Nanocapsules (MPN Technology) offer an elegant way to deliver antibodies inside tumor cells. The relevant antibodies are encapsulated in multi-layer nanocapsules of approximately 1/10,000th of a millimeter in diameter. The nanocapsules are specifically designed around the physicochemical properties of antibodies, to protect them from degradation in the blood stream. Libera Bio believes that this might be the only nanotechnology with in vivo proof of concept of delivering whole antibodies intracellularly. In addition, MPNs can deliver other biologic modalities or combinations of a biologic and a small molecule in the same nanocapsule. Passively or actively targeted, the MPNs deliver these compounds through a cell membrane and to intracellular targets.

Whole antibodies, close to their natural form, can be delivered in this manner. Talem will leverage its antibody discovery and development expertise and access, including without limitation, the LENSai Technology from BioStrand B.V., an independently operating subsidiary of IPA. BioStrand has developed a proprietary, AI-driven platform to optimize the design of such antibodies. BioStrand computationally generates and rapidly screens a large set of diverse antibody candidates against a prioritized list of targets, including intracellular targets.

Talem and Libera Bio will jointly develop novel antibodies for use with MPN delivery, with the goal of offering them to larger pharma companies to conduct late-stage development and commercialization. The work launches with the investigation of two intracellular targets with very high unmet patient needs to offer options to the oncologists treating them. "As we continue to push the boundaries of cancer therapy, the ability to target intracellular proteins has been the ‘Holy Grail’ in oncology. Libera Bio’s ground-breaking approach of enabling biologics to penetrate the cell membrane and reach previously ‘undruggable’ targets is an exciting development that has the potential to transform the way we treat cancer," said Dr. Jennifer Bath, CEO and President of Immunoprecise Antibodies Ltd.

"The Libera Bio team has been very impressed with the combination of modern in silico tools and wet lab capabilities at the IPA Family of companies. We are looking forward to this alliance that just may yield dozens of new options for cancer treatment," added Olivier Jarry, Co-Founder and CEO of Libera Bio.

Verdine GL, Walensky LD. The challenge of drugging undruggable targets in cancer: lessons learned from targeting BCL-2 family members. Clin Cancer Res. 2007;13(24):7264-70. doi:10.1158/1078-0432.CCR-07-2184.

On March 15, 2023 EpicentRx, a leading edge, clinical stage biopharmaceutical company, reported publication of results in the well-respected, international journal, Frontiers in Immunology, from a small 12 patient, 12-week, open label Phase 1 clinical trial called PRIMETIME (NCT02518958) (Press release, EpicentRx, MAR 15, 2023, View Source [SID1234628823]).

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PRIMETIME was a pilot study to evaluate the safety of RRx-001 and nivolumab in patients with advanced checkpoint inhibitor non-responsive tumors and no standard options. RRx-001 reprograms tumor associated macrophages (TAMs), which normally aid, and abet cancer cells, to go on the attack against them. The presence of TAMs in tumors is responsible for resistance to the anticancer effects of checkpoint inhibitors like nivolumab. This was the basis to combine RRx-001 and nivolumab since the addition of RRx-001 may drive efficacy in tumor types where checkpoint blockade monotherapy is traditionally ineffective.

The combination treatment was well tolerated with no dose limiting toxicities and demonstrated an unconfirmed response rate of 25% and a disease control rate of 67% across four different dose levels in 12 heavily pre-treated patients with non-immunogenic tumor types. The main side effect due to RRx-001 was infusion related discomfort (33%). The main "side effect" from the combination of RRx-001 and nivolumab, which is probably not really a side effect at all, was pseudoprogression (25%). This describes an apparent increase of tumor size on imaging due to immune cell infiltration in the absence of actual tumor progression.

Dr. Tony Reid, EpicentRx CEO and manuscript lead author, commented that "this was a 12 patient, limited duration study so the usual caveats apply with such a small sample size that was treated for such a short time. However, checkpoint inhibitors are only beneficial in a small subset of patients with particular tumor types like melanoma. In other so-called "cold" tumor types like pancreatic and prostate they aren’t effective at all. Because RRx-001 revs up TAMs to attack tumor cells, it may succeed where other drugs have not to sensitize these otherwise poorly immune checkpoint sensitive cancers, which is exciting."

About RRx-001
The lead EpicentRx small molecule, RRx-001 is a highly selective NLRP3 inhibitor with vascular normalization and tumor associated macrophage polarization properties that resensitizes tumors to previously administered therapies. RRx-001 is under investigation in a Phase 3 trial for the treatment of small cell lung cancer (SCLC), and in a Phase 2 trial for protection against oral mucositis in first line head and neck cancer. It is also under development as a treatment for neurodegenerative diseases like Parkinson’s and ALS/MND.

On March 15, 2023 Champions Oncology, Inc. (Nasdaq: CSBR), a leading global technology-enabled biotech that is transforming drug discovery through innovative AI-driven pharmaco-pheno-multiomic integration, reported its financial results for its third quarter of fiscal 2023, ended January 31, 2023 (Press release, Champions Oncology, MAR 15, 2023, View Source [SID1234628822]).

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Third Quarter and Recent Highlights:

•Record quarterly bookings
•Quarterly revenue of $12.8 million
•Adjusted EBITDA loss of $1.6 million, driven by a $1 million increase in R&D for our target discovery program
•Commenced in-vivo efficacy testing for therapeutic hits on lead programs

Ronnie Morris, CEO of Champions, commented, "Our third quarter results were weaker than we’ve been accustomed to delivering, impacted primarily by the macro-economic environment. Despite the financial performance, we continued to expand our platform and invest in on our drug discovery efforts." Morris added, "Our long-term strategy remains in-tact and we look forward to improving results in fiscal 2024."

David Miller, CFO of Champions, added, "As addressed last quarter, an increase in first half study cancellations would lead to a decline in third quarter revenue and profitability. We’re well positioned to absorb the short-term decline and remain positioned for the expected increase in bookings and revenue heading into fiscal 2024."

Third Fiscal Quarter Financial Results

Total revenue for the third quarter of fiscal 2023, was $12.8 million, a decrease of 3.2%, compared to $13.2 million for the same period last year. The decline in revenue resulted from an increase in cancellations during the first half of the year due to the macro-economic environment, which caused our customers to re-evaluate their spending budgets. Total costs and operating expenses for the third quarter of fiscal 2023 were $15.2 million compared to $12.4 million for the third quarter of fiscal 2022, an increase of $2.9 million or 23.2%.

For the third quarter of fiscal 2023, Champions reported a loss from operations of $2.5 million, including $331,000 in stock-based compensation and $575,000 in depreciation and amortization expenses, compared to income from operations of $830,000, inclusive of $310,000 in stock-based compensation and $396,000 in depreciation and amortization expenses, in the third quarter of fiscal 2022. Excluding stock-based compensation, depreciation and amortization expenses, Champions reported an adjusted EBITDA loss for the quarter of $1.6 million, primarily driven by lower revenue and an increase in R&D spending for our target discovery program, compared to adjusted EBITDA of $1.5 million in the prior year period.
Cost of oncology solutions was $7.7 million for the three-months ended January 31, 2023, an increase of $1.3 million, or 20.2% compared to $6.4 million for the three-months ended January 31, 2022. The increase in cost of sales was primarily from compensation expenses. For the three-months ended January 31, 2023, total gross margin was 40% compared to 51% for the three-months ended January 31, 2022. The lower margin resulted from the aforementioned increase in compensation which was incurred to support the bookings growth that failed to convert to revenue due to cancellations.

Research and development expense for the three-months ended January 31, 2023 was $3.2 million, an increase of $1.0 million or 46.8%, compared to $2.2 million for the three-months ended January 31, 2022. The increase was primarily from compensation and lab supply expenses related to the investment in our therapeutic discovery platform. Sales and marketing expense for the three-months ended January 31, 2023 was $1.8 million, an increase of $212,000, or 13.7%, compared to $1.5 million for the three-months ended January 31, 2022. The increase was primarily due to an increase in compensation and conference expenses to support sales effort expansion. General and administrative expense for the three-months ended January 31, 2023 was $2.6 million, an increase of $342,000, or 15.4%, compared to $2.2 million for the three-months ended January 31, 2022. The increase was primarily due to depreciation and amortization expenses and IT related costs to support the growth of the business.

Net cash provided by operating activities was $1.6 million for the three months ended January 31, 2023. The cash generated from operating activities was primarily due to a decrease in accounts receivable, in the ordinary course of business, and an increase in deferred revenue due to solid bookings. The Company ended in the quarter in a strong cash position with cash on hand of $11.6 million and no debt.

Year-to-Date Financial Results

For the first nine months of fiscal 2023, revenue increased 12.6% to $40.8 million compared to $36.2 million for the first nine months of fiscal 2022. The increase in revenue was due to the expansion of our platforms and business lines. Total costs and operating expenses for the first nine months of fiscal 2023 were $43.5 million compared to $35.3 million for the first nine months of fiscal 2022, an increase of $8.2 million or 23.3%.

For the first nine months of fiscal 2023, Champions reported a net loss from operations of $2.7 million, including $656,000 in stock-based compensation and $1.7 million in depreciation and amortization

expenses, compared to income from operations of $918,000, inclusive of $724,000 in stock-based compensation and $1.1 million in depreciation and amortization expenses, in the first nine months of fiscal 2022. Excluding stock-based compensation, depreciation and amortization expenses, Champions reported an adjusted EBITDA loss of $400,000 for the first nine months of fiscal 2023 compared to adjusted EBITDA of $2.7 million in the first nine months of fiscal 2022.

Cost of oncology solutions was $22.2 million for the nine-months ended January 31, 2023, an increase of $4.8 million, or 27.5% compared to $17.4 million for the nine-months ended January 31, 2022. The increase in cost of sales was primarily from compensation, mice and lab supply expenses resulting from the increase in study volume and expected strength in future bookings. For the nine-months ended January 31, 2023, total gross margin was 45.6% compared to 51.9% for the nine-months ended January 31, 2022. For the same respective periods, pharmacology services margin was 48.1% vs 53.0%. The decrease in gross margin was primarily attributable to an increase in study related expenses on lower than expected revenue conversion.

Research and development expense for the nine-months ended January 31, 2023 was $8.7 million, an increase of $1.9 million or 28.2%, compared to $6.8 million for the nine-months ended January 31, 2022. The increase was primarily from compensation, sequencing costs, and lab supplies as we increased investment in our therapeutic target discovery platforms. Sales and marketing expense for the nine-months ended January 31, 2023 was $5.2 million, an increase of $389,000, or 8.2%, compared to $4.8 million for the nine-months ended January 31, 2022. The increase was primarily due to an increase in compensation and conference related expenses to support the expansion of our sales efforts. General and administrative expense for the nine-months ended January 31, 2023 was $7.5 million, an increase of $1.1 million, or 17.9%, compared to $6.4 million for the nine-months ended January 31, 2022. The increase was primarily due to an increase in compensation and IT related expenses to support the overall infrastructure growth of the organization as well as depreciation and amortization expenses.

Net cash provided by operating activities was $4.7 million for the nine-months ended January 31, 2023. The cash generated from operating activities was primarily due to a decrease in accounts receivable and an increase in accounts payable due to timing differences in the ordinary course of business. Net cash used in investing activities was $2.1 million and was primarily from investment in additional lab and computer equipment.

Conference Call Information:
The Company will host a conference call today at 4:30 p.m. EDT (1:30 p.m. PDT) to discuss its third quarter financial results. To participate in the call, please call 888-506-0062 (Domestic) or 973-528-0011 (International) and enter the access code 500542, or provide the verbal reference "Champions Oncology".
Full details of the Company’s financial results will be available by March 17, 2023 in the Company’s Form 10-Q at www.championsoncology.com.
* Non-GAAP Financial Information
See the attached Reconciliation of GAAP net income (loss) to Non-GAAP net income (loss) for an explanation of the amounts excluded to arrive at Non-GAAP net income (loss) and related Non-GAAP earnings (loss) per share amounts for the three and nine months ended January 31, 2023 and 2022. Non-GAAP financial measures provide investors and management with supplemental measures of operating

performance and trends that facilitate comparisons between periods before and after certain items that would not otherwise be apparent on a GAAP basis. Certain unusual or non-recurring items that management does not believe affect the Company’s basic operations do not meet the GAAP definition of unusual or non-recurring items. Non-GAAP net income (loss) and Non-GAAP earnings (loss) per share are not, and should not, be viewed as a substitute for similar GAAP items. Champions defines Non-GAAP dilutive earnings (loss) per share amounts as Non-GAAP net earnings (loss) divided by the weighted average number of diluted shares outstanding. Champions’ definition of Non-GAAP net earnings (loss) and Non-GAAP diluted earnings (loss) per share may differ from similarly named measures used by other companies.