On May 6, 2021 McKesson Corporation (NYSE:MCK) reported results for the fourth quarter and fiscal year ended March 31, 2021 (Press release, McKesson, MAY 6, 2021, View Source [SID1234579354]).

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"Our notable performance in fiscal 2021 reflects the continued momentum in our businesses and is a testament to the leadership role McKesson plays in the healthcare supply chain. McKesson’s differentiated capabilities make us the partner of choice for our customers and government entities in their COVID-19 response efforts. I am proud of our employees and what we have accomplished together," said Brian Tyler, chief executive officer. "Despite the dynamic macro environment, the business demonstrated strong execution as we grew Adjusted Earnings per diluted share by 15%. These results allowed us to generate $3.9 billion of Free Cash Flow."

"As we enter fiscal 2022, our top priorities remain the safety of our employees, the success of our customers, and fulfilling our leadership responsibility as the centralized distributor of COVID-19 vaccines and ancillary supplies in the U.S.," Mr. Tyler continued. "We have positioned the business for long-term growth through strategic investments in the areas of oncology and biopharma services and successful transformation of our operating model. Our accomplishments in fiscal 2021 are the foundation for the future and we remain confident in our ability to create long-term value for our shareholders."

Fourth-quarter revenues were $59.1 billion, up 1% from a year ago, driven by market growth and higher volumes from retail national account customers in the U.S. Pharmaceutical segment, partially offset by the prior year acceleration in demand driven by the onset of the COVID-19 pandemic. Full-year revenues were $238.2 billion, up 3% from a year ago, driven by growth in the U.S. Pharmaceutical segment, largely due to market growth and higher specialty volumes, partially offset by branded to generic conversions.

Fourth-quarter earnings per diluted share from continuing operations was $4.15 compared to $5.82 a year ago, a decrease of 29%. Full-year loss per diluted share from continuing operations of ($28.26) included a pre-tax $8.1 billion expense accrual related to the estimated liability for opioid-related claims. This charge was taken in the company’s third-quarter and is not included in full-year Adjusted Earnings per diluted share.

Fourth-quarter Adjusted Earnings per diluted share was $5.05 compared to $4.27 a year ago, an increase of 18%, primarily driven by the contribution from COVID-19 vaccine distribution and kitting programs with the U.S. government and a lower share count, partially offset by a higher tax rate and the prior year contribution from the company’s now separated investment in Change Healthcare LLC ("Change Healthcare"). Fourth-quarter Adjusted Earnings per diluted share included pre-tax net gains of approximately $44 million, or $0.21 per diluted share, associated with McKesson Ventures’ equity investments.

Full-year Adjusted Earnings per diluted share was $17.21 compared to $14.95 a year ago, an increase of 15%, primarily driven by a lower share count and the contribution from COVID-19 vaccine distribution and kitting programs with the U.S. government, partially offset by the prior year contribution from the company’s now separated investment in Change Healthcare. Full-year Adjusted Earnings per diluted share included pre-tax net gains of approximately $133 million, or $0.60 per diluted share, associated with McKesson Ventures’ equity investments.

For the full year, McKesson returned $1.0 billion of cash to shareholders, which included $770 million of common stock repurchases and $276 million of dividend payments. During the fiscal year, McKesson generated cash from operations of $4.5 billion, and invested $641 million in capital expenditures, resulting in Free Cash Flow of $3.9 billion.

Business Highlights

U.S. Pharmaceutical’s operational excellence and scaled distribution network was highlighted by the successful distribution of over 150 million COVID-19 vaccines through April 30, 2021.
McKesson continued to invest in Ontada, the company’s differentiated oncology technology and insights business and also joined MYLUNG, a collaborative real-world research consortium designed to advance precision medicine for non-small cell lung cancer patients.
Prescription Technology Solutions finished fiscal 2021 with positive momentum and Access for More Patients (AMP) contributed to profit growth in the fourth quarter.
Medical-Surgical Solutions played a central role in the COVID-19 response efforts, assembling and distributing the ancillary supply kits needed for COVID-19 vaccinations and distributing COVID-19 tests to healthcare provider customers.
Segment Financials

U.S. Pharmaceutical Segment

Fourth-Quarter:

Revenues were $47.0 billion, an increase of 3%, driven by market growth and higher volumes from retail national account customers, partially offset by the prior year acceleration in demand driven by the onset of the COVID-19 pandemic and branded to generic conversions.
Segment Operating Profit was $892 million. Adjusted Segment Operating Profit was $813 million, an increase of 7% from a year ago, driven by the contribution from COVID-19 vaccine distribution, offset by the prior year acceleration in demand driven by the onset of the COVID-19 pandemic and higher operating costs to support oncology growth initiatives.
Full-Year:

Revenues were $189.3 billion, an increase of 4%, driven by market growth and higher specialty volumes, partially offset by branded to generic conversions.
Segment Operating Profit was $2.8 billion. Adjusted Segment Operating Profit was $2.7 billion, an increase of 3% from a year ago, driven by growth in distribution of specialty products to providers and the contribution from COVID-19 vaccine distribution, offset by the prior year acceleration in demand driven by the onset of the COVID-19 pandemic and higher operating costs to support oncology growth initiatives.
Prescription Technology Solutions Segment

Fourth-Quarter:

Revenues were $789 million, an increase of 7%, driven by higher volumes of technology and service offerings to support biopharma customers.
Segment Operating Profit was $125 million. Adjusted Segment Operating Profit was $146 million, an increase of 11%, driven by organic growth from access and adherence solutions including the contribution from AMP.
Full-Year:

Revenues were $2.9 billion, an increase of 7%, driven by higher volumes of technology and service offerings to support biopharma customers.
Segment Operating Profit was $395 million. Adjusted Segment Operating Profit was $467 million, flat to prior year. Organic growth from access and adherence solutions was offset by higher operating costs to support biopharma services growth initiatives.
Medical-Surgical Solutions Segment

Fourth-Quarter:

Revenues were $2.7 billion, an increase of 23%, driven by demand for COVID-19 tests.
Segment Operating Profit was $171 million. Adjusted Segment Operating Profit was $192 million, an increase of 13%, driven by demand for COVID-19 tests and the contribution from kitting and distribution of ancillary supplies for the U.S. government’s COVID-19 vaccine program, partially offset by inventory charges on certain personal protective equipment (PPE) incurred to support customers through the extraordinary demand related to the COVID-19 pandemic.
Full-Year:

Revenues were $10.1 billion, an increase of 22%, driven by demand for COVID-19 tests and personal protective equipment in the Primary Care and Extended Care businesses.
Segment Operating Profit was $707 million. Adjusted Segment Operating Profit was $805 million, an increase of 19%, driven by demand for COVID-19 tests and the contribution from kitting and distribution of ancillary supplies for the U.S. government’s COVID-19 vaccine program, partially offset by inventory charges on certain PPE and related products.
International Segment

Fourth-Quarter:

Revenues were $8.6 billion. On an FX-adjusted basis, revenues were $7.9 billion, a decline of 18%, driven by the contribution of McKesson’s German wholesale business to a joint venture with Walgreens Boots Alliance.
Segment Operating Profit was $76 million. On an FX-adjusted basis, Adjusted Segment Operating Profit was $126 million, a decline of 8%.
Full-Year:

Revenues were $36.0 billion. On an FX-adjusted basis, revenues were $34.9 billion, a decline of 9%, driven by the contribution of McKesson’s German wholesale business to a joint venture with Walgreens Boots Alliance.
Segment Operating Loss was ($37) million, primarily driven by a GAAP-only pre-tax long-lived asset impairment charge of $115 million. On an FX-adjusted basis, Adjusted Segment Operating Profit was $466 million, an increase of 1%.
Company Updates

McKesson’s commitment to transform its operating model resulted in annual pre-tax cost savings in excess of $400 million, achieving the company’s three-year target of $400 million to $500 million by the end of Fiscal 2021.
Susan Shiff joined McKesson as president of Ontada, the company’s oncology technology and insights business within the U.S. Pharmaceutical segment.
As part of the company’s strategy and actions towards better health for people and the planet, McKesson committed to set science-based targets to reduce the company’s greenhouse gas emissions.
Fiscal 2022 Outlook

McKesson expects full-year fiscal 2022 Adjusted Earnings per diluted share of $18.85 to $19.45, which reflects Adjusted Operating Profit growth in all segments coupled with disciplined, efficient capital deployment, including approximately $2 billion of share repurchases. Fiscal 2022 Adjusted Earnings per diluted share guidance assumes $0.40 to $0.50 related to U.S. government COVID-19 vaccine distribution and $0.10 to $0.20 related to the kitting and distribution of ancillary supplies.

The fiscal 2022 outlook is based on the following key assumptions and expectations and is subject to risks and uncertainties such as those described in the Cautionary Statements below:

Additional modeling considerations will be provided in the earnings call presentation.

Other remaining businesses

Other reflects equity earnings and charges for retrospective periods for the company’s previous investment in Change Healthcare, which was separated from the company during the fourth quarter of fiscal 2020.

Conference Call Details

The company has scheduled a conference call for today, Thursday, May 6th at 4:30 PM ET to discuss the company’s financial results. A live audio webcast of the conference call will be available on McKesson’s Investor Relations website at View Source An archive of the conference call will also be available on the company’s Investor Relations website at View Source

Upcoming Investor Events

McKesson management will be participating in the following investor conferences:

BofA Securities Virtual 2021 Healthcare Conference, May 13, 2021
Goldman Sachs 42nd Annual Global Healthcare Conference, June 8, 2021
Audio webcasts will be available live and archived on the company’s Investor Relations website at View Source A complete listing of upcoming events for the investment community, including details and updates, will be available on the company’s Investor Relations website.

Non-GAAP Financial Measures

GAAP refers to the U.S. generally accepted accounting principles. This press release includes GAAP financial measures as well as Non-GAAP financial measures, including Adjusted Gross Profit, Adjusted Operating Expenses, Adjusted Other Income, Adjusted Equity Income from Change Healthcare, Adjusted Income Tax Expense, Adjusted Earnings, Adjusted Earnings per Diluted Share, Adjusted Segment Operating Profit, Adjusted Segment Operating Profit Margin, Adjusted Corporate Expenses, Adjusted Operating Profit, FX-Adjusted results and Free Cash Flow which are financial measures not calculated in accordance with GAAP. Refer to the "Supplemental Non-GAAP Financial Information" section of the accompanying financial statement tables for the definitions and usefulness of the Company’s Non-GAAP financial measures and the attached schedules for reconciliations of the differences between the Non-GAAP financial measures and their most directly comparable GAAP financial measures.

The Company does not provide forward-looking guidance on a GAAP basis as McKesson is unable to provide a quantitative reconciliation of this forward-looking Non-GAAP measure to the most directly comparable forward-looking GAAP measure, without unreasonable effort, because McKesson cannot reliably forecast LIFO inventory-related adjustments, gains from antitrust legal settlements, restructuring, impairment and related charges, and other adjustments, which are difficult to predict and estimate. These items are inherently uncertain and depend on various factors, many of which are beyond the company’s control, and as such, any associated estimate and its impact on GAAP performance could vary materially.

On May 6, 2021 Caladrius Biosciences, Inc. (Nasdaq: CLBS) ("Caladrius" or the "Company"), a clinical-stage biopharmaceutical company dedicated to the development of cellular therapies designed to reverse disease, reported financial results for the three months ended March 31, 2021 (Press release, Caladrius Biosciences, MAY 6, 2021, View Source [SID1234579353]).

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"We are at a truly exciting point in our evolution with tremendous opportunities ahead of us. While the pandemic has impacted many companies, during the first quarter of 2021 we were able to both markedly strengthen our financial position and advance and expand our clinical pipeline," stated David J. Mazzo, Ph.D., President and Chief Executive Officer of Caladrius. To date, we are seeing good progress with site activation for our Phase 2b clinical trial of CLBS16 in the U.S., known as the FREEDOM Trial, for the treatment of coronary microvascular dysfunction as we continue to accelerate enrollment. Additionally, we remain optimistic that we soon will complete enrollment in our registration-eligible study of HONEDRA in critical limb ischemia and Buerger’s disease in Japan. However, enrollment for this program has been greatly impacted by the Japanese government-issued states of emergency tied to the pandemic. Lastly, we are working with the U.S. Food and Drug Administration ("FDA") to finalize the protocol design for our CLBS201 proof-of-concept study in diabetic kidney disease and have targeted initiation of that Phase 2 study in the third quarter of 2021."

Product Development and Financing Highlights

CLBS16 for the treatment of coronary microvascular dysfunction

Caladrius reported in May 2020 the compelling positive results of its ESCaPE-CMD Phase 2a study of CLBS16 for the treatment of coronary microvascular dysfunction ("CMD"), a disease that continues to be underdiagnosed and potentially afflicts millions annually – a vast majority of whom are female – with no current treatment options. The Company is committed to raising awareness of this growing women’s health crisis and finding an effective treatment. Caladrius recently initiated, and is currently treating patients in, a rigorous 105-subject Phase 2b clinical trial (the FREEDOM Trial), which to our knowledge, is the first controlled regenerative medicine trial in CMD. The trial is targeted to complete enrollment by the end of 2021 with top line data anticipated for the third quarter of 2022. This double-blind, randomized, placebo-controlled Phase 2b trial will evaluate the efficacy and safety of delivering autologous CD34+ cells to the hearts of subjects with CMD.

HONEDRA (CLBS12) for the treatment of critical limb ischemia

The Company’s open-label, registration-eligible study of SAKIGAKE-designated HONEDRA in Japan for the treatment of critical limb ischemia ("CLI") and Buerger’s disease (an orphan-sized subset of CLI) has shown strong results to date. The initial responses observed in the subjects who have reached an endpoint in this study are consistent with a therapeutic effect and safety profile reported by previously published clinical trials in Japan and the U.S. The study’s enrollment continues to be slowed by the pandemic’s impact in Japan, however, the Company is encouraged by the patient pre-screening pipeline and continues to make progress towards study completion, the exact date of which is impossible to predict given the continuing impact of COVID-19 on clinical trials in Japan. While the final outcome of the trial will depend on all data from all subjects, the data to date is very encouraging (~60% of subjects in the completed Buerger’s disease cohort have reached a positive "CLI-free" endpoint despite a natural history of such patients that predicts continuing disease progression to amputation). In the U.S., the Company was pleased to report that the FDA granted orphan designation to CLBS12 as a treatment for Buerger’s disease.

CLBS201 for the treatment of diabetic kidney disease

The Company’s most recently proposed development program, CLBS201, is designed to assess the safety and efficacy of CD34+ cell therapy as a treatment for diabetic kidney disease in patients not yet requiring dialysis. Based on a wealth of published preclinical and early clinical data, it appears that the innate ability of CD34+ cells to promote the growth of new microvasculature could be a means to attenuate the progression of the disease or even reverse the course of diabetic kidney disease. A Phase 2 proof of concept, randomized, placebo-controlled study is planned for initiation in the second half of 2021.

OLOGOTM for the treatment of no option refractory disabling angina ("NORDA")

Caladrius acquired the rights to data and regulatory filings for a CD34+ cell therapy program for NORDA that had been advanced to Phase 3 by a previous sponsor. Based on the clinical evidence from the completed studies that a single administration of OLOGOTM reduces mortality, improves angina and increases exercise capacity in patients with otherwise untreatable angina, this product received Regenerative Medicine Advanced Therapy ("RMAT") designation from the FDA. Caladrius remains in ongoing discussions with the FDA regarding the size and scope of an appropriate and practical Phase 3 trial, which in combination with previously filed Phase 1, 2 and 3 data, will be considered for the registration of OLOGOTM. Notably, the RMAT designation affords the product a 6-month review time for a biologics license application ("BLA"), once submitted.

Sufficient capital to fund operations beyond multiple key data readouts (>2023)

As previously disclosed, in January 2021, Caladrius raised $25.0 million in a private placement priced at-the-market under Nasdaq rules. In February 2021, the Company announced that it closed a $65.0 million capital raise through the sale of its common stock to several institutional and accredited investors in two registered direct offerings priced at-the-market under Nasdaq rules.

First Quarter 2021 Financial Summary

Research and development expenses for the three months ended March 31, 2021 were $5.1 million, compared to $1.5 million for the three months ended March 31, 2020. Research and development in the current year period focused on the advancement of our ischemic repair platform and related to:

•Ongoing expenses for HONEDRA in critical limb ischemia and Buerger’s disease in Japan for which we continue to focus spending on patient enrollment and Japanese NDA preparation; and

•Expenses associated with efforts to advance the FREEDOM Trial where the first patient was dosed in the first quarter of 2021; and

•Expenses associated with the planning and preparation of an IND and proof-of-concept protocol for CLBS201 as a treatment for diabetic kidney disease.

General and administrative expenses, which focus on general corporate related activities, were $3.0 million for the three months ended March 31, 2021 compared to $2.6 million for the three months ended March 31, 2020, representing an increase of 18%.

Overall, net losses were $8.1 million and $4.0 million for the years ended March 31, 2021 and 2020, respectively.
Balance Sheet Highlights

As of March 31, 2021, Caladrius had cash, cash equivalents and marketable securities of approximately $111.5 million. Based on existing programs and projections, the Company remains confident that its current cash balances will fund its operations for the next several years, notably through study completion for the FREEDOM Trial, through the registration-eligible study completion for HONEDRA and through the Phase 2 proof-of-concept study for CLBS201, while still providing capital to explore additional pipeline expansion opportunities.

Conference Call
Caladrius will hold a live conference call today, May 6, 2021, at 4:30 p.m. (ET) to discuss financial results, provide a business update and answer questions. To join the conference call, please refer to the dial-in information provided below. A live webcast of the call will also be available under "Events" in the Investors section of the Caladrius website, View Source, and will be available for replay for 90 days after the conclusion of the call.

On May 6, 2021 INmune Bio, Inc. (NASDAQ: INMB) (the "Company"), a clinical-stage immunology company focused on developing treatments that harness the patient’s innate immune system to fight disease reported its financial results for the first quarter ended March 31, 2021 and provided a business update (Press release, INmune Bio, MAY 6, 2021, View Source [SID1234579352]).

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"We continued to treat patients in the Phase I XPro1595 Alzheimer’s disease trial and expand the extensive biomarker data," stated RJ Tesi, M.D., chief executive officer of INmune Bio. "The interim data that we reported in January confirms that XPro1595 decreases neuroinflammation in patients with Alzheimer’s disease and supports transitioning to a blinded randomized placebo-controlled Phase II trial later this year. We regard these results as extremely promising and look forward to further confirmation of XPro1595’s potential benefit to these patients in a rigorously designed Phase 2 study. We will report the additional biomarker data later this Summer."

"We have started screening patients in the Phase I INKmune NK cell priming platform trial in patients with high-risk myelodysplastic syndrome (MDS). MDS is a serious hematopoietic stem cell disorder in which patients have functionally defective NK cells, and approximately one-third of cases progress to AML. We created a short 5-minute video that we believe does a wonderful job explaining why NK cells fail to clear cancer and how the cellular and molecular interactions by INKmune activate NK cells to kill resistant tumors. The video can be found by clicking here."

"Finally, in our Phase 2 trial of Quellor in hospitalized COVID-19 patients with pulmonary complications, we continue to enroll patients. We expect to receive a ‘go/no-go’ decision by the independent Data Safety Monitoring Board following the analysis of the first 100 patients. We believe Quellor will neutralize soluble TNF, the ‘master cytokine’ of the cytokine storm to decrease progressive respiratory symptoms in these hospitalized patients."

"In summary, notwithstanding the ongoing pandemic that continues to disrupt drug development timelines around the world, we believe that we are well positioned to make meaningful advancements across all of our key programs this year," Dr. Tesi concluded.

Q1 2021 and Recent Corporate Highlights

DN-TNF Platform Highlights:

Announced interim Phase 1b data demonstrating that XPro1595 decreased neuroinflammation measured by CSF cytokines correlated with decreases in white matter free water, a validated non-invasive biomarker of neuroinflammation. The data showed the benefits of decreased neuroinflammation with decreased neurodegeneration and improved synaptic function as measured by CSF proteomics and remodeling and repair in the brain due to improvements in white and gray matter quality as measured by MRI.
Data strongly support initiation of a blinded, randomized, placebo-controlled Phase 2 study in 2021 to explore the clinical impact of long-term control of neuroinflammation with XPro1595 in patients with Alzheimer’s disease.
Presented detailed biomarker data during a Key Opinion Leader webinar on January 21, 2021, a replay of which can be accessed here.
Continued to advance its Phase 2 trial of Quellor in hospitalized COVID-19 patients suffering from pulmonary complications toward a "go/no-go" decision by the DSMB around mid-year.
Financial Highlights:

During the first quarter, the Company raised approximately $29 million from the sale of its common shares through a pre-existing open sale market agreement (At-the-Market, or ATM).
Upcoming Milestones:

Report on the first 100 patients enrolled in the company’s Quellor trial in COVID-19 which will provide proof-of-concept and inform a "go/no go" decision by the Data Safety Monitoring Board (DSMB).
Initiate XPro1595 Phase 2 program for treatment resistant depression, funded in part by a $2.9 million NIH grant in the second half of 2021.
Initiate XPro1595 Phase 2 program for Alzheimer’s disease in patients with neuro-inflammation in the second half of 2021.
Initiation of INKmune high-risk MDS trial.
The company plans additional clinical trials after the COVID-19 pandemic has been controlled. The exact timing of these trials cannot be predicted at this time. These trials include:
INKmune Phase 1 program for ovarian cancer.
LIVNate Phase 2 program for NASH.
INB03 Phase 2 program for MUC4 expressing cancer.
Financial Results for the First Quarter Ended March 31, 2021:

Net loss attributable to common stockholders for the quarter ended March 31, 2021 was approximately $4.6 million, compared to approximately $2.1 million for the quarter ended March 31, 2020.

Research and development expense totaled approximately $2.5 million for the quarter ended March 31, 2021, compared to approximately $0.8 million during the quarter ended March 31, 2020.

General and administrative expense was approximately $2.1 million for the quarter ended March 31, 2021, compared to approximately $1.3 million during the quarter ended March 31, 2020.

As of March 31, 2021, the Company had cash and cash equivalents of approximately $45.3 million and no debt.

As of May 5, 2021, the Company had approximately 14.9 million common shares outstanding.

Earnings Call Information

To participate in this event, dial approximately 5 to 10 minutes before the beginning of the call.

Date: Wednesday, May 5, 2021
Time: 4:30 PM Eastern Time
Participant Dial-in: 877-407-0784
Participant Dial-in (international): 201-689-8560

A transcript will follow approximately 24 hours from the scheduled call. A replay will also be available through May 12, 2021 by dialing 1-844-512-2921 or 1-412-317-6671 (international) and entering PIN no. 13718747.

About XPro1595

XPro1595 is a next-generation inhibitor of tumor necrosis factor (TNF) that is currently in clinical trial and acts differently than currently existing TNF inhibitors in that it neutralizes soluble TNF (sTNF), without affecting trans-membrane TNF (tmTNF) or TNF receptors. XPro1595 could have substantial beneficial effects in patients with neurologic disease by decreasing neuroinflammation. For more information about the importance of targeting neuroinflammation in the brain to improve cognitive function and restore neuronal communication visit this section of the INmune Bio’s website.

On May 6, 2021 ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, reported financial results and operational updates for the quarter ended March 31, 2021 (Press release, ORIC Pharmaceuticals, MAY 6, 2021, View Source [SID1234579351]).

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"We continue to make steady progress in advancing our robust pipeline of novel oncology candidates," said Jacob Chacko, M.D., president and chief executive officer. "As planned, we will present preliminary safety, pharmacokinetic, and translational data, as well as early efficacy data from our ongoing Phase 1 trial of ORIC-101 in combination with nab-paclitaxel in solid tumors at the upcoming ASCO (Free ASCO Whitepaper) Annual Meeting. In addition, we expect to achieve multiple other milestones throughout the remainder of 2021, including reporting preliminary data from our second trial for ORIC-101 in combination with enzalutamide in prostate cancer, and IND/CTA filings for ORIC-533, our oral small molecule CD73 inhibitor, ORIC-944, our allosteric PRC2 inhibitor, and ORIC-114, our brain penetrant EGFR/HER2 exon 20 inhibitor."

First Quarter 2021 and Other Recent Highlights

Acceptance of Two Abstracts at ASCO (Free ASCO Whitepaper): Two abstracts highlighting preliminary results from the Phase 1b study of ORIC-101 in combination with nab-paclitaxel have been accepted for poster presentations during the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, to be held June 4 – 8, 2021. The ASCO (Free ASCO Whitepaper) presentations will highlight interim safety, pharmacokinetic, efficacy, and translational data from the ongoing Phase 1b study of ORIC-101 in combination with nab-paclitaxel.
Preclinical Data Presented at AACR (Free AACR Whitepaper): In April 2021, ORIC presented posters on four programs at the 2021 American Association for Cancer Research (AACR) (Free AACR Whitepaper) virtual annual meeting. Key findings of the presentations included:
ORIC-101: Glucocorticoid Receptor (GR) Antagonist

GR upregulation and activation, an established preclinical resistance mechanism for antiandrogens, may drive resistance when antiandrogens are combined with AKT inhibitors.
ORIC-101 was able to overcome this resistance and restore antitumor activity in preclinical prostate cancer cell lines.
ORIC-533: Oral Small Molecule CD73 Inhibitor

Nanomolar concentrations of ORIC-533 efficiently rescued cytotoxic T-cell function in the presence of high AMP concentrations, reflective of AMP levels observed in tumors.
Inhibitors of adenosine receptors were only able to rescue CD8+ T-cell function in the context of low AMP, and were ineffective in moderate or high AMP levels.
ORIC-533 has potential best-in-class properties in inhibiting adenosine production and reversing immunosuppression in tumors.
ORIC-944: Allosteric PRC2 Inhibitor

ORIC-944 has potential best-in-class drug properties compared to first generation PRC2 inhibitors, including a clean CYP profile.
ORIC-944 demonstrated superior activity compared to an EZH2 inhibitor in an in vivo DLBCL model.
ORIC-944 demonstrated strong tumor growth inhibition as a single agent with once daily oral dosing in both enzalutamide-responsive and enzalutamide-resistant in vivo prostate cancer models.
ORIC-114: Brain Penetrant EGFR/HER2 exon 20 Inhibitor

ORIC-114 is highly selective for the EGFR family of receptors with superior kinome selectivity compared to other exon 20 inhibitors.
ORIC-114 demonstrated low nanomolar potency across exon 20 insertion variants in biochemical and cell-based assays.
Significant tumor regression was observed in multiple EGFR exon 20 patient-derived xenograft models using once daily oral administration of ORIC-114.
ORIC-114 displayed superior brain exposure relative to other compounds targeting exon 20 insertion mutations, and greater activity compared to other EGFR inhibitors in an intracranial NSCLC EGFR mutant xenograft model.
Anticipated Milestones

ORIC anticipates the following milestones in 2021:
ORIC-101: Report interim safety, efficacy, and translational data from ongoing combination trial with nab-paclitaxel at ASCO (Free ASCO Whitepaper)
ORIC-101: Report interim safety, efficacy, and translational data from ongoing combination trial with enzalutamide in the second half of 2021
ORIC-533: File an IND in the second quarter of 2021
ORIC-944: File an IND in the second half of 2021
ORIC-114: File a CTA in the second half of 2021
Present additional preclinical data at scientific conferences in 2021
First Quarter 2021 Financial Results

Cash, Cash Equivalents and Short-term Investments: Cash, cash equivalents, and short-term investments totaled $278.1 million as of March 31, 2021. The company expects its current cash, cash equivalents, and short-term investments will be sufficient to fund its current operating plan into the second half of 2023.
R&D Expenses: Research and development expenses were $11.7 million for the three months ended March 31, 2021, compared to $7.3 million for the three months ended March 31, 2020, an increase of $4.4 million. The increase was primarily driven by an increase in external expenses related to the advancement of ORIC-101 and our other product candidates of $3.6 million, as well as higher personnel costs, including additional non-cash stock-based compensation of $0.8 million for the three months ended March 31, 2021, as compared to the same period in 2020.
G&A Expenses: General and administrative expenses were $4.9 million for the three months ended March 31, 2021, compared to $1.9 million for the three months ended March 31, 2020, an increase of $3.0 million. The increase was primarily due to higher personnel costs, including additional non-cash stock-based compensation of $1.4 million for the three months ended March 31, 2021, as compared to the same period in 2020, and higher professional services and related costs to operate as a public company.

On May 6, 2021 MEI Pharma, Inc. (NASDAQ: MEIP), a late-stage pharmaceutical company focused on advancing new therapies for cancer, reported results for the quarter ended March 31, 2021 and highlighted recent corporate progress (Press release, MEI Pharma, MAY 6, 2021, View Source [SID1234579350]).

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"The first several months of 2021 have been very eventful for MEI, highlighted by the completion of enrollment in the follicular lymphoma efficacy population arm of the zandelisib TIDAL study. In addition, we recently reported preclinical data at AACR (Free AACR Whitepaper) 2021, demonstrating the ability of voruciclib to downregulate MYC and synergize with KRAS inhibitors in KRAS mutant cancers," said Daniel P. Gold, Ph.D., president and chief executive officer of MEI Pharma. "While we continue to work diligently to advance the clinical development of voruciclib and ME-344, we anticipate additional important milestones from the zandelisib program this calendar year, including top-line TIDAL data by the end of 2021, the initiation of our Phase 3 COASTAL study evaluating zandelisib in combination with rituximab in patients with second line follicular or marginal zone lymphomas expected to start around mid-year, and clinical data updates from the ongoing Phase 1b study at the ASCO (Free ASCO Whitepaper), EHA (Free EHA Whitepaper) and ICML annual meetings."

Anticipated Calendar Year 2021 Drug Candidate Pipeline Developments

Zandelisib – Oral PI3K delta inhibitor for the treatment of various B-cell malignancies

Reporting of topline data from the Phase 2 TIDAL study in the fourth quarter from the follicular lymphoma primary efficacy population. The complete data from the follicular lymphoma arm of the Phase 2 TIDAL study data are intended to be submitted to FDA to support an accelerated approval application.
Initiation around mid-2021 of enrollment in COASTAL, a Phase 3 study evaluating zandelisib in combination with rituximab in follicular and marginal zone lymphoma patients who received one or more prior lines of treatment. This study is intended to support FDA approval for additional indications and act as the required confirmatory study for the potential accelerated approval of zandelisib in patients with relapsed or refractory follicular lymphoma or marginal zone lymphoma.
Clinical data updates from the Phase 1b study of zandelisib at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) and European Hematology Association (EHA) (Free EHA Whitepaper) annual meetings, including the combination with zanubrutinib.
Voruciclib – CDK9 inhibitor for the treatment of B-cell malignancies and acute myeloid leukemia

Program updates, including data from the Phase 1 program evaluating voruciclib in patients with acute myeloid leukemia and B-cell malignancies.
ME-344 – Tumor selective mitochondrial inhibitor

Initiation of a Phase 2 pilot study of ME-344 in solid tumors in the first half of calendar 2022.
Recent and Third Quarter Fiscal Year 2021 Corporate Highlights

In April 2021, MEI completed enrollment in the follicular lymphoma primary efficacy population of the global Phase 2 TIDAL study evaluating zandelisib. Topline data from the study is on track to be reported in the fourth quarter. The complete Phase 2 TIDAL study data are intended to be submitted to FDA to support accelerated approval applications.

In April 2021, MEI reported preclinical data demonstrating that voruciclib, an orally administered cyclin-dependent kinase (CDK) inhibitor that is potent against CDK9, downregulates MYC by inhibiting MYC transcription and stabilization, and synergizes with KRAS inhibitors in KRAS mutant cancers. The research was featured as an E-Poster Session presentation titled, "Voruciclib, a CDK9 inhibitor, downregulates MYC and inhibits proliferation of KRAS mutant cancers in preclinical models" at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2021.

In January 2021, MEI announced that the Phase 1b trial arm exploring zandelisib in combination with zanubrutinib in collaboration with BeiGene, Ltd. completed the dose optimization stage in patients with B-cell malignancies and is expanding into disease specific B-cell malignancy cohorts. The Safety Review Committee recommended moving forward with a dosing regimen found to be generally well tolerated and active following a planned safety analysis.
Third Quarter Fiscal Year 2021 Financial Results

As of March 31, 2021, MEI had $164.6 million in cash, cash equivalents, and short-term investments with no outstanding debt.
For the quarter ended March 31, 2021, cash used in operations was $15.6 million, compared to $10.3 million for the same period in 2020. The increase in cash used in operations primarily relates to costs associated with our clinical development programs. For the nine months ended March 31, 2021, cash used in operations was $20.7 million, compared to $34.9 million for the same period in 2020. The year-to-date decrease in cash used in operations reflects $20.9 million of cash received from the Japanese taxing authorities as a refund of withholding tax associated with the Kyowa Kirin commercialization agreement signed in April 2019, offset by increased costs associated with our clinical development programs.
Research and development expenses were $17.9 million for the quarter ended March 31, 2021, compared to $9.0 million for the quarter ended March 31, 2020. The increase was primarily related to increased development costs associated with zandelisib, including increased activity in the TIDAL study and start-up costs related to the Phase 3 study, as well as increased personnel costs to support clinical trial activities.
General and administrative expenses were $6.2 million for the quarter ended March 31, 2021, compared to $3.9 million for the quarter ended March 31, 2020. The increase primarily relates to personnel costs and general corporate expenses incurred during the quarter ended March 31, 2021.
MEI recognized revenues of $2.4 million for the quarter ended March 31, 2021, compared to $1.2 million for the quarter ended March 31, 2020. The increase in revenue primarily related to the license agreement with Kyowa Kirin and included the recognition of fees allocated to research and development obligations.
Net loss was $31.3 million, or $0.28 per share, for the quarter ended March 31, 2021, compared to net loss of $4.3 million, or $0.04 per share for the quarter ended March 31, 2020. The Company had 112,591,778 shares of common stock outstanding as of March 31, 2021, compared with 105,998,677 shares as of March 31, 2020.
The adjusted net loss for the quarter ended March 31, 2021, excluding non-cash expenses related to changes in the fair value of the warrants (a non-GAAP measure), was $22.0 million, compared to an adjusted net loss of $12.1 million for the quarter ended March 31, 2020.