On May 16, 2022 IO Biotech (Nasdaq: IOBT), a clinical-stage biopharmaceutical company developing novel, immune-modulating cancer therapies based on its T-win technology platform, reported financial results for the quarter ended March 31, 2022 (Press release, IO Biotech, MAY 16, 2022, View Source [SID1234614642]).

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"During our first quarter and in recent weeks we continued to advance our promising pipeline of immune-modulating cancer therapies, highlighted by the initiation of our IOB-022 / KN-D38 Phase 2 Trial," said Mai-Britt Zocca, Ph.D., President and Chief Executive Officer of IO Biotech. "This trial will evaluate IOB102-103 with KEYTRUDA (pembrolizumab) in previously untreated patients with three different tumor types in the first line setting, and we look forward to expanding our data set in these additional indications. We were also pleased to see the presentation of updated efficacy data and subgroup analyses from our MM1636 Phase 1/2 clinical trial evaluating IO102-IO103 as investigational agents in metastatic melanoma at the AACR (Free AACR Whitepaper) annual meeting in April. These data further demonstrate the three-year survival probability of 73% for 3% for IO102-IO103 in combination with nivolumab for these patients, and we are encouraged by the clinical activity demonstrated in this trial. As previously disclosed, we expect to provide guidance regarding the timing for the interim readout for our IOB-013/KN-D18 Phase 3 trial towards the middle of this year. We believe our platform and product candidates may represent a paradigm shift in the management of cancer, and with a solid balance sheet we have a substantial cash runway to carry us through multiple data readouts into mid-2024."

Highlights for First Quarter 2022 and Recent Weeks

Hosted Part 1 of Key Opinion Leader Webinar Series: A New Way to Kill Tumors–IO102-IO103 Phase 3 Trial in Combination with Anti-PD-1 in Advanced Melanoma
Announced initiation and dosing of first patient in Phase 2 IOB-022 / KN-D38 trial (NCT05077709)
New data from MM1636 Phase 1/2 Clinical Trial presented at 2022 AACR (Free AACR Whitepaper) Annual Meeting
Three-year Survival Probability of 73%
Subgroup analyses including patients with poor prognosis
David V. Smith Appointed to Board of Directors
First Quarter Financial Results

Net loss for the three months ended March 31, 2022 was $17.2 million, compared to $3.7 million for the quarter ended March 31, 2021.
Research and development expenses were $10.3 million for the three months ended March 31, 2022, compared to $2.8 million for the three months ended March 31, 2021. The increase of $7.5 million was primarily related to an increase in costs for chemistry, manufacturing and control, or CMC, activities of $2.3 million, an increase in personnel costs of $2.4 million primarily related to an increase in headcount and related recruiting costs and an increase in clinical trial-related activities for our IO102-IO103 product candidate, including the completion of our Phase 1/2 clinical studies, of $2.4 million.
General and administrative expenses were $6.7 million for the three months ended March 31, 2022, compared to $1.0 million for the three months ended March 31, 2021. The increase of $5.7 million was primarily related to an increase in professional services of $1.4 million related primarily to corporate legal fees and audit and tax fees and other consulting costs in support of our growth as well as an increase in personnel costs of $1.6 million primarily related to an increase in headcount and related recruiting costs and an increase in consultants and other costs of $2.7 million.
Cash and cash equivalents at March 31, 2022 were $187.9 million, compared to $211.5 million at December 31, 2021. Cash on hand is expected to support operations through anticipated data readouts into mid-2024.
About the IOB-013 / KN-D18 Clinical Trial

IOB-013 / KN-D18 (Clinical Trials.gov: NCT05155254) is an open label, randomized Phase 3 clinical trial being conducted in collaboration with Merck of IO102-IO103 in combination with pembrolizumab versus pembrolizumab alone in patients with previously untreated, unresectable or metastatic (advanced) melanoma. Target enrollment will be 300 patients from centers spread across Europe, Australia, and the United States. Biomarker analyses will also be conducted. IO Biotech will sponsor the Phase 3 trial and Merck will supply pembrolizumab. IO Biotech maintains global commercial rights to IO102-IO103.

About IOB-022 / KN-D38

IOB-022 / KN-D38 is a non-comparative, open label trial to investigate the safety and efficacy of IO102-IO103 in combination with pembrolizumab in each of the following first-line indications: NSCLC, SCCHN, and mUBC. The clinical trial will be sponsored by IO Biotech and conducted in collaboration with Merck. IO Biotech maintains global commercial rights to IO102-IO103.

About IO102-IO103

IO102-IO103 is an investigational cancer immunotherapy designed to target the immunosuppressive mechanisms mediated by the key immunosuppressive proteins indoleamine 2,3-dehydrogenase (IDO) and PD-L1.

On May 16, 2022 RenovoRx, Inc. ("RenovoRx" or the "Company") (Nasdaq: RNXT), a biopharmaceutical company and innovator in targeted cancer therapy, reported its financial results for the quarter ended March 31, 2022 (Press release, Renovorx, MAY 16, 2022, View Source [SID1234614658]).

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"As we report our Q1 2022 results, we acknowledge that May is Cancer Research Month. RenovoRx is fighting cancer through our innovative localized treatment of difficult-to-treat tumors via our proprietary RenovoTAMP (RenovoRx Trans-Arterial Micro-Perfusion) therapy platform," said Shaun Bagai, CEO of RenovoRx. "Today, we are midway through a Phase 3 pancreatic cancer clinical trial, designed to provide an improved treatment option to the generally ineffective standard of care, systemic (intravenous) chemotherapy for patients. The study’s goal is to improve survival and quality of life for patients with a cancer that currently has a five-year survival rate of 11%."

Bagai added, "RenovoRx is at the frontline of cancer research with our late-stage product candidate, RenovoGemTM. Later this year, we plan on extending its utility to extrahepatic cholangiocarcinoma (eCCA), a rare and aggressive cancer that forms in bile ducts that lead out of the liver and join with the gallbladder. The FDA granted RenovoRx Orphan Drug Designation for this indication in April 2021, and for pancreatic cancer in 2018."

Financial Highlights for the Quarter Ended March 31, 2022

●Cash and cash equivalents as of March 31, 2022, were $13.1 million.
●Research and development expenses were $1.3 million for the quarter ended March 31, 2022, compared to $0.6 million for the quarter ended March 31, 2021. The increase was due to higher costs incurred on our Phase 3 trial, including consulting, employee and related benefit costs, and an increase in costs for a secondary manufacturer of our RenovoCath delivery systems.
●General and administrative expenses were $1.7 million for the quarter ended March 31, 2022, compared to $0.4 million for the quarter ended March 31, 2021. This increase was due to higher employee and related benefits costs, an increase in legal fees reflecting the costs of public company compliance requirements, an increase in professional and consulting services relating to post-IPO support, and Directors and Officers Liability Insurance.
●Net loss was $3.0 million for the quarter ended March 31, 2022, compared to net loss of $1.1 million for quarter ended March 31, 2021.
●As of March 31, 2022, the Company had 9,029,305 common shares outstanding.

About the Phase 3 TIGeR-PaC Clinical Trial

TIGeR-PaC is a randomized multi-center Phase 3 study using RenovoRx’s innovative therapy platform, RenovoTAMPTM (RenovoRx Trans-Arterial Micro-Perfusion). The study is evaluating the Company’s first product candidate, RenovoGemTM, to treat locally advanced pancreatic cancer (LAPC) through the intra-arterial delivery of gemcitabine (FDA-approved chemotherapy). The study has a primary endpoint of overall survival and several secondary endpoints, including quality of life.

TIGeR-PaC is currently enrolling unresectable LAPC patients at several sites across the US. To learn more about the study and the participating clinical trial sites, visit View Source

On 16, 2022 PharmaEssentia USA Corporation, a subsidiary of PharmaEssentia Corporation (TPEx:6446), a global biopharmaceutical innovator leveraging deep expertise and proven scientific principles to deliver new biologics in hematology and oncology, reported the appointment of Meredith Manning to President of the Americas, effective immediately (Press release, PharmaEssentia, MAY 16, 2022, View Source [SID1234614674]).

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"PharmaEssentia has continued to build momentum with our strong pipeline and partnerships around the world. Now, with a world-class foundation built in the U.S. and launch underway, we are expanding our growth ambition across the American continents to address the clear gaps today in therapeutic options for the treatment of myeloproliferative neoplasms (MPNs)," said Ko-Chung Lin, PhD, co-founder and chief executive officer. "Meredith has built an incredible team of expert leaders and has established a strong infrastructure already in Boston, so they are well poised to build our presence with communities in both North and South America."

In this new scope, Ms. Manning will be supported by her U.S. leadership team to evaluate potential commercial strategies and partnerships to reach MPN patient communities throughout the American continents, with a near-term focus on Canada and Latin America. The company’s ongoing clinical trial SURPASS-ET, evaluating a potential therapy in the treatment of essential thrombocythemia (ET) has recently expanded into sites in Canada.

"The progress we’ve made in the last two years has been transformative for our mission and has established the right foundation to enable strong and sustainable growth as we expand into new markets," said Ms. Manning. "Together with our seasoned leadership team here in the U.S., I am optimistic that we can introduce our portfolio in areas that remain underserved today to help advance care of people with MPNs around the world."

Ms. Manning has served as General Manager for the U.S. subsidiary of PharmaEssentia since February 2020, expanding the team nearly three-fold since her arrival and leading the organization through the U.S. regulatory approval and commercial launch of the Company’s first product, BESREMi. With a sharp focus on data-driven market insights and commercial strategy, Ms. Manning’s career has been focused on introducing transformative therapies into underserved communities. She was previously Chief Commercial Officer at resTORbio, and prior to that served as a vice president of marketing for a seven-brand hemophilia portfolio at Baxter BioScience (now Takeda). Earlier in her career, Meredith built and managed successful commercial teams for Vertex and Pfizer.

On May 16,2022 Allarity Therapeutics, Inc. ("Allarity" or the "Company"), a clinical-stage pharmaceutical company developing novel oncology therapeutics together with drug-specific DRP companion diagnostics for personalized cancer care, reported financial results for the fourth quarter and year ended December 31, 2021, and provided a corporate update (Press release, Allarity Therapeutics, MAY 16, 2022, View Source [SID1234614753]).

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"2021 was a momentous year for Allarity Therapeutics," said Steve Carchedi, President and Chief Executive Officer. "We advanced our clinical-stage assets, raised a record amount of new investment for the Company, and completed our listing on the U.S. Nasdaq stock exchange. We are grateful for the collective support of our internal team, shareholders, and advisors, who are enabling the further development of our prioritized programs to address significant unmet needs within difficult-to-treat cancers. As we await further feedback from the United States Food and Drug Administration (FDA) regarding our NDA application for dovitinib, we remain steadfast in our mission to pair promising cancer therapeutics with our proprietary companion diagnostic technology to help significantly improve treatment outcomes for patients suffering from cancer. We look forward to sharing further updates on dovitinib and our other two priority clinical programs throughout the year."

A delay in filing the Company’s Form 10-K triggered a notification of non-compliance by Nasdaq concerning Listing Rule 5250(c)(1), as announced on April 22, 2022. Issuing a promissory note to Novartis to replace an unenforceable note issued by one of the Company’s Danish subsidiaries in 2018 and an error in the calculation of a tax Net Operating Loss allowance led to a restatement of the Company’s Form 10-Q dated September 30, 2021, and financial statements for the twelve months ended December 31, 2020, were the primary cause of the delay. The Company has filed the restated Form 10-Q for September 30, 2021, and its Form 10-K for 2021 today with the U.S. Securities and Exchange Commission (SEC). With these filings completed, the Company expects to regain compliance with Nasdaq Listing Rule 5250(c)(1) in the near future. The restatement of our financial statements for the year ended December 31, 2020, also resulted in a "Triggering Event" under our Certificate of Designations for our Series A Preferred Stock (the "Preferred Stock") because of the requirement to file a post-effective amendment to the Company’s Form S-1 registration statement that registers shares of our common stock issuable upon conversion of the Preferred Stock. As previously disclosed, the Investor that holds all of our Preferred Stock and the Company entered into a Forbearance Agreement and Waiver, dated April 27, 2022, providing the Company a forbearance period until June 4, 2022, in order to have the post-effective amendment declared effective by the SEC.

Full Year 2021 and Recent Highlights

In March 2022, entered into two agreements amending the LiPlaCis program. As a result of this amendment, Allarity will be exempt from any future financial obligation associated with the further development of LiPlaCis, including the cancellation of outstanding liability of $971million. Allarity will also maintain its ability to receive possible future milestone payments of up to $3.5 million
Scheduled a Type C meeting with the FDA, to be held in Q2 2022, to discuss potential paths to approval for dovitinib. This action followed the FDA’s issuance of Refusal to File (RTF) letters in February 2022 in response to the Company’s New Drug Application (NDA) and related Pre-Market Approval (PMA) application for dovitinib
Announced licensing agreements with Oncoheroes Biosciences, which will fund and advance the clinical development of both dovitinib and stenoparib in pediatric cancers utilizing Allarity’s DRP companion diagnostics
Completed listing on the U.S. Nasdaq Stock Market under the trading symbol "ALLR"
Received a $20 million PIPE investment from an institutional investor in conjunction with U.S. Nasdaq listing
Entered into an agreement with Lonza Group for the manufacturing of dovitinib to meet anticipated future commercial production needs
Entered, in July 2021, into an agreement for the sale of our irofulven program and assets to Lantern Pharma, Inc., under which Allarity received a $1 million upfront payment; the Company is eligible to receive an additional $1 million in payments plus up to U.S. $16 million in milestone payments from Lantern over the life of the program, in addition to royalties on future commercial net sales of the product. In Q1 2022, the Company received a fee payment from Lantern Pharma under the this agreement
Completed an oversubscribed rights issue, raising SEK 102.8 million ($12.1 million) before issue costs to further finance the development of Allarity’s three priority pipeline programs
Announced positive preclinical data in osteosarcoma in which dovitinib increased the median survival time in animals by 50% compared to the control group
Initiated a Phase 2 trial of IXEMPRA in Europe for the second-line treatment of metastatic breast cancer (mBC), with trial sites opened in a number of European countries
Expanded enrollment in an ongoing Phase 2 trial of stenoparib for the treatment of ovarian cancer (OC), with new trial sites opened or planned in the U.S. and Europe.

Anticipated Milestones in 2022

Announcing results of the Type C meeting with the FDA and outlining future development plans for dovitinib and its DRP-Dovitinib companion diagnostic
Initiation of prospective clinical study of dovitinib in metastatic Renal Cell Carcinoma together with its DRP-Dovitinib companion diagnostic
Interim data readout of Phase 2 clinical trial for IXEMPRA in mBC anticipated in Q4 2022
Interim data readout of Phase 2 clinical trial for stenoparib in OC anticipated in Q4 2022
Fourth Quarter and Full Year 2021 Financial Results

Balance Sheet: As of December 31, 2021, Allarity’s cash was $19.6 million, as compared to $298 thousand as of December 31 2020. This includes net proceeds from the Company’s December 2021 initial public offering in the U.S. The Company’s current cash, are expected to fund operations through 2022.

R&D Expenses: Research and Development (R&D) expenses were $9.5 million for the three months ended December 31, 2021, and $14.2 million for the full year 2021, compared to $1.7 million and $4.2 million for comparable periods in 2020, respectively.

G&A Expenses: General and Administrative (G&A) expenses were $6.2 million for the three months ended December 31, 2021, and $12.4 million for the full year 2021, compared to $856 thousand and $4.1 million for comparable periods in 2020, respectively.

Net Loss: Net loss was $16.8 million for the three months ended December 31, 2021, and $26.6 million for the full year 2021, compared to $1.7 million and $6.6 million for comparable periods in 2020, respectively.

On May 16, 2022 CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers in the brain and central nervous system, reported its financial results for the quarter ended March 31, 2022 and provided a clinical update of its anti-cancer drug candidates currently in development for the treatment of primary and metastatic brain and CNS cancer (Press release, CNS Pharmaceuticals, MAY 16, 2022, View Source [SID1234614643]).

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"Since the start of 2022, we have significantly expanded our international presence with clinical approvals in Spain, France and Switzerland received for our potentially pivotal study of Berubicin for the treatment of GBM. Once again our team demonstrated its operational, clinical and regulatory expertise this quarter. These efforts enable us to continue building momentum with patient enrollment – the cornerstone of any successful drug development program. The unmet need in GBM is enormous and knows no geographic borders and this critically important and state of the art trial will, most importantly, advance a much needed potential treatment option to patients. We have been and remain laser focused on executing on all of our operational efforts and look forward to an exciting year ahead," commented John Climaco, CEO of CNS Pharmaceuticals.

Clinical Programs Update

Berubicin – Novel anthracycline

CNS’ lead product candidate, Berubicin, is a novel anthracycline and the first anthracycline to appear to cross the blood-brain barrier. Berubicin is currently being evaluated in a potentially pivotal global study evaluating its efficacy and safety in the treatment of GBM. The potentially pivotal global trial is an adaptive, multicenter, open-label, randomized and controlled study in adult patients with recurrent glioblastoma multiforme (WHO Grade IV) after failure of standard first-line therapy. Approximately 243 patients with GBM after failure of standard first line therapy will be randomized in a 2:1 ratio to receive Berubicin or lomustine for the evaluation of Overall Survival, the primary endpoint of the study. Overall Survival is a rigorous endpoint that the U.S. Food and Drug Administration (FDA) has recognized as a basis for approval of oncology drugs when a statistically significant improvement can be shown relative to a randomized control arm.

A pre-planned, non-binding futility analysis will be performed after approximately 30 to 50% of all planned patients have completed the primary endpoint at 6 months. This review will include additional evaluation of safety as well as secondary efficacy endpoints. Enrollment will not be paused during this interim analysis.

The FDA recently granted CNS Pharmaceuticals Fast Track Designation for Berubicin which enables more frequent interactions with the FDA to expedite the development and review process. As previously announced, the Company also received Orphan Drug Designation from the FDA which may provide seven years of marketing exclusivity upon approval of an NDA.

For more information about the potentially pivotal Berubicin trial, visit clinicaltrials.gov and reference identifier NCT04762069.

Upcoming Milestones

Continue to expand potentially pivotal study to evaluate efficacy of Berubicin in the treatment of adult GBM into additional countries;
Interim analysis of the trial when 30-50% of the total expected patients have been on study for 6 months (expected during first half of 2023); and
Complete enrollment in potentially pivotal clinical trial for GBM.
WP1244 Portfolio – Novel class of DNA-binding agents

The Company continues to advance the development of its WP1244 drug technology portfolio, which utilizes anthracycline and distamycin-based scaffolds to create small molecule agents and is believed to be 500x more potent than daunorubicin in inhibiting tumor cell proliferation. Preclinical studies of WP1244 demonstrated high uptake in the brain with antitumor activity. The Company’s development work has produced a new mesylate salt of WP1244, now identified as WP1874. The enhanced solubility of this salt may increase its ability to be formulated for use in an IV infusion, while maintaining similar potency and toxicity characteristics. Going forward, WP1874 will be the primary focus in our development efforts of the WP1244 portfolio. CNS Pharmaceuticals is also evaluating the use of WP1244/WP1874 in the treatment of other primary brain and central nervous system cancers, as well as cancers metastatic to the brain including pancreatic, ovarian, and lymphomas.

Upcoming Milestones

File IND in 2023.
Summary of Financial Results for the First Quarter 2022

The net loss for the three months ended March 31, 2022 was approximately $2.8 million compared to approximately $3.6 million for the comparable period in 2021. The change in net loss is primarily attributable to increased drug manufacturing activities in 2021 in preparation for the commencement of the Company’s clinical trials as well as the timing of annual employee incentive compensation, partially offset by an increase in contract research organization expenses as we are now actively conducting the trial of Berubicin.

The Company reported Research and development expenses of $1.5 million for the three months ended March 31, 2022 compared to approximately $2.2 million for the comparable period in 2021. The change in net loss is primarily attributable to increased drug manufacturing activities in 2021 in preparation for the commencement of the Company’s clinical trials, as well as by the payment of annual employee incentive compensation during the three months ended March 31, 2021 and not having been paid by March 31, 2022, offset by an increase in expenses during the three months ended March 31, 2022 related to contract research organization (CRO) activites in conducting our trial of Berubicin.

General and administrative expense was approximately $1.3 million for the three months ended March 31, 2022 compared to approximately $1.4 million for the comparable period in 2021. This change is primarily due to the payment of annual employee incentive compensation during the three months ended March 31, 2021 and not having been paid by March 31, 2022.

As of March 31, 2022, the Company had cash of approximately $12.4 million and working capital of approximately $13.7 million. In early January 2022, the Company completed an offering of common stock and warrants for gross proceeds of $11.5 million. The Company’s current expectation is that the cash on hand and the proceeds from the offering during January is sufficient to fund our operations into the first quarter of 2023. The timing and costs of clinical trials are difficult to predict and trial plans may change in response to evolving circumstances and as such the foregoing estimates may prove to be inaccurate.