On August 12, 2021 Applied Therapeutics, Inc. (Nasdaq: APLT), a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates against validated molecular targets in indications of high unmet medical need, reported financial results for the second quarter ended June 30, 2021 (Press release, Applied Therapeutics, AUG 12, 2021, View Source [SID1234586467]).

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"Our pediatric Galactosemia program advanced significantly in the second quarter," said Shoshana Shendelman, PhD, CEO, Founder and Chair of the Board of Applied Therapeutics. "We continue to prepare for our NDA submission in the third quarter and our anticipated commercial launch in 2022. We are excited to launch our registrational study in SORD and complete enrollment in ARISE-HF, both of which are expected later this year."

Recent Highlights

Granted Fast Track Designation by FDA for AT-007 for Galactosemia. In June 2021, the U.S Food and Drug Administration (FDA) granted Fast Track Designation to AT-007 for the treatment of Galactosemia. Applied Therapeutics plans to submit a New Drug Application (NDA) for Accelerated Approval of AT-007 for the treatment of Galactosemia in the third quarter of this year. FDA had previously granted Orphan Drug Designation and Pediatric Rare Disease status to AT-007 for Galactosemia.
Presented Data on the Prevalence of Diabetic Cardiomyopathy (DbCM) at the 81st Scientific Sessions of the 2021 Annual Meeting of the American Diabetes Association. In June 2021, the Company announced data presentations confirming the high prevalence of DbCM in adults with diabetes or pre-diabetes. The analysis estimated that ~ 1 in 5 people with diabetes or pre-diabetes have DbCM, a serious and progressive disease that limits the heart’s ability to function. The Phase 3 registrational ARISE-HF study evaluating AT-001 in patients with DbCM continues to enroll.
Added to Russell Microcap Index. In June 2021, the Company announced that it had joined the Russell Microcap Index, effective after the market close on Friday, June 25, 2021. Membership in the Russell Microcap Index, which remains in place for one year, means automatic inclusion in the appropriate growth and value style indexes. FTSE Russell determines membership for its Russell indexes primarily by objective, market-capitalization rankings and style attributes.
Presented Data on Galactosemia Disease Progression at the 2021 Annual Clinical Genetics Meeting of the American College of Medical Genetics and Genomics. In April 2021, the Company presented data featuring a cross-sectional analysis of nineteen pediatric patients with Classic Galactosemia, providing meaningful insight on the progressive worsening of the central nervous system phenotype with age.
Financial Results

Cash and cash equivalents and short-term investments totaled $125.6 million as of June 30, 2021, compared with $148.1 million at March 31, 2021.

Research and development expenses for the three months ended June 30, 2021 were $14.8 million, compared to $20.8 million for the three months ended June 30, 2020. The decrease of $6.0 million was related to a decrease in drug manufacturing and formulation costs of $7.1 million primarily related to the completion and release of AT-001 and AT-007 drug product batches in the three months ended March 31, 2021; a decrease in stock-based compensation of $0.1 million due to forfeitures of stock option and restricted stock unit grants related to personnel terminations; an increase in clinical and pre-clinical expense of $0.9 million, primarily related to the progression of the AT-007 ACTION-Galactosemia adult extension study and the AT-007 ACTION-Galactosemia Kids pediatric registrational study; and an increase in personnel expenses of $0.3 million due to the increase in headcount in support of our clinical program pipeline.

General and administrative expenses were $11.1 million for the three months ended June 30, 2021, compared to $7.5 million for the three months ended June 30, 2020. The increase of $3.6 million was primarily related to an increase of $1.9 million related to the expansion of the commercial department; an increase in stock-based compensation of $1.1 million related to an increase in headcount; an increase of $0.2 million related to increased insurance costs; an increase of $0.9 million in other expenses related to increased costs of rent and other office expenses; and a decrease of $0.4 million in legal and professional fees due to lower external legal fees.

Net loss for the second quarter of 2021 was $25.8 million, or $0.99 per basic and diluted common share, compared to a net loss of $28.1 million, or $1.27 per basic and diluted common share, for the second quarter 2020.

On August 12, 2021 Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a precision oncology medicine company pioneering the discovery and development of small molecule, MasterKey therapies, reported financial results for the second quarter ended June 30, 2021 and provided a corporate update (Press release, Black Diamond Therapeutics, AUG 12, 2021, View Source [SID1234586466]).

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"We continue to advance our clinical and pre-clinical pipeline of MasterKey therapies, including BDTX-189, for which we expect to initiate the Phase 2 trial in the second half of this year. Our early-stage programs continue to advance as well, and we look forward to submitting Investigational New Drug (IND) applications for our BDTX-1535, BRAF (B-Raf), and fibroblast growth factor receptor (FGFR) programs in 2022," said David M. Epstein, Ph.D., President and Chief Executive Officer of Black Diamond Therapeutics. "We remain committed to the discovery and development of novel precision medicine therapies to address genetically defined cancers with unmet medical need."

Recent Developments

BDTX-189:

Black Diamond completed the Phase 1 dose-escalation portion of the MasterKey-01 study, a Phase 1/2 clinical trial of BDTX-189. The Company has selected the preliminary recommended Phase 2 dose for BDTX-189 and, pending dialogue with the U.S. Food and Drug Administration (FDA), is on track to initiate the Phase 2 portion of the study in the second half of 2021.
In May 2021, Black Diamond presented initial clinical pharmacokinetic (PK), safety, and preliminary efficacy data from the Phase 1 dose-escalation portion of the MasterKey-01 study of BDTX-189 in advanced solid tumors at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting:
BDTX-189 was generally well-tolerated with medically manageable toxicities observed.
Preliminary anti-cancer activity was observed in a heavily pre-treated patient population (prior epidermal growth factor receptor (EGFR)-/human epidermal growth factor receptor 2 (HER2)-directed and/or immuno-oncology (I/O) agents) in a variety of tumor types and genomic alterations in EGFR or HER2, including confirmed partial responses.
BDTX-1535:

Black Diamond continues to advance BDTX-1535 through IND-enabling studies and expects to file an IND application in the first half of 2022.
In April 2021, the Company presented pre-clinical data on BDTX-1535 at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting:
BDTX-1535 demonstrated a favorable brain-penetrant PK profile in mouse, rat, and dog models, and tumor growth inhibition in mouse models bearing intracranial GBM6 patient-derived tumors expressing allosteric EGFR mutants was achieved.
BDTX-1535 demonstrated potent and selective inhibition of rare Exon 18 mutations and the C797S mutation, supporting the potential for utility beyond glioblastoma (GBM), such as in non-small cell lung cancer (NSCLC).
Early-Stage Pipeline:

Black Diamond continues to progress its early-stage pipeline programs designed to target cancers driven by mutations in BRAF and FGFR. The Company anticipates IND filings for the BRAF and FGFR programs in 2022.
Corporate:

In August 2021, Black Diamond announced the appointment of Elizabeth Buck, Ph.D., as Chief Scientific Officer and Karsten Witt, M.D., as Interim Chief Medical Officer. Additionally, the Company announced the departures of Rachel Humphrey, M.D., the Company’s Chief Medical Officer, and Christopher Roberts, Ph.D., the Company’s Chief Scientific Officer.
In August 2021, Black Diamond appointed Mark Velleca, M.D., Ph.D., to its Board of Directors.
Financial Highlights

Black Diamond ended the second quarter of 2021 with $263.5 million in cash, cash equivalents, and investments compared to $345.0 million as of June 30, 2020. Net cash used in operations was $25.2 million for the second quarter of 2021 compared to $24.9 million for the second quarter of 2020.
Research and development (R&D) expenses were $26.7 million for the second quarter of 2021 compared to $10.2 million for the second quarter of 2020. The increase in R&D expenses was primarily related to an increase in headcount and increased spend across preclinical and clinical development.
General and administrative (G&A) expenses were $8.0 million for the second quarter of 2021 compared to $4.9 million for the second quarter of 2020. The increase in G&A expenses was primarily due to an increase in personnel and other corporate-related costs.

On August 12, 2021 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CFBI), a biotechnology company with a pipeline of proprietary small molecule drugs that bind specifically to the A3 adenosine receptor (A3AR), addressing cancer, liver and inflammatory diseases, reported that it has entered into a definitive agreement with a single healthcare-focused institutional investor for the purchase and sale of 5,000,000 of the Company’s American Depositary Shares (ADSs) (or ADS equivalents in lieu thereof), at an effective purchase price of $2.00 per ADS, in a registered direct offering (Press release, Can-Fite BioPharma, AUG 12, 2021, View Source [SID1234586465]). Can-Fite has also agreed to issue and sell to the investor, in a concurrent private placement, unregistered warrants to purchase up to an aggregate of 5,000,000 ADSs. Each ADS represents thirty (30) ordinary shares, par value NIS 0.25 per share, of Can-Fite. The offering is expected to close on or about August 16, 2021, subject to satisfaction of customary closing conditions.

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H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

The warrants will have an exercise price of $2.00 per ADS and will be exercisable at any time upon issuance and will expire three (3) years following the effectiveness of an initial resale registration statement registering the ADSs issuable upon the exercise of the warrants.

The gross proceeds from the offering (without taking into account any proceeds from any future exercises of warrants issued in the concurrent private placement), before deducting the placement agent’s fees and other estimated offering expenses payable by the Company, are expected to be $10.0 million. Can-Fite intends to use the net proceeds for funding research and development and clinical trials and for other working capital and general corporate purposes.

The ADSs and the ADSs equivalents (but not the warrants or the ADSs underlying the warrants) are being offered by Can-Fite pursuant to a "shelf" registration statement on Form F-3 (File No. 333-249063) originally filed with the U.S. Securities and Exchange Commission (the "SEC") on September 25, 2020 and declared effective by the SEC on October 9, 2020. The offering of the ADSs and the ADSs equivalents is being made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and the accompanying prospectus relating to the ADSs and the ADSs equivalents being offered will be filed with the SEC. Electronic copies of the final prospectus supplement and the accompanying prospectus may be obtained, when available, on the SEC’s website at View Source or by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (212) 856-5711 or e-mail at [email protected].

The warrants described above were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act"), and Regulation D promulgated thereunder and, along with the ADSs underlying the warrants, have not been registered under the Act, or applicable state securities laws. Accordingly, the warrants and underlying ADSs may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Act and such applicable state securities laws.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction.

On August 12, 2021 Moleculin Biotech, Inc., (Nasdaq: MBRX) (Moleculin or the Company), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors and viruses, reported its financial results for the quarter ended June 30, 2021 (Press release, Moleculin, AUG 12, 2021, View Source [SID1234586464]). The Company also provided an update on its portfolio of oncology drug candidates for the treatment of highly resistant tumors and viruses.

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"I am pleased with the progress made over the course of the past quarter, of particular note, in the clinical development program for Annamycin, our next-generation anthracycline. We are committed to advancing our three core technologies to meet the needs in a number of oncology and viral indications. We believe the next 18 months hold a number of key inflection points and value drivers for the Company. We believe Moleculin is well-positioned to continue building momentum and drive shareholder value in the near- and long-term," commented Walter Klemp, Chairman and CEO of Moleculin.

Recent Highlights

Received approval to extend dose escalation in Phase 1/2 European clinical trial evaluating Annamycin for the treatment of acute myeloid leukemia (AML).
Commenced enrollment and dosed the first subject in its U.S. Phase 1b/2 clinical trial evaluating Annamycin for the treatment of soft tissue sarcoma (STS) lung metastases.
Held further meetings with the MHRA in the UK regarding a healthy volunteer trial with WP1122 for the treatment of COVID-19.
Programs Update

Next Generation Anthracycline – Annamycin

Annamycin, the Company’s next-generation anthracycline was designed to be noncardiotoxic (unlike all currently approved anthracyclines) and has demonstrated its lack of cardiotoxicity in recently conducted human clinical trials for the treatment of AML. The Company believes that, because of this unique improvement in safety, the use of Annamycin may not face the same usage limitations imposed on doxorubicin. Additionally, Annamycin has been shown in animal models to accumulate in the lungs at up to 30-fold the level of doxorubicin. Annamycin is currently in development for the treatment of AML and STS lung metastases. For more information about the Phase 1b/2 study evaluating Annamycin for the treatment of STS lung metastases, please visit clinicaltrials.gov and reference identifier NCT04887298.

Upcoming Milestones Expectations

H2 2021: Report cohort topline results from the ongoing Phase 1/2 study for treatment of AML and report the study’s topline results.
H2 2021: Commence Phase 1/2 study in Europe for the treatment of AML evaluating combination therapy of Annamycin + AraC.
H2 2021: Commencement of an investigator-funded, second Phase 1b/2 clinical trial of Annamycin in sarcoma lung metastases in Europe
First-in-class p-STAT3 Inhibitors – WP1066 and WP1220

WP1066 is one of several Immune/Transcription Modulators, designed to stimulate the immune response to tumors by inhibiting the errant activity of Regulatory T-Cells (TRegs) while also inhibiting key oncogenic transcription factors, including p-STAT3 (phosphorylated signal transducer and activator of transcription 3), c-Myc (a cellular signal transducer named after a homologous avian virus called Myelocytomatosis) and HIF-1α (hypoxia inducible factor 1α). These transcription factors are widely sought targets that are believed to contribute to an increase in cell survival and proliferation, and the angiogenesis (coopting vasculature for blood supply), invasion, metastasis and inflammation associated with tumors. They may also play a role in the inability of immune checkpoint inhibitors to affect more resistant tumors. WP1220 is a close analog to WP1066 that the Company has developed as a potential topical therapy for skin-related diseases.

WP1220 was evaluated for the treatment of Cutaneous T-Cell Lymphoma (CTCL) and, based on those results, we are seeking collaborators for future development. WP1066 is currently being evaluated for the treatment of pediatric brain tumors, including Diffuse Interstitial Pontine Glioma (DIPG). Additionally, WP1066 + radiation is being evaluated, pre-clinically, in the treatment of Glioblastoma Multiforme (GBM).

Upcoming Milestones Expectations

H2 2021: File a US Investigative New Drug application (IND) for the treatment of certain adult cancer(s) with WP1066 and identify an institution to commence an associated investigator-funded Phase 1a/1B study.
H2 2021: Continue support of the physician-sponsored pediatric brain tumor clinical trial
H1 2022: Facilitate launch of physician-sponsored Phase 2 study of WP1066 for the treatment of pediatric brain tumors including DIPG.
Actively seek collaboration with a strategic partner in the near term for external funding for the continued development of WP1220 in a Phase 2 clinical trial as a topical therapy for CTCL.
Infectious Disease and Metabolism/Glycosylation Inhibitors- WP1122, WP1096 and WP1097 Portfolio

Moleculin has new compounds designed to target the roles of glycolysis and glycosylation in both cancer and viral diseases. The Company’s lead Metabolism/Glycosylation Inhibitor, WP1122, is a prodrug of 2-DG that appears to improve the drug-like properties of 2-DG by increasing its circulation time and improving tissue/organ distribution. Recent published research has identified that 2-DG has antiviral potential against SARS-CoV-2 in vitro and, based on publicly available information, a recently completed Phase 2 clinical trial by an unrelated company in India has reported efficacy in COVID-19 patients, resulting in the Emergency Use Authorization of 2-DG by the Drugs Controller General of India. Moleculin believes WP1122 has the potential to become an important drug to potentiate existing therapies, including checkpoint inhibitors. The Company recently engaged in discussions with the Medicines and Healthcare Products Regulatory Agency (MHRA) in the United Kingdom (UK) regarding the potential for beginning clinical trials of WP1122 without the need for additional preclinical animal efficacy models. Based on their initial discussions with the MHRA, the Company believes that a COVID-19 animal model will not be required in order to submit a clinical trial application (CTA) for a Phase 1 clinical trial beginning with healthy volunteers in that country, although no final determination has been made by the MHRA. During the second quarter these discussions continued. Additionally, the Company is in the process of identifying countries where potential future Phase 2 clinical studies could occur. The Company is also engaged in preclinical development of additional antimetabolites (WP1096 and WP1097) targeting glycolysis and glycosylation.

Upcoming Milestones Expectations

H2 2021: Seek to initiate Phase 1a/1b study of WP1122 for the treatment of COVID-19 in the UK.
H2 2021: Potential to launch Phase 2 pivotal study of WP1122 for the treatment of COVID-19 outside the U.S.
H2 2021: File an IND in the U.S. for the treatment of certain cancers such as GBM and pancreatic cancer, with WP1122.
Ongoing preclinical development work in anti-viral indications such as HIV, Zika, and Dengue. IND targeted for 2022.
Summary of Financial Results for Second Quarter 2021

Research and development (R&D) expense was $3.0 million and $3.3 million for the three months ended June 30, 2021 and 2020, respectively. The decrease of $0.3 million is mainly related to the timing of costs incurred in 2020 of producing additional drug product for Annamycin clinical trials.

General and administrative expense was $2.4 million and $1.7 million for the three months ended June 30, 2021 and 2020, respectively. The increase of $0.7 million is mainly related to an increase in consulting and advisory fees and an increase in the Company’s corporate insurance.

For the six months ended June 30, 2021 and 2020, the Company incurred net losses of $8.7 million and $11.3 million, respectively, and had net cash flows used in operating activities of $10.4 million and $9.3 million, respectively.

The Company ended the quarter with approximately $79.5 million of cash. The Company believes that this cash is sufficient to meet its projected operating requirements, which include a forecasted increase over its current R&D rate of expenditures, into 2024.

On August 12, 2021 Monopar Therapeutics Inc. (Monopar or the Company) (Nasdaq: MNPR), a clinical-stage biopharmaceutical company primarily focused on developing proprietary therapeutics designed to extend life or improve the quality of life for cancer patients, reported second quarter 2021 financial results and recent business updates (Press release, Monopar Therapeutics, AUG 12, 2021, View Source [SID1234586463]).

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Recent Business Updates

Validive

Monopar’s Phase 2b/3 VOICE clinical trial of Validive (clonidine HCl mucobuccal tablet) for the prevention of severe oral mucositis (SOM) in patients undergoing chemoradiotherapy (CRT) for oropharyngeal cancer successfully reached its target of 20 activated clinical trial sites for the Phase 2b portion of the trial. Monopar plans to activate additional clinical trial sites, potentially including sites outside of the U.S. There is no FDA-approved prevention or treatment for CRT-induced SOM. The VOICE trial is on track for reaching interim analysis in the first half of 2022.
Camsirubicin and MNPR-202 and Related Analogs

The U.S. Food and Drug Administration cleared Monopar to proceed under its Investigational New Drug (IND) application with an open-label Phase 1b dose-escalation clinical trial evaluating camsirubicin plus growth factor support (pegfilgrastim) in patients with advanced soft tissue sarcoma (ASTS). Monopar anticipates dosing the first patient in the fourth quarter of 2021.
Monopar entered into a collaboration agreement with the Cancer Science Institute of Singapore, one of Asia’s premier cancer research centers, at the National University of Singapore (consistently ranked as one of the world’s top universities) to evaluate the activity of MNPR-202 and related analogs in preclinical models of multiple types of cancer. MNPR-202, a camsirubicin analog, was designed to retain the same potentially non-cardiotoxic backbone as camsirubicin but is modified at other positions which may enable it to be efficacious in certain cancers that are resistant to camsirubicin and doxorubicin. MNPR-202 and related analogs are covered under a newly issued U.S. composition of matter patent (US10,450,340).
MNPR-101 RIT and Related Compounds

Monopar and NorthStar Medical Radioisotopes, LLC (NorthStar) filed a provisional patent application with the U.S. Patent and Trademark Office (USPTO) titled "Bio-Targeted Radiopharmaceutical Compositions Containing Ac-225 and Methods of Preparation." Radiopharmaceutical therapy is a promising approach to treat cancer and other diseases using radioactive metals bound to proteins/antibodies to target and kill cells. Actinium-225 (Ac-225) is emerging as a radioactive isotope of choice for radiopharmaceuticals due to favorable properties such as its long half-life and selective induction of localized tumor cell death.

Monopar and NorthStar filed a provisional composition of matter patent application titled "Urokinase Plasminogen Activator Receptor-Targeted Radiopharmaceutical" covering a radiotherapeutic consisting of Monopar’s proprietary antibody MNPR-101 bound to Ac-225 via the metal binding agent PCTA. This radioimmunotherapeutic (RIT) has demonstrated 98% radiochemical purity and high stability, and has the potential to be a highly selective, potent treatment for a variety of cancers, severe COVID-19, and other diseases characterized by aberrant urokinase plasminogen activator receptor expression.
Additions to Monopar’s Executive Management Team

Monopar appointed Andrew Cittadine, MBA, as its Chief Operating Officer. Mr. Cittadine is an experienced healthcare executive and serial entrepreneur who has founded or led multiple healthcare businesses from concept through acquisition by Fortune Global 1000 firms. These include founding two successful diagnostic imaging companies, Sensant Corp. and American Biooptics, where he also served as CEO, and led both through stock or asset acquisitions by Siemens and Olympus, respectively. He also served as CEO of a critical care company, SonarMed, which was acquired by Medtronic. Mr. Cittadine brings to Monopar considerable leadership experience, including managing manufacturing and quality systems implementation, executing multi-center clinical trials, and achieving regulatory clearances for new technologies in both the U.S. and Europe.

Monopar appointed Octávio Costa, MD, as its Chief Medical Officer. Dr. Costa joined Monopar with over 30 years of experience overseeing clinical development, clinical operations, development strategy and global medical affairs. He has extensive Phase 1 through Phase 4 clinical development expertise and related regulatory experience. Dr. Costa’s previous roles include positions of increasing responsibility in clinical development at Merck, Celgene, Novartis and most recently as Chief Medical Officer at Rafael Pharmaceuticals. He has played an important role in the development and life-cycle management of significant marketed oncology products, including the blockbuster product REVLIMID (lenalidomide) in Latin America.
Results for the Second Quarter Ended June 30, 2021, Compared to the Second Quarter Ended June 30, 2020

Cash and Net Loss

Cash and cash equivalents as of June 30, 2021, were $24.3 million. Monopar anticipates that its current cash and cash equivalents will fund the Company’s major programs at least through September 2022, including: completing the Phase 2b portion of the VOICE clinical trial and commencing of the Phase 3 portion; funding the camsirubicin Phase 1b clinical trial; continuing advancement of the MNPR-101 RIT program including related compounds; continuing the development of MNPR-101 and related technologies in cancer; and developing MNPR-202 and related analogs in various cancers. The Company plans to raise additional funds and/or engage a partner within the next 12 months to complete the VOICE clinical program and continue the camsirubicin clinical development beyond the Phase 1b clinical trial.

Net loss for the second quarter of 2021 was $2.1 million or $0.17 per share compared to net loss of $1.4 million or $0.14 per share for the second quarter of 2020.

Research and Development (R&D) Expenses

R&D expenses for the second quarter of 2021 were $1.4 million compared to $0.8 million for the second quarter of 2020. This increase of $0.6 million was primarily attributed to increases of (1) $0.3 million for VOICE clinical trial expenses, (2) $0.2 million for R&D personnel expenses, and (3) $0.1 million for planning of the Phase 1b camsirubicin clinical trial including regulatory and manufacturing-related expenses.

General and Administrative (G&A) Expenses

G&A expenses for the second quarter of 2021 were $0.6 million, essentially the same as the G&A expenses for the second quarter of 2020.