On August 11, 2022 Diffusion Pharmaceuticals Inc. (NASDAQ: DFFN) ("Diffusion" or the "Company"), a biopharmaceutical company developing novel therapies that may enhance the body’s ability to deliver oxygen to areas where it is needed most, reported financial results for the quarter ended June 30, 2022, and provided a business update (Press release, Diffusion Pharmaceuticals, AUG 11, 2022, View Source [SID1234618241]).

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Development Updates

Aligned with FDA on Innovative Trial Design in Glioblastoma Multiforme ("GBM") Patients: In July 2022, Diffusion announced that it had aligned with the U.S. Food and Drug Administration ("FDA") on the design of an open-label, dose-escalation, Phase 2 safety and efficacy study of its lead product candidate, trans sodium crocetinate ("TSC"), administered with standard of care to patients newly diagnosed with glioblastoma multiforme. The trial, which has been designated Study 200-208, has been designed to incorporate an innovative use of positron emission tomography ("PET") to map hypoxia within the tumor. The use of PET is designed to allow the Company to directly quantify the effects of TSC on tumor hypoxia, and thereby test TSC’s ability to enhance oxygen within the tumor microenvironment. These initial imaging readouts are expected to be available within one year of study initiation, thereby providing objective surrogate data readouts significantly faster than historical clinical trials in patients with GBM. The Company expects to initiate the trial by the end of 2022 with the first patient dosed in the first quarter of 2023.

Reported Positive Results from Altitude Trial: In June 2022, positive results were reported from the Company’s Altitude Trial. The data suggested that a higher dose of TSC (2.5 mg/kg dose) decreased blood acidity (lower lactate accumulation) and enhanced metabolic recovery at 10 minutes after completion of exercise under the stressful conditions of simulated high altitude and exercise. Additionally, positive changes were observed in blood markers of oxygen utilization, indicating that TSC may enhance oxygen availability at the cellular level, reinforcing Diffusion’s belief in the therapeutic potential of TSC.

"During the second quarter of 2022, we maintained significant momentum across our clinical and corporate programs achieving clinical and operational milestones we believe will help build Diffusion’s long-term success. Specifically, we were pleased to report positive results from our Altitude Trial, which we believe support our plans for further development of TSC to treat hypoxic solid tumors like GBM," commented Robert Cobuzzi, Jr., Ph.D., President and Chief Executive Officer of Diffusion. "Additionally, we are very pleased to have reached alignment with the FDA on an innovative GBM Trial design, and our team is already working to initiate the trial. We believe TSC has the potential to enhance the effectiveness of available treatment of this devastating disease."

Business Updates

Appointed Raven Jaeger, M.S., as Chief Regulatory Officer: In May 2022, Diffusion appointed Ms. Raven Jaeger as the Company’s Chief Regulatory Officer. Ms. Jaeger will, among other things, oversee the development and implementation of regulatory and related strategies to support the development and commercialization of Diffusion’s product development candidates.

Ended Quarter with $28.5 Million in Cash, Cash Equivalents and Marketable Securities with Expected Cash Runway into First Quarter of 2024

Research and development expenses in the second quarter of 2022 were $2.1 million, compared to $2.0 million in the prior year period. There was a decrease in costs associated with clinical trials and drug manufacturing, offset by an increase in salaries and wages and stock-based compensation related to increased headcount.

General and administrative expenses were $2.1 million during the second quarter of 2022 versus $1.8 million in the comparable quarter last year. The increase reflects a rise in professional fees related to the reverse stock split that occurred in April 2022, as well as increased salary expenses related to additional headcount.

As of June 30, 2022, Diffusion had $28.5 million in cash, cash equivalents, and marketable securities, which the Company currently expects will enable it to fund its operating expenses and capital expenditure requirements into the first quarter of 2024, without giving effect to any business development activities the Company may undertake.

On August 11, 2022 Brickell Biotech, Inc. ("Brickell" or the "Company") (Nasdaq: BBI), a clinical-stage pharmaceutical company striving to transform patient lives by developing innovative and differentiated prescription therapeutics for the treatment of autoimmune, inflammatory, and other debilitating diseases, reported financial results for the second quarter ended June 30, 2022 and provided a corporate update (Press release, Vical, AUG 11, 2022, View Source [SID1234618220]).

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"Advancement of BBI-02 into the clinic is a significant milestone for our company as it marks the first time a DYRK1A inhibitor intended for patients with autoimmune diseases has been orally administered in humans," commented Robert Brown, Chief Executive Officer of Brickell. "We are pleased with the progress in the Phase 1 study and remain on track to initiate the MAD part of the study next month and report SAD and MAD topline results by early 2023."

Research and Development Highlights

BBI-02: a potential first-in-class DYRK1A inhibitor for the treatment of autoimmune and inflammatory diseases

Continue to enroll and dose patients in the Phase 1 clinical trial of BBI-02 (BBI-02-101) in Canada, a randomized, double-blind, placebo-controlled study designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of BBI-02 capsules in both healthy subjects and patients with atopic dermatitis (AD).
Part 1A of the study is a single ascending dose (SAD) assessment of BBI-02 capsules or placebo in healthy subjects. Part 1B of the study will be a multiple ascending dose (MAD) assessment of BBI-02 capsules or placebo administered once daily for 14 days in healthy subjects. Part 2 of the study will compare BBI-02 to placebo in patients with moderate-to-severe AD over 28 days of dosing and will include a preliminary assessment of efficacy. Additional information on this clinical trial can be found on www.clinicaltrials.gov under identifier NCT05382819.
The Company expects to initiate the MAD assessment next month and remains on track to report topline results from the SAD and MAD parts of the Phase 1 trial by early 2023.
BBI-10: a covalent Stimulator of Interferon Genes (STING) inhibitor for the potential treatment of autoimmune, inflammatory, and rare genetic diseases

Preclinical development activities for BBI-10, the Company’s lead STING inhibitor candidate, are underway.
Next-Generation Kinase Inhibitors: a cutting-edge platform with the potential to produce treatments for autoimmune, inflammatory, and other debilitating diseases

The Company is engaged in research to identify both brain penetrant and non-brain penetrant kinase inhibitors from the Company’s library of novel compounds, including next-generation DYRK1A inhibitors and other new chemical entities that specifically inhibit LRRK2, TTK, and CLK kinases.
A number of these drug candidates have the potential to penetrate the blood brain barrier, presenting an opportunity to address neuroinflammatory conditions of high unmet need such as Down Syndrome, Alzheimer’s Disease, and Parkinson’s Disease, while other peripherally acting novel LRRK2, TTK, and CLK kinase inhibitors could be developed in additional therapeutic areas within autoimmunity, inflammation, and oncology.
Recent Corporate Highlights

On July 5, 2022, Brickell effected a 1-for-45 reverse stock split of the Company’s common stock. Proportional adjustments were also made to the number of shares of Brickell’s common stock subject to outstanding equity awards and warrants, as well as the applicable exercise price(s). The purpose of the 1-for-45 reverse stock split was to raise the per-share trading price of the Company’s common stock to regain compliance with the $1.00 per share minimum bid price requirement for continuous listing on The Nasdaq Capital Market ("Nasdaq"). On July 19, 2022, the Company received formal notice from Nasdaq stating that the Company had regained compliance with the minimum bid price requirement for continued listing on Nasdaq, and, accordingly, the previously-scheduled hearing regarding the delisting action had been canceled and the Company’s common stock will continue to be listed and traded on Nasdaq.

On May 3, 2022, Brickell signed and closed a definitive asset purchase agreement ("APA") with Botanix SB Inc., a subsidiary of Botanix Pharmaceuticals Limited (ASX: BOT) ("Botanix"). Under the terms of the APA, Botanix acquired all of Brickell’s rights and assets primarily related to sofpironium bromide. In exchange, Brickell received $3.0 million at closing and is eligible to receive from Botanix potential near-term regulatory milestone payments of (a) $2.0 million upon the acceptance by the U.S. Food and Drug Administration of a new drug application ("NDA") submission for sofpironium bromide gel, 15%, and (b) $4.0 million if marketing approval in the U.S. for sofpironium bromide gel, 15%, is received on or before September 30, 2023, or $2.5 million if such marketing approach is received after September 30, 2023 but on or before February 17, 2024. Brickell also is eligible to receive additional success-based regulatory and sales milestone payments of up to $168 million and tiered earnout payments ranging from high-single digits to mid-teen digits on net sales of sofpironium bromide gel. Certain of these amounts are subject to payments by Brickell to its former licensor. Brickell additionally will receive certain payments from sales by its former sublicensee, Kaken Pharmaceutical Co. ("Kaken"). Under the APA, Botanix is responsible for all further research, development, and commercialization of sofpironium bromide globally. In connection with the sale of sofpironium bromide, Brickell and Botanix entered into a transition services agreement ("TSA") whereby Brickell is providing consulting services to Botanix as an independent contractor through filing and potential approval of the U.S. NDA for sofpironium bromide gel, 15%. Botanix has reported that it plans to submit the NDA for sofpironium bromide gel, 15% in the third quarter of 2022.

Second Quarter 2022 Financial Results

The Company reported cash and cash equivalents of $14.5 million as of June 30, 2022, compared to $26.9 million as of December 31, 2021. The Company expects its cash and cash equivalents as of June 30, 2022, combined with $2.0 million from expected near-term payments under the APA with Botanix, will support its operations for at least the next 12 months.

Revenue was $4.3 million for the second quarter of 2022, compared to $0.2 million for the second quarter of 2021. Revenue for the three months ended June 30, 2022 consisted of contract revenue recognized under the APA and TSA with Botanix, while revenue for the three months ended June 30, 2021 was driven by royalty revenue earned on a percentage of net sales of ECCLOCK in Japan under the Kaken agreement. Contract revenue for the three months ended June 30, 2022 consisted of an upfront payment from Botanix of $3.0 million, reimbursed development expenditures from Botanix under the APA of $0.6 million, fees for consulting services the Company provided under the TSA of $0.4 million, and sublicense income under the APA of $0.3 million.

Research and development expenses were $1.9 million for the second quarter of 2022, compared to $8.8 million for the second quarter of 2021, which decrease was driven primarily by lower clinical expenses related to sofpironium bromide, partially offset by increased clinical costs for BBI-02. Throughout 2021, the Company was executing its U.S. Phase 3 pivotal clinical program for sofpironium bromide gel, 15%, which concluded in the fourth quarter of 2021. During the second quarter of 2022, the Company initiated its Phase 1 clinical trial for BBI-02 and began incurring research and development expenses related to the clinical trial.

General and administrative expenses were $3.9 million for the second quarter of 2022, compared to $2.9 million for the second quarter of 2021. The increase was primarily related to expenses incurred in the second quarter of 2022 associated with entering into the APA and higher legal, compensation, and other administrative fees.

Brickell’s net loss was $1.1 million for the second quarter of 2022 compared to $11.1 million for the second quarter of 2021.

Conference Call and Webcast Information

Brickell’s management will host a conference call today at 4:30 p.m. EDT to discuss the financial results and recent corporate developments. The dial-in number for the conference call is 1-844-826-3035 for domestic participants and 1-412-317-5195 for international participants, with Conference ID #: 10168280. A live webcast of the conference call can be accessed at (click here) or through the Investors section of the Brickell website at View Source A replay will be available on this website shortly after conclusion of the event for approximately 90 days.

On August 11, 2022 Onconova Therapeutics, Inc. (NASDAQ: ONTX), ("Onconova"), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, reported financial results for the three months ended June 30, 2022, and provided a business update (Press release, Onconova, AUG 11, 2022, View Source [SID1234618219]).

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Highlights for the second quarter of 2022 and recent weeks include:

Safety data from the ongoing Phase 1 solid tumor trials of narazaciclib in the United States and China continue to be encouraging with the maximum tolerated dose not yet reached in either study. The trial in the United States is currently enrolling its fifth dose escalation cohort, with continuous dosing. The trial in China is also enrolling its fifth dose escalation cohort but once a day on days 1-21 of 28-day cycles. A protocol amendment to enable further dose escalation in the trial in China is being prepared.
Data from in vitro and cell-based assays that suggest narazaciclib’s inhibitory profile may provide safety and efficacy advantages over currently approved CDK4/6 inhibitors were featured in an abstract published at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.
Each of rigosertib’s investigator-sponsored trials continues to progress. A Phase 2 trial evaluating rigosertib plus pembrolizumab in patients with checkpoint inhibitor refractory metastatic melanoma is on schedule to be initiated in the second half of 2022. The expansion cohort of the Phase 1/2a trial of rigosertib plus nivolumab in patients with KRAS-mutated non-small cell lung cancer continues to enroll patients, with additional data from the trial expected in Q3 2022. The Phase 2 trial of rigosertib monotherapy in advanced squamous cell carcinoma associated with recessive dystrophic epidermolysis bullosa also continues to enroll patients.
Mark Guerin was appointed Chief Operating Officer in addition to his role as Chief Financial Officer and Dr. Adar Makovski Silverstein was promoted to Senior Director and Head of Corporate Development.
Cash and cash equivalents at June 30, 2022 were $46.5 million, which the Company believes will be sufficient to fund ongoing clinical trials and business operations for at least eighteen months.
Management Commentary

"We saw sustained progress across our pipeline over the past months and are well positioned to complete our current Phase 1 trials as we move through the second half of the year," said Steven M. Fruchtman, M.D., President and Chief Executive Officer of Onconova. "Narazaciclib continues to show a favorable safety profile in its Phase 1 studies, which will be key to informing the design of future trials seeking to address the unmet needs posed by the limitations of currently available CDK4/6 inhibitors. These limitations stem from issues related to safety, tolerability, and primary and acquired drug resistance, which we believe narazaciclib’s differentiated inhibitory profile may overcome. We were pleased to publish preclinical data supporting this hypothesis at the most recent ASCO (Free ASCO Whitepaper) meeting and look forward to continued efforts to translate these promising findings to the clinic."

Dr. Fruchtman continued, "Alongside narazaciclib’s advancement, we also made key progress in rigosertib’s investigator-sponsored studies. This includes a Phase 2 trial evaluating rigosertib combined with a PD-1 checkpoint inhibitor in checkpoint inhibitor refractory metastatic melanoma which is on schedule to open for enrollment in the second half of 2022. This study seeks to leverage rigosertib’s immunomodulatory effects and is supported by initial data from the ongoing trial of rigosertib plus anti-PD-1 therapy in KRAS-mutated NSCLC. These data provided strong evidence of the studied doublet’s activity in patients who previously failed checkpoint inhibitor therapy, which is a finding we aim to build upon with the presentation of additional data at a medical meeting later this quarter. Data has been presented, which will be updated, demonstrating that responses seen with rigosertib in this setting are agnostic to the type of KRAS mutation present. This upcoming milestone highlights how rigosertib’s investigator-sponsored studies enable the capital efficient pursuit of value creating opportunities to complement our lead narazaciclib program."

Second Quarter Financial Results

Cash and cash equivalents as of June 30, 2022, were $46.5 million, compared with $55.1 million as of December 31, 2021. The Company believes that its cash and cash equivalents will be sufficient to fund ongoing clinical trials and business operations for at least eighteen months.

Research and development expenses were $2.0 million for the second quarter of 2022, compared with $1.9 million for the second quarter of 2021.

General and administrative expenses were $2.1 million for the second quarter of 2022, compared with $2.9 million for the second quarter of 2021.

Net loss for the second quarter of 2022 was $4.0 million, or $0.19 per share on 20.9 million weighted shares outstanding, compared with a net loss of $4.2 million, or $0.27 per share for the second quarter of 2021 on 15.8 million weighted shares outstanding.

Conference Call and Webcast

Onconova will host an investment community conference call today beginning at 4:30 p.m. Eastern Time, during which management will discuss financial results for the second quarter of 2022, provide a business update, and answer questions. Interested parties can participate by dialing (800) 289-0571 (domestic callers) or (856) 344-9290 (international callers) and using conference ID 3600715.

A live webcast of the conference call will be available in the Investors & Media section of the Company’s website at www.onconova.com. A replay of the webcast will be available on the Onconova website for 90 days following the call.

On August 11, 2022 Achieve Life Sciences, Inc. (NASDAQ: ACHV), a late-stage clinical pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation and nicotine addiction, reported second quarter 2022 financial results and provided an update on the cytisinicline clinical development program (Press release, OncoGenex Pharmaceuticals, AUG 11, 2022, View Source [SID1234618218]).

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Recent Events & Highlights

Reported statistically significant results from the Phase 3 ORCA-2 clinical trial of cytisinicline in 810 adult smokers
Awarded $2.5 million grant from the National Institutes of Health (NIH) to conduct ORCA-V1 Phase 2 trial of cytisinicline in nicotine e-cigarette users
Initiated the Phase 2 ORCA-V1 clinical trial to evaluate cytisinicline in adult e-cigarette users
"We continue to build upon the progress of cytisinicline with the announcement of the initiation of the ORCA-V1 trial and the continued enrolment in ORCA-3, our final NDA-enabling smoking cessation clinical trial," stated John Bencich, CEO of Achieve Life Sciences. "We remain focused on executing on our milestones and potentially expanding cytisinicline to e-cigarette and vaping users who currently have no FDA-approved cessation treatments."

Reported Phase 3 ORCA-2 Results
In April, Achieve announced positive, statistically significant results in its Phase 3 ORCA-2 clinical trial of cytisinicline in 810 adult smokers across 17 clinical trial locations in the United States. ORCA-2 evaluated the efficacy and safety of 3mg of cytisinicline dosed 3 times daily for either 6 or 12-weeks compared to placebo in adult smokers. Both the primary and secondary endpoints demonstrated increased quit rates, showing 6-8 times increased odds of smoking abstinence when compared to placebo. Cytisinicline was well tolerated with single-digit rates of adverse events observed and no treatment-related serious adverse events reported.

Awarded $2.5 Million from NIH for Phase 2 ORCA-V1 Trial
In June, Achieve was awarded $2.5 million in grant funding from the NIH to evaluate the use of cytisinicline as a treatment for cessation of nicotine e-cigarette use. In total, $2.8 million has been awarded and is expected to cover approximately half of the ORCA-V1 trial costs.

Initiated Phase 2 ORCA-V1 Trial
Also in June, following the NIH grant award, Achieve initiated the ORCA-V1 clinical trial across five trial locations in the United States. Approximately 150 participants are planned to be randomized to receive 3mg of cytisinicline 3 times daily or placebo for 12 weeks in combination with standard behavioral support.

Financial Results
As of June 30, 2022, the company’s cash, cash equivalents, and restricted cash were $29.4 million. Total operating expenses for the three and six months ended June 30, 2022 were $10.1 million and $17.3 million, respectively. Total net loss for the three and six months ended June 30, 2022 was $10.5 million and $18.0 million, respectively.

As of August 11, 2022, Achieve had 9,681,855 shares outstanding.

Conference Call Details
Achieve will host a conference call at 4:30 PM EDT, Thursday, August 11, 2022. To access the webcast, please use the following link 2Q22 Earnings Webcast. Alternatively, you may access the live conference call by dialing (888) 645-4404 (Domestic) or (404) 267-0371 (International) and referencing conference ID 13731865. A webcast replay will be available approximately three hours after the call and will be archived on the website for 90 days.

On August 11, 2022 Marker Therapeutics, Inc. (Nasdaq: MRKR), a clinical-stage immuno-oncology company specializing in the development of next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications, reported financial results for the second quarter ended June 30, 2022 (Press release, Marker Therapeutics, AUG 11, 2022, View Source [SID1234618217]).

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"We are proud of our progress this year in advancing our Company-sponsored clinical program in AML, and early results support the ability of MT-401, a multiTAA-specific T cell product, to drive results for patients with AML," said Peter L. Hoang, Marker’s President and Chief Executive Officer. "This quarter, we continued to dose patients in the Phase 2 AML study, and we expect to provide a topline readout of active disease patients in Q3 2022. The recent $8 million upfront cash payment to Marker by Wilson Wolf has aided the efficient execution of Marker’s programs."

Mr. Hoang continued: "In addition, we recently announced that FDA cleared our IND investigating the safety and efficacy of MT-601 in patients with relapsed/refractory lymphoma, and that we are on track to file another IND by year-end to investigate the safety and efficacy of MT-601 in patients with pancreatic cancer, which has already received FDA Orphan Drug Designation. We anticipate dosing the first patients in these trials, in addition to dosing patients in our off-the-shelf therapy for AML, next year."

"We are very optimistic about the ability of MT-401 to drive results for patients with measurable residual disease given the results we have seen to date in the ARTEMIS study," said Dr. Mythili Koneru, Marker’s Chief Medical Officer. "Of note, we were very pleased to note that the second patient we treated with MRD+ disease was found to be MRD- by that patient’s week 8 follow-up. The ability to administer MT-401 without the need for lymphodepletion, coupled with our improved accelerated manufacturing process, enable us to treat patients who have MRD+ disease. We believe that the results observed to date support the notion that patients with AML would have meaningful benefit from a multi-antigen targeted T cell therapy approach."

PROGRAM UPDATES AND EXPECTED MILESTONES

Acute Myeloid Leukemia (MT-401)

Marker has enrolled 13 evaluable patients in total, including 6 in the Safety Lead-in cohorts.
5 patients have been treated with MT-401 manufactured by a revised process and have completed dose-limiting toxicity (DLT) periods with no DLTs reported.
One additional MRD+ patient was treated and became MRD- at 8 weeks after the first infusion.
Marker remains on track to dose the first patient in 2023 with MT-401-OTS, a scalable, off-the-shelf product candidate with the potential to match patients to treatment in under three days. The Company is in the process of developing a patient cell bank inventory.
Lymphoma (MT-601)

On August 4, 2022, Marker announced that the U.S. Food and Drug Administration (FDA) cleared the Company’s Investigational New Drug (IND) application for MT-601, a multi-tumor-associated antigen (multiTAA)-specific T cell product targeting six antigens, for the treatment of patients with relapsed/refractory non-Hodgkin lymphoma who have failed or are ineligible to receive anti-CD19 CAR T cell treatment.
Marker expects to initiate a Phase 1 trial in 2023.
Pancreatic Cancer (MT-601)

Marker is on track to file an IND for MT-601 for the treatment of pancreatic cancer in 2022.
The Company intends to initiate a Phase 1 multicenter study of MT-601 administered in combination with front-line chemotherapy to patients with locally advanced unresectable or metastatic pancreatic cancer in 2023.
SECOND QUARTER 2022 FINANCIAL RESULTS

Cash Position and Guidance: At June 30, 2022, Marker had cash and cash equivalents of $25.8 million.
R&D Expenses: Research and development expenses were $6.6 million for the quarter ended June 30, 2022, compared to $7.4 million for the quarter ended June 30, 2021.
G&A Expenses: General and administrative expenses were $3.5 million for the quarter ended June 30, 2022, compared to $3.6 million for the quarter ended June 30, 2021.
Net Loss: Marker reported a net loss of $9.2 million for the quarter ended June 30, 2022, compared to a net loss of $10.9 million for the quarter ended June 30, 2021.
Organizational Restructuring

On August 10, 2022, the Company implemented changes to the Company’s organizational structure as part of an operational cost reduction plan to conserve the Company’s available capital. In connection with these changes, the Company reduced headcount in its general and administrative function by approximately 23.5%, including the separation of the Company’s Chief Financial Officer. The Company estimates that the severance and termination-related costs will total approximately $0.7 million and will be recorded in the third quarter of 2022. The Company expects that the payment of these costs will be substantially complete in September of 2023.