On February 9, 2023 Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel drug candidates for immuno-inflammatory diseases, reported that members of the Aclaris management team will participate in a fireside chat during the Virtual SVB Securities Global Biopharma Conference on Tuesday, February 14, 2023 at 9:20 AM ET (Press release, Aclaris Therapeutics, FEB 9, 2023, View Source [SID1234627013]).

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A webcast of the fireside chat may be accessed through the "Events" page of the "Investors" section of Aclaris’ website, www.aclaristx.com. The webcast will be archived for at least 30 days on the Aclaris website.

On February 9, 2023 Beyond Air, Inc. (NASDAQ: XAIR) ("Beyond Air" or the "Company") a commercial stage medical device and biopharmaceutical company focused on developing inhaled nitric oxide (NO) for the treatment of patients with respiratory conditions, including serious lung infections and pulmonary hypertension, and, through its affiliate Beyond Cancer, Ltd., ultra-high concentration nitric oxide (UNO) for the treatment of solid tumors, reported financial results for its third fiscal quarter ended December 31, 2022 (Press release, Beyond Air, FEB 9, 2023, View Source [SID1234627012]).

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"We are successfully executing on our planned limited launch of LungFit PH in the United States. Demand among targeted hospitals for demonstrations and evaluations continues to grow, and we look forward to recording our first sales during the March quarter," said Steve Lisi, Chairman and Chief Executive Officer of Beyond Air.

"Over the past few years, we have presented data which have demonstrated the safety of inhaled nitric oxide at high concentrations, administered intermittently, in more than 12 clinical settings with over 170 patients treated and more than 5,000 treatments administered with no serious adverse reactions related to nitric oxide. Strong efficacy signals were also demonstrated, especially in viral respiratory infections. We believe high concentration NO delivery with our LungFit PRO generator and delivery system can be a powerful tool against any type of pneumonia, regardless of the type of virus, including SARS-CoV2, and our company is dedicated to bringing this important therapy to market as soon as possible."

"Throughout the year, the team at Beyond Cancer has made incredible progress," continued Mr. Lisi. "The pre-clinical results presented during the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2022 annual meeting in November offer an encouraging first look at the potential synergistic effect of UNO therapy when combined with anti-PD-1 therapy. We are pleased to have also published our early pre-clinical work in the peer-reviewed journal Cancer Cell International ("CCI") in December. These impressive data support our understanding of UNO as an immunomodulating therapeutic option for the treatment of solid tumors and prevention of metastases and we look forward to further elucidating the powerful effects of UNO in human trials."

Recent Highlights and Upcoming Milestones

LungFit PH
Ongoing progress with limited release phase of commercial launch, making it the first and only nitric oxide generator, delivery, and monitoring system available in the United States
CE Mark anticipated to be received in the first half of fiscal year 2024, which is expected to be followed by an international commercial partnership
Expect to submit a PMA supplement for a cardiac label expansion for LungFit PH to the FDA in the first half of calendar year 2023
LungFit PRO
ID Week 2022 – the Company presented positive data showing a strong safety profile and statistically significant results on key endpoints in patients hospitalized with viral respiratory infections, including SARS-CoV2
Plan to initiate a U.S. trial for patients hospitalized with viral community-acquired pneumonia (VCAP), including COVID-19, in the fourth quarter of calendar year 2023, pending discussion with the FDA
LungFit GO
American College of Chest Physicians (CHEST) Annual Meeting 2022 – the Company presented positive safety, tolerability, and efficacy data from the LungFit GO pilot at-home study of patients with severe, treatment refractory, NTM lung disease
Plan to initiate a U.S. trial for patients with NTM in the second half of fiscal year 2025, pending discussion with the FDA
Plan to initiate a U.S. pilot trial in COPD patients who are hospitalized due to a exacerbation in the fourth quarter of calendar 2024, pending discussion with FDA
Beyond Cancer’s Solid Tumor Program
Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting 2022 – presented promising new data in mice for UNO therapy, which showed a doubling of survival when UNO was combined with anti-PD1 compared with anti-PD1 alone
Published pre-clinical data in Cancer Cell International (CCI) on December 13, 2022, which demonstrated that the company’s tumor ablation method results in a potent systemic immune response to the specific tumor type treated. Treated mice were immune to a re-introduction or tumor challenge resulting in a significant improvement in survival for UNO treated mice compared to control mice
Received a notice of allowance for its patent titled, "System and Method for Delivery or Gas to a Tissue", which is the first patent covering Beyond Cancer’s UNO therapy
Announced a sponsored research agreement with Stanford University, and the expansion of Beyond Cancer’s Scientific Advisory Board (SAB)
Financial Results for the Fiscal Quarter Ended December 31, 2022

Research and development expenses for the fiscal quarter ended December 31, 2022 were $5.0 million, compared with $2.5 million for the fiscal quarter ended December 31, 2021. The increase was driven mainly by compensation costs from scaling up operations in Beyond Cancer as well as from increased investments in pre-clinical work being done across the Group in our targeted therapeutic areas.

General and administrative expenses for the fiscal quarter ended December 31, 2022 increased to $8.9 million, compared with $4.9 million for the fiscal quarter ended December 31, 2021. The increase includes $3.0 million of planned structural investments in Beyond Cancer and $1.0 million attributable to continued investments in people and systems necessary to support the commercial launch of LungFit PH in the U.S.

Other income and expense was a $0.2 million gain for the fiscal quarter ended December 31, 2022, compared with a $0.5 million loss for the fiscal quarter ended December 31, 2021. The two main drivers in this year-over-year improvement were gains made from the Company’s investment in marketable securities as well as favorable foreign exchange movements.

For the fiscal quarter ended December 31, 2022, the Company had a GAAP net loss of $13.8 million, of which $12.7 million, or ($0.43) per share, was attributable to the shareholders of Beyond Air, Inc., compared with a net loss of $7.7 million, or ($0.29) per share, for the fiscal quarter ended December 31, 2021.

As of December 31, 2022, the Company reported cash and cash equivalents, marketable securities, and restricted cash of $63.2 million.

Total cash burn in the quarter ended December 31, 2022, was $9.3 million, which is in line with the Company’s quarterly cash burn guidance of $8.0 – 10.0 million per quarter. Through the first nine months of the Company’s fiscal year 2023, total cash burn was $27.0 million which includes $2.5 million in non-recurring expense.

On February 9, 2023 Applied DNA Sciences, Inc. (NASDAQ: APDN) ("Applied DNA" or the "Company"), a leader in PCR-based DNA technologies, reported its consolidated financial results for the first quarter of fiscal 2023, ended December 31, 2022 (Press release, Applied DNA Sciences, FEB 9, 2023, View Source;id=254293&p=2257612&I=1206939-c7Z3G6f3m8 [SID1234627011]).

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"Applied DNA delivered a solid start to the fiscal year with sequential and year-over-year revenue growth driven by molecular diagnostic testing demand at ADCL, our clinical laboratory subsidiary, several orders for linearDNA, including a pair of orders from first-time biopharma customers for mRNA research and development use, and from deferred textile DNA tagging revenue," stated Dr. James A. Hayward, president and CEO of Applied DNA. "Our top-line performance was paired with a 72% and 74% reduction in operating loss sequentially and year-over-year, respectively, due in part to higher testing volumes coupled with cost management actions previously taken at ADCL.

"We also achieved progress on our strategic priority of establishing linearDNA and our LinearDNA platform as the common denominator for the manufacture of the next generation of nucleic acid-based therapies while working to concurrently position ADCL and our supply chain traceability businesses for profitable growth and positive cash flows," continued Dr. Hayward. "Since the launch of our linearDNA IVT template production offering last summer, interest has grown steadily as the industry gains an appreciation for our capacity for high quality, enzymatically produced template to meet therapy developers’ need for this critical mRNA manufacturing starting material. Concurrently, the industry’s clinical interest in mRNA extends beyond COVID-19 vaccines to new applications for mRNA, such as personalized cancer treatments and other therapeutic uses. Our linearDNA IVT templates can be produced rapidly with chemical modifications and highly homogeneous poly(T) tails that we believe are very well suited to support this next chapter in mRNA therapeutics.

"Our linearDNA activities were also centered on fine-tuning our platform and forging relationships with platform materials partners to create a rapid, end-to-end production platform to capture commercial-scale IVT templating and, potentially, mRNA production opportunities empowered by the unique qualities of linearDNA. To that end, we remain committed to our timeline to building a cGMP manufacturing facility by the end of the current calendar year but are pivoting to a cost-efficient footprint within our corporate headquarters that maintains our ability to produce cGMP-grade product for current and prospective customers to validate for use in clinical trials. We also plan to leverage our platform advantages in the coming months to offer industry-leading DNA-sequence-to-IVT-template turnaround times."

Concluded Dr. Hayward, "At ADCL, we believe we are well positioned to leverage the population health platform we built during the pandemic to propel this subsidiary into the genetic testing marketplace of the future. Approaching enterprise customers with a reference lab model differentiates ADCL from those labs struggling to gain reimbursement from third parties and insurance companies. We have successfully completed our clinical validation and data analysis for our pharmacogenomics (PGx) testing panel and plan to file our validation package with New York State Department of Health in the coming weeks. Prospective PGx customer feedback has been very encouraging and gives us confidence that PGx testing can be a profitable post-pandemic path forward. In our supply chain traceability business, we continued to add CertainT platform customers for isotopic analysis testing, which is an excellent complement to DNA tagging. We are encouraged by the macro environment for textile material provenance testing following the recent passage of the federal Omnibus Bill that increases funding for compliance with the Uyghur Forced Labor Prevention Act."

First Quarter Fiscal 2023 Financial Highlights:

Total revenues increased 26% to $5.3 million, which included $4.5 million in clinical laboratory service revenues (COVID-19 testing revenue). This compares with total revenues of $4.2 million in the prior fiscal year period, which included $3.2 million of clinical laboratory service revenues.

The year-over-year increase was offset by a decrease in product revenues of $310 thousand due to a decrease in sales of our molecular diagnostics (MDx) test kits and supplies.

Gross profit was $2.4 million, or 45%, compared to $1.1 million, or 27%, in the prior fiscal year period. The improvement in gross margin was primarily the result of an improved gross profit margin for our MDx testing service. This improvement was the result of higher testing volumes, coupled with cost management efforts for our contracts where we also provide and staff the test collection centers. To a lesser extent, the improvement in gross profit for the current period was due to the prior fiscal year period having a high COVID-19 positivity rate, which resulted in our clinical laboratory having to reduce the test pooling size, which increased the cost of consumables per sample, therefore having a negative impact on gross profit.

Total operating expenses were $3.6 million compared to $5.8 million in the prior fiscal year period, reflecting a decrease in stock-based compensation expense of $1,6 million, primarily relating to officer stock option grants during the first three months of fiscal 2022, that vested immediately, as well as to the annual non-employee board of director grant that vests one-year from the date of grant. The remainder of the decrease primarily relates to a decrease in bad debt expense of $300,000 for the collection of an outstanding receivable that was previously fully reserved for.

Operating loss was $1.2 million compared to an operating loss of $4.7 million in the prior fiscal year period.

Excluding non-cash expenses, Adjusted EBITDA was negative $1.1 million compared to negative $2.7 million in the prior fiscal year period. See below for information regarding non-GAAP measures.

Cash and cash equivalents stood at $12.9 million on December 31, 2022, compared with $15.2 million as of September 30, 2022.

Our current warrants outstanding on December 31, 2022, stood at 7.3 million. Approximately 2.2 million of these warrants have exercise prices ranging from $2.80 to $2.84 per warrant share, which, if exercised, could result in exercise proceeds to the Company of approximately $6.3 million; 5.1 million of these warrants have an exercise price of $4.00 per warrant share, which, if exercised, could result in total exercise proceeds of approximately $20.3 million. Of the 5.1 million warrants, 2.1 million expire in September 2023, which, if exercised, would total proceeds of $8.4 million.
First Quarter Fiscal 2023 Conference Call Information

The Company will hold a conference call and webcast to discuss its first quarter of fiscal year 2023 financial results on Thursday, February 9, 2023, at 4:30 PM ET. To participate in the conference call, please follow the instructions below. While every attempt will be made to answer investors’ questions on the Q&A portion of the call, not all questions may be answered.

On February 10, 2023 Imugene Limited (ASX: IMU), a clinical stage immuno-oncology company, reported that it has received a Notice of Allowance from the U.S. Patent and Trademark Office (USPTO) for patent application number 16/498,929, related to its B-cell activating immunotherapy PD1-Vaxx, currently in clinical development for non-small cell lung cancer (NSCLC) (Press release, Imugene, FEB 9, 2023, View Source [SID1234627010]).

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The patent titled "HUMAN PD1 PEPTIDE VACCINES AND USES THEREOF" protects to 2038 the composition of matter and method of treatment in cancer of Imugene’s PD1-Vaxx for the generation of a therapeutic antibody response against the programmed death-1 (PD1) checkpoint target. Final preparations are in place for a clinical trial combining PD1-Vaxx in combination with atezolizumab (Tecentriq), an immune checkpoint inhibitor (ICI) targeting PD-L1, in patients NSCLC.

The objectives of the phase 1b trial, "An Open Label, Multi-Center, Dose Escalation/Expansion, Phase 1 Study of IMU-201 (PD1-Vaxx), a B-Cell Immunotherapy as monotherapy or in combination with atezolizumab, in Adults with Non-Small Cell Lung Cancer," are to determine safety, efficacy, and optimal dose of PD1-Vaxx in combination with atezolizumab as either first-line therapy in ICI treatment-naïve NSCLC patients or ICI pre-treated patients. The study will be conducted at sites in USA and Australia.

Imugene’s PD1-Vaxx is a B-cell activating immunotherapy designed to treat tumours such as lung cancer by interfering with PD-1/PD-L1 binding and interaction and produce an anti-cancer effect similar to Tecentiqâ, Keytrudaâ, Opdivoâ and the other immune checkpoint inhibitor monoclonal antibodies that are transforming the treatment of a range of cancers.

Imugene MD & CEO Leslie Chong said: "It’s vital to our business that we continue locking in intellectual property protection across the portfolio of assets, and I am proud to continue to strengthen our IP. With the US being the largest healthcare market in the world, this is a particularly important patent to protect our PD1-Vaxx technology as we continue its development."

On February 9, 2023 Veru Inc. (NASDAQ: VERU), a biopharmaceutical company focused on developing novel medicines for COVID-19 and other viral ARDS-related diseases and for oncology, reported financial results for its fiscal 2023 first quarter and provided a business update (Press release, Veru, FEB 9, 2023, View Source [SID1234627009]).

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"We have been busy seeking emergency authorization for sabizabulin for the treatment of hospitalized moderate to severe COVID-19 patients at high risk for ARDS with major global regulatory bodies," said Mitchell Steiner, M.D., Chairman, President, and Chief Executive Officer of Veru. "Our U.S. and international commercial teams are on standby. We are actively enrolling subjects in our advanced breast and prostate cancer Phase 3 clinical studies. Further, we have put in place a multi-pronged strategy to increase revenues from our sexual health program which appears to be successful as Q2 FY 2023 sales are significantly improving. As we await regulatory decisions, we have implemented measures to prudently conserve our cash, and we will provide an update once we are able to determine our path forward."

Infectious Disease Program Updates

Sabizabulin, a Novel Oral Microtubule Disruptor, for the Treatment of Hospitalized Moderate to Severe COVID-19 Patients at High Risk for Acute Respiratory Distress Syndrome (ARDS)

Sabizabulin for the treatment of COVID-19 is currently under regulatory review for potential emergency authorization by U.S. Food and Drug Administration (FDA), European Union’s European Medicines Agency (EMA), United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA), Australia’s Therapeutic Goods Administration (TGA), Canada’s Health Canada, South Korea’s Ministry of Food and Drug Safety (MFDS), and Switzerland’s Swissmedic. With respect to Europe, if the EMA authorizes sabizabulin for emergency use under Article 18, then individual EU nations may decide to authorize sabizabulin in their respective countries.

In October 2022, Phase 3 data of sabizabulin for the treatment of COVID-19 was presented as a late-breaker at IDWeek (Infectious Disease Week) 2022. Clinical highlights from the presentation include statistically and clinically significant reductions in mortality with sabizabulin treatment resulting in a 22.4 absolute percentage point and 81.2% relative reduction in deaths compared to the placebo (p=0.0090) in a subset analysis of hospitalized moderate to severe WHO-4 COVID-19 patients at high risk for ARDS.

Oncology Program Updates

Enobosarm, a Novel Oral Selective Androgen Receptor Targeting Agonist, and Abemaciclib, a CDK 4/6 Inhibitor, Combination Therapy for the 2nd Line Treatment of AR+ER+HER2- Metastatic Breast Cancer

Enrollment has been ongoing in the Phase 3 multicenter, open label, randomized (1:1), active control ENABLAR-2 trial to evaluate the combination of enobosarm and abemaciclib for the treatment of AR+ER+HER2- metastatic breast cancer. We have a collaboration and supply agreement with Eli Lilly and Company for this trial.

Enobosarm for the 3rd Line Treatment of AR+ER+HER2- Metastatic Breast Cancer

Enrollment has been ongoing in the Phase 3 multicenter, international, open label, randomized (1:1) ARTEST trial to evaluate enobosarm for the treatment of AR+ER+HER2- metastatic breast cancer.

Sabizabulin for the Treatment of Metastatic Castration and Androgen Receptor Targeting Agent Resistant Prostate Cancer

Enrollment has been ongoing in the Phase 3 VERACITY open label, randomized (2:1), multicenter trial to evaluate sabizabulin 32mg for the treatment of chemotherapy naïve men with metastatic castration resistant prostate cancer who have tumor progression after previously receiving at least one androgen receptor targeting agent.

VERU-100, a Novel Proprietary Long-Acting Gonadotropin-Releasing Hormone (GnRH) Antagonist Peptide 3-Month Subcutaneous Depot Formulation, for Androgen Deprivation Therapy of Advanced Prostate Cancer

Enrollment has been ongoing in the Phase 2 clinical dose finding trial to evaluate VERU-100 for the treatment of androgen deprivation therapy in patients with advanced prostate cancer.

Urev – Sexual Health Program Updates

FC2 Female Condom/Internal Condom

The Company markets and sells the FC2 Female Condom, an FDA-approved product for dual protection against unplanned pregnancy and the transmission of sexually transmitted infections.

ENTADFI (finasteride and tadalafil) capsules for oral use, a New Treatment for Benign Prostatic Hyperplasia (BPH)

The Company markets ENTADFI, an FDA-approved oral, once daily product for benign prostatic hyperplasia (BPH) for men with an enlarged prostate experiencing the signs and symptoms of BPH for up to 26 weeks.

First Quarter Financial Summary: Fiscal 2023 vs Fiscal 2022

Net revenues decreased to $2.5 million from $14.1 million

Gross profit decreased to $0.7 million from $11.8 million

Research and development expenses increased to $18.7 million from $10.1 million

Selling, general and administrative expenses increased to $17.5 million from $6.7 million

Operating loss was $35.6 million versus $5.0 million

Net loss was $36.8 million, or $0.46 per share, compared to $6.4 million, or $0.08 per share

Balance Sheet Information

Cash and cash equivalents were $46.9 million as of December 31, 2022 versus $80.2 million as of September 30, 2022

Net accounts receivable were $3.9 million as of December 31, 2022 versus $3.6 million as of September 30, 2022

Event Details

The audio webcast will be accessible under "Investor Kit" in the Investors page of the Company’s website at www.verupharma.com. To join the conference call via telephone, please dial 1-800-341-1602 (domestic) or 1-412-902-6706 (international) and ask to join the Veru Inc. call. An archived version of the audio webcast will be available for replay on the Company’s website for approximately three months. A telephonic replay will be available on February 9, 2023 at approximately 12:00 p.m. ET by dialing 1-877-344-7529 (domestic) or 1-412-317-0088 (international) passcode 9127050 for one week.