On August 12, 2022 POINT Biopharma Global Inc. (NASDAQ: PNT) (the "Company" or "POINT"), a company accelerating the discovery, development, and global access to life-changing radiopharmaceuticals, reported financial results for the second quarter ended June 30, 2022 and provided an update on business highlights (Press release, Point Biopharma, AUG 12, 2022, View Source [SID1234618267]).

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"We continue to execute across our pipeline and platform," said Dr. Joe McCann, CEO of POINT Biopharma. "The Phase 3 SPLASH trial in pre-chemotherapy mCRPC began European randomization in the second quarter, and I look forward to the release of further data from the 27-patient lead-in of the SPLASH trial this fall."

"One of the achievements from this past quarter I am most proud of is the commencement of the FRONTIER trial – the Phase 1 trial for PNT2004, our pan-cancer fibroblast activation protein targeted program," Dr. McCann continued. "This program is a true cross-functional collaboration highlighting POINT’s strengths in chemistry, radiochemistry, biology, clinical development and regulatory to enable the acceleration of radioligand discovery, progressing from in-license of a non-radiopharmaceutical molecule to a Phase 1 trial for both an imaging agent and a therapeutic agent in just 2 years. 68Ga-PNT6555 and 177Lu-PNT6555, the leads of the PNT2004 program, have now advanced into the clinic, a significant step forward in the development of a pan-cancer theranostic."

Recent Developments and Upcoming Milestones

Pipeline Updates

PNT2002: 177Lu-based PSMA targeted radiopharmaceutical

In April 2022, the Company dosed its first European Union patient in the SPLASH trial. The SPLASH trial is currently enrolling patients across 53 sites in North America, Europe, and UK, and site activations remain ongoing to expedite accrual. The Company continues to expect to report top line data from SPLASH mid-2023.

PNT2004: fibroblast activation protein-alpha (FAP-alpha) targeted radiopharmaceutical

The Company filed a clinical trial application (CTA) with Health Canada at the end of the first quarter of 2022 for PNT6555, the lead of the pan-cancer PNT2004 fibroblast activation protein-alpha (FAP-alpha) targeted program, and a No Objection Letter was received from Health Canada in May 2022. The first patient was dosed in FRONTIER in July 2022.

The Company also presented posters on PNT6555 at two recent academic conferences including the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2022 Annual Meeting in April 2022, and the Society for Nuclear Medicine and Molecular Imaging (SNMMI) 2022 Annual Meeting in June 2022. Both posters are accessible at View Source

Management Updates:

In June 2022, the Company appointed Chris Horvath as Executive Vice President, Commercial. Mr. Horvath brings almost twenty years of experience in the pharmaceutical industry, having led or worked on the launch of a number of key oncology products, including Pluvicto (lutetium 177Lu vipivotide tetraxetan), Locametz (gallium 68Ga gozetotide), Nubeqa (darolutamide), and Zytiga (abiraterone acetate). In his new role at POINT, Mr. Horvath will lead the commercial strategy for POINT’s pipeline.

Mr. Horvath began his career as a scientist, working at both DuPont and Novartis Institutes for BioMedical Research. He then transitioned to commercial roles of increasing responsibility at Janssen, Dendreon, Merck, Bayer, and most recently Advanced Accelerator Applications (Novartis). Mr. Horvath holds a BSc in Chemistry & Biology from Wilfrid Laurier University, a MSc in Analytical Science from the University of Guelph, and an MBA from Rutgers Business School.

Three Months and Six Months Ended 2022 Financial Results

Cash, Cash Equivalents and Investments: As of June 30, 2022, POINT had approximately $204.3 million in cash, cash equivalents and investments, which is anticipated to fund operations into the first quarter of 2024.

Net Loss: Net loss was $24.6 million, or $0.27 net loss per share, for the three months ended June 30, 2022, as compared to a net loss of $8.8 million, or $0.15 net loss per share, for the same period in 2021. Net loss was $41.0 million, or $0.45 net loss per share, for the six months ended June 30, 2022, as compared to a net loss of $14.6 million, or $0.26 net loss per share, for the same period in 2021.

Research and Development Expenses: Research and development expenses were $20.8 million for the three months ended June 30, 2022, as compared to $6.7 million for the same period in 2021. Research and development expenses were $33.3 million for the six months ended June 30, 2022, as compared to $11.0 million for the same period in 2021.

General and Administrative Expenses: General and administrative expenses were $4.1 million for the three months ended June 30, 2022, as compared to $1.9 million for the same period in 2021. General and administrative expenses were $7.9 million for the six months ended June 30, 2022, as compared to $3.4 million for the same period in 2021.

On August 12, 2022 Beyond Air, Inc. (NASDAQ: XAIR), a 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, ultra-high concentration nitric oxide (UNO) for the treatment of solid tumors, reported financial results for its first fiscal quarter ended June 30, 2022 (Press release, Beyond Air, AUG 12, 2022, View Source [SID1234618266]).

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"Our sales team has quickly ramped up the initial phase of the commercial launch for the LungFit PH, which received FDA approval in late-June. This initial activity includes conducting product demonstrations at numerous U.S. hospitals, which we are pleased to report have generated positive feedback from the participating hospital staff. We are also highly encouraged by the feedback received during the medical conferences our team has attended since approval. The early success of this program and initial feedback received is expected to put us on schedule to equip the first small group of hospitals with LungFit PH systems over the next several months. We look forward to the upcoming American Association for Respiratory Care (AARC) in November and encourage investors to come see us in New Orleans," commented Steve Lisi, Chairman and Chief Executive Officer of Beyond Air. "We continue to expect to receive CE Mark for LungFit PH in Europe during the second half of calendar year 2022. In addition, we are planning to submit a PMA supplement for an expanded cardiac label for the LungFit PH system to the U.S. FDA."

Recent Highlights and Upcoming Milestones

LungFit PH
Received U.S. FDA approval on June 28, 2022 to treat term and near-term neonates with hypoxic respiratory failure
Initiated limited release phase of commercial launch, making it the first and only nitric oxide generator, delivery and monitoring system available in the U.S.; and already conducted numerous on-site demonstrations
CE Mark anticipated to be received in the second half of calendar year 2022, which is expected to be followed by an international commercial partnership
Expect to submit a PMA supplement for an expanded cardiac label for the LungFit PH to the U.S. FDA prior to year-end 2022
LungFit PRO
Planning 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 FDA
Will present data in a poster session at an upcoming conference this Fall from the Company’s recently completed VCAP study
LungFit GO
Will present data from the pilot study of at-home LungFit GO for nontuberculous mycobacterial (NTM) lung infection at CHEST 2022 in Nashville on October 17, 2022
Expect to initiate a pilot study in COPD patients who are hospitalized due to an exacerbation in the fourth quarter of calendar 2023
Beyond Cancer’s Solid Tumor Program
Anticipate dosing the first patient in a first-in-human Phase 1 study to assess the safety and efficacy of ultra-high concentration nitric oxide for the treatment of solid tumors in the current quarter
Financial Results for the fiscal quarter ended June 30, 2022

Research and development expenses for the fiscal quarter ended June 30, 2022 were $3.2 million, compared with $2.7 million for the fiscal quarter ended June 30, 2021.

General and administrative expenses for the fiscal quarter ended June 30, 2022 increased to $8.2 million, compared with $3.9 million for the fiscal quarter ended June 30, 2021. The increase is mainly attributable to the staffing and scaling up of Beyond Cancer in both the U.S. and Israel, as well as continued investments necessary to support the commercial launch of LungFit PH in the U.S.

Other income and expense for the fiscal quarter ended June 30, 2022 was a loss of $0.2 million, compared with a loss of $0.2 million for the fiscal quarter ended June 30, 2021.

For the fiscal quarter ended June 30, 2022, the Company had a net loss of $11.7 million, of which $10.9 million, or ($0.37) per share, was attributable to the shareholders of Beyond Air, compared with a net loss of $6.7 million, or ($0.31) per share, for the fiscal quarter ended June 30, 2021.

As of June 30, 2022, the Company reported cash and cash equivalents of $72.8 million.

Net cash used in operations, including Beyond Cancer, was $6.8 million in the fiscal quarter ended June 30, 2022. This is below the quarterly cash burn guidance of $8.0 – 10.0 million. The Company expects to see the quarterly average cash burn during the fiscal year 2023 to fall within this range.

On August 12, 2022 Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX), reported financial results for the second quarter ended June 30, 2022 (Press release, Crinetics Pharmaceuticals, AUG 12, 2022, View Source [SID1234618263]).

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"Enrollment is on-track in our Phase 3 PATHFNDR program for paltusotine in acromegaly and our Phase 2 study in carcinoid syndrome, with results from these studies expected in 2023," said Scott Struthers, Ph.D., founder and chief executive officer of Crinetics. "We continue to validate the unique early de-risking efficiency of our endocrine drug development paradigm. CRN04894 is now our third program to successfully demonstrate pharmacologic proof-of-concept in Phase 1. We are now working with global regulators to align on clinical plans for both CRN04777 and CRN04894 with the goal of initiating clinical studies in congenital HI, Cushing’s disease, and CAH."

SECOND QUARTER 2022 AND RECENT HIGHLIGHTS

Reported positive top-line results from multiple-ascending dose (MAD) cohorts of the CRN04894 Phase 1 study. In May 2022, Crinetics announced positive data from the MAD cohorts of a Phase 1 healthy volunteer study of CRN04894, the company’s adrenocorticotropic hormone (ACTH) antagonist being developed as a treatment for Cushing’s disease, congenital adrenal hyperplasia (CAH) and other conditions of ACTH excess. Pharmacodynamic data from the trial demonstrated pharmacologic proof-of-concept for CRN04894, while pharmacokinetic data demonstrated its oral bioavailability and support a once-daily dosing schedule. No serious adverse events nor study drug discontinuations due to treatment-related adverse events were observed.
Presented clinical and research results at the ENDO 2022 Annual Conference. Presentations included an oral presentation featuring results from the Phase 1 study of CRN04894, a poster presentation featuring results from a Phase 1 study of CRN04777, the company’s somatostatin receptor type 5 (SST5) agonist being developed as a treatment for congenital hyperinsulinism (HI), and a late-breaking poster presentation on the company’s preclinical parathyroid hormone (PTH) receptor antagonist program.
Strengthened balance sheet with successful $125 million common stock offering. In April 2022, Crinetics successfully completed an underwritten follow-on offering of its common stock raising gross proceeds of $125 million. Based on its current plans, the company expects that current cash, cash equivalents and short-term investments will fund its current operating plan into the second half of 2024.

SECOND QUARTER 2022 FINANCIAL RESULTS

Research and development expenses were $33.0 million for the three months ended June 30, 2022, compared to $20.5 million for the same period in 2021. The increase was primarily attributable to an increase spending on manufacturing and development activities of $7.6 million associated with clinical and nonclinical activities for paltusotine, CRN04777, CRN04894 and other preclinical programs, and an increase in personnel costs of $3.9 million.
General and administrative expenses were $10.5 million for the three months ended June 30, 2022, compared to $5.6 million for the same period in 2021. The increase was primarily attributable to an increase in personnel costs of $3.1 million.
Net loss for the three months ended June 30, 2022, was $42.4 million, compared to a net loss of $26.1 million for the same period in 2021.
Revenues were $0.4 million for the three months ended June 30, 2022, consisting of license revenue recognized from the license agreement entered into with Sanwa Kagaku Kenkyusho Co., Ltd. in February 2022.
Unrestricted cash, cash equivalents and investments totaled $408.5 million as of June 30, 2022, compared to $333.7 million as of December 31, 2021.
The company had 53,752,778 common shares outstanding as of August 9, 2022.

On August 12, 2022 Xenetic Biosciences, Inc. (NASDAQ:XBIO) ("Xenetic" or the "Company"), a biopharmaceutical company focused on advancing innovative immune-oncology technologies addressing hard to treat oncology indications, reported its financial results for the second quarter of 2022 and provided a business update (Press release, Xenetic Biosciences, AUG 12, 2022, View Source [SID1234618262]).

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"The past quarter was marked by a shift in our focus and prioritization of our pipeline with the in-licensing of our DNase-based oncology platform. With this transaction, we now have a clear path toward a Phase 1 clinical study in pancreatic carcinoma and other advanced solid tumors, creating the potential for value driving regulatory and clinical milestones," commented Jeffrey Eisenberg, Chief Executive Officer of Xenetic. "As a demonstration of our commitment to advance this important program, we engaged Catalent, a preeminent contract development and manufacturing organization, to produce cGMP clinical supply for our planned Phase 1 study. We also entered into a research and development collaboration with Belgian Volition SARL, and we look forward to advancing this exploratory program to develop NETs-targeted adoptive cell therapies. We are focused on executing on our preclinical and clinical development plans and look forward to unlocking the full potential of this oncology platform."

DNase Oncology Platform:Targeting Neutrophil Extracellular Traps ("NETs") to improve cancer therapies with a focus on advancing systemic DNase program into the clinic as an adjunctive therapy for pancreatic carcinoma and other locally advanced or metastatic solid tumors.

Program Highlights:

In April 2022, executed exclusive license and sublicense agreements with CLS Therapeutics to develop its interventional DNase-based oncology platform, which is designed to improve outcomes of existing treatments, including immunotherapies.
Advancing toward planned first-in-human study to evaluate DNase combined with immune checkpoint inhibitors or chemotherapy.
Systemic DNase program initially targeting multi-billion-dollar indications including pancreatic carcinoma.
DNase armored CAR T program focused on demonstrating that armoring CAR T cells to secrete DNase can support depth and durability of response of CAR T therapy against solid tumor indications.
In June 2022, entered into a manufacturing agreement with Catalent Pharma Solutions LLC, which will include cGMP manufacturing of Phase 1 clinical supply.
Subsequent to quarter end, entered into a collaboration agreement with Belgian Volition SARL to develop NETs-targeted adoptive cell therapies for the treatment of cancer.
XCART Platform Technology: Significantly differentiated, proprietary approach to personalized CAR T lymphoma therapy targeting tumor-specific neoantigens that target independently of CD19 or other surface antigens that are common to both normal and malignant B-cells.

Program Highlights:

Bolstered intellectual property portfolio with issuance of a U.S. patent covering the co-administration of XCART-derived CAR T cells, together with a personalized vaccine designed to enhance the effectiveness of the CAR T therapy.
PolyXen Platform Technology: Patent-protected platform technology designed for protein or peptide therapeutics, enabling next-generation biological drugs by prolonging a drug’s circulating half-life and potentially improving other pharmacological properties.

Program Highlight:

Royalty payments of approximately $0.4 million were received in the three months ended June 30, 2022, representing an approximate 45% increase over the same period in 2021 as Takeda’s sublicensee continued its worldwide launch of the product.
Summary of Financial Results for Second Quarter 2022

Net loss for the quarter ended June 30, 2022 was approximately $2.7 million. Research and development ("R&D") expenses for the three months ended June 30, 2022 increased by approximately $1.6 million, or 296.1%, to approximately $2.1 million from approximately $0.5 million in the comparable quarter in 2021 due to in-process research and development ("IPR&D") expense of $1.3 million. During the three months ended June 30, 2022, the Company expensed $1.3 million of IPR&D associated with the Company’s licensing of the DNase platform. There was no similar expense in 2021. Excluding the $1.3 million of IPR&D expense from total R&D expense of $2.1 million, R&D expense for the three months ended June 30, 2022 increased by $0.3 million, or 47.3%, primarily due to increased spending related to our XCART platform technology program. General and administrative expenses for the three months ended June 30, 2022 increased by approximately $0.1 million, or 15.2%, to approximately $1.0 million from approximately $0.9 million in the comparable quarter in 2021. The increase was primarily due to an increase in legal costs related to the licensing of the DNase platform during the three months ended June 30, 2022 compared to the same period in 2021.

The Company ended the quarter with approximately $14.9 million of cash.

On August 12, 2022 Ocuphire Pharma, Inc. (Nasdaq: OCUP), a clinical-stage ophthalmic biopharmaceutical company focused on developing and commercializing therapies for the treatment of refractive and retinal eye disorders, reported financial results for the second quarter ended June 30, 2022 and provided a corporate update (Press release, Ocuphire Pharma, AUG 12, 2022, View Source [SID1234618261]).

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"Ocuphire has continued to deliver in the second quarter of 2022 on execution as a highly-productive and capital efficient company, with continued success in late-stage clinical trials, multiple positive data presentations featured at medical meetings, and additional IP protection granted for both Nyxol and APX3330," said Mina Sooch, MBA, founder and CEO of Ocuphire Pharma. "With the completion of the final clinical trials of Nyxol in reversal of mydriasis, we remain focused on a late 2022 NDA filing as we ramp up our pre-commercial activities and entertain discussions with commercial partners in preparation for the anticipated approval of Nyxol as the first and only dilation reversal drop in 2023. We look forward to reporting top-line results in the second half of this year from the Phase 2b trial of APX3330 in diabetic retinopathy (DR). The opportunity in retina has multi-billion dollar potential. We are well positioned to deliver on our upcoming late-stage clinical and regulatory milestones through the second half of 2022."

Dr. Jay Pepose, Ocuphire’s Chief Medical Advisor and Board Member added, "A disruptive catalyst later this year will be top-line results from the ongoing multi-center, randomized, double-masked, placebo-controlled Phase 2b ZETA-1 trial evaluating APX3330 in diabetic retinopathy. APX3330 is a novel oral therapy with a dual mechanism of action in validated pathways, decreasing both abnormal angiogenesis and inflammation. It has shown a favorable safety profile for a systemic oral drug in hundreds of patients in 11 prior clinical trials. More recently, masked safety data from 70% of the 103 enrolled patients who completed 24 weeks of treatment in ZETA-1 trial were presented in July confirming the favorable safety and tolerability profile seen in prior trials. If approved, APX3330 has the potential to be a convenient oral treatment for diabetic patients with non-proliferative diabetic retinopathy and other diabetes-related complications. This could represent a paradigm shift from observation and monitoring progression today to an early, non-injection treatment option."

Key Anticipated Future Milestones

Reversal of Mydriasis (RM): Planned New Drug Application (NDA) with the FDA for Nyxol in RM indication in late 2022, with potential launch as first dilation reversal drop in 2H 2023
Presbyopia: Plan to initiate VEGA-2 trial, the first of two Phase 3 registration trials intended to support the use of Nyxol alone and Nyxol with 0.4% low dose pilocarpine (LDP) in presbyopia, in 2H of 2022; if successful, the Company expects to file a supplemental NDA for Nyxol as a single-agent for presbyopia and a new NDA for the combination thereafter
Diabetic Retinopathy (DR) and Diabetic Macular Edema (DME): Report top-line results from the APX3330 Phase 2b ZETA-1 trial in 2H 2022
Second Quarter and Recent Business Highlights

Clinical Development

In April, the Company announced positive results from the MIRA-4 Phase 3 pediatric study in subjects aged 3-12 years, the final clinical trial supporting a planned NDA submission with for Nyxol in RM. The study met its primary safety endpoint, demonstrating a favorable safety and tolerability profile with no adverse events reported with similar efficacy seen in adults.
In May, the Company announced positive top-line results from the LYNX-1 Phase 3 trial evaluating Nyxol for Night Vision Disturbance (NVD). The study met the FDA-agreed upon primary endpoint with statistically significantly more Nyxol-treated subjects having gained 15 or more letters of mesopic low contrast distance visual acuity compared to placebo. Key secondary efficacy endpoints were also met with statistical significance, and Nyxol showed a favorable safety and tolerability profile with no serious adverse events reported. This is the first Phase 3 trial to study NVD and to show an improvement in distance and contrast vision at night with a pupil modulation mechanism which has cross-over safety differentiation to presbyopia. The Phase 3 protocol for VEGA-2 was submitted to the FDA in July.
In June, the Company held a Type B Pre-NDA meeting with the FDA at which it received guidance on the content of CMC, clinical and non-clinical modules of the planned NDA for Nyxol in RM. The FDA confirmed that OraVerse and Regitine were appropriate to use as reference listed drugs to support a 505(b)(2) NDA.
Presentations, Publications, and Conferences

From April through August 2022, Ocuphire was represented at conferences by Mina Sooch and several prominent key thought leaders, including David Boyer, MD, Peter Kaiser, MD, David Lally, MD, and Michael Allingham, MD, PhD who presented updates on APX3330 in DR, as well as Jay Pepose, MD, PhD, Marguerite McDonald, MD, Inder Paul Singh, MD, Ralph Chu, MD, James Katz, MD and Douglas Devries, OD who presented data for Nyxol in Presbyopia and RM. Since the beginning of the year, 9 podium papers, 5 posters, and over 10 panel or company talks were presented across a total of 20 medical, scientific, industry and investment conferences.
In June at the 45th Annual Macula Society Meeting in Germany and in July at the American Society of Retina Specialists (ASRS) 2022 in New York, David Boyer, MD and David Lally MD, presented updated masked safety data from the ongoing ZETA-1 Phase 2b trial evaluating APX3330. The latest data from mid-June represented 100% of 103 subjects having completed 12 weeks or more and 70% having completed 24 weeks. These safety data are consistent with favorable safety profile from the prior 11 clinical trials with total exposure experience of over 9,000 subject-days with a 600 mg daily dose of APX3330.
In July, at the 40th Annual Meeting of ASRS, David Boyer, MD, presented for the first time to the retina medical community a late-breaking paper highlighting positive data from the MIRA-2 and MIRA-3 Phase 3 registration trials for Nyxol eye drops to rapidly reverse mydriasis.
In July, the Company announced the publication of a preclinical study supporting the novel mechanism of action inhibiting NFkB and the inflammatory pathway for APX3330 and APX pipeline candidates. The publication, titled "RelA is an Essential Target for Enhancing Cellular Responses to the DNA Repair/Ref-1 Redox Signaling Protein and Restoring Perturbated Cellular Redox Homeostasis in Mouse PDAC Cells" was published in Frontiers in Oncology and can be accessed here.
Corporate

In April, Ocuphire appointed Jay Pepose, MD, PhD, as Chief Medical Advisor in addition to his Board of Directors role.

Ocuphire was granted two new patents covering APX3330 and Nyxol:
APX3330 for Use in Diabetics: U.S. Patent No. 11,351,130 with claims to methods of treating inflammation and chronic pain in subjects suffering from diabetes using APX3330 was issued on June 7, 2022 with expiry in 2038.
Nyxol for Reversal of Mydriasis: U.S. Patent No. 11,400,077 with claims directed to methods for mydriasis treatment using phentolamine was issued on August 2, 2022 with expiry in 2039.
Second Quarter Ended June 30, 2022 Financial Highlights

As of June 30, 2022, Ocuphire had cash and cash equivalents of approximately $17.0 million. Based on current projections, management believes the current cash on hand will be sufficient to fund operations through the third quarter of 2023. Net cash used in operating activities in the second quarter of 2022 was $3.8 million, with a cumulative total for the six months ended June 30, 2022 of $10.0 million.

General and administrative expenses for the three and six months ended June 30, 2022, were $1.8 million and $3.5 million, respectively, compared to $3.4 million and $5.million, respectively, for the three and six months ended June 30, 2021.

Research and development expenses for the three and six months ended June 30, 2022, were $3.2 million and $7.9 million, respectively, compared to $3.8 million and $7.3 million, respectively, for the three and six months ended June 30, 2021. The decrease from the comparable second quarter in 2021 was primarily attributable to the completion of clinical trials and the timing manufacturing activities for Nyxol and APX3330. The increase from the comparable six-month period in 2021 was primarily attributable to more ongoing clinical trials and manufacturing activities for Nyxol and APX3330 as well as regulatory, preclinical and other development activities.

The total loss from operations for the three and six months ended June 30, 2022, was $4.9 million and $11.4 million, respectively, compared to $7.1 million and $12.3 million, respectively, for the three and six months ended June 30, 2021.

Net loss for the three and six months ended June 30, 2022, was $4.9 million and $11.5 million, respectively, compared to $7.1 million and $46.2 million, respectively, for the three and six months ended June 30, 2021. Net loss per share for the three and six months ended June 30, 2022, was ($0.25) and ($0.60) per share, respectively, compared to ($0.52) and ($3.76) per share, respectively, for the comparable periods in 2021.

For further details on Ocuphire’s financial results, refer to the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2022 to be filed with the Securities and Exchange Commission.