On August 14, 2023 bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company addressing the need for noninvasive detection of early-stage lung cancer and other diseases of the lung, reported financial results for the three and six months ended June 30, 2023, and provided a business update (Press release, BioAffinity Technologies, AUG 14, 2023, View Source [SID1234634406]).

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Highlights from the second quarter of 2023 and subsequent weeks included:

Corporate and Commercial Highlights

The American Medical Association (AMA) issued a Current Procedural Terminology (CPT) code for use with CyPath Lung with an effective date of Oct. 1, 2023. CPT codes provide a uniform system to identify medical services and procedures and seek reimbursement from private payers and public health insurance programs, including Medicare and Medicaid.
The Department of Defense (DOD) purchased CyPath Lung tests for use in an observational study on active military personnel at high risk for developing lung cancer (NCT05870592) and for research on the use of bronchoalveolar lavage fluid to assess cardiopulmonary function and exercise performance in military personnel post COVID-19 infection.
Michael Dougherty joined the management team as Chief Financial Officer. Previously, he served as CFO of Amazon’s Alexa commercial domains with responsibility for financial strategy over Alexa’s multibillion-dollar investments in AI-generated customer experiences.
The Company launched a pilot marketing and sales program in select cities in Texas to provide insights and strategies for the successful product rollout for CyPath Lung.
Research and Development Highlights

Presented advancements in CyPath Lung at the Cleveland Clinic’s invitation-only fourth annual "Advances in Early Lung Cancer Detection" symposium, which focuses on accelerating the development and implementation of new technologies and methods for the early detection of lung cancer.
Presented a poster titled "Development of porphyrin-stained polystyrene compensation beads for use on an automated analysis platform" at CYTO 2023, the annual Congress for the International Society for the Advancement of Cytometry, that demonstrated the suitability of the Company’s proprietary compensation beads for commercial use with flow cytometry, including with CyPath Lung.
Presented a poster titled "Vitamin B12 deprivation does not phenocopy selective cytotoxicity of CD320 and LRP2 silencing" at the University of Massachusetts T.H. Chan Medical School’s fifth annual RNA Therapeutics Symposium demonstrating that deprivation of vitamin B12 does not play a role in the selective cytotoxicity of cancer cells observed after silencing the expression of CD320 and LRP2; this research follows the Company’s discovery that using small interfering RNA (siRNA) to knock down CD320 and LRP2 killed cancer cells in vitro without harming healthy cells.
Management Commentary

"Our sales team is implementing a test market pilot program of CyPath Lung across various target markets in Texas, and we are encouraged with their progress. The pilot program is a tactical program to test various marketing and selling approaches to accelerate the development of a successful regional and then national roll out of the CyPath Lung test. Issuance of a CPT code by the AMA specifically for CyPath Lung is another important milestone that we believe signals the value our diagnostic adds to the clinical care of patients at high risk for developing lung cancer," bioAffinity President and Chief Executive Officer Maria Zannes said.

"We are building brand awareness and finetuning our market positioning at the same time we are showcasing our innovation at prestigious medical and scientific conferences. The result is increased recognition and adoption of CyPath Lung, including interest by the DOD. We expect revenues from CyPath Lung to grow as we expand our geographic reach, add prescribing physicians and focus on larger medical systems," Ms. Zannes added.

Second Quarter Financial Results

Revenue for the second quarter of 2023 was $20,000, compared with $1,000 for the prior-year period. Revenue is generated from royalties from the Company’s licensee, Precision Pathology Services, from sales of CyPath Lung as a laboratory developed test, from clinical flow cytometry services provided to Precision Pathology Services related to CyPath Lung and from CyPath Lung tests purchased by the DOD. Sales to the DOD were $10,000 for the second quarter of 2023.

Research and development expenses were $335,000 for the second quarter of 2023, compared with $248,000 for the comparable period in 2022. The increase was primarily due to higher compensation costs from adding research personnel and higher costs for lab supplies and reagents.

Clinical development expenses were $35,000 for the second quarter of 2023, compared with $28,000 for the second quarter of 2022. The increase was primarily due to higher professional fees related to clinical strategy evaluation as the Company prepares to launch the CyPath Lung pivotal trial.

Selling, general and administrative expenses were $1.4 million for the second quarter of 2023, compared with $409,000 for the comparable period in 2022. The increase was primarily attributed to higher consulting, legal and professional fees related to being a publicly traded company, higher board compensation, and sales and marketing costs for commercialization of CyPath Lung.

Net loss for the second quarter of 2023 was $1.7 million, or $0.20 per share, compared with a net loss of $88,000, or $0.03 per share, for the comparable period in 2022.

Cash and cash equivalents were $8.3 million as of June 30, 2023, compared with $11.4 million as of December 31, 2022. bioAffinity Technologies believes that its available cash will be sufficient to fund planned operations for at least the next 12 months.

On August 14, 2023 XNK Therapeutics reported that it will participate at NK2023 in Oslo in September and present the latest research relating to the company’s leading natural killer (NK) cells therapies (Press release, XNK Therapeutics, AUG 14, 2023, View Source [SID1234634405]). Two abstracts have been accepted for presentation at the meeting.

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The data have been generated in collaboration with XNK’s external partners, Anders Ullén and Fernanda Costa Svedman at the Department of Oncology-Pathology, Karolinska Institute, Stockholm, Sweden, for the bladder cancer abstract, and Abhishek Maiti and Naval Daver at The University of Texas MD Anderson Cancer Center in Houston, Texas, USA, for the AML abstract.

NK2023 is the 20th annual meeting arranged by the Society of Natural Immunity and takes place in Oslo, Norway, on September 26-29, 2023. The meeting will attract more than 450 participants and is focused entirely on NK cells, with a preceding day entirely focused on the development of NK cell-based immunotherapies.

"Discussing our pipeline with the world’s combined expertise really helps us moving forward and as one of the leading companies in the field we are pleased to contribute to this important meeting," said Anna-Karin Maltais, CSO of XNK Therapeutics.

On August 14, 2023 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) reported recent operational highlights and financial results for the second quarter ended June 30, 2023 (Press release, Oncolytics Biotech, AUG 14, 2023, View Source [SID1234634404]). All dollar amounts are expressed in Canadian currency unless otherwise noted.

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"Our core programs in pancreatic and breast cancer are both progressing rapidly towards registrational studies on the back of the impressive clinical data showing the potential of pelareorep as a backbone immunotherapy," said Dr. Matt Coffey, President and Chief Executive Officer. "Data reported at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting from our BRACELET-1 randomized phase 2 trial demonstrated robust improvements in objective response rate (ORR) and progression-free survival (PFS) with a hazard ratio of 0.29 (95% CI: 0.09, 0.98). This has unlocked the potential for including PFS as a dual endpoint in our registrational trial, which could considerably reduce the time to a pivotal readout. At the same time, pelareorep was selected for inclusion in the ongoing Precision Promise pancreatic cancer platform trial. Precision Promise, created by the Pancreatic Cancer Action Network, provides us with the opportunity to reduce the time and costs needed for a potential approval, and we are honored to have been selected for participation in this novel and exclusive trial."

Second Quarter and Subsequent Highlights

Breast Cancer Program

BRACELET-1 data demonstrated a >50% improvement in progression-free survival and a nearly three-fold increase in confirmed overall response rate

An oral presentation at the ASCO (Free ASCO Whitepaper) Annual Meeting featured results from a randomized trial of pelareorep in HR+/HER2- metastatic breast cancer. As of a March 3, 2023 cut-off date, BRACELET-1 data in the paclitaxel plus pelareorep cohort showed median PFS of 9.5 months, compared to 6.3 months in the paclitaxel monotherapy cohort. This resulted in a hazard ratio of 0.29 (95% CI: 0.09, 0.98), indicating the pelareorep-paclitaxel combination reduced the risk of disease progression by 71%. Confirmed ORR in these cohorts was 37.5% for paclitaxel plus pelareorep and 13.3% for paclitaxel. Overall survival data continues to mature as several patients are still on study. With these data, the HR+/HER2- metastatic breast cancer program is now phase 3-ready, and, with two randomized phase 2 trials showing meaningful benefits to patients, the focus is now on progressing to a registrational trial evaluating pelareorep-paclitaxel compared to paclitaxel alone.

Oncolytics hosted a key opinion leader (KOL) webinar on June 5, 2023 where breast cancer experts and the management team discussed recent data from the BRACELET-1 study. A link to the replay is available by clicking here.

Pancreatic Cancer Program

Pelareorep selected for inclusion in Precision Promise Pivotal Phase 3 Platform Trial

Pelareorep has been selected for inclusion as a new investigational treatment in Precision Promise. Created by the Pancreatic Cancer Action Network (PanCAN), Precision Promise is an innovative adaptive phase 3 clinical trial designed to streamline registration pathways for promising pancreatic cancer therapies. Inclusion is expected to accelerate the registrational pathway and reduce by half the phase 3 costs compared to a traditional trial. The study is designed to evaluate pelareorep in combination with a checkpoint inhibitor and the chemotherapeutic agents gemcitabine and nab-paclitaxel in comparison to gemcitabine and nab-paclitaxel standard of care therapy. This clinical study is expected to support the approval of the pelareorep combination therapy as a treatment for first-line metastatic pancreatic ductal adenocarcinoma.

Additional Immunotherapeutic Opportunity

Preclinical pelareorep-chimeric antigen receptor (CAR) T cell therapy combination program

A poster presentation at ASCO (Free ASCO Whitepaper) showed preclinical results of pelareorep synergistically enhancing CAR T cell therapy efficacy in murine solid tumor models (link to the poster). The results suggest pelareorep could substantially expand the commercial potential of CAR T cell therapy beyond hematologic malignancies to include solid tumors, which represent the vast majority of cancer cases. Oncolytics is currently advancing preclinical research collaborations evaluating pelareorep-CAR T cell combination therapies.

Financial Highlights

As of June 30, 2023, the Company reported $24.4 million in cash, cash equivalents, and marketable securities, then successfully closed a US$15 million public offering on August 8, 2023. On a pro forma basis, including the estimated US$13.6 million in net proceeds from the public offering, the Company’s cash, cash equivalents and marketable securities would have been approximately $42.7 million.
The net loss for the second quarter of 2023 was $7.4 million, compared to a net loss of $5.1 million for the second quarter of 2022. The basic and diluted loss per share was $0.12 in the second quarter of 2023, compared to a basic and diluted loss per share of $0.09 in the second quarter of 2022.
Net cash used in operating activities for the six months ended June 30, 2023 was $16.3 million, compared to $13.2 million for the six months ended June 30, 2022. The change reflected higher net operating activities and non-cash working capital changes.
General and administrative expenses for the second quarter of 2023 were $3.5 million, compared to $2.8 million for the second quarter of 2022. The increase was primarily due to higher investor relations activities and annual general meeting of shareholders costs.
Research and development expenses for the second quarter of 2023 were $3.7 million, compared to $3.2 million for the second quarter of 2022. The increase was primarily due to higher manufacturing expenses associated with an engineering production run along with process and analytical development activities and higher personnel-related expenses. The increase was partly offset by lower BRACELET-1 study costs.
Anticipated Milestones and Catalysts

Updated GOBLET study data in advanced/metastatic pancreatic ductal adenocarcinoma (PDAC): H2 2023
Update on GOBLET study’s metastatic colorectal and anal cancer cohorts: H2 2023
Guidance on both the HR+/HER2- metastatic breast cancer and advanced/metastatic PDAC registration paths: H2 2023
BRACELET-1 phase 2 metastatic breast cancer study overall survival data
Webcast and Conference Call

Management will host a conference call for analysts and investors at 8:30 a.m. ET today, August 14, 2023. To access the call, please dial (888) 664-6383 (North America) or (416) 764-8650 (International) and, if needed, provide confirmation number 5411-4798. To join the conference call without operator assistance, please click here. A live webcast of the call will also be available by clicking here or on the Investor Relations page of Oncolytics’ website (LINK) and will be archived for three months. A dial-in replay will be available for one week and can be accessed by dialing (888) 390-0541 (North America) or (416) 764-8677 (International) and using replay code: 114-798#.

On August 14, 2023 Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a late-stage biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products reported business and financial results for the fiscal third quarter ended June 30, 2023 (Press release, Citius Pharmaceuticals, AUG 14, 2023, View Source [SID1234634403]).

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Fiscal Q3 2023 Business Highlights and Subsequent Developments

Achieved 92 required events for completion of the Mino-Lok Phase 3 trial, subject to confirmation by an independent review committee;
Mino-Lok trial to continue recruiting in the near term; additional patients in active treatment, which may result in additional events;
Citius to engage with the FDA to address enhanced product testing requirements identified in the complete response letter (CRL) for LYMPHIR, received July 28, 2023, in preparation for Resubmission; such efforts are not expected to impact Company’s cash runway, which extends to August 2024;
Citius preparing for an End of Phase 2 meeting with the FDA following positive topline results of Phase 2b trial of Halo-Lido for the treatment of hemorrhoids; and,
$15 million in capital raised through a registered direct offering of common stock and warrants at a purchase price of $1.20 per share on May 8, 2023.
Financial Highlights

Cash and cash equivalents of $33.3 million as of June 30, 2023
R&D expenses were $3.8 million and $11.9 million for the three and nine months ended June 30, 2023, respectively, compared to $4.9 million and $13.8 million for the three and nine months ended June 30, 2022, respectively;
G&A expenses were $3.7 million and $11.1 million for the three and nine months ended June 30, 2023, respectively, compared to $3.0 million and $9.0 million for the three and nine months ended June 30, 2022, respectively;
Stock-based compensation expense was $1.2 million and $3.5 million for the three and nine months ended June 30, 2023, respectively, compared to $1.0 million and $2.9 million for the three and nine months ended June 30, 2022, respectively; and,
Net loss was $8.5 million and $22.6 million, or ($0.06) and ($0.15) per share for the three and nine months ended June 30, 2023, respectively, compared to a net loss of $8.9 million and $25.6 million, or ($0.06) and ($0.18) per share for the three and nine months ended June 30, 2022, respectively.
"I am pleased to report significant progress in our pipeline and positive milestones on multiple fronts. We believe we have achieved the minimum 92-event threshold required to complete the Phase 3 Mino-Lok trial, pending confirmation by a committee of independent reviewers. We have also made progress in other areas of our business, including announcing positive topline results for the Phase 2b Halo-Lido trial, extending our financial runway through August 2024 with a $15 million capital raise, and clarifying our path toward approval for LYMPHIR (denileukin diftitox)," stated Leonard Mazur, Chairman and Chief Executive Officer of Citius.

"Although we were disappointed to receive the FDA’s complete response letter for LYMPHIR, we are encouraged that no clinical data issues related to safety or efficacy were noted. Rather, the FDA focused primarily on enhanced product testing, which we are already addressing. We plan to work closely with the FDA in preparation for a Resubmission package. The timing of our contemplated spin-off of LYMPHIR will be adjusted in accordance with the asset’s regulatory path. Coupled with our recent financing, we believe we have sufficient funds to advance our pipeline, including efforts to remediate the CRL, and continue to prepare our commercial infrastructure for the ultimate launch of LYMPHIR, if approved," added Mazur.

THIRD QUARTER 2023 FINANCIAL RESULTS:

Liquidity

As of June 30, 2023, the Company had $33.3 million in cash and cash equivalents.

As of June 30, 2023, the Company had 146,211,130 common shares outstanding.

On May 8, 2023, the Company closed a registered direct offering of 12,500,001 common shares and accompanying warrants to purchase up to an aggregate of 12,500,001 shares of its common stock, at a purchase price of $1.20 per share. The warrants have an exercise price of $1.50 per share, are exercisable six months from the date of issuance, and expire five years from the date of issuance. The Company also issued 875,000 warrants to the placement agent as part of the transaction. Net proceeds of the offering totaled $13.8 million.

The Company estimates that its available cash resources will be sufficient to fund its operations through August 2024. We anticipate the need to raise additional capital in the future to support our operations beyond August 2024.

Research and Development (R&D) Expenses

R&D expenses were $3.8 million and $11.9 million for the three and nine months ended June 30, 2023, respectively, compared to $4.9 million and $13.8 million for the comparable periods ended June 30, 2022. The decrease reflects lower Mino-Lok and LYMPHIR trial costs offset by higher Halo-Lido Phase 2b study costs as the trial was completed during the three months ended June 30, 2023. Additionally, a decrease of $1 million for the three months ended June 30, 2023, reflects NoveCite manufacturing startup costs incurred in the three months ended June 30, 2022, which are no longer realized.

We expect that research and development expenses will stabilize in fiscal 2023 as we focus on the commercialization of LYMPHIR and complete our Phase 3 trial for Mino-Lok and our Phase 2b trial for Halo-Lido.

General and Administrative (G&A) Expenses

G&A expenses were $3.7 million and $11.1 million for the three and nine months ended June 30, 2023, respectively, compared to $3.0 million and $9.0 million for the comparable periods ended June 30, 2022. The increase was primarily due to pre-launch and market research activities associated with LYMPHIR. General and administrative expenses consist primarily of compensation costs, professional fees for legal, regulatory, accounting, and corporate development services, and investor relations expenses.

Stock-based Compensation Expense

For the fiscal quarter ended June 30, 2023, stock-based compensation expense was $1.2 million as compared to $1.0 million for the prior year period. For the nine months ended June 30, 2023, stock-based compensation expense was $3.5 million as compared to $2.9 million for the nine months ended June 30, 2022. The increase reflects expenses related to new grants made to employees (including new hires), directors and consultants.

Net loss

Net loss was $8.5 million, or ($0.06) per share for the three months ended June 30, 2023, compared to a net loss of $8.9 million, or ($0.06) per share for the three months ended June 30, 2022.

The decrease in the net loss was primarily due to a decrease in research and development offset by an increase in general and administrative expenses.

Net loss was $22.6 million, or ($0.15) per share for the nine months ended June 30, 2023, compared to a net loss of $25.6 million, or ($0.18) for the nine months ended June 30, 2022.

The decrease in net loss primarily reflects an increase in other income from the $3.6 million gain recognized in connection with the sale of certain New Jersey income tax net operating losses to a third party under the New Jersey Technology Business Tax Certificate Transfer Program offset by increased operating expenses during the period.

On August 14, 2023 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, 2023, and provided a business update (Press release, Point Biopharma, AUG 14, 2023, View Source [SID1234634402]).

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"This quarter, we began to reveal our strategy to realize one of the great opportunities presented by radioligands – the use of patient imaging to evaluate how candidate ligands perform in humans before committing substantial time and resources required to run an interventional trial," said Joe McCann, Ph.D., CEO of POINT Biopharma. "Imaging can quickly reveal ligand properties and expression of a molecular target. By pairing ligand properties with complementary isotope properties, the potential for therapeutic effect can be efficiently evaluated to optimize clinical development decisions. We are committed to leveraging these theranostic principles and making data-driven program investment decisions in pursuit of accelerated development pathways for new targeted radioligand therapies."

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Business Highlights and Upcoming Milestones

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Pipeline Updates

PNT2002: 177Lu-labelled PSMA-targeted radioligand therapy

Enrollment in PNT2002’s phase 3 SPLASH trial (NCT04647526) is complete and topline data is expected in the fourth quarter of 2023. Six trial sites remain open for recruitment to complete a separate pharmacokinetic sub-study.

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PNT2004: fibroblast activation protein-α (FAP-α) targeted radioligand therapy

In May 2023, enrollment in cohort 3 of the phase 1 FRONTIER trial (NCT05432193) began, and a total of seven participants have been dosed with 177Lu-PNT6555 to date. We continue to anticipate data from the full FRONTIER study to be available in the first half of 2024.

In June 2023, a Trial-in-Progress poster for FRONTIER was presented at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, which included trial background information, study design considerations, and a cohort enrollment status update.

Later in June 2023, we published and presented preclinical data at the 2023 Annual Meeting of the Society of Nuclear Medicine & Molecular Imaging (SNMMI). The auger electron and beta emitting isotope terbium-161 was paired with POINT’s FAP-targeted PNT6555 ligand and showed robust anti-tumor efficacy, similar to 225Ac-PNT6555 and 177Lu-PNT6555. Also, preclinical proof-of-concept was established for synergistic interaction of immuno- and radioligand therapies with 177Lu-PNT6555.

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PNT2001: 225Ac-labelled next-generation PSMA-targeted radioligand therapy

At our virtual Investor Day in June 2023, we unveiled the trial design for the phase 1 portion of ACCEL, the first-in-human phase 1/2 clinical trial for PNT2001’s actinium-225 program. The trial was designed to enable the parallel exploration of PNT2001 in two patient populations: later-stage mCRPC patients and earlier-stage BCR or PSMA-positive oligorecurrent patients. We anticipate a health authority submission in the fourth quarter of 2023, and expect the first patient dosed in this trial to be in the first quarter of 2024.

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Manufacturing & Supply Chain Updates

In April 2023, we announced an agreement for the supply of actinium-225 with Eckert & Ziegler. Eckert & Ziegler will provide predetermined amounts of GMP grade actinium-225 to POINT for use in the development of POINT’s pipeline of next generation actinium-225-based radioligands.

In May 2023, we announced a collaboration to create Ionetix Alpha Corp. (Ionetix-α). Ionetix-α, a new subsidiary of IONETIX Corp., is focused on near-term, commercial-scale production of GMP grade therapeutic isotopes, such as actinium-225. IONETIX has transferred its alpha therapy isotope business assets into Ionetix-α. POINT will invest $10 million into Ionetix-α.

In June 2023, we announced the intent to collaborate with AdvanCell, an Australian clinical stage radiopharmaceutical company, for the development of a global lead-212 radioisotope and radioligand supply chain and drug manufacturing network to specifically support the clinical development and commercialization of lead-212-labeled radioligands by each company.

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Corporate Updates

In June 2023, Bridget Martell, M.A., M.D. was appointed to our Board of Directors filling a previous vacancy.

In June 2023, we hosted a virtual Investor Day, and a replay of the presentation can be found at this link View Source

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Second Quarter 2023 Financial Results

Cash, Cash Equivalents, and Investments: As of June 30, 2023, POINT had approximately $434.8 million in cash, cash equivalents, and investments, which is anticipated to fund operations into 2026.

Net Loss: Net loss was $25.4 million and $41.9 million, or $0.24 and $0.40 net loss per share, for the three and six months ended June 30, 2023, respectively, as compared to a net loss of $24.6 million and $41.0 million, or $0.27 and $0.45 net loss per share, respectively, for the same periods in 2022.

Research and Development Expenses: Research and development expenses were $31.3 million and $58.2 million for the three and six months ended June 30, 2023, respectively, as compared to $20.8 million and $33.3 million, respectively, for the same periods in 2022.

General and Administrative Expenses: General and administrative expenses were $5.1 million and $10.1 million for the three and six months ended June 30, 2023, respectively, as compared to $4.1 million and $7.9 million for the same periods in 2022.