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.

On August 14, 2023 Lantern Pharma Inc. (NASDAQ: LTRN), an artificial intelligence (AI) company developing targeted and transformative cancer therapies using its proprietary RADR AI and machine learning (ML) platform with multiple clinical-stage drug programs, reported to have received a notice of allowance from the United States Patent and Trademark Office (USPTO) covering a method of treatment for Atypical Teratoid Rhabdoid Tumor (ATRT) using LP-184, an aggressive and rapidly growing form of cancer of the central nervous system (CNS) (Press release, Lantern Pharma, AUG 14, 2023, View Source [SID1234634401]).

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"This patent allowance further fortifies Lantern Pharma’s intellectual property portfolio, providing us with an additional layer of protection for our potential blockbuster LP-184 program, which is being developed for multiple targeted oncology indications, including ATRT in pediatric patients," said Panna Sharma, CEO of Lantern Pharma. "Historically, pediatric ATRT has been treated with a combination of surgery, radiation, and chemotherapy, but unfortunately, these approaches have often resulted in unfavorable long-term outcomes for the children affected."

Drs. Kosj and Jaymi Yamoah, Co-founders of Hope4ATRT, a research entity dedicated to directing resources and research to families in the fight against ATRT, commented, "As parents of a child who did not survive ATRT, we are compelled to advocate for more effective and less toxic treatment options for children still in this battle, and we are always thrilled to see progress in ATRT research. The work by Lantern scientists to rapidly develop new therapies with potential to treat ATRT brings us hope for the future."

Sharma continued, "The urgent need for new treatment options for pediatric brain cancers cannot be overstated. Our in-silico and in-vivo observations indicate that LP-184 has the potential to become an essential part of the treatment options for these patients, and this patent allowance provides a further assurance of protection for our advances in the treatment of this devastating disease."

LP-184 is the first of Lantern’s drug candidates developed by leveraging Lantern’s AI and ML platform, RADR, to advance to a first-in-human Phase 1 basket trial. Lantern has rapidly advanced the clinical development of LP-184, activated the initial clinical trial sites, and has begun screening patients. Indications for the LP-184 trial are anticipated to include relapsed/refractory advanced pancreatic cancer, glioblastoma (GBM), brain metastases (brain mets), and multiple other recurring, advanced solid tumors with DNA damage response deficiencies.

The dosage and safety data obtained in the Phase 1 trial will be used to advance the CNS indications, including ATRT, for a future Phase 2 trial to be sponsored by Lantern’s wholly-owned subsidiary, Starlight Therapeutics Inc. Globally, the aggregate annual market potential of LP-184’s target indications is estimated to be approximately $10+ billion, consisting of $5+ billion for CNS cancers and $6+ billion for other solid tumors.

The U.S. Food and Drug Administration (FDA) has previously granted LP-184 Rare Pediatric Disease Designation and Orphan Drug Designation (ODD) for the treatment of pediatric patients with ATRT. The FDA has also previously granted LP-184 ODD for the treatment of pancreatic cancer and for the treatment of malignant glioma, including GBM.

A notice of allowance is issued after the USPTO determines that the prosecution on the merits of a patent has been completed and grants the patent upon payment of the patent issuance fee. Additional corresponding patent applications are pending in Europe, Japan, Canada, and Australia.

About ATRT

ATRT is an aggressive and rare form of cancer of the central nervous system that predominantly affects children under the age of three. The National Cancer Institute (NCI) classifies ATRT as Grade IV tumors, meaning they are malignant (cancerous), aggressive, and fast-growing. The root genetic cause of ATRTs is attributed to bi-allelic mutations that inactivate either SMARCB1 (also known as INI1) or SMARCA4. Approximately 90 percent of pediatric ATRTs can be attributed to alterations in the SMARCB1 gene. SMARCB1 was included among several genes whose expression negatively correlated with LP-184 sensitivity in tumors. This in silico correlation was confirmed by in vitro and in vivo assessments of LP-184 in ATRT, with the highest potency of LP-184 in vivo having been seen in ATRT xenografts.

On August 14, 2023 SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant infections, reported financial results for the second quarter ended June 30, 2023 (Press release, Scynexis, AUG 14, 2023, View Source [SID1234634400]).

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"In the second quarter, we continued to execute on our key priorities, by maximizing ibrexafungerp’s value and by advancing our ground-breaking class of antifungals to fight serious global health threats," said David Angulo, M.D., President and Chief Executive Officer of SCYNEXIS. "We were pleased to achieve the first development milestone under our exclusive licensing agreement with GSK based on the progress of the Phase 3 ibrexafeungerp MARIO study and to report the successful NDA filing of ibrexafungerp for VVC in China. Our innovative triterpenoid antifungal platform is poised to provide significant value and we are rapidly advancing the next generation fungerp SCY-247 and anticipate filing an IND in 2024. With our current cash balance and modest projected spending over the next years, we are well-positioned to support the entire clinical development of SCY-247 and continue the fight against life-threatening fungal infections."

Corporate Developments

On June 21, 2023, SCYNEXIS announced the achievement of a $25 million performance-based development milestone under its exclusive license agreement with GSK for ibrexafungerp. The milestone payment follows the achievement of a development goal for the Phase 3 MARIO study for ibrexafungerp in invasive candidiasis.
Ibrexafungerp Clinical and Regulatory Updates

SCYNEXIS and partner Hansoh Pharmaceutical Group Company Limited (3692.HK) announced that China’s NMPA has accepted for review an NDA for oral ibrexafungerp tablets for the treatment of adult and post-menarchal pediatric females with vulvovaginal candidiasis (VVC) in the Chinese mainland. The application, submitted by Hansoh Pharma, is based on positive results from Phase 3 studies in which ibrexafungerp successfully achieved statistically significant superiority over placebo for the primary and key secondary study endpoints.
Ibrexafungerp Scientific Presentations and Publications

Presented an overview of the innovative study design of the ongoing Phase 3 MARIO trial investigating oral ibrexafungerp as a step-down therapy for invasive candidiasis and shared interim data analyses from its ongoing Phase 3 FURI and CARES studies at the 33rd Annual European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) held in Copenhagen, Denmark, April 15-18, 2023.
SCY-247 Preclinical Development Program

IND-enabling development activities for SCY-247 continue to progress. SCY-247 is a broad-spectrum antifungal with potential oral and IV systemic therapeutic formulations for multiple drug-resistant pathogens. A portion of these activities, including assessing the activity against Candida auris and Mucorales, are being supported by NIH grants. IND filing for this compound is anticipated in the second half of 2024.
Second Quarter 2023 Financial Results

We recognized $131.5 million in total revenue for Q2 2023 compared with $1.3 million in Q2 2022. The increase in revenue was associated primarily with the recognition of $131.0 million in licensing agreement revenues from GSK.

Research and development expense for Q2 2023 was $7.0 million, compared to $7.1 million for Q2 2022.

Selling, general & administrative (SG&A) expense for Q2 2023 decreased to $7.5 million from $15.8 million for Q2 2022. The decrease of $8.3 million, or 53%, for Q2 2023, was primarily driven by a decrease of $9.0 million in commercial expense due to the costs incurred in the prior comparable period associated with the active promotion of BREXAFEMME which ceased in the fourth quarter of 2022, a decrease of $1.1 million in salary related expense primarily driven by the workforce reduction in the fourth quarter of 2022 concentrated in the commercial and medical affairs functions, a decrease of $0.5 million in other medical affairs related expense, and a net decrease in other selling, general, and administrative expense of $0.6 million, offset in part by an increase in professional fees of $2.9 million. The $2.9 million increase in professional fees is primarily due to a $3.1 million expense incurred during the current period for business development associated with the License Agreement with GSK.

Total other income was $5.7 million for Q2 2023, versus total other income of $8.4 million for Q2 2022. During Q2 2023 and Q2 2022, SCYNEXIS recognized a non-cash gain of $8.2 million and a non-cash gain of $9.7 million, respectively, on the fair value adjustment of the warrant liabilities.

Net income for Q2 2023 was $122.3 million, or $2.56 basic income per share and $2.46 diluted income per share, compared to a net loss of $13.3 million, or $0.31 basic and diluted loss per share for Q2 2022.

Cash Balance

Cash, cash equivalents and investments totaled $91.9 million on June 30, 2023, compared to $73.5 million on December 31, 2022, The June 30, 2023 cash balance is after deduction of the approximately $36 million Hercules Capital and Silicon Valley Bridge Bank loan which was repaid in full in the second quarter and does not include the $25 million development milestone recognized in the second quarter. Based upon its current operating plan which assumes modest spending in 2024 and receipt of the $25 million development milestone payment from partner GSK, SCYNEXIS believes that its existing cash, cash equivalents and investments will provide a cash runway beyond two years.

About Triterpenoid Antifungals

Triterpenoid antifungals (also known as "fungerps") are a novel class of structurally-distinct glucan synthase inhibitors that combine the well-established activity of glucan synthase inhibitors with the potential flexibility of having oral and intravenous (IV) formulations. They have demonstrated broad-spectrum antifungal activity against multidrug-resistant pathogens, including azole- and echinocandin-resistant strains. Ibrexafungerp is the first representative of this novel class of antifungal agents. Ibrexafungerp, formerly known as SCY-078, is currently approved in the U.S. for the treatment of vulvovaginal candidiasis and is in late-stage of development for invasive candidiasis and other indications. SCY-247 is a next generation fungerp in pre-clinical development for the treatment of life-threatening and often multi-drug resistant fungal diseases including Candida auris infections.