On August 11, 2023 Kineta, Inc. (Nasdaq: KA), a clinical-stage biotechnology company focused on the development of novel immunotherapies in oncology that address cancer immune resistance, reported financial results for the second quarter ended June 30, 2023 and provided a corporate update (Press release, Kineta, AUG 11, 2023, View Source;utm_medium=rss&utm_campaign=kineta-reports-second-quarter-2023-financial-results-and-provides-corporate-update [SID1234634275]).

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"Steady progress towards achieving key scientific and business milestones continued during the second quarter, highlighted by our VISTA-targeting KVA12123 clinical program," said Shawn Iadonato, Ph.D., Chief Executive Officer of Kineta. "We are pleased with recruitment into the monotherapy cohorts of our ongoing KVA12123 Phase 1/2 clinical trial and we expect to share initial clinical data by the end of the year. In the coming months, we anticipate enrolling patients in Part B of the clinical study, where we will evaluate KVA12123 in combination with pembrolizumab, moving one step closer towards our goal of developing a next-generation immunotherapy for cancer patients."

RECENT CORPORATE HIGHLIGHTS

Ongoing phase 1/2 clinical study evaluating KVA12123 alone and in combination with pembrolizumab in patients with advanced solid tumors continues to recruit new patients in monotherapy cohorts
Seven U.S. clinical trial sites engaged to conduct the KVA12123 Phase 1/2 clinical study
Presented VISTA biomarker data and KVA12123 Phase 1/2 clinical trial update at the AACR (Free AACR Whitepaper) Annual Meeting 2023
Received $5 million development milestone payment from its research and development collaboration with Merck (known as MSD outside the United States and Canada)
Expanded the company’s Board of Directors with biotech industry leaders Kim Drapkin and Scott Dylla
Analyst coverage initiated by Robert Burns from H.C. Wainwright & Co. and John Vandermosten from Zack’s Investment Research
Joined the Russell Microcap Index at the conclusion of the 2023 Russell indexes annual reconstitution

ANTICIPATED FUTURE MILESTONES

Dose first patient in the combination arm (Part B) of KVA12123 with pembrolizumab in the ongoing Phase 1/2 clinical study in Q3 2023

Report initial clinical data on KVA12123 by end of 2023

SECOND QUARTER AND YEAR-TO-DATE 2023 FINANCIAL HIGHLIGHTS

Cash position: As of June 30, 2023, cash was $7.8 million, compared to $13.1 million as of December 31, 2022. The decrease was primarily due to cash used for clinical trial development of KVA12123 as well as general corporate purposes, partially offset by $5.5 million net proceeds received from the registered direct offering in April 2023. We believe our cash position as of June 30, 2023, together with the $5.0 million in cash received from the Merck milestone payment in July 2023 plus the committed proceeds of $22.5 million pursuant to the second closing of the private placement expected in October 2023, will be sufficient to fund operating expenses and capital expenditure requirements into early 2025.
Revenues: Total revenues were $5.2 million for the three months ended June 30, 2023 compared to $0.8 million for the three months ended June 30, 2022 and were $5.4 million for the six months ended June 30, 2023 compared to $1.3 million for the six months ended June 30, 2022. Revenues in 2023 were primarily due to our achievement of a development milestone under the Merck Exclusive License and Research Collaboration Agreement in the second quarter, which triggered a $5.0 million milestone payment. Revenues in 2022 were primarily due to research and development services from the Genentech Option and License Agreement, which was terminated in December 2022.

Research and development (R&D) expense: R&D expenses were $2.7 million for the three months ended June 30, 2023 compared to $3.9 million for the three months ended June 30, 2022 and were $5.6 million for the six months ended June 30, 2023 compared to $7.9 million for the six months ended June 30, 2022. The decreases in R&D expenses were primarily due to lower activities for KVA12123 manufacturing and clinical study start up as the company began enrolling the first patient in the study, which occurred in April 2023. The company expects R&D expenses to increase over time this year as additional patients are enrolled and dosed.
General and administrative expense: General and administrative expenses were $3.4 million for the three months ended June 30, 2023 compared to $1.8 million for the three months ended June 30, 2022 and were $7.4 million for the six months ended June 30, 2023 compared to $3.4 million for the six months ended June 30, 2022. The increases were primarily due to higher personnel-related costs from non-cash stock-based compensation for stock options issued during 2023 and increased public company expenses such as professional services fees and insurance.
Net Income (loss): Net income was $0.4 million, or $0.04 per basic and diluted share, for the three months ended June 30, 2023, compared to a net loss of $5.9 million, or $1.23 per basic and diluted share, for the three months ended June 30, 2022. Net loss was $6.1 million, or $0.65 per basic and diluted share, for the six months ended June 30, 2023, compared to a net loss of $10.9 million, or $2.28 per basic and diluted share, for the six months ended June 30, 2022.

On August 11, 2023 IO Biotech (Nasdaq: IOBT), a clinical-stage biopharmaceutical company developing novel, immune-modulating cancer vaccines based on its T-win technology platform, reported financial results for the second quarter ended June 30, 2023 (Press release, IO Biotech, AUG 11, 2023, View Source [SID1234634274]).

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"We have made a great deal of progress during the first half of the year in the development of our novel, investigational immune-modulating cancer vaccine, IO102-IO103," said Mai-Britt Zocca, PhD, President and CEO of IO Biotech. "We have achieved the important recruitment milestone of having enrolled 225 patients in our pivotal Phase 3 trial for patients with advanced melanoma. We now look forward to the interim analysis which, per the protocol, is to be conducted one year after 225 patients have been randomized. If the data from this interim analysis are supportive, we anticipate submitting a Biologics License Application for accelerated approval in the US. We are continuing to see enrollment in this trial accelerate and remain on track to reach full enrollment by the end of this year. We continue to be encouraged by the strong interest from investigators and patients in our clinical studies."

Dr. Zocca continued, "With a very strong balance sheet and executives now hired into critical roles, we are well prepared for the key activities necessary to continue progressing our lead candidate cancer vaccine, IO102-IO103, towards the market. I look forward to a very productive second half of the year."

Second Quarter 2023 and Recent Business Highlights:

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In June 2023, the company achieved a significant recruitment milestone of having enrolled 225 patients in its Phase 3 ‘IOB-013/KN-D18’ trial. The Phase 3 trial protocol calls for an interim analysis of the overall response rate one year after 225 patients have been enrolled. If the data are supportive, this interim analysis could allow for submission of a Biologics License Application for accelerated approval in the US.

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Full enrollment for the Phase 3 IOB-013/KN-D18 trial was increased from 300 to 380 patients with the aim of accelerating the time to reach the primary endpoint of progression free survival (PFS). The company expects the trial to be fully enrolled with 380 patients by the end of 2023.

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The Phase 2 basket trial (‘IOB-022/KN-D38’) evaluating IO102-IO103 in combination with pembrolizumab in patients with metastatic non-small cell lung cancer, recurrent or metastatic head and neck cancer continued enrolling patients. The company will be closing the metastatic bladder cancer cohort of this basket trial due to the changing treatment landscape in this indication and the possibility of further exploring the safety and efficacy of IO Biotech products in this indication in a separate IIT. Data from the lung cohort of this basket trial will be presented in a mini oral presentation at the IASLC 2023 World Conference on Lung Cancer (WCLC) in September 2023 and in a poster presentation at the ESMO (Free ESMO Whitepaper) Congress in October 2023.

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Three of five investigator-initiated trials (IITs) that the company is supporting have recently started enrolling patients. These three IITs include: (1) a Phase 1 trial to investigate IO102-IO103 in combination with pembrolizumab for BCG-unresponsive or intolerant, non-muscle invasive bladder cancer (NMIBC), (NCT05843448); (2) the Phase 2 KIEO (Keytruda-IO102-IO103 Extended-pre-Operative) trial to investigate neoadjuvant pembrolizumab and IO102-IO103 prior to curative-intent surgical care for squamous cell carcinoma of the head and neck (SCCHN), (NCT05977907); and (3) a Phase 2 trial evaluating IO102-IO103 and a fixed-dose combination of nivolumab-relatlimab in treatment-naïve patients with unresectable Stage III/IV melanoma, (NCT05912244).

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The company strengthened its executive team with the appointments of Christine Richter, PhD, MBA, as Senior Vice President, Commercial and Program Lead; Qasim Ahmad, MD, as Chief Medical Officer; and the promotion of Eric Faulkner from Sr. Vice President, CMC to Chief Technical Officer.

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The Company appointed Heidi Hunter to its Board of Directors.

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On August 7, 2023, the company entered into a definitive securities purchase agreement. Under the securities purchase agreement, the investors have agreed to purchase 37,065,647 shares of the company’s common stock and accompanying warrants to purchase up to an aggregate of 37,065,647 shares of common stock, at a combined purchase price of $2.025 per share and accompanying warrant. Each accompanying warrant will represent the right to purchase one share of the company’s common stock at an exercise price of $2.47 per share. The warrants will be exercisable for a period of three years and six months following the date of issuance.

Second Quarter 2023 Financial Results

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Net loss for the three months ended June 30, 2023 was $21.2 million, compared to $18.5 million for the three months ended June 30, 2022.

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Research and development expenses were $16.5 million for the three months ended June 30, 2023, compared to $12.2 million for the three months ended June 30, 2022. The increase was primarily related to clinical trial-related activities for our IO102-IO103 product candidate, including the continued execution of our Phase 3 clinical trial. The Company recognized $0.9 million in research and development equity-based compensation for the three months ended June 30, 2023, compared to $0.5 million for the three months ended June 30, 2022.

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General and administrative expenses were $5.3 million for the three months ended June 30, 2023, compared to $5.9 million for the three months ended June 30, 2022. The decrease was related to lower professional services and consulting costs, offset by an increase in headcount. The Company recognized $0.7 million in general and administrative equity-based compensation for the three months ended June 30, 2023, compared to $0.8 million for the three months ended June 30, 2022.

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Cash and cash equivalents as of June 30, 2023 were $110.1 million, compared to $142.6 million at December 31, 2022. During the three months ended June 30, 2023, the Company used cash, cash equivalents and restricted cash of $18.3 million from operating and investing activities with an additional decrease of $0.1 million in cash due to the effects of foreign currency exchange rates.

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Cash on hand is expected to support operations into the fourth quarter of 2025.

Upcoming events

Morgan Stanley 21st Annual Global Healthcare Conference. New York City. September 11-13, 2023. Dr. Zocca and Ms. Sullivan will participate in a fireside chat and one-on-one meetings on Tuesday, September 12.

H.C. Wainwright 25th Annual Global Investment Conference. New York City. September 11-13, 2023. Dr. Zocca will present a corporate overview and Dr. Zocca and Ms. Sullivan will participate in one-on-one meetings on Wednesday, September 13.

A live audio webcast of each presentation will be available on the Investors section of the IO Biotech website at www.iobiotech.com. A webcast replay of the presentations will be available on IO Biotech’s website for 90 days following the presentation.

IASLC 2023 World Conference on Lung Cancer (WCLC). Singapore, September 9-12, 2023. One abstract has been accepted for a Mini Oral presentation.

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Abstract Title: Ph 2 Trial of IO102-IO103 Vaccine Plus Pembrolizumab: Preliminary Results for the First-line Treatment of Lung Adenocarcinoma

Session: MA15—Bringing New Discoveries into Early Phase Clinical Trials

Session Date & Time: September 12, 2023 at 10:45 AM—11:45 AM

Presenter: Jonathan Riess, MD

ESMO Congress 2023. Madrid, October 20-24, 2023. One abstract has been accepted for a poster presentation.

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Abstract Title: A Phase 2 trial of the IO102-IO103 vaccine plus pembrolizumab: preliminary analysis for first line (1L) treatment of Non-Small Cell Lung Cancer (NSCLC) and Squamous Cell Carcinoma of the Head and Neck (SCCHN)

Presentation number: 1038P

Presenter: Jonathan Riess, MD

About IO102-IO103

IO102-IO103 is an investigational immune-modulating cancer vaccine designed to target the immunosuppressive mechanisms mediated by the proteins indoleamine 2,3-dioxygenase (IDO) and PD-L1. The company is currently conducting a Phase 3 trial (IOB-013/KN-D18; NCT05155254) evaluating IO102-IO103 in combination with pembrolizumab in first-line advanced melanoma patients, and a Phase 2 basket trial (IOB-022/KN-D38; NCT05077709).

About the IOB-013/KN-D18 Phase 3 Clinical Trial

IOB-013/KN-D18 (NCT05155254) is an open label, randomized Phase 3 clinical trial being conducted in collaboration with Merck of IO102-IO103 in combination with pembrolizumab versus pembrolizumab alone in patients with previously untreated, unresectable or metastatic (advanced) melanoma. Target enrollment is 380 patients from centers spread across the United States, Europe, Australia, Israel and South Africa. Biomarker analyses will also be conducted. IO Biotech is sponsoring the Phase 3 trial and Merck is supplying pembrolizumab. IO Biotech maintains full global commercial rights to IO102-IO103.

About IOB-022/KN-D38 Phase 2 Solid Tumor Basket Trial

IOB-022/KN-D38 (NCT05077709) is a non-comparative, open label trial to investigate the safety and efficacy of IO102-IO103 in combination with pembrolizumab in each of the following first-line advanced cancers: non-small cell lung cancer (NSCLC), squamous cell carcinoma of the head and neck (SCCHN), and urothelial bladder cancer (UBC). The clinical trial is sponsored by IO Biotech and conducted in collaboration with Merck. IO Biotech maintains global commercial rights to IO102-IO103.

On August 11, 2023 HCW Biologics Inc. (the "Company" or "HCW Biologics") (NASDAQ: HCWB), a clinical-stage biopharmaceutical company focused on discovering and developing novel immunotherapies to lengthen healthspan by disrupting the link between inflammation and age-related diseases, reported financial results and recent business highlights for its second quarter ended June 30, 2023 (Press release, HCW Biologics, AUG 11, 2023, View Source [SID1234634273]).

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"During the period ended June 30, 2023, we have made significant progress in crystalizing our understanding of the anti-cancer mechanism of action of HCW9218, especially in relation to how it complements immune checkpoint inhibitors ("ICIs"). HCW9218 has a unique mechanism that we believe allows it to turn a ‘cold’ tumor into a ‘hot’ tumor, potentially opening up the possibility of improving the response rate for checkpoint inhibitors which has remained stubbornly low," stated Dr. Hing C. Wong, Founder and CEO of HCW Biologics.

Dr. Wong continued, "Our excitement about the potential of HCW9218 as a combination therapy with checkpoint inhibitors is fueled by key discoveries made as a result of extensive animal testing in different cold tumor models. First, HCW9218 stimulates and expands progenitor exhausted stem-like T cells and transitory CD8+ effector T cells in the tumor draining lymph nodes followed by trafficking of these cells into the tumors. This opens a pathway for enhancing the anti-tumor activity of checkpoint inhibitors. Secondly, HCW9218 also substantially lowers the TGF-β activity in the tumor microenvironment to lessen immunosuppression. This further boosts the ICI response to block the PD1/PDL1 axis and enhances the anti-tumor activity of HCW9218-activated CD8+ effector T cells."

Business Highlights:

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In a Phase 1 clinical trial to evaluate HCW9218 in the treatment of chemo-refractory/chemo-resistant solid tumors, sponsored by the Masonic Cancer Center, University of Minnesota, the first patient was dosed in the expansion phase of the trial. There has been no dose-limiting toxicity to date. The Company expects this trial to be completed in the second half of 2023 and intends to disclose human clinical data from this trial and the mechanism of action underlying HCW9218 anti-cancer activities at a major industry conference prior to the end of the year.
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In a Company-sponsored Phase 1b clinical trial to evaluate HCW9218 in the treatment of chemo-refractory/chemo-resistant pancreatic cancer, the trial has completed two dose escalation cohorts and has begun a third, with no dose-limiting toxicity to date. The Company expects this trial to be completed late in 2023 or early 2024, with a human clinical data readout in the first half of 2024.
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On April 21, 2023, the Company entered into a secured Development Line of Credit Agreement with Prime Capital Ventures, LLC, as lender, pursuant to which the Company may borrow up to $26.3 million with a scheduled maturity date of April 20, 2028. In connection with this loan, the Company established a $5.3 million deposit for interest reserve. The Company plans to refinance its existing long-term debt with some of the proceeds from this line of credit. On August 10, 2023 the Company obtained construction permits required to begin the buildout of its new headquarters. This satisfies the final condition precedent to accessing the $26.3 million line of credit.
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On June 13, 2023, the Company was granted U.S. Patent No. 11,672,826 by the United States Patent and Trademark Office which contains methods of use claims directed to administering HCW9218 to treat various forms of cancer, including colorectal cancer, breast cancer, ovarian cancer, hepatocellular carcinoma, gastric cancer, urothelial carcinoma, and melanoma.

Second Quarter 2023 Financial Results:

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Revenues: Revenues for the quarter ended June 30, 2022 and 2023 were $454,000 and $622,807, respectively. Revenues for the six months ended June 30, 2022 and 2023 were $3.6 million and $664,690, respectively. Revenues were derived exclusively from the sale of licensed molecules to the Company’s licensee, Wugen. The licensed molecules are one of the inputs for manufacturing Wugen’s products. We expect Wugen to limit its purchases in 2023, due primarily to changes in its clinical development program and delays in ramping up its manufacturing process.

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Research and development (R&D) expenses: R&D expenses for the quarter ended June 30, 2022 and 2023 were $2.0 million and $1.6 million, respectively, a decrease of $353,216, or 18%. R&D expenses for the six months ended June 30, 2022 and 2023 were $3.8 million and $3.9 million, respectively, an increase of $112,921, or 3%. The change is primarily attributable to a decrease in preclinical expenses and manufacturing costs and an increase in costs associated with clinical trial activities. As of June 30, 2023, the Company anticipates it has the required supplies of its lead molecules, HCW9218 and HCW9302, in place to provide for planned clinical development activities for the next 24 months. Manufacturing costs in 2023 primarily reflect ancillary costs of shipping, storage and insurance. Preclinical costs were incurred to complete IND-enabling activities for HCW9302. In first half of 2023, IND-enabling activities focused on additional research studies required for the Company’s IND submission. The Company expects to submit an IND application for permission to conduct a clinical trial to evaluate HCW9302 in an autoimmune disorder by the end of 2023.

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General and administrative (G&A) expenses: G&A expenses for the quarter ended June 30, 2022 and 2023 were $1.7 million and $3.0 million, respectively, an increase of $1.3 million, or 76%. G&A expenses for the six months ended June 30, 2022 and 2023 were $3.6 million and $6.1 million, an increase of $2.5 million, or 71%. The increase was primarily attributable to increases in professional fees, which include legal fees associated with legal proceedings brought against the Company by Altor BioScience, LLC and NantCell, Inc., or Altor/NantCell.

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Net loss: Net loss for the quarter ended June 30, 2022 and 2023 was $3.5 million and $4.3 million, respectively, an increase of $793,859, or 23%. Net loss for the six months ended June 30, 2022 and 2023 was $5.6 million and $9.4 million, an increase of $3.8 million, or 68%.

Financial Guidance

As of June 30, 2023, the Company held $17.4 million in cash, cash equivalents and U.S. Treasury bills of short duration. In addition, there were prepaid expenses of $6.6 million, including the $5.3 million deposit for interest reserve. The Company funded $3.2 million toward the new lab and manufacturing facilities while awaiting permits to begin construction and activating access to project financing. Funds for this project will be provided from financing in the future. With the current cash, cash equivalents and U.S. Treasury bills on hand, the Company has adequate capital to fund operations and other commitments to Q4 2024.

On April 27, 2023, in connection with the Altor/NantCell matter, the U.S. District Court for the Southern District of Florida (the "Court") approved the parties’ stipulation and ordered the parties to arbitration. On May 1, 2023, Altor/NantCell filed a demand against the Company before JAMS. On May 3, 2023, Altor/NantCell dismissed the federal court action without prejudice and the Court ordered the case dismissed without prejudice and closed the case. Altor/NantCell’s proceeding against the Company is now proceeding in arbitration before JAMS. Although adverse decisions (or settlements) may occur in arbitration, it is not possible to reasonably estimate the possible loss or range of loss, if any, associated therewith at this time. As such, no accrual for these matters has been recorded within the Company’s financial statements. In the year ahead, the Company expects to continue to incur legal expenses on its own behalf in connection with the legal proceedings brought against it by Altor/NantCell. However, legal expenses incurred by Dr. Wong in connection with the arbitration against him that was initiated by Altor/NantCell, are covered through advancement of expenses from Altor/NantCell.

On August 11, 2023 Decibel Therapeutics (Nasdaq: DBTX), a clinical-stage biotechnology company dedicated to discovering and developing transformative treatments to restore and improve hearing and balance, reported financial results for the second quarter ended June 30, 2023 and provided a corporate update (Press release, Decibel Therapeutics, AUG 11, 2023, View Source [SID1234634272]).

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"This week we announced a definitive agreement with Regeneron Pharmaceuticals to acquire Decibel, which we believe reflects the tremendous promise of gene therapy for hearing loss," said Laurence Reid, Ph.D., Chief Executive Officer of Decibel. "We remain highly focused on executing on the CHORD clinical trial and excited by the potential benefit that DB-OTO may provide to people with otoferlin-related hearing loss. With six active clinical trial sites at prestigious institutions across three countries, we continue to work towards our goal of addressing this unmet medical need."

Pipeline Highlights and Upcoming Milestones:

Gene Therapies for Congenital, Monogenic Hearing Loss

Phase 1/2 CHORDTM Dose Escalation Clinical Trial of DB-OTO in Pediatric Patients:

DB-OTO is an AAV-based dual-vector gene therapy product candidate designed to be delivered one time to selectively express functional otoferlin (OTOF) in the inner hair cells of individuals with OTOF deficiency with the goal of enabling the ear to transmit sound to the brain and enable durable, physiological hearing. Decibel has been developing DB-OTO in collaboration with Regeneron Pharmaceuticals.
In May 2023, Decibel announced the initiation of CHORD, a global Phase 1/2 dose escalation clinical trial of DB-OTO in pediatric patients. Decibel has opened clinical trial sites in the U.S., the U.K. and Spain and has commenced patient screening activities. DB-OTO received Orphan Drug Designation from the European Medicines Agency (EMA) Committee on Orphan Medicinal Products (COMP) in May 2023, adding to its Orphan Drug and Rare Pediatric Disease Designations from the U.S. Food and Drug Administration (FDA).
Continued Progress with IND-Enabling Activities to Support the Advancement of AAV.103 for GJB2-Related Hearing Loss Program:

In March 2023, Decibel achieved a pre-investigational new drug (IND) milestone under its collaboration agreement with Regeneron Pharmaceuticals related to the initiation of manufacturing of AAV.103, Decibel’s gene therapy product candidate designed to restore hearing in individuals with mutations in the gap junction beta-2 (GJB2) gene, the leading cause of autosomal recessive, non-syndromic, congenital hearing loss worldwide.
Otoprotection Therapeutic

Received FDA Breakthrough Therapy Designation for DB-020:

In July 2023, Decibel received FDA Breakthrough Therapy Designation for DB-020, a novel, proprietary formulation of sodium thiosulfate (STS), designed to protect against hearing loss in cancer patients receiving cisplatin chemotherapy. This was supported by Decibel’s Phase 1b clinical trial in which 87% of treated patients experiencing ototoxicity in their placebo-treated ear were partially or completely protected from ototoxicity. Breakthrough Therapy Designation is intended to expedite the development and review of medicines intended to treat serious or life-threatening conditions that have preliminary clinical evidence indicating that the drug may demonstrate substantial improvement over available treatments. A Breakthrough Therapy Designation conveys all the fast-track program features, more intensive FDA guidance on the drug development program, an organizational commitment involving senior FDA managers and eligibility for rolling review and priority review.
Corporate Update:

Announced definitive agreement for Regeneron Pharmaceuticals to acquire Decibel:

On August 9, 2023, Decibel and Regeneron announced the entry into an agreement for Regeneron to acquire Decibel to build on the existing collaboration, and accelerate and further resource key gene therapy programs for hearing loss. The proposed acquisition values Decibel at a total equity value of approximately $109 million based on the amount payable at closing, and a total equity value of up to approximately $213 million if the contingent value right (CVR) milestones are achieved.
Second Quarter 2023 Financial Results:

Cash Position: As of June 30, 2023, cash, cash equivalents and available-for-sale securities were $78.3 million, compared to $104.6 million as of December 31, 2022.
Research and Development Expenses: Research and development expenses were $12.8 million for the second quarter of 2023, compared to $11.2 million for the same period in 2022. The increase in research and development expenses for the second quarter 2023 was primarily due to higher clinical development and related costs for the Company’s Phase 1/2 clinical trial of DB-OTO, additional regulatory and clinical costs for DB-020, and higher personnel-related costs due to increased headcount, wages and stock-based compensation.
General and Administrative Expenses: General and administrative expenses were $6.2 million for the second quarter of 2023, compared to $5.9 million for the same period in 2022. The increase in general and administrative expenses for the second quarter 2023 was primarily due to increased facility-related costs due to decreased sublease income and higher personnel-related costs due to increased headcount, wages and stock-based compensation, partially offset by decreased professional fees year over year.

On August 11, 2023 Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a clinical-stage precision oncology company developing MasterKey therapies that target families of oncogenic mutations in patients with genetically defined cancers, reported financial results for the second quarter ended June 30, 2023, and provided a corporate update (Press release, Black Diamond Therapeutics, AUG 11, 2023, View Source [SID1234634271]).

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"The second quarter of 2023 marked a crucial period of clinical and operational execution for Black Diamond, and I am incredibly pleased with our initial dose escalation data demonstrating a favorable tolerability profile and clinical proof of activity for BDTX-1535 in NSCLC patients harboring acquired resistance and intrinsic driver EGFR mutations. With these data in hand, we believe we are well positioned for rapid advancement of this novel MasterKey inhibitor for NSCLC patients and are looking forward to meeting with FDA later this year to discuss our dose optimization strategy that may enable a potential accelerated approval pathway as well as the opportunity to study BDTX-1535 in newly diagnosed NSCLC patients with intrinsic driver mutations," said David Epstein, Ph.D., President and Chief Executive Officer of Black Diamond Therapeutics. "Our recently completed underwritten public offering provides us with a strong cash position and extended runway to execute on the robust set of upcoming milestones for BDTX-1535 and our broader pipeline, all with the goal of bringing our MasterKey therapies to patients in need."
Recent Developments & Upcoming Milestones:

BDTX-1535:

•In June 2023, Black Diamond announced initial clinical data from the dose escalation portion of the Phase 1 clinical study of BDTX-1535, an epidermal growth factor receptor (EGFR) MasterKey inhibitor, demonstrating a favorable tolerability profile and clinical proof of activity in non-small cell lung cancer (NSCLC) patients harboring both acquired resistance and intrinsic driver EGFR mutations. Key highlights from the readout include:

◦Confirmed radiographic partial response (PR) by RECIST 1.1 achieved across predicted therapeutic doses in 5 of 12 NSCLC patients in a subgroup, who had measurable disease at study start, and underwent post baseline tumor assessment by RECIST 1.1. One additional patient demonstrated unconfirmed PR, while the remaining six patients had stable disease.
◦Confirmed PRs were observed in NSCLC patients with a wide range of EGFR mutations including classical and intrinsic driver mutations and acquired C797S resistance mutation, as well as complex mutations that include a combination of classical, intrinsic, and acquired resistance mutations. Two NSCLC patients demonstrated radiographic improvement in the peripheral disease and central nervous system (CNS) metastases.
◦BDTX-1535 was generally well tolerated by NSCLC and glioblastoma multiforme (GBM) patients and the overall safety profile was consistent with the EGFR tyrosine kinase inhibitor (TKI) class of drugs. The most common drug-related adverse events were mild to moderate rash, diarrhea, stomatitis, paronychia, nausea and fatigue. No patients experienced dose limiting toxicity at 15-200 mg once-daily (QD) doses. One of 15 patients treated at the 300 mg QD dose experienced dose limiting diarrhea and 5 of 12 patients at the 400 mg QD dose experienced dose limiting toxicity (diarrhea, 2 patients; rash, stomatitis, fatigue and decreased appetite, 1 patient each). No unexpected safety signal was identified during dose escalation.
•In July 2023, Black Diamond initiated expansion cohorts to assess overall response rate (ORR) by RECIST 1.1 in NSCLC patients with EGFR acquired resistance mutations after progression on a third generation EGFR TKI and intrinsic driver mutations after progression on an EGFR TKI.
•Black Diamond anticipates the following key milestones for BDTX-1535:
◦Presentation of the full BDTX-1535 dose escalation data in NSCLC at a medical conference in the fourth quarter of 2023.
◦Meeting with the U.S. Food and Drug Administration (FDA) in the fourth quarter of 2023 to align on dosing strategy to enable a potential accelerated approval pathway in NSCLC.
◦Initiation of an expansion cohort in newly diagnosed NSCLC patients with intrinsic driver mutations after discussion with the FDA.
◦Clinical update on BDTX-1535 Phase 1 dose escalation data in recurrent GBM patients in the fourth quarter of 2023.

BDTX-4933:
•BDTX-4933 is designed as a brain-penetrant, oral MasterKey inhibitor of oncogenic BRAF Class I, II and III and RAS mutations, while also avoiding paradoxical activation.
•In April 2023, Black Diamond presented a poster at the 2023 American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, outlining its approach to characterizing RAF, RAS and MAPK pathways in addition to the design and preclinical development of BDTX-4933. Based on preclinical data, BDTX-4933 has a potential best-in-class profile to treat cancer patients harboring oncogenic BRAF Class I, II, III and RAS mutations, with or without brain disease.
•Black Diamond initiated a Phase 1 clinical trial for BDTX-4933 in select indications for patients harboring all-class BRAF or RAS mutations in the second quarter of 2023.
BDTX-4876:

•BDTX-4876 is a development candidate FGFR 2/3 MasterKey inhibitor, selective against FGFR 2 and 3 alterations, while sparing FGFR 1 and 4.
•Black Diamond is evaluating strategic alternatives for BDTX-4876 as it deepens focus on its two clinical-stage assets.
Discovery-Stage Pipeline and MAP Drug Discovery Engine:
•Black Diamond continues to leverage its Mutation-Allostery-Pharmacology (MAP) drug discovery engine to advance its discovery-stage pipeline to bring therapies to underserved patients and expects to progress another undisclosed program in solid tumors to development candidate nomination in 2023.

Corporate:

•In June 2023, Black Diamond announced the promotion of Melanie Morrison to Chief Development Officer.
•In July 2023, Black Diamond closed an underwritten public offering (Follow-on Offering) of 15,000,000 shares of its common stock at a public offering price of $5.00 per share for gross proceeds of approximately $75.0 million, before deducting underwriting discounts and commissions and other offering expenses.
Financial Highlights
•Cash Position: Black Diamond ended the second quarter of 2023 with approximately $89.5 million in cash, cash equivalents, and investments compared to $122.8 million as of December 31, 2022. Net cash used in operations was $14.4 million for the second quarter of 2023 compared to $18.1 million for the second quarter of 2022.
•Research and Development Expenses: Research and development (R&D) expenses were $13.2 million for the second quarter of 2023, compared to $16.2 million for the same period in 2022. The decrease in R&D expenses was primarily due to reduced clinical trial activities stemming from the discontinuation of the development of BDTX-189 to focus on advancement of the Company’s pipeline programs, BDTX-1535 and BDTX-4933.
•General and Administrative Expenses: General and administrative (G&A) expenses were $6.9 million for the second quarter of 2023, compared to $7.0 million for the same period in 2022. The decrease in G&A expenses was primarily due to a decrease in legal and other professional fees.
•Net Loss: Net loss for the second quarter of 2023 was $20.0 million, as compared to $23.2 million for the same period in 2022.

Financial Guidance

•Black Diamond ended the second quarter of 2023 with approximately $89.5 million in cash, cash equivalents and investments. The Company believes that the net proceeds from the Follow-on Offering, together with its existing cash, cash equivalents and investments, will enable the Company to fund its operating expenses and capital expenditure requirements into the first half of 2025.